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Responsiveness, Reliability, and Minimally Important and Minimal Detectable Changes of 3 Electronic Patient-Reported Outcome Measures for Low Back Pain: Validation Study
Author(s) -
Robert Froud,
Carol Fawkes,
Jonathan G. K. Foss,
Martin Underwood,
Dawn Carnes
Publication year - 2018
Publication title -
jmir. journal of medical internet research/journal of medical internet research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.446
H-Index - 142
eISSN - 1439-4456
pISSN - 1438-8871
DOI - 10.2196/jmir.9828
Subject(s) - intraclass correlation , receiver operating characteristic , medicine , physical therapy , visual analogue scale , minimal clinically important difference , low back pain , back pain , standard error , psychometrics , randomized controlled trial , surgery , statistics , clinical psychology , alternative medicine , mathematics , pathology
Background The Roland Morris Disability Questionnaire (RMDQ), visual analog scale (VAS) of pain intensity, and numerical rating scale (NRS) are among the most commonly used outcome measures in trials of interventions for low back pain. Their use in paper form is well established. Few data are available on the metric properties of electronic counterparts. Objective The goal of our research was to establish responsiveness, minimally important change (MIC) thresholds, reliability, and minimal detectable change at a 95% level (MDC 95 ) for electronic versions of the RMDQ, VAS, and NRS as delivered via iOS and Android apps and Web browser. Methods We recruited adults with low back pain who visited osteopaths. We invited participants to complete the eRMDQ, eVAS, and eNRS at baseline, 1 week, and 6 weeks along with a health transition question at 1 and 6 weeks. Data from participants reporting recovery were used in MIC and responsiveness analyses using receiver operator characteristic (ROC) curves and areas under the ROC curves (AUCs). Data from participants reporting stability were used for analyses of reliability (intraclass correlation coefficient [ICC] agreement) and MDC 95 . Results We included 442 participants. At 1 and 6 weeks, ROC AUCs were 0.69 (95% CI 0.59 to 0.80) and 0.67 (95% CI 0.46 to 0.87) for the eRMDQ, 0.69 (95% CI 0.58 to 0.80) and 0.74 (95% CI 0.53 to 0.95) for the eVAS, and 0.73 (95% CI 0.66 to 0.80) and 0.81 (95% CI 0.69 to 0.92) for the eNRS, respectively. Associated MIC thresholds were estimated as 1 (0 to 2) and 2 (–1 to 5), 13 (9 to 17) and 7 (–12 to 26), and 2 (1 to 3) and 1 (0 to 2) points, respectively. Over a 1-week period in participants categorized as “stable” and “about the same” using the transition question, ICCs were 0.87 (95% CI 0.66 to 0.95) and 0.84 (95% CI 0.73 to 0.91) for the eRMDQ with MDC 95 of 4 and 5, 0.31 (95% CI –0.25 to 0.71) and 0.61 (95% CI 0.36 to 0.77) for the eVAS with MDC 95 of 39 and 34, and 0.52 (95% CI 0.14 to 0.77) to 0.67 (95% CI 0.51 to 0.78) with MDC 95 of 4 and 3 for the eNRS. Conclusions The eRMDQ was reliable with borderline adequate responsiveness. The eNRS was responsive with borderline reliability. While the eVAS had adequate responsiveness, it did not have an attractive reliability profile. Thus, the eNRS might be preferred over the eVAS for measuring pain intensity. The observed electronic outcome measures’ metric properties are within the ranges of values reported in the literature for their paper counterparts and are adequate for measuring changes in a low back pain population.

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