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EDITORIAL CONSORT and QUOROM guidelines for reporting randomized clinical trials and systematic reviews David L. Turpin, Editor-in-Chief Seattle, Wash A s practitioners strive to improve the delivery of patient care, it is increasingly important that they find it easier to identify studies with the highest level of evidence. Once found, there must be some assurance that the studies were carried out satis- factorily and the methodology was sound. To assist in meeting this challenge, the Consolidated Standards of Reporting 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 controlled clinical trials. 1 CONSORT comprises a checklist and a flow diagram (Figs 1 and 2) to help improve the quality of reports of randomized controlled trials (RCTs). It offers a standard way for researchers to report their findings. The checklist includes items, based on evidence, that should be addressed in the report; the flow diagram gives readers a clear picture of the progress of all participants in the trial, from the time they are random- ized until the end of their involvement. The intent is to make the experimental process transparent, flawed or not, so that users of the data can more appropriately evaluate the validity for their purposes. The key ele- ments start when the researcher submits an article for review and completes the standardized forms. The com- pleted checklist should accompany the manuscript through the review process and identify the page on which each item is addressed. The completed flow diagram should appear as a figure in the manuscript. Nearly a year ago, the AJO-DO mandated a structured abstract with each submission; this is one of the first items on the CONSORT checklist. There are good reasons for this change and for all other requests listed. According to Sharma and Harrison, 2 “the quality of information pro- vided in journals with structured abstracts is greater than in those with nonstructured abstracts.” These authors concluded that the quality of information in an abstract improves when a journal changes to a structured format. It is believed that this move by the AJO-DO will help guide readers toward well-designed, well-conducted, and well- written studies. There is also evidence that structured abstracts improve citation retrieval from Medline and positively affect the Impact Factor. Unfortunately, many details about RCTs are poorly recorded in some reports, and better coordination is needed to produce accurate articles. With the publica- tion of this issue, the AJO-DO will ask authors of RCTs to 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 greater confidence in the peer-review process. Nothing can be of more value to the spirit of evidence-based dentistry at this time than implementation of these guidelines. Systematic reviews are another way to assimilate large quantities of research information from published clinical trials, and data are often analyzed in a process called meta-analysis. 3 Meta-analysis is a method of combining the results from several studies in an orga- nized way to estimate the effectiveness of a particular intervention; practitioners can then use this information in treating the problem. Meta-analysis has evolved to produce systematic reviews that separate insignificant, unsound, or redundant material in the literature from the salient and critical studies that are worthy of consider- ation. The value of meta-analysis is evident in the work of the 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 be flawed. The authors of a meta-analysis report not only on the methods they used to review the articles, but also on the research methods in the articles they analyzed. With this in mind, several investigators have suggested guidelines for reporting meta-analyses—the equivalent of CONSORT— but to be applied to systematic re- views. This move resulted in the Quality of Reporting of Meta-analyses (QUOROM) statement, with a check- list and a flow diagram (Figs 3 and 4). 4 The checklist is organized into headings and subheadings to encourage authors to give information on searches, selection, validity Am J Orthod Dentofacial Orthop 2005;128:681-6 0889-5406/$30.00 Copyright © 2005 by the American Association of Orthodontists. doi:10.1016/j.ajodo.2005.10.010 681

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

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Page 1: 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

Seattle, Wash

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

Am J Orthod Dentofacial Orthop 2005;128:681-60889-5406/$30.00Copyright © 2005 by the American Association of Orthodontists.

doi:10.1016/j.ajodo.2005.10.010

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

authors to give information on searches, selection, validity

681

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American Journal of Orthodontics and Dentofacial OrthopedicsDecember 2005

682 Editorial

Fig 1. CONSORT guidelines checklist.

Page 3: CONSORT and QUOROM guidelines for reporting randomized clinical trials and systematic reviews

American Journal of Orthodontics and Dentofacial OrthopedicsVolume 128, Number 6

Editorial 683

Fig 2. CONSORT flow diagram.

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American Journal of Orthodontics and Dentofacial OrthopedicsDecember 2005

684 Editorial

Fig 3. QUOROM statement checklist.

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American Journal of Orthodontics and Dentofacial OrthopedicsVolume 128, Number 6

Editorial 685

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.

OM fl

1896-900.