Participants at the 3 sites were selected using a homogeneous purposive sampling method [31] and given an option to use the app. During the first clinical visit, patients who consented to the study for their data to be collected were offered a choice to either register an account with the app [25] to share their data with the research and clinical teams through the app’s monitoring portal or provide their data on paper-based questionnaires during pain clinic visits. Participants who continued to record their pain experiences and enter data in the app after 30 days of first registering were considered to be in the app group. Participants who declined to use the app or those who registered but had no records in the app after 30 days were considered to be in the nonapp group. A cutoff of 30 days was used based on its acceptance in the mobile app industry as a benchmarked metric of retention [24] and on its determination by the clinical team involved in the study as a meaningful duration of information that could inform clinical decision making.

Participants were asked to complete questionnaires on the following pain-related outcomes: anxiety, depression, pain catastrophizing, pain disability, patient global impression of change, and daily opioid consumption. Daily opioid consumption was measured in oral morphine equivalents in milligrams upon entry into the study during the initial visit and as a part of the first follow-up clinical visit within 4.5 months of the initial visit (short-term follow-up) and during the second follow-up clinical visit between 4.5 and 7 months after the initial visit (long-term follow-up). Given that our objective was to validate the impact of the app in a real-world clinical environment, the date ranges of follow-up visits were more broadly defined to align with the date of the actual clinical visit. Clinicians at each participating site were encouraged to use the clinical reports, either digitally through the portal or printed, during their clinical visits with the patients.

Participants who agreed to use the app but did not have in-person clinical appointments within these time frames were still remotely prompted to complete the questionnaires through the app portal by research staff. Patients in the nonapp group provided their data only by completing paper-based questionnaires during clinic visits or via a phone interview if no in-person clinical visit was scheduled during study-related follow-ups.

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