Alexandra Schmidt

Chronic non-cancer pain (CNCP) is commonly managed in primary care with long-term opioid therapy (LTOT), despite limited effectiveness and substantial risks. Sex and gender shape pain experiences, treatment responses, and health outcomes, yet are rarely addressed in chronic pain interventions. This study aims to inform primary care pain management by addressing opioid-related harms, gender-based inequities, and the integration of biopsychosocial approaches. The development of the GESCO intervention was guided by the updated UK Medical Research Council (MRC) Framework for complex interventions. A participatory, theory-informed, and evidence-based approach was employed. Core development steps included literature reviews, qualitative interviews with patients and GPs, and a collaboratively developed Theory of Change (ToC). Intervention modules and evaluation tools were co-created and piloted with the stakeholders. The GESCO intervention is a structured, gender-sensitive, multi-component GP consultation to improve care for patients with chronic pain and LTOT. Two 30-minute consultations integrate narrative medicine, expectation management, medication review, empowerment strategies, and tools such as the Positive Health tool and Social Network Mapping. Implementation is supported by a two-day GP training program, a toolbox of practical resources, and a patient brochure, a manual on sex-/gender-sensitive pharmacotherapy, and follow-up case conferences. Intervention design and evaluation is guided by a ToC framework, drawing on the COM-B model by Michie et al. GESCO represents a theory-informed intervention that aims to integrate gender sensitivity into a structured consultation model for chronic pain care in primary care settings. Its participatory development process is intended to support applicability in routine practice. In a subsequent stage of the project, GESCO will be piloted in ten practices with 40 patients to examine feasibility and explore preliminary effects.

Background: Advance care planning (ACP) empowers individuals to make informed decisions about future medical care. While research has focused on patients with advanced chronic or terminal conditions, there remains a notable gap in understanding the perspectives and experiences of ambulatory individuals who proactively engage in ACP. Objective: To explore ambulatory patients' perspectives on and experiences with facilitated ACP provided by trained professionals in German general practices, focusing on the expectations, motivations and outcomes of the ACP process. Design: Longitudinal qualitative design using semi‐structured telephone interviews, conducted before, immediately after and 12 months after ACP facilitation. Interviews were analysed using thematic qualitative text analysis by Kuckartz. Setting and Participants: Interviews were conducted with eight German patients (six females and two males; mean age: 63.6 years; frailty score from 1 to 5) in two general practice settings. Results: Participants valued comprehensive advance directives (ADs) and structured ACP conversations in general practice. Key motivators for seeking ACP facilitation were maintaining autonomy and reducing family burden. Trustworthy discussions with professional facilitators, structured guidance and clear communication, particularly involving healthcare proxies, were essential for a satisfying ACP process. Despite expressing a prior interest in discussing care preferences, some participants had not yet initiated these conversations. Conclusions: ACP facilitation enables patients to articulate their values and healthcare preferences, supporting decision‐making and reducing uncertainty. Integrating structured ACP discussions into routine primary care could enhance patient autonomy and preparedness. Future research should explore strategies to optimise ACP implementation and assess its long‐term impact on patient outcomes. Patient or Public Contribution: Stakeholder and patient involvement is a crucial aspect of empowering research subjects and improving study feasibility and relevance. In this study, stakeholders such as experts in the field of ACP (one female GP and two male GPs), other GPs and patients were involved as an expert panel in a stepwise participatory approach. The process involved training in ACP facilitation for AS before conducting the study, expert panel meetings to identify research gaps and prioritise research topics, focus group discussions to conceptualise study design and data collection procedures, as well as the development of interview guidelines and data analysis. A patient advisory board (seven females and four males; age: 36–78 years with chronic illnesses) associated with the Institute of General Practice and Primary Care (iamag) was also involved in creating the interview guidelines (guidelines can be found in Appendix 2–4). Trial Registration: German Clinical Trial Register (DRKS) (ID: DRKS00027368; date of registration: April 2023; URL: https://www.drks.de/DRKS00027368 ).

