Discussions with relatives are relevant and crucial aspects of the organ donation process and contribute to aconsolidated and sustainable decision by the families of the deceased. Despite the great importance of family care, there is no systematic analysis of the quality of this communication, in contrast to the diagnosis of irreversible loss of brain function, organ retrieval and organ transplantation. For this reason, organ donation experts were interviewed about recurring characteristics of communication with relatives of the deceased. The aim of this qualitative study was to define criteria for the assessment of the structure and quality of the communication process with relatives for internal quality management in Germany. Based on asystematic literature review and with the help of the 5‑stage S2PS2 (system for creating a questionnaire) procedure according to Kruse, interview guidelines were initially developed. As asecond step, in guideline-based interviews 10experienced organ donation experts were questioned about structural, procedural and ethical aspects of their discussions with relatives. Following the interviews, asoftware-based qualitative content analysis was carried out with acombined inductive-deductive category system. Finally, the first quality assurance measures for the interviews with relatives were developed in amultistep process, closely following the methodological principles V1.1 of the Institute for Quality Assurance and Transparency in Health Care (IQTIG). The individual research steps were accompanied by an expert group consisting of physicians, nurses, theologians and ethicists utilizing an anonymous Delphi procedure. In the qualitative content analysis, 5main categories with 30subcategories on quality relevant aspects could be identified (including, standardization and technique of conversation, interview framework and context factors, professional expertise of the interviewers, wishes of the organ donation experts). On this basis, 6criteria for the structural quality and 7criteria for the process quality of the discussions with relatives were formulated and summarized in arespective quality bundle. These criteria address, among other things, interprofessional communication, structured training concepts, regular further training of all team members, use of standardized communication and counselling strategies as well as documented preliminary meetings and debriefings, including supervising elements. They emphasize interdisciplinary professionalism and process management in aprotected environment as well as quality assured communication and documentation. Recommendations were made for expanding the existing documentation for the organ donation process and for documenting the preliminary meetings and debriefings. Recurring communication and process characteristics as well as requirements for the members of the treatment team who conduct the conversation can be identified for the interviews with relatives, which show potential for improvement to various degrees. This justifies the structured derivation of aquality bundle for the structural and process quality family care related to organ donation, which should enable alow-threshold entry into an institution internal systematic quality assessment of communication with relatives in Germany. Due to the different legal, medical and social specifics in an international context, the study results cannot be directly transferred to other countries.
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