Reporting Guidelines
Health research reporting guidelines are designed to support the accurate, complete, and transparent publication and presentation of health research. Reporting guidelines offer authors support in writing manuscripts and scientific journals support as they evaluate manuscripts in peer review. All healthcare stakeholders benefit from familiarity with, and use of, health research reporting guidelines.
In 1962, the Kefauver-Harris amendment to the Food Drug and Cosmetic Act in the United States required pre-approval testing for new pharmaceutical drugs and medical devices for safety AND efficacy using randomized controlled trial (RCTs) to establish safety and efficacy. Health research reporting guidelines were developed, in part, to facilitate the aggregation and evaluation of controlled trial results in systematic reviews and meta-analyses.
A group of journal editors, clinical trialist experts, epidemiologists and research methodologists met in 1993 to develop quality assessment tools for controlled trials. This led to the publication of the CONSORT guidelines (Consolidated Standards Of Reporting Trials) in 1996 and the CARE guidelines (CAse REports) in 2013. The EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research) was founded in 2006 to improve the quality of health research publications using reporting guidelines for all health research publications.