A novel digital approach to describe real world outcomes among patients with constipation

Abstract

Understanding day-to-day variations in symptoms and medication management can be important in describing patient centered outcomes for people with constipation. Patient Generated Health Data (PGHD) from digital devices is a potential solution, but its utility as a tool for describing experiences of people with frequent constipation is unknown. We conducted a virtual, 16-week prospective study of individuals with frequent constipation from an online wellness platform that connects mobile consumer digital devices including wearable monitors capable of passively collecting steps, sleep, and heart rate data. Participants wore a Fitbit monitoring device for the study duration and were administered daily and monthly surveys assessing constipation symptom severity and medication usage. A set of 38 predetermined day-level behavioral activity metrics were computed from minute-level data streams for steps, sleep and heart rate. Mixed effects regression models were used to compare activity metrics between constipation status (irregular or constipated vs. regular day), medication use (medication day vs. non-medication day) and the interaction of medication day with irregular or constipation days, as well as to model likelihood to treat with constipation medications based on daily self-reported symptom severity. Correction for multiple comparisons was performed with the Benjamini–Hochberg procedure for false discovery rate. This study analyzed 1540 enrolled participants with completed daily surveys (mean age 36.6 sd 10.0, 72.8% female, 88.8% Caucasian). Of those, 1293 completed all monthly surveys and 756 had sufficient Fitbit data density for analysis of activity metrics. At a daily-level, 22 of the 38 activity metrics were significantly associated with bowel movement or medication treatment patterns for constipation. Participants were measured to have fewer steps on irregular days compared to regular days (−200 steps, 95% CI [−280, −120]), longer periods of inactivity on constipated days (9.1 min, 95% CI [5.2, 12.9]), reduced total sleep time on irregular and constipated days (−2.4 min, 95% CI [−4.3, −0.4] and −4.0 min, 95% CI [−6.5, −1.4], respectively). Participants reported greater severity of symptoms for bloating, hard stool, difficulty passing, and painful bowel movements on irregular, constipation and medication days compared to regular days with no medication. Interaction analysis of medication days with irregular or constipation days observed small increases in severity compared to non-medication days. Participants were 4.3% (95% CI 3.2, 5.3) more likely to treat with medication on constipated days versus regular. No significant increase in likelihood was observed for irregular days. Daily likelihood to treat increased for each 1-point change in symptom severity of bloating (2.4%, 95% CI [2.0, 2.7]), inability to pass (2.2%, 95% CI [1.4, 3.0]) and incomplete bowel movements (1.3%, 95% CI [0.9, 1.7]). This is the first large scale virtual prospective study describing the association between passively collected PGHD and constipation symptoms and severity at a day-to-day granularity level. Constipation status, irregular or constipated, was associated with a number of activity metrics in steps and sleep, and likelihood to treat with medication increased with increasing severity for a number of constipation symptoms. Given the small magnitude of effect, further research is needed to understand the clinical relevance of these results. PGHD may be useful as a tool for describing real world patient centered experiences for people with constipation.

Parkinson’s Disease Management via Wearable Sensors: A Systematic Review

“…Reference [75] is a non-PD digital approach to evaluating constipation via the FitBit monitoring device through which several health bio-markers were gathered, and regression models were used to assess activity on days with constipation and without. The study was a 16-week program with 1540 participants.…”

The potential use of digital health technologies in the African context: a systematic review of evidence from Ethiopia

“…Health technology innovations are transforming the discovery, development, and delivery of health products and services 1 – 4 and significantly changing the way health conditions are diagnosed, treated, and prevented 5 , 6 . These innovations are building a sustainable foundation for affordable, accessible, and high-quality medicines, vaccines, medical devices, and system innovations, pursuing novel solutions, entrepreneurial ventures, and public sector efforts to the most challenging health problems 7 , 8 .…”

Laxatives are Associated with Poorer Polysomnography-derived Sleep Quality

“…[9][10][11] Prior literature has demonstrated that constipation may be associated with poorer sleep continuity. Constipation was linked to difficulty falling asleep, 12 changes in total sleep time, [13][14][15][16] and overall reduced sleep quality 17 (Table 1). However, these observational studies, except for one, 16 relied on subjective questionnaires to assess sleep continuity in constipated patients.…”

“…Constipation was linked to difficulty falling asleep, 12 changes in total sleep time, [13][14][15][16] and overall reduced sleep quality 17 (Table 1). However, these observational studies, except for one, 16 relied on subjective questionnaires to assess sleep continuity in constipated patients. Past studies have also indicated that constipation may be linked with insomnia.…”

“…13,14 Table 1 provides an overview of prior studies that have examined the relationship between sleep continuity (or insomnia) and constipation. [12][13][14][15][16][17][18] While subjective reports of sleep continuity and insomnia have been linked to the presence of constipation particularly in the middle-aged and elderly, the impact of constipation on objective metrics of sleep continuity has remained underexplored. Thus, the primary purpose of this study was to investigate the association of laxative use and laxative subtypes (markers of constipation) on objective markers of sleep continuity in a middle-aged/elderly population (≥40 years old).…”