Abstract
BackgroundPractitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements.MethodsThe development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact.DiscussionThe evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased.Trial registrationClinicalTrials.gov, NCT04669483. Registered 15 December 2020.German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020
Highlights
In most countries, every medical intervention requires informed consent [1,2,3,4]
This study aims at investigating the effects of evidence-based informed consent forms for total knee arthroplasty (TKA) surgery in clinical practice
The overall aim of this project is to investigate whether newly developed evidence-based informed consent forms for surgery and anesthesia can reduce the deficits of the standardized consent forms regarding patients’ anxiety, nocebo effects, and risk perception
Summary
Background and rationale In most countries, every medical intervention requires informed consent [1,2,3,4]. The Council of Europe’s Convention on Human Rights and Biomedicine (chapter II, article 5), for example, declares that ‘an intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risk.’. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements
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