Is equipoise a useful concept to justify RCTs in a different cultural context? A survey of clinicians in Pakistan in relation to an RCT of talking therapy for self-harm

Abstract

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 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 Clinical Trial (RCT) to evaluate the Youth Culturally Adapted Manual Assisted Psychological Intervention (Y-CMAP) in Pakistan. We compared the views (11 statements relating to the clinical care of young people at risk of suicide and self-harm) of clinicians involved in RCT recruitment to those of a sample of clinicians not involved in trial recruitment, comparing their sociodemographic characteristics and the proportions of those in each group agreeing with each statement. Results There was a response rate of 96%. 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 patients at risk of self-harm or suicide. Although there was 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 similar clinicians treating patients not involved in the trial 31(88.6%) versus 36 (90%), p = 0.566). A significantly higher percentage of health professionals (87.5%) not involved in YCMAP as compared to (48.5%) in the trial (p = .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 importantly acknowledged that there was nothing on which their preference was based, however confident they felt about them, thus accepting clinical equipoise as moral 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), and in on 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. These findings have important implications for researchers conducting RCTs and for the robustness of trial findings.