制定试验随访程序的简单步骤。
Simple steps to develop trial follow-up procedures.
作者信息
McCarthy Ona, French Rebecca S, Roberts Ian, Free Caroline
机构信息
Department of Population Health, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, United Kingdom.
Department of Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
出版信息
Trials. 2016 Jan 15;17:28. doi: 10.1186/s13063-016-1155-1.
BACKGROUND
Loss to follow-up in randomised controlled trials reduces statistical power and increases the potential for bias. Almost half of all trials fail to achieve their follow-up target. Statistical methods have been described for handling losses to follow-up and systematic reviews have identified interventions that increase follow-up. However, there is little guidance on how to develop practical follow-up procedures. This paper describes the development of follow-up procedures in a pilot randomised controlled trial of a sexual health intervention that required participants to provide and return questionnaires and chlamydia test samples in the post. We identified effective methods to increase follow-up from systematic reviews. We developed and tested prototype procedures to identify barriers to follow-up completion. We asked trial participants about their views on our follow-up procedures and revised the methods accordingly.
RESULTS
We identified 17 strategies to increase follow-up and employed all but five. We found that some postal test kits do not fit through letterboxes and that that the test instructions were complicated. After identifying the appropriate sized test kit and simplifying the instructions, we obtained user opinions. Users wanted kits to be sent in coloured envelopes (so that they could identify them easily), with simple instructions and questionnaires and wanted to be notified before we sent the kits. We achieved 92 % (183/200) overall follow-up for the postal questionnaire at 1 month and 82 % (163/200) at 12 months. We achieved 86 % (171/200) overall follow-up for the postal chlamydia test at 3 months and 80 % (160/200) at 12 months.
CONCLUSIONS
By using established methods to increase follow-up, testing prototype procedures and seeking user opinions, we achieved higher follow-up than previous sexual health trials. However, it is not possible to determine if the increase in response was due to our follow-up procedures.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN02304709 Date of registration: 27 March 2013.
背景
随机对照试验中的失访会降低统计效力并增加偏倚风险。几乎一半的试验未能达成其随访目标。已有统计方法用于处理失访情况，系统评价也已确定了可提高随访率的干预措施。然而，关于如何制定切实可行的随访程序，指导意见却很少。本文描述了一项性健康干预试点随机对照试验中随访程序的制定过程，该试验要求参与者通过邮寄方式提供并返还问卷及衣原体检测样本。我们从系统评价中确定了提高随访率的有效方法。我们开发并测试了原型程序，以识别完成随访的障碍。我们询问了试验参与者对我们随访程序的看法，并据此对方法进行了修订。
结果
我们确定了17种提高随访率的策略，除5种外全部采用。我们发现一些邮寄检测试剂盒无法通过信箱投递，且检测说明复杂。在确定了合适尺寸的检测试剂盒并简化说明后，我们征求了用户意见。用户希望试剂盒用彩色信封寄送（以便轻松识别），附带简单的说明和问卷，并希望在我们寄送试剂盒之前得到通知。对于邮寄问卷，1个月时的总体随访率达到92%（183/200），12个月时为82%（163/200）。对于邮寄衣原体检测，3个月时的总体随访率达到86%（171/200），12个月时为80%（160/200）。
结论
通过使用既定方法提高随访率、测试原型程序并征求用户意见，我们取得了比以往性健康试验更高的随访率。然而，无法确定回复率的提高是否归因于我们的随访程序。
试验注册
当前受控试验ISRCTN02304709 注册日期：2013年3月27日。
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