Abstract
Hypothesis: Compliance with a paper diary protocol would be improved by using auditory signaling.Background: Prior research has demonstrated that compliance with the reporting schedule in paper diary protocols is poor.Methods: Adults with chronic pain (N = 27) were recruited from the community to participate in a 24-day experience sampling protocol of 3 pain assessments per day (10:00 a.m., 4:00p.m., 8:00p.m.). Diaries were instrumented to record openings and closings, thereby permitting determination of date and time when the participant could have made diary entries. Participants were signaled with a programmed wristwatch at the onset of each 30-min assessment window. Two compliance windows were defined: ± 15 min and ± 45 min of the targeted assessment time.Results: Self-reported compliance based on participants’ paper diaries was 85% and 91% for the 30- and 90-min windows. Verified compliance was 29% and 39% for the two windows. Signaling produced a significant increment in verified compliance when compared with an identical trial without signaling. A significant eroding of verified compliance was observed across the 3 weeks of the study.Conclusions: Self-report dating of diary entries may be misleading investigators about compliance with diary protocols. Although auditory signaling enhances compliance, the result is still unsatisfactory.
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Disclosure: invivodata, inc. supplies software for the use of electronic diaries in clinical trials. Saul Shiffman is a co-founder and the Chief Science Officer of invivodata, inc. Michael Hufford is Vice President for Scientific Affairs at invivodata, inc. Arthur A. Stone is Associate Chair of the Scientific Advisory Board of invivodata, inc.
This research was supported by National Cancer Institute Grant CA-85819 (Arthur A. Stone, Principal Investigator) and in-kind support from invivodata, inc., Pittsburgh, PA.
We thank Daniel Arnold, Doyle Carney, Julie Grassell, Corey Harmon, and Jill Jackowski for assistance with completing this study.
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Broderick, J.E., Schwartz, J.E., Shiffman, S. et al. Signaling does not adequately improve diary compliance. ann. behav. med. 26, 139–148 (2003). https://doi.org/10.1207/S15324796ABM2602_06
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DOI: https://doi.org/10.1207/S15324796ABM2602_06