Building an international network for a primary care research program: reflections on challenges and solutions in the set-up and delivery of a prospective observational study of acute cough in 13 European countries

BMC Family Practice

Correspondence

Herman Goossens¹  Robert ER Veen²  Theo JM Verheij²  Curt Brugman²  Jacqueline Nuttall³  Christopher C Butler³  Kerenza Hood³  Paul Little⁴ 

[1] Campus Drie Eiken, D.S313, Universiteitsplein 1, 2610, Wilrijk, Belgium;Julius Center for Health, Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, Stratenum, 6th Floor, 6.111, 3584 CX, Utrecht, The Netherlands;South East Wales Trials Unit (SEWTU), Department of Primary Care and Public Health, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, UK;University of Southampton, SO16 5ST, Southampton, UK;

关键词: Case Report Form;    Work Package;    Back Translation;    Primary Care Research;    Acute Cough;   

DOI  :  10.1186/1471-2296-12-78

 received in 2010-12-16, accepted in 2011-07-27,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundImplementing a primary care clinical research study in several countries can make it possible to recruit sufficient patients in a short period of time that allows important clinical questions to be answered. Large multi-country studies in primary care are unusual and are typically associated with challenges requiring innovative solutions. We conducted a multi-country study and through this paper, we share reflections on the challenges we faced and some of the solutions we developed with a special focus on the study set up, structure and development of Primary Care Networks (PCNs).MethodGRACE-01 was a multi-European country, investigator-driven prospective observational study implemented by 14 Primary Care Networks (PCNs) within 13 European Countries. General Practitioners (GPs) recruited consecutive patients with an acute cough. GPs completed a case report form (CRF) and the patient completed a daily symptom diary. After study completion, the coordinating team discussed the phases of the study and identified challenges and solutions that they considered might be interesting and helpful to researchers setting up a comparable study.ResultsThe main challenges fell within three domains as follows:selecting, setting up and maintaining PCNs;designing local context-appropriate data collection tools and efficient data management systems; andgaining commitment and trust from all involved and maintaining enthusiasm.The main solutions for each domain were:i) appointing key individuals (National Network Facilitator and Coordinator) with clearly defined tasks, involving PCNs early in the development of study materials and procedures.ii) rigorous back translations of all study materials and the use of information systems to closely monitor each PCNs progress;iii) providing strong central leadership with high level commitment to the value of the study, frequent multi-method communication, establishing a coherent ethos, celebrating achievements, incorporating social events and prizes within meetings, and providing a framework for exploitation of local data.ConclusionsMany challenges associated with multi-country primary care research can be overcome by engendering strong, effective communication, commitment and involvement of all local researchers. The practical solutions identified and the lessons learned in implementing the GRACE-01 study may assist in establishing other international primary care clinical research platforms.Trial registrationClinicalTrials.gov Identifier: NCT00353951

【 授权许可】

CC BY   
© Nuttall et al; licensee BioMed Central Ltd. 2011