Purpose: This study is part of the GESCO feasibility project (funded by the German Federal Ministry of Health) aimed at developing a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain (CNCP) receiving long-term opioid therapy (LTOT). To inform the intervention design, we explored general practitioners’ (GPs) experiences and needs in managing this patient group, with a particular focus on the role of sex and gender. Methods: We conducted semi-structured telephone interviews with five GPs in Germany using a convenience sample. Interviews were transcribed verbatim and analyzed using the Rapid approach to integrate findings quickly into the broader project. Results: Treating patients with CNCP and LTOT is highly complex and emotionally demanding. GPs described feeling caught between patients’ high expectations and their own limitations, which often strained therapeutic relationships. Gender dynamics played a key role in shaping these interactions. While male GPs emphasized neutrality, underlying gender stereotypes still influenced their behavior. Female GPs reported stronger trust with female patients, while male GPs described a greater focus on asserting control. Stigmatization—especially affecting female patients—was reported to hinder open communication and trust. GPs expressed the need for more time, better training in gender-sensitive care, and stronger interdisciplinary collaboration. Conclusion: To improve care for patients with CNCP and LTOT, recommendations include: extending consultation times with adequate reimbursement, ensuring comprehensive medical histories, enhancing GP training in gender-sensitive care, improving diagnostic tools, and promoting peer collaboration. Further measures involve supporting patient self-management, empathy, and communication, as well as adopting a biopsychosocial and sex- and gender-sensitive approach to treatment.

Purpose: Substance use disorders (SUD) are a challenging comorbidity in patients with chronic non-cancer pain (CNCP) as they complicate diagnosis and therapy, especially when opioids are part of the therapeutic regimen. A definite diagnosis of opioid use disorder (OUD) in patients with CNCP on long-term opioid therapy (LTOT) is a prerequisite for effective and targeted therapy but may be complicated as some criteria of OUD might be attributed to the desire of the patient to relieve the pain. For instance, the desire to increase the dose can be based on both a SUD as well as inadequate pain therapy. Many scientific studies use standardized questions. Therefore, potential misunderstandings due to possible diagnostic overlaps often cannot be clarified. Methods: 14 qualitative guided interviews were conducted and analyzed (Kuckartz content analysis), with the intention to verify if patient’s initial response to simple questions based on the wording of the DSM-5, as commonly used in research and practice, were consistent with the results of a more in-depth inquiry. Results: The results suggest that without in-depth investigation, there is a particular risk of false-positive assessment of the DSM-5 criteria for OUD when opioids are prescribed, especially when the questions are considered independently of chronic pain. The risk of a false-negative assessment has also been shown in isolated cases. Conclusion: Only after asking for and describing specific situations it was possible to determine whether the patient’s positive or negative answers were based on a misunderstanding of the question. To avoid misdiagnosis, staff conducting DSM-5 interviews should be trained in pain-specific follow-up questions that may help to uncover diagnostic confounding.

