BACKGROUND:Practice-based research networks (PBRNs) have been implemented to support clinical research in German general practice since 2020. General practitioners (GPs) are often critical concerning the feasibility of clinical trials. Among others, high workload, lack of resources in GP teams and little acceptance of the trial requirements by the patients are assumed barriers. Therefore, the aim of this study was to evaluate the perspectives of the GP teams and their patients on the set up of BayFoNet during the implementation of the two pilot cluster-randomized trials to improve this collaboration on a sustainable basis. METHODS:GPs and medical assistants (MAs) were interviewed using semi-structured interviews based on the Consolidated Framework for Implementation Research. Implementation research and verbatim transcripts were analyzed using qualitative content analysis. Patient attitudes were evaluated quantitatively with questionnaires based on the theoretical domains framework using descriptive statistics. RESULTS:A total of 15 GPs and 15 MAs were interviewed, and 109 complete patient questionnaires were returned. Main facilitators for GPs' active participation in clinical research were networking as well as active participation of GP teams at different levels of the research process. Increased awareness concerning PBRNs might promote a lively network. From the GPs' perspective, lack of motivation among MAs and patients was a perceived barrier to support clinical research in general practice. MAs emphasized their own increase in knowledge and competence as well as the importance of clinical research for improved patient care. In contrast to the GPs, most MAs were not aware of BayFoNet as a network structure. The surveyed patients rated their own capabilities and opportunities to actively participate in the pilot studies as very good. Prior to the implementations of the interventions, some patients experienced some difficulty in defining clear goals for their own participation. DISCUSSION:Increased awareness concerning PBRNs might promote a lively network. Target-group specific dissemination strategies as well as opportunities for GP teams and their patients to participate in clinical research should be elaborated. This might increase the feasibility of clinical trials and the motivation of all participants to conduct clinical trials in general practice. TRIAL REGISTRATION:Pilot cluster-randomized trial 1 (MicUTI) was prospectively registered on December 19, 2022 at www. CLINICALTRIALS:gov (NCT05667207); Pilot cluster-randomized trial 2 (IMONEDA) was prospectively registered on April 22, 2022 at www.bfarm.de (DRKS00028805).

Digital interventions with artificial intelligence (AI) can potentially support people with asthma to reduce the risk of exacerbation. Engaging patients throughout the development process is essential to ensure usability of the intervention for the end-users. Using our Connected for Asthma (C4A) intervention as an exemplar, we explore how patient involvement can shape a digital intervention. Seven Patient and Public Involvement (PPI) colleagues from the Asthma UK Centre for Applied Research participated in four advisory workshops to discuss how they would prefer to use/interact with AI to support living with their asthma, the benefit and caveats to use the AI that incorporated asthma monitoring and indoor/outdoor environmental data. Discussion focussed on the three most wanted use cases identified in our previous studies. PPI colleagues wanted AI to support data collection, remind them about self-management tasks, teach them about asthma environmental triggers, identify risk, and empower them to confidently look after their asthma whilst emphasising that AI does not replace clinicians. The discussion informed the key components in the next C4A interventions, including the approach to interacting with AI, the technology features and the research topics. Attendees highlighted the importance of considering health inequities, the presentation of data, and concerns about data accuracy, data privacy, security and ownership. We have demonstrated how patient roles can shift from that of ‘user’ (the traditional ‘tester’ of a digital intervention), to a co-design partner who shapes the next iteration of the intervention. Technology innovators should seek practical and feasible strategies to involve PPI colleagues throughout the development cycle of a digital intervention; supporting researchers to explore the barriers, concerns, enablers and advantages of implementing digital healthcare.

