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- Title
Effect of Mobile Device-Assisted N-of-1 Trial Participation on Analgesic Prescribing for Chronic Pain: Randomized Controlled Trial.
- Authors
Odineal, David D.; Marois, Maria T.; Ward, Deborah; Schmid, Christopher H.; Cabrera, Rima; Sim, Ida; Wang, Youdan; Wilsey, Barth; Duan, Naihua; Henry, Stephen G.; Kravitz, Richard L.
- Abstract
<bold>Objectives: </bold>Opioids and non-steroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed for chronic musculoskeletal pain, despite limited evidence of effectiveness and well-documented adverse effects. We assessed the effects of participating in a structured, personalized self-experiment ("N-of-1 trial") on analgesic prescribing in patients with chronic musculoskeletal pain.<bold>Methods: </bold>We randomized 215 patients with chronic pain to participate in an N-of-1 trial facilitated by a mobile health app or to receive usual care. Medical records of participating patients were reviewed at enrollment and 6 months later to assess analgesic prescribing. We established thresholds of ≥ 50, ≥ 20, and > 0 morphine milligram equivalents (MMEs) per day to capture patients taking relatively high doses only, patients taking low-moderate as well as relatively high doses, and patients taking any dose of opioids, respectively.<bold>Results: </bold>There was no significant difference between the N-of-1 and control groups in the percentage of patients prescribed any opioids (relative odds ratio (ROR) = 1.05; 95% confidence interval [CI] = 0.61 to 1.80, p = 0.87). There was a clinically substantial but statistically not significant reduction of the percentage of patients receiving ≥ 20 MME (ROR = 0.58; 95% CI = 0.33 to 1.04, p = 0.07) and also in the percentage receiving ≥ 50 MME (ROR = 0.50; 95% CI = 0.19 to 1.34, p = 0.17). There was a significant reduction in the proportion of patients in the N-of-1 group prescribed NSAIDs compared with control (relative odds ratio = 0.53; 95% CI = 0.29 to 0.96, p = 0.04), with no concomitant increase in average pain intensity. There was no significant change in use of adjunctive medications (acetaminophen, gabapentenoids, or topicals).<bold>Discussion: </bold>These exploratory results suggest that participation in N-of-1 trials may reduce long-term use of NSAIDs; there is also a weak signal for an effect on use of opioids. Additional research is needed to confirm these results and elucidate possible mechanisms.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT02116621.
- Subjects
CHRONIC pain; ANTI-inflammatory agents; DRUG prescribing; NONSTEROIDAL anti-inflammatory agents; MOBILE apps; OPIOID analgesics; THERAPEUTIC use of narcotics; RESEARCH; ANALGESICS; POCKET computers; ACETAMINOPHEN; RESEARCH methodology; MEDICAL cooperation; EVALUATION research; COMPARATIVE studies; RANDOMIZED controlled trials
- Publication
JGIM: Journal of General Internal Medicine, 2020, Vol 35, Issue 1, p102
- ISSN
0884-8734
- Publication type
journal article
- DOI
10.1007/s11606-019-05303-0