Development and piloting of a decision coaching intervention to support informed decision-making about vaccination against COVID-19: study protocol

Aus Public-Health Perspektive besteht das Interesse eine möglichst hohe Impfquote gegen COVID-19 von Erwachsenen zu erreichen. Es zeichnet sich ab, dass es großer Anstrengungen bedarf, diese Quote zu erreichen. In Deutschland besteht derzeit keine Impfpflicht. Bürger*innen haben ein Recht auf eine individuelle und informierte Entscheidung hinsichtlich der Schutzimpfung gegen COVID-19. Eine informierte Entscheidung liegt dann vor, wenn die Entscheidung von den Betroffenen basierend auf ausreichendem Wissen über die Handlungsalternativen und im Einklang mit ihren persönlichen Präferenzen getroffen wird. Ziel des Forschungsprojektes ist die Entwicklung einer komplexen Intervention bestehend aus einem nicht-direktiven Decision Coaching durch geschulte Gesundheitsfachpersonen. Bürger*innen werden ermutigt und unterstützt, evidenzbasierte Gesundheitsinformationen im Prozess der Entscheidungsfindung zu nutzen und diese zu verstehen. Dabei haben sie die Möglichkeit, eigene Werte und Präferenzen hinsichtlich der Optionen sowie zu erwartenden Ergebnissen zu klären. Durch die Coaching-Intervention soll verschiedenen Gruppen (z. B. Jugendliche, vulnerable Gruppen, Gesundheitsfachpersonen) eine informierte Entscheidungsfindung bezüglich der Schutzimpfung gegen COVID-19 ermöglicht werden. Im Vorfeld erhalten die Gesundheitsfachpersonen eine Schulung. Die Intervention wird in Anlehnung an das MRC-Framework zur Entwicklung und Evaluation komplexer Interventionen in einem iterativen Prozess entwickelt und pilotiert (Phase 1 und 2-Studie)

Quality of COVID-19 vaccine informed consent forms - study protocol

Seit kurzem besteht die Möglichkeit einer Corona-Virus-Impfung. In Deutschland gibt es keine Impfpflicht. Den Bürger*innen wird das Recht auf eine informierte Entscheidung zugesprochen. Ärzt*innen sind verpflichtet vor der Durchführung von invasiven Maßnahmen, die informierte Zustimmung der Patient*innen einzuholen. Diese besteht in der Regel aus einem mündlichen Aufklärungsgespräch und wird auf einem schriftlichen Aufklärungsbogen dokumentiert. Bisherige Forschungsergebnisse deuten darauf hin, dass relevante Informationen in Aufklärungsbögen fehlen, die eine informierte Entscheidung ermöglichen. Das Studienprotokoll beschreibt das methodische Vorgehen für die systematische Suche nach Aufklärungsbögen über die Corona-Virus-Impfung und deren kritische Bewertung. Die Ergebnisse können Implikationen für die Optimierung der Aufklärungsbögen liefern, um Bürger*innen eine informierte Entscheidung für oder gegen die Corona-Virus-Impfung zu ermöglichen

Implementation of shared decision-making in oncology: development and pilot study of a nurse-led decision-coaching programme for women with ductal carcinoma in situ

Abstract Background To implement informed shared decision-making (ISDM) in breast care centres, we developed and piloted an inter-professional complex intervention. Methods We developed an intervention consisting of three components: an evidence-based patient decision aid (DA) for women with ductal carcinoma in situ, a decision-coaching led by specialised nurses (breast care nurses and oncology nurses) and structured physician encounters. In order to enable professionals to gain ISDM competencies, we developed and tested a curriculum-based training programme for specialised nurses and a workshop for physicians. After successful testing of the components, we conducted a pilot study to test the feasibility of the entire revised intervention in two breast care centres. Here the acceptance of the intervention by women and professionals, the applicability to the breast care centres’ procedures, women’s knowledge, patient involvement in treatment decision-making assessed with the MAPPIN’SDM-observer instrument MAPPIN’Odyad, and barriers to and facilitators of the implementation were taken into consideration. We used questionnaires, structured verbal and written feedback and video recordings. Qualitative data were analysed descriptively, and mean values and ranges of quantitative data were calculated. Results To test the DA, focus groups and individual interviews were conducted with 27 women. Six expert reviews were obtained. The components of the nurse training were tested with 18 specialised nurses and 19 health science students. The development and piloting of the components were successful. The pilot test of the entire intervention included seven patients. In general, the intervention is applicable. Patients attained adequate knowledge (range of correct answers: 9–11 of 11). On average, a basic level of patient involvement in treatment decision-making was observed for nurses and patient–nurse dyads (M(MAPPIN-Odyad): 2.15 and M(MAPPIN-Onurse): 1.90). Relevant barriers were identified; physicians barely tolerated women’s preferences that were not in line with the medical recommendation. Classifying women as inappropriate for ISDM due to age or education led physicians to neglect eligible women during the recruitment phase. Conclusion Decision-coaching is feasible. Nevertheless, there are some indications that structural changes are needed for long-term implementation. We are currently evaluating the intervention in a cluster randomised controlled trial in 16 breast care centres

Communicating prognosis to women with early breast cancer – overview of prediction tools and the development and pilot testing of a decision aid

