Evidence map›Paper›PMID 41645261›Full record

ArticleJournal of orthopaedic surgery and research2026

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

Sandro Zacher, Julia Lauberger, Deha Murat Ates, Holger Bäthis, Andreas Böhmer, Stefanie Bühn, Anke Kaulbert, Tim Mathes, Sarah Oerder, Henning Rosenau and 4 more

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Article in Journal of orthopaedic surgery and research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Sandro Zacher *Institute 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.
Julia Lauberger *Institute of Health, Midwifery and Nursing Science, Medical Faculty of Martin Luther University Halle-Wittenberg, University Medicine Halle, Magdeburger Straße 8, 06112, Halle (Saale), Germany.
Deha Murat AtesDepartment of Trauma and Orthopedic Surgery, University of Witten/Herdecke, Cologne-Merheim Medical Center, Ostmerheimer Str. 200, 51109, Cologne, Germany.
Holger BäthisDepartment of Trauma and Orthopedic Surgery, University of Witten/Herdecke, Cologne-Merheim Medical Center, Ostmerheimer Str. 200, 51109, Cologne, Germany.
Andreas BöhmerDepartment of Anaesthesiology and Intensive Care Medicine, Cologne-Merheim Medical Center, University of Witten-Herdecke, Ostmerheimer Straße 200, 51109, Cologne, Germany.
Stefanie BühnFaculty of Health-School of Medicine, Institute for Research in Operative Medicine, University of Witten/Herdecke, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.
Anke KaulbertFaculty of Health-School of Medicine, Institute for Research in Operative Medicine, University of Witten/Herdecke, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.
Tim MathesInstitute for Medical Statistics, University Medical Center Goettingen, Humboldtallee 32, 37073, Göttingen, Germany.
Sarah OerderFaculty of Health-School of Medicine, Institute for Research in Operative Medicine, University of Witten/Herdecke, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.
Henning RosenauInterdisciplinary Scientific Center for Medicin, Ethics and Law, Martin Luther University Halle-Wittenberg, Universitätsplatz 5, 06108, Halle (Saale), Germany.
Anke SteckelbergInstitute of Health, Midwifery and Nursing Science, Medical Faculty of Martin Luther University Halle-Wittenberg, University Medicine Halle, Magdeburger Straße 8, 06112, Halle (Saale), Germany.
Felicia SteffenInterdisciplinary Scientific Center for Medicin, Ethics and Law, Martin Luther University Halle-Wittenberg, Universitätsplatz 5, 06108, Halle (Saale), Germany.
Alina WeiseFaculty of Health-School of Medicine, Institute for Research in Operative Medicine, University of Witten/Herdecke, Ostmerheimer Str. 200, Building 38, 51109, Cologne, Germany.
Julia LühnenInstitute of Health, Midwifery and Nursing Science, Medical Faculty of Martin Luther University Halle-Wittenberg, University Medicine Halle, Magdeburger Straße 8, 06112, Halle (Saale), Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInformed 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.

methodsWe 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.

resultsWe 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.

conclusionsThe 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.

Indexed as

AnesthesiaArthroplasty, Replacement, KneeConsent FormsEvidence-Based MedicineInformed ConsentAgedFemaleFocus GroupsHumansMaleMiddle AgedPilot ProjectsArthroplasty MeSH-TermConsent documentsConsent formsInformed consent formOsteoarthritisPatient educationRisk communication

Identifiers

PMID41645261
PMCPMC12930710

What Socratic holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.