Abstract
Objectives
Most researchers who study the effects of hormonal contraception on menstrual bleeding rely on self-reported data via paper diaries, for which completeness and timeliness have been shown to be poor. The purpose of this exploratory study was to compare the completeness and timeliness of bleeding data collected via paper diaries, text messages or smartphone application (a.k.a “app”).
Methods
This was a sub-study of a double-blinded, placebo-controlled randomized trial comparing the effects of a non-steroidal anti-inflammatory drug, naproxen, with placebo when using a copper IUD. Participants tracked bleeding and symptoms over 112 days. Participants tracked bleeding daily using a paper diary as well as with either text messages or a smartphone app. Participants who used paper and the app were also able to record non-bleeding symptoms.
Results
Twenty-five participants submitted diaries. Of these participants, 10 completed both paper and app diaries, 7 completed both paper and text messages, 4 completed the paper diary only, 4 completed the app only. Text messages had the most complete data (108 days), followed by the app (96 days) and paper diaries (84 days). The lag time between a bleeding event and the date recording that event was 0.10 days for text, 1.0 days for app, and 4.73 days for paper diaries. Participants using the app reported a median of 33 other symptoms over the study period compared to 7 for the paper diaries.
Discussion
Our findings suggest texts demonstrated more complete and timely bleeding data than either paper diaries, or the app. Compared to paper diaries, the app delivered more complete, timely data, and also collected a large set of symptoms.
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Acknowledgements
This study was supported in part by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1 TR002319 and an independent investigator grant funded by CooperSurgical, Inc. We thank Amanda Shea and Marija Vlajic Wheeler from BioWink for their help with procuring data from the Clue app and reviewing the manuscript. We thank Joel Marcus and Evelyn Chanasyk for their editorial assistance. Dr. Godfrey receives grant funding from Bayer Women’s Health and honoraria from Merck as a Nexplanon trainer. None of the other authors has any conflicts of interest related to the submitted work.
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Josephy, T., Sanan, S., Thayer, E. et al. Comparison of Paper Diaries, Text Messages and Smartphone App to Track Bleeding and Other Symptoms for Contraceptive Studies. Matern Child Health J 26, 1211–1216 (2022). https://doi.org/10.1007/s10995-021-03362-6
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DOI: https://doi.org/10.1007/s10995-021-03362-6