Kenneth F. SchulzpersName, Douglas G. AltmanpersName, David MoherpersName (2010date). “CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials.” PLOS Medicinetitle·j, DurhamplaceName.
Object of study — How randomised controlled trialsterm·key should be reported, and what changed in the 2010date revision of the standard.
Research question — What minimum set of items must a randomised controlled trialterm·mth report so its methods and findings can be appraised?
Contribution — Provides CONSORTterm·mth, the reporting standardterm·mth for randomised controlled trialsterm·key, completing the evidence-based reporting-guideline family alongside PRISMA and STROBE.
phenomenon · claim-type · cross-domain-transfer · mechanism · claim-relation · replication-status · limitation — grounded in the full text| phenomenon | reporting of randomised controlled trials — “Efforts to improve the reporting of randomised controlled trials accelerated in the mid-1990s, spurred partly by methodological research.” | |
| claim-type | method — “The CONSORT 2010 Statement is this paper including the 25 item checklist in the table ( Table 1 ) and the flow diagram ( Figure 1 ).” | |
| method — evidence | — “Thirty one members of the CONSORT 2010 Group met in Montebello, Canada, in January 2007 to update the 2001 CONSORT statement.” | |
| object of study — evidence | — “To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings.” | |
| transfer | from statistics (design of experiments, randomization): the randomized controlled trial methodology (randomization / experimental design from statistics) as the gold standard for evaluating medical interventions — “Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions” | transfers[0] |
| mechanism | Item numbers were deliberately preserved through the revision because other guidelines point at them - identifiers must be stable when other things reference them — “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.” | mechanisms[0] |
| mechanism | Items are admitted or dropped on empirical evidence about whether the practice affects bias, not on what seems desirable — “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.” | mechanisms[1] |
| mechanism | Breaking composite items into sub-items closes a loophole in how the checklist is used: an author could cite one page for an item and have addressed only half of it — “CONSORT 2010 relieves obfuscations and forces authors to provide page numbers in the checklist for both eligibility and settings.” | mechanisms[2] |
| mechanism | A misused term was replaced by a description of the thing it was supposed to denote, rather than being redefined — “We replaced mention of “intention to treat” analysis, a widely misused term, by a more explicit request for information about retaining participants in their original assigned groups [26] .” | mechanisms[3] |
| mechanism | The standard governs content and explicitly not form, because a rigid format was tried and failed — “Indeed, SORT [19] tried a rigid format, and it failed in a pilot run with an editor and authors.” | mechanisms[4] |
| mechanism | An ongoing database of methodological studies supplies the evidence for each revision, so the guideline updates from accumulating research rather than from opinion — “More than 700 studies comprise the CONSORT database (located on the CONSORT website), which provides the empirical evidence to underpin the CONSORT initiative.” | mechanisms[5] |
| extends | CONSORT 2001 statement — “CONSORT 2010 supplants the prior version published in 2001.” | claim_relations[1] |
| builds-on | original 1996 CONSORT (Consolidated Standards of Reporting Trials) statement and its 2001 revision — “That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] .” | claim_relations[2] |
| extends | the 2001 CONSORT statement, which this revises and replaces — “Consequently, we organised a CONSORT Group meeting to update the 2001 statement [6] , [7] , [8] . We introduce here the result of that process, CONSORT 2010.” | claim_relations[3] |
| extends | the original 1996 CONSORT statement — “That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] .” | claim_relations[4] |
| supports | the reporting guidelines for systematic reviews, diagnostic and observational studies that took CONSORT as their model — “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 interventions, [16] diagnostic studies, [17] and observational studies. [18]” | claim_relations[5] |
| critiques | SORT, the rigid-format reporting attempt — “Indeed, SORT [19] tried a rigid format, and it failed in a pilot run with an editor and authors.” | claim_relations[6] |
| sense | CONSORT - the 2001 version: the previous statement, whose item numbers survive into the new one — “Thirty one members of the CONSORT 2010 Group met in Montebello, Canada, in January 2007 to update the 2001 CONSORT statement.” | senses[0] |
| sense | CONSORT - the 2010 version: this paper plus its 25-item checklist and flow diagram, the three together being the statement — “The CONSORT 2010 Statement is this paper including the 25 item checklist in the table ( Table 1 ) and the flow diagram ( Figure 1 ).” | senses[1] |
| sense | the standard - as governing CONTENT: what must be addressed somewhere in the article — “Authors should simply address checklist items somewhere in the article, with ample detail and lucidity.” | senses[2] |
| sense | the standard - as NOT governing FORM: the group explicitly declines to prescribe structure, citing a rigid format that failed — “With CONSORT 2010, we again intentionally declined to produce a rigid structure for the reporting of randomised trials.” | senses[3] |
| sense | intention to treat - the term, withdrawn from the checklist because practitioners use it for different things — “We replaced mention of “intention to treat” analysis, a widely misused term, by a more explicit request for information about retaining participants in their original assigned groups [26] .” | senses[4] |
| sense | Randomized controlled trial as gold standard - only when design, conduct, and reporting are all appropriate — “Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour [1] . To assess a trial accurately, readers of a published report 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 [2] , [3] , [4] . That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] . While those statements improved the reporting quality for some randomised controlled trials [9] , [10] , many trial reports still remain inadequate [2] . Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement [6] , [7] , [8] . We introduce here the result of that process, CONSORT 2010” | senses[5] |
| sense | CONSORT 2010 core scope - 25-item checklist plus flow diagram, focused on individually randomized two-group parallel trials — “The CONSORT 2010 Statement is this paper including the 25 item checklist in the table ( Table 1 ) and the flow diagram ( Figure 1 ). It provides guidance for reporting all randomised controlled trials, but focuses on the most common design type—individually randomised, two group, parallel trials” | senses[6] |
| sense | CONSORT extension - additional information required for cluster and non-inferiority designs — “Other trial designs, such as cluster randomised trials and non-inferiority trials, require varying amounts of additional information” | senses[7] |
| sense | Explanation and Elaboration - item rationale, methodological background, and published reporting exemplars — “Along with the CONSORT statement, we have updated the explanation and elaboration article, [13] which explains the inclusion of each checklist item, provides methodological background, and gives published examples of transparent reporting” | senses[8] |
| sense | Checklist adherence - explicit reporting improves clarity and exposes research deficiencies without directly prescribing conduct — “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 2010 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 exist. 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 trial's inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work” | senses[9] |
| sense | CONSORT evidence base - a monitored database of more than 700 methodological studies used for updates — “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 authors reported such trials poorly, and empirical evidence began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias [14] Two initiatives aimed at developing reporting guidelines culminated in one of us (DM) and Drummond Rennie organising the first CONSORT statement in 1996. [5] Further methodological research on similar topics reinforced earlier findings [15] and fed into the revision of 2001. [6] , [7] , [8] Subsequently, the expanding body of methodological research informed the refinement of CONSORT 2010. More than 700 studies comprise the CONSORT database (located on 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” | senses[10] |
| sense | Minimum criteria - only absolutely fundamental reporting items, with exclusions when evidence or consensus is lacking — “Thirty one members of the CONSORT 2010 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 participants 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 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 instructions 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 2010 Statement thus addresses the minimum criteria, although that should not deter authors from including other information if they consider it important” | senses[11] |
