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['PMC6964112'] | ['31969977'] | ['MOESM1', 'Tab1'] | No significant baseline differences were revealed between participants allocated to the OT or PL group for any of the questionnaires (see Additional file1: Table S3) or in terms of participant characteristics (see Table1). | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['Fig2', 'Tab2', 'Tab2'] | Between-group analyses revealed no significant main effect of treatment (F(1,76) = .12,p= .37, ŋ2= .00), nor a treatment × session interaction effect (F(2,76) = 1.17,p= .16, ŋ2= .03), indicating that pre-to-post changes in self-reported social responsiveness were not significantly larger in the OT compared to the PL group (see Fig.2and Table2for the effect sizes of between-group differences separately for each session). Within-group analyses showed that Social Responsiveness Scale (SRS-A) scores were significantly reduced (compared to baseline) in the OT group at session T1 (immediately after treatment:p= .033), T2 (1 month post-treatment;p= .048), and at trend-level at session T3 (1 year post-treatment:p= .07). However, a similar reduction (compared to baseline) was evident in the PL group at session T2 (p= .015), indicating no specific benefit of OT over the PL treatment (see Table2reporting single-samplettests assessing within-group changes from baseline).Fig. 2Effects of oxytocin treatment on autism symptoms and attachment. Mean pre-to-post changes (change from baseline) on self-report and informant-based questionnaires are visualized for the oxytocin (OT) and placebo (PL) treatment groups at assessment session “T1” (immediately after the four-week treatment), “T2” (at follow-up, one month post-treatment), and “T3” (at follow-up, 1 year post-treatment). Mean changes from baseline are visualized separately foraSocial Responsiveness Scale (SRS-A) self-report version,bSRS-A informant-based version,cRepetitive Behavior Scale-Revised (RBS-R),dState Adult Attachment Measure (SAAM) Avoidance subscale,eSAAM Security subscale, andfSAAM Anxiety subscale. Lower scores indicate improvement for the SRS-A, RBS-R, SAAM Avoidance, and SAAM Anxiety questionnaires. For the SAAM Security questionnaire, higher scores indicate improvement. Vertical bars denote ± standard errors. Asterisks (*) indicate Cohen’s d ≥ .50 (medium-sized effect). Circles (°) indicate Cohen’sd≥ .80 (large-sized effect) | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['Fig2', 'Tab2', 'Tab2'] | Between-group analyses of the informant-rated SRS-A scores revealed no significant main effect of treatment (F(1, 60) = .78,p= .19, ŋ2= .03), nor a treatment x session interaction effect (F(2, 60) = .83,p= .22, ŋ2= .03), indicating that pre-to-post changes in informant-rated social responsiveness were not significantly larger in the OT compared to the PL group (see Fig.2and Table2for the effect sizes of between-group differences separately for each session). Note however that at session T2 (1 month post-treatment), informant-rated SRS-A scores were significantly reduced in the OT group (compared to baseline) (p= .002), but not in the PL group (p= .67) (see Table2reporting single-samplettests assessing within-group changes from baseline). | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['Fig2', 'Tab2', 'Tab2'] | In terms of repetitive behaviors, between-group analyses identified a significant main effect of treatment (F(1, 74) = 3.20,p= .04, ŋ2= .08) (but no treatment x session interaction:F(2, 74) = 1.04,p= .18, ŋ2= .03), indicating that across assessment sessions, pre-to-post improvements in repetitive behaviors were significantly larger in the OT compared to the PL group (see Fig.2and Table2for the effect sizes of between-group differences separately for each session). Within-group analyses confirmed that Repetitive Behavior Scale-Revised (RBS-R) scores were significantly reduced (compared to baseline) in the OT group at session T1 (immediately after treatment:p= .002), T2 (1 month post-treatment;p= .002), and session T3 (1 year post-treatment:p= .02), but not consistently in the PL group (T1:p= .15; T2:p= .012; T3:p= .70) (see Table2reporting single-samplettests assessing within-group changes from baseline). | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['Fig2', 'Tab2', 'Tab2'] | In terms of attachment avoidance, between-group analyses identified a significant main effect of treatment (F(1,76) = 3.70,p= .03, ŋ2= .09) (but no treatment x session interaction:F(2,76) = .27,p= .38, ŋ2= .01), indicating that across assessment sessions, pre-to-post improvements in attachment avoidance were significantly larger in the OT compared to the PL group (see Fig.2and Table2and for the effect sizes of between-group differences separately for each session). Within-group analyses confirmed that attachment avoidance scores were significantly reduced (compared to baseline) in the OT group at session T1 (immediately after treatment:p= .016), T2 (1-month post-treatment;p= .018), and session T3 (1-year post-treatment:p= .05), but not in the PL group (T1:p= .81; T2:p= .73; T3:p= 1.00) (see Table2reporting single-samplettests assessing within-group changes from baseline). | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['Fig2', 'Tab2', 'Tab2'] | Between-group analyses identified no main effect of treatmentF(1,76) = .88,p= .18, ŋ2= .02), nor a treatment × session interaction effect (F(2,76) = 1.08,p= .17, ŋ2= .03), indicating no treatment-specific improvement in attachment security across assessment sessions (see Fig.2and Table2for the effect sizes of between-group differences separately for each session). Also no significant within-group pre-to-post changes were identified in the OT or PL group separately (see Table2). | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['Fig2', 'Tab2', 'Tab2'] | Between-group analyses identified no main effect of treatment (F(1,76) = .25,p= .31, ŋ2= .01), nor a treatment × session interaction effect (F(2,76) = 1.566,p= .10, ŋ2= .04), indicating no treatment-specific improvement in attachment anxiety across assessment sessions (see Fig.2and Table2and for the effect sizes of between-group differences separately for each session). Also no significant within-group pre-to-post changes were identified in the OT or PL group separately (see Table2). | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['MOESM1', 'Tab2', 'Tab2'] | Between-group analyses showed that pre-to-post changes in self-reported secure attachment toward peers and parents were not significantly larger in the OT compared to the PL group (no main effects of treatment: peers:F(1,76) = .20,p= .33, ŋ2= .01; mother:F(1,74) = .57,p= .23, ŋ2= .02; father:F(1,74) = .78,p= .19, ŋ2= .02; nor treatment × session interaction effects: peers:F(2,76) = 1.08,p= .17, ŋ2= .03; mother:F(2,74) = .32,p= .36, ŋ2= .01; father:F(2,74) = .03,p= .49, ŋ2= .00) (see Additional file1: Figure S2 and Table2for the effect sizes of between-group differences separately for each session). Also no significant within-group pre-to-post changes were identified in the OT or PL group separately (see Table2). | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['MOESM1', 'Tab2', 'Tab2'] | Between-group analyses showed that pre-to-post changes in self-reported quality of life were not significantly larger in the OT, compared to the PL group (no main effect of treatment:F(1,74) = .77,p= .19, ŋ2= .02, nor a treatment x session interaction effect:F(2,74) = .96,p= .19, ŋ2= .03) (see Additional file1: Figure S2 and Table2for the effect sizes of between-group differences separately for each session). Also, no significant within-group pre-to-post changes were identified in the OT or PL group separately (see Table2). | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['MOESM1', 'Tab2', 'Tab2', 'Tab2', 'MOESM1', 'Tab2'] | As listed in detail in Additional file1: Table S2, only minimal, non-treatment specific side effects were reported. In terms of changes in mood as assessed with the Profile of Mood states (POMS), between-group analyses identified a significant main effect of treatment for the mood state “vigor” (F(1,76) = 4.09,p= .03, ŋ2= .10) (but no treatment × session interaction:F(2,76) = .04,p= .96, ŋ2= .001), indicating that across assessment sessions, self-reports of “vigor” (feeling “energetic,” “active,” “lively”) were significantly higher in the OT group compared to the PL group (see Table2for the effect sizes of between-group differences separately for each session). While no significant pre-to-post changes were evident within the OT group, the PL group showed a significant reduction (compared to baseline) in self-reported vigor at session T1 (p= .002) (see Table2reporting single-samplettests assessing within-group changes from baseline). No treatment-specific changes were identified for the other mood states (tension, anger, depression, fatigue) (see Table2and Additional file1: Figure S1), although note that significant reductions (compared to baseline) in feelings of tension and fatigue were reported both in the OT group and in the PL group (see Table2reporting single-sample t-tests assessing within-group changes from baseline). | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['CR17', 'CR17', 'MOESM1'] | Taken together, treatment-specific effects of a 4-week OT treatment were most pronounced in terms of improvements in repetitive behaviors (RBS-R) and perceived attachment avoidance (SAAM). Here, we specifically explored whether and how the quantitative autism characteristics (SRS-A and RBS-R) (assessed at baseline) were associated with the adopted attachment characteristics (SAAM and IPPA). We additionally explored whether individuals with ASD displayed more impairments in attachment, when their baseline behavioral characterizations were compared to those previously obtained from a sample of neurotypical individuals (n= 40, mean age = 21.1, S.D. = 2.6) (data adopted from [17]). Higher self-reported SRS-A scores (at baseline) (more impairment in social responsiveness) were significantly associated with lower perceived secure attachment (IPPA) towards peers (r= − .55,p< .001), mother (r= − .51,p= .001) and father (r= − .34,p= .034) and with higher perceived attachment avoidance (SAAM) (r= .38,p= .018), but not with other reports of attachment characteristics (security:r= − .26,p= .12; anxiety:r= .08,p= .63). Further, higher scores on the RBS-R (more frequent and/or severe repetitive and restricted behaviors) were significantly associated with lower perceived secure attachment (IPPA) toward the mother (r= − .56,p< .001), but not the father (r= − .31;p= .056) or peers (r= − .22,p= .19). Finally, higher scores on the RBS-R were also significantly associated with higher perceived attachment avoidance (r= .50,p= .002), but not with other reports of attachment characteristics (security:r= − .11,p= .50; anxiety:r= − .02,p= .89). Notably, exploratory analyses also showed that as a group, the individuals with ASD reported significantly higher perceived attachment avoidance (t(76) = − 2.51,p= .014), lower attachment security (t(76) = 2.48,p= .015), and a trend toward lower perceived secure attachment toward peers (IPPA) (t(76) = 1.74,p= .085), when compared to a neurotypical sample of adult men (data obtained from [17]) (Additional file1: Table S4). | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['CR9', 'CR12', 'CR37', 'Tab2', 'CR13', 'CR14', 'CR33', 'CR38', 'CR17', 'CR20', 'CR18', 'CR19', 'CR39', 'CR40', 'CR4', 'CR8', 'CR10', 'CR9', 'CR11', 'CR14', 'CR4', 'CR8', 'CR9', 'CR14', 'CR17', 'CR1', 'CR8', 'CR9', 'CR41', 'CR42', 'CR42', 'CR22', 'CR43', 'CR44', 'CR38'] | The current trial demonstrated no treatment-specific effects in the primary outcome assessing social symptoms (SRS-A, self- and informant-rated). In particular, with respect to self-reports of social responsiveness, pre-to-post improvements were evident both in the OT (at session T1 and T2) and in the PL group (at session T2), but with no specific benefit of OT over the PL treatment (no significant between-group difference). Correspondingly, in three previous long-term administration trials, improvements in social symptoms (SRS-A: [9,12]) (ADOS subscale assessing social reciprocity: 10) were identified both in participants receiving the OT treatment and in those receiving the placebo treatment, but with no significant difference between the two groups. As suggested by Yatawara et al. (2016), one explanation for these unspecific effects may be the presence of a placebo response which has been shown to occur frequently in pediatric autism pharmacological and dietary placebo-controlled trials [37]. In the context of OT trials, increased public attention over the last decade may have influenced the expectations of patients or parents especially with respect to the anticipated effects of OT treatment on social functioning (hence the observed unspecific improvements in self-rated SRS-A scores directly assessing the social domain). Also with respect to the effect of multiple-dose OT treatment on informant-based reports of social responsiveness (SRS-A), no overall treatment-specific improvements were observed (despite the identification of a reduction in informant-rated symptom severity in the OT group, but not in the PL group at session T2) (see Table2reporting within-group changes). In prior studies with young children with ASD, significant treatment-specific improvements in caregiver-rated social responsiveness have been identified immediately after 4 or 5 weeks of OT treatment [13,14]. The lack of a treatment-specific effect in our trial versus previous trials in children might relate to the frequency of contact of children versus adult populations with their respective informants (i.e., more frequent, sustained child-informant contact), potentially rendering more subtle improvements in social functioning in the adult population to remain undetected by informants. While no significant treatment-specific effects were identified in social symptoms, exploratory analyses identified long-lasting OT-specific improvements in a secondary outcome assessing attachment characteristics (SAAM), indicating a reduction in feelings of avoidance in the OT, compared to the PL group. While the exact neuromodulatory mechanisms of OT treatment are unknown, OT has been implicated in enhancing the salience of socially relevant cues, inducing reductions in (social) stress and anxiety, and modulating approach/avoidance motivational tendencies, presumably by impacting on limbic circuits (e.g., amygdala) and the central reward system (e.g., nucleus accumbens). As such, by enhancing social salience and reducing social stress/anxiety, the daily OT administrations over a course of 4 weeks, may have induced increased feelings of approachability (reduced avoidance) during social interactions. Furthermore, the observation that these beneficial effects of multiple-dose OT treatment on perceived attachment avoidance outlasted the period of actual administration until 1 month and 1 year post-treatment, provides support to the notion that repeated administrations over an extended period of time might induce long-lasting adaptations in social brain circuits, presumably in an experience-dependent manner. Indeed, through positive re-enforcement, the recursive experience of the social environment as more “secure” or “approachable” (during the period of actual OT administrations) can be anticipated to have contributed to the observed long-lasting adaptations in one’s motivational tendencies (i.e., increased feelings of social approachability). Considering that attachment avoidance reflects a reluctance to trust others and an emphasis on autonomy, whereas attachment anxiety reflects insecurity about oneself (low trust in oneself) and fear of being rejected [33], our results suggest that the 4-week OT treatment predominantly improved a person’s reluctance toward closeness or trust in others (i.e., attachment avoidance), but that it could not induce significant long-term alterations in a person’s feelings of insecurity about one’s own abilities (i.e., attachment anxiety). The notion that OT may thus predominantly influence one’s reluctance to engage in closeness or intimacy with others (rather than one’s fear of being rejected) may be interpreted within the framework of the recently proposed affiliative-motivation hypothesis [38] suggesting that OT specifically acts by increasing affiliative strivings and that individuals with a decreased tendency to affiliate (e.g., avoidantly attached individuals rather than anxiously attached individuals) may be most likely to benefit from OT treatment. Overall, the observation of a beneficial effect of OT on feelings of approachability is in line with findings from a previous study from our lab [17], in which we demonstrated similar treatment-specific reductions in perceived avoidant attachment (as well as improvements in perceived secure attachment to peers) after a 2-week course of OT treatment in neurotypical men. Our findings also extend previous studies showing beneficial effects of a single dose of OT on attachment security [20], development of trust and cooperation [18], and improved communal traits and altered agency [19]. In addition to the treatment-specific effect on attachment avoidance, long-lasting treatment-specific improvements were also identified in terms of repetitive behaviors (RBS-R), indicating an overall reduction in repetitive behaviors in the OT group, compared to the PL group. While the exact link between expressions of repetitive behaviors and difficulties in the social domain is unclear, it has been suggested that at least in a subset of individuals with ASD, the experience of the external (social) milieu as “unapproachable” or even “threatening” may result in an increased “need for sameness” in order to sustain a level of control over the external surroundings [39,40]. The current study provides preliminary evidence that multiple-dose OT treatment may relieve an individual from this increased “need for sameness” and the resulting need for engaging in repetitive and restricted behaviors. Overall, these observed effects on repetitive behaviors are in line with previous trials with adult men with ASD showing beneficial effects of OT on repetitive behaviors after 4 h of intravenous OT administration [4] and after 6 weeks of daily administrations [8,10]. Note however that one 1-week trial with adult men with ASD did not show OT-specific improvements on informant-based reports of repetitive behaviors [9]. Also, in previous trials with children and adolescents with ASD, no improvements on repetitive behaviors were observed after 4 days or 4, 5, or 8 weeks of daily OT administration [11–14]. In this view, it appears that beneficial effects of OT treatment on repetitive behaviors were mostly demonstrated in studies that adopted assessments based on self-reports (current study, [4,8]), whereas no beneficial effects were evident in studies adopting informant-based reports of repetitive behavior [9–14]. Together, these findings may therefore indicate that self-reports, as opposed to informant-based reports, may be more sensitive for capturing subtle, self-experienced changes in repetitive behaviors. While not included as an explicit outcome measure, screenings of changes in mood states (Profile of Mood States questionnaire (POMS)) showed a treatment-specific effect for the mood state “vigor,” indicating higher reports of feelings of vigor (e.g., feeling “energetic,” “active,” “lively”) in the OT group, compared to the PL group. To our knowledge, this is the first study adopting screenings of mood states in an OT trial with ASD patients. In a previous study from our lab [17], the POMS was also adopted to evaluate the effects of a 2-week OT treatment in neurotypical men, and while here, no treatment-specific changes in vigor were detected, the POMS revealed OT-specific reductions in feelings of tension and anger. In the current study, reductions in feelings of tension were also reported, but irrespective of received treatment, indicating no specific benefit of OT over the PL treatment. While speculative, the stabilizing effect of OT administration on reports of vigor might be related to the (highly understudied, but in the ASD community heavily discussed) phenomenon of “autistic burnout.” Individuals with ASD describe “autistic burnout” as an extreme fatigue and inability to meet the demands of everyday life caused by a continuous attempt to mask and/or deal with their ASD symptoms (i.e., sensory disorders, repetitive behaviors [1]). The overall mitigation of repetitive behavior symptoms and increased feelings of social approachability by the OT treatment may therefore have been accompanied with overall higher reports of feeling “energetic,” “active,” “lively” in the OT group, compared to the PL group. However, considering the exploratory nature of the identified effects, more research is needed to further elucidate the impact of OT treatment on mood states in ASD. Finally, with respect to the effect of OT on general aspects of quality of life, the current study identified no treatment-specific improvements. To date, evidence on the effects of OT on quality of life is relatively scarce since only two prior studies have addressed this topic. Contrary to our findings, Anagnostou et al. [8] reported an OT-specific improvement in quality of life (socio-emotional section) after a 6-week treatment in adult men with ASD. Watanabe et al. [9] on the other hand, only observed a trend toward improvement in quality of life immediately after a 6-week trial in adult men with ASD. Importantly, recent reviews stated that most individuals with ASD have poor quality of life (note that most studies included children with ASD) [41] or lower quality of life than typically developing adults [42]. Note, however, that to date there is no comprehensive ASD-specific quality of life assessment tool validated and consequently, the tools used in the general population (i.e., WHO-QOL) might not be the most adequate to assess quality of life in ASD (and thus changes in quality of life after intervention) [42]. In terms of associations between core autism characteristics and attachment characteristics, our study showed that impairments in social responsiveness and more frequent and/or severe repetitive behaviors were associated with a more avoidant attachment style and with less secure attachment