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Table 1 Summary of outcomes, measurement instruments and time of measurement

From: An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial

Outcome Domain Measurement instrument Source Assessor perspective Study period Data type
    Patient Clinician Enrolment Pre-Visit (t0) Visit
(t1)
Post-Visit (t2) Follow-up (t3) Close-out  
Enrolment
Eligibility screen      x       -
Informed consent      x       -
Intervention
Decision aid        x     -
Routine care        x     -
Assessments
Sociodemographic data
Sociodemographic Sociodemographic questionnaire Self-made     x      -
PROM
Pain & function Oxford Knee Score (OKS) [42] x    x    x   con
(0-48)
Generic health related quality of life EQ-5D-5l [43] x    x    x   con
(0-1)
Subjective suffering, health related quality of life, pain Numeric rating scale (0-10) Self-made x    x    x   con
(0-10)
Pain Patient survey Self-made x    x    x   cat
Muscoloscleral complaints Musculoskeletale morbidities Self-made x    x    x   cat
Global treatment outcome 5-point Likert-scale [44] x       x   cat
Disease-related Symptoms, complaints disabilities 3-point Likert-scale Self-made x    x    x   cat
Treatment goals
Expectations 3-point Likert-scale Self-made, [45] x    x      cat
Fullfilment of expectation 5-point Likert-scale Self-made x       x   cat
Estimation of the probability of fulfillment 5-point Likert-scale Self-made, [45]   x   x      cat
CBO
Range of motion Angular measurement    x     xb    con
Stability Joint clearance : Mediolateral and anteroposterior    x     xb    cat
BMI Weight and length measurement   x      xb    con
Morbidity Anamnesis    x     xb    cat
Contraindication Anamnesis    x     xb    cat
Degree of Osteoarthritis Kallgren & Lawrence    x     xb    cat
Joint space narrowing X-ray    x     xb    cat
Leg axis position X-ray    x     xb    cat
Decision making and patient participation
Participation in therapy decision PEF–FB-9 [46] x      x    con
(0-100)
Preference for involvement in decision-making Control Preferences Scale (CPS) [47] x    x      cat
Decision quality DQI-Knee Osteoarthritisa [48] x      x x   cat
  Decision Process Score of the DQI-Knee Osteoarthritisa [48] x      x    con
(0-100)
  4-point Likert Scare Selfmade     x   x    cat
Decision regret Decision Regret Scale (DRS) [49] x       x   con
(0-100)
Satisfaction with consultation (physician) 5-point Likert-scale Self-made x      x    cat
Satisfaction with consultation (patient) 5-point Likert-scale Self-made   x     x    cat
Agreed medical treatment decision NA Self-made   x     x    cat
Adherence to clinical guideline Fulfillment of indication criteria Self-made   x     x x   cat
Previous therapy
Conservative therapy Patient survey Self-made x    x    x   -
Operative therapy Patient survey Self-made x    x      -
  1. a Modified version of the DQI- Knie; PROM: Patient reported outcome measure; CBO: Clinician-based outcome; Categorial (cat); Continuous (con) b in the intervention group during counseling