Froud, Robert J., Fawkes, Carol, Foss, Jonathan G. K., Underwood, Martin and Carnes, Dawn (2018) Responsiveness, reliability, and minimally important and minimal detectable change of three electronic patient reported outcome measures for low back pain : a validation study. Journal of Medical Internet Research . doi:10.2196/jmir.9828

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Abstract

Background

The Roland Morris Disability Scale (RMDQ), Visual Analogue Scale of pain intensity (VAS) 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

To establish responsiveness, minimal important change (MIC) thresholds, reliability, and minimal detectable change (MDC95) for electronic (e) versions of the RMDQ, VAS, and NRS as delivered via iOS app, Android app, and web app.

Methods

We recruited people with low back pain who visited osteopaths. We invited participants to complete the eRMDQ, eVAS, and eNRS at baseline, one-week, and six-weeks, along with a health transition question (TQ) at one and six-weeks. Data from participants reporting recovery were used in responsiveness and MIC analyses, using Receiver Operator Characteristic curves. Data from participants reporting stability were used for analyses of reliability (ICC agreement) and minimal detectable change (MDC95).

Results

We included 442 participants. At one and then six-weeks, ROC AUCs were 0.69 (95%CI 0.59 to 0.80) then 0.67 (0.46 to 0.87) for the eRMDQ; 0.69 (0.58 to 0.80) then 0.74 (0.53 to 0.95) for the eVAS; and 0.73 (0.66 to 0.80) then 0.81 (0.69 to 0.92) for the eNRS. Associated MIC thresholds were estimated as 1 (0 to 2) then 2 (-1 to 5), 13 (9 to 17) then 7 (-12 to 26), and 2 (1 to 3) then 1 (0 to 2) points, respectively. Over one-week in stable and ‘about the same’ participants ICCs were 0.87 (0.66 to 0.95) and 0.84 (0.73 to 0.91) for the eRMDQ, with MDC95 of 4 and 5; 0.31 (-0.25 to 0.71) and 0.61 (0.36 to 0.77) for the eVAS with MDC95 of 39 and 34; and 0.52 (0.14 to 0.77) to 0.67 (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 range of values reported in the literature for their paper counterparts and are adequate for measuring changes in a low back pain population.

Item Type:	Journal Article
Subjects:	R Medicine > RD Surgery
Divisions:	Faculty of Science > Computer Science Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Backache -- Diagnosis, Back -- Diseases, Medical informatics
Journal or Publication Title:	Journal of Medical Internet Research
Publisher:	JMIR Publications
ISSN:	1438-8871
Official Date:	2018
Dates:	Date Event 2018 Published 24 October 2018 Available 18 June 2018 Accepted
DOI:	10.2196/jmir.9828
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID Impact Fund University of Warwick http://dx.doi.org/10.13039/501100000741

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