toward significant others (especially the mother). Albeit exploratory, we also showed that, as a group, the individuals with ASD scored higher on avoidant attachment and lower on secure attachment, when compared to a sample of neurotypical individuals. Together, these findings provide indications that—at least to some extent—associations are evident between core autism characteristics and attachment characteristics, a notion that is generally supported by a recent meta-analysis showing an association between the severity of autism characteristics and less secure attachment in children with ASD [22], as well as by other studies showing more insecure attachment toward parents or romantic partners in unmarried [43] or married adults with ASD [44], respectively. However, since research on this topic to date is limited, it currently remains speculative whether the reported feelings of insecure attachment are a result of the social difficulties experienced by individuals with ASD, or conversely, whether difficulties in the social domain are—in part or within a subset of individuals with ASD—a result of a decreased tendency or inability to form secure attachments. Nevertheless, elucidating the interaction between autism symptomology and attachment style may be of particular relevance in the context of OT treatment, since—according to the aforementioned affiliative-motivation hypothesis—especially individuals with a decreased tendency to affiliate (i.e., avoidantly attached individuals) have been proposed to benefit the most from receiving OT treatment [38]. The current findings of significant ameliorations in attachment avoidance, but no treatment-specific effects on social responsiveness, are in line with this notion and together suggest that attachment characteristics may be more sensitive for evaluating treatment responses, as compared to evaluations based on core autism characteristics alone. Considering the mixed pattern of effects of OT treatment on core autism symptomatology (e.g., SRS-A, RBS-R, ADOS), it seems of great relevance for future multiple-dose clinical trials with individuals with ASD to additionally include more in-depth characterizations of attachment-related constructs both dimensionally and longitudinally (pre-post treatment). In view of the current observations, these explorations are anticipated to be informative for evaluating and predicting treatment responses, and potentially for delineating patient populations that will benefit the most from a course of OT treatment. | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | ['CR8', 'CR10', 'CR12', 'CR14', 'CR11', 'CR45'] | Although the current study provides new insights regarding long-lasting effects of multiple-dose OT treatment in ASD and the relation between autism characteristics and attachment characteristics, several limitations need to be considered. First, although our sample size was comparable to that of prior similar clinical trials, studies with larger samples are warranted. Indeed, considering this is an initial pilot study exploring long-term effects of OT treatment (without correction for multiple comparisons), the findings of long-term improvements in repetitive behaviors; attachment avoidance and vigor mood state should be interpreted with caution. Second, in the current study, participants administered the OT nasal spray once a day (in the morning) while the majority of prior multiple-dose OT studies administered two doses/day (one in the morning and one in the afternoon) ([8–10,12–14], but see [11]). While elevated levels of OT have been demonstrated up to 7 h after a single-dose administration [45], future studies are needed to identify at what point in time the effects of intranasal administration of OT fade out and when OT levels return back to baseline. Also potential interactions with diurnal patterns of endogenous OT levels need to be explored to identify the most optimal dosing and timing of intranasal OT administrations. Third, considering the adopted evaluations were predominantly based on self-report questionnaires, the possibility of subjective bias cannot be ruled out. Participants’ own beliefs about the received treatment, however, were assessed and inclusion of this factor did not modulate the identified treatment effects. Finally, since only adult men with ASD were included, the current observations of beneficial effects of OT treatment cannot be extended to women or children with ASD. | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6964112'] | ['31969977'] | [] | To conclude, while the 4-week, once-daily treatment with OT induced no treatment-specific changes in primary outcome measures of social symptoms in ASD, exploratory analyses of secondary outcomes showed long-lasting, medium to large-sized improvements in repetitive behaviors and a reduction in perceived attachment avoidance, that outlasted the period of actual administration until 1 month and even 1-year post-treatment. Overall, the observation that the OT treatment primarily targeted long-term adaptations in repetitive behaviors and perceived attachment characteristics indicates that these constructs are sensitive for capturing OT treatment effects in adult men with ASD. In line with the central role of the human oxytocinergic system in interpersonal bonding, trust, and attachment, the current observations may therefore urge future multiple-dose clinical trials to continue to include characterizations of attachment-related constructs when evaluating the potential of OT treatment for ASD. While the exploratory observations of long-term beneficial effects of OT treatment on repetitive behaviors and perceived attachment avoidance are promising, future studies are warranted to further elucidate the long-term impact of OT treatment. | PMC6964112 | Research | null | 31,969,977 | Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up | Bernaerts S, Boets B, Bosmans G, Steyaert J, Alaerts K. | Mol Autism. 2020 Jan 15;11(1):6. doi: 10.1186/s13229-020-0313-1. eCollection 2020. | Bernaerts S | Mol Autism | 2,020 | 2020/01/24 | PMC6964112 | null | 10.1186/s13229-020-0313-1 | oa_comm/txt/all/PMC6964112.txt | 4f1b87bb5194c7a07b8becc3f905d158 | Mol Autism. 2020 Jan 15; 11:6 | 2021-06-19 04:55:42 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref001', 'pone.0206874.ref002', 'pone.0206874.ref003', 'pone.0206874.ref004', 'pone.0206874.ref005', 'pone.0206874.ref001', 'pone.0206874.ref006', 'pone.0206874.ref007', 'pone.0206874.ref008', 'pone.0206874.ref005', 'pone.0206874.ref009', 'pone.0206874.ref010', 'pone.0206874.ref011', 'pone.0206874.ref012', 'pone.0206874.ref013', 'pone.0206874.ref014', 'pone.0206874.ref015', 'pone.0206874.ref018', 'pone.0206874.ref019', 'pone.0206874.ref015', 'pone.0206874.ref018', 'pone.0206874.ref020', 'pone.0206874.ref024', 'pone.0206874.ref025', 'pone.0206874.ref026', 'pone.0206874.ref027', 'pone.0206874.ref029', 'pone.0206874.ref030', 'pone.0206874.ref031', 'pone.0206874.ref038', 'pone.0206874.ref026', 'pone.0206874.ref030', 'pone.0206874.ref027', 'pone.0206874.ref029', 'pone.0206874.ref032', 'pone.0206874.ref033', 'pone.0206874.ref036', 'pone.0206874.ref038', 'pone.0206874.ref039', 'pone.0206874.ref028', 'pone.0206874.ref031', 'pone.0206874.ref040', 'pone.0206874.ref041', 'pone.0206874.ref019', 'pone.0206874.ref042', 'pone.0206874.ref043'] | Cancer related cognitive impairments (CRCI) in breast cancer patients and survivors have been subjectively reported [1] and objectively detected [2], [3] as an adverse reaction to chemotherapy. Subjective cognitive function is defined as a patient’s self-perceived experience of mental processes and function [4], whereas objective cognitive function refers to mental processes that are assessed using neuropsychological measures [5]. Evidence suggests that 21–90% of breast cancer patients report difficulties in cognitive function [1] and 15–45% are objectively detected [6]. Chemotherapy can have long-term effects on self-reported and objective cognitive functioning of breast cancer patients, with impairments evident from four months to 20 years post-chemotherapy [7], [8]. CRCI have been objectively detected and subjectively reported in a range of cognitive domains including memory, attention, concentration and executive function [5], [9], [10] and can be subtle or dramatic, temporary or permanent, and stable or progressive [11]. Furthermore, cognitive decline as subjectively reported by cancer survivors can have a profound negative impact on productivity and work ability [12], as well as detrimental effects on patients’ feelings of fatigue, anxiety, depression and overall quality of life [13], [14]. It has been suggested that subjective complaints and objective assessment of CRCI are not associated with one another [15–18] but in fact associated with psychosocial distress and fatigue [19] which may be a predisposing risk factor for developing CRCI following chemotherapy for breast cancer [15–18], [20–24]. Despite growing evidence for subjective and objective CRCI, interventions addressing these difficulties among breast cancer patients both during and following primary treatment for cancer have been limited, varied in methods, and report mixed results. The wide range of intervention methods have included: cognitive behavioural training [25], [26]; cognitive training [27–29]; memory training [30]; and physical activity programs ranging from Tai Chi, yoga and Qigong (posture and breathing) to aerobic and resistance training and walking [31–38]. Mixed effects on objective cognitive function have been found post-treatment in breast cancersurvivors, through the implementation of cognitive behavioural training [26], memory and health training [30], cognitive training [27], [29] and physical activity [32], [33], [36], [38], [39]. Hartman et al. (2017) noted improvements in processing speed following a 12 week physical activity intervention in their sample of breast cancer survivors who were within 2 years of diagnosis, leading them to suggest the need for early implementation of exercise interventions. Similarly, interventions to manage cognitive difficulties experienced by breast cancerpatientsduring chemotherapy have yielded mixed results [28], [31]. Poppelreuter et al. (2009) implemented cognitive training strategies during chemotherapy and found no effects on objective cognitive function, whereas Baumann et al. (2011) found positive effects on cognitive function following 12 weeks of resistance training using a battery of neuropsychological measures. In contrast, evidence demonstrates promising effects of easy-moderate levels of walking as a protective strategy for managing cognitive impairment in healthy individuals, and the elderly [40], [41] as assessed by objective measures. Greater physical activity has also been associated with better working memory and executive function in breast cancer survivors [19], [42] as detected objectively using neuropsychological measures. In light of the evidence outlined above, we propose that moderate levels of walking may also be of benefit to patients receiving chemotherapy for their breast cancer. To our knowledge, this is the first intervention to investigate the effects of a self-managed, home based, moderate intensity walking intervention among breast cancer patients receiving chemotherapy. The primary outcomes for the intervention were changes in subjective and objective cognitive functioning. Secondary outcome measures investigated the effects of the intervention upon the psychosocial functioning (anxiety, depression, fatigue, self-esteem and mood) of breast cancer patients. The results for the secondary outcomes have been published elsewhere [43]. In the current study we hypothesise that a self-managed, home based moderate intensity walking intervention may help in managing CRCI experienced by breast cancer patients during chemotherapy. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | [] | The randomised controlled parallel trial compared 12 weeks of self-managed moderate intensity walking plus usual care (n = 25) to usual care alone (n = 25). Subjective and objective assessments of cognitive functioning and psychosocial measures were completed pre-intervention and 12 weeks later at post-intervention (the same measures were also completed prior to the experimental sessions, but as this was only for the purpose of familiarisation, these data did not contribute towards the main analyses). Ethical approval for the study was obtained from both Loughborough University and the NHS Research Ethics Committee in East Midlands and Northampton (REC ref: 11/EM/0437, date of REC approval: 02/02/12). All participants provided written consent. Research was conducted according to the principles expressed in the Declaration of Helsinki. At the time of initial participant enrolment, the researchers were unaware of trial registration resulting in a delay in registering the current study. The authors confirm that all ongoing and related trials for this intervention are registered. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | [] | Participants were recruited over a 16-month period from three outpatient clinics at the Leicester Royal Infirmary, UK between 01/06/12 and 01/10/2013. Patients with a diagnosis of breast cancer waiting to begin adjuvant or neo-adjuvant chemotherapy who were considered fit to participate in moderate intensity exercise by their oncologist were invited to take part in the study. The researcher met the participants following their initial consultations with their oncologist, provided them with a participant information sheet and explained the nature of the study. Those who showed an interest were followed up 5–7 days later. Women aged between 18 and 75 years were eligible for the study if they: had a primary diagnosis of stage I to III breast cancer; were waiting to begin chemotherapy; were able to read and speak English; were able to walk unassisted; and were relatively inactive (<30min a day, 5 times a week of moderate intensity walking). They were excluded if they had previously been diagnosed with cancer or if they had a current psychiatric illness that could hinder participation in the intervention. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.g001'] | Cognitive functioning was measured objectively using neuropsychological assessments and subjectively using self-report measures of cognitive difficulties. Measures of Psychosocial well-being and both objective and subjective measures of physical activity were also collected. Experimental assessments took place at two-time points: pre-intervention (after two cycles of chemotherapy) and post-intervention (after the completion of six cycles of chemotherapy). All participants had been prescribed eight cycles of FEC or FEC-T chemotherapy. Participants were randomised to either the intervention (n = 25) or control (n = 25) group after completing the pre-intervention assessment. Following guidance from oncologists, the same measures were also completed pre-chemotherapy to enable familiarisation with the researcher and research methods (seeFig 1). Measures were counterbalanced within each of the cognitive tasks to avoid practice effects. Participants began the walking intervention after two cycles of treatment, as discussions with oncologists suggested that the intervention would be better received after patients had begun chemotherapy and understood what they were facing. Therefore, assessments of cognitive and psychosocial functioning were compared at time two and time three (pre- and post-intervention) in line with oncologist recommendations. Those who were randomised into the physical activity group were provided with the intervention materials and those in the control group continued with usual medical care alone provided by oncology nurses and doctors. At the time of data collection, patients receiving treatment at the Leicester Royal Infirmary were not routinely advised of the benefits of physical activity during chemotherapy and therefore the control group did not receive any information from either the researcher or their medical team encouraging them to be more active. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref044', 'pone.0206874.ref043', 'pone.0206874.ref045', 'pone.0206874.ref046', 'pone.0206874.ref047', 'pone.0206874.ref048'] | The intervention consisted of 12 weeks of home-based, self-managed, moderate intensity walking compared with usual care alone. The design of the walking intervention was based on the Theory of Planned Behaviour (TPB) [44]. Full details of the intervention and materials are reported elsewhere [43], [45]. Patients were provided with an intervention booklet including guidance and recommendations to promote adherence to the intervention, tips and encouragement outlining the benefits of walking, and a copy of the Borg Rating of Perceived Exertion Scale [46] (RPE) which encouraged them to rate the intensity of their walking. They were also provided with a diary to keep a log of walking duration and intensity (using the RPE) and to log their weekly goals based on principles of the TPB. Walking schedules were self-managed; however, the researcher recommended that participants begin by completing 10 minutes of walking at any one time and then steadily increasing the duration to 30 minutes five times a week, in line with recommended guidelines of 150 minutes of moderate to vigorous intensity exercise per week for the general population [47] and breast cancer survivors [48]. Patients were also provided with the researcher’s contact details in case they had any questions regarding the intervention or the booklet and were encouraged to discuss any potential side effects with their health professionals should they occur. The intervention group was provided with a Yamax Digi-Walker SW-200 pedometer for the duration of the intervention to measure daily step count, to provide patients with immediate feedback, and with the aim of enhancing motivation for the 12-week period. They were also asked to keep a daily exercise diary including the number of steps taken, duration of walking bouts and perceived exertion rates. Those randomised to the control group continued to receive usual care alone. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref049', 'pone.0206874.ref050', 'pone.0206874.ref051', 'pone.0206874.ref052', 'pone.0206874.ref043', 'pone.0206874.ref045'] | Demographic information was gathered via a recruitment questionnaire and disease or treatment related data was gathered via medical records. Assessments of psychosocial well-being included anxiety and depression (Hospital Anxiety and Depression Scale) [49], mood (Profile of Mood States) [50], fatigue (Functional Assessment of Cancer Therapy- Fatigue) [51], and self-esteem (The Self-Esteem Scale) [52]. Further details about psychosocial measures can be found elsewhere [43], [45]. Measures of cognitive functioning and physical activity are described below. Self-reported physical activity and subjectively and objectively measured cognitive function were conducted at familiarisation, pre and post intervention. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref053', 'pone.0206874.ref013', 'pone.0206874.ref023', 'pone.0206874.ref054', 'pone.0206874.ref055'] | A computerised version of the Stroop task [53] was used to measure executive function in two blocks. The first required participants to name, using a key press, the print colour of a series of four Xs, and the second consisted of colour words printed in incongruent ink colours (e.g. the word ‘red’ printed in blue). The incongruent condition requires inhibition of the pre-potent response of responding to word meaning. Reading the colour name occurs as an automatic cognitive sub-routine, which interferes with the recognition of the colour itself. In each of the two blocks, 96 stimuli were presented (24 presentations of four colours: red, green, blue, and yellow) and in the incongruent task each colour word was presented six times in each of the four colours. The task was counterbalanced each time it was completed (familiarisation, time two, and time three). Mean reaction time was recorded for each of the two tasks, following the removal of outliers +/- 2 standard deviation’s (SD’s), and an interference (difference) score was calculated to give a measure of executive functioning. This task was chosen as it has frequently been used to illustrate CRCI in chemotherapy patients [13], [23], [54], [55]. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref056', 'pone.0206874.ref013', 'pone.0206874.ref023', 'pone.0206874.ref054', 'pone.0206874.ref055', 'pone.0206874.ref057', 'pone.0206874.ref058', 'pone.0206874.ref059'] | Working memory was assessed using forwards and backwards digit span as used in the Wechsler Adult Intelligence Scale-III [56]. Each task is made up of six pairs of numbers which were read aloud by the researcher. The ‘digits forward’ version specifically targets the phonological loop and requires participants to repeat number sequences in the order in which they are presented. ‘Digits backwards’ targets the visuospatial sketchpad and central executive processes of working memory by asking participants to repeat the number sequence in reverse order, therefore making the task more challenging. Scoring was paper-based with scores for digits forward ranging from 3–9 and digits backwards ranging from 2–8 with high scores in both tasks indicating better performance. Digit span is commonly used to demonstrate CRCI in breast cancer patients [13], [23], [54], [55], [57], [58]. A meta-analysis of the sensitivity of neuropsychological tests used to detect CRCI in breast cancer patients [59] found that digit span produced the largest effect size out of all the tests they reviewed. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref060', 'pone.0206874.ref061'] | Sustained attention was measured using a computerised version of the Sustained Attention to Response Task (SART) [60]. The task presented participants with sequences of digits between 1 and 9 in a quasi-random order and varying font size at a rhythmic rate of one every 250 milliseconds. There were 225 stimuli (each of the 9 digits displayed 25 times), each followed by a mask displayed for 900 milliseconds. The mask is a ring with a diagonal cross inside which acts as a distracter to break up the presentation of the digits. Participants were asked to press the same response key each time, which rapidly becomes an automatic response. However, they were required to withhold this automatic response when they were presented with the number ‘3’. The number of false presses (responses to the number ‘3’) and reaction times before and after false presses were recorded. The SART has previously demonstrated lower scores of sustained attention in cancer patients who had higher levels of emotional distress following diagnosis in comparison to patients who were more emotionally stable at this same time point [61]. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref056', 'pone.0206874.ref059'] | Visuospatial skills were measured using the WAIS Block Design as used in the Wechsler Adult Intelligence Scale-III [56]. This task required participants to arrange a set of coloured blocks in the same pattern as that demonstrated by the researcher or shown in picture format within the specified time limit. This becomes increasingly difficult through the addition of blocks and the complexity of the designs presented. This test was selected as in a previous meta-analysis [59] it demonstrated significant moderate effect sizes of sensitivity in determining CRCI in breast cancer patients. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref062', 'pone.0206874.ref016', 'pone.0206874.ref021', 'pone.0206874.ref054', 'pone.0206874.ref063', 'pone.0206874.ref065'] | The Cognitive Failures Questionnaire (CFQ) [62] measured subjective cognitive functioning on a 25 item scale focusing on minor mistakes made across a one month time frame. This self-report measure generates a score between 1 and 100, with higher scores indicating higher levels of subjective cognitive failures. The scale takes approximately five minutes to complete and has frequently been used with breast cancer patients [16], [21], [54], [63–65]. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref066'] | All participants were provided with ActiGraph GT3X+ accelerometers and were instructed to wear the device for 10 hours a day for seven days at baseline and after the completion of chemotherapy. In line with previous findings, seven days of continuous monitoring is recommended to assess habitual physical activity in adults and provides a trade-off between feasibility, reliability and acceptable participant burden [66]. Accelerometers were clipped to clothing or worn on a belt above the hip and measured the frequency, intensity and duration of physical activity assessed through body movement. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | [] | The Yamax Digi-walker SW-200 pedometer was worn by participants randomised to the intervention group for 10 hours a day for the duration of the 12-week intervention. The devices were attached to participants’ clothing above the hip and recorded the number of steps taken per day. Participants were asked to make a daily note of steps taken before resetting the device. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref046', 'pone.0206874.ref067', 'pone.0206874.ref070', 'pone.0206874.ref071'] | The Borg Rating of Perceived Exertion Scale [46] was completed by participants in the intervention group to measure the intensity of walking exercises. Subjective measures of perceived exertion are often measured using the RPE in this population [67–70]. The scale asked participants to rate how hard they feel their bodies are working based on the physical sensations they experience, including increased heart rate, breathing rate and sweating. Exertion is measured on a rating scale between ‘6’ and ‘20’ with ‘6’ indicating ‘no exertion at all’ and ‘20’ indicating ‘maximal exertion’. Moderate intensity exercise is rated between 12 and 14 on Borg’s scale. Patients in the intervention group were asked to rate the exertion of their walking sessions and record it in their walking diaries. They were encouraged to aim towards walking at a moderate intensity. The Talk Test [71] was used by participants within the intervention group as a guide to monitor the intensity and pace of their walking. This informal subjective measure allows individuals to judge their own intensity with the understanding that if they are carrying out moderate intensity walking they should still be able to maintain a conversation but not sing (whereas carrying out vigorous intensity exercise will prevent individuals from speaking more than a couple of words). The Talk Test was verbally explained to all participants in the intervention group and it was also outlined in the booklets. Participants in the intervention group were encouraged to use the measure whilst carrying out their walking exercises to gauge the intensity of their walking and ensure that they were walking at moderate intensities. As this is an informal measure for personal use by participants no data were recorded. However, it provided participants with immediate feedback regarding the intensity of their walking. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | [] | The General Practice Physical Activity Questionnaire is a validated tool published by the Department of Health in 2002 to assess physical activity levels in 16–74 year olds. The questionnaire rates physical activity on four levels: active, moderately active, moderately inactive, and inactive. The measure was used to gain subjective measures of physical activity levels pre and post intervention. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref072'] | Block randomisation using four blocks was used to allocate patients into one of two groups. Within each group of four patients, two were allocated to the intervention group and two to the control group, and the allocation of groups within each block was random. This method was used rather than simple random allocation, to ensure equal numbers of consecutive patients in both groups, as recruitment was staggered [72]. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref025', 'pone.0206874.ref026', 'pone.0206874.ref073'] | Sample size calculations were based previous research with this population [25], [26]. The study was designed to detect a standardised effect size of 0.5 [73] for repeated measures ANOVA with a power of 0.80 and two-tailed α set at 5% significance level. Thus, 26 participants were needed per arm. To allow for attrition, 62 participants (31 in each arm) were planned for recruitment. Over the recruitment period, a total of 63 participants completed time one measures. However, 13 were lost due to attrition before randomisation and therefore a total of 50 participants were split between the intervention and control arms. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref074'] | All analyses were carried out using IBM SPSS version 21.0 for Windows. All between-group differences in categorical variables were analysed using Pearson’s chi-square. Initial analyses compared baseline ratings of subjective and objective outcomes of cognitive function. Intention to treat (ITT) [74] analysis was used to include all randomised patients in the groups to which they were randomly assigned regardless of subsequent withdrawal from treatment or deviation from the protocol. Mixed model ANOVAs were used to test the difference between the two groups (intervention and control) and difference within each group (pre and post) on outcome measures of cognitive function. Scores at time one and time two were compared for the control and intervention groups using t-tests to follow-up on significant interactions. Lastly, Pearson’s correlations were conducted to explore the relationship between variables of psychosocial well-being and self-reported cognitive function. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.g001'] | Of the 96 eligible participants 33 (34%) declined participation due to high levels of distress following their diagnosis. In total, 63 breast cancer patients due to begin adjuvant and neo adjuvant chemotherapy met the inclusion criteria, consented to take part, and completed recruitment measures (recruitment rate of 69%). A further 13 participants were lost to attrition, due to changes in treatment as a result of chemotherapy related side effects, after providing consent. Therefore, 50 participants receiving chemotherapy were randomised to the intervention (n = 25) or control group (n = 25) seeFig 1. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.t001'] | The age of participants in the intervention group ranged from 27–74 years (mean = 52.1 years; SD = 11.7) and 29–66 years in the control group (mean = 52.4; SD = 8.9). The majority of participants received adjuvant chemotherapy: 20 (80%) in the intervention group and 21 (84%) in the control group (seeTable 1). | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref043', 'pone.0206874.ref043'] | Chi-Square analysis revealed no significant differences in self-reported levels of physical activity between groups at pre-interventionx2(2, N = 50) = 0.12, p = 0.94 (findings published elsewhere [43]). Sixty four percent of the intervention group classed themselves as ‘inactive’ compared to 60% in the control group. There were no significant between group differences in baseline measures using neuropsychological tests in the domains of sustained attention, executive function, memory and visuospatial skills. The intervention group had significantly lower baseline scores on the measure of perceived cognitive function in comparison to the control group; however, when within group effects was entered as a factor this difference was accounted for within the analysis. There was no significant difference in age between those who completed the study (mean = 52 years; SD = 10.29) and those who withdrew (mean = 55 years; SD = 12.67) following familiarisation. Those who withdrew from the study had lower educational qualifications and were less likely to be in employment. Participants did not differ on any other demographic or cancer-related characteristics (breast cancer type & grade, chemotherapy, treatment and surgery type and menopausal status)- please refer to [43]. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | [] | Adherence for the intervention group was calculated based upon the completion of the 12-week physical activity intervention, completion of intervention diaries, and goal setting. Although adherence was not calculated based on total amount of physical activity completed (as walking schedules were self-prescribed by individuals), the duration, intensity and frequency of physical activity completed across the 12-week intervention is reported below. Twenty (80%) out of the twenty-five participants who were randomised to the physical activity group adhered to the intervention and completed walking diaries through recording of goal setting, duration, intensity and frequency of their walking. Five participants discontinued participation within the first few weeks of the 12-week intervention, did not complete diaries, but completed all follow up measures post-intervention. Reasons for discontinuing participation in the intervention included hospitalisation or medical complications. Of the 20 participants that continued with the intervention, 16 completed walking diaries on a weekly basis and four had one or more weeks of missing data due to hospitalisation but continued with the intervention after they were discharged. Walking schedules were self-prescribed, but it was recommended that participants should aim to walk for 30 minutes, five times a week at moderate intensity. Analysis of weekly walking diaries revealed that the 20 participants who completed the intervention walked at moderate intensity (as recorded using the RPE) for an average of 157.4 minutes per week across the 12-week intervention. On average, patients participated in 4.85 walking sessions per week for an average of 30.49 minutes. Findings suggest that the 20 participants who adhered to the intervention met the recommended guidelines of 30 minutes of moderate intensity walking 5 times a week. There was no significant difference between week one and week 12 of the intervention in the number of minutes walkedF(1, 19) = 0.14,p= 0.71 or the number of sessions completedF(1, 19) = 0.03,p= 0.85. Findings indicate that patients were able to complete the recommended dose of physical activity throughout the course of the intervention and their chemotherapy treatment. Findings revealed that participants walked an average of 36,217 steps per week as gathered using the Yamax Digi-walker SW-200. There was no significant difference in the number of steps recorded between week one and week 12 of the interventionF(1, 19) = 2.13,p= 0.16, suggesting that levels of walking remained consistent across the 12-week period. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref045'] | Chi-Square analysis showed that at post-intervention significant differences were observed between groups on perceived levels of physical activity,x2(3, N = 50) = 17.15, p = 0.001. When looking at groups separately, the majority of the intervention group (36%) classed themselves as ‘active’ compared with 0% in the control group (please refer to table of result published elsewhere [45]. Those who received the physical activity intervention altered their levels of perceived physical activity from ‘inactive’ to ‘active’. Furthermore, the majority of the control group remained in the inactive group across the 12-week period. Findings indicate a positive change in subjective levels of physical activity following the 12-week intervention. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | [] | Comparisons between objective measures of physical activity between groups were not possible due to low compliance of wearing and returning accelerometers. Thirty-one participants (49%) out of the 63 who completed the familiarisation session at baseline (pre-chemotherapy), returned accelerometers. A total of 32 patients were lost due to non-compliance. The most common reasons for missing data were forgetting to wear the device and forgetting to return the device to the researcher. Out of the 31 participants who returned data, six participants complied with recommended wear time with an average of five days, and average wear per day ranged from 39 minutes to 7 hours. Wear time for the 25 participants that did not comply ranged from 7 hours to 3 days. Participants were asked to wear the device for a further 7 days post-intervention, after the completion of their chemotherapy. Of the 50 participants randomised, seven participants in the intervention arm and three in the control group returned accelerometers at post-intervention. The most common reasons for missing data at post-intervention were forgetting to wear the device, wearing the device incorrectly preventing valid data collection, declining to wear the device, or not returning the device. Due to low numbers and non-compliance, wear time analysis between groups across the intervention period were not possible. At post-intervention, Chi-square analyses showed no significant differences between the intervention and control group in the proportion of patients forgetting to wear the accelerometer, wearing the device incorrectly preventing valid data collection, declining to wear the device, or not returning the device, x2(3, N = 40) = 2.41, p = 0.49. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.t002'] | Analysis of objectively measured cognitive performance revealed no significant main effects for between or within group, or a significant interaction between the two for Stroop interference, sustained attention, visuospatial skills, or memory as assessed by the digit backwards task. There was also no significant interaction for the digit span forwards task. Additional analyses were conducted to examine the main effects whilst removing the interaction as this can mask a significant main effect. There were small effect sizes for the non-significant interactions effects for all measures of objective cognitive functioning. Therefore, these non-significant findings could be due to an inadequate sample size. However, there were significant main effects between groupsF(1, 48) = 8.27,p< 0.01,ƞp2=0.147 and within groups,F(1, 48) = 4.55,p= 0.03,ƞp2=0.087. Inspection of the means indicated that digit span was slightly, though significantly, greater in the intervention group (mean = 7.8, SD = 1.21) than the control group (mean = 6.8, SD = 1.09) and at post-intervention (mean = 7.4, SD = 1.24) compared with pre-intervention (mean = 7.0, SD = 1.18). Analysis of self-reported cognitive failures revealed a significant interaction,F(1, 48) = 3.90;p= 0.05,ƞp2=0.075. As seen inTable 2, although scores remained stable in the intervention group across the 12 week period, t (24) = -1.26,p= 0.9, they increased significantly in the control group, t (24) = -2.39,p= 0.02, suggesting that the walking intervention protected against self-reported cognitive decline. Inspection of the means indicated that self-reported cognitive failures were significantly higher in the control group (mean = 45.4, SD = 17.3) than the intervention group (mean = 32.7, SD = 8.4) post-intervention. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | [] | Further exploratory analysis was conducted in order to examine if any psychosocial wellbeing variables contributed towards self-reported cognitive failures. Change scores from pre- to post-intervention were calculated, and correlations conducted for each group between change in reported cognitive failures and change in depression, anxiety, self-esteem, fatigue, and mood; however no significant associations were observed. Similarly, correlations conducted for each group between change in reported cognitive function and objectively detected cognitive function were non-significant. Exploratory analyses were conducted using Pearson’s two-tailed correlations to explore the relationship between the amount of self-reported physical activity completed by the intervention group and subjective cognitive function. These revealed a significant negative correlation between mean duration of walking (in minutes) and self-reported cognitive failures,rs= -0.40, p = 0.05, suggesting that as physical activity increased, self-reported cognitive failures decreased. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref039', 'pone.0206874.ref036', 'pone.0206874.ref043', 'pone.0206874.ref075', 'pone.0206874.ref076', 'pone.0206874.ref031', 'pone.0206874.ref042', 'pone.0206874.ref041', 'pone.0206874.ref077', 'pone.0206874.ref041', 'pone.0206874.ref019', 'pone.0206874.ref042', 'pone.0206874.ref019', 'pone.0206874.ref031', 'pone.0206874.ref041', 'pone.0206874.ref042', 'pone.0206874.ref009', 'pone.0206874.ref078', 'pone.0206874.ref079', 'pone.0206874.ref080', 'pone.0206874.ref081', 'pone.0206874.ref083', 'pone.0206874.ref084', 'pone.0206874.ref001', 'pone.0206874.ref001'] | This randomised controlled trial is the first to investigate moderate levels of a self-managed, home-based walking intervention on cognitive functioning of patients during chemotherapy treatment for their breast cancer. The aim of the study was to assess the effectiveness of a self-managed, home-based walking intervention on subjectively reported and objectively assessed cognitive function during chemotherapy. There was no effect of the intervention on neuropsychological measures of cognitive function. However, small effect sizes for all non-significant interactions for objective measures of cognitive function suggest that these could be explained by the small sample size. We found that perceived cognitive impairment (as measured by self-reported cognitive failures) remained stable in the intervention group whereas it declined in the control group, indicating that moderate levels of walking may help to protect against decline in self-reported cognitive functioning. The maintenance of subjectively perceived cognitive function in the intervention group provides further support for previous literature reporting the benefits of physical activity such as Tai Chi [39] and Qigong [36] in breast cancer patients on improving self-reported cognitive function. Patients are aware of perceived cognitive impairments and the negative impact they can place on overall quality of life, therefore the maintenance of perceived cognitive functioning is noteworthy as it has important implications for the overall health of patients during treatment. Exploratory correlations between change in reported cognitive failures and change in depression, anxiety, self-esteem, fatigue, and mood were non-significant. Contrary to predictions, maintenance of perceived cognitive function was not due to improvements in psychosocial well-being following the completion of the home-based moderate intensity walking intervention but may be due to a direct effect of participating in the self-managed walking intervention. Furthermore, duration of walking completed by patients was negatively associated with self-reported cognitive function, suggesting that as physical activity increased, self-reported cognitive failures decreased, and that improvements in subjectively detected cognitive function might be dose-dependent. The dose-dependent relationship between duration of physical activity and perceived cognitive function make vital contributions to limited literature within this area of research, leading to crucial implications for the healthcare of breast cancer patients treated with chemotherapy. As previously reported [43], breast cancer patients completing 12 weeks of moderate intensity walking had better psychosocial functioning in comparison to usual care alone. Therefore, this suggests that improvements in psychosocial well-being are not a direct reflection of the amount of physical activity completed but rather the result of patients participating in physical activity. Findings from our study do not support previous findings which suggest a direct relationship between the amount of physical activity completed and psychosocial well-being in breast cancer survivors treated with chemotherapy [75]. Inconsistencies between our study and previous findings may be explained by the self-prescribed nature of our study. Our findings suggest that rather than imposing pressure to conform to a prescribed dose of exercise, successful outcomes may be achieved with self-prescribed levels of physical activity. This notion is further supported by a study investigating the effects of prescribed doses of exercise in depressed patients [76] which reported that completing preferred levels of physical activity produced better