| sense | Consensus iteration - seven major checklist revisions followed by larger-group feedback and explanation-document convergence — “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 feedback, 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 statement. 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 entire group for additions, deletions, and changes. That final iterative process converged to the CONSORT 2010 Explanation and Elaboration” | senses[12] |
| sense | Evolutionary revision - wording, style, specificity, and sub-items changed while the checklist lineage remained stable — “The revision process resulted in evolutionary, not revolutionary, changes to the checklist ( Table 1 ), and the flow diagram was not modified except for one word ( Figure 1 ). 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, 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 2010 versions” | senses[13] |
| sense | Sub-item specificity - separate page locations prevent one reported element from hiding another omitted element — “We enhanced specificity of appraisal by breaking some items into sub-items. 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” | senses[14] |
| sense | Allocation concealment reporting - actual implementation steps rather than generic assurances — “Item 9 (allocation concealment mechanism)— We reworded this to include mechanism in both the report topic and the descriptor to reinforce that authors should report the actual steps taken to ensure allocation concealment rather than simply report imprecise, perhaps banal, assurances of concealment” | senses[15] |
| sense | Blinding assessment - report how blinding was done, but do not require an unsupported success test — “Item 11 (blinding)— We added the specification of how blinding was done and, if relevant, a description of the similarity of interventions and procedures. We also eliminated text on “how the success of blinding (masking) was assessed” because of a lack of empirical evidence supporting the practice as well as theoretical concerns about the validity of any such assessment” | senses[16] |
| sense | Interpretation discipline - conclusions should match results and balance benefits against harms — “Item 22 (interpretation)— We changed the topic from “Overall evidence.” Indeed, we understand that authors should be allowed leeway for interpretation under this nebulous heading. However, the CONSORT Group expressed concerns that conclusions in papers frequently misrepresented the actual analytical results and that harms were ignored or marginalised. Therefore, we changed the checklist item to include the concepts of results matching interpretations and of benefits being balanced with harms” | senses[17] |
| sense | CONSORT audience - authors, editors, reviewers, and readers using the checklist with its Explanation and Elaboration — “We developed CONSORT 2010 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 2010 Explanation and Elaboration provides 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” | senses[18] |
| sense | Content without rigid form - address every item with detail while retaining journal and field structure — “With CONSORT 2010, we again intentionally declined to produce a rigid structure for the reporting of randomised trials. Indeed, SORT [19] tried a rigid format, and it failed in a pilot run with an editor and authors. [20] 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 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” | senses[19] |
| sense | Reporting-guideline gaming - guidance can elicit fictitious compliance, checked against protocols, registers, and regulators — “CONSORT urges completeness, 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, peer 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” | senses[20] |
| sense | Reporting versus trial quality - CONSORT elicits disclosure but is neither a design prescription nor a quality-score instrument — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised 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 intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist 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 editorial 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 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards” | senses[21] |
| sense | Evolving CONSORT - perpetual reappraisal from criticism, experience, and accumulating evidence — “We emphasise that CONSORT 2010 represents an evolving guideline. It requires perpetual reappraisal and, if necessary, 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” | senses[22] |
| edge | CONSORT —operationalised-as→ checklist — “The CONSORT 2010 Statement is this paper including the 25 item checklist in the table ( Table 1 ) and the flow diagram ( Figure 1 ).” | concept_edges[0] |
| edge | CONSORT —is-a→ reporting guidelines — “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 interventions, [16] diagnostic studies, [17] and observational studies. [18]” | concept_edges[2] |
| audit | CONSORT —contrasted-with→ SORT — Audit 2026-09-28: DOUBTFUL - read against its full span and kept, but endpoint by anaphora: 'Indeed, SORT tried a rigid format' answers the previous sentence, where CONSORT declined a rigid structure. — “Indeed, SORT [19] tried a rigid format, and it failed in a pilot run with an editor and authors.” | concept_edges[3] |
| edge | explanation and elaboration —part-of→ CONSORT — “Along with the CONSORT statement, we have updated the explanation and elaboration article, [13] which explains the inclusion of each checklist item, provides methodological background, and gives published examples of transparent reporting.” | concept_edges[4] |
| audit | International Committee of Medical Journal Editors —causes→ CONSORT — Audit 2026-09-28: DOUBTFUL - read against its span and kept, but the committee ENDORSED CONSORT; causes is the wrong type for an endorsement. — “Moreover, thousands more have implicitly supported it with the endorsement of the CONSORT statement by the International Committee of Medical Journal Editors ( http://www.icmje.org ).” | concept_edges[11] |
| weight | International Committee of Medical Journal Editors —causes→ CONSORT — 0.9 — “Moreover, thousands more have implicitly supported it with the endorsement of the CONSORT statement by the International Committee of Medical Journal Editors ( http://www.icmje.org ).” | concept_edges[11] |
| note | lack methodological rigour —causes→ biased results — The paper directly says trials can yield biased results if they lack methodological rigor. — “Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour [1] . To assess a trial accurately, readers of a published report 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 [2] , [3] , [4] . That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] . While those statements improved the reporting quality for some randomised controlled trials [9] , [10] , many trial reports still remain inadequate [2] . Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement [6] , [7] , [8] . We introduce here the result of that process, CONSORT 2010” | concept_edges[14] |
| note | Diligent adherence —causes→ clarity, completeness, and transparency of reporting — Checklist adherence is stated to facilitate reporting clarity, completeness, and transparency. — “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 2010 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 exist. 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 trial's inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work” | concept_edges[15] |
| note | CONSORT —distinct-from→ designing and conducting randomised trials — CONSORT explicitly excludes recommendations for designing and conducting trials. — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised 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 intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist 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 editorial 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 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards” | concept_edges[16] |
| note | checklist —distinct-from→ quality score — The paper explicitly says the checklist is not appropriate for constructing a quality score. — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised 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 intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist 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 editorial 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 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards” | concept_edges[17] |
| for which use | limitation — everything outside reporting: the statement DOES NOT INCLUDE RECOMMENDATIONS FOR DESIGNING, CONDUCTING and analysing trials — “does not include recommendations for designing, conducting, and analysing trials.” | limitations[0] |
| for which use | limitation — the inference from a well-reported trial to a well-conducted one: A REPORTING GUIDELINE MIGHT ENCOURAGE SOME AUTHORS TO REPORT FICTITIOUSLY THE INFORMATION SUGGESTED BY THE GUIDANCE RATHER THAN WHAT WAS ACTUALLY DONE - the standard can change what it measures — “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.” | limitations[1] |
