Umsetzungshilfe zu methodischen Kriterien des CONSORT-Statements zur transparenten Publikation von RCTs in der Augenheilkunde

Zusammenfassung

Das CONSORT-Statement (Consolidated Standards of Reporting Trials) stellt eine evidenzbasierte Minimalempfehlung für die standardisierte Berichterstattung randomisierter Studien (RCT) dar. Entlang einer Checkliste aus 25 Kriterien zu redaktionellen, regulatorischen und methodischen Determinanten einer RCT ermöglicht die Anleitung deren strukturierte und standardisierte Berichtung; besonderes Augenmerk gilt dabei der Charakterisierung von Designs und Ergebnissen mit Blick auf deren Generalisierbarkeit. Ziel der Anleitung ist eine vollständige und transparente Berichterstattung, um für Leser eine kritische Bewertung und Interpretation der zugrunde liegenden Studiendaten sicherzustellen. In der Realität zeigt sich jedoch immer wieder, dass vor allem die Umsetzung der methodischen Kriterien dieser Checkliste für publizierende Arbeitsgruppen eine Herausforderung darstellt. Hierzu soll mit der folgenden Übersicht eine illustrierte Anleitung zu Mindestangaben zu methodischen Determinanten von Design und Ergebnisdarstellung sowie deren möglicher Ausführung gegeben werden.

Abstract

The CONSORT Statement (Consolidated Standards of Reporting Trials) recommends an evidence-based, minimum set of recommendations for the standardised and transparent reporting of randomised clinical trials. This statement includes a checklist of 25 items on regulatory and methodological, as well as characteristics of editorial clinical trial design and results. The recommendations help authors of RCT reports to ensure the complete and transparent reporting of design and result determinants with regard to the standards of evidence-based medicine; furthermore, it seeks to enable readers to critically assess and interpret the presented information and possible limitations of the underlying study data. However, it has repeatedly been shown that the implementation of, in particular, the adherence to methodological criteria is a challenge to RCT authors. Therefore, the following overview summarises an illustrated guidance to the minimum necessary information to take into account key methodological items in the CONSORT statement.

Schlüsselwörter

CONSORT - klinische Studien - Qualitätssicherung - Berichterstattung

Key words

CONSORT - clinical trials - quality assurance - trial reporting

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