Brueton V C, Tierney J F, Stenning S, Meredith S, Harding S, Nazareth I, Rait G
MRC Clinical Trials Unit at UCL, London, UK.
BMJ Open. 2014 Feb 4;4(2):e003821. doi: 10.1136/bmjopen-2013-003821.
To quantify the effect of strategies to improve retention in randomised trials.
Systematic review and meta-analysis.
Sources searched: MEDLINE, EMBASE, PsycINFO, DARE, CENTRAL, CINAHL, C2-SPECTR, ERIC, PreMEDLINE, Cochrane Methodology Register, Current Controlled Trials metaRegister, WHO trials platform, Society for Clinical Trials (SCT) conference proceedings and a survey of all UK clinical trial research units.
Included trials were randomised evaluations of strategies to improve retention embedded within host randomised trials. The primary outcome was retention of trial participants. Data from trials were pooled using the fixed-effect model. Subgroup analyses were used to explore the heterogeneity and to determine whether there were any differences in effect by the type of strategy.
38 retention trials were identified. Six broad types of strategies were evaluated. Strategies that increased postal questionnaire responses were: adding, that is, giving a monetary incentive (RR 1.18; 95% CI 1.09 to 1.28) and higher valued incentives (RR 1.12; 95% CI 1.04 to 1.22). Offering a monetary incentive, that is, an incentive given on receipt of a completed questionnaire, also increased electronic questionnaire response (RR 1.25; 95% CI 1.14 to 1.38). The evidence for shorter questionnaires (RR 1.04; 95% CI 1.00 to 1.08) and questionnaires relevant to the disease/condition (RR 1.07; 95% CI 1.01 to 1.14) is less clear. On the basis of the results of single trials, the following strategies appeared effective at increasing questionnaire response: recorded delivery of questionnaires (RR 2.08; 95% CI 1.11 to 3.87); a 'package' of postal communication strategies (RR 1.43; 95% CI 1.22 to 1.67) and an open trial design (RR 1.37; 95% CI 1.16 to 1.63). There is no good evidence that the following strategies impact on trial response/retention: adding a non-monetary incentive (RR=1.00; 95% CI 0.98 to 1.02); offering a non-monetary incentive (RR=0.99; 95% CI 0.95 to 1.03); 'enhanced' letters (RR=1.01; 95% CI 0.97 to 1.05); monetary incentives compared with offering prize draw entry (RR=1.04; 95% CI 0.91 to 1.19); priority postal delivery (RR=1.02; 95% CI 0.95 to 1.09); behavioural motivational strategies (RR=1.08; 95% CI 0.93 to 1.24); additional reminders to participants (RR=1.03; 95% CI 0.99 to 1.06) and questionnaire question order (RR=1.00, 0.97 to 1.02). Also based on single trials, these strategies do not appear effective: a telephone survey compared with a monetary incentive plus questionnaire (RR=1.08; 95% CI 0.94 to 1.24); offering a charity donation (RR=1.02, 95% CI 0.78 to 1.32); sending sites reminders (RR=0.96; 95% CI 0.83 to 1.11); sending questionnaires early (RR=1.10; 95% CI 0.96 to 1.26); longer and clearer questionnaires (RR=1.01, 0.95 to 1.07) and participant case management by trial assistants (RR=1.00; 95% CI 0.97 to 1.04).
Most of the trials evaluated questionnaire response rather than ways to improve participants return to site for follow-up. Monetary incentives and offers of monetary incentives increase postal and electronic questionnaire response. Some strategies need further evaluation. Application of these results would depend on trial context and follow-up procedures.
量化提高随机试验中受试者留存率的策略效果。
系统评价与荟萃分析。
检索的来源有:医学期刊数据库(MEDLINE)、荷兰医学文摘数据库(EMBASE)、心理学文摘数据库(PsycINFO)、循证医学数据库(DARE)、考克兰中心对照试验注册库(CENTRAL)、护理学与健康领域数据库(CINAHL)、C2 - 光谱数据库(C2 - SPECTR)、教育资源信息中心数据库(ERIC)、医学预印本数据库(PreMEDLINE)、考克兰方法学注册库、当前对照试验元注册库、世界卫生组织试验平台、临床试验协会(SCT)会议论文集以及对所有英国临床试验研究单位的一项调查。
纳入的试验为嵌入在主要随机试验中的提高留存率策略的随机评估。主要结局是试验参与者的留存情况。试验数据采用固定效应模型进行汇总。亚组分析用于探讨异质性,并确定按策略类型划分在效果上是否存在差异。
共识别出38项留存试验。评估了六种主要类型的策略。能提高邮寄问卷回复率的策略有:增加,即给予金钱激励(相对风险度[RR]=1.18;95%置信区间[CI]=1.09至1.28)以及更高价值的激励(RR = 1.12;95% CI = 1.04至1.22)。给予金钱激励,即在收到完整问卷时给予激励,也能提高电子问卷回复率(RR = 1.25;95% CI = 1.14至1.38)。关于较短问卷(RR = 1.04;95% CI = 1.00至1.08)以及与疾病/状况相关问卷(RR = 1.07;95% CI = 1.01至1.14)的证据不太明确。基于单项试验结果,以下策略在提高问卷回复率方面似乎有效:挂号邮寄问卷(RR = 2.08;95% CI = 1.11至3.87);一套邮寄沟通策略(RR = 1.43;95% CI = 1.22至1.67)以及开放试验设计(RR = 1.37;95% CI = 1.16至1.63)。没有充分证据表明以下策略会影响试验回复率/留存率:增加非金钱激励(RR = 1.00;95% CI = 0.98至1.02);给予非金钱激励(RR = 0.99;95% CI = 0.95至1.03);“强化”信件(RR = 1.01;95% CI = 0.97至1.05);金钱激励与提供抽奖机会相比(RR = 1.04;95% CI = 0.91至1.19);优先邮寄(RR = 1.02;95% CI = 0.95至1.09);行为激励策略(RR = 1.08;95% CI = 0.93至1.24);向参与者额外提醒(RR = 1.03;95% CI = 0.99至1.06)以及问卷问题顺序(RR = 1.00,0.97至1.02)。同样基于单项试验,这些策略似乎无效:电话调查与金钱激励加问卷相比(RR = 1.08;95% CI = 0.94至1.24);提供慈善捐赠(RR = 1.02,95% CI = 0.78至1.32);向研究点发送提醒(RR = 0.96;95% CI = 0.83至1.11);提前发送问卷(RR = 1.10;95% CI = 0.96至1.26);更长且更清晰的问卷(RR = 1.01,0.95至1.07)以及由试验助手进行参与者病例管理(RR = 1.00;95% CI = 0.97至1.04)。
大多数试验评估的是问卷回复情况,而非提高参与者返回研究点进行随访的方法。金钱激励以及提供金钱激励会提高邮寄和电子问卷的回复率。一些策略需要进一步评估。这些结果的应用将取决于试验背景和随访程序。