Process evaluation in practice based research networks: a study protocol for a mixed-methods implementation study
IntroductionGeneral 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...
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Published in | BMJ open Vol. 13; no. 7; p. e065947 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
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England
British Medical Journal Publishing Group
12.07.2023
BMJ Publishing Group LTD BMJ Publishing Group |
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Abstract | IntroductionGeneral 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 analysisThe 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 disseminationResearch 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 numbersDRKS00028805, NCT05667207. |
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AbstractList | 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. IntroductionGeneral 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 analysisThe 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 disseminationResearch 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 numbersDRKS00028805, NCT05667207. 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 . 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. 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. 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. DRKS00028805, NCT05667207. |
Author | Roos, Marco Gensichen, Jochen Sanftenberg, Linda Kühlein, Thomas Gagyor, Ildiko Dreischulte, Tobias Kosub, Helena Kurotschka, Peter Konstantin Burggraf, Larissa Eck, Stefanie Härdtlein, Annette |
AuthorAffiliation | 1 Institute of General Practice and Family Medicine , University Hospital, LMU Munich , Munich , Germany 4 Institute of General Practice and Health Services Research , Technical University of Munich , Munich , Germany 5 General Practice , University of Augsburg , Augsburg , Germany 2 Department of General Practice , Julius-Maximilians-Universitaet Wuerzburg , Wuerzburg , Germany 3 Institute of General Practice, Friedrich-Alexander-University Erlangen-Nuernberg (FAU) , Erlangen University Hospital , Erlangen , Germany |
AuthorAffiliation_xml | – name: 1 Institute of General Practice and Family Medicine , University Hospital, LMU Munich , Munich , Germany – name: 2 Department of General Practice , Julius-Maximilians-Universitaet Wuerzburg , Wuerzburg , Germany – name: 4 Institute of General Practice and Health Services Research , Technical University of Munich , Munich , Germany – name: 5 General Practice , University of Augsburg , Augsburg , Germany – name: 3 Institute of General Practice, Friedrich-Alexander-University Erlangen-Nuernberg (FAU) , Erlangen University Hospital , Erlangen , Germany |
Author_xml | – sequence: 1 givenname: Linda orcidid: 0000-0002-3174-5297 surname: Sanftenberg fullname: Sanftenberg, Linda email: Linda.Sanftenberg@med.uni organization: Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany – sequence: 2 givenname: Tobias surname: Dreischulte fullname: Dreischulte, Tobias organization: Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany – sequence: 3 givenname: Annette surname: Härdtlein fullname: Härdtlein, Annette organization: Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany – sequence: 4 givenname: Helena surname: Kosub fullname: Kosub, Helena organization: Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany – sequence: 5 givenname: Ildiko orcidid: 0000-0002-7974-7603 surname: Gagyor fullname: Gagyor, Ildiko organization: Department of General Practice, Julius-Maximilians-Universitaet Wuerzburg, Wuerzburg, Germany – sequence: 6 givenname: Peter Konstantin surname: Kurotschka fullname: Kurotschka, Peter Konstantin organization: Department of General Practice, Julius-Maximilians-Universitaet Wuerzburg, Wuerzburg, Germany – sequence: 7 givenname: Thomas surname: Kühlein fullname: Kühlein, Thomas organization: Institute of General Practice, Friedrich-Alexander-University Erlangen-Nuernberg (FAU), Erlangen University Hospital, Erlangen, Germany – sequence: 8 givenname: Larissa surname: Burggraf fullname: Burggraf, Larissa organization: Institute of General Practice, Friedrich-Alexander-University Erlangen-Nuernberg (FAU), Erlangen University Hospital, Erlangen, Germany – sequence: 9 givenname: Stefanie surname: Eck fullname: Eck, Stefanie organization: Institute of General Practice and Health Services Research, Technical University of Munich, Munich, Germany – sequence: 10 givenname: Marco surname: Roos fullname: Roos, Marco organization: General Practice, University of Augsburg, Augsburg, Germany – sequence: 11 givenname: Jochen surname: Gensichen fullname: Gensichen, Jochen organization: Institute of General Practice and Family Medicine, University Hospital, LMU Munich, Munich, Germany – sequence: 12 givenname: Jochen surname: Gensichen fullname: Gensichen, Jochen |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/37438058$$D View this record in MEDLINE/PubMed |
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Cites_doi | 10.1186/1748-5908-6-42 10.1186/s12890-022-02217-2 10.1093/eurjcn/zvab059 10.1186/s13012-017-0605-9 10.3122/jabfm.2012.05.120100 10.3109/13814788.2013.879116 10.1136/bmj.d1028 10.1001/jama.2013.281053 10.3122/jabfm.2015.05.150227 10.1136/bmj.i5239 10.1186/1748-5908-4-50 10.1136/bmj.i6795 10.1186/s13012-016-0534-z 10.1093/fampra/cmm066 10.1016/j.jclinepi.2005.08.022 10.1186/1745-6215-13-205 10.1007/978-3-658-37985-8_32 |
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Snippet | IntroductionGeneral practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their... General practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their engagement... Introduction General practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their... INTRODUCTIONGeneral practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their... Introduction General practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their... |
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SubjectTerms | Antibiotics Clinical medicine Clinical Trial Clinical trials Collaboration Colleges & universities Cross-sectional studies Data Collection Documentation Employees Ethics Committees Funding GENERAL MEDICINE (see Internal Medicine) General practice / Family practice Health care Humans Infrastructure Microscopy Mixed methods research Patients Practice research PRIMARY CARE Prospective Studies QUALITATIVE RESEARCH Research Design Software Teams Urinary tract diseases Urinary tract infections Urogenital system Womens health |
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Title | Process evaluation in practice based research networks: a study protocol for a mixed-methods implementation study |
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