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Table 1 Study measures

From: Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study)

Construct assessed Data collection instrument Time of collection
Primary outcome measure   
Pain, symptoms, physical function and QOL Average score of four of the KOOS subscales, KOOS4 0, 12, 26 and 52 weeks
Secondary outcome measures Data collection instrument Time of collection
  PROMs  
Pain, symptoms, ADL, QOL and Sport & Rec The five individual subscales of KOOS 0, 12, 26 and 52 weeks
Health outcome EQ-5D-3 L 0, 12, 26 and 52 weeks
Self-efficacy in improving pain, function and QOL 100 mm VAS 0, 12, 26 and 52 weeks
Pain intensity in various situations 100 mm VAS 0, 12, 26 and 52 weeks
Pain location Region-divided body chart 0, 12, 26 and 52 weeks
  Objective measures  
Functional performance Timed Up and Go 0, 12, 26 and 52 weeks
Functional performance 20-meter walk test 0, 12, 26 and 52 weeks
Weight change Percentage-wise change in weight from baseline to follow-up 0, 12, 26 and 52 weeks
Muscle strength HHD - maximum isometric strength in flexion and extension 0, 12, 26 and 52 weeks
Pain reactions Handheld algometer – PPTs at four sites in the peripatellar region and at m. tibialis anterior 0, 12, 26 and 52 weeks
Other measures Data collection instrument Time of collection
Compliance with exercise Treatment records, log-book Continuously
Use of medication Questionnaire 0, 12, 26 and 52 weeks
Compliance with diet, insoles and patient education A five-point scale (ranging from never to all the time) 0, 12, 26 and 52 weeks
Satisfaction A five-point Likert scale 0, 12, 26 and 52 weeks
Adverse events Treatment records, hospital records and questionnaire Continuously
Health and non-health care costs Hospital records and questionnaire 0, 12, 26 and 52 weeks
  1. PROMs = Patient-reported outcome measures, QOL = quality of life, ADL = activities of daily living, Sport & Rec = sports and recreational activities, HHD = Handheld Dynamometer, PPTs = Pressure pain thresholds.