Bill-Axelson Anna, Christensson Anna, Carlsson Marianne, Norlén Bo Johan, Holmberg Lars
Department of Urology, Uppsala University Hospital, Uppsala, Sweden.
Scand J Urol Nephrol. 2008;42(4):358-63. doi: 10.1080/00365590801950253.
Recruitment of both patients and clinicians to randomized trials is difficult. Low participation carries the risk of terminating studies early and making them invalid owing to insufficient statistical power. This study investigated patients' and clinicians' experiences of randomization with the aim of facilitating trial participation in the future.
This was a qualitative study using content analysis. Patients offered to participate in a randomized trial and randomizing clinicians were interviewed. Five participants, four non-participants and five randomizing clinicians were interviewed, 2-8 years from randomization.
Clinicians used strategies in interaction with the patients to facilitate decision making. Patients' attitudes differed and experiences of relatives or friends were often stated as reasons for treatment preferences. Patients described that letting chance decide treatment was a difficult barrier to overcome for randomization. The clinicians used a number of different strategies perceived to make randomization more acceptable to their patients. The clinicians' own motivation for randomizing patients for trials depended on the medical relevance of the study question and the clinicians' major obstacle was to maintain equipoise over time. Regular meetings with the study group helped to maintain equipoise and motivation.
To establish a good platform for randomization the clinician needs to know about the patient's treatment preferences and the patient's attitude concerning the role of the clinician to facilitate decision making. The strategies used by the clinicians were perceived as helpful and could be tested in an intervention study.
招募患者和临床医生参与随机试验很困难。参与率低存在提前终止研究并因统计效力不足而使其无效的风险。本研究调查了患者和临床医生对随机分组的体验，旨在促进未来的试验参与。
这是一项采用内容分析法的定性研究。对主动提出参与随机试验的患者以及进行随机分组的临床医生进行了访谈。访谈了5名参与者、4名非参与者和5名进行随机分组的临床医生，访谈时间距离随机分组2至8年。
临床医生在与患者互动时采用策略以促进决策。患者的态度各不相同，亲属或朋友的经历常被作为治疗偏好的理由。患者表示让机会决定治疗是随机分组难以克服的障碍。临床医生采用了一些不同的策略，以使随机分组更容易被患者接受。临床医生将患者随机分组参与试验的自身动机取决于研究问题的医学相关性，而临床医生的主要障碍是长期保持 equipoise（平衡）。与研究小组定期开会有助于维持平衡和积极性。
为建立一个良好的随机分组平台，临床医生需要了解患者的治疗偏好以及患者对临床医生在促进决策中所起作用的态度。临床医生使用的策略被认为是有帮助的，可以在干预研究中进行测试。
