University College London (UCL), London, UK.
Pakistan Institute of Living and Learning (PILL), Karachi, Pakistan.
Trials. 2023 Aug 8;24(1):506. doi: 10.1186/s13063-023-07397-8.
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.
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.
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).
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.
临床均衡，也被定义为不确定性原则，被认为是招募临床试验受试者时必不可少的。然而，当临床医生受到自身偏好的影响时，均衡就会受到威胁。很少有研究调查过试验招募中的均衡问题。
本横断面调查研究了临床医生的观点（通过与在一项针对年轻人的心理干预试验中提供的 11 种治疗方法相关的 11 项陈述来操作），这些观点涉及在为有自伤或自杀风险的年轻人招募到一项随机对照试验（RCT）中进行道德辩护的情况下，临床试验中的均衡和个人治疗偏好，以评估在巴基斯坦开展的青年文化适应手动辅助心理干预（Y-CMAP）试验。我们比较了参与 Y-CMAP RCT 招募的临床医生的观点与未参与试验招募但治疗类似患者的临床医生样本的观点，比较了他们的社会人口学特征以及每组中同意每个陈述的比例。
回应率为 96%（75/78）。研究结果表明，在试验招募期间且在 RCT 结果公布之前，大多数参与回应的临床医生（73.3%）认为 Y-CMAP 是一种对有自伤或自杀风险的年轻人有效的治疗方法。尽管人们承认对干预措施有个人偏好，但几乎达成共识（90%）需要进行 RCT 以做出基于证据的决策。然而，与非招募临床医生相比，报告对 Y-CMAP 治疗偏好的招募临床医生的比例没有显著差异（31（88.6%）与 36（90%），p=0.566）。与试验中的（48.5%）相比，非招募临床医生（87.5%）表示可能有其他同等适合患者的治疗方法的比例更高（p=0.000），这似乎削弱了对干预措施的偏好。那些报告治疗偏好的人也承认，他们的偏好没有任何依据，无论他们对此感觉多么有信心，因此他们接受临床均衡作为进行 RCT 的伦理辩护。在认为治疗总体上因年轻患者参与 Y-CMAP 试验而更好的观点上存在显著的组间差异（p=0.015）（即更多未参与试验的临床医生同意这一说法）。同样，更多未参与试验的临床医生同意存在其他对有自伤风险的年轻人有益的治疗选择的看法（p<0.05）。
本文强调，巴基斯坦的临床医生接受了临床均衡作为患者参与 RCT 的伦理辩护的概念。临床界认为，需要进行 RCT 以产生证据基础并减少偏倚。
