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

BACKGROUND: Total knee arthroplasty (TKA) is an option for the treatment of knee osteoarthritis (OA). Patients have high expectations regarding the benefits of the actual operation. Patients can seek a second opinion on the indication for TKA. In a study, less than half of recommended TKAs were confirmed by the second opinion and conservative treatments are not fully utilized. Informed consent forms that are used in Germany usually do not meet the requirements to support informed decision-making. Our aim was to describe the process from the diagnosis of knee OA through the decision-making process to the informed consent process for TKA, and to understand when, how, and by whom decisions are made. Moreover, we wanted to describe patients' information needs and preferences about knee OA and its treatment, including TKA, and find out what information is provided. We also wanted to find out what information was important for decision-making and identify barriers and facilitators for the optimal use of evidence-based informed consent forms in practice. METHODS: We chose a qualitative approach and conducted semi-structured interviews with patients who were going to receive, have received, or have declined TKA, and with general practitioners (GP), office-based as well as orthopaedists and anaesthesiologists in clinics who obtain informed consent. The interviews were audio-recorded, transcribed and analysed using qualitative content analysis. RESULTS: We conducted interviews with 13 patients, three GPs, four office-based orthopaedists and seven doctors in clinics who had obtained informed consent. Information needs were modelled on subjective disease theory and information conveyed by the doctors. Patients in this sample predominantly made their decisions without having received sufficient information. Trust in doctors and experiences seemed to be more relevant in this sample than fact-based information. Office-based (GPs, orthopaedists) and orthopaedists in clinics had different understandings of their roles and expectations in terms of providing information. CONCLUSIONS: We were able to identify structural barriers and assumptions that hinder the implementation of evidence-based informed consent forms.

Enhancing Transsectoral Interdisciplinary Patient-Centered Care for Patients With Rare Cancers: Protocol for a Mixed Methods Process Evaluation.

BACKGROUND: Rare cancers account for approximately 24% of all new cancers. The category of rare tumor diseases includes almost 200 different entities. In particular, the treatment of patients with extensive care needs requires cooperation between service providers, both between sectors (outpatient and inpatient) and within sectors (eg, between different medical disciplines). The treatment pathway is associated with a high need for coordination and information sharing between providers. When crossing sectoral boundaries in the German health care system, interface problems between the outpatient and inpatient sectors can lead to gaps in care delivery. The multicomponent program Trans-sectoral Personalised Care Concept for Patients with Rare Cancers aims to optimize transsectoral cooperation and coordination of care to enhance patient involvement and the medical care coordination of patients with rare cancers. OBJECTIVE: This process evaluation will contribute to answering questions about intervention fidelity and the implementation of transsectoral communication, identifying and describing the intended and nonintended effects of the intervention, and exploring the barriers to and facilitators of the implementation. METHODS: We will include patients who participate in the intervention phase; all persons and staff involved in the development and implementation of the intervention (Onco Coach, psychologists, physicians on the contact platform, IT staff, and staff of the Bavarian Association of Statutory Health Insurance Physicians); physicians from the Ludwig-Maximilians-University Hospital Munich and the hospital of the Technical University Munich who are involved in the treatment of patients during the course of the project; and participating office-based hematologists and oncologists. Data collection will be conducted at the beginning, during, and at the end of the intervention using mixed methods. Data will be collected from questionnaires, document analyses, semistructured interviews, and structured observations and will cover different aspects of process evaluation. These include examining the context to explore existing patterns, changes in patterns, attitudes, and interactions; analyzing the implementation of intervention elements; and exploring the complex causal pathways and mediators of the intervention. Qualitative data will be analyzed using thematic analysis. The data will then be combined using between-methods triangulation. RESULTS: This project received funding on March 1, 2022. The intervention phase and recruitment for the process evaluation began on March 1, 2023, and the recruitment is expected to end on September 30, 2025. At the time of protocol submission in June 2023, a total of 8 doctors from hematology and oncology practices were enrolled. Data collection began on March 14, 2023. CONCLUSIONS: The Trans-sectoral Personalised Care Concept for Patients with Rare Cancers project is a complex intervention that is to be implemented in an equally complex health care context. The process evaluation will help understand the influence of contextual factors and assess the mechanisms of change. TRIAL REGISTRATION: ISRCTN registry ISRCTN16441179; https://doi.org/10.1186/ISRCTN16441179. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49731.

Development and Piloting of a Web-Based Tool to Teach Relative and Absolute Risk Reductions.

Interpreting study results is an essential component of decision-making. Both laypeople and healthcare professionals often misinterpret treatment effects that are presented as relative risk reduction. Therefore, we developed and piloted a web-based tool to teach the difference between relative and absolute risk reductions. This project follows the UKMRC-guidance for complex interventions. The tool was developed based on adult learning and design theories. This was followed by a qualitative feasibility study focusing on acceptance, applicability, and comprehensibility with healthcare professionals and laypersons. We conducted think-aloud and semi-structured interviews and analysed them using qualitative content analysis. In addition, we explored calculation skills. Between January 2020 and April 2021, we conducted 22 interviews with 8 laypeople and 14 healthcare professionals from different settings. Overall, the tool proved to be feasible and relevant. With regard to comprehension, we observed an awareness of the interpretation of risk reduction, presented therapy effects were questioned more critically, and the influence of relative effects was recognized. Nevertheless, there were comprehension problems in some of the participants, especially with calculations in connection with low mathematical skills. The tool can be used to improve the interpretation of risk reductions in various target groups and to supplement existing educational programs.

Evidence-based decision-making in nursing - development and piloting of a train-the-trainer concept for teachers at schools for health care professionals: A pilot study.

BACKGROUND: Train-the-trainer concepts (TTT concepts) to impart evidence-based practice competences aim at promoting the implementation of evidence-based practice. The aim of this study was to develop and pilot-test a TTT training program for teachers at schools for health care professionals. The program is based on the core curriculum "Evidence-based Decision-making" set up by the German Network for Evidence-based Medicine e.V. (DNEbM). METHOD: The study was conducted according to the UKMRC framework for complex interventions and consisted of Phase 1 (Development) and Phase 2 (Piloting). In Phase 1, the intervention was modelled on the basis of a systematic literature search. In Phase 2, the TTT concept was piloted with teachers at two schools for health care professionals. For the evaluation, short interviews with the participants were carried out after each module; classroom observations took place during the training and were followed by a focus group interview. In addition, baseline characteristics were collected prior to the training and descriptively evaluated. Critical health competence was surveyed using the Critical Health Competence Test (CHC test) before and after the course. The questionnaires, interviews and classroom observation protocols were processed according to Mayring's qualitative content analysis. Person parameters ±SD were calculated to determine the level of competence. RESULTS: Piloting took place in September 2018 and from September to November 2019. Eight teachers from two training institutions participated. The evaluation of the focus group interviews and the classroom observation protocols resulted in a category system comprising 6 main and 17 subcategories. The feasibility of the materials and methods could be demonstrated in both pilot tests. Reactivation and extension of prior knowledge were confirmed by the participants. The small group size was appreciated; the participants took an active part during the lessons and were stimulated to plan their own lessons. The evaluation of the CHC test revealed average person parameters of 432 ± 45 (pretest, n=8) and 512 ± 65 (posttest, n=8). DISCUSSION: Using mixed methods, the results show the feasibility of the curriculum. CONCLUSION: Further evaluation in a randomized controlled trial (RCT) is needed to prove the efficacy of the curriculum.

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

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.