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Background <p>Informed consent is a legal and ethical prerequisite for elective procedures such as total knee arthroplasty (TKA). However, standard informed consent forms often lack evidence-based content and do not adequately support informed decision-making. The aim was to develop and pilot test an evidence-based informed consent form for TKA.</p> Methods <p>We conducted a two-phase study. In Phase 1, we developed an extended, evidence-based informed consent form for TKA, as well as a corresponding form for anaesthesia, based on systematic evidence syntheses, expert reviews, and standards outlined in the <i>Guideline Evidence-based Health Information</i>. We also developed an e-learning program to train clinicians in the appropriate use of informed consent forms. In addition, we developed a multiple-choice test to assess patients’ knowledge and risk perception. In Phase 2, we piloted the informed consent forms with potential patients through think-aloud interviews and focus groups, assessing their acceptability, usability and comprehensibility with iterative revisions. The multiple-choice test was also piloted and revised. Qualitative data were analysed using qualitative content analysis.</p> Results <p>We developed evidence-based informed consent forms for TKA and anaesthesia. Content and risk communication follow the <i>Guideline Evidence-based Health Information</i> and meet legal requirements under German law. Benefits and complications were presented using natural frequencies and visualised with bar charts. The forms were piloted in six think-aloud and three focus group interviews with 17 participants. Feedback from participants and experts highlighted the need for revisions in the presentation of numerical data, terminology, structure and layout, which were addressed iteratively. Overall, the forms were rated as understandable, relevant and helpful, though individual information needs varied. The 12-item multiple-choice knowledge test was revised to improve clarity and was perceived as comprehensible and applicable. The e-learning programme includes videos, texts and interactive elements, and is designed for flexible use over 90 to 180&#xa0;min.</p> Conclusions <p>The informed consent forms are now available. Evidence-based informed consent forms are feasible and perceived by patients as helpful and understandable. The variety of patients’ information needs underlines the need for personalised counselling and structural adjustments in clinical practice so that the potential of evidence-based informed consent forms can be exploited.</p>

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

  • 期刊论文

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  • 发表日期：

    2026年2月5日

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  • Sandro Zacher,
  • Julia Lauberger,
  • Deha Murat Ates,
  • Holger Bäthis,
  • Andreas Böhmer,
  • Stefanie Bühn,
  • Anke Kaulbert,
  • Tim Mathes,
  • Sarah Oerder,
  • Henning Rosenau,
  • Anke Steckelberg,
  • Felicia Steffen,
  • Alina Weise,
  • Julia Lühnen

摘要

Background

Informed consent is a legal and ethical prerequisite for elective procedures such as total knee arthroplasty (TKA). However, standard informed consent forms often lack evidence-based content and do not adequately support informed decision-making. The aim was to develop and pilot test an evidence-based informed consent form for TKA.

Methods

We conducted a two-phase study. In Phase 1, we developed an extended, evidence-based informed consent form for TKA, as well as a corresponding form for anaesthesia, based on systematic evidence syntheses, expert reviews, and standards outlined in the Guideline Evidence-based Health Information. We also developed an e-learning program to train clinicians in the appropriate use of informed consent forms. In addition, we developed a multiple-choice test to assess patients’ knowledge and risk perception. In Phase 2, we piloted the informed consent forms with potential patients through think-aloud interviews and focus groups, assessing their acceptability, usability and comprehensibility with iterative revisions. The multiple-choice test was also piloted and revised. Qualitative data were analysed using qualitative content analysis.

Results

We developed evidence-based informed consent forms for TKA and anaesthesia. Content and risk communication follow the Guideline Evidence-based Health Information and meet legal requirements under German law. Benefits and complications were presented using natural frequencies and visualised with bar charts. The forms were piloted in six think-aloud and three focus group interviews with 17 participants. Feedback from participants and experts highlighted the need for revisions in the presentation of numerical data, terminology, structure and layout, which were addressed iteratively. Overall, the forms were rated as understandable, relevant and helpful, though individual information needs varied. The 12-item multiple-choice knowledge test was revised to improve clarity and was perceived as comprehensible and applicable. The e-learning programme includes videos, texts and interactive elements, and is designed for flexible use over 90 to 180 min.

Conclusions

The informed consent forms are now available. Evidence-based informed consent forms are feasible and perceived by patients as helpful and understandable. The variety of patients’ information needs underlines the need for personalised counselling and structural adjustments in clinical practice so that the potential of evidence-based informed consent forms can be exploited.