Background: Pragmatic randomized controlled trials are able to make an essential contribution to the further development of evidence-based treatment recommendations for primary care patients. However, drug trials are regulated by specific guidelines and have not yet become a routine task in GP practices. Within the scope of a multi-center, double-blind, randomized controlled trial on treating urinary tract infections in women with and without antibiotics (REGATTA), the feasibility of pharmaceutical studies in GP practices was evaluated by means of a questionnaire sent out to participating physicians and practice nurses.
Methods: Using a self-designed, non-validated questionnaire, the perspectives, attitudes and experiences of participating physicians and practice nurses were assessed anonymously. In this way, we identified both hindering and beneficial factors affecting the conduct of drug trials in German GP practices.
Results: 39 physicians and 48 practice nurses participated in the survey. 95 % of the physicians and 88 % of the practice nurses indicated that the implementation of drug trials with all their regulatory requirements is, in principle, possible in GP practices. In particular, the high amount of time and documentation necessary were identified as barriers. The implementation can be facilitated by formulating a research question that is relevant to practice and patients and by support from the study center.
Conclusion: Although participation in a drug trial is an additional burden in everyday practice, it is considered feasible and worthwhile by the GPs and practice nurses involved. Due to an assumed selection bias, the predominantly positive experiences of the respondents may be overestimated and transferable only to a limited extent.
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http://dx.doi.org/10.1016/j.zefq.2021.11.005 | DOI Listing |
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