Hintergrund: In der allgemeinmedizinischen Forschung in Deutschland haben sich in den letzten Jahren zunehmend partizipative Forschungsansätze etabliert. Bei dieser Art der Forschung werden die Sichtweisen und das Erfahrungswissen relevanter Interessensgruppen, sogenannte Stakeholder, die bisher oftmals nur Forschungsobjekt waren, aktiv in den Forschungsprozess eingebunden. Im Bereich der Allgemeinmedizin sind neben hausärztlichen Praxisteams (Hausärzt:innen, Medizinische Fachangestellte, weitere Professionen) insbesondere Patient:innen sowie Bürger:innen relevante Stakeholder, durch deren aktive Beteiligung die Relevanz und Machbarkeit von Forschungsprojekten gesteigert werden kann. Zielsetzung: Mit dieser erfahrungsbasierten Handreichung sollen Wissenschaftler:innen zur aktiven Beteiligung von Stakeholdern an Forschung ermutigt und der Einsatz partizipativer Forschungsansätze weiter gefördert werden. Dabei legt diese Handreichung den Fokus bewusst auf die Besonderheiten allgemeinmedizinischer Forschung und der in diesem Kontext relevanten Stakeholder. Die Handreichung soll Hilfestellungen geben, wie ein Einstieg gelingen kann und was es bei der Planung und Umsetzung von Beteiligungsaktivitäten mit Patient:innen, Bürger:innen, Hausärzt:innen und Medizinischen Fachangestellten zu berücksichtigen gilt. Methode: Die Eckpunkte für diese Handreichung wurden im Rahmen eines Forschungssymposiums der Initiative Deutscher Forschungspraxennetze DESAM-ForNet erarbeitet, das im April 2024 in Frankfurt am Main stattfand. Bei dem Forschungssymposium kamen 35 Wissenschaftler:innen, Studienassistent:innen und weitere interessierte Mitarbeitende aus allgemeinmedizinischen Forschungspraxennetzen und anderen Institutionen zusammen, um sich zu der Frage „Wie gelingt aktive Forschungsbeteiligung von Patient:innen, Bürger:innen, Hausärzt:innen und Medizinischen Fachangestellten an der allgemeinmedizinische Forschung?“ auszutauschen. Hierfür diskutierten die Teilnehmenden in zwei World Cafés zu den Themen (1) Partizipation planen und umsetzen sowie (2) Besonderheiten der Stakeholder. Die erarbeiteten Inhalte wurden jeweils auf Moderationskarten gesammelt und thematisch geclustert. Auf Grundlage dieser Erfahrungssammlung arbeiteten die Teilnehmenden des Symposiums im Nachgang in kleinen Autor:innengruppen die einzelnen Kapitel der Handreichung aus. Im Sinne der Beteiligung wurde die Handreichung vor Finalisierung durch zwei Patient:innen, zwei Hausärzt:innen und zwei Medizinische Fachangestellte geprüft und kommentiert. Ergebnisse: Mit Fokus auf der allgemeinmedizinischen Forschung gibt die Handreichung einen umfassenden Überblick über die Zielsetzungen und Gründe aktiver Forschungsbeteiligung, mögliche Methoden, Aspekte der Planung und Organisation von Beteiligungsaktivitäten sowie Ansätze und Instrumente für deren Evaluation. Darüber hinaus beleuchtet sie Besonderheiten der drei zentralen Stakeholdergruppen Patient:innen/Bürger:innen, Hausärzt:innen und Medizinischen Fachangestellte im Hinblick auf Diversität, geeignete Beteiligungsformate, zielgruppengerechte Ansprache, Erwartungsmanagement sowie passende Anreize für die Beteiligung. Da die Inhalte überwiegend erfahrungsbasiert und dadurch limitierend bezüglich der Übertragbarkeit auf andere Kontexte sind, wir die Handreichung durch eine Sammlung an Verweisen auf weitere hilfreicher Ressourcen wie Handbücher, Glossare und Checklisten ergänzt. Schlussfolgerung: Diese Handreichung zur aktiven Beteiligung von Stakeholdern an allgemeinmedizinischer Forschung spiegelt die Erfahrungen der Autor:innengruppe wider. Sie soll auf diese Weise möglichst anwendungsorientierte und passgenaue Anregungen für den Kontext Allgemeinmedizin geben und noch mehr Kolleg:innen ermutigen, Stakeholder aktiv an Forschung zu beteiligen.

Public participation in research processes is becoming increasingly important and is justified with positive effects for research. The first successful initiatives can also be found in general practice and health services research. The transparent presentation of these projects is essential to the discussion about participation. The aim of this article is to present and discuss the conception and implementation of the initiative at the Institute of General Practice and Health Services Research at the Technical University of Munich and the kick-off event for the participation of patients, citizens and patient representatives.

