三项关于增加基于手机的戒烟支持的随机对照试验招募干预措施的对照试验。

Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support.

机构信息

NPHIRU, LSHTM, London, UK.

出版信息

Clin Trials. 2010 Jun;7(3):265-73. doi: 10.1177/1740774510367687.

DOI:10.1177/1740774510367687

PMID:20484492

Abstract

BACKGROUND

Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial.

PURPOSE

To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants.

METHODS

Single blind controlled trials with allocation concealment.

INTERVENTIONS

Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures.

RESULTS

Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2).

LIMITATIONS

There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic.

CONCLUSION

Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.

摘要

背景

招募是试验的主要挑战，但几乎没有证据表明干预措施可以增加试验招募。我们报告了三项旨在增加 Txt2stop 试验招募的干预措施的对照试验。

目的

评估：试验 1. 关于在线注册设施的短信对注册的影响；试验 2. 随附附信的 5 英镑对符合条件的试验参与者的随机分配的影响；试验 3. 包含现有参与者引述的短信对随机分配的影响。

方法

单盲对照试验，采用分配隐藏。

干预措施

试验 1：关于我们新的在线注册设施的短信；试验 2：随附 5 英镑的信；试验 3：包含参与者引述的四条短信。每个试验的对照组均接受标准的 Txt2stop 程序。

结果

试验 1：干预组的注册率为 3.6%（17/470），对照组为 1.1%（5/467），风险差异为 2.5%（95%CI 0.6-4.5）。干预组中没有成功在线注册的比例为 0%（0/470），对照组为 0.2%（1/467），风险差异为-0.2（95%CI -0.6-0.2）；试验 2：干预组的随机分配率为 4.5%（11/246），对照组为 0.4%（1/245），风险差异为 4.0%（95%CI 1.4-6.7）；试验 3：干预组的随机分配率为 3.5%（14/405），对照组为 0%（0/406），风险差异为 3.5（95%CI 1.7-5.2）。