psychological and social outcomes in comparison to those completing interventions with prescribed doses of exercise. To the authors’ knowledge, this is the first intervention to investigate the effects of a self-managed, home-based, walking interventionduringchemotherapy for breast cancer and makes vital contributions to current evidence and clinical practice. This self-managed intervention requires very little input from health professionals and therefore has the potential to mitigate impairments in perceived cognitive function for a large number of breast cancer patients’ receiving chemotherapy. However, as it is the first intervention of its kind and has a relatively small sample size, as highlighted by small effect sizes for all non-significant measures of objective cognitive function, further research with larger sample size is required to confirm findings. Future interventions could examine the dose and intensity of physical activity required for effective maintenance of self-reported cognitive function. Contrary to previous research, there was no effect of the intervention on neuropsychological measures assessing sustained attention, executive function, memory and visuospatial skills. However, as the effect sizes for non-significant interactions were small, this suggests that further research with larger sample sizes would help to clarify these findings. Moderate levels of exercise have demonstrated positive effects on cognitive function among breast cancer patients [31], [42], healthy adults, and the elderly [41], [77]. In line with the current study, 20 minute bouts of moderate intensity walking have previously been found to reduce the risk of developing Alzheimer’s disease in adults [41]. Moderate to vigorous amounts of physical activity among breast cancer survivors has also been associated with better executive function and working memory [19], [42]. Therefore, findings from the current study were unexpected, as it was anticipated that similar benefits would be seen among our sample of breast cancer patients. A possible explanation for null findings of objective cognitive function in the current study may be the intensity and dose of physical activity completed in our small sample of patients. As discussed above, evidence suggest that moderate levels of physical activity can help to improve cognitive functioning [19], [31], [41], [42]. However, unfortunately, due to the lack of valid data collected through accelerometers as an objective measure of physical activity, in the current study we are unable to objectively determine if patients were completing the intensity of physical activity required to observe improvements in neuropsychological measures of cognitive function. Furthermore, although the self-perception of activity levels changed from ‘inactive’ to ‘active’ in the intervention group following 12 weeks of walking, data collected through diaries suggested that overall there was no increase in physical activity over the 12-week period. Therefore, it is possible that the amount and levels of physical activity completed by our sample were not effective in eliciting changes in objective cognitive function and is a limitation of the current study. A further possible explanation for not detecting an effect of the intervention on objectively measured cognitive function may be due to the selection of neuropsychological measures and the subtle nature of cognitive difficulties experienced by breast cancer patients. Evidence suggests that many standard neuropsychological tests do not detect subtle change experienced by cancer patients [9]. The neuropsychological measures included in the study were selected as in previous research they have successfully detected chemotherapy-induced cognitive decline in breast cancer patients. However, it may be that the selected tests are not sensitive enough to pick up on subtle differences experienced by patients across the 12-week intervention period. A review by the International Cognition and Cancer Task Force [78] has proposed the use of the Hopkins Verbal Learning Test-Revised, Trail Making Test and the Controlled Oral Word Association [79]. Unfortunately, the recommendation to use these tests was not published at the time of designing the current study but may be a valuable addition for future studies to detect subtle cognitive deficits experienced by breast cancer patients during chemotherapy. In the present study there were no significant effects relating to the backwards digit span task, whilst there was a small but significant improvement in recall on the forwards task from pre- to post-intervention, and superior performance overall for the intervention group compared with the control. It is unclear why our findings differed for the forwards and backwards tasks. However, there is evidence that different strategies are employed during forwards and backwards recall. One argument suggests that, unlike forwards recall, backwards recall involves executive control and may be considered as a complex span measure of working memory [80]. Similarly, the improvements in the forwards task could be explained by the simple recall of digits forwards as opposed to the complex nature of recalling digits backwards which require the use of executive function and attention. Therefore, this is consistent with the null findings observed in the other complex measures of cognitive functioning used in the present study. Mixed measures analyses comparing objective levels of physical activity between groups at pre- and post-intervention were not possible due to low compliance of wearing and returning accelerometers. This is a limitation of the current study but provides vital contributions to research within this vulnerable population. It is anticipated that low compliance was largely the result of the timing in which participants were asked to wear the device. Baseline data was collected in the period between initial consultations with oncologists informing participants that they would receive chemotherapy and beginning treatment. This is a highly distressing time for patients when many are still coming to terms with their diagnosis and are preparing for chemotherapy both physically and emotionally. Follow up measures of objective levels of physical activity were gathered post-intervention when patients had completed treatment and were no longer visiting the hospital. Previous home-based studies have successfully measured objective levels of physical activity using pedometers or accelerometers, [81–83] and therefore our lack of valid data is surprising. However, these studies were conducted with cancer survivors post-treatment. For breast cancer patients facing treatments other validated measures worn on the wrist or thigh, which were not available at the time of this study, may provide more convenient and accurate collection of objective physical activity. Furthermore, direct interaction with health care professionals in previous studies may have acted as motivation to wear the device for the recommended 7 days. Future self-managed, home-based studies assessing objective levels of physical activity during treatment should consider daily notifications reminding participants to wear their device. The 80% adherence rate to the intervention is noteworthy and a strength of the self-managed, home-based intervention in line with previous evidence which reported that over 50% of breast cancer patients prefer to exercise alone [84]. Current findings suggest that the intervention was well-received by breast cancer patients receiving chemotherapy and emphasises the need for more self-managed interventions within this population. Further self-managed intervention studies with larger sample sizes of patients receiving treatment for their breast cancer are required in order to strengthen current findings that moderate levels of physical activity can protect patients from a decline in subjective cognitive function. Overall, our study reports benefits of a self-managed, home-based, moderate intensity walking intervention upon cognitive function when subjectively reported but not objectively detected. These findings further support existing evidence for the lack of associations between subjective and objective measures of cognitive decline experienced by breast cancer patients [1]. A possible explanation for the discrepancy in the reporting and measuring of cognitive decline in our study could be due to differences in methodological procedures involved in the gathering of data. Objective measures of cognitive function only provide a snapshot of the individual’s levels of functioning at the time of assessment and may not detect decline. On the other hand, self-report measures ask patients to rate their experiences over a period of time, which may result in more accurate levels of reporting. Discrepancies between the reporting and measurement of cognitive decline in our sample further support previous studies [1] and confirms the need to include both objective and subjective measures of assessment to provide a comprehensive understanding of patients’ cognitive function. Positive findings using self-report measures are noteworthy, as patients are concerned with perceived deficits and the impact it places on their quality of life. Therefore, maintaining self-reported cognitive function is important to patients, even though perceived deficits have a limited association with objective measures. This study makes a vital contribution towards the advancement of current clinical practice to improve the quality of life of patients during treatment. Furthermore, the self-managed, home-based nature of the study requires little input from healthcare professionals and therefore can be implemented to benefit a larger population of patients. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6261560'] | ['30485297'] | ['pone.0206874.ref078'] | The self-managed, home-based intervention had a good adherence rate and was successful in protecting against decline in self-reported cognitive difficulties experienced by patients treated with chemotherapy for their breast cancer. Surprisingly, intervention effects were not detected for objective measures of sustained attention, executive function, memory and visual spatial skills in the current study, which could be explained by our small effect sizes. Therefore, further investigations with large sample sizes conducted over multiple sites are required in order to examine the effects of physical activity upon objectively detected cognitive impairment among breast cancer patients. These studies should optimise the use of the standardised set of neuropsychological measures recently acknowledged as suitable for detecting subtle cognitive decline experienced by breast cancer patients [78] and should also provide daily notification reminders to patients to wear their accelerometers in order to optimise the collection of objective measures of physical activity. | PMC6261560 | Research Article; Biology and Life Sciences; Neuroscience; Cognitive Science; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Biology and Life Sciences; Neuroscience; Cognitive Neuroscience; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Neurology; Cognitive Neurology; Cognitive Impairment; Medicine and Health Sciences; Public and Occupational Health; Physical Activity; Medicine and Health Sciences; Oncology; Cancers and Neoplasms; Breast Tumors; Breast Cancer; Biology and Life Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Physiology; Biological Locomotion; Walking; Medicine and Health Sciences; Oncology; Cancer Treatment; Cancer Chemotherapy; Medicine and Health Sciences; Pharmaceutics; Drug Therapy; Chemotherapy; Cancer Chemotherapy; Medicine and Health Sciences; Clinical Medicine; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Oncology; Clinical Oncology; Cancer Chemotherapy; Medicine and Health Sciences; Health Care; Patients; Medicine and Health Sciences; Oncology; Cancer Treatment; Medicine and Health Sciences; Health Care; Psychological and Psychosocial Issues | null | 30,485,297 | Does walking protect against decline in cognitive functioning among breast cancer patients undergoing chemotherapy? Results from a small randomised controlled trial | Gokal K, Munir F, Ahmed S, Kancherla K, Wallis D. | PLoS One. 2018 Nov 28;13(11):e0206874. doi: 10.1371/journal.pone.0206874. eCollection 2018. | Gokal K | PLoS One | 2,018 | 2018/11/29 | PMC6261560 | null | 10.1371/journal.pone.0206874 | oa_comm/txt/all/PMC6261560.txt | a3eebec88f093e15772f4afd00c1bab3 | PLoS One. 2018 Nov 28; 13(11):e0206874 | 2021-06-19 03:14:34 | CC BY | no |
['PMC6528987'] | ['31112548'] | ['pone.0216489.ref001', 'pone.0216489.ref002', 'pone.0216489.ref003', 'pone.0216489.ref004', 'pone.0216489.ref003', 'pone.0216489.ref005', 'pone.0216489.ref006', 'pone.0216489.ref007', 'pone.0216489.ref008', 'pone.0216489.ref009', 'pone.0216489.ref010', 'pone.0216489.ref008', 'pone.0216489.ref011', 'pone.0216489.ref012', 'pone.0216489.ref013', 'pone.0216489.ref014', 'pone.0216489.ref015'] | Health service delivery is an essential element of any health system [1]. The goal of health delivery is to improve the health of the community and respond to the expectations of the people, together with inequality reduction in both cases [2]. In burn injuries, successful service delivery is very important because burn injuries are a major cause of death and infirmity around the world. It is estimated that more than 300,000 people die every year from fire-related burn injuries. Millions suffer from burn injuries, many of which are permanent [3]. Burn injuries result in the imposition of short-term and long-term costs to the victim, families, communities and nations [4]. The mortality rate of burn injuries varies in different parts of the world. Progress in the treatment and care of burn patients has also contributed to reducing the mortality rate in many high-income countries [3]. Burning care costs up to $1000 a day per patient in developed countries [5]. But, in the majority of low and middle-income countries, there is a lack of major surgical infrastructure such as an operating room, high tech instruments and a lack of skilled burn medical and nurse personnel. In addition, they experience an unpredictable supply chain constraints on raw materials and wound dressing [6]. Three WHO regions including Eastern Mediterranean, Southeast Asia and Africa account for almost two third of the total burden of injuries [7]. In Iran, the 2003 global burden of disease study showed that burn injury is the 13th cause of the burden of disease in the general population and the seventh cause in children aged 5 to 14 years old [8]. Trends in burn incidence showed that an increase of burn admissions or burn incidence rates in Iran between 2005–2009 [9]. Moreover, the rate of burn-related mortality was reported 3.8 for every 100 thousand individuals in Iran [10]. The treatment of burns is complex, expensive and time-consuming, because patients need special care, well-equipped medical instruments and trained staff [8]. Currently, the burn delivery system is not clearly defined in Iran’s health system. A small number of specialised burns hospitals (SBHs) located in big provinces provide burn services in which burn patients with more severe conditions are referred to them. Simultaneously, burn units in general hospitals, also, provide primary burn care services. Since 2013, special measures have been taken to treat burn patients in the form of the Health Evaluation Plan in Iran, including the development of specialised burns sections and hospital emergency equipment, the development and standardisation of burn wards and burn medical care units (BICUs). As more burns occurred in the poor, vulnerable communities and underprivileged districts, treatment deputy of Iran’s Ministry of Health also prioritising burn cares in order to provide fair access to essential burn services for all through scaling up equitable access to burn cares in the society. Despite the numerous advances, the gap between effective action and demand remains remarkable. Having money and technology is not sufficient for efficiency. Even with more money and better technologies, there remains a major challenge: improving health services [11]. In such a situation, identifying the challenges for delivering burn services is an invaluable field of study. To the best of our knowledge, no comprehensive studies were found in this field in Iran. Nonetheless, in South Asia, a lack of resources at current burn centres, lack of specialised care facilities, overcrowding of centres, delay in follow-up care for burns, lack of funding for low-income and people living in rural areas, and the lack of specialised rehabilitation services for burns were major challenges [12]. Jagnoor et al. (2018) identified a number of barriers to providing burn care services in India. This study showed that the lack of operating standards for burn treatment, different knowledge and skills from health professionals in providing burn care, along with resource shortages, affect the quality of burn care for patients [13]. Jagnoor et al. (2017) identified the challenges of burn and recovery care such as poor communication between health care providers and burn victims, limited rehabilitation services, transportation problems to health centres, and high costs of burn treatment and confirmed the need for long-term rehabilitation [14]. Wang et al. (2018) identified the challenges and improvements in burn wound healing, infection, pain and wound and explained there are challenges in long-term treatment and wound healing, infection, pain and hypertrophic wounds in burn management [15]. Given the importance of the delivering burn services for due treatment of burn patients as well as the significance of burn services for burn victims and their families, the aim of this study was to identify the challenges of delivering burn services in SBHs in Iran. This study will inform policymakers and health authorities to adopt appropriate policy for providing burn services. | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | ['pone.0216489.ref001', 'pone.0216489.s001', 'pone.0216489.ref016', 'pone.0216489.ref017', 'pone.0216489.ref018', 'pone.0216489.ref019'] | This study received the required ethics approval from Isfahan University of Medical Sciences Research Ethics Committee, Isfahan, Iran with ethics code No. IR.MUI.REC.1395.2.292. Moreover, participants’ informed consent was acquired from all study participant and assured their anonymity and confidentiality of any information they might present. A qualitative study using content analysis approach was designed to investigate the challenges of service delivery in specialised burns hospitals. The study was performed during February 2017 to April 2018 at the national level of the country. The population of study include all key informants related to the burn services delivery in Iran. To identify and select key informants related to the phenomenon of interest, purposeful sampling technique with a maximum variation approach was used. Maximum variation allows us to explore important shared patterns that cut across heterogeneities. The informant participants were recruited at national and provincial levels from Ministry of Health and Medical Education (MoHME) and medical university experts. Also, CEOs, managers, dermatologists, matrons and supervisor nurses that have worked in cities owning SBHs (Tehran, Isfahan, Ahvaz, Shiraz, Bushehr, Mashhad, Tabriz and Yazd) were interviewed. Accordingly, the eligible interviewees were key informants related to burn care delivery across different provinces of Iran. Key informants were excluded for this study if they had an experience <5 years and/or cancelled the interview meeting more than four times. The required data was gathered through face-to-face, semi-structured interviews with the participants. We developed an interview guide informed by the World Health Organisation’s framework for health system functions [1] and the research objectives (S1 File). Further, to check the validity of the interview guide, at first the questions of interview had been discussed among research team with collaboration of one external expert and revised, accordingly. Later, the interview guide was tested on three non-participants to verify the number and order of the questions in the study. Interviews were carried out in the interviewee’s office or any places where the participant suggested by one trained member of the study team (MJM). The interviews continued until a saturation point in which no additional data collection was necessary. It is attained with the analysis and comparison of interview contents until no new or relevant data seems to be emerging concerning a theme. Lastly, 21 face-to-face semi-structured interviews were conducted. Each interview time lasted between 30–90 minutes, with an average of 40 minutes. Most interviews were tape-recorded (with participants’ informed consent) and then transcribed verbatim. One of the participants (number 10) did not allow to record his voice, so that interviewer was take field notes. A thematic analysis with an inductive approach was employed to analysis of transcribed documents assisted by MAXQDA Plus version 12 (Release 12.3.0, VERBI GmbH Berlin). A step-by-step guide proposed by Braun and Clarke [16] was served to conducting thematic analysis. Accordingly, the following steps were done: (1) three of the authors (MAR, FM, and NSZ) as data coders, familiarised with data by immersed themselves in the data by listening to recorded interviews and reading and re-reading transcribed data. (2) the initial list of ideas behind the data was generated and initial codes from the data were produced. In this stage, the most basic segment and repeated interesting patterns were identified and related to each code. (3) after all the data were initially coded and collated, codes were analysed aiming at combining different codes to an inclusive theme. At this stage we also found out sub-themes within themes, viz., essentially themes within a theme. (4) the themes were reviewed and refined during two 3-hour sessions with the main members of the research team in which all the accumulated extracts for each theme were read and coherence of their patterns were considered. (5) at this point, defining and naming of themes was done. Besides paraphrasing the themes, overlaps between themes and sub-themes