Cargando…

Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm

BACKGROUND: Clinical equipoise, also defined as the uncertainty principle, is considered essential when recruiting subjects to a clinical trial. However, equipoise is threatened when clinicians are influenced by their own preferences. Little research has investigated equipoise in the context of tria...

Descripción completa

Detalles Bibliográficos
Autores principales: Memon, Rakhshi, Asif, Muqaddas, Pitman, Alexandra, Chaudhry, Nasim, Husain, Nusrat, Edwards, Sarah J. L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10408059/
https://www.ncbi.nlm.nih.gov/pubmed/37553645
http://dx.doi.org/10.1186/s13063-023-07397-8
_version_ 1785086101299396608
author Memon, Rakhshi
Asif, Muqaddas
Pitman, Alexandra
Chaudhry, Nasim
Husain, Nusrat
Edwards, Sarah J. L.
author_facet Memon, Rakhshi
Asif, Muqaddas
Pitman, Alexandra
Chaudhry, Nasim
Husain, Nusrat
Edwards, Sarah J. L.
author_sort Memon, Rakhshi
collection PubMed
description BACKGROUND: Clinical equipoise, also defined as the uncertainty principle, is considered essential when recruiting subjects to a clinical trial. However, equipoise is threatened when clinicians are influenced by their own preferences. Little research has investigated equipoise in the context of trial recruitment. METHODS: This cross-sectional survey sought clinicians’ views (operationalised as 11 statements relating to treatments offered in a trial of a psychological intervention for young people) about equipoise and individual treatment preferences in the context of moral justification for recruiting young people at risk of self-harm or suicide to a randomised controlled trial (RCT) to evaluate the Youth Culturally Adapted Manual Assisted Psychological Intervention (Y-CMAP) in Pakistan. We compared the views of clinicians involved in Y-CMAP RCT recruitment to those of a sample of clinicians not involved in trial recruitment but treating similar patients, comparing their sociodemographic characteristics and the proportions of those in each group agreeing with each statement. RESULTS: There was a response rate of 96% (75/78). Findings showed that, during trial recruitment and before the RCT results were known, the majority of all responding clinicians (73.3%) considered Y-CMAP to be an effective treatment for young people at risk of self-harm or suicide. Although there was an acknowledgement of individual preferences for the intervention, there was near consensus (90%) on the need to conduct an RCT for reaching an evidence-based decision. However, there were no significant differences in the proportion of recruiting clinicians reporting a treatment preference for Y-CMAP than non-recruiting clinicians (31 (88.6%) versus 36 (90%), p = 0.566). A significantly higher proportion of non-recruiting clinicians (87.5%) as compared to (48.5%) in the trial (p = 0.000) stated that there may be other treatments that may be equally good for the patients, seemingly undermining a preference for the intervention. Those reporting a treatment preference also acknowledged that there was nothing on which this preference was based, however confident they felt about them, thus accepting clinical equipoise as ethical justification for conducting the RCT. There was a significant group difference in views that treatment overall is better as a result of young patients’ participation in the Y-CMAP trial (p = 0.015) (i.e. more clinicians not involved in the trial agreed with this statement). Similarly, more clinicians not involved in the trial agreed on the perceived availability of other treatment options that were good for young people at risk of self-harm (p < 0.05). CONCLUSIONS: The paper highlights that clinicians in Pakistan accept the notion of clinical equipoise as an ethical justification for patient participation in RCTs. The need for conducting RCTs to generate evidence base and to reduce bias was considered important by the clinical community.
format Online
Article
Text
id pubmed-10408059
