Article type
Abstract
"Background
In Germany, medical interventions require informed consent for ethical and legal reasons. The informed consent forms currently used tend to be risk-centered and often do not provide sufficient support for informed decisions.
Objectives
The aim was to develop and pilot test evidence-based informed consent forms for total knee arthroplasty (TKA) and the associated anesthesia procedures.
Methods
The development of the informed consent forms followed the guideline evidence-based health information. Compliance with the legal requirements for informed consent was checked during the development process. Information needs, relevant outcome measures and the research questions to be answered were determined using literature searches, exploratory interviews and clinical expertise. Systematic reviews and meta-analyses were conducted to compare the efficacy and complications of different TKA options, as well as conservative treatment and anesthetic procedures. The qualitative feasibility study explored acceptance, applicability and understanding in the target group of patients with osteoarthritis of the knee. Data was collected using think-aloud and group interviews. The audio-recorded and transcribed interviews were analyzed using Mayring's qualitative content analysis in an iterative process of analysis and revision.
Results
Evidence-based informed consent forms were developed for TKA and the associated anesthesia procedures. In addition, an information brochure was produced for TKA, which primarily presents a comparison of the benefits of different TKA options. Between 10/2021 and 05/2022, six think-alouds and three group interviews were conducted with 17 patients. Overall, the information was largely considered relevant and comprehensible. However, the scope and complexity sometimes exceeded the subjective need for information. For example, participants reported difficulties in understanding the figures on benefits and complications as well as the concept of efficacy studies.
Conclusions
Overall, the informed consent forms and the information brochure appear to be applicable and understandable. Further piloting is planned. An adapted version of the developed materials is currently being compared with standard information sheets in a before/after pilot study.
CoI: no interests to declare
Funding: The project is funded by the Innovation Committee at the German Federal Joint Committee; funding code: 01VSF19025.
"
In Germany, medical interventions require informed consent for ethical and legal reasons. The informed consent forms currently used tend to be risk-centered and often do not provide sufficient support for informed decisions.
Objectives
The aim was to develop and pilot test evidence-based informed consent forms for total knee arthroplasty (TKA) and the associated anesthesia procedures.
Methods
The development of the informed consent forms followed the guideline evidence-based health information. Compliance with the legal requirements for informed consent was checked during the development process. Information needs, relevant outcome measures and the research questions to be answered were determined using literature searches, exploratory interviews and clinical expertise. Systematic reviews and meta-analyses were conducted to compare the efficacy and complications of different TKA options, as well as conservative treatment and anesthetic procedures. The qualitative feasibility study explored acceptance, applicability and understanding in the target group of patients with osteoarthritis of the knee. Data was collected using think-aloud and group interviews. The audio-recorded and transcribed interviews were analyzed using Mayring's qualitative content analysis in an iterative process of analysis and revision.
Results
Evidence-based informed consent forms were developed for TKA and the associated anesthesia procedures. In addition, an information brochure was produced for TKA, which primarily presents a comparison of the benefits of different TKA options. Between 10/2021 and 05/2022, six think-alouds and three group interviews were conducted with 17 patients. Overall, the information was largely considered relevant and comprehensible. However, the scope and complexity sometimes exceeded the subjective need for information. For example, participants reported difficulties in understanding the figures on benefits and complications as well as the concept of efficacy studies.
Conclusions
Overall, the informed consent forms and the information brochure appear to be applicable and understandable. Further piloting is planned. An adapted version of the developed materials is currently being compared with standard information sheets in a before/after pilot study.
CoI: no interests to declare
Funding: The project is funded by the Innovation Committee at the German Federal Joint Committee; funding code: 01VSF19025.
"