Responsiveness, reliability, and minimally important and minimal detectable changes of 3 electronic patient-reported outcome measures for low back pain : validation study

Froud, Robert (Clinical Trials Unit, Warwick Medical School, University of Warwick, Civentry, United Kingdom ; Institute of Health Sciences, Kristiania University College, Oslo, Norway) ; Fawkes, Carol (Barts and the London School of Medicine and Dentistry, Queen Mary University of London, United Kingdom) ; Foss, Jonathan (Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, United Kingdom ; Department of Computer Science, University of Warwick, Coventry, United Kingdom) ; Underwood, Martin (Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, United Kingdom) ; Carnes, Dawn (Barts and the London School of Medicine and Dentistry, Queen Mary University of London, United Kingdom ; School of Health Sciences, HES-SO Fribourg)

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 (MDC95) 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 MDC95. 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 MDC95 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 MDC95 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 MDC95 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.

Article Type:
Recherche appliquée et développement Santé HEDS-FR
17 p.
Published in:
Journal of Medical Internet Research
Numeration (vol. no.):
2018, vol. 20, no. 10, pp 1-17
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 Record created 2019-11-14, last modified 2020-10-27

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