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Evidence-based informed consent forms for total knee arthroplasty and anaesthesia: development and pilot study.

Sandro Zacher1, Julia Lauberger2, Deha Murat Ates3

  • 1Institute of Health, Midwifery and Nursing Science, Medical Faculty of Martin Luther University Halle-Wittenberg, University Medicine Halle, Magdeburger Straße 8, 06112, Halle (Saale), Germany. sandro.zacher@medizin.uni-halle.de.

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|February 6, 2026
PubMed
Summary

Developed evidence-based informed consent forms for total knee arthroplasty (TKA) are feasible and perceived as helpful by patients. These forms enhance understanding and support shared decision-making in surgical procedures.

Keywords:
Arthroplasty MeSH-TermConsent documentsConsent formsInformed consent formOsteoarthritisPatient educationRisk communication

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Area of Science:

  • Medical Ethics
  • Health Communication
  • Surgical Patient Care

Background:

  • Standard informed consent forms for total knee arthroplasty (TKA) often lack evidence-based content, hindering informed decision-making.
  • There is a need for improved informed consent processes in elective surgical procedures.

Purpose of the Study:

  • To develop and pilot test an evidence-based informed consent form for TKA.
  • To enhance patient understanding and support shared decision-making in TKA.

Main Methods:

  • A two-phase study involving the development of extended, evidence-based informed consent forms and an e-learning program.
  • Systematic evidence syntheses, expert reviews, and patient pilot testing through think-aloud interviews and focus groups were employed.
  • Qualitative content analysis was used to analyze patient and expert feedback for iterative revisions.

Main Results:

  • Evidence-based informed consent forms for TKA and anesthesia were developed, adhering to evidence-based guidelines and legal requirements.
  • Forms presented benefits and complications using natural frequencies and visualizations, and were rated as understandable and helpful by patients.
  • An e-learning program and a revised knowledge test were developed to support clinician training and patient comprehension.

Conclusions:

  • Evidence-based informed consent forms for TKA are feasible and positively perceived by patients.
  • Patient feedback highlighted the importance of personalized counseling and structural adjustments for optimal use.
  • The developed forms and associated training tools can improve the informed consent process in TKA.