Providing Feedback on Study Results

DOI: 10.3238/zfa.2011.078

Internationale Empfehlungen und Erfahrungen aus der PRoMPT-Studie zur Depressionsbehandlung in Hausarztpraxen

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Corina Guethlin, Karola Mergenthal, Vera Kleppel, Ingrid Gerlach, Ferdinand Michael Gerlach, Juliana Petersen, Jochen Gensichen

Keywords: patient information feedback of study results clinical trials Ethics – Professional

International Guidelines and Experience from the PRoMPT Trial on Depression in Primary Care

Background: The need to provide feedback to patients on the results of clinical trials is a controversial issue in the scientific literature and will be discussed here for familiy practice. While some authors see an ethical obligation to provide information to patients following the conclusion of a trial, others point out that the extent to which it is necessary depends on the study design.

Methods: Internationally published recommendations for feedback provision of trial results to trial participants are presented here and discussed on the basis of the ‘Primary Care Monitoring for Depressive Patients’ Trial’ (PRoMPT), whereby the focus of the discussion is on feasibility.

Results: A patient information leaflet to be handed out to study patients by family doctors was prepared in accordance with the wishes of doctors who participated in the PRoMPT trial. For this purpose only those recommendations were taken into account that were deemed practicable.

Conclusions: For ethical reasons, international recommendations of providing feedback on trial results should be discussed as part of research in primary care. Patient information leaflets should be tailored to the needs of the target group and thoroughly evaluated with respect to their effects on patients.

(State: 07.02.2011)

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