Research Appraisals
Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.
Showing 2 appraisals
JMIR formative research
Development of iGET Living, a Digital Graded Exposure Intervention for Youth With Chronic Pain: Multiphase User-Centered Design and Pilot Study
BACKGROUND: Pediatric chronic pain affects up to one-third of youth and is associated with significant disruptions in social, emotional, and behavioral functioning. Although behavioral treatments are effective, access remains limited due to geographic, financial, and systemic barriers. Digital behavioral health interventions offer a promising solution, but many lack user-centered design, iterative refinement, and implementation-informed development strategies that support usability and scalability. OBJECTIVE: This study aimed to develop and iteratively refine iGET Living, a digital graded exposure intervention for youth with chronic pain, using a combined user-centered and implementation-informed framework, and to evaluate its preliminary acceptability, feasibility, and user-perceived success. METHODS: Guided by the Consolidated Framework for Implementation Research (CFIR) and the mHealth (mobile health) Agile Development and Lifecycle model, intervention development proceeded through 3 phases. Phase 0 translated an evidence-based in-person graded exposure treatment (GET Living) into an initial digital prototype. Phase 1 involved iterative user-centered refinement across 3 cycles of qualitative development sessions with youth with chronic pain (n=15), incorporating think-aloud usability testing, Likert-rated feedback, and rapid qualitative analysis mapped to CFIR constructs to guide real-time modifications to content, design, and functionality. Phase 2 piloted the refined intervention with a new sample of youth (n=38, n=30 completers) recruited from a tertiary pediatric pain clinic to evaluate feasibility, acceptability, treatment credibility and expectancy, and user-perceived functional improvements. Quantitative outcomes were summarized descriptively, and qualitative exit interview data were analyzed using rapid qualitative analysis. RESULTS: Across development cycles, youth feedback informed substantive refinements to the intervention, including reducing text density, incorporating animated educational videos, enhancing interactive features, and improving navigation and layout. These changes resulted in progressive improvements in clarity, satisfaction, and acceptability across prototypes. In the Phase 2 pilot study, participants reported moderate-to-high treatment credibility (mean of 19.71 out of 30) and expectancy (mean of 17.96 out of 30), as well as high satisfaction (mean of 46.12 out of 60). Acceptability ratings across domains of the Theoretical Framework of Acceptability were favorable. Qualitative exit interviews highlighted the interventions' perceived role in helping youth re-engage in valued activities. CONCLUSIONS: Using a combined CFIR and agile development approach, iGET Living emerged as a feasible, acceptable, engaging digital graded exposure intervention for youth with chronic pain. These findings highlight the value of integrating implementation frameworks and participatory design early in digital intervention development and support further evaluation in a preliminary efficacy trial.
18 Apr 2026
Read appraisal →JMIR research protocols
Targeted Real-Time Assessment of Chronic Pain (TRAC-Pain) in Youth: Protocol for a Digital Biosignature Development Through a Prospective Observational Cohort Study
BACKGROUND: Approximately 1 in 5 children and adolescents live with chronic pain, with musculoskeletal (MSK) pain being one of the most prevalent subtypes. Unfortunately, some studies show that less than half of youth (<18 years) experience improvements with existing evidence-based treatments. Self-report measures-the current gold standard for monitoring the pain experience-are limited in their use as a single point-of-care assessment and their vulnerability to recall bias. The ubiquitous adoption of wearable technology presents a promising solution for improved monitoring of the pain experience via real-time tracking through a multisystemic lens. OBJECTIVE: The purpose of this study is (1) to develop a digital biosignature of the pain experience in youth with chronic MSK pain and (2) to assess the feasibility, acceptability, and appropriateness of the captured data for future applications. METHODS: All aspects of this study were designed in partnership with people with lived experience and patient advocacy partners. This is a longitudinal observational cohort study, with all study activities taking place remotely over a 12-week period. Up to 500 youth (between 14 and 24 years old) with chronic MSK pain will be enrolled through a multipronged recruitment strategy to ensure a representative sample. The participants will wear an Apple Watch throughout the study to continuously monitor physiological, sleep, and physical activity metrics. In addition, participants will complete brief "daily check-in" surveys that include gold-standard measures of the pain experience (eg, pain interference, mood, fatigue) and the option to report a "pain flare" (ie, a temporary but noticeable worsening of the usual pain symptoms). Participants will also complete a modified online Trier Social Stress Test and a 30-second sit-to-stand task to capture individual responses to standardized challenges. Traditional machine learning and deep representation learning methods will be used to develop a digital biosignature of the pain experience. The accuracy of the biosignature will be assessed through measures of model performance as compared to gold-standard self-reports. RESULTS: This study was funded in September 2024, with data collection beginning in March 2025. As of December 15, 2025, 190 participants are enrolled, with data collection and analysis ongoing. CONCLUSIONS: This is the first study to leverage wearable health technology for real-time monitoring of the pain experience in youth with chronic MSK pain. The resulting digital end points are expected to heighten the rigor of clinical trials and provide opportunities for individually tailored interventions. The second phase of this study will investigate the implementation of "wellness alerts" triggered by abnormal smartwatch readings. Alerts would empower users toward preemptive self-management strategies, thereby enhancing self-efficacy in those living with chronic MSK pain. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/84781.
8 Apr 2026
Read appraisal →