gms | German Medical Science

Introduction: Missing or unclear information in publications is leading to considerable doubts concerning the validity of study results. The reasons may be real methodological flaws in the performance of studies, but also poor quality of reporting. As a tool for the improvement of reporting methods and results of RCTs, the Consolidated Standards of Reporting Trials” (CONSORT) were developed in the mid-nineties as a statement, comprising a checklist with 25 items and a flow diagram. The checklist items refer to the design, analyses and interpretation of the trials, and the flow diagram describes the progress of participants through the study. The statement is intended to be used as a standardised aid for authors.

Our aim was to show the differences between risk of bias and quality of reporting within the context of an HTA about health promotion interventions for health care personel.

Methods: On behalf of the German Institute of Medical Documentation and Information (DIMDI) we conducted an HTA according to international standards.

Results: We identified eleven intervention studies and two systematic reviews. Interventions and populations were completely heterogeneous. Most health programs led to improvements regarding physical and mental complaints. All studies were affected by methodological flaws with high potential of bias such as missing or inadequate descriptions of randomisation, allocation concealment and blinding; in addition further skewing of study results by small sample sizes, high drop-out rates, short study duration and effect measurements provided by the participants couldn’t be excluded.

Poor reporting necessitated queries to all authors for the comprehension and adequate representation of interventions, methods, number of participants and survey instruments. We therefore also focused on aspects differentiating between the assessments of risk of bias and quality of reporting, both influencing the validity of results.

Conclusion: The goal for adequate reporting and protection against bias must be transparency, which can be reached only by a shared responsibility of authors, peer-reviewers and editors. The evidence of a recently published Cochrane review [1] suggests, that the reporting of RCTs still remains sub-optimal.

As a means of calling one of the key movers of the CONSORT initiative Douglas Altman may be cited: “Good reporting is not an optional extra: it is an essential component of doing good research”.