| for which use | limitation — the same scope as limitations[0] - reporting only, not design or conduct — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised trials.” | limitations[2] |
| for which use | limitation — trial-quality appraisal, which the authors rule out in their own voice: THUS, CONSORT 2010 IS NOT INTENDED AS AN INSTRUMENT TO EVALUATE THE QUALITY OF A TRIAL - so any quality score built from the checklist is a use the instrument does not bear — “Thus, CONSORT 2010 is not intended as an instrument to evaluate the quality of a trial.” | limitations[3] |
| for which use | limitation — any trial design other than the one it was built for: CONSORT 2010 FOCUSES PREDOMINANTLY ON THE TWO GROUP, PARALLEL RANDOMISED CONTROLLED TRIAL, WHICH ACCOUNTS FOR OVER HALF OF TRIALS IN THE LITERATURE — “CONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature.” | limitations[4] |
| duplicate of | limitation — limitations[4] — “CONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature.” | limitations[5] |
| for which use | limitation — the same scope as limitations[4] - other designs need published extensions — “CONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature.” | limitations[5] |
| for which use | limitation — any reading of the checklist as a standard of good reporting: THE CONSORT 2010 STATEMENT THUS ADDRESSES THE MINIMUM CRITERIA, ALTHOUGH THAT SHOULD NOT DETER AUTHORS FROM INCLUDING OTHER INFORMATION — “The CONSORT 2010 Statement thus addresses the minimum criteria, although that should not deter authors from including other information if they consider it important.” | limitations[6] |
| for which use | limitation — any inference from absence on the checklist to unimportance: 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 — “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 instructions for authors.” | limitations[7] |
| for which use | limitation — any claim that the guideline fixed reporting: WHILE THOSE STATEMENTS IMPROVED THE REPORTING QUALITY FOR SOME RANDOMISED CONTROLLED TRIALS, MANY TRIAL REPORTS STILL REMAIN INADEQUATE — “While those statements improved the reporting quality for some randomised controlled trials [9] , [10] , many trial reports still remain inadequate [2] .” | limitations[8] |
| for which use | limitation — the scope of what the 2010 revision changed: THE REVISION PROCESS RESULTED IN EVOLUTIONARY, NOT REVOLUTIONARY, CHANGES TO THE CHECKLIST, AND THE FLOW DIAGRAM WAS NOT MODIFIED EXCEPT FOR ONE WORD — “The revision process resulted in evolutionary, not revolutionary, changes to the checklist ( Table 1 ), and the flow diagram was not modified except for one word ( Figure 1 ).” | limitations[9] |
| weight | availability of the trial protocol → adherence to the protocol — 0.7 — “Item 23 (registration)— We added a new item on trial registration. Empirical evidence supports the need for trial registration, and recent requirements by journal editors have fostered compliance [29] . Item 24 (protocol)— We added a new item on availability of the trial protocol. Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol. [4] , [22] Hence, availability of the protocol can instigate adherence to the protocol before publication and facilitate assessment of adherence after publication. Item 25 (funding)— We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimated treatment effects” | unhoused_relations[3] |
| weight | funding source → estimated treatment effects — 0.8 — “Item 23 (registration)— We added a new item on trial registration. Empirical evidence supports the need for trial registration, and recent requirements by journal editors have fostered compliance [29] . Item 24 (protocol)— We added a new item on availability of the trial protocol. Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol. [4] , [22] Hence, availability of the protocol can instigate adherence to the protocol before publication and facilitate assessment of adherence after publication. Item 25 (funding)— We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimated treatment effects” | unhoused_relations[4] |
| weight | potential drawback → report fictitiously — 0.5 — “CONSORT urges completeness, 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, peer 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” | unhoused_relations[5] |
| weight | ensuing scrutiny → well conducted trials — 0.9 — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised 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 intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist 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 editorial 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 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards” | unhoused_relations[6] |
| replication | untested | |
| no type for this | Transparent reporting → deficiencies in research — Transparent reporting reveals research deficiencies; exposes is absent from the eight relation types. — “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 2010 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 exist. 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 trial's inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work” | unhoused_relations[0] |
| no type for this | CONSORT database → evidence base — The CONSORT database provides the evidence base for statement updates; provides-basis-for is absent from the governed types. — “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 authors reported such trials poorly, and empirical evidence began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias [14] Two initiatives aimed at developing reporting guidelines culminated in one of us (DM) and Drummond Rennie organising the first CONSORT statement in 1996. [5] Further methodological research on similar topics reinforced earlier findings [15] and fed into the revision of 2001. [6] , [7] , [8] Subsequently, the expanding body of methodological research informed the refinement of CONSORT 2010. More than 700 studies comprise the CONSORT database (located on 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” | unhoused_relations[1] |
| no type for this | specificity of appraisal → multiple elements — Breaking multi-element items into sub-items enhances appraisal specificity; improves-through-splitting is absent from the eight types. — “We enhanced specificity of appraisal by breaking some items into sub-items. 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” | unhoused_relations[2] |
| no type for this | availability of the trial protocol → adherence to the protocol — Protocol availability can instigate prepublication adherence and facilitate postpublication assessment; enables is absent from the edge registry. — “Item 23 (registration)— We added a new item on trial registration. Empirical evidence supports the need for trial registration, and recent requirements by journal editors have fostered compliance [29] . Item 24 (protocol)— We added a new item on availability of the trial protocol. Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol. [4] , [22] Hence, availability of the protocol can instigate adherence to the protocol before publication and facilitate assessment of adherence after publication. Item 25 (funding)— We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimated treatment effects” | unhoused_relations[3] |
| no type for this | funding source → estimated treatment effects — Funding source is sometimes associated with estimated treatment effects; associated-with is absent from the eight types. — “Item 23 (registration)— We added a new item on trial registration. Empirical evidence supports the need for trial registration, and recent requirements by journal editors have fostered compliance [29] . Item 24 (protocol)— We added a new item on availability of the trial protocol. Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol. [4] , [22] Hence, availability of the protocol can instigate adherence to the protocol before publication and facilitate assessment of adherence after publication. Item 25 (funding)— We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimated treatment effects” | unhoused_relations[4] |
| no type for this | potential drawback → report fictitiously — A reporting guideline might encourage fictitious reporting; may-encourage is absent, and forcing causes would hide both the modal hedge and the normative mechanism. — “CONSORT urges completeness, 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, peer 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” | unhoused_relations[5] |
| no type for this | ensuing scrutiny → well conducted trials — Scrutiny rewards well-conducted trials and penalizes poorly conducted ones; rewards/penalizes is absent from the edge registry. — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised 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 intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist 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 editorial 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 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards” | unhoused_relations[6] |
| no type for this | evolving guideline → perpetual reappraisal — An evolving guideline requires perpetual reappraisal; requires is absent from the eight types. — “We emphasise that CONSORT 2010 represents an evolving guideline. It requires perpetual reappraisal and, if necessary, 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” | unhoused_relations[7] |
