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Chapter 9 226 In terms of technical issues arising during the study, minor bugs occurring as a consequence of ever evolving smartphones and operating systems are practically inevitable. It is our experience therefore that continuous maintenance and software updating by a development (IT) team is crucial to avoid data-loss and potential agitation of the study participant due to application malfunctioning. Consequently, the feasibility of using a smartphone application as a primary data-collection method depends to a large extent on skills and availability of development team staff and research groups should check if appropriate support is available before opting for such methods. Many high-quality IBS trials have used Interactive Voice Response Systems (IVRS) as the primary data-collection method. 28-31 In spite of this frequent use, the IVRS used in IBS trials have not been described in detail, thereby hampering replication and implementation of the used methodology in other trials. For comparison to our methodology, we therefore depended on what is known about IVRS in general. Akin to a digital symptom diary, the IVRS method allows control of time-windows in which surveys should be completed, provides automated time-stamps to answers, performs data verification and validation, follows a predefined routing schema, enables automatic reminders, collects and stores data “real-time”, and leads to an overall consistent survey administration. In addition, both methods equally depend on telephone- or internet- service, and require staff to program and maintain the software. A potential advantage of the IVRS over the digital diary is that it does not depend on literacy skills of the participant. An IVRS may also need fewer software updates than required by smartphone applications due to the high paced updates of operating systems. Potential disadvantages of the IVRS compared to a digital symptom diary are e.g. 1) the inability to get clarification during the survey, whereas a digital symptom diary can have built-in optional clarification of questions; 2) not all IVRS are equipped with speech-recognition, open-ended questions then require transcription by a data-manager; 3) the quality of open-ended question recordings is dependable on enunciation, background noise, and connection; and 4) usage of the IVRS requires extensive participant training and could be less user-friendly. 32 As for patient adherence to the IVRS, this was reported by only one recent IBS trial. They reported a mean adherence rate of 71% and 73% in the two groups examined, when adherence was defined as completing at least 80% of the scheduled calls to the IVRS. 30 The adherence to the IVRS in that study was thus notably lower than the adherence to the digital symptom diary found in the current study. The current study described the overall framework for digitalized data-collection used in the PERSUADE study. In addition to the digital symptom diary, the electronic framework used in this drug trial consisted of web-based patient questionnaires and an
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