Abstract
BackgroundElectronic questionnaires can ease data collection in randomized controlled trials (RCTs) in clinical practice. We found no existing software that could automate the sending of emails to participants enrolled into an RCT at different study participant inclusion time points.ObjectiveOur aim was to develop suitable software to facilitate data collection in an ongoing multicenter RCT of low back pain (the Acuback study). For the Acuback study, we determined that we would need to send a total of 5130 emails to 270 patients recruited at different centers and at 19 different time points.MethodsThe first version of the software was tested in a pilot study in November 2013 but was unable to deliver multiuser or Web-based access. We resolved these shortcomings in the next version, which we tested on the Web in February 2014. Our new version was able to schedule and send the required emails in the full-scale Acuback trial that started in March 2014. The system architecture evolved through an iterative, inductive process between the project study leader and the software programmer. The program was tested and updated when errors occurred. To evaluate the development of the software, we used a logbook, a research assistant dialogue, and Acuback trial participant queries.ResultsWe have developed a Web-based app, Survey Email Scheduling and Monitoring in eRCTs (SESAMe), that monitors responses in electronic surveys and sends reminders by emails or text messages (short message service, SMS) to participants. The overall response rate for the 19 surveys in the Acuback study increased from 76.4% (655/857) before we introduced reminders to 93.11% (1149/1234) after the new function (P<.001). Further development will aim at securing encryption and data storage.ConclusionsThe SESAMe software facilitates consecutive patient data collection in RCTs and can be used to increase response rates and quality of research, both in general practice and in other clinical trial settings.
Highlights
A common problem for clinical research in general practice is the ability to conduct randomized controlled trials (RCTs) with large enough sample sizes [1]
All data collection and monitoring have become Internet based. We suggest signifying this type of data collection and monitoring in RCTs as an electronic randomized controlled trial
We developed a Web-based software app that schedules and sends automated emails with links to e-surveys in LimeSurvey, an open source program used by many colleges and universities worldwide
Summary
A common problem for clinical research in general practice is the ability to conduct randomized controlled trials (RCTs) with large enough sample sizes [1]. A high degree of response in a trial is essential to keep the sample size sufficient, and a substantial level of nonresponse may lead to bias and less accurate data [6] Such factors are limiting the quality, number, and progression of conducting RCTs in general practice [7]. Objective: Our aim was to develop suitable software to facilitate data collection in an ongoing multicenter RCT of low back pain (the Acuback study). Methods: The first version of the software was tested in a pilot study in November 2013 but was unable to deliver multiuser or Web-based access. Conclusions: The SESAMe software facilitates consecutive patient data collection in RCTs and can be used to increase response rates and quality of research, both in general practice and in other clinical trial settings
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