| limitation | CONSORT covers reporting only, not the design, conduct, or analysis of trials — “does not include recommendations for designing, conducting, and analysing trials.” | limitations[0] |
| limitation | A reporting guideline may induce some authors to report what the guideline asks for rather than what they actually did. — “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.” | limitations[1] |
| limitation | The statement covers reporting only and gives no guidance on how trials should be designed or conducted. — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised trials.” | limitations[2] |
| limitation | The checklist is not a trial-quality appraisal instrument and must not be turned into a quality score. — “Thus, CONSORT 2010 is not intended as an instrument to evaluate the quality of a trial.” | limitations[3] |
| limitation | Scope is restricted mainly to the two-group parallel design; other designs need extensions. — “CONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature.” | limitations[4] |
| limitation | Built for the two-group parallel trial, with other designs needing extensions — “CONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature.” | limitations[5] |
| limitation | The checklist is a minimum, not a description of good reporting — “The CONSORT 2010 Statement thus addresses the minimum criteria, although that should not deter authors from including other information if they consider it important.” | limitations[6] |
| limitation | Items fundamental to a trial may still be absent from the checklist if another mechanism already enforces them — “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 instructions for authors.” | limitations[7] |
| limitation | Two revisions on from 1996 and reporting remains inadequate in many trials — “While those statements improved the reporting quality for some randomised controlled trials [9] , [10] , many trial reports still remain inadequate [2] .” | limitations[8] |
| limitation | The revision is described as evolutionary rather than revolutionary, so it inherits whatever the earlier versions got wrong — “The revision process resulted in evolutionary, not revolutionary, changes to the checklist ( Table 1 ), and the flow diagram was not modified except for one word ( Figure 1 ).” | limitations[9] |
finding · quantity · variable · definition · key-term — grounded in the full text| finding | trials lacking methodological rigour can yield biased results — “randomised trials can yield biased results if they lack methodological rigour” | content_tags.findings[0] |
| finding | CONSORT adoption appears to improve reporting quality — “when used by authors and journals, CONSORT seems to improve reporting” | content_tags.findings[1] |
| finding | the statement governs reporting only, not trial design or conduct — “It solely addresses the reporting of what was done and what was found” | content_tags.findings[2] |
| finding | the checklist must not be turned into a trial quality score — “Nor is it appropriate to use the checklist to construct a “quality score” | content_tags.findings[3] |
| evidence status note | finding — QUOTE RECOVERED FROM THE PAPER'S OWN CHARACTERS. The recorded quote was LETTERS-ONLY IDENTICAL to this stretch of the staged text but not an exact substring of it - spaces, hyphens, ligature glyphs or mathematical operators differed, so it could never anchor. This is the file's own text between the same two letters: not produced by a rule about the damage, copied out of the file. Round-trip checked (the recovered span is letters-only equal to the original) and length-checked. The text as originally recorded is kept in evidence as extracted. | content_tags.findings[3] |
| finding | those statements improved reporting quality for some randomised trials, yet many trial reports still remain inadequate — “While those statements improved the reporting quality for some randomised controlled trials [9] , [10] , many trial reports still remain inadequate [2] .” | content_tags.findings[4] |
| finding | authors frequently analyse outcomes that were not their pre-specified ones while ignoring those that were — “This followed from empirical evidence that authors frequently provide analyses of outcomes in their published papers that were not the prespecified primary and secondary outcomes in their protocols, while ignoring their prespecified outcomes (that is, selective outcome reporting).” | content_tags.findings[5] |
| finding | assessment of blinding success was dropped for lack of evidence that it works — “We also eliminated text on “how the success of blinding (masking) was assessed” because of a lack of empirical evidence supporting the practice as well as theoretical concerns about the validity of any such assessment [23] , [24] .” | content_tags.findings[6] |
| finding | funding source is sometimes associated with the estimated treatment effect, which is why funding became an item — “Item 25 (funding)— We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimated treatment effects [30] .” | content_tags.findings[7] |
| finding | more than 400 journals have explicitly supported the CONSORT statement — “More than 400 journals, published around the world and in many languages, have explicitly supported the CONSORT statement.” | content_tags.findings[8] |
| quantity | 25 items — size of the CONSORT reporting checklist — “The CONSORT 2010 Statement is this paper including the 25 item checklist in the table ( Table 1 ) and the flow diagram ( Figure 1 ).” | content_tags.quantities[0] |
| quantity | 700 studies — empirical studies underpinning the guideline — “More than 700 studies comprise the CONSORT database” | content_tags.quantities[1] |
| quantity | 400 journals — journals explicitly endorsing the statement — “More than 400 journals, published around the world and in many languages, have explicitly supported the CONSORT statement” | content_tags.quantities[2] |
| quantity | 31 members — group members who met to update the statement — “Thirty one members of the CONSORT 2010 Group met in Montebello, Canada” | content_tags.quantities[3] |
| quantity | 7 iterations — revision rounds before distribution — “After seven major iterations, a revised checklist was distributed to the larger group for feedback.” | content_tags.quantities[4] |
| quantity | 25 item checklist — the size of the 2010 instrument — “The CONSORT 2010 Statement is this paper including the 25 item checklist in the table ( Table 1 ) and the flow diagram ( Figure 1 ).” | content_tags.quantities[5] |
| quantity | Thirty one members — the size of the 2007 revision meeting — “Thirty one members of the CONSORT 2010 Group met in Montebello, Canada, in January 2007 to update the 2001 CONSORT statement.” | content_tags.quantities[6] |
| quantity | More than 700 studies — the methodological evidence base underpinning the revisions — “More than 700 studies comprise the CONSORT database (located on the CONSORT website), which provides the empirical evidence to underpin the CONSORT initiative.” | content_tags.quantities[7] |
| quantity | More than 400 journals — explicit institutional uptake — “More than 400 journals, published around the world and in many languages, have explicitly supported the CONSORT statement.” | content_tags.quantities[8] |
| quantity | seven major iterations — how many drafts the checklist went through after the meeting — “After seven major iterations, a revised checklist was distributed to the larger group for feedback.” | content_tags.quantities[9] |
| quantity | over half of trials — share of the literature using the two-group parallel design the standard targets — “CONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature.” | content_tags.quantities[10] |
| variable | allocation ratio (design parameter to be reported) — “Description of trial design (such as parallel, factorial) including allocation ratio” | content_tags.variables[0] |
| variable | sample size (design determination to be reported) — “How sample size was determined” | content_tags.variables[1] |
| variable | effect size (outcome estimate with precision) — “the estimated effect size and its precision (such as 95% confidence interval)” | content_tags.variables[2] |
| variable | funding source (potential confounder of treatment effects) — “funding source sometimes being associated with estimated treatment effects” | content_tags.variables[3] |
| definition | CONSORT — “the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996” | content_tags.definitions[0] |
| definition | allocation concealment — “describing any steps taken to conceal the sequence until interventions were assigned” | content_tags.definitions[1] |
| definition | intention to treat — ““intention to treat” analysis, a widely misused term” | content_tags.definitions[2] |
| evidence status note | definition — QUOTE RECOVERED FROM THE PAPER'S OWN CHARACTERS. The recorded quote was LETTERS-ONLY IDENTICAL to this stretch of the staged text but not an exact substring of it - spaces, hyphens, ligature glyphs or mathematical operators differed, so it could never anchor. This is the file's own text between the same two letters: not produced by a rule about the damage, copied out of the file. Round-trip checked (the recovered span is letters-only equal to the original) and length-checked. The text as originally recorded is kept in evidence as extracted. | content_tags.definitions[2] |
