[Measurement and assessment of study quality and reporting quality]

Abstract

Clinical trials are undertaken to evaluate the effectiveness and safety of clinical interventions or to investigate other unclarified (e.g. diagnostic) research questions. But not every clinical study is optimally planned, conducted and analysed and is therefore exposed to risk of systematic errors which can distort (bias) the study results. Clinical studies should be conducted in accordance with specific quality criteria in order to reduce these risks. To estimate the methodological quality of studies instruments such as the Cochrane Risk of Bias tool were developed. But it can only be appraised what is reported. Often important information on the conduct and analysis of a study is missing in research articles, and in most cases detailed study protocols are not freely available. Reporting guidelines available for different study types can help improve the transparency and completeness of reports of clinical studies and thus the reporting quality.

Keywords: Berichtsqualität; Bias; CONSORT Statement; Leitlinien zur Berichterstattung von Studien; Publication; Publikation; Studienqualität; Validität; bias; reporting guideline; reporting quality; study quality; validity.