Core Outcome Measures in Effectiveness Trials

Developing and testing a consensus-based core set of outcome measures for rehabilitation in musculoskeletal diseases

General Information

OBJECTIVES: Rehabilitation is important for people with musculoskeletal diseases (MSDs), and evaluating the effect of rehabilitation on both an individual and group level is advocated. A consensus concerning use of outcome measures will improve collaboration between healthcare providers, and increase the possibility of conducting meta-analyses in future research. The aim of this study was to develop a consensus-based core set of outcome measures for rehabilitation in MSDs, and to test the feasibility and responsiveness of the set. METHOD: The core set was developed through a stepwise process comprising a Delphi consensus procedure, systematic literature searches, and a pilot study, including 386 patients, to test the feasibility and responsiveness of the set. RESULTS: The following aspects and outcome measures were selected: pain [numeric rating scale (NRS)], fatigue (NRS), physical fitness (the 30-second Sit to Stand test), mental health (Hopkins Symptom Checklist 5), daily activities (Hannover Functional Questionnaire), goal attainment (Patient-Specific Functional Scale including motivation score for baseline assessment), quality of life (5-level EuroQol 5 Dimensions), social participation (the social participation item from COOP/WONCA) and coping (Effective Musculoskeletal Consumer Scale-17). All tested outcome measures were found to be feasible, with high completion rates and acceptable score distribution. Standard response means varied from 0.3 to 0.9. CONCLUSIONS: A consensus-based core set of patient reported outcome measures is presented for evaluating rehabilitation in MSDs. The core set is feasible and responsive for use in Norway, but needs further testing in other countries.

Klokkerud, M. Dagfinrud, H. Uhlig, T. Dager, T. N. Furunes, K. A. Klokkeide, A. Larsen, M. Nygard, S. Nylenna, S. Oie, L. Kjeken, I.


Scand J Rheumatol
225 - 234
Further Study Information

Funding source(s):
not reported

Health Area

Disease Category

Disease Name
Musculoskeletal conditions

Target Population

Age Range


Nature / type of Intervention


Delphi process
Semi structured discussion
Use of the International Classification of Functioning, Disability and Health (ICF)

The process of reaching an agreement upon which aspects to measure started with a workshop in May 2013, including lectures and discussions, to ensure a common understanding of MSD rehabilitation (Phase 1, Figure 1). Thereafter, a brainstorming session for relevant aspects was conducted in the group. The suggested aspects were categorized according to the five main components in the International Classification of Functioning, Disability and Health (ICF): body function/ structure, activity, participation, environmental factors, and personal factors (10). Duplicates and synonymous results were merged, and three Delphi voting rounds were conducted to reach a consensus (> 75% agreement) on the 10 most important aspects.

Stakeholders Involved

Clinical experts
Consumers (patients)

Study Type

COS for clinical trials or clinical research
COS for practice

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