title: Survey Email Scheduling and Monitoring in eRCTs (SESAMe): A Digital Tool to Improve Data Collection in Randomized Controlled Clinical Trials.
abstract: Electronic 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.
  
  
  
  Our 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.
  
  
  
  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. 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.
  
  
  
  We 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.
  
  
  
  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.
authors.affiliation: Institute of Health and Society, Department of General Practice, University of Oslo, Oslo, Norway.|Centre for Medical Web Research, Oslo, Norway.
authors.forename: Trygve
authors.identifier: 0000-0003-4816-076X
authors.initials: T
authors.lastname: Skonnord
authors.affiliation: Centre for Medical Web Research, Hong Kong, China.
authors.forename: Finn
authors.identifier: 0000-0002-4031-3226
authors.initials: F
authors.lastname: Steen
authors.affiliation: Institute of Health and Society, Department of General Practice, University of Oslo, Oslo, Norway.
authors.forename: Holgeir
authors.identifier: 0000-0002-7586-8651
authors.initials: H
authors.lastname: Skjeie
authors.affiliation: Institute of Health and Society, Department of General Practice, University of Oslo, Oslo, Norway.
authors.forename: Arne
authors.identifier: 0000-0001-8566-1972
authors.initials: A
authors.lastname: Fetveit
authors.affiliation: Institute of Health and Society, Department of General Practice, University of Oslo, Oslo, Norway.
authors.forename: Mette
authors.identifier: 0000-0003-3454-2329
authors.initials: M
authors.lastname: Brekke
authors.affiliation: Institute of Health and Society, Department of General Practice, University of Oslo, Oslo, Norway.|Centre for Medical Web Research, Oslo, Norway.
authors.forename: Atle
authors.identifier: 0000-0002-2917-1845
authors.initials: A
authors.lastname: Klovning
mesh_terms: D000328:Adult; D003625:Data Collection / Q000379:methods*; D034742:Electronic Mail; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D010865:Pilot Projects; D011795:Surveys and Questionnaires; D060145:Text Messaging
keywords: Internet; data collection; email; quality improvement; randomized controlled trials; sample size; surveys and questionnaires; text messaging