and their relations to the others were examined carefully. Also, final names were given to the themes and sub-themes. (6) the report as the final opportunity for analysis was produced and scholarly publication wrote-up. For assessing the quality of current qualitative study, we ensured four trustworthiness criteria suggested by Lincoln and Guba [17]. Credibility was ensured with a prolonged engagement (the study process continued nearly fifteen months) and respondent validation (the process whereby the researchers provided some transcribed interviews to the participants and asked them to ensure that there is a good correspondence between their findings and the perspectives of participants). Further, to improve credibility, opposite issues in findings were discussed among research team to reveal the reasons. Transferability of our qualitative findings was enhanced through purposive sampling technique and thick descriptions. Dependability of the research was adopted by an auditing approach in which the study’s colleagues accompanying by an external auditor engaged in complementary comments in coding process and analysing of interview text as well as cross-checked the data we collected. To increase confirmability, we not openly allowed our personal values to conduct the research and the findings obtaining from it. According to the Hewitt-Taylor [18], we maintained reflexivity by abstractly hypothesizing in a more divorced manner concerning research questions and how the data we gathered gave insight into these, as well we have used field note taking to enrich the data. Moreover, we have tried to shrink the impact of our experiences on different stages of the study process [19]. | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | ['pone.0216489.t001', 'pone.0216489.t002', 'pone.0216489.s003'] | Interviewees are described inTable 1(i.e. their organisation affiliation, years of experience and city). Four themes and twelve subthemes on challenges of delivering services in SBHs were extracted. Themes related to challenges of SBHs were as follows: burn care continuum, regionalisation of burning services, costs of providing BRSs, and non-compliance with standardized care (Table 2andS1 Fig). | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Given that a burn does not have a definitive treatment and is a chronic disease, the best way to treat it is prevention. However, there is no a National Program on Burn Prevention (NPBP). One of the interviewees noted that: The necessity of developing regulations on burn prevention by the MoHME as well as advocacy of ministries of other sectors, particularly the Ministry of Petroleum and the Ministry of Energy, and their engagement in developing a NPBP are among important issues noted by interviewees. Inadequate training of different groups of the society is an important challenge to provide preventive care, particularly given that most of the burns occur in individuals with lower levels of literacy. As an interviewee acknowledged, preventing the burn is better than providing treatment, as prevention is better than treatment. Appropriate and adequate training can substantially reduce burn probability: Interviewees mentioned the insufficient awareness about burn prevention and burn patients as well as insufficient attention of media, particularly the national TV, for training of burn prevention. | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Pre-hospital measures, such as fluid therapy, oxygen therapy, catheterisation, and early bandaging, are vital. These measures prevent expansion of burn wound, renal complications, shock, damage to cells, and complication of treatment process. However, based on interviewees’ responses there are some challenges as follow: insufficient skills of physicians in providing pre-hospital care in non-specialized centres, insufficient skills of emergency medical technicians in providing first aid cares to burn patients, shortage of ambulance to transport patients, and delays in referring patients to SBHs: | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Challenges to provide hospital care are one of the important challenges in providing BRSs. As one of the interviewees noted, the treatment structure of SBHs led into either patients’ death or discharging them with deformity and sticky wounds. Many of these consequences remain for the rest of life, even after several surgeries. Failure to observe infection control codes by patients’ companion(s) is another challenge. Companion(s) must observe all sterile and isolation standards. As well, there are limitations and regulations that must be observed by companion(s), which are not always observed. Another challenge is lack or inadequacy of psychologist in SBHs to meet psychological needs of patients. For patients’ nutrition, on one hand the SBHs have problems in providing high calorie and protein food regimens, and on the other hand, families can’t afford the costs of appropriate food regimens. Insufficient access to health professionals is another problem of patients with burn problems. Due to a low number of physicians in evening and night shifts, and high workloads, physicians do not spend enough time for patients. One supervisor nurse told: As well, sometimes general practitioners examine burn patients, that don’t provide burn therapy. As most of interviewees noted, burn patients do not receive advanced and new therapies: | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | For patients, a burn is a chronic disease. Most of the treatments must be provided after patients’ discharge. When patient is discharged, must be followed by health professional to ensure that necessary care, nutritional regimen, dressing codes, and rehabilitations services as well as social-spiritual supports are received and observed, to avoid sticky wounds, deformities, scars, and other consequences. As one of the interviewees mentioned, lack of active follow-up system for to monitor after patients’ services is a serious challenge. Treatment can be provided through referral system along with active role of family physician. However, financial barriers are mentioned as an important factor. A national policy-maker noted that: | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | University professionals note that developed countries are making policies to reduce hospitalisation, particularly for lower degree burns, that can be treated at home. Home care services can reduce hospital expenditures, increase participation of households in patients' treatment, and reduce hospital infections. Challenges related to the home care are as follow: lack of strengthened home care services at SBHs, an insufficient number of nurses to provide home care services, difficulties of providing home care services to referred patients from other cities and towns, and ignoring obedience of home care treatment by patients and their companions. | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Inadequate access to other specialties in SBHs is an important challenge to provide BRSs in Iran. Given that in burn many organs are damaged and patients are typically multi-trauma (e.g. burn and falling due to electrocution, traffic-related accident and burn, and acid burn with eye damages), due to lack of all specialties in SBHs, and of course a lack of economic justification, patients' treatment faces with barriers. In such cases patients must be referred to other healthcare centres or healthcare professional from other centres must be invited to join the treatment team, that each has its own problems and challenges, such as patients' immobility and delays in service provision. In addition, in some cases, burn patients have co-morbidities, such as diabetes, cardiovascular diseases, etc, or a pregnant woman may face a burn. In such cases, services cannot be provided appropriately. An interviewee noted that:“Given that it’s a single specialty hospital and is only for burn patients,it has the advantage of easier control of infection and treating wounds (i.e.the probability of infection transmission is lower),but given that burn patients need multiply specialties there are problems in access to healthcare services.In such cases health professionals must be invited from other centres or patients must be referred,which each has its own challenges,and typically all needed services won't be received (interviewee number 7). The SBHs can't have multi-speciality teams, which is against current standards of treating burn patients. Complementary diagnostic tests are another challenge. Due to a lack of advanced laboratories, the SBHs typically sign contracts with other hospitals to receive advanced laboratory services, which creates problems for coordination, in time admission, and, sometimes, reluctance to accept burn patients due to their physical status (deformity and obnoxiousness). | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Specialised care for burn patients are only available in eight provinces (out of 31), that has led into challenges in provinces without a SBH. For most of the provinces, the distance between province capitals is long, then patients’ conditions got worse and even may die. Sometimes, SBHs’ beds are fully occupied and patients cannot be hospitalised, or it may be delayed. Transportation costs and problems related to hoteling services for burn patients are among other challenges that are mentioned in the current study. One of the interviewees noted that: “Transporting patients from general hospitals to a SBH usually creates problems.There are costs that must be paid to transport the patient.Even if we ignore treatment costs,companion(s) needs a place to stay,which has its own costs.Who pays the costs?The companion(s) does not have enough money.Even we have staffs in our hospital which raise money to buy food and fruits for companions.Or there are companion(s) who takes the hospital foods and eat in streets around the hospital” (interviewee number 10). A lack of trained and skilled staff as well as shortage of equipment and medicines for burn patients in cities without a SBH, are among the other mentioned challenges that can result in hospital infections, infection of burn wounds, increased mortality, and deformity. | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Based on interviewees’ responses, currently the Iranian healthcare system doesn’t have a defined and appropriate service regionalisation for BRSs. Although during the past years, measures are performed to address the shortcomings, but they were not enough. However, there may be informal contracts between SBHs to referrer patients, but there is no formal system. A policy-maker engaged in policies related to burn patients noted that: Based on the responses of many of the interviewees, current structure of providing services to burn patients is not acceptable, regarding the defined standards. Separating the SBHs from other hospital can harm burn patients’ treatment process, instead of improving the quality of services. Non-compliance with service regionalisation standards, mainly due to shortage of beds, skilled personnel, and physical space in the SBHs, is another important challenge. Given interviewees’ responses, triaging patients based on burn degree and a defined protocol, is a neglected measure. Triaging patients into three degrees is too important: degree one, there is no need for hospitalisation, only by outpatient services patients can be treated; degree two, patients must be hospitalised in burn wards of general hospitals; and degree three, specialised services are needed and patients must be hospitalised in a SBH. Therefore, the next challenge is patients’ triage. One of the interviewees noted that:“Triaging patients is the first step of the burn patients’ treatment,particularly if many patients are damaged.For example,imagine that a big building is on fire and many are burned,the first step is to triage patients,i.e.the percentage of burn injury and its depth must be determined.Then,based on the percentage area of burn and its depth,patients must be categorized” (interviewee number 6). | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Expensive services and supplies are an important challenge to provide BRSs. It is said that burn is expensive, which creates problems at both demand and prevention sides. For the demand side, due to the lack of financial ability or being poor many patients do not seek treatment or, if seek, don’t receive complete services, due to high price of medicines and surgeries. Generally, burn is an additional painful tragedy for many patients. One of the interviewees noted that: “There are patients who cannot afford the treatment costs … for about 80% of them,the burn is an additional bad tragedy,because they are poor and cannot pay the bills … secondly,if they can afford the costs,medicines are too expensive and numerous,so that the family faces catastrophic payments” (interviewee number 12). On the supply side, because of using new bandages, antibiotics, strong disinfectants, expensive supplies, plastic surgeries (including skin grafting), and high depreciation of equipment, for most of the SBHs costs are higher than incomes and allocated budgets. Hence, they face severe challenges to provide BRSs: | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Long hospitalisation is an important challenge that increases the treatment costs for burn patients: Usually, long hospitalisation both increases the treatment costs, and hospitals' workload and bed occupancy ratio. At the same time, beds turnover is low. These factors increase the costs of SBHs in comparison to other specialised hospitals. | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Lack of guidelines to provide care for burn-related patients is another important challenge that has created problems. If guidelines be available, service provision can be facilitated. For example, what services should be provided in cases of acid burn or gas or fire. Also, treatment of wound injuries, how to move burn patients, and how to care different organs that are burned can be defined. Currently, due to lack of guidelines there is no clear instruction to treat burn patients, and personal decisions have an important role that sometimes can be non-scientific. One of the interviewees noted that: | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Currently, in terms of physical space and number of beds, we have a lot to do to reach global standards. Indeed, insufficient physical space, in comparison with number of patients, creates challenges for treatment of burn patients. A policy-maker noted that: | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | ['pone.0216489.ref003', 'pone.0216489.ref020', 'pone.0216489.ref013', 'pone.0216489.ref021', 'pone.0216489.ref022', 'pone.0216489.ref013', 'pone.0216489.ref013', 'pone.0216489.ref013', 'pone.0216489.ref022', 'pone.0216489.ref020', 'pone.0216489.ref006', 'pone.0216489.ref013', 'pone.0216489.ref013', 'pone.0216489.ref023', 'pone.0216489.ref024', 'pone.0216489.ref025', 'pone.0216489.ref006', 'pone.0216489.ref005', 'pone.0216489.ref014'] | The current study aimed to identify challenges in providing healthcare services in SBHs in Iran, based on a qualitative approach. The results revealed that there are four themes including defects of burn care continuum, regionalization of BRSs, costs related to the burn service provision, non-compliance with standardised care. Defects of burn care continuum are facing with a variety of challenges in continuum burn care delivery from preventive care and pre-hospital care to home care. The results showed that challenges of preventive care are related to people’s insufficient awareness, inadequate media notification, and particularly, a lack of a national plan for burn prevention. Based on the WHO report, developed countries have substantially reduced burn-related deaths during the past four decades, which most of that can be attributed to the burn prevention. Although, using advanced treatments had a substantial role in this decline [3]. Rode et al. in 2015 have also emphasised the necessity and impact of society education about burn prevention [20]. They showed that implementing prevention strategy results in significant improvement, especially in primary and secondary prevention. Also, some other studies noted that weak performance of burn wards is not due to hospital performance or severity of injuries, but it is mostly due to society’s awareness about burn, primary measures and prevention [13]. A study by Hodgins et al. has also emphasized awareness of burns [21].The study of Atiyeh et al. also showed that low level of family education is a risk factor for burns. In this study the importance of burn prevention programs has been emphasized in burn management protocols [22]. The other important challenge was related to pre-hospital care. Burn patients reside in provinces without a SBH, usually receive poor pre-hospital emergency services and necessarily refer to the SBHs that located in a few number of Iran’s provinces. This leads to some difficulties for the patients. Insufficient skill of ambulance staff and low quality of first aid services usually result in delayed arrival of patients to hospitals, severe consequences, increased hospitalisation, and higher costs for patients and health system. Moreover, physicians in non-SBHs are not fully expert in providing pre-hospital care for burn patient such as oxygen and fluid therapies. As a result, next hospital cares will be accompanied by some side effects including sticky wounds and deformity, which require additional treatments such as plastic surgery. As well as in hospital care, supportive services such as nutritional consultations are not sufficient and generally high calorie and high protein regimes are not served. In hospital care, there is other important challenges which include the provision of out date care that is related to the financial shortages and lack of appropriate training. In hospital, burn patients’ companions often do not have the required knowledge to control infections, mostly due to a low level of health literacy. Various unplanned visits and ignoring sanitary codes by patients’ families, also increase the secondary infections in hospitalised burn patients. Jagnoor et al. showed that lack of society’s awareness on basic burn services can reduce desired consequences [13]. Lack of patients’ follow-up, mainly due to financial barriers, is another import challenge to provide high quality BRSs, which in combination with a shortage of home care, results in consequences such as infection or deformity. In addition, since specialised care is only available in specialised hospitals in big cities, receiving further care can be an important obstacle for patients in small cities. In line with the findings of the current study, Jagnoor has also found that lack of patients’ follow-up is an important challenge in treating burn patients in India. Many of the identified challenges were related to the patients’ socioeconomic status, their literacy level and lack of facilities [13]. Regionalisation of BRSs was another theme in the current study, which include three themes. First, poor access to other specialities and medical services. Due to deliver specialised burn services only in SBHs, burn patients with multi-trauma and co-morbidity that may need cardiovascular, vision, and other specialised cares are exposed with a heavy cost burden, as well it imposes costs on the health system. In addition, this situation usually leads into delayed provision of medical services and patients’ referral to other hospitals. A lack of multi-disciplinary teams along with inadequate access to advanced diagnostic technologies are among other important obstacles to provided BRSs. Jagnoor also has mentioned that inadequate specialised and experienced human resources as important obstacles to provide BRSs. But, because in India BRSs are available in public hospitals, access limitation to specialised services were lesser. Besides, the authors found that insufficient skills of health staff, including physicians with general surgery skills, is an important obstacle to provide high quality BRSs in all healthcare centres [13]. In the study by Atyieh et al, the researchers emphasized on regionalization of burn care and linkage between primary, secondary and tertiary levels. They suggested a registry system for burn services [22]. Also Rode et al proposed a structure for regionalized burn services which include day hospital clinics, primary health care plus district hospital, regional hospital and provincial tertiary hospital [20]. Second, inadequate access to specialised services in provinces without a SBH is another important challenge. Long distances and lack of equipped ambulances, transportation costs, inadequate skills of staff in provinces without a SBH, and a lack of equipment and medicine along with delayed referral due to lack of burn-specialized beds, hinder the provision of high quality services. In many cases the provided services by healthcare facilities were not appropriate, that resulted into consequences such as secondary infections. In addition, delayed referral of patients to equipped healthcare centres increases the treatment period and costs. Gallaher et al. showed that in Africa BRSs are available in the burn department of general hospitals, rather than a SBH, so there are less challenges [6]. Meanwhile, Jagnoor only mentioned to the shortage of equipment and facilities in public sector, including hospital beds, to isolate patients to avoid infection [13]. In India, also, because BRSs are providing through public hospitals, there are less challenges. Third, a lack of a defined regionalisation system for BRSs is another important challenge. Ignoring regionalisation standards and referral system sometimes lead into refusing to hospitalise patients or delayed hospitalisation, that both can result in severe consequences. Jagnoor et al.’s work is consistent with the results of current study [13]. Holmes et al. investigated the effectiveness of regionalisation from 2000 to 2007, and emphasised on the effectiveness of regionalization of BRSs. They noted that a single healthcare centre cannot provide the best possible services [23]. Literature on standardising care in SBHs show that 24 hours a day and seven days a week access to a specialised team (i.e. physicians, nurses, and other staff) to provide