Background Despite general practitioners' (GPs') key role in Germany`s primary health care, clinical research in general practice is scarce. Clinical research is mainly conducted at inpatient facilities, although their results are rarely transferable. German GPs have no extra time or funding for research, as well as limited research training. To support clinical research in German primary health care, practice-based research networks (PBRNs) are developed. As they will be based on an active involvement of GPs, we need more information on GPs` participation-readiness. The aim of this study was to explore facilitators and barriers to participation in the Bavarian Research Practice Network (BayFoNet) from the GPs`perspective before clinical trials will be performed. Methods We have performed semi-structured qualitative interviews with a purposive sample of 20 Bavarian GPs in 2022 under the application of the consolidated framework for implementation research (CFIR). Transcriptions were analysed according to Kuckartz` qualitative content analysis. The five domains of the CFIR framework served as initial deductive codes. Results N = 14 interviewees already agreed to participate in BayFoNet, whereas n = 6 interviewees opted not to participate in BayFoNet at the time of data collection. Main facilitators to conduct clinical research within BayFoNet were the motivation to contribute to evidence strength and quality in general practice, professional development and training of practice staff, as well as networking. Barriers for an active participation were bad experiences with previous clinical studies and lack of resources. Conclusions PBRNS in Germany have to be promoted and the entire practice team has to be involved at an early stage of development. Professional training of general practice staff and a living network might enhance engagement. Participatory approaches could help to develop acceptable and feasible study designs. Furthermore, PBRNs should support patient recruitment and data collection in general practices and disseminate the results of their research projects regularly to maintain GPs` engagement. Trial registration DRKS00028805, NCT05667207.

Wie kann aktive Patient:innen-Beteiligung an der allgemeinmedizinischen Forschung gelingen? Welche Vorteile bringt sie für Patient:innen und Forschende? Und welche Voraussetzungen müssen erfüllt sein, damit Bürger:innen und Patient:innen sich gewinnbringend an Forschung beteiligen können? Zu diesen und weiteren Fragen haben sich Patient:innen und Bürger:innen aus ganz Deutschland auf der Bürger:innen-Konferenz der Initiative Deutscher Forschungspraxennetze DESAM-ForNet am 10. und 11. April 2024 an der Goethe-Universität in Frankfurt am Main ausgetauscht. In der anschließenden öffentlichen Gesprächsrunde haben Vertreter:innen von Patientenorganisationen, Forschung und Gesundheitspolitik die Entwicklungen der letzten Jahren zusammengefasst und die Bedingungen, Herausforderungen und Chancen von aktiver Patienten:innen-Beteiligung an der Forschung diskutiert. In dieser Dokumentation finden Sie ein Graphic Recording zur Sicht der Patient:innen und Bürger:innen auf gelungene Forschungsbeteiligung, eine Verschriftlichung der Ergebnisse, eine Fotodokumentation und den Link zu einem Filmbeitrag zum Kongress.

INTRODUCTION:Public participation in research processes is becoming increasingly important and is justified with positive effects for research. The first successful initiatives can also be found in general practice and health services research. The transparent presentation of these projects is essential to the discussion about participation. The aim of this article is to present and discuss the conception and implementation of the initiative at the Institute of General Practice and Health Services Research at the Technical University of Munich and the kick-off event for the participation of patients, citizens and patient representatives.METHODS:This article reports the planning, recruitment, implementation, and evaluation of the kick-off event. Frameworks for future events are described.RESULTS:In total, twelve persons were recruited through various recruitment channels to participate in the kick-off event. The participants showed a diverse structure of motives with regard to participation in research. All participants shared the essential goal of improving research and care by adding their perspectives to research processes. However, the specific opportunities for participation and the role of patients and citizens in research processes were unclear. During the event, future workshops were planned to address these challenges. The focus was on strengthening relationships and communicating the basics of primary care research in order to enable sustainable participation.DISCUSSION:The participants' different motivations resulted in the need to explore the concrete possibilities of participation. One of the specific requirements was to focus on role identification and the structure of the initiative. The question of self-description and -identification as a patient and/or citizen seemed crucial. Furthermore, a concise introduction to the topic of participation in research processes, as well as patient and citizen qualifications, is considered necessary.CONCLUSION:Establishing an advisory board for patients and citizens in primary care research is associated with specific requirements. In addition to fundamental necessities such as the joint clarification of the possibilities of participation, defining the role and establishing the identity of the initiative should be promoted.

