Core Outcome Measures in Effectiveness Trials

A systematic review highlights the need to investigate the content validity of patient-reported outcome measures for physical functioning in patients with low back pain

General Information

OBJECTIVES: To summarize the evidence on content and structural validity of 17 patient-reported outcome measures (PROMs) to measure physical functioning in patients with low back pain (LBP). STUDY DESIGN AND SETTING: MEDLINE, EMBASE, CINAHL, PsycINFO, SportDiscus, and Google Scholar were searched (February 2017). Records on development and studies assessing content validity or unidimensionality in patients with LBP were included. Two reviewers defined eligible studies and assessed their methodological quality with updated Consensus-based Standards for the Selection of Health Measurement Instruments standards. Evidence was synthesized for three separate aspects of content validity: relevance, comprehensiveness, and comprehensibility, and for unidimensionality, a modified GRADE approach was applied to evidence synthesis. RESULTS: High-quality evidence showed that 24-item Roland Morris Disability Questionnaire (RMDQ-24) is a comprehensible but not comprehensive PROM. Low to very low quality evidence underpinned the content validity of the other PROMs. Unidimensionality was: sufficient for Brief Pain Inventory pain interference subscale (moderate quality evidence); inconsistent for RMDQ-23, Oswestry Disability Index 2.1a (ODI 2.1a), and Quebec Back Pain Disability Scale (moderate quality); insufficient for RMDQ-24, ODI 1.0, and RMDQ-18 (high quality) and Short Form 36 physical functioning subscale (SF36-PF, moderate quality). CONCLUSION: The content validity of PROMs to measure physical functioning in patients with LBP is understudied. Structural validity of several widely used PROMs is problematic.

Chiarotto, A. Ostelo, R. W. Boers, M. Terwee, C. B.


J Clin Epidemiol
73 - 93
Further Study Information

Funding source(s):

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Low back pain

Target Population

Age Range
18 - 100


Nature / type of Intervention


Systematic review

Stakeholders Involved


Study Type

Systematic review of outcome measures/measurement instruments

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