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 | - |