| definition | CONSORT — “the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996” | content_tags.definitions[4] |
| definition | selective outcome reporting — “authors frequently provide analyses of outcomes in their published papers that were not the prespecified primary and secondary outcomes in their protocols, while ignoring their prespecified outcomes (that is, selective outcome reporting)” | content_tags.definitions[5] |
| definition | allocation concealment mechanism — “Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned” | content_tags.definitions[6] |
| definition | EQUATOR — “The Enhancing the Quality and Transparency of Health Research (EQUATOR) Network will facilitate development of reporting guidelines and help disseminate the guidelines” | content_tags.definitions[7] |
| key-terms | randomised controlled trials, CONSORT, checklist, flow diagram, allocation concealment, blinding, transparent reporting, randomisation, trial registration, methodological rigour, randomised controlled trial, intention to treat, selective outcome reporting, protocol, effect size, harms, generalisability, EQUATOR, explanation and elaboration, reporting guidelines |
| concept | intention to treat — not defined in this paper's own words; the analysis principle whose NAME was removed from the checklist for being widely misused — “We replaced mention of “intention to treat” analysis, a widely misused term, by a more explicit request for information about retaining participants in their original assigned groups [26] .” | concepts[9] |
| concept | gold standard — not defined in this paper's own words; evaluation status assigned to appropriately designed, conducted, and reported randomized trials — “Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour [1] . To assess a trial accurately, readers of a published report 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 [2] , [3] , [4] . That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] . While those statements improved the reporting quality for some randomised controlled trials [9] , [10] , many trial reports still remain inadequate [2] . Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement [6] , [7] , [8] . We introduce here the result of that process, CONSORT 2010” | concepts[21] |
| concept | lack methodological rigour — not defined in this paper's own words; methodological deficiency through which randomized trials can yield bias — “Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour [1] . To assess a trial accurately, readers of a published report 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 [2] , [3] , [4] . That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] . While those statements improved the reporting quality for some randomised controlled trials [9] , [10] , many trial reports still remain inadequate [2] . Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement [6] , [7] , [8] . We introduce here the result of that process, CONSORT 2010” | concepts[22] |
| concept | biased results — not defined in this paper's own words; distorted trial findings produced by inadequate methodological rigor — “Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour [1] . To assess a trial accurately, readers of a published report 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 [2] , [3] , [4] . That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] . While those statements improved the reporting quality for some randomised controlled trials [9] , [10] , many trial reports still remain inadequate [2] . Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement [6] , [7] , [8] . We introduce here the result of that process, CONSORT 2010” | concepts[23] |
| concept | complete, clear, and transparent information — not defined in this paper's own words; report content readers need to assess a trial accurately — “Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour [1] . To assess a trial accurately, readers of a published report 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 [2] , [3] , [4] . That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] . While those statements improved the reporting quality for some randomised controlled trials [9] , [10] , many trial reports still remain inadequate [2] . Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement [6] , [7] , [8] . We introduce here the result of that process, CONSORT 2010” | concepts[24] |
| concept | reporting quality — not defined in this paper's own words; quality of randomized-trial reports improved but not fully solved by earlier CONSORT versions — “Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour [1] . To assess a trial accurately, readers of a published report 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 [2] , [3] , [4] . That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] . While those statements improved the reporting quality for some randomised controlled trials [9] , [10] , many trial reports still remain inadequate [2] . Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement [6] , [7] , [8] . We introduce here the result of that process, CONSORT 2010” | concepts[25] |
| concept | 25 item checklist — not defined in this paper's own words; reporting checklist forming part of the CONSORT 2010 statement — “The CONSORT 2010 Statement is this paper including the 25 item checklist in the table ( Table 1 ) and the flow diagram ( Figure 1 ). It provides guidance for reporting all randomised controlled trials, but focuses on the most common design type—individually randomised, two group, parallel trials” | concepts[26] |
| concept | individually randomised, two group, parallel trials — not defined in this paper's own words; most common trial design and principal focus of CONSORT 2010 — “The CONSORT 2010 Statement is this paper including the 25 item checklist in the table ( Table 1 ) and the flow diagram ( Figure 1 ). It provides guidance for reporting all randomised controlled trials, but focuses on the most common design type—individually randomised, two group, parallel trials” | concepts[27] |
| concept | cluster randomised trials — not defined in this paper's own words; trial design requiring a CONSORT extension and added reporting information — “Other trial designs, such as cluster randomised trials and non-inferiority trials, require varying amounts of additional information” | concepts[28] |
| concept | non-inferiority trials — not defined in this paper's own words; trial design requiring additional reporting guidance — “Other trial designs, such as cluster randomised trials and non-inferiority trials, require varying amounts of additional information” | concepts[29] |
| concept | additional information — not defined in this paper's own words; design-specific reporting content beyond the core statement — “Other trial designs, such as cluster randomised trials and non-inferiority trials, require varying amounts of additional information” | concepts[30] |
| concept | published examples of transparent reporting — not defined in this paper's own words; transparent-reporting exemplars in the explanation and elaboration article — “Along with the CONSORT statement, we have updated the explanation and elaboration article, [13] which explains the inclusion of each checklist item, provides methodological background, and gives published examples of transparent reporting” | concepts[31] |
| concept | Diligent adherence — not defined in this paper's own words; author compliance with checklist items — “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 2010 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 exist. 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 trial's inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work” | concepts[32] |
| concept | clarity, completeness, and transparency of reporting — not defined in this paper's own words; reporting properties facilitated by checklist adherence — “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 2010 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 exist. 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 trial's inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work” | concepts[33] |
| concept | Transparent reporting — not defined in this paper's own words; disclosure mechanism that exposes design and conduct deficiencies — “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 2010 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 exist. 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 trial's inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work” | concepts[34] |
| concept | deficiencies in research — not defined in this paper's own words; trial weaknesses made visible by transparent reporting — “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 2010 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 exist. 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 trial's inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work” | concepts[35] |
| concept | CONSORT database — not defined in this paper's own words; collection of more than 700 methodological studies supporting 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 authors reported such trials poorly, and empirical evidence began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias [14] Two initiatives aimed at developing reporting guidelines culminated in one of us (DM) and Drummond Rennie organising the first CONSORT statement in 1996. [5] Further methodological research on similar topics reinforced earlier findings [15] and fed into the revision of 2001. [6] , [7] , [8] Subsequently, the expanding body of methodological research informed the refinement of CONSORT 2010. More than 700 studies comprise the CONSORT database (located on 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” | concepts[36] |
