Cockayne Sarah, Fairhurst Caroline, Adamson Joy, Hewitt Catherine, Hull Robin, Hicks Kate, Keenan Anne-Maree, Lamb Sarah E, Green Lorraine, McIntosh Caroline, Menz Hylton B, Redmond Anthony C, Rodgers Sara, Torgerson David J, Vernon Wesley, Watson Judith, Knapp Peter, Rick Jo, Bower Peter, Eldridge Sandra, Madurasinghe Vichithranie W, Graffy Jonathan
Department of Health Sciences, York Trials Unit, University of York, York, YO10 5DD, UK.
Podiatry Services, Harrogate and District NHS Foundation Trust, Harrogate District Hospital, Lancaster Park Road, Harrogate, UK.
Trials. 2017 Mar 28;18(1):144. doi: 10.1186/s13063-017-1797-7.
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.
随机对照试验通常被视为确定干预措施有效性的“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更长。当前的嵌入式试验评估了优化后的患者信息表对预防跌倒试验中参与者招募的有效性。
在英国国家卫生研究院资助的“使用矫形器和多方面足病学干预减少跌倒（REFORM）”队列随机对照试验中进行了一项三臂嵌入式随机方法试验。65岁以上的常规国民保健服务足病患者被随机分配，以接收主试验的对照患者信息表（PIS）或两个优化版本之一，即定制的经过用户测试的PIS或模板开发的PIS。主要结局是每组中继续被随机分配到主试验的患者比例。
6900名患者以1:1:1的比例被随机分配到嵌入式试验中。共有193名（2.8%）继续被随机分配到主要的REFORM试验中（对照组n = 62，模板开发组n = 68；定制用户测试组n = 63）。信息表分配并未改善试验的招募情况（三组两两比较的优势比：模板组与对照组为1.10（95%CI 0.77 - 1.56，p = 0.60）；用户测试组与对照组为1.01（95%CI 0.71 - 1.45，p = 0.94）；用户测试组与模板组为0.92（95%CI 0.65 - 1.31，p = 0.65））。
这项嵌入式方法试验表明，关于在REFORM研究中使用优化信息材料对招募和保留率的益处，证据有限。
国际标准随机对照试验编号注册库，ISRCTN68240461。于2011年7月1日注册。
