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Table 1 Participant timeline (SPIRIT figure)

From: Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

 

Study period (25 months)

 

Pre-phase

Interruption

Post-phase

Time-point

4 weeks before surgery

2–4 days before surgery

1 day before surgery

Surgery

3 days after discharge

30 days after discharge

4 weeks before surgery

2–4 day before surgery

1 day before surgery

Surgery

3 days after discharge

30 days after discharge

Enrolment

Eligibility screen

X

      

X

     

Informed consent

X

     

X

     

Control

Standard consent form anesthesia

Xa

Xa

          

Standard consent form TKA

 

X

          

Intervention

Evidence-based consent form anesthesia

      

Xa

Xa

    

Evidence-based consent form TKA

       

X

    
 

Surgery

   

X

     

X

  

Assessments

Patient characteristics

X

     

X

     

Baseline anxiety

X

     

X

     

Anxiety

  

X

     

X

   

Health knowledge

  

X

     

X

   

Satisfaction with physician-patient-communication

  

X

     

X

   

Nocebo-effect

    

X

     

X

 

Quality of Life

     

X

     

X

Pain and function

     

X

     

X

  1. aInformed consent for anesthesia takes place approximately 4 weeks or 2–4 days before surgery, depending on the patients’ morbidity and the flexibility in scheduling