Sharp L, Cotton S C, Alexander L, Williams E, Gray N M, Reid J M
National Cancer Registry Ireland, Cork, Ireland.
Clin Trials. 2006;3(5):431-42. doi: 10.1177/1740774506070812.
Better understanding of motivators for, and barriers to, participation in randomized controlled trials (RCTs) in different study populations and settings has the potential to improve participation of historically under-represented groups (eg, women) in future trials.
To investigate reasons why women agreed, or declined, to participate in a RCT.
In two postal questionnaire-based studies, we investigated women's reasons for participation or non-participation in TOMBOLA, a RCT comparing management policies for low-grade cervical abnormalities. Four-hundred and ninety-two TOMBOLA participants (response rate 56%) completed questionnaires on reasons for participation. One-hundred and thiry-seven women (38%) who declined TOMBOLA participation completed questionnaires on reasons for this.
Eighty percent of women reported that one of their reasons for attending their TOMBOLA recruitment appointment was worries about their smear result. Ninety-four percent participated in the RCT because it was a worthwhile contribution to the cervical screening programme and other women; for 70% this was the most important reason. These proportions did not vary by socio-demographic factors. Thirty-two percent thought participation would result in better care. The most common reason for non-participation was preference for follow-up from the woman's GP. Logistical issues (eg, inconvenient appointments, travel time, arranging time off work or child-care) were commonly cited. Fourteen percent were too frightened to participate; this was unrelated to the grade of the recruitment smear.
Response rates were not high, but there was little evidence of response bias. Structured questionnaires were used.
Future research should address how best to deliver information to ensure different social groups appreciate potential benefits of RCT participation and provide reassurance regarding fears about participation. Simple strategies (eg, appealing to the altruism of potential participants or offering flexible recruitment clinic locations and times) might enhance RCT recruitment rates. This in turn would ensure best use of research resources thus bringing the greatest benefits to participants and the population.
更好地了解不同研究人群和环境中参与随机对照试验（RCT）的动机和障碍，有可能提高历史上代表性不足的群体（如女性）在未来试验中的参与率。
调查女性同意或拒绝参与RCT的原因。
在两项基于邮寄问卷的研究中，我们调查了女性参与或不参与TOMBOLA（一项比较低度宫颈异常管理政策的RCT）的原因。492名TOMBOLA参与者（回复率56%）完成了关于参与原因的问卷。137名拒绝参与TOMBOLA的女性（38%）完成了关于拒绝原因的问卷。
80%的女性表示，她们参加TOMBOLA招募预约的原因之一是担心自己的涂片结果。94%的女性参与RCT是因为这对宫颈筛查计划和其他女性有价值；对70%的女性来说，这是最重要的原因。这些比例不因社会人口因素而有所不同。32%的女性认为参与会带来更好的护理。不参与的最常见原因是更倾向于由女性的全科医生进行后续跟进。后勤问题（如预约不方便、出行时间、安排请假或 childcare）经常被提及。14%的女性因过于害怕而不愿参与；这与招募涂片的分级无关。
回复率不高，但几乎没有证据表明存在回复偏差。使用了结构化问卷。
未来的研究应探讨如何以最佳方式提供信息，以确保不同社会群体认识到参与RCT的潜在益处，并消除对参与的担忧。简单的策略（如唤起潜在参与者的利他主义或提供灵活的招募诊所地点和时间）可能会提高RCT的招募率。这反过来将确保研究资源的最佳利用，从而为参与者和人群带来最大利益。
