Mills Nicola, Donovan Jenny L, Smith Monica, Jacoby Ann, Neal David E, Hamdy Freddie C
Department of Social Medicine, University of Bristol, Canynge Hall, Whiteladies Road, Bristol BS8 2PR, United Kingdom.
Control Clin Trials. 2003 Jun;24(3):272-82. doi: 10.1016/s0197-2456(03)00020-5.
Recruitment to trials is known to be difficult. Previous research suggests that a crucial factor may be participants' difficulty with the concept of randomization. This study explored patients' perceptions of randomization and reasons for consent or refusal to participate in the ProtecT study (a randomized trial of surgery, radiotherapy, and monitoring for localized prostate cancer). In-depth interviews were conducted with 21 men diagnosed with localized prostate cancer who were invited to participate in the ProtecT treatment trial. Interviewees were selected purposefully from three U.K. clinical centers to ensure the inclusion of similar proportions of those agreeing or refusing random treatment allocation in each of the treatment groups. Interviews explored men's recall and understanding of chance, comparison, and equipoise, and reasons for consent/refusal of randomization and acceptance/rejection of treatment allocation. Data were analyzed methodically using the techniques of constant comparison. Checking of coding and interpretation was assured by four experienced qualitative researchers. Recall and understanding of the major principles of the randomized design were good and were similar for "chance" and "comparison" between those who consented to and refused randomization. Clinical equipoise, however, caused difficulty. Almost all recalled and understood it, but those who found it acceptable tended to consent to randomization and those who could not accept it tended to refuse to participate. Belief in clinical equipoise was key to participants' consent to randomization. Ensuring patients understand and accept equipoise may thus increase their readiness to consent to participate in trials. A priority for future research is to focus on the provision and presentation of suitable and effective trial information, concentrating in particular on the neglected concept of clinical equipoise.
众所周知，招募受试者参与试验很困难。先前的研究表明，一个关键因素可能是受试者难以理解随机化的概念。本研究探讨了患者对随机化的看法以及同意或拒绝参与ProtecT研究（一项针对局限性前列腺癌的手术、放疗和监测的随机试验）的原因。对21名被诊断为局限性前列腺癌且被邀请参与ProtecT治疗试验的男性进行了深入访谈。受访者是从英国的三个临床中心有目的地挑选出来的，以确保每个治疗组中同意或拒绝随机治疗分配的比例相似。访谈探讨了男性对机会、比较和 equipoise 的回忆与理解，以及同意/拒绝随机化和接受/拒绝治疗分配的原因。使用持续比较技术对数据进行了系统分析。由四位经验丰富的定性研究人员确保编码和解释的准确性。对于同意和拒绝随机化的人来说，对随机设计主要原则的回忆和理解都很好，并且在“机会”和“比较”方面相似。然而，临床 equipoise 造成了困难。几乎所有人都回忆并理解了它，但那些认为它可以接受的人倾向于同意随机化，而那些无法接受的人倾向于拒绝参与。对临床 equipoise 的信任是参与者同意随机化的关键。因此，确保患者理解并接受equipoise可能会增加他们同意参与试验的意愿。未来研究的一个重点是关注提供和呈现合适且有效的试验信息，尤其要关注被忽视的临床equipoise概念。