BRSs as well as patients’ follow-up are among basic standards. To achieve this standard, there must be a precise estimation of minimum level of staff [24]. Moreover, studies indicated that patients with major burn injury require a multi-disciplinary team. In this line, services regionalisation can be a useful step [25]. The results also showed that high costs are an important challenge. On one hand, due to the high workload of personnel, and high price of medical equipment and medicine, the cost of provided services is high. On the other hand, public resources are not sufficient to cover these costs. In a study on analysing costs of a burn ward in Africa, high cost was mention as a main challenge. This study has emphasised on possibility of provision of comprehensive BRSs with lower costs in low-and-middle income countries [6]. Finally, another challenge of BRSs’ provision in Iran is non-compliance with international standards. It can be attributed to a lack of clinical guidelines to treat different burned organs, infection control, and using personal ideas in treatment process of burn patients. In addition, defining specific standards on beds per population, intensive care unit beds per burn-related beds, physical and human resources in burn wards had intensified the gap. As interviewees noted, non-compliance with standards had resulted in low quality services. However, non-compliance is mostly the result of financial shortages in low-and-middle income countries [5]. In India, also, standards are not fully complied in which provided interventions and services substantially vary from one hospital to another. Partly it is due to lack of clinical guidelines [14]. | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | There are some limitations in the current study that are worth declaring. The first limitation could be the issue of subjectivity. Nevertheless, we analysed the data by three colleagues and checked the analyses with an external reviewer to enhance credibility of our results, our interpretation of data may remain subjective and our findings cannot claim a total truth. However, given that our research theoretical paradigm is a constructive approach rather a positivism one, this situation is unavoidable and is defensible. The second possible limitation of this study is that interviewees might have been affected by a social desirability bias. Namely, interviewees may have narrated what they thought interviewers want to hear, rather than the actual events. We minimised this limitation via asking probing questions during the interview process. | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | The current study showed that Iran has faced with several challenges in terms of delivering BRSs. The results may provide policy actions on improving of BRSs delivery, which include strengthening burn care continuum, burn care regionalisation, allocating sufficient budgets to burn services and formulating burn guidelines. As well, to provide appropriate burn services, intra-sectoral collaborations among MoHME and other organisations and institutions as well as advocacy can be helpful. | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | Interview guide used for collecting qualitative data related to service delivery in the Iranian specialised burns hospitals. (PDF) | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | (MX12) | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC6528987'] | ['31112548'] | [] | (PDF) | PMC6528987 | Research Article; Medicine and Health Sciences; Dermatology; Burn Management; Medicine and Health Sciences; Critical Care and Emergency Medicine; Trauma Medicine; Traumatic Injury; Burns; People and Places; Geographical Locations; Asia; Iran; People and Places; Population Groupings; Professions; Medical Personnel; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Medical Doctors; Physicians; Medicine and Health Sciences; Health Care; Health Care Providers; Allied Health Care Professionals; Medicine and Health Sciences; Surgical and Invasive Medical Procedures; Engineering and Technology; Equipment; Medicine and Health Sciences; Health Care; Health Education and Awareness | null | 31,112,548 | How the service delivery works in the Iranian specialised burns hospitals? A qualitative approach | Shaarbafchi Zadeh N, Mohammadi F, Amini Rarani M, Javadi M, Mohammadzade M, Yazdi-Feyzabadi V. | PLoS One. 2019 May 21;14(5):e0216489. doi: 10.1371/journal.pone.0216489. eCollection 2019. | Shaarbafchi Zadeh N | PLoS One | 2,019 | 2019/05/22 | PMC6528987 | null | 10.1371/journal.pone.0216489 | oa_comm/txt/all/PMC6528987.txt | 4efe5c35de031c75bea0383c10b56799 | PLoS One. 2019 May 21; 14(5):e0216489 | 2021-06-19 03:56:03 | CC BY | no |
['PMC10290249'] | ['37351885'] | [] | With the growing cancer survivor population,1it is increasingly important to find effective ways to address treatment-related symptoms and to target care for patients who are most in need. In patients with breast cancer, prevalent physical and psychological symptoms,2including distress, anxiety and depression,3pain4,5and fatigue,6and distress at diagnosis, may be associated with long-term distress3and physical symptoms such as pain.5Although some patients with breast cancer are able to recover and return to a quality of life corresponding to that of the general population,7a large group of patients report unmet needs for both emotional and physical concerns,8,9which have potential implications for health-related quality of life (HRQOL), treatment adherence,10and prognosis.11Patients with breast cancer who experience high distress at diagnosis may be especially at risk for later physical symptoms.4 Nurse navigation12,13,14,15,16and similar approaches provided by specialist breast cancer nurses (SBCNs)17,18focus on collaborative care in which the nurses address both physical and psychological symptoms and refer patients to relevant specialists19by being patient-centered and engaging patients in their own care,20which may be pivotal for patient satisfaction as well as for sustainable symptom reduction. The effects of nurse navigation have been mixed,12,13,14,15,16although SBCN interventions have shown small but consistent improvements in breast cancer–specific HRQOL, anxiety, and depression.18The benefits of these interventions in specific patient subgroups remain largely unexplored. We need to identify and further evaluate promising nurse navigation approaches and to target patients who may benefit the most from them. The REBECCA (Rehabilitation After Breast Cancer) intervention was developed to target both psychological and physical symptoms through patient-centered and collaborative care, combining for the first time, to our knowledge, nurse navigation and systematic symptom screening in patients with breast cancer who were psychologically vulnerable, defined as having moderate to high psychological distress.21The pilot randomized clinical trial (RCT) showed the promising effects of REBECCA on distress, anxiety, and depression at the 12-month follow-up.21Thus, in this current full-scale RCT, we aimed to examine the long-term effects of the REBECCA nurse navigation intervention compared with usual care in patients with breast cancer and symptoms of distress. We hypothesized that patients receiving the intervention would experience beneficial effects on psychological distress (the primary outcome) and on anxiety, depression, breast cancer–specific HRQOL, fear of recurrence, sleep, cognitive function, health behavior, and need for support (the secondary outcomes) compared with the standard care group. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | ['note-ZOI230593-1-s'] | The study design was a parallel RCT, and the participants were females with breast cancer who were psychologically vulnerable. The trial protocol (Supplement 1) was approved by the Regional Research Ethics Committee. Data sharing was not possible due to European Union General Data Protection Regulation. All participants provided written informed consent. We followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline. Between August 2017 and October 2019, all patients at the Department of Breast Surgery in Rigshospitalet in Copenhagen, Denmark, were recruited and evaluated for eligibility by 3 trained project nurses (H.D. and B.M.). The inclusion criteria were new (prior to treatment) diagnosis of primary breast cancer; breast cancer surgery; aged 18 years or older; Danish speaking; physically able to attend rehabilitation; able to provide written informed consent; and moderate to high psychological distress, with a score of 7 or higher on the well-validated instrument Distress Thermometer (“Please circle the number [0-10] that best describes how much distress you have been experiencing in the last week including today”), as established previously in Danish patients with breast cancer.22Exclusion criteria were severe cognitive problems or dementia and unmanaged psychiatric disease that prevented participation, such as schizophrenia, alcohol use disorder, or narcotic dependence. Patients were involved in the development of the REBECCA intervention through a previous longitudinal study on symptoms and need for support during breast cancer treatment3,5,6,8and through reporting acceptability in the pilot RCT.21,23Patients expressed high satisfaction, and thus only minor adjustments were made, such as creating electronic rather than paper-based questionnaires. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | ['zoi230593f1'] | Enrolled patients were randomized 1:1 by the 3 project nurses using computer-generated assignment and were stratified according to age (<60 or ≥60 years) and treatment modality (none, adjuvant chemotherapy, or neoadjuvant chemotherapy). Patients were randomized to either the standard care or the REBECCA intervention plus standard care (Figure 1). Group allocation was concealed from the navigation nurses until after randomization, but blinding during the trial was not possible due to the behavioral intervention. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | [] | At baseline, 156 patients in the intervention group and 153 in the standard care group were analyzed. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | ['note-ZOI230593-1-s'] | REBECCA is a manualized intervention with 2 components21,24: (1) systematic screening for patient-reported outcomes of psychological and physical symptoms 3, 9, and 18 weeks after baseline (eFigure 1 inSupplement 2) and (2) nurse navigation, including approximately 6 individual sessions within the first 8 months after baseline per patient need (first session was face-to-face at the breast surgery clinic; other sessions could be by telephone) that are typically either full length (<60 minutes) or short (<10 minutes), to check in on patient status per patient need. The sessions were designed to activate patient engagement; enhance patient attitude, knowledge, and self-efficacy in managing their symptoms; and encourage use of existing rehabilitation services at the hospital or local rehabilitation center. Patient-centered techniques are applied, such as (1) empathetic dialogue and forming of an alliance; (2) joint analysis of the situation, including cognitive behavioral therapy techniques such as cognitive restructuring; (3) assessment and prioritizing of needs for support; (4) psychoeducation; (5) goal setting using SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) goals, including (when relevant) referral for management of pain at the oncology department or for management of clinical depression in up to 6 individual sessions with a project psychologist; (6) agreements, homework, and planning; and (7) debriefing. The REBECCA intervention was delivered by 3 experienced nurses (all of whom had ≥20 years’ experience with different patient groups) who were trained in the manualized sessions through a 3-day program. Patients in both intervention and standard care groups had access to usual care, which included regular treatment and nurse support at chemotherapy and radiotherapy appointments as well as municipality-based rehabilitation, including patient support groups and physical training. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | ['note-ZOI230593-1-s'] | Questionnaire data were collected between August 2017 and March 2021 either electronically or on paper (based on patient preference) at baseline and at 6, 12, and 18 months after diagnosis. The primary outcome was psychological distress, as measured using the Distress Thermometer22with a score range of 0 to 10 points and a higher score indicating greater distress. The secondary outcomes included (1) symptoms of anxiety measured by the 7-item Generalized Anxiety Disorder,25with a score range of 0 to 21 points and a higher score indicating greater anxiety and a minimally important difference (MID) of 3 points; (2) symptoms of depression measured by the 9-item Patient Health Questionnaire,26with a score range of 0 to 27 points and a higher score indicating higher level of depression and an MID of 5 points; (3) breast cancer–specific HRQOL measured by the Trial Outcome Index–Physical/Functional/Breast score from the Functional Assessment of Cancer Therapy–Breast scale,27with a score range of 0 to 148 points and a higher score indicating greater HRQOL, and an MID of 5 to 6 points; (4) fear of recurrence measured by the 4-item Concerns About Recurrence Questionnaire,28with a score range of 0 to 40 points and a higher score indicating greater fear of recurrence; (5) sleep measured by the Pittsburgh Sleep Quality Index,29with a score range of 0 to 21 points and a higher score indicating worse sleep; (6) cognitive function and perceived cognitive impairment measured using the Functional Assessment of Cancer Therapy–Cognitive Function30scale, with a score range of 0 to 72 points and a higher score indicating better function; (7) patient activation as an indicator of self-efficacy measured by the Patient Activation Measure,31with a score range of 0 to 100 points and a higher score (>67 points) indicating greater activation; (8) pain measured using the Neuropathic Pain Scale for Postsurgical Patients,32with a score range of 0 to 5; (9) health behavior, such as smoking, alcohol use, and physical activity; (10) body mass index, which was calculated as weight in kilograms divided by height in meters squared; and (11) need for support. Baseline data were collected on demographic characteristics (age: <60 or ≥60 years33); years of education (<10, 10-12, >12-15, or >15 years); employment status (not employed or employed); cohabitating partner (no or yes); and social support measured with the short version of the Medical Outcomes Social Support Survey,34with scores in the higher quantile (≥25%) indicating better support (eFigure 1 inSupplement 2). Because we were not able to include patients who were not Danish speaking, no information was collected on ethnicity. From medical records, we obtained information on breast surgery (lumpectomy, mastectomy, or mastectomy with primary reconstruction), axillary surgery (axillary dissection or sentinel node biopsy), adjuvant radiotherapy (no or yes), adjuvant endocrine therapy (no or yes), chemotherapy (adjuvant, neoadjuvant, or none), and trastuzumab (no or yes). Additionally, nurse registrations on intervention exposure (3 single items) and patient-reported acceptability (7 single items) were obtained in the intervention group. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | [] | An a priori sample size evaluation was established based on results regarding distress (primary outcome) as well as symptoms of depression and anxiety (secondary outcomes) from the pilot RCT, in which up to 30% between-group difference was observed in change from case to noncase in distress, anxiety, and depression.21In this full-scale trial, we expected a conservative 20% between-group difference. With a 2-year recruitment, we expected to recruit 324 patients, with approximately 20% having missing data or dropping out, resulting in a total of 260 participants (130 in each group) and a power of 84%. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | [] | Deviations from the original analysis plan were made and finalized prior to data analyses and are described here. Descriptive analyses were applied to examine the differences between study groups at baseline. In intention-to-treat analyses, we applied linear mixed-regression models to examine the effect of the intervention on the primary outcome (distress) and secondary continuous outcomes (symptoms of anxiety and depression, breast cancer–specific HRQOL, fear of recurrence [no baseline data were included, and thus different effects of the intervention were allowed at all time points], sleep, cognitive function, and patient activation) in repeated-measures analyses, with a random effect for patients at 4 time points: baseline and 6-, 12-, and 18-month follow-up. The models assumed no difference between groups at baseline and were in the revised analysis plan, adjusted for randomization strata of age (<60 or ≥60 years) and treatment modality (none, adjuvant chemotherapy, or neoadjuvant chemotherapy). Statistical significance was interpreted at 2-sidedP< .01 to accommodate multiple testing. However, in the revised analysis plan, 99% CIs were replaced by 95% CIs for comparability with other studies. Effect size was evaluated using Cohend. In the revised analysis plan, we included visual comparisons of the strength of the associations between the outcomes in forest plots, where we fitted models with standardized outcome scores by subtracting the sample mean score from each score and dividing by the SD across time points. Logistic regression models were added to the revised analysis plan to examine the differences between study groups at 18 months in unmet need for support and health behavior, adjusted for baseline outcome values. In the revised analysis plan, we added exploratory analyses to examine whether the intervention effects were modified by age, years of education, social support, patient activation, and chemotherapy, using an interaction term between treatment group and the specific effect modifier. We conducted sensitivity analyses to examine the potential effect of missing data. The last-observation-carried-forward method in the revised analysis plan was replaced by multiple imputations using fully conditional specification methods35to impute missing values for the outcomes at different follow-up times, with information from covariates (years of education, breast surgery, axillary surgery, adjuvant radiotherapy, adjuvant endocrine therapy, and chemotherapy) and with values from the same patient imputed together. Two scenarios were examined: assuming that data were missing at random, and assuming patients with missing data had 20% worse symptoms than expected. Intervention exposure and acceptability were assessed descriptively. Analyses were performed using R, version 4.0.4 (R Core Team)36from June 2021 to October 2022. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | ['zoi230593f1', 'zoi230593t1', 'zoi230593f1', 'zoi230593t2'] | A total of 1535 patients were evaluated for eligibility, of which 1222 were excluded (514 were not eligible, 408 declined, and 300 were not distressed). After exclusions, 313 patients were randomized to either the intervention (n = 157) or standard care (n = 156) group (Figure 1). However, 4 patients were withdrawn after randomization as they had not received surgery and did not fulfill inclusion criteria. Thus, 309 female patients were included for analyses in the intervention (n = 156) and standard care (n = 153) groups. These patients had a mean (SD) age of 56 (11) years, included 207 (67%) living with a partner, and varied little across intervention and standard care groups (Table 1). During follow-up, 8 patients (3 in the intervention group, and 5 in the standard care group) died, no patients dropped out, and all attrition was due to nonresponse to questionnaires (Figure 1). Participants in the intervention group and the standard care group, had high levels of distress (mean [SD] score, 8.20 [1.09] vs 8.22 [1.03]), anxiety (mean [SD] score, 10.67 [5.21] vs 10.96 [4.88]), and depression (mean [SD] score, 7.84 [5.05] vs 8.34 [5.13]) at baseline, which declined over time (Table 2). | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | ['zoi230593t2', 'zoi230593f2', 'zoi230593t2', 'zoi230593f2', 'note-ZOI230593-1-s', 'note-ZOI230593-1-s'] | Patients in the intervention group reported lower distress, although not significantly lower, at the 6-, 12-, and 18-month follow-up, with the largest reductions observed at 12 months (estimated effect = −0.51 [95% CI, −1.05 to 0.04]; effect size [ES] = −0.49) (Table 2,Figure 2). Significant reductions were seen for symptoms of depression at 6 months (estimated effect = −1.39 [95% CI, −2.33 to −0.44]; ES = −0.27) and breast cancer–specific HRQOL at 12 months (estimated effect = 4.03 [95% CI, 1.28- 6.77]; ES = 0.31). Changes that were not significant were seen for symptoms of anxiety at 6 months (estimated effect = −1.00 [95% CI, −1.95 to −0.06]; ES = −0.21) and 12 months (estimated effect = −1.01 [95% CI, −1.97 to −0.04]; ES = −0.21) and for patient activation at 18 months (estimated effect = 3.52 [95% CI, −0.09 to 7.12]; ES = 0.25) as well as for fear of recurrence, sleep, and cognitive function (Table 2,Figure 2) or unmet needs for support and health behavior (eTable 1 inSupplement 2). In analyses using imputation models, the intervention effect was similar or stronger in both multiple imputed scenarios (eTable 2 inSupplement 2). | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | [] | Standardized outcome scores were applied using fitted models by subtracting the sample mean score from each score and dividing by the SD. Models were adjusted for randomization strata of age (<60 years or ≥60 years) and treatment modality (none, adjuvant chemotherapy, or neoadjuvant chemotherapy). HRQOL indicates health-related quality of life. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | ['note-ZOI230593-1-s', 'zoi230593f3'] | Stronger intervention effects were seen for vulnerable subgroups, such as patients 60 years or older, patients with less education, patients with low patient activation, and patients with low social support, with different strengths for the individual outcomes (eFigures 2 to 9 inSupplement 2). For example, in patients with low patient activation, significant effects were seen for distress at the 6-month (estimated effect = −1.35; 95% CI, −2.21 to −0.49) and 12-month (estimated effect = −1.08; 95% CI, −1.95 to −0.22) follow-up. Patients in the intervention group had a median (range) of 4 (0-9) sessions, with most of the sessions being face-to-face and the largest proportion of referrals being municipality-based rehabilitation (42%) (Figure 3A-D). Patient satisfaction was high: 91% of patients discussed the issues most important to them. No harmful effects were reported during the study. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | [] | Nurse navigation and systematic screening for symptoms provided in the REBECCA intervention showed promise in reducing several psychological symptoms and increasing quality of life. Reduced, but not significant, intervention effects were observed for the primary outcome of distress, and significant effects were observed for symptoms of depression and breast cancer–specific HRQOL. Additionally, nonsignificant effects were found for symptoms of anxiety and patient activation. The intervention effects did not meet the established MIDs, and small to moderate effect sizes were observed (ES = 0.21-0.31). In the pilot RCT (n = 50), significant improvements in distress were found after 12 months. That the effect on distress was not significant has no obvious explanation, but a possible reason is that the effect was especially pronounced in patients with few resources, as we found significant effects at all follow-up periods for patients with fewer than 12 years of education and for patients with low patient activation. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | [] | Previous nurse navigation intervention studies rarely demonstrated substantial symptom reduction, such as studies on patients with breast cancer or mixed cancer (including breast) that found no significant effects of nurse navigation on distress, fatigue, quality of life, and health care use (n = 251)13; studies on breast cancer–related quality of life (n = 251)16; or studies on patient experience outcomes according to depression (n = 190).12Still, 6 RCTs on SBCN interventions showed small improvements in cancer-specific HRQOL as well as anxiety and depression.18 The main strength of this RCT is that, to our knowledge, it was the first to test the effect of a manualized nurse navigation program on female patients with high distress levels at diagnosis, thus minimizing a floor effect, and it was also the first to examine long-term effects over 18 months. Previous nurse navigation interventions were only superficially described and covered a variety of techniques, including addressing needs,12,13,14referral to services (eg, for depression),12,13,14counseling,12,13,14and inclusion of an informal caregiver if relevant,13whereas SBCN interventions during treatment were often based on minimally described counseling.18In further development of nurse navigation, rigorousness should be applied to the theoretical intervention framework and specific techniques should be applied. The high participation rate of 60% indicates that the intervention was relevant to a broad range of patients with breast cancer, which supports the generalizability of the study results. The REBECCA intervention may work through several pathways: systematic screening for patient-reported outcome symptoms may enhance the detection and professional management of the symptoms.37Concurrently, through the patient-centered approach, the nurse navigation may enhance more needs-based support as well as patient motivation and skills in self-managing the symptoms. For several outcomes, the intervention had a stronger effect on patients with limited social support, low patient activation, a lower level of educational attainment, and age 60 years or older, suggesting that the intervention effects may be strongest in patients with social vulnerabilities. To our knowledge, supportive care interventions have rarely examined the differences in effectiveness across patients with different levels of resources. Some studies have suggested that it may be feasible to address socioeconomic inequality in cancer care through supportive care interventions, yet the evidence on their effects on symptoms is still limited.38Due to the challenges of inequality in cancer care, it is essential to further explore if the REBECCA intervention and similar supportive care interventions may have the greatest benefits for cancer populations with psychological symptoms and/or social vulnerabilities. The REBECCA intervention is delivered through a median of 4 nurse sessions, has a mixed telephone and physical format, and is potentially cost-effective; however, we plan to investigate its cost-effectiveness in a separate study. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | ['zoi230593f1'] | This study has limitations. With 120 patients per group included at the 18-month follow-up (Figure 1), the study did not completely achieve the recruitment goal of 130 per group, slightly limiting the power of the study. However, with this large study size, we expected the effect to be minimal. Due to the number of analyses conducted, we applied a strict significance level (P< .01), but the results of the secondary interaction analyses should still be considered as exploratory and should be interpreted with caution. As anticipated, over an 18-month follow-up period, we observed attrition of up to 22%; however, similar attrition rates were seen across groups and sensitivity analyses. Applying different attrition scenarios supported the strong intervention effects. We did not obtain information on ethnicity, and as eligibility required understanding and speaking Danish, we cannot exclude the limited generalizability to ethnic minority groups. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC10290249'] | ['37351885'] | [] | We believe the REBECCA intervention fills an important gap in the existing literature regarding providing patient-centered care to patients with breast cancer and social and psychological vulnerabilities. In this RCT, we observed reduced distress in patients who received the REBECCA intervention, especially after 12 months, although the effect was not significant. The intervention resulted in significant improvement in symptoms of depression and breast cancer–specific HRQOL, especially at the 6- and 12-month follow-up, and nonsignificant improvement in symptoms of anxiety and patient activation. The effect sizes were small, but effects were especially pronounced in subgroups with social vulnerabilities, and patient satisfaction was high. To our knowledge, this is the first trial to show the feasibility (through a simple triage approach) of systematically selecting patients with breast cancer who had psychological symptoms of distress and to offer them more comprehensive supportive care, with the nurse navigator actively supporting the patient in accessing health care services that are available within the health care system. These findings warrant further research to develop the nurse navigation framework and to explore the potential translation of this intervention into clinical practice. | PMC10290249 | Research; Original Investigation; Online Only; Oncology | null | 37,351,885 | Effect of a Nurse Navigation Intervention on Mental Symptoms in Patients With Psychological Vulnerability and Breast Cancer: The REBECCA Randomized Clinical Trial | Bidstrup PE, Johansen C, Kroman N, Belmonte F, Duriaud H, Dalton SO, Andersen KG, Mertz B. | JAMA Netw Open. 2023 Jun 1;6(6):e2319591. doi: 10.1001/jamanetworkopen.2023.19591. | Bidstrup PE | JAMA Netw Open | 2,023 | 2023/06/23 | PMC10290249 | null | 10.1001/jamanetworkopen.2023.19591 | oa_comm/txt/all/PMC10290249.txt | ab233a5912036825e7465febf88010f6 | JAMA Netw Open. 2023 Jun 23; 6(6):e2319591 | 2023-06-26 23:18:52 | CC BY | no |
['PMC8547096'] | ['34702164'] | ['CR1', 'CR2', 'CR3', 'CR4', 'CR5', 'CR6', 'CR7', 'CR8', 'CR9', 'CR10', 'CR11', 'CR12', 'CR8', 'CR13', 'CR14', 'CR15', 'CR13', 'CR16', 'CR13', 'CR14', 'CR17', 'CR17', 'CR18', 'CR8', 'CR15', 'CR19', 'CR20', 'CR21'] | Increasing the Iranian elderly population from 6.4% in 2020 to 11% in 2036 is inevitable [1]. Older people are at a higher risk of hospitalization [2]. The prolonged hospitalization of elderly patients reduces their cognitive and functional abilities [3]. Delirium is a common geriatric syndrome that affects one-third of the hospitalized elderly patients [4]. Delirium has adverse effects on the patients’ recovery, functional abilities, length of hospital stay, admission in long-term centers, and rates of death [5,6]. Standard treatments under medical conditions may be difficult due to the development of delirium [7]; so, primary prevention could be the most efficient strategy to decrease delirium, since at least 30 to 40% of delirium cases are preventable [8,9] and the prevention of delirium is preferred to its treatment [10]. Implementing the multicomponent interventions’ with help of an interdisciplinary aged care team could be an effective strategy to prevent delirium; because the members of aged care teams recognize the multifactorial etiology of delirium [11]. The Hospital Elder Life Program (HELP) is a multi-component intervention for dealing with risk factors in delirium (reversible cognitive impairment, sleep deprivation, immobility, visual impairment, hearing impairment, and dehydration) in the hospital settings, implemented by interdisciplinary teams, included a geriatric nurse, elder life specialists, trained volunteers, and geriatricians who work closely with the primary nurses [12]. The HELP program is effective in preventing delirium [8,13,14], cognitive and functional decline [15], fall in hospital [13,16], and decreasing in the length of hospital stay [13,14,17]. The program is cost-effective and reduces hospital costs [17,18]. It has been shown that HELP is an effective program and can reduce delirium rates by 40% [8] and it can also reducethe rates of functional decline in hospitalized older patients by 67% [15]. The literature reveals that today, hospitals have made efforts to use the HELP program, but a lack of aged care services for hospitalized elderly in Iran, and deficiency of geriatric wards in Iranian hospitals made preventing the integration of HELP into medical care system. Consequently, it is necessary to carry out a trial study to modify some interventions and protocols in the HELP program which are compatible with the Iranian facility, care system capability, and the nature of the Iranian elderly population. Meanwhile, some interventions, which depend on the patients’ literacy, should be changed due to the high illiteracy rates in the Iranian elderly population [19]. Moreover, in the Iranian culture, the family members support the elderly and take care of these patients even in hospital settings [20], so, some interventions, which depend on the patients’ families, have to be modified in the HELP model. Besides, in the Iranian care system, getting help from volunteers in hospitals is not common; therefore, there is a need to change the volunteers’ protocols in the Iranian HELP version. Accordingly, it seems that it is necessary to modify the HELP program in developing countries based on their potential and abilities. Therefore, the present study was conducted to determine the effect of the Iranian modified HELP on the prevention of delirium among hospitalized elderly patients in internal wards, due to the rapid growth of the Iranian elderly population, also the high prevalence of delirium (22%) among the Iranian hospitalized elderly patients, lack of adjustability of the original HELP program with the present Iranian hospital facilities, and a lack of studies on the modified HELP program in developing countries [21]. Besides, this study made an effort to assess the effects of HELP on the other program outcomes including the prevention of frailty, recovery from physical function and cognitive function disabilities, the decrease in fall rates in hospitalized patients, and the reduction in the length of hospitalization. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | ['CR22'] | On this study used a parallel-group, double-blind (evaluation and analysis), randomized clinical trial that was designed based on recommendations to conduct trial studies [22]. The participants were selected using the allocation stratified block random sampling method. This study was registered at the Iranian Registry of Clinical Trials IRCT20180910040995N1 at 2019-02-07. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | The participants, who comprised geriatric patients, were selected from the Internal Medicine wards of a university hospital in Kashan province of Iran for a period that lasted from October 2019 to October 2020. The inclusion criteria were as follows: being 70 years old and over, being admitted into one of the Internal Medicine wards, not being delirious at admission time, having at least one of the delirium risk factors at the time of admission (cognitive impairment, vision/hearing impairments, immobilization, sleep deprivation, dehydration: BUN/Cr ratio > 18), being willing to participate in the study, and being able to communicate verbally or in writing. The exclusion criteria included coma, mechanical ventilation, aphasia (expressive and/or receptive), severely impaired communication ability, terminal/end stage conditions, imminent death, combative or dangerous behaviors, a severe psychotic disorder that prevent patients from participating in interventions, severe dementia (being unable to communicate based on SPMSQ 10 errors), airborne precautions (e.g., tuberculosis), being isolated, droplet precautions (e.g., influenza), neutropenic precautions, being discharged around 48 h after admission, patient’s refusal to participate in the study, and patient’s family members or physician’s refusal to let the patient participate in the study in the case of incompetent patients. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | Based on the results of admission into the hospital, the participants in the intervention group received HELP interventions for 5 days with the help of three volunteer nursing BSc students. On the other hand, the participants in the control group received usual medical and nursing care during the hospitalization process. The volunteers identified the principal family caregivers within the first 24 h of the admission and used a face-to-face communication strategy to train them to provide the patients with some interventions. Moreover, the volunteer nurses delivered them with an informative booklet, which contained information on certain strategies and recommendations to prevent delirium. Furthermore, they provided the family caregivers with a notebook and pencil for two reasons: one to record the conditions in which the interventions were provided to the patients and two to mention the non-adherence reasons in the conditions in which they did not provide the patients with the relevant interventions. Interventions were followed according to HELP protocols. They were translated into the Persian language and modified according to the Iranian culture, accessibility to facilities, potential of services, and types of equipment in this pilot hospital like as Focus Group Discussions (FGD) among head nurses and nursing supervisors. Then the modified interventions were organized based on FGD meetings and HELP protocols. Finally, they were modified, based on the daily visits of the team director. The protocols were included; cognitive protocol, vision/ hearing protocol, sleep protocol, mobility, hydration and feeding assistance. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | Orientation (patient orientation card, including names of care team members, time, place, and daily schedule), cognitive stimulation, therapeutic activities (discussion of current events, puzzle, and memory games). All of the interventions provided are based on the cognitive - HELP protocol. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | Reminding the patients on using their glasses or hearing aids, training caregivers to communicate with the patients suffering from vision/hearing impairment. Some activities were unsuccessful, due to the lack of facilities including magnifying lenses and adaptive equipment (e.g., large illuminated telephone keypads, large print books, and fluorescent tape on the call bell), lack of daily reinforcement of the portable amplifying. Also, the patients’ referral to the specialists for ear wax removal. Nonetheless, the caregivers were given some training on how to administer vision/hearing interventions based on the HELP protocol. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | The suggested sleep improvement interventions based on the original HELP included: using individual considerations for normal routines (can you think about something that might help you to go to sleep, that is, something you did not at home when you had trouble sleeping), making offer some interventions to the patient and caregiver (warm milk, back-rub, relaxation music play on a portable music player), doing additional sleep-promoting activities (avoiding caffeine after 2 p.m., exercising during the day as much as possible, avoiding day time napping, maintaining a regular time for going to bed each night), using strategies to reduce the noise in the wards (e.g., silent pill crushers, vibrating beepers, and quiet hallways), and adjusting schedules to facilitate sleep uninterrupted (e.g., re-scheduling the medications and procedures). Although most interventions were informed to the patients and caregivers, some interventions (drinking herbal tea, relaxing with music, back massage, using silent pill crushers, and vibrating beepers) could not be provided. Likewise, the nurses were trained to use some strategies including noise reduction in the wards, and re-scheduling in medications and procedures. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | All of the suggested interventions were provided to the patients based on the original HELP, including ambulating or doing active range of motion exercises three times daily, minimizing the use of immobilizing equipment (e.g., bladder catheters and restraints). Moreover, several amenities (cane and walker in the pilot wards) were provided to the patients. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | The feeding assistance and encouragement during the meal followed based on the original HELP protocol. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | ['Tab1'] | Fluid repletion interventions (an early recognition of dehydration and oral volume repletion, i.e., encouragement of oral intake of fluids) was followed according to the hydration - HELP protocol. Table1provides a comparison of the original HELP protocols and adapted HELP to the Iranian situation.Table 1Comparison between the original and the Iranian HELP programsOriginal HELP protocolsImplementing HELP in this studyScreeningElder life nurse specialist within 48 hGeriatric nurse specialist within 48 hExclusion criteriaIntubation or respiratory isolation, aphasia, terminally ill, severe dementia, respiratory isolation, and expected discharge within 48 h after admission.Another exclusion criterion was added (admitting in the participants’ group wards for the second time).ProtocolsOrientation/daily visiting: Orienting the board with the names of care team members, daily schedule, and orienting communication.All interventions were done, without changes.Therapeutic activities: Cognitive stimulation activities three times daily (e.g., discussion of current events, structured reminiscence, and word games).Both of them were done as well as telling the story.Sleep enhancements: Individualized considering of normal routines (can you think of something that might help you to sleep, or you did at home when you had trouble in sleep), offering to the patient and caregiver (drinking warm milk, back-rub, relaxation with a portable music player), additional sleep-promoting actions (avoiding caffeine after 2 p.m., increase exercise and mobility during the day as much as possible, avoid daytime napping, preserve regular time for going to bed each night), ward-wide noise reduction strategies (e.g., silent pill crushers, vibrating beepers, and quiet hallways), and schedule adjustments to allow uninterrupted sleep (e.g., re-scheduling of medications and procedures).Some interventions were not provided, e.g., drinking herbal tea, relaxing with music, back massage, using silent pill crushers, and vibrating beepers. Although, most intervention strategies’ informed the patients and caregivers.Also, noise reduction strategies were trained by patients and caregivers. The nurses were trained about ward-wide noise reduction strategies in the re-scheduling of medications and procedures.Early mobilization: Ambulating or active range-of-motion exercises three times daily and minimizing the use of immobilizing equipment (e.g., bladder catheters, restraints).All interventions were done, without changes.Vision protocol: Visual aids (e.g., glasses or magnifying lenses) and adaptive equipment (e.g., large illuminated telephone keypads, large print books, and fluorescent tape on call bell), with daily reinforcement of their use.Reminding in use of own glasses, caregivers’ training in how to communicate with the patient with the vision impairment. These activities failed, because of lacking facilities included magnifying lenses and adaptive equipment (e.g., large illuminated telephone keypads, large print books, and fluorescent tape on call bell)Feeding Assistance: Feeding assistance and encouragement during mealsAll interventions were done, without changes.Fluid repletion: Early recognition of dehydration and oral volume depletion, i.e., encouragement of oral intake of fluidAll interventions were done, without changes.volunteersVolunteer shifts: Ranging from one to three times daily based protocols.Role of the volunteers: Providing program interventions, directly at the bedside.Daily, once in the morning or the evening.Volunteer duty: Teaching family members and supervising them during the provision of the HELP interventions.Nursing staffThe ELS and ELNS are in contact with the staff nurses.The program director, geriatric nurse, and volunteers were in contact with the staff nurses. