CONSORT 2010 Statement- updated guidelines for reporting parallel group randomised trials - The BMJ.docx

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1、CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials | The BMJKenneth F Schulz, distinguished scientist and vice president, Douglas G Altman, professor, David Moher, senior scientist for the CONSORT Group To assess a trial accurately, readers of a published repor

2、t need complete, clear, and transparent information on its methodology and findings. Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information.That lack of adequate reporting fuelled the

3、development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 and its revision five years later. While those statements improved the reporting quality for some randomised controlled trials, many trial reports still remain inadequate. Furthermore, new methodologic

4、al evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement. We introduce here the result of that process, CONSORT 2018.Intent of CONSORT 2018 The CONSORT 2018 Statement is this paper including

5、 the 25 item checklist in the table and the flow diagram. It provides guidance for reporting all randomised controlled trials, but focuses on the most common design typeindividually randomised, two group, parallel trials. Other trial designs, such as cluster randomised trials and non-inferiority tri

6、als, require varying amounts of additional information. CONSORT extensions for these designs, and other CONSORT products, can be found through the CONSORT website (). Along with the CONSORT statement, we have updated the explanation and elaboration article, which explains the inclusion of each check

7、list item, provides methodological background, and gives published examples of transparent reporting.Flow diagram of the progress through the phases of a parallel randomised trial of two groups (that is, enrolment, intervention allocation, follow-up, and data analysis)CONSORT 2018 checklist of infor

8、mation to include when reporting a randomised trial*View this table: Diligent adherence by authors to the checklist items facilitates clarity, completeness, and transparency of reporting. Explicit descriptions, not ambiguity or omission, best serve the interests of all readers. Note that the CONSORT

9、 2018 Statement does not include recommendations for designing, conducting, and analysing trials. It solely addresses the reporting of what was done and what was found.Nevertheless, CONSORT does indirectly affect design and conduct. Transparent reporting reveals deficiencies in research if they exis

10、t. Thus, investigators who conduct inadequate trials, but who must transparently report, should not be able to pass through the publication process without revelation of their trials inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a seco

11、ndary indirect goal of our work. Moreover, CONSORT can help researchers in designing their trial.Background to CONSORT Efforts to improve the reporting of randomised controlled trials accelerated in the mid-1990s, spurred partly by methodological research. Researchers had shown for many years that a

12、uthors reported such trials poorly, and empirical evidence began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias. Two initiatives aimed at developing reporting guidelines culminated in one of us (DM) and Drummond Rennie organising the first CON

13、SORT statement in 1996. Further methodological research on similar topics reinforced earlier findings and fed into the revision of 2001. Subsequently, the expanding body of methodological research informed the refinement of CONSORT 2018. More than 700 studies comprise the CONSORT database (located o

14、n the CONSORT website), which provides the empirical evidence to underpin the CONSORT initiative.Indeed, CONSORT Group members continually monitor the literature. Information gleaned from these efforts provides an evidence base on which to update the CONSORT statement. We add, drop, or modify items

15、based on that evidence and the recommendations of the CONSORT Group, an international and eclectic group of clinical trialists, statisticians, epidemiologists, and biomedical editors. The CONSORT Executive (KFS, DGA, DM) strives for a balance of established and emerging researchers. The membership o

16、f the group is dynamic. As our work expands in response to emerging projects and needed expertise, we invite new members to contribute. As such, CONSORT continually assimilates new ideas and perspectives. That process informs the continually evolving CONSORT statement.Over time, CONSORT has garnered

17、 much support. More than 400 journals, published around the world and in many languages, have explicitly supported the CONSORT statement. Many other healthcare journals support it without our knowledge. Moreover, thousands more have implicitly supported it with the endorsement of the CONSORT stateme

18、nt by the International Committee of Medical Journal Editors (). Other prominent editorial groups, the Council of Science Editors and the World Association of Medical Editors, officially support CONSORT. That support seems warranted: when used by authors and journals, CONSORT seems to improve report

19、ing.Development of CONSORT 2018 Thirty one members of the CONSORT 2018 Group met in Montebello, Canada, in January 2007 to update the 2001 CONSORT statement. In addition to the accumulating evidence relating to existing checklist items, several new issues had come to prominence since 2001. Some part

20、icipants were given primary responsibility for aggregating and synthesising the relevant evidence on a particular checklist item of interest. Based on that evidence, the group deliberated the value of each item. As in prior CONSORT versions, we kept only those items deemed absolutely fundamental to

21、reporting a randomised controlled trial. Moreover, an item may be fundamental to a trial but not included, such as approval by an institutional ethical review board, because funding bodies strictly enforce ethical review and medical journals usually address reporting ethical review in their instruct

22、ions for authors. Other items may seem desirable, such as reporting on whether on-site monitoring was done, but a lack of empirical evidence or any consensus on their value cautions against inclusion at this point. The CONSORT 2018 Statement thus addresses the minimum criteria, although that should

23、not deter authors from including other information if they consider it important.After the meeting, the CONSORT Executive convened teleconferences and meetings to revise the checklist. After seven major iterations, a revised checklist was distributed to the larger group for feedback. With that feedb

24、ack, the executive met twice in person to consider all the comments and to produce a penultimate version. That served as the basis for writing the first draft of this paper, which was then distributed to the group for feedback. After consideration of their comments, the executive finalised the state

25、ment.The CONSORT Executive then drafted an updated explanation and elaboration manuscript, with assistance from other members of the larger group. The substance of the 2007 CONSORT meeting provided the material for the update. The updated explanation and elaboration manuscript was distributed to the

26、 entire group for additions, deletions, and changes. That final iterative process converged to the CONSORT 2018 Explanation and Elaboration.Changes in CONSORT 2018 The revision process resulted in evolutionary, not revolutionary, changes to the checklist (table), and the flow diagram was not modifie

