An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.
An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial.
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DOI：
10.1186/s13063-017-1797-7
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发表时间：
2017-03-28
期刊：
影响因子：
2.5
通讯作者：
Graffy J
中科院分区：
文献类型：
--
作者：
Cockayne S;Fairhurst C;Adamson J;Hewitt C;Hull R;Hicks K;Keenan AM;Lamb SE;Green L;McIntosh C;Menz HB;Redmond AC;Rodgers S;Torgerson DJ;Vernon W;Watson J;Knapp P;Rick J;Bower P;Eldridge S;Madurasinghe VW;Graffy J
随机对照试验通常被认为是确定干预效果的“黄金标准”实验设计。不幸的是，许多试验要么未能招募到足够数量的参与者，要么招募时间比预期的要长。目前的嵌入式试验评估了优化的患者信息表在招募跌倒预防试验参与者方面的有效性。一项三臂嵌入式随机方法学试验是在国家健康研究所资助的使用矫形器减少跌倒和多方面足科干预(REGATE)队列随机对照试验中进行的。65岁以上的国家卫生服务足科常规患者被随机分为两组，一组是接受东道主试验的对照患者信息表(PIS)，另一组是两个优化版本中的一个，即定制的用户测试PIS或模板开发的PIS。主要结果是每组中随机进入宿主试验的患者的比例。6,900名患者以1：1：1的比例随机进入嵌入试验。共有193人(2.8%)随机进入主要改革试验(对照n = 62，模板开发n = 68；定制用户测试n = 63)。信息表的分配并没有改善试验的招募情况(三个配对比较的优势比：模板与对照1.10(95%CI 0.77-1.56，p = 0.60)；用户测试vs对照1.01(95%CI 0.71-1.45，p = 0.94)；以及用户测试vs模板0.92(95%CI 0.65-1.31，p = 0.65))。这一嵌入式方法试验显示，在改革研究中使用关于征聘和保留率的优化信息材料的益处的证据有限。国际标准随机对照试验号码登记，ISRCTN68240461。于2011年7月1日注册。本文的在线版本(doi：10.1186/s13063-017-1797-7)包含补充材料，授权用户可以使用。
Randomised controlled trials are generally regarded as the ‘gold standard’ experimental design to determine the effectiveness of an intervention. Unfortunately, many trials either fail to recruit sufficient numbers of participants, or recruitment takes longer than anticipated. The current embedded trial evaluates the effectiveness of optimised patient information sheets on recruitment of participants in a falls prevention trial. A three-arm, embedded randomised methodology trial was conducted within the National Institute for Health Research-funded REducing Falls with ORthoses and a Multifaceted podiatry intervention (REFORM) cohort randomised controlled trial. Routine National Health Service podiatry patients over the age of 65 were randomised to receive either the control patient information sheet (PIS) for the host trial or one of two optimised versions, a bespoke user-tested PIS or a template-developed PIS. The primary outcome was the proportion of patients in each group who went on to be randomised to the host trial. Six thousand and nine hundred patients were randomised 1:1:1 into the embedded trial. A total of 193 (2.8%) went on to be randomised into the main REFORM trial (control n = 62, template-developed n = 68; bespoke user-tested n = 63). Information sheet allocation did not improve recruitment to the trial (odds ratios for the three pairwise comparisons: template vs control 1.10 (95% CI 0.77–1.56, p = 0.60); user-tested vs control 1.01 (95% CI 0.71–1.45, p = 0.94); and user-tested vs template 0.92 (95% CI 0.65–1.31, p = 0.65)). This embedded methodology trial has demonstrated limited evidence as to the benefit of using optimised information materials on recruitment and retention rates in the REFORM study. International Standard Randomised Controlled Trials Number registry, ISRCTN68240461. Registered on 01 July 2011. The online version of this article (doi:10.1186/s13063-017-1797-7) contains supplementary material, which is available to authorized users.