评估货币激励措施对临床试验随访期间问卷回收率的影响：一项试验中的随机研究。

Evaluation of the effects of an offer of a monetary incentive on the rate of questionnaire return during follow-up of a clinical trial: a randomised study within a trial.

作者信息

Hardy Pollyanna, Bell Jennifer L, Brocklehurst Peter

机构信息

Nuffield Department of Population Health, National Perinatal Epidemiology Unit CTU, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.

Institute for Women's Health, University College London, London, UK.

出版信息

BMC Med Res Methodol. 2016 Jul 15;16:82. doi: 10.1186/s12874-016-0180-9.

DOI:10.1186/s12874-016-0180-9

PMID:27421268

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4946239/

Abstract

BACKGROUND

A systematic review on the use of incentives to promote questionnaire return in clinical trials suggest they are effective, but not all studies have sufficient funds to use them. Promising an incentive once data are returned can reduce the cost-burden of this approach, with possible further cost-savings if the offer were restricted to reminder letters only. This study aimed to evaluate the effect of promising a monetary incentive at first mailout versus a promise on reminder letters only.

METHODS

This was a randomised Study Within A Trial (SWAT) nested within BUMPES, a multicentre randomised controlled trial of maternal position in the late stage of labour in women with an epidural. The follow-up questionnaire asked for information on the women's health, wellbeing and health service use one year following the birth of their baby. Women who consented to be contacted were randomised to a promise of a monetary incentive at first mailout or a promise on reminder letters only. Women were given an option of completing the questionnaire on paper or on online. The incentive was posted out on receipt of a completed questionnaire. The primary outcome was the overall return rate, and secondary outcomes were the return rate without any chasing from the study office, and the total cost of the vouchers.

RESULTS

A total of 1,029 women were randomised, 508 to the first mailout group and 518 to the reminder group. There was no evidence to suggest a difference between groups in the overall return rate (adjusted RR 1.03 (95 % CI 0.96 to 1.11), however the proportion returned without chasing was higher in the first mailout group (adjusted RR 1.22, 95 % CI 1.07 to 1.39). The total cost of the vouchers per participant was higher in the first mailout group (mean difference £4.56, 95 % CI £4.02 to £5.11).

CONCLUSIONS

Offering a monetary incentive when a reminder is required could be cost-effective depending on the sample size of the study and the resources available to administer the reminder letters.

TRIAL REGISTRATION

The BUMPES Trial is registered with Current Controlled Trials: ISRCTN35706297 , 26(th) August 2009.

摘要

背景

一项关于在临床试验中使用激励措施以提高问卷回收率的系统评价表明，这些措施是有效的，但并非所有研究都有足够资金来使用它们。在数据返回后承诺给予激励可以降低这种方法的成本负担，如果仅将该提议限制在催函上，可能会进一步节省成本。本研究旨在评估在首次邮寄时承诺给予金钱激励与仅在催函上承诺激励的效果。

方法

这是一项嵌套在BUMPES试验中的试验内随机研究（SWAT），BUMPES是一项关于硬膜外麻醉产妇分娩后期体位的多中心随机对照试验。随访问卷询问了女性在产后一年的健康、幸福状况及医疗服务使用情况。同意被联系的女性被随机分为两组，一组在首次邮寄时承诺给予金钱激励，另一组仅在催函上承诺激励。女性可以选择纸质或在线完成问卷。问卷填写完成后即寄出激励物品。主要结局是总体回收率，次要结局是在未得到研究办公室任何催促情况下的回收率以及代金券的总成本。

结果

共有1029名女性被随机分组，508名进入首次邮寄组，518名进入催函组。没有证据表明两组在总体回收率上存在差异（调整后的风险比为1.03（95%置信区间为0.96至1.11）），然而，在首次邮寄组中，未经催促而返回的比例更高（调整后的风险比为1.22，95%置信区间为1.07至1.39）。首次邮寄组每位参与者的代金券总成本更高（平均差值为4.56英镑，95%置信区间为4.02至5.11英镑）。