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Table 1 Outcome measures

From: Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol

Primary Outcome measure*

Data collection instrument

WOMAC composite score

WOMAC-3.1 patient-rated questionnaire [30–32]

Secondary Outcome measures

Timed up-and-go

Physical test [38, 39]

30 second sit-to-stand

Physical test [37]

40 m self-paced walk

Physical test [32, 39]

WOMAC subscales: A) Pain; B) Stiffness C) Physical Function;

WOMAC-3.1 [33, 34] patient-rated questionnaire

Numeric pain rating

NPRS [33, 34] patient-rated questionnaire

Self-efficacy and pain beliefs

The Pain Belief Screening Instrument [40, 41]

Depression

The two-item case-finding instrument [42]

Patient's global assessment

GROC [33, 34, 36] patient-rated scale

OARSI response criteria

Composite of WOMAC, NPRS, GROC [34]

American College of Rheumatology criteria for diagnosis of OA

Clinician-rated criteria [22–24, 45, 46] from physical tests and symptoms

New Zealand National Clinical Priority System score

Clinician-rated criteria [47];

Adverse events

MOA field team audit; ODHB records; self-report questionnaire

Overall health status†

SF-12 general health survey [43]

Surgical intervention†

Self-report questionnaire; health system records [44]

Healthcare consumption and related costs†

Self-report questionnaire; health system records

  1. *The primary end-point for data analysis is 12 months. All outcome measures will be undertaken at baseline, 9 weeks, 6 months, 1 year and 2 years, with the exception of patients' global assessment and OARSI response criteria, which will not be assessed at baseline. †The primary endpoint for cost-utility and surgical intervention is at 2 years. WOMAC = Western Ontario and McMaster osteoarthritis index; NPRS = numeric pain rating scale; GROC = global rating of change; OA = Osteoarthritis; OARSI = Osteoarthritis Research Society International; MOA = the Management of OsteoArthritis Trial; ODHB = Otago District Health Board.