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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