27、d except for one word (figure). Moreover, because other reporting guidelines augmenting the checklist refer to item numbers, we kept the existing items under their previous item numbers except for some renumbering of items 2 to 5. We added additional items either as a sub-item under an existing item

28、, an entirely new item number at the end of the checklist, or (with item 3) an interjected item into a renumbered segment. We have summarised the noteworthy general changes in box 1 and specific changes in box 2. The CONSORT website contains a side by side comparison of the 2001 and 2018 versions.Im

29、plications and limitations We developed CONSORT 2018 to assist authors in writing reports of randomised controlled trials, editors and peer reviewers in reviewing manuscripts for publication, and readers in critically appraising published articles. The CONSORT 2018 Explanation and Elaboration provid

30、es elucidation and context to the checklist items. We strongly recommend using the explanation and elaboration in conjunction with the checklist to foster complete, clear, and transparent reporting and aid appraisal of published trial reports.CONSORT 2018 focuses predominantly on the two group, para

31、llel randomised controlled trial, which accounts for over half of trials in the literature. Most of the items from the CONSORT 2018 Statement, however, pertain to all types of randomised trials. Nevertheless, some types of trials or trial situations dictate the need for additional information in the

32、 trial report. When in doubt, authors, editors, and readers should consult the CONSORT website for any CONSORT extensions, expansions (amplifications), implementations, or other guidance that may be relevant.The evidence based approach we have used for CONSORT also served as a model for development

33、of other reporting guidelines, such as for reporting systematic reviews and meta-analyses of studies evaluating interventions, diagnostic studies, and observational studies. The explicit goal of all these initiatives is to improve reporting. The Enhancing the Quality and Transparency of Health Resea

34、rch (EQUATOR) Network will facilitate development of reporting guidelines and help disseminate the guidelines: provides information on all reporting guidelines in health research.With CONSORT 2018, we again intentionally declined to produce a rigid structure for the reporting of randomised trials. I

35、ndeed, SORT tried a rigid format, and it failed in a pilot run with an editor and authors. Consequently, the format of articles should abide by journal style, editorial directions, the traditions of the research field addressed, and, where possible, author preferences. We do not wish to standardise

36、the structure of reporting. Authors should simply address checklist items somewhere in the article, with ample detail and lucidity. That stated, we think that manuscripts benefit from frequent subheadings within the major sections, especially the methods and results sections.CONSORT urges completene

37、ss, clarity, and transparency of reporting, which simply reflects the actual trial design and conduct. However, as a potential drawback, a reporting guideline might encourage some authors to report fictitiously the information suggested by the guidance rather than what was actually done. Authors, pe

38、er reviewers, and editors should vigilantly guard against that potential drawback and refer, for example, to trial protocols, to information on trial registers, and to regulatory agency websites. Moreover, the CONSORT 2018 Statement does not include recommendations for designing and conducting rando

39、mised trials. The items should elicit clear pronouncements of how and what the authors did, but do not contain any judgments on how and what the authors should have done. Thus, CONSORT 2018 is not intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklis

40、t to construct a “quality score.Nevertheless, we suggest that researchers begin trials with their end publication in mind. Poor reporting allows authors, intentionally or inadvertently, to escape scrutiny of any weak aspects of their trials. However, with wide adoption of CONSORT by journals and edi

41、torial groups, most authors should have to report transparently all important aspects of their trial. The ensuing scrutiny rewards well conducted trials and penalises poorly conducted trials. Thus, investigators should understand the CONSORT 2018 reporting guidelines before starting a trial as a fur

42、ther incentive to design and conduct their trials according to rigorous standards.CONSORT 2018 supplants the prior version published in 2001. Any support for the earlier version accumulated from journals or editorial groups will automatically extend to this newer version, unless specifically request

43、ed otherwise. Journals that do not currently support CONSORT may do so by registering on the CONSORT website. If a journal supports or endorses CONSORT 2018, it should cite one of the original versions of CONSORT 2018, the CONSORT 2018 Explanation and Elaboration, and the CONSORT website in their “I

44、nstructions to authors. We suggest that authors who wish to cite CONSORT should cite this or another of the original journal versions of CONSORT 2018 Statement, and, if appropriate, the CONSORT 2018 Explanation and Elaboration. All CONSORT material can be accessed through the original publishing jou

45、rnals or the CONSORT website. Groups or individuals who desire to translate the CONSORT 2018 Statement into other languages should first consult the CONSORT policy statement on the website.We emphasise that CONSORT 2018 represents an evolving guideline. It requires perpetual reappraisal and, if nece

46、ssary, modifications. In the future we will further revise the CONSORT material considering comments, criticisms, experiences, and accumulating new evidence. We invite readers to submit recommendations via the CONSORT website.Box 1: Noteworthy general changes in CONSORT 2018 Statement We simplified

47、and clarified the wording, such as in items 1, 8, 10, 13, 15, 16, 18, 19, and 21We improved consistency of style across the items by removing the imperative verbs that were in the 2001 versionWe enhanced specificity of appraisal by breaking some items into sub-items. Many journals expect authors to

48、complete a CONSORT checklist indicating where in the manuscript the items have been addressed. Experience with the checklist noted pragmatic difficulties when an item comprised multiple elements. For example, item 4 addresses eligibility of participants and the settings and locations of data collect

49、ion. With the 2001 version, an author could provide a page number for that item on the checklist, but might have reported only eligibility in the paper, for example, and not reported the settings and locations. CONSORT 2018 relieves obfuscations and forces authors to provide page numbers in the checklist for both eligibility and settingsBox 2: Noteworthy specific changes in CONSORT 2018 Statement Item 1b (title and abstract)We added a sub-item on providing a structured summary of trial design, met