Better Doctors, Better Patients, Better Decisions: Envisioning Health Care 2020

6. Reporting of Research: Are We in for Better Health Care by 2020?

6 Reporting of Research Are We in for Better Health Care by 2020? Holger Schünemann, Davina Ghersi, Julia Kreis, Gerd Antes, and Jean Bousquet Abstract Background: Logical arguments support the view that complete, transparent, and objective reporting of research results avoids systematic error, misinformation, and unrealistic expectations. Evidence about publication bias (selective publication of research results on the basis of the obtained results), selective outcome reporting bias (reporting on outcomes research depending on the obtained results), increased demand for information by consumers, and ethical considerations supports these logical arguments. Based on requests from the organizing committee of this Strüngmann Forum, we addressed the following questions: Should there be a requirement to publish or report all results? If so, who or what should require the results to be published? What protocols and standards exist for publication and reporting, and how can they help to address the problem? Is the problem solvable? We conclude by summarizing whether the current suggestions are real solutions. Methods: Using logical arguments informed by electronic searches of PubMed and web sites of the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and the EQUATOR Network as well as reviews of references lists, we informed the discussion at this Strüngmann Forum. After the Forum, based on resulting dialog, we refined the answers to these key questions. Results: In addition to appealing to researchers to report all research results, there are three key strategies to improve reporting of research results: (a) mandatory complete reporting to oversight agencies (regulatory agencies and ethics boards), (b) prospective study registration, and (c) requirements by journal editors for complete and standardized reporting of research. Enforcement of complete reporting by regulatory agencies is a simple solution for those interventions for which approval is requested. This data should be made public. Prospective registration of clinical trials should reduce the risk for reporting bias and a number of initiatives exist. Biomedical journal publishers can enhance reporting by enforcing, for example, the Uniform Requirements for Manuscripts Submitted to Biomedical Journals developed by the International Committee of Medical Journal Editors (ICMJE). The EQUATOR Network is a 84 H. Schünemann et al. resourceful collaboration that focuses on complete and accurate reporting of research results. Protocols and guidelines (supplemented by checklists) for the reporting of various research study types exist, and include the CONSORT statement for randomized controlled trials, the STARD for diagnostic research studies, STROBE for observational studies, and PRISMAand MOOSE for systematic reviews. Developers of clinical practice guidelines can use the GRADE approach to ensure transparent and standardized development of guidance documents, which can be evaluated using the AGREE or the COGS instrument. However, while these and many other checklist and reporting criteria exist, there is limited evidence to show that reporting has improved as a result. In fact, journals often fail to adhere to their own reporting guidelines. Conclusions: Complete reporting and publishing of research results has become increasingly recognized as a way to reduce bias when interpreting research. However, there is much room for improvement. Prospective study registration offers one way to improve the situation and should go beyond the field of clinical trials to include observational studies and all systematic reviews. New processes and mechanisms that implement reporting requirements for all research are needed. The usual candidate is an appropriate platform on the Internet that limits the influence of conflict of interest, and those who make profit with the Internet should fund it. Introduction Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available . Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication. —Declaration of Helsinki (WMA 2009) Clinical research, like any research, is driven by highly trained people who are motivated, for the most part, by intellectual curiosity and academic advancement . Research is also driven by financial gains and the aspiration for power. The currency of research for academic promotion and advancement as well as profit and power is publicizing research results in scientific journals. Reporting...