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-104080592023-08-09 Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm Memon, Rakhshi Asif, Muqaddas Pitman, Alexandra Chaudhry, Nasim Husain, Nusrat Edwards, Sarah J. L. Trials Research BACKGROUND: Clinical equipoise, also defined as the uncertainty principle, is considered essential when recruiting subjects to a clinical trial. However, equipoise is threatened when clinicians are influenced by their own preferences. Little research has investigated equipoise in the context of trial recruitment. METHODS: This cross-sectional survey sought clinicians’ views (operationalised as 11 statements relating to treatments offered in a trial of a psychological intervention for young people) about equipoise and individual treatment preferences in the context of moral justification for recruiting young people at risk of self-harm or suicide to a randomised controlled trial (RCT) to evaluate the Youth Culturally Adapted Manual Assisted Psychological Intervention (Y-CMAP) in Pakistan. We compared the views of clinicians involved in Y-CMAP RCT recruitment to those of a sample of clinicians not involved in trial recruitment but treating similar patients, comparing their sociodemographic characteristics and the proportions of those in each group agreeing with each statement. RESULTS: There was a response rate of 96% (75/78). Findings showed that, during trial recruitment and before the RCT results were known, the majority of all responding clinicians (73.3%) considered Y-CMAP to be an effective treatment for young people at risk of self-harm or suicide. Although there was an acknowledgement of individual preferences for the intervention, there was near consensus (90%) on the need to conduct an RCT for reaching an evidence-based decision. However, there were no significant differences in the proportion of recruiting clinicians reporting a treatment preference for Y-CMAP than non-recruiting clinicians (31 (88.6%) versus 36 (90%), p = 0.566). A significantly higher proportion of non-recruiting clinicians (87.5%) as compared to (48.5%) in the trial (p = 0.000) stated that there may be other treatments that may be equally good for the patients, seemingly undermining a preference for the intervention. Those reporting a treatment preference also acknowledged that there was nothing on which this preference was based, however confident they felt about them, thus accepting clinical equipoise as ethical justification for conducting the RCT. There was a significant group difference in views that treatment overall is better as a result of young patients’ participation in the Y-CMAP trial (p = 0.015) (i.e. more clinicians not involved in the trial agreed with this statement). Similarly, more clinicians not involved in the trial agreed on the perceived availability of other treatment options that were good for young people at risk of self-harm (p < 0.05). CONCLUSIONS: The paper highlights that clinicians in Pakistan accept the notion of clinical equipoise as an ethical justification for patient participation in RCTs. The need for conducting RCTs to generate evidence base and to reduce bias was considered important by the clinical community. BioMed Central 2023-08-08 /pmc/articles/PMC10408059/ /pubmed/37553645 http://dx.doi.org/10.1186/s13063-023-07397-8 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Memon, Rakhshi
Asif, Muqaddas
Pitman, Alexandra
Chaudhry, Nasim
Husain, Nusrat
Edwards, Sarah J. L.
Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm
title Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm
title_full Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm
title_fullStr Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm
title_full_unstemmed Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm
title_short Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm
title_sort is equipoise a useful concept to justify randomised controlled trials in the cultural context of pakistan? a survey of clinicians in relation to a trial of talking therapy for young people who self-harm
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10408059/
https://www.ncbi.nlm.nih.gov/pubmed/37553645
http://dx.doi.org/10.1186/s13063-023-07397-8
work_keys_str_mv AT memonrakhshi isequipoiseausefulconcepttojustifyrandomisedcontrolledtrialsintheculturalcontextofpakistanasurveyofcliniciansinrelationtoatrialoftalkingtherapyforyoungpeoplewhoselfharm
AT asifmuqaddas isequipoiseausefulconcepttojustifyrandomisedcontrolledtrialsintheculturalcontextofpakistanasurveyofcliniciansinrelationtoatrialoftalkingtherapyforyoungpeoplewhoselfharm
AT pitmanalexandra isequipoiseausefulconcepttojustifyrandomisedcontrolledtrialsintheculturalcontextofpakistanasurveyofcliniciansinrelationtoatrialoftalkingtherapyforyoungpeoplewhoselfharm
AT chaudhrynasim isequipoiseausefulconcepttojustifyrandomisedcontrolledtrialsintheculturalcontextofpakistanasurveyofcliniciansinrelationtoatrialoftalkingtherapyforyoungpeoplewhoselfharm
AT husainnusrat isequipoiseausefulconcepttojustifyrandomisedcontrolledtrialsintheculturalcontextofpakistanasurveyofcliniciansinrelationtoatrialoftalkingtherapyforyoungpeoplewhoselfharm
AT edwardssarahjl isequipoiseausefulconcepttojustifyrandomisedcontrolledtrialsintheculturalcontextofpakistanasurveyofcliniciansinrelationtoatrialoftalkingtherapyforyoungpeoplewhoselfharm