Eldridge Sandra M, Ashby Deborah, Feder Gene S
Centre for General Practice and Primary Care, Institute of Community Health Sciences, Queen Mary, University of London, UK.
Clin Trials. 2005;2(2):91-8. doi: 10.1191/1740774505cn070oa.
Cluster randomized trials are increasingly common. Obtaining informed patient consent to participation in these trials raises practical challenges and ethical issues. The aims of this paper were to 1) develop a typology of interventions employed in cluster randomized trials in primary care; 2) assess whether the likelihood of seeking individual consent to participation varies by intervension type; 3) assess whether this likelihood has increased over time; 4) assess evidence for under reporting of consent procedures; 5) articulate reasons for not obtaining consent; and 6) make recommendations for future trial investigators. We collected data on trial interventions and consent procedures from reports of 152 recently published trials, and 47 unpublished trials. We develop a typology of interventions based on reasons for adopting a clustered design. We examine proportions seeking individual consent to participation among trials involving different types of intervention, in different periods, and among published and unpublished trials. Two-thirds of the trials had multifaceted interventions. Trials involving different types of intervention had different propensities to seek consent, largely because of practical obstacles to obtaining consent. Obtaining consent can compromise internal validity. More recent trials are no more likely to obtain consent than past trials. There was no evidence of under-reporting of consent procedures in publications. In conclusion, future trial investigators should consider both practical reasons and scientific arguments for not obtaining individual patient consent for all interventions in their trials. Where feasible, they should allow patients to opt out of the trial. Lay individuals should represent trial participants as part of the process of cluster consent to participation, and lay individuals could also be involved in considering ethical issues during trial planning. A more public debate may clarify the general acceptability of not obtaining consent in certain situations.
整群随机试验越来越普遍。获得患者对参与这些试验的知情同意带来了实际挑战和伦理问题。本文的目的是：1）构建基层医疗整群随机试验中所采用干预措施的类型学；2）评估寻求个体参与同意的可能性是否因干预类型而异；3）评估这种可能性是否随时间增加；4）评估同意程序报告不足的证据；5）阐明未获得同意的原因；6）为未来的试验研究者提出建议。我们从152项近期发表的试验报告和47项未发表的试验中收集了关于试验干预措施和同意程序的数据。我们基于采用整群设计的原因构建了干预措施的类型学。我们研究了在不同类型干预、不同时期以及已发表和未发表试验中寻求个体参与同意的比例。三分之二的试验有多方面的干预措施。涉及不同类型干预的试验寻求同意的倾向不同，主要是因为获得同意存在实际障碍。获得同意可能会损害内部效度。与过去的试验相比，近期的试验获得同意的可能性并没有更高。在已发表的文献中没有证据表明同意程序报告不足。总之，未来的试验研究者应考虑在试验中不对所有干预措施寻求个体患者同意的实际原因和科学论据。在可行的情况下，他们应允许患者退出试验。非专业人员应作为整群参与同意过程的一部分代表试验参与者，并且非专业人员也可参与试验规划期间的伦理问题考量。更公开的辩论可能会阐明在某些情况下不获得同意的普遍可接受性。