Zusammenfassung: Ziel der Studie In Deutschland leben etwa 350.000 Menschen mit Störungen der geistigen bzw. intellektuellen Entwicklung. Sie sind bei Kommunikation mit den Leistungserbringenden des Gesundheitswesens auf Unterstützung angewiesen. Ein unzureichender Informationstransfer kann dabei folgenschwer sein. Diese Studie untersucht Erfahrungen, Barrieren und Lösungsansätze in der Kommunikation bei der Versorgung von Menschen mit intellektueller Entwicklungsstörung. Die Potentiale des Einsatzes digitaler Anwendungen zum Informationstransfer sollen eine besondere Betrachtung finden. Methodik Es wurden 13 leitfadengestützte Expert*innen-Interviews mit Betreuenden und medizinisch Versorgenden von Menschen mit intellektueller Entwicklungsstörung geführt. Es wurde eine inhaltlich strukturierende Inhaltsanalyse mit deduktiv-induktiver Kategorienbildung nach Meuser und Nagel durchgeführt. Ergebnisse Die Versorgung von Menschen mit intellektueller Entwicklungsstörung ist geprägt von Zeitmangel und Unsicherheit im Umgang, wenn Erfahrungen im Umgang fehlen. Der Informationstransfer ist geprägt von einer Informationsflut von sehr individuellen Informationen, die mündlich oder schriftlich durch Betreuende weitergegeben werden, sowie von einer passiven Rolle der Patient*innen häufig ohne gezielte Einbindung in die Kommunikation. Hinsichtlich der Potentiale zur Einbindung digitaler Anwendungen zum Informationstransfer zeigt sich eine Kontroverse zwischen Chance und Risiko. Schlussfolgerung Fortbildung im Umgang mit Menschen mit intellektueller Entwicklungsstörungen sowie ausreichende Zeitkontingente sind zentrale Faktoren für erfolgreiche Schnittstellenkommunikation. Externe Arbeiten zeigen, dass Informationstransfer durch digitale Anwendungen unterstützt werden kann, wenn handhabbare und implementierbare technische Ausstattung bereitsteht. Digitale Anwendungen bieten dabei neue Möglichkeiten, mit Menschen mit intellektueller Entwicklungsstörung zu kommunizieren, wie durch die Nutzung von Formaten mit leichter oder bildlicher Sprache. Hierzu bedarf es jedoch anknüpfenden Forschung, welche sich mit der digitalen Kontroverse in dieser Arbeit auseinandersetzt.

Background: To evaluate patients’ perspectives and their experiences with a consultation involving a computer-assisted and patient-centered discontinuation strategy (arriba-PPI tool) as part of a German multicenter study on reducing the prescription of proton pump inhibitors (PPIs). Methods: Qualitative in-depth telephone interviews on proton pump inhibitors with patients who had received an arriba-PPI tool-based counseling by their general practitioner (GP). A random sample of 30 patients was taken from study participants. Interviews were conducted in 2020 and analyzed using a thematic qualitative text analysis. Results: Although this was meant to be the key to shared decision making with regard to PPI reduction, study participants mostly did not recall the visual features of the tool. However, a few patients remembered them very clearly. Above all, patients appreciated a trustful relationship with the GP as well as comprehensive, individualized counseling. Conclusion: Application of the arriba-PPI tool can support the decision process but can also hinder the consultation process if the tool is not properly embedded in the consultation. GPs using the arriba-PPI tool to support the shared decision-making process should consider the patients’ and their own expectations on the benefit of the visual representation of the tool.

Background: In Germany, there are neither guidelines provided by the medical associations nor a public discussion about general practitioners (GPs) treating their family members. Only few studies on this topic from the primary care setting exist. The aim of this study is to describe GPs’ treatment of family members and to generate empirical data on the most common reasons for this.Methods: In June 2018 we conducted a postal survey among GPs in the North Rhine region of Germany. The questionnaire was developed in a stepwise process including initial expert panels, interviews with GPs, item construction workshops, cognitive pre-tests and pilot testing with 40 questionnaires. The final questionnaire addressed: type and frequency of treatment, documentation and place of treatment, engagement as the official GP as well as reasons for and against the treatment. For data evaluation, descriptive and explorative statistical analyses were conducted.Results: Overall, 393 questionnaires were returned (response rate 39.8%). 96.7% of the GPs had treated at least one family member during the last 12 months. Services that were provided frequently (more than three times in the last 12 months) included the prescription or dispensing of medication (partner 45%, children 37%, parents 43%, partner’s parents 26%), physical examinations (partner 18%, children 24%, parents 25%, partner’s parents 15%), and the arrangement or provision of laboratory tests (partner 14%, children 7%, parents 16%, partner’s parents 9%). Less than one third of the study participants always treated their relatives in their office. Male GPs more often provided care to family members (except children) registered in their practice. Senior male GPs treated their relatives more often than junior female GPs. Family members were most commonly treated for practical reasons.Conclusion: The subject of GPs treating their relatives is of high everyday relevance, since nearly all GPs are involved in the treatment of their family members. Frequent at-home treatments and low documentation rates may indicate risks due to deviating from the professional routine.