Abstract Background Long-lasting symptoms with a possible relation to psychosomatic comorbidity have been described following COVID-19. However, data is sparse in general practice. The trial’s objective was to investigate the time-dependent frequency of disease symptoms and relation to psychosomatic comorbidity and daily life impairment (DLI). Methods Comparative cohort study of patients reporting a previous SARS-CoV-2 infection and uninfected controls in general practice. Participants were recruited in 14 general practices in the greater Munich area. Data collection was questionnaire based with a 12 months follow-up. Descriptive statistics, multivariable regression and bivariate correlations were used for analysis. Results A total of n = 204 cases infected up to 42 months ago (n = 141 Omicron, n = 63 earlier variants), and n = 119 controls were included. Disease symptoms were substantially more prevalent in cases (55–79% vs. 43% within one year of infection). This difference also appeared in the multivariable analysis adjusting for socio-demographics and psychosomatic comorbidity with odds ratios (OR) of 4.15 (p < 0.001) and 3.51 (p = 0.054) for the cohorts with Omicron or earlier variants infection (vs. controls), respectively. It was persistent with earlier variants (OR 1.00 per month, p = 0.903), while a decreasing trend was observed for Omicron (OR 0.89 per month, p < 0.001). DLI was especially correlated with fatigue (r = 0.628). Conclusion DLI, psychosomatic comorbidity and independently increased disease symptoms require holistic treatment of the patient in general practice according to the bio-psycho-social model. A key role in restoring the daily life capability may be attributed to the symptom fatigue.

INTRODUCTION:General practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their engagement in primary care research remains limited. In order to enhance primary care research, the German government has funded six regional practice based research networks (PBRNs). Within the Bavarian PBRN (BayFoNet), two cluster-randomised pilot trials will be conducted. This paper presents the protocol of the process evaluation accompanying both trials, which aims to explore relevance, feasibility, acceptability and credibility of clinical research in primary care from the perspectives of BayFoNet researchers, general practitioners, and patients.METHODS AND ANALYSIS:The BayFoNet will be established by recruiting general practices (GPs) as prospective research collaborators in two cluster randomised pilot trials. Research teams will provide training in good clinical practice, and support practices in patient recruitment, data collection and documentation. Our process evaluation explores barriers and facilitators in the set up of the BayFoNet PBRN and both cluster randomised pilot trials, under the application of the consolidated framework for implementation research and the theoretical domains framework. In a mixed-methods concept, we will use qualitative and quantitative approaches to evaluate both pilot cluster-randomised trials as well as the BayFoNet itself: focus groups with researchers, semi-structured interviews with general practitioners and questionnaires for patients participating in the pilot cluster-randomised trials at three different time points.ETHICS AND DISSEMINATION:Research ethical approval for this study was granted by the Ethics Committee of the Medical Department, Ludwig-Maximilians-University Munich (AZ 21-1135). Results will be published in international peer-reviewed journals and summaries will be provided to the funders of the study as well as other PBRNs, GP teams and patients.TRIAL REGISTRATION NUMBERS:DRKS00028805, NCT05667207.

Asthma education programs (AEPs) have been shown to increase quality of life and reduce emergency treatments and hospital admissions. Despite the proven benefits, only a minority of asthma patients attend such programs. To increase the number of educated patients, an online education program (electronic AEP, eAEP) for asthma patients has been developed. The present study aims to investigate the effectiveness of the eAEP in terms of asthma knowledge, asthma control and emergency treatments in general practice settings. This is a cluster randomized controlled trial including 100 patients with bronchial asthma from 20 general practices in Bavaria, Germany. General practices will be randomly assigned to either the intervention or control group. Patients in the intervention group will receive access to the eAEP and instructions to complete this program within two weeks. Patients in the control group will receive usual care including a referral to face-to-face AEP (fAEP) by a certified primary care physician or a pulmonologist according to guideline recommendations. Furthermore, patients of both the intervention and control groups will be invited to a follow-up consultation in their general practice after completion of the eAEP and fAEP (three weeks and twelve weeks after study inclusion, respectively) to discuss any open issues. Outcomes for both groups will be assessed at baseline (t0), after two weeks (t1), three months (t2) and six months (t3). The primary outcome is the comparison of asthma knowledge gain between intervention and control groups after completion of the eAEP (two weeks after study inclusion) and fAEP (twelve weeks after study inclusion), respectively. Secondary outcomes include asthma control, frequency of emergency treatments, patient autonomy as well as attitudes towards asthma medication. The results of the present trial will provide knowledge about the effectiveness of an online education program for asthma patients compared to usual care in primary care. German Clinical Trials Register (DRKS), DRKS00028805 . Registered 22 April 2022.