Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

Abstract

Background Practitioners 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. Methods The 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. Discussion The 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 registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

A Well-understood Surgical Informed Consent : A Scoping Review

“…The 6 articles in this scoping review use websites, audio visuals and mobile applications as information media to provide education about surgical procedures. Obtained significant results in increasing the level of patient understanding (Axelrod et al, 2017;Lin et al, 2017;Rouf et al, 2017;Marcus et al, 2018;Fudman et al, 2019;Wiesen et al, 2020;Weise et al, 2021). Interesting audio visuals can be used in disabled patients.…”

Informed consent for total knee arthroplasty: exploration of patient`s information acquisition and decision-making processes—a qualitative study

“…Since the aim of the study is to explore and understand processes and needs, a qualitative approach was chosen. The study protocol was published in the context of the entire project (Sub-study I) [ 25 ]. For a comprehensive description, the doctors' perspective was included in addition to the patients' perspective.…”

“…These do not usually meet the requirements for supporting informed decision-making [ 24 ]. In a current project, we developed evidence-based patient consent forms for surgery and anaesthesia for TKA in order to compare these new consent forms with the standard ones [ 25 ]. Since the informed consent to TKA and anaesthesia is the final step in the decision-making process, we wanted to explore the processes of information acquisition and decision-making in order to better understand the context in which the informed consent is imbedded.…”