| concept | empirical evidence — not defined in this paper's own words; research basis used to revise and justify reporting items — “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 authors reported such trials poorly, and empirical evidence began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias [14] Two initiatives aimed at developing reporting guidelines culminated in one of us (DM) and Drummond Rennie organising the first CONSORT statement in 1996. [5] Further methodological research on similar topics reinforced earlier findings [15] and fed into the revision of 2001. [6] , [7] , [8] Subsequently, the expanding body of methodological research informed the refinement of CONSORT 2010. More than 700 studies comprise the CONSORT database (located on 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” | concepts[37] |
| concept | evidence base — not defined in this paper's own words; continually monitored foundation for statement updates — “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 authors reported such trials poorly, and empirical evidence began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias [14] Two initiatives aimed at developing reporting guidelines culminated in one of us (DM) and Drummond Rennie organising the first CONSORT statement in 1996. [5] Further methodological research on similar topics reinforced earlier findings [15] and fed into the revision of 2001. [6] , [7] , [8] Subsequently, the expanding body of methodological research informed the refinement of CONSORT 2010. More than 700 studies comprise the CONSORT database (located on 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” | concepts[38] |
| concept | items deemed absolutely fundamental — not defined in this paper's own words; reporting entries retained only when judged indispensable — “Thirty one members of the CONSORT 2010 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 participants 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 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 instructions 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 2010 Statement thus addresses the minimum criteria, although that should not deter authors from including other information if they consider it important” | concepts[39] |
| concept | minimum criteria — not defined in this paper's own words; floor rather than ceiling for trial reporting — “Thirty one members of the CONSORT 2010 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 participants 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 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 instructions 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 2010 Statement thus addresses the minimum criteria, although that should not deter authors from including other information if they consider it important” | concepts[40] |
| concept | lack of empirical evidence or any consensus — not defined in this paper's own words; reason desirable items may be excluded from the checklist — “Thirty one members of the CONSORT 2010 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 participants 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 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 instructions 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 2010 Statement thus addresses the minimum criteria, although that should not deter authors from including other information if they consider it important” | concepts[41] |
| concept | seven major iterations — not defined in this paper's own words; seven-cycle checklist revision before broader feedback — “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 feedback, 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 statement. 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 entire group for additions, deletions, and changes. That final iterative process converged to the CONSORT 2010 Explanation and Elaboration” | concepts[42] |
| concept | evolutionary, not revolutionary, changes — not defined in this paper's own words; incremental characterization of the 2010 revision — “The revision process resulted in evolutionary, not revolutionary, changes to the checklist ( Table 1 ), and the flow diagram was not modified except for one word ( Figure 1 ). 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, 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 2010 versions” | concepts[43] |
| concept | specificity of appraisal — not defined in this paper's own words; greater report-checking precision achieved by splitting items — “We enhanced specificity of appraisal by breaking some items into sub-items. 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” | concepts[44] |
| concept | multiple elements — not defined in this paper's own words; distinct reporting obligations hidden under one checklist item — “We enhanced specificity of appraisal by breaking some items into sub-items. 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” | concepts[45] |
| concept | important changes to methods after trial commencement — not defined in this paper's own words; post-commencement method changes newly required to be reported with reasons — “Item 3a (trial design)— We added a new item including this sub-item to clarify the basic trial design (such as parallel group, crossover, cluster) and the allocation ratio. Item 3b (trial design)— We added a new sub-item that addresses any important changes to methods after trial commencement, with a discussion of reasons. Item 4 (participants)— Formerly item 3 in CONSORT 2001. Item 5 (interventions)— Formerly item 4 in CONSORT 2001. We encouraged greater specificity by stating that descriptions of interventions should include “sufficient details to allow replication” [3]” | concepts[46] |
| concept | sufficient details to allow replication — not defined in this paper's own words; intervention description sufficient for replication — “Item 3a (trial design)— We added a new item including this sub-item to clarify the basic trial design (such as parallel group, crossover, cluster) and the allocation ratio. Item 3b (trial design)— We added a new sub-item that addresses any important changes to methods after trial commencement, with a discussion of reasons. Item 4 (participants)— Formerly item 3 in CONSORT 2001. Item 5 (interventions)— Formerly item 4 in CONSORT 2001. We encouraged greater specificity by stating that descriptions of interventions should include “sufficient details to allow replication” [3]” | concepts[47] |
| concept | prespecified primary and secondary outcomes — not defined in this paper's own words; protocol outcomes at risk of being ignored in selective reporting — “Item 6 (outcomes)— We added a sub-item on identifying any changes to the primary and secondary outcome (endpoint) measures after the trial started. This followed from empirical evidence that authors frequently provide analyses of outcomes in their published papers that were not the prespecified primary and secondary outcomes in their protocols, while ignoring their prespecified outcomes (that is, selective outcome reporting)” | concepts[48] |
| concept | actual steps taken to ensure allocation concealment — not defined in this paper's own words; concrete allocation-hiding actions required in place of vague claims — “Item 9 (allocation concealment mechanism)— We reworded this to include mechanism in both the report topic and the descriptor to reinforce that authors should report the actual steps taken to ensure allocation concealment rather than simply report imprecise, perhaps banal, assurances of concealment” | concepts[49] |
| concept | assurances of concealment — not defined in this paper's own words; imprecise statements rejected as substitutes for allocation steps — “Item 9 (allocation concealment mechanism)— We reworded this to include mechanism in both the report topic and the descriptor to reinforce that authors should report the actual steps taken to ensure allocation concealment rather than simply report imprecise, perhaps banal, assurances of concealment” | concepts[50] |
| concept | success of blinding — not defined in this paper's own words; assessment removed for lack of evidence and validity concerns — “Item 11 (blinding)— We added the specification of how blinding was done and, if relevant, a description of the similarity of interventions and procedures. We also eliminated text on “how the success of blinding (masking) was assessed” because of a lack of empirical evidence supporting the practice as well as theoretical concerns about the validity of any such assessment” | concepts[51] |
| concept | relative and absolute effect sizes — not defined in this paper's own words; paired binary-outcome measures recommended for clinical interpretability — “Sub-item 17b (outcomes and estimation)— For appropriate clinical interpretability, prevailing experience suggested the addition of “For binary outcomes, presentation of both relative and absolute effect sizes is recommended”” | concepts[52] |
