Starr Kathryn, McPherson Gladys, Forrest Mark, Cotton Seonaidh C
Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen, AB25 2ZD, Scotland.
Trials. 2015 Jul 8;16:295. doi: 10.1186/s13063-015-0808-9.
Patient-reported outcomes are vital in informing randomised controlled trials (RCTs) and health-care interventions and policies from the patient's perspective. However, participant non-response may introduce bias and can affect the generalisability of the trial. This study evaluates two interventions aimed at increasing response rates to postal questionnaires within a large, UK-wide RCT: pre-notification via short messenger service (SMS) text prior to sending the initial mailing of trial questionnaires versus no pre-notification; for non-responders to the initial mailing of the questionnaires, an e-mail reminder (containing a hyperlink to complete the questionnaire online) versus a postal reminder.
This study is a 2 × 2 partial factorial design RCT nested within an RCT of medical expulsive therapy for ureteric stone disease. Participants who supplied a mobile telephone number were randomly assigned to receive an SMS text pre-notification of questionnaire delivery or no pre-notification. Those who supplied an e-mail address were randomly assigned to receive a questionnaire reminder by e-mail or post. Participants could be randomly assigned to the pre-notification comparison or the reminder comparison or both. The primary outcome measure was response rate at each questionnaire time point.
Four hundred eighteen participants were randomly assigned to the SMS pre-notification comparison (80% were male, and the mean age was 41 years with a standard deviation (SD) of 11.1). The intervention had no effect on response rate at either questionnaire time point. In subgroup analyses, SMS pre-notification increased response rates in women but only at the first questionnaire time point. One hundred nineteen participants were randomly assigned to the reminder comparison (80% were male, and the mean age was 42 years with an SD of 12.1). There was no difference in response rate in those who received an e-mail reminder compared with those who received a postal reminder.
SMS text pre-notification of questionnaire delivery and email delivery of questionnaire reminders did not improve response rates. There was some evidence to suggest that SMS text pre-notification may be effective in women, and further studies to investigate this may be warranted. E-mail reminders for participants to return their postal questionnaire could be advantageous given that response rates were similar following either type of reminder and the low cost of delivering an e-mail compared with a postal reminder. This is a substudy of the SUSPEND trial (ISCTRN69423238) (18 Nov. 2010).
患者报告的结果对于从患者角度为随机对照试验(RCT)、医疗保健干预措施及政策提供信息至关重要。然而,参与者无应答可能会引入偏差,并可能影响试验的普遍性。本研究评估了在一项大型全英RCT中旨在提高邮寄问卷回复率的两种干预措施:在首次邮寄试验问卷之前通过短信息服务(SMS)短信进行预先通知与不进行预先通知;对于问卷首次邮寄的无应答者,通过电子邮件提醒(包含在线完成问卷的超链接)与邮寄提醒。
本研究为2×2部分析因设计的RCT,嵌套于输尿管结石病药物排石治疗的RCT中。提供手机号码的参与者被随机分配接受问卷发送的SMS短信预先通知或不接受预先通知。提供电子邮件地址的参与者被随机分配通过电子邮件或邮寄方式接收问卷提醒。参与者可被随机分配到预先通知比较组或提醒比较组或两者。主要结局指标是每个问卷时间点的回复率。
418名参与者被随机分配到SMS预先通知比较组(80%为男性,平均年龄41岁,标准差(SD)为11.1)。该干预措施在两个问卷时间点的回复率上均无效果。在亚组分析中,SMS预先通知提高了女性的回复率,但仅在第一个问卷时间点。119名参与者被随机分配到提醒比较组(80%为男性,平均年龄42岁,SD为12.1)。与接受邮寄提醒的人相比,接受电子邮件提醒的人的回复率没有差异。
问卷发送的SMS短信预先通知和问卷提醒的电子邮件发送并未提高回复率。有一些证据表明SMS短信预先通知可能对女性有效,可能需要进一步研究来对此进行调查。鉴于两种提醒方式后的回复率相似且与邮寄提醒相比电子邮件发送成本较低,通过电子邮件提醒参与者返还邮寄问卷可能具有优势。这是SUSPEND试验(ISCTRN69423238)(2010年11月18日)的一项子研究。