BOX 5-3

A History of Reporting Guidelines for Comparative Effectiveness Research

In 1993 the Standards for Reporting Trials (SORT) group met to address inadequate reporting of randomized controlled trials (RCTs). This group developed the concept of a structured reporting guideline, and proposed a checklist of essential items for reporting RCTs. Five months later the Asilomar Working group met independently to discuss challenges in reporting RCTs and developed a reporting checklist. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed in 1996 and consolidated the recommendation from both groups. The CONSORT statement consists of a checklist of reporting items, such as the background, methods, results, discussion, and conclusion sections, as well as a flow diagram for documenting participants through the trial. Many journals have adopted the CONSORT statement. It has been extended to address a number of specific issues in the reporting of RCTs (e.g., reporting of harms, noninferiority and equivalence RCTs, cluster RCTs).

Following the success of the CONSORT statement, two international groups of review authors, methodologists, clinicians, medical editors, and consumers developed standard formats for reporting systematic reviews (SRs) and meta-analyses: Quality of Reporting of Meta-analyses (QUOROM) and Meta-analysis of Observational Studies in Epidemiology (MOOSE). The statements consist of checklists of items to include in reports and flow diagrams for documenting the search process. However, unlike CONSORT, reporting guidelines for SRs and meta-analyses have not been widely adopted by prominent journals.

In 2009, the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement was published to update the QUOROM statement. According to its developers, PRISMA reflects the conceptual and practical advances made in the science of SRs since the development of QUOROM. These conceptual advances include the following: completing an SR is an iterative process; the conduct and reporting of research are distinct processes; the assessment of risk of bias requires both a study-level assessment (e.g., adequacy of allocation concealment) and outcome-level assessment (i.e., reliability and validity of the data for each outcome); and the importance of addressing reporting bias. PRISMA decouples several checklist items that were a single item on the QUOROM checklist and links other items to improve the consistency across the SR report. PRISMA was funded by the Canadian Institutes of Health Research; Universita di Modena e Reggio Emilia, Italy; Cancer Research U.K.; Clinical Evidence BMJ Knowledge; The Cochrane Collaboration; and GlaxoSmithKline, Canada.a It has been endorsed by a number of organizations and journals, including the Centre for Reviews and Dissemination, Cochrane Collaboration, British Medical Journal, and Lancet.b


a The following Institute of Medicine committee members were involved in the development of PRISMA: Jesse Berlin, Kay Dickersin, and Jeremy Grimshaw.


b See the following website for a full list of organizations endorsing PRISMA: (accessed July 14, 2010).

SOURCES: Begg et al. (1996); Ioannidis et al. (2004); IOM (2008); Liberati et al. (2009); Moher et al. (1999, 2001a, 2001b, 2007, 2009); Stroup et al. (2000).

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