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | ['CR23', 'CR24', 'CR24', 'CR25', 'CR26', 'CR27', 'CR8', 'CR26', 'CR28'] | Within the first 48 h of admission, the elderly patients were evaluated by researchers based on the inclusion criteria. After asking the patients or their family members to sign the consent form and getting their permission to involve the patients in the study, the patients were randomly placed in one of the HELP or control groups. The selected patients were evaluated by three geriatric nurses. The gathered data included: Sociodemographic data (age, sex, marital status, education level, accommodation, type of insurance, monthly income level), polypharmacy, addiction, smoking, alcohol abuse, support by a family member, use of walking aids, health status, oral health, level of ambulation, hospitalization history, past medical history, ability to move and walk, mobility level (independent or needs assistance), and the ability to climb stairs. Impairments in the basic Activities of Daily Living (ADL) before hospitalization was assessed using the Barthel index, which measures the elderly patients’ functional abilities during the performance of 10 activities in daily life. The internal consistency of the Iranian version BI was significant (Cronbach’s alpha = 0.938,P< 0.001) [23]. The Lawton Instrumental Activity of Daily Living (IADL) scale was used to assess the status of elderly patients before hospitalization. The sensitivity and specificity of the Iranian version of Lawton IADL were reported to be 0.75 and 0.96, respectively, the Cronbach alpha and ICC were higher than 0.75 [24]. The patients’ cognitive impairment was determined using the Pfeiffer’s Short Portable Mental Status Questionnaire (SPMSQ), the reliability was determined to be 0.88 with a cut-off point three for Iranian older adults [24]. Moreover, the Digit Span (DS) was used to assess the patients’ short-term memory and attention, as a test of attention and working memory [25]. At cut-off < 3 digits, the sensitivity and specificity of DSB in the detection of major cognitive disorders (including dementia, delirium, and cognitive impairment which are not otherwise specified) obtained 77 and 78%, respectively [26]. Frailty was assessed using the Rockwood Frailty Index. This was derived from the Canadian Study of Health and Aging (CASH), which was highly correlated (r= 0.80) with the Frailty Index [27]. Delirium was assessed using the Confusion Assessment Method (CAM) scale [8]. In an Iranian study, the sensitivity and specificity of the ICU CAM scale were reported being 66.7 and 99.1%, respectively [26]. The other assessment tools at the admission time were the Charlson Comorbidity Index [28], dehydration index, the number of medications that were prescribed, visual acuity, hearing impairment, nutrition status, and sleep. Moreover, medical or nursing procedures (bladder catheterization, nasogastric tube placement, venous or arterial access, blood sample acquisition), and other invasive procedures were recorded. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | ['CR29'] | The primary outcome was to reduce the incidence of delirium in hospitalized elderly in Internal Medicine wards, which was assessed by the Confusion Assessment Method (CAM) scale [29]. Nurses performed a daily delirium evaluation with CAM and recorded it in every shift, also a well-trained nurse examined the patients on the incidence of daily delirium by interviewing their caregivers. The secondary outcomes included changes in physical function status, cognitive function, frailty, and dehydration between admission (T0) and hospital discharge (T1) times, also the length of hospital stay (LOS), and fall incidence in hospital. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | A sample of 46 elderly patients in each group was selected using the 3.192 version of G*Power software and x2test, and considering the effect size 0.6, alpha =5%, and beta =10%. The sample size was considered to be 55 patients per group, due to a 20% difference. Finally, this study involved 84 geriatric patients in the intervention group and 111 elderly patients in the control group. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | We used stratified sampling since delirium risk (moderate and severe level) confounds the results. The elderly participants were randomly assigned to two groups using a simple random sampling method, used by six blocks with a proportion of 4: 2. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | This study used the double-blind method. The patients and people who assessed the patients were uninformed about the objectives of the study and the patients’ condition in the intervention group and control group, although, the researcher was informed about them. Several measures were used to prevent communication between these groups. These measures included selecting only one patient per room (all rooms had four beds) so that other patients and their caregivers could not observe the implemented interventions. Interventions and evaluations were carried out by different personnel to avoid measurement biases. Moreover, the personnel were trained in separate sessions and the data were analyzed by a person who had not taken part in the evaluation and intervention processes. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | ['CR11'] | In the original HELP manuals, an Elder Life Specialist (ELS) and an Elder Life Nurse Specialist were involved in the team [11]. While, in the Iranian HELP team was applied a gerontologist (PhD) as the director of the program, three geriatric nurses, and three nursing students as volunteers. A team director planned the interventions, according to the delirium risk factors that were detected with the used tools in HELP. Some interventions were changed based on the daily evaluation of the elderly patients by a team director. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | Volunteers were selected from the BSc nursing students, who were interested in taking care of elderly patients. They were trained by a director of the program. Volunteers’ training consisted of classroom instructions including didactic training and small groups demonstration. At the end of the training sessions, the researchers administered a test to the volunteers based on the volunteers’ manual. Next, the volunteers provided the interventions according to the plan that the team director organized, then the director recorded all of the interventions in the patients’ files. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | Statistical significance was appointed atp= 0.05. All of the tests were two-tailed tests. A descriptive analysis of the study variables was carried out (means, standard deviations, number of cases, and proportions). The normality of distribution was checked using the Shapiro–Wilk test. The researchers used both parametric statistics(i.e., Student’s t-test) and nonparametric statistics (i.e. Man-Whitney test) to analyze the collected data. The efficacy of the intervention was examined using the relative risk ratio (RR) and 95% confidence interval (95% CI). All of the analyses were performed as an intention to treat approach. The data analysis was carried out using SPSS20 statistical package. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | [] | After getting permission from Dr. Sharon Inouye, who is the developer of the original HELP, the contents and protocols of the program were separately translated into Persian, with the help of two translators and one gerontologist. Moreover, the contents of the program were modified, based on the Iranian hospital care system. The Research Ethics Committee of the University of Social Welfare and Rehabilitation Sciences approved this study (IR.USWR.REC.2017.5.25). In terms of ethical considerations, first, the aims of this study were explained to the participants and their caregivers. Next, informed consent was obtained from illiterate participants and their family members. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | ['Fig1', 'Tab2', 'Tab2', 'Tab3'] | In this study, 220 geriatric patients were evaluated for eligibility. Based on the results of the evaluation,195 elderly patients met the inclusion criteria (88.6%). Regarding the objectives of this study, 84 elderly patients (43.07%) from among the 195 eligible patients were randomly assigned to the intervention group and 111 (56.92%) of them were assigned to the control group. Two participants in the intervention group (2.4%) and one patient in the control group (0.9%) died during hospitalization. Nonetheless, the collected data on delirium status were available for these subjects. Moreover, one patient in the intervention group (1.2%) and two patients in the control group (1.8%) can not continue the study, due to the worsening condition of the disease. Moreover, seven patients in the control group (6.3%) were excluded from the study, since they were discharged from the hospital before 1 week (Fig.1).Fig. 1The participants’ flow diagram (CONSORT 2010) [30] The mean ages of the participants in the intervention and control groups were 79.12 (SD: 5.72) and 77.75 (SD: 6.01) years, respectively. In both of the groups, most of the patients were male (intervention group: 59.5%, control group: 55.9%). More than half of the participants (62.56%) were illiterate (interventiongroup: 57.14%, control group: 66.67%).The other characteristics of the geriatric patients in each group at admission time are provided in Table2. There were not any significant differences between the intervention group and the control group in terms of any of the characteristics. The mean number of the risk factors per patient at admission time was similar in both groups [Table2].Table 2Characteristics of the geriatric hospitalized patients on admission timeVariablesComplete sampleControl groupHELP groupP-valueGender(n) %0.608Male(112) 55.9%(62)55.9%(50) 59.5Marital Status0.276Married(129) 66.15%68(61.26%)(61)72.62%Widowed(63) 32.31%40(36.4%)(23)27.38%Other(3) 1.53%3(0.27%)0Education0.176Illiterate(122)62.56%(74)66.67%(48)57.14%Primary School(65)33.33%(35)31.53%(30)35.71%High School(2)2.38%0(2)1.03%University(6)3.08%(2)1.8%(4)4.76%Polypharmacy0.647Less than three drugs(52)26.67%(31)27.93%(21)25%More than three drugs(143)73.33%(80)72.07%(63)65%AddictionYes(14)7.18%(10)9.01%(4)4.76%0.255Charlson Comorbidity Index; mean ± SD2.72 ± 1.832.66 ± 1.822.79 ± 1.850.624Hypertension(118)60.51%(67)60.36%(51)60.76%1.000Diabetes(79)40.51%(38)34.23%(41)48.81%0.055aCAD(103)52.82%(57)51.35(46)54.760.834CHFb(27)13.85%(18)16.22%(9)10.71%0.271cCVA(14)7.18%(8)7.21%(6)7.14%1.000Parkinson(4)2.055(3)2.70%(1)1.19%0.636History of dementia(18)9.23%(12)10.81%(6)7.1450.381Kidney failure(31)15.90%(18)16.22%(13)15.48%0.889Liver failure(7)3.59%(5)4.50%(2)2.38%0.701COPD(28)10.81%(12)10.81%16)19.05%)0.148Depression(15)7.69%(7)6.31%(8)9.53%0.461Cancer(8)4.10%(5)4.50%(3)3.57%1.000Frailty Index0.191Very fit(1)0.5%0(1)1.2%Well – without active disease(14)7.2%(7)6.3%(7)8.3%Well, with treated comorbid disease(31)15.9%(20)18%(11)13.1%Apparently vulnerable(52)26.7%(30)27%(22)26.2%Mildly frail(24)12.3%(9)8.1%(15)17.9%Moderately frail,(53)27.2%(30)27%(23) 27.4%Severely frail(20)10.3%(15)13.5%(5)6%Age; mean ± SD (years)5.87 ± 78.536.01 ± 77.755.72 ± 79.120.108SPMSQ score mean ± SD3.30 ± 2.963.50 ± 3.122.73 ± 3.050.288score Digit span mean ± SD4.76 ± 2.284.20 ± 2.855.19 ± 2.810.229ADL-Barthel mean ± SD16.46 ± 5.3716.18 ± 5.2916.83 ± 5.480.015Targeted risk factorsCognition impairment(102)52.2%(59)53.2%(43)51.2%0.217Immobility(114)58.46%(66)59.41%(48)57.140.255Visual impairment(126)64.26%(73)65.77%(53)63.10%0.534Hearing impairment(78)40%(48)43.24%(30)35.71%0.334Dehydration(79)40.5%(41)36.9%(38)45.2%0.242Sleep disorder(88)45.13%(47)42.34%(41)48.81%0.273aCoronary Arty DiseasebChronic Heart FailurecCerebroVascular Accident Table3provides the primary and secondary outcomes during hospitalization. The primary outcomes showed that 18 (9.78%) participants had delirium during hospitalization.Table 3HELP-related outcomes during hospitalization in study groupsOutcomesTotal sample (n= 184)Control group (n= 102)HELP group (n=82)P-valueDelirium (yes/no)18(9.78%)15(14.71%)3(3.66%)0.003FrailtyVery fit(1)0.5%0(1)1.2%< 0.001Well – without active disease(15)8.2%(4)3.9%(11)13.6%Well, with treated comorbid disease(28)15.3%(19)18.6%(9)11.1%Apparently vulnerable(60)32.8%(19)28.4%(31)38.3%Mildly frail(19)10.4%(5)4.9%(14)17.3%Moderately frail(40)21.9%(30)29.4%(10)12.3%Severely frail(20)10.9%(15)14.7%(5)6.2%fall (yes/no)(6).3.3%(4)4%(2)2.5%0.694length of stay in hospital8.02 ± 3.527.62 ± 1.498.00 ± 2.240.196SPMSQ score4.65 ± 1.483.68 ± 2.742.65 ± 2.490.009score Digit span4.63 ± 2.864.19 ± 2.845.18 ± 2.810.021ADL-Barthel score16.01 ± 5.2415.18 ± 5.5917.04 ± 4.590.015Dehydration(73)40.1%(36)35.6%(37)45.7%0.170 The delirium incidence rate was higher in the control group (14.71%) in comparison with the interventiongroup (3.66%) (Odds Ratio [OR] 0.12),P= 0.003). Logistic regression results (after entering age, sex, and frailty variables) showed a statistically significant reduction in the risk of delirium due to the intervention. The results of the logistic regression showed that frailty increased the incidence of delirium (OR: 1.8, CI: 1.16–3.08). According to the Rockwood Frailty Index, at admission time, most of the patients in the interventiongroup (27.4%) and the control group (27%) were at the sixth level of frailty (moderately frail) and there were not any statically significant differences between these groups in this regard. At discharge time, most of the patients in the interventiongroup (38.3%) were at the fourth level of the Rockwood Frailty Index (apparently vulnerable). On theother hand, in the control group, most of the patients were at the sixth level (29.4%) of frailty and there were statically significant differences between the two groups regarding the frailty level (P< 0.001). The results of the logistic regression (after entering age, sex, delirium, and frailty at the admission variables) indicated a statistically significant reduction in the risk of frailty due to the intervention (OR: 0.124, CI: 0.03–0.48). Besides, statically meaningful difference in age (OR: 1.1, CI: 1.002–1.022), delirium (OR: 22.76, CI: 2.10–246.09), and being frail in the admission time (OR: 111.55, CI: 27.14–458.41) observed with frailty indischarge time. Furthermore, the rates of fall in the control group (4%) were higher than the fall rates in the HELP group (% 2.5). Nonetheless, no significant difference was found between the groups concerning the patients’ fall rates. In the selected sample, the mean length of hospitalization was 8.02 days (SD = 3.52). In the intervention group, the length of hospitalization was higher than that of the control group. However, this difference between the groups did not reach the significance level. At the admission time, the differences in the scores on SPMSQ were not statistically significant. Notwithstanding, at the discharge time, the mean score of the incorrect answers on SPMSQ in the intervention group was lower than the mean score of these answers on SPMSQ in the control group and this difference reached the significance level (2.65 vs 3.68, diff mean: 1.02,P= 0.009). At the admission time, the differences in scores on the Digit Span were not statistically significant. However,the mean value of Digit Span in the interventiongroup was more than the mean value of the answers to this test in the control group. At the discharge time, while the mean score of Digit Span increased in the interventiongroup, it decreased in the control group and statistically significant differences were observed between the intervention group and control group regarding the mean value of Digit Span (5.1 vs 4.1, mean diff: 0.987,P= 0.02). Concerning the functional measure, the participants in the intervention group had a higher mean value in ADL-Barthel in comparison with the participants in the control group at the discharge time. Furthermore, a significant difference was observed between the two groups (17.04 (SD: 4.59) vs 15.18 (SD: 5.59), mean diff: 1.86,P= 0.01). However, the mean difference between the groups on ADL-Barthel at admission and discharge times were not statistically significant. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
['PMC8547096'] | ['34702164'] | ['CR31', 'CR32', 'CR33', 'CR34', 'CR35', 'CR36', 'CR37', 'CR33', 'CR33', 'CR38', 'CR39'] | This paper summarizes an example of the successful modification and implementation of a clinical program (HELP). Regarding the feasibility of the Iranian HELP version, the results of the present study showed that it was possible to implement this model in Iran, despite cultural differences and limited human resources. This study indicated that the Hospital Elder Life Program (HELP) is effective in preventing delirium in hospitalized geriatric patients. Moreover, it showed that some modified interventions in the original HELP program could prevent the incidence of delirium. Moreover, our findings showed that the HELP program could recover the frailty syndrome in participated patients in HELP. Chen et al. [31] reported that modified HELP on gastrointestinal surgery older patients decreased the rates of frailty incidence during hospitalization in the HELP group. Moreover, our findings indicated that the Iranian HELP version was affective to protect in cognitive decline. In a study, Huson et al. [32] showed the effectiveness of the HELP program for the elderly patients ≥70 years old who were admitted to a rehabilitation setting and reported that the patients who received the HELP showed greater improvement regarding the cognitive and functional outcomes including short-term memory and recall. In the present study, one of the effective factors which improved the patients’ cognitive abilities was the regular presence of a member of the patient’s family in the patient’s room to provide the patient orientation/ therapeutic activity interventions in the cognitive protocol. Our findings showed that the HELP interventions improved functional abilities among elderly patients in the hospital. In our study, the patients, who received 7 days of HELP interventions, had a one-point increase in ADL –Barthel score. Likewise, a study on the functional benefits of the HELP program reported that the ADL function (assessed by the BI) in the control group decreased by 27.9 points during 2 weeks of hospitalization. However, it decreased by only 11.8 points in the interventiongroup [33]. In our study, there was not a difference in the fall rate between the interventiongroup and the control. In a study (Gorski et al., 2017) that assessed the effectiveness of non-pharmacological multi-components prevention in geriatric hospitalized at an internal ward in Poland, the researchers noticed that there was not a statistically significant difference between the intervention and control groups, viewing in the number of falls during hospitalization (4.61% versus 4.61%;p= 1.00) [34]. Falls in hospitals represent a major patient-safety problem that may complicate a patient’s care and treatment [35]. It seems that most of the hospitals in Iran could follow fall prevention guidelines and apply some of the strategies of the HELP program. The results of our study showed that the HELP did not change the length of hospitalization. Similarly, the study on aged care wards reported that multi-component interventions like HELP could not reduce the length of hospital stay [36]. Several factors such as characteristics of patients’ families [37], decision making by the clinical team, family and patients’ conditions, scarcity of equipment and facilities could influence the discharge of elderly patients. Therefore, to determine the effect of the HELP program on the length of hospital stay, our study needs to continue for a longer period and in other hospitals. Our study has several innovations in comparison with the previous studies. The first one is employing nursing students and family caregivers as volunteers to compensate for the deficit of volunteers in Iran. In addition,nursing studentsasvolunteers were able to learn special care for elderly patients. On the other hand, the selection of nursing students caused us to spend less time training volunteers, and in fact, the process of selecting volunteers became shorter. Second, the other studies like Chen et al. [33], have done some HELP protocols, but we did all of the protocols by modifications. The implementation of all interventions was achieved through the proper management of human resources and facilities. Third, in most of the studies [33,38], the HELP program has been performed in surgical wards, but we implemented it in the internal wards with patients with various diseases. The fourthinnovationof our study was the administration of the interventions through using nursing students rather than the existing ward staff. Consequently, the workload of the nurses did not increase in the HELP program. Moreover, since the program was carried out involving nursing students, it was not costly. The detection of delirium is difficult in routine care [39]. However, our study was standardized using validated and reliable instruments and staff training. This study had several important limitations. First, due to randomly select the patients in the groups of the study, the effectiveness of HELP interventions results should may not real and accurate (because of differentiation in types of high care need and low needs of care) that might not indicate the real result of the interventions. The second limitation was the role of family members in the provision of care and support to elderly patients after their admission to the hospital. We provided some interventions in the HELP group with the help of the family members. Similarly, in the control group, also some family caregivers took care of the patients. | PMC8547096 | Research | null | 34,702,164 | The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial | Kojaie-Bidgoli A, Sharifi F, Maghsoud F, Alizadeh-Khoei M, Jafari F, Sadeghi F. | BMC Geriatr. 2021 Oct 26;21(1):599. doi: 10.1186/s12877-021-02520-3. | Kojaie-Bidgoli A | BMC Geriatr | 2,021 | 2021/10/27 | PMC8547096 | null | 10.1186/s12877-021-02520-3 | oa_comm/txt/all/PMC8547096.txt | a235e65a92b7aa54f500b8cab803448c | BMC Geriatr. 2021 Oct 26; 21:599 | 2021-11-05 06:50:01 | CC BY | no |
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