Capturing Diabetes-Related Distress and Burden From the Perspective of Patients With Type 1 or Type 2 Diabetes: Protocol for an Explorative Mixed Methods Study.

BACKGROUND: Diabetes is one of the most common diseases worldwide and is associated with increased morbidity, mortality, and reduced quality of life. Many patients experience high diabetes-related distress as well as depression and anxiety symptoms, which are associated with poor diabetes self-management. As disease management is a central component in diabetes treatment, poor management enhances the occurrence of micro- and macrovascular complications. This emphasizes the relevance of reducing diabetes-related distress and providing adequate treatment options addressing the individual psychosocial burden of patients with diabetes. Since patients' perspectives diverge significantly from those of practitioners in terms of relevant treatment aspects, the patient perspective on, for example, barriers to and facilitators of diabetes treatment is crucial for adequate and effective treatment as well as improvements to self-management and therefore, needs to be further explored. OBJECTIVE: This study aims to examine diabetes-related distress, the course of distress throughout diabetes management, as well as barriers and facilitating factors in dealing with diabetes from the individual perspective of patients with type 1 and type 2 diabetes. METHODS: The study employs a mixed methods design combining qualitative and quantitative data. Semistructured interviews (N=40) will be conducted with patients with type 1 diabetes (n=20) and patients with type 2 diabetes (n=20). The primary outcomes comprise (1) diabetes-related distress, (2) the severity of distress, (3) the course of distress throughout diabetes management, (4) barriers, and (5) facilitating factors. Questionnaires will provide data on the following secondary outcomes: diabetes-related emotional distress (the Problem Areas in Diabetes scale), symptoms of depression and anxiety (Patient Health Questionnaire, German version), personality functioning (Operationalized Psychodynamic Diagnosis-Structure Questionnaire), mentalizing capacities (Mentalization Questionnaire), epistemic trust (Epistemic Trust, Mistrust and Credulity Questionnaire) and experiences of child maltreatment (Childhood Trauma Questionnaire), and the overall health status of the patient (routine medical data). RESULTS: As of April 2022, the conceptualization phase of the study was finalized. Ethics approval was received in January 2022 from the local ethics committee of the Justus Liebig University Giessen - Faculty of Medicine (AZ 161/21). CONCLUSIONS: This study will provide insights into the individual perspective of patients with type 1 and type 2 diabetes regarding their experiences with diabetes management and what they perceive to be relevant, obstructive, or beneficial. The insights gained could help further tailor diabetes treatment to the individual needs of patients with diabetes and therefore optimize diabetes self-management. TRIAL REGISTRATION: German Clinical Trial Register DRKS00024999; https://tinyurl.com/2wb4xdh8. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/38477.

["We knew it was going to be tough, but we didn't expect this!" Experiences with the inclusion of cancer patients with a migrant background and their relatives in the field of psycho-oncology]. / "Wir wussten, dass es schwierig wird, doch damit haben wir nicht gerechnet!" Erfahrungen beim Studieneinschluss von Krebspatient*innen mit Migrationshintergrund und Angehörigen im Bereich der Psychoonkologie.

BACKGROUND: The process of enrolling participants is an important component and often a time-consuming step in scientific research projects. Due to different financial, organisational and ethical framework conditions, the enrolment of participants is often a challenge. In this article, we report our experiences of enrolling patients in clinical trials made in the project "Psycho-oncological care of cancer patients with a migration background - a mixed methods study" (POM). METHODS: Participants were recruited through outpatient haemato-oncology practices. Patients and relatives were primarily made aware of the project by the treating physicians and recruited to participate in qualitative interviews. RESULTS: Nine patients and relatives were interviewed nationwide in individual qualitative interviews. In addition to the COVID-19 pandemic, there were other patient enrolment challenges. In many cases, participation was refused. The reasons included: "not interested", the use of the terms "psycho-oncology" or "person with a migration background", family denying permission to participate, no face-to-face interview due to the COVID-19 pandemic as well as too much emotional distress and deterioration of health after prior consent. DISCUSSION: Enrolling study participants from vulnerable groups for a sensitive topic such as psycho-oncology entails multiple challenges. In order to achieve successful study inclusion, regular telephone and written exchanges with the respective practice staff proved to be helpful, allowing an overview of challenges to be gained and study inclusion to be evaluated and adjusted in a timely manner. CONCLUSION: In research projects with vulnerable groups and on sensitive topics, both a target-group-specific, sensitive approach in plain language (layman's terms) and regular consultations with the persons responsible for study inclusion in care facilities should take place in order to adapt the existing procedure during the study inclusion process, if necessary.