| concept | results matching interpretations — not defined in this paper's own words; requirement that conclusions correspond to analytical results — “Item 22 (interpretation)— We changed the topic from “Overall evidence.” Indeed, we understand that authors should be allowed leeway for interpretation under this nebulous heading. However, the CONSORT Group expressed concerns that conclusions in papers frequently misrepresented the actual analytical results and that harms were ignored or marginalised. Therefore, we changed the checklist item to include the concepts of results matching interpretations and of benefits being balanced with harms” | concepts[53] |
| concept | benefits being balanced with harms — not defined in this paper's own words; interpretive balance added because harms were often marginalized — “Item 22 (interpretation)— We changed the topic from “Overall evidence.” Indeed, we understand that authors should be allowed leeway for interpretation under this nebulous heading. However, the CONSORT Group expressed concerns that conclusions in papers frequently misrepresented the actual analytical results and that harms were ignored or marginalised. Therefore, we changed the checklist item to include the concepts of results matching interpretations and of benefits being balanced with harms” | concepts[54] |
| concept | availability of the trial protocol — not defined in this paper's own words; access enabling prepublication adherence and postpublication assessment — “Item 23 (registration)— We added a new item on trial registration. Empirical evidence supports the need for trial registration, and recent requirements by journal editors have fostered compliance [29] . Item 24 (protocol)— We added a new item on availability of the trial protocol. Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol. [4] , [22] Hence, availability of the protocol can instigate adherence to the protocol before publication and facilitate assessment of adherence after publication. Item 25 (funding)— We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimated treatment effects” | concepts[55] |
| concept | adherence to the protocol — not defined in this paper's own words; correspondence between trial behavior and the prespecified protocol — “Item 23 (registration)— We added a new item on trial registration. Empirical evidence supports the need for trial registration, and recent requirements by journal editors have fostered compliance [29] . Item 24 (protocol)— We added a new item on availability of the trial protocol. Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol. [4] , [22] Hence, availability of the protocol can instigate adherence to the protocol before publication and facilitate assessment of adherence after publication. Item 25 (funding)— We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimated treatment effects” | concepts[56] |
| concept | funding source — not defined in this paper's own words; financial provenance empirically associated with treatment estimates — “Item 23 (registration)— We added a new item on trial registration. Empirical evidence supports the need for trial registration, and recent requirements by journal editors have fostered compliance [29] . Item 24 (protocol)— We added a new item on availability of the trial protocol. Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol. [4] , [22] Hence, availability of the protocol can instigate adherence to the protocol before publication and facilitate assessment of adherence after publication. Item 25 (funding)— We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimated treatment effects” | concepts[57] |
| concept | estimated treatment effects — not defined in this paper's own words; trial estimates empirically associated with funding source — “Item 23 (registration)— We added a new item on trial registration. Empirical evidence supports the need for trial registration, and recent requirements by journal editors have fostered compliance [29] . Item 24 (protocol)— We added a new item on availability of the trial protocol. Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol. [4] , [22] Hence, availability of the protocol can instigate adherence to the protocol before publication and facilitate assessment of adherence after publication. Item 25 (funding)— We added a new item on funding. Empirical evidence points toward funding source sometimes being associated with estimated treatment effects” | concepts[58] |
| concept | rigid structure — not defined in this paper's own words; article format explicitly declined after SORT's failed pilot — “With CONSORT 2010, we again intentionally declined to produce a rigid structure for the reporting of randomised trials. Indeed, SORT [19] tried a rigid format, and it failed in a pilot run with an editor and authors. [20] 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 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” | concepts[59] |
| concept | potential drawback — not defined in this paper's own words; possibility that guidance elicits invented rather than actual information — “CONSORT urges completeness, 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, peer 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” | concepts[60] |
| concept | report fictitiously — not defined in this paper's own words; authors claiming guidance-recommended information that was not actually produced — “CONSORT urges completeness, 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, peer 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” | concepts[61] |
| concept | trial registers — not defined in this paper's own words; external source for checking whether trial reports reflect what occurred — “CONSORT urges completeness, 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, peer 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” | concepts[62] |
| concept | designing and conducting randomised trials — not defined in this paper's own words; trial activities intentionally outside CONSORT's direct recommendations — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised 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 intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist 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 editorial 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 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards” | concepts[63] |
| concept | quality score — not defined in this paper's own words; checklist-derived scalar use explicitly rejected by CONSORT — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised 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 intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist 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 editorial 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 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards” | concepts[64] |
| concept | ensuing scrutiny — not defined in this paper's own words; evaluation produced by transparent disclosure under wide adoption — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised 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 intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist 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 editorial 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 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards” | concepts[65] |
| concept | well conducted trials — not defined in this paper's own words; rigorous trials rewarded when transparent reporting permits scrutiny — “Moreover, the CONSORT 2010 Statement does not include recommendations for designing and conducting randomised 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 intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklist 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 editorial 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 2010 reporting guidelines before starting a trial as a further incentive to design and conduct their trials according to rigorous standards” | concepts[66] |
| concept | evolving guideline — not defined in this paper's own words; standard expected to change with evidence and experience — “We emphasise that CONSORT 2010 represents an evolving guideline. It requires perpetual reappraisal and, if necessary, 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” | concepts[67] |
| concept | perpetual reappraisal — not defined in this paper's own words; continuous review and possible modification of CONSORT — “We emphasise that CONSORT 2010 represents an evolving guideline. It requires perpetual reappraisal and, if necessary, 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” | concepts[68] |
| confidence-interval CI | — “For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)” | content_tags.statistics[0] |
| effect-size d | — “For binary outcomes, presentation of both absolute and relative effect sizes is recommended” | content_tags.statistics[1] |
| sample-size n/N | — “How sample size was determined” | content_tags.statistics[2] |
| phenomenon | reporting of randomised controlled trials — a second reading reaching the same value; recorded: reporting of randomised controlled trials — “However, randomised trials can yield biased results if they lack methodological rigour [1] .” | alternatives.phenomenon |
Full text — tagged
The reference list is not part of the text we hold for this paper. Our copy was extracted from the publisher's page and the bibliography did not survive that extraction, so the article below ends before its references. Nothing has been removed by us.
