MacLennan Graeme, McDonald Alison, McPherson Gladys, Treweek Shaun, Avenell Alison
Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Trials. 2014 Jan 8;15:13. doi: 10.1186/1745-6215-15-13.
Postal questionnaires are simple and economical for collecting outcome data for randomised controlled trials (RCTs) but are prone to non-response. In the RECORD trial (a large pragmatic publicly funded RCT in UK) non-responders were sent a reminder and another questionnaire at 1 year, of which 40% were returned. In subsequent years we investigated the effect of an advance telephone call to non-responders on responses rate to reminder questionnaires and the next questionnaire 4 months later.
Non-responders to annual questionnaires were randomised to receive a telephone call from the trial office ahead of the reminder questionnaire in addition to the usual reminder schedule (n=390) or to a control group that received the usual reminder schedule only (n=363). The primary outcome was response to the reminder questionnaire within 21 days; secondary outcomes were response to a questionnaire 4 months later; completeness of quality of life instruments; and the number of participants declining further follow-up. Results are presented as odds ratios from a logistic regression intention-to-treat (ITT) analysis and then percentage difference and 95% confidence intervals (CI) for both ITT and average treatment effect on the treated (ATT) analyses.
The proportions that responded were 67.8% (265/390) in the intervention group compared to 62.5% (227/363) in the control group. The ITT estimate was a 5.4% increase (95% CI -1.4 to 12.2). Four months later percentages responding were 51.8% (202) and 42.7% (155). The ITT estimate was a 9.1% increase (95% CI 2.0 to 16.2). In the intervention group 12.3% (48/390) of participants were not telephoned because questionnaires were returned before the scheduled telephone call. ATT estimates adjusting for this were 6.2% (95% CI -1.6 to 14.0) and 10.4% (95% CI 2.2 to 18.5), respectively.
The telephone call resulted in a slight increase in response to the reminder questionnaire, however at 4 months later the proportion in the telephoned group responding was greater. This study suggests that pre-notification telephone calls may only be worthwhile if further questionnaires are to be sent out soon after reminder questionnaires.
Current Clinical Trials ISRCTN51647438.
邮寄问卷调查对于收集随机对照试验(RCT)的结果数据而言简单且经济,但容易出现无应答情况。在“记录”试验(英国一项大型实用型公共资助RCT)中,对于无应答者在1年时发送了提醒及另一份问卷,其中40%被返还。在随后几年,我们调查了提前给无应答者打电话对提醒问卷及4个月后下一份问卷应答率的影响。
对年度问卷无应答者被随机分为两组,一组除常规提醒安排外,在提醒问卷之前接收来自试验办公室的电话(n = 390),另一组为仅接受常规提醒安排的对照组(n = 363)。主要结局是在21天内对提醒问卷的应答;次要结局是4个月后对一份问卷的应答;生活质量量表的完整性;以及拒绝进一步随访的参与者数量。结果以逻辑回归意向性分析(ITT)的比值比呈现,然后是ITT及对治疗组的平均治疗效应(ATT)分析的百分比差异和95%置信区间(CI)。
干预组的应答比例为67.8%(265/390),对照组为62.5%(227/363)。ITT估计值增加了5.4%(95%CI -1.4至12.2)。4个月后,应答百分比分别为51.8%(202)和42.7%(155)。ITT估计值增加了9.1%(95%CI 2.0至16.2)。在干预组中,12.3%(48/390)的参与者未接到电话,因为问卷在预定电话之前已被返还。对此进行调整后的ATT估计值分别为6.2%(95%CI -1.6至14.0)和10.4%(95%CI 2.2至18.5)。
电话通知使提醒问卷的应答略有增加,但4个月后接到电话组的应答比例更高。本研究表明,只有在提醒问卷之后很快要发送进一步问卷时,预先通知电话可能才值得。
当前临床试验ISRCTN51647438。