Abstract Background Shared decision-making in oncology requires information on individual prognosis. This comprises cancer prognosis as well as competing risks of dying due to age and comorbidities. Decision aids usually do not provide such information on competing risks. We conducted an overview on clinical prediction tools for early breast cancer and developed and pilot-tested a decision aid (DA) addressing individual prognosis using additional chemotherapy in early, hormone receptor-positive breast cancer as an example. Methods Systematic literature search on clinical prediction tools for the effects of drug treatment on survival of breast cancer. The DA was developed following criteria for evidence-based patient information and International Patient Decision Aids Standards. We included data on the influence of age and comorbidities on overall prognosis. The DA was pilot-tested in focus groups. Comprehension was additionally evaluated through an online survey with women in breast cancer self-help groups. Results We identified three prediction tools: Adjuvant!Online, PREDICT and CancerMath. All tools consider age and tumor characteristics. Adjuvant!Online considers comorbidities, CancerMath displays age-dependent non-cancer mortality. Harm due to therapy is not reported. Twenty women participated in focus groups piloting the DA until data saturation was achieved. A total of 102 women consented to participate in the online survey, of which 86 completed the survey. The rate of correct responses was 90.5% and ranged between 84 and 95% for individual questions. Conclusions None of the clinical prediction tools fulfilled the requirements to provide women with all the necessary information for informed decision-making. Information on individual prognosis was well understood and can be included in patient decision aids

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

BackgroundRare 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. ObjectiveThis 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. MethodsWe 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. ResultsThis 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. ConclusionsThe 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 RegistrationISRCTN registry ISRCTN16441179; https://doi.org/10.1186/ISRCTN16441179 International Registered Report Identifier (IRRID)DERR1-10.2196/4973

Specialised nursing tasks in cancer care and their effects

<jats:title>Zusammenfassung</jats:title><jats:p>Die penetrierende Kniegelenkverletzung ist ein seltenes Trauma, welches jedoch nicht unterschätzt werden darf. In der Regel besteht die Indikation zur zeitnahen operativen Versorgung. Dieser Fallbericht handelt von einem 17-jährigen Patienten, der durch einen Messerstich eine Knorpelverletzung der lateralen Femurkondyle erlitt. Es folgte die Gelenkspülung mit Bergung des Knorpelflakes und endgültiger Versorgung mittels autologer Chondrozytentransplantation. Die Gewinnung von Knorpelzellen aus dem Flake unterblieb aufgrund des Risikos einer Keimbesiedlung sowie des Qualitätsverlustes der Chondrozyten.</jats:p&gt

MAPPinfo, mapping quality of health information: Study protocol for a validation study of an assessment instrument

Abstract - Introduction Health information is a prerequisite of informed decision-making. Criteria for development, content and presentation have recently been published in a corresponding guideline. Within a systematic search, 27 relevant checklists were identified, none of them, however, complying with the guideline or providing reasonably operationalised measurement items. Therefore, a draft of a checklist with 19 criteria was drafted. The current study aims at developing and validating this measure of quality. Methods and analysis - The validation design consists of five single studies to be conducted at the University of Halle-Wittenberg/Germany and Graz/Austria. (1) Achieving content validity through expert reviews of the first draft, (2) achieving feasibility using ‘think aloud’ in piloting with untrained users, (3) pretesting the instrument applied to health information materials without use of secondary sources: determining inter-rater reliability and criterion validity, (4) determining construct validity using information on proceedings and methods in the development process provided by the developers and (5) determining divergent validity in comparison with the Ensuring Quality Information for Patients (EQUIP) (expanded) Scale. The substudies will use varying samples of experts, students and developers and will apply the instrument to materials of various domains. Sample sizes will be adjusted to the particular research designs and questions. Analyses will employ qualitative methods, such as content analyses and discourse within the expert panel, and correlation-based methods both for determining inter-rater reliability and validity. Ethics and dissemination - The project is approved by the ethics committee of the Martin Luther University Halle-Wittenberg (approval number: 2019 115). Results will be published, and the instrument made accessible on public health platforms. It is meant to become a certification standard. MAPPinfo can be used as a screening instrument without training or secondary sources. Although developed in the German language, the instrument will be applicable also in other languages

Coping Self-Efficacy and Its Relationship with Psychological Morbidity after Genetic Test Result Disclosure: Results from Cancer-Unaffected BRCA1/2 Mutation Carriers

Women who are found to carry a BRCA1/2 pathogenic variant experience psychological distress due to an increased risk of breast and ovarian cancer. They may decide between different preventive options. In this secondary analysis of data collected alongside a larger randomized controlled trial, we are looking at 130 newly found BRCA1/2 pathogenic variant carriers and how their coping self-efficacy immediately after genetic test result disclosure is related to their psychological burden and status of preventive decision making. Participants received the Coping Self-Efficacy Scale, the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the Decisional Conflict Scale, and the Stage of Decision-Making Scale after positive genetic test result disclosure. We found that women with higher coping self-efficacy showed fewer symptoms of anxiety or depression and were less affected by receiving the genetic test result in terms of post-traumatic stress. However, coping self-efficacy had no relationship with any decision-related criteria, such as decisional conflict or stage of decision making. This shows that despite its buffering capacity on psychological burden, possessing coping self-efficacy does not lead to more decisiveness in preference-sensitive decisions