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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