CONSORT and QUOROM guidelines for reporting randomized clinical trials and systematic reviews

EDITORIAL

CONSORT and QUOROM guidelines forreporting randomized clinical trials andsystematic reviewsDavid L. Turpin, Editor-in-Chief

As practitioners strive to improve the delivery ofpatient care, it is increasingly important thatthey find it easier to identify studies with the

highest level of evidence. Once found, there must besome assurance that the studies were carried out satis-factorily and the methodology was sound. To assist inmeeting this challenge, the Consolidated Standards ofReporting Trials (CONSORT) guidelines were devel-oped by a team of dedicated journal editors, epidemi-ologists, and statisticians. They determined the stan-dards for authors reporting the findings of controlledclinical trials.1 CONSORT comprises a checklist and aflow diagram (Figs 1 and 2) to help improve the quality ofreports of randomized controlled trials (RCTs). It offers astandard way for researchers to report their findings.The checklist includes items, based on evidence, thatshould be addressed in the report; the flow diagramgives readers a clear picture of the progress of allparticipants in the trial, from the time they are random-ized until the end of their involvement. The intent is tomake the experimental process transparent, flawed ornot, so that users of the data can more appropriatelyevaluate the validity for their purposes. The key ele-ments start when the researcher submits an article forreview and completes the standardized forms. The com-pleted checklist should accompany the manuscriptthrough the review process and identify the page on whicheach item is addressed. The completed flow diagramshould appear as a figure in the manuscript.

Nearly a year ago, the AJO-DO mandated a structuredabstract with each submission; this is one of the first itemson the CONSORT checklist. There are good reasons forthis change and for all other requests listed. According toSharma and Harrison,2 “the quality of information pro-vided in journals with structured abstracts is greater thanin those with nonstructured abstracts.” These authorsconcluded that the quality of information in an abstractimproves when a journal changes to a structured format. It

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is believed that this move by the AJO-DO will help guidereaders toward well-designed, well-conducted, and well-written studies. There is also evidence that structuredabstracts improve citation retrieval from Medline andpositively affect the Impact Factor.

Unfortunately, many details about RCTs are poorlyrecorded in some reports, and better coordination isneeded to produce accurate articles. With the publica-tion of this issue, the AJO-DO will ask authors of RCTsto adhere to the CONSORT guidelines (www.consort-statement.org). This change will give readers more infor-mation to judge the quality of RCTs, leading to greaterconfidence in the peer-review process. Nothing can be ofmore value to the spirit of evidence-based dentistry at thistime than implementation of these guidelines.

Systematic reviews are another way to assimilatelarge quantities of research information from publishedclinical trials, and data are often analyzed in a processcalled meta-analysis.3 Meta-analysis is a method ofcombining the results from several studies in an orga-nized way to estimate the effectiveness of a particularintervention; practitioners can then use this informationin treating the problem. Meta-analysis has evolved toproduce systematic reviews that separate insignificant,unsound, or redundant material in the literature from thesalient and critical studies that are worthy of consider-ation. The value of meta-analysis is evident in the work ofthe international Cochrane Collaboration; its primary pur-pose is to generate and disseminate high-quality system-atic reviews of health care interventions.

Like any research enterprise, a meta-analysis can beflawed. The authors of a meta-analysis report not onlyon the methods they used to review the articles, but alsoon the research methods in the articles they analyzed.With this in mind, several investigators have suggestedguidelines for reporting meta-analyses—the equivalentof CONSORT—but to be applied to systematic re-views. This move resulted in the Quality of Reportingof Meta-analyses (QUOROM) statement, with a check-list and a flow diagram (Figs 3 and 4).4 The checklist isorganized into headings and subheadings to encourage

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Fig 1. CONSORT guidelines checklist.

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Fig 2. CONSORT flow diagram.

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Fig 3. QUOROM statement checklist.

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assessment, data abstraction, study characteristics, quan-titative data synthesis, and trial flow. Based on this,authors are asked to provide a flow diagram with infor-mation about the number of RCTs identified, included,and excluded, and the reasons for excluding them.

The QUOROM checklist and flow diagram areavailable (www.consort-statement.org/QUOROM.pdf).The people involved in their creation hope that thestatement will generate further interest in meta-analysisand, like the CONSORT initiative, become accepted asit is disseminated to researchers, clinicians, and editors.Continual review and revision of both CONSORT and

Fig 4. QUOR

QUOROM are essential to keep them evidence-based

and of help to practitioners in their search for thehighest level of evidence when planning treatment.

REFERENCES

1. Newcombe RG. Reporting of clinical trials in the JO—theCONSORT guidelines. J Orthod 2000;27:69-70.

2. Sharma S, Harrison JE. Structured abstracts: do they improve thequality of information provided in abstracts. Am J Orthod Dento-facial Orthop 2005; in press.

3. Harrison JE. Evidence-based orthodontics: where do I find theevidence? J Orthod 2000;27:71-8.

4. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF.Improving the quality of reports of meta-analyses of randomizedcontrolled trials: the QUOROM statement. Lancet 1999;354:

ow diagram.

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