York Trials Unit, Department of Health Sciences, University of York, Heslington, YO10 5DD York, UK.
J Clin Epidemiol. 2012 Dec;65(12):1348-52. doi: 10.1016/j.jclinepi.2012.05.008. Epub 2012 Aug 15.
To assess the effectiveness of prenotification using a newsletter to increase questionnaire response rates within a randomized controlled trial (RCT).
An RCT set within the context of the Medical Research Council's SCOOP trial of screening older women for fracture risk.
A subsample of SCOOP participants were randomized in equal numbers to receive a newsletter approximately 6 weeks before the follow-up questionnaire or no newsletter. Of the 1,342 participants in the newsletter group, 1,291 (96.2%) returned their 24-month follow-up questionnaire compared with 1,271 of the 1,344 participants who were not allocated to receive the newsletter (94.6%). The difference of 1.6% was statistically significant (P=0.05), with an odds ratio (OR) of 1.45 (95% confidence interval [CI]: 1.01, 2.10). The newsletter and no newsletter groups required a similar number of reminders (OR 0.88, 95% CI: 0.73, 1.06), had a similar number with a complete primary outcome (OR 0.95, 95% CI: 0.57, 1.58), and took a similar time to respond (log rank 1.30, P=0.25).
This study supports previous research that suggests that prenotification increases survey response rate: albeit a small absolute increase. No previous study has shown this to be so within the context of patients enrolled within an RCT. Trials that use newsletters to keep their participants informed of the study's progress should use the newsletter as a prenotification device as this will increase overall response rates.
评估使用新闻稿进行预通知对提高随机对照试验(RCT)中问卷回复率的效果。
在医学研究委员会 SCOOP 试验的背景下进行的 RCT,该试验对老年女性进行骨折风险筛查。
SCOOP 参与者的一个子样本被随机等分为两组,一组在随访问卷前大约 6 周收到新闻稿,另一组不发新闻稿。在新闻稿组的 1342 名参与者中,有 1291 名(96.2%)返回了他们的 24 个月随访问卷,而在未被分配接收新闻稿的 1344 名参与者中,有 1271 名(94.6%)返回了问卷。这 1.6%的差异具有统计学意义(P=0.05),优势比(OR)为 1.45(95%置信区间[CI]:1.01,2.10)。新闻稿组和无新闻稿组需要发送的提醒数量相似(OR 0.88,95%CI:0.73,1.06),具有完整主要结局的人数相似(OR 0.95,95%CI:0.57,1.58),且回复时间相似(对数秩检验 1.30,P=0.25)。
本研究支持了先前的研究,即预通知可以提高调查回复率:尽管绝对增加幅度较小。以前没有研究在 RCT 中招募的患者背景下证明这一点。使用新闻稿向参与者通报研究进展的试验应将新闻稿用作预通知设备,因为这将提高总体回复率。