Abstract

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"). This was a sub-study of a double-blinded,placebo-controlled randomized trial comparing the effects of a non-steroidal anti-inflammatory drug, naproxen, withplacebo when using a copper IUD.Participants tracked bleeding and symptoms over 112 days. Participantstracked bleeding daily using a paper diary as well as with either text messages or a smartphone app. Participantswho used paper and the app were also able to record non-bleeding symptoms. Twenty-five participantssubmitted diaries. Of these participants, 10 completed both paper and app diaries, 7 completed both paper and textmessages, 4 completed the paper diary only, 4 completed the app only. Text messages had the most completedata (108 days), followed by the app (96 days) and paper diaries (84 days). The lag time between a bleeding eventand 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 thepaper diaries. Our findings suggest texts demonstrated more complete and timely bleeding data thaneither paper diaries, or the app. Compared to paper diaries, the app delivered more complete, timely data, and alsocollected a large set of symptoms.

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