CONSORT 2010 Sttement lacademia and clinic vides information on all reporting guidelines in health 1 and e Elaboration (13). als (SORT)(19)tried a rigid format,and it failed in a pilot run with an editor and aur 20).Conse CHANGES IN CONSORT 2010 by journa The revision process resulted in evolutionar nat re olutionary,changes to the checklist (Table).and the flow diagram was not modified except for 1 word (Figure) 、Aoreoverbecause cite humbers,ve kept the sisuiag article,with ample detail and lucidity to 。 h renumbering of items 2 to5.We added additional items itfropay he methodncto CONSORT urges completeness,clarity,and transpar tria nterecteademinoatem segmen ifc cha rather than what was actually done.Authors,peer review. versions. IMPLICATIONS AND LIMITATIONS rerer,for exam 5.to We developed conSORT 2010 to assist authors in writing reports of randomized,controlled trials,editors and does not include recommendations for designing and con ducting randomized trials.The items should licit clea CONSORT how and what the authors did,but do Explan the provi ended as an instrument to evaluate the quality of a trial junction with the checkli ist to foster complete,clear,and transparent reporting and aid appraisal of published trial reporONSORT 2010 focus counts for over half of trials in the literature (2).Most of Bax.Noteworthy general changes in the CONSORT2010 pes of ed fo authors.editors.and readers should consult the CONSOR'T Web site for any CONSORT extensions,expansions(am. cations),implementations,or other guidance that may used fo nent o other reporting guidelines,such as for reporting systematic an ite Itiple ele tem 4 reviews and meta-analyses of studies evaluating interven studies and ob rvationa umber for tha the setting Traparency of e Researc (EQUATOR)Nework www.annals.orgthe 2007 CONSORT meeting provided the material for the update. The updated explanation and elaboration manuscript was distributed to the entire group for addi￾tions, deletions, and changes. That final iterative process converged to the CONSORT 2010 Explanation and Elaboration (13). CHANGES IN CONSORT 2010 The revision process resulted in evolutionary, not rev￾olutionary, changes to the checklist (Table), and the flow diagram was not modified except for 1 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 subitem under an existing item, an entirely new item number at the end of the checklist, or (with item 3) an interjected item into a renumbered segment. We have summarized the noteworthy general changes in Box 1 and specific changes in Box 2. The CONSORT Web site con￾tains a side-by-side comparison of the 2001 and 2010 versions. IMPLICATIONS AND LIMITATIONS We developed CONSORT 2010 to assist authors in writing reports of randomized, controlled trials, editors and peer reviewers in reviewing manuscripts for publication, and readers in critically appraising published articles. The CONSORT 2010 Explanation and Elaboration provides elucidation and context to the checklist items. We strongly recommend using the explanation and elaboration in con￾junction with the checklist to foster complete, clear, and transparent reporting and aid appraisal of published trial reports. CONSORT 2010 focuses predominantly on the 2-group, parallel randomized, controlled trial, which ac￾counts for over half of trials in the literature (2). Most of the items from the CONSORT 2010 Statement, however, pertain to all types of randomized trials. Nevertheless, some types of trials or trial situations dictate the need for additional information in the trial report. When in doubt, authors, editors, and readers should consult the CONSORT Web site for any CONSORT extensions, expansions (am￾plifications), implementations, or other guidance that may be relevant. The evidence-based approach we have used for CONSORT also served as a model for development of other reporting guidelines, such as for reporting systematic reviews and meta-analyses of studies evaluating interven￾tions (16), diagnostic studies (17), and observational studies (18). The explicit goal of all these initiatives is to improve reporting. The Enhancing the Quality and Transparency of Health Research (EQUATOR) Network will facilitate development of reporting guidelines and help disseminate the guidelines: www.equator-network.org pro￾vides information on all reporting guidelines in health research. With CONSORT 2010, we again intentionally de￾clined to produce a rigid structure for the reporting of randomized trials. Indeed, Standards of Reporting Tri￾als (SORT) (19) tried a rigid format, and it failed in a pilot run with an editor and authors (20). Conse￾quently, 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 standardize the structure of report￾ing. Authors should simply address checklist items somewhere in the article, with ample detail and lucidity. That stated, we think that manuscripts benefit from fre￾quent subheadings within the major sections, especially the methods and results sections. CONSORT urges completeness, clarity, and transpar￾ency of reporting, which simply reflects the actual trial design and conduct. However, as a potential drawback, a reporting guideline might encourage some authors to re￾port fictitiously the information suggested by the guidance rather than what was actually done. Authors, peer review￾ers, and editors should vigilantly guard against that poten￾tial drawback and refer, for example, to trial protocols, to information on trial registers, and to regulatory agency Web sites. Moreover, the CONSORT 2010 Statement does not include recommendations for designing and con￾ducting randomized 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 2010 is not in￾tended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist to construct a “quality score.” Box 1. Noteworthy general changes in the CONSORT 2010 Statement. We simplified and clarified the wording, such as in items 1, 8, 10, 13, 15, 16, 18, 19, and 21. We improved consistency of style across the items by removing the imperative verbs that were in the 2001 version. We enhanced specificity of appraisal by breaking some items into subitems. Many journals expect authors to 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 collection. 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 2010 relieves obfuscations and forces authors to provide page numbers in the checklist for both eligibility and settings. CONSORT 2010 Statement Academia and Clinic www.annals.org 1 June 2010 Annals of Internal Medicine Volume 152 • Number 11 729