Abstract. Kenneth SchulzpersName and colleagues describe the 2010date version of the CONSORTterm·mth Statement, which updates the previous reporting guidelineterm·mth based on new methodological evidence and accumulated experience. Introduction Randomised controlled trialsterm·key, when appropriately designed, conducted, and reported, represent the gold standardterm in evaluating healthcare interventions. However, randomised trials can yield biased resultsterm if they lack methodological rigourterm [1] . To assess a trial accurately, readers of a published report need complete, clear, and transparent informationterm 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 [2] , [3] , [4] . That lack of adequate reporting fuelled the development of the original CONSORTterm·mth (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] . While those statements improved the reporting qualityterm for some randomised controlled trialsterm·key [9] , [10] , many trial reports still remain inadequate [2] . Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORTterm·mth Group meeting to update the 2001 statement [6] , [7] , [8] . We introduce here the result of that process, CONSORTterm·mth 2010date. Intent of CONSORTterm·mth 2010date The CONSORTterm·mth 2010date Statement is this paper including the 25 item checklistterm in the table ( Table 1 ) and the flow diagramterm·mth ( Figure 1 ). It provides guidance for reporting all randomised controlled trialsterm·key, but focuses on the most common design type—individually randomised, two group, parallel trialsterm. Other trial designs, such as cluster randomised trialsterm and non-inferiority trialsterm, require varying amounts of additional informationterm. CONSORTterm·mth extensions for these designs, [11] , [12] and other CONSORTterm·mth products, can be found through the CONSORTterm·mth website ( http://www.consort-statement.org ). Along with the CONSORTterm·mth statement, we have updated the explanation and elaborationterm·mth article, [13] which explains the inclusion of each checklistterm·mth item, provides methodological background, and gives published examples of transparent reportingterm. 10.1371/journal.pmed.1000251.g001 Figure 1 Flow diagramterm·mth of the progress through the phases of a parallel randomised trial of two groups (that is, enrolment, intervention allocation, follow-up, and data analysis). (For a downloadable version of this diagram see Figure S1 or the CONSORTterm·mth website.) 10.1371/journal.pmed.1000251.t001 Table 1 CONSORTterm·mth 2010date checklistterm·mth of information to include when reporting a randomised trial (for a downloadable version of this checklistterm·mth see Text S1 or the CONSORTterm·mth website). * Section/Topic Item No Checklistterm·mth item Reported on page No Title and abstract 1a Identification as a randomised trial in the title 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORTterm·mth for abstracts [21] , [31] ) Introduction Background and objectives 2a Scientific background and explanation of rationale 2b Specific objectives or hypotheses Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratioterm·var 3b Important changes to methods after trial commencementterm (such as eligibility criteria), with reasons Participants 4a Eligibility criteria for participants 4b Settings and locations where the data were collected Interventions 5 The interventions for each group with sufficient details to allow replicationterm, including how and when they were actually administered Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 6b Any changes to trial outcomes after the trial commenced, with reasons Sample sizeterm·var 7a How sample sizeterm·var was determined 7b When applicable, explanation of any interim analyses and stopping guidelines Randomisationterm·key: Sequence generation 8a Method used to generate the random allocation sequence 8b Type of randomisationterm·key; details of any restriction (such as blocking and block size) Allocation concealment mechanismterm·def 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Blindingterm·mth 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11b If relevant, description of the similarity of interventions Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses Results Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome 13b For each group, losses and exclusions after randomisationterm·key, together with reasons Recruitment 14a Dates defining the periods of recruitment and follow-up 14b Why the trial ended or was stopped Baseline data 15 A table showing baseline demographic and clinical characteristics for each group Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Outcomes and estimation 17a For each primary and secondary outcome, results for each group, and the estimated effect sizeterm·mth and its precision (such as 95% confidence intervalterm·stat) 17b For binary outcomes, presentation of both absolute and relative effect sizesterm·mth is recommended Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Harmsterm·dom 19 All important harmsterm·dom or unintended effects in each group (for specific guidance see CONSORTterm·mth for harmsterm·dom [28] ) Discussion Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Generalisabilityterm·dom 21 Generalisabilityterm·dom (external validity, applicability) of the trial findings Interpretation 22 Interpretation consistent with results, balancing benefits and harmsterm·dom, and considering other relevant evidence Other information Registration 23 Registration number and name of trial registry Protocolterm·mth 24 Where the full trial protocolterm·mth can be accessed, if available Funding 25 Sources of funding and other support (such as supply of drugs), role of funders *We strongly recommend reading this statement in conjunction with the CONSORTterm·mth 2010date Explanation and Elaborationterm·mth [13] for important clarifications on all the items. If relevant, we also recommend reading CONSORTterm·mth extensions for cluster randomised trialsterm [11] , non-inferiority and equivalence trials [12] , non-pharmacological treatments [32] , herbal interventions [33] , and pragmatic trials [34] . Additional extensions are forthcoming: for those and for up to date references relevant to this checklistterm·mth, see http://www.consort-statement.org . Diligent adherenceterm by authors to the checklistterm·mth items facilitates clarity, completeness, and transparency of reportingterm. Explicit descriptions, not ambiguity or omission, best serve the interests of all readers. Note that the CONSORTterm·mth 2010date 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, CONSORTterm·mth does indirectly affect design and conduct. Transparent reportingterm reveals deficiencies in researchterm if they exist. 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 trial's inadequacies. That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work. Moreover, CONSORTterm·mth can help researchers in designing their trial. Background to CONSORTterm·mth Efforts to improve the reporting of randomised controlled trialsterm·key accelerated in the mid-1990s, spurred partly by methodological research. Researchers had shown for many years that authors reported such trials poorly, and empirical evidenceterm began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias [14] Two initiatives aimed at developing reporting guidelinesterm·mth culminated in one of us (DM) and Drummond Rennie organising the first CONSORTterm·mth statement in 1996. [5] Further methodological research on similar topics reinforced earlier findings [15] and fed into the revision of 2001. [6] , [7] , [8] Subsequently, the expanding body of methodological research informed the refinement of CONSORTterm·mth 2010date. More than 700 studies comprise the CONSORT databaseterm (located on the CONSORTterm·mth website), which provides the empirical evidenceterm to underpin the CONSORTterm·mth initiative. Indeed, CONSORTterm·mth Group members continually monitor the literature. Information gleaned from these efforts provides an evidence baseterm on which to update the CONSORTterm·mth statement. We add, drop, or modify items based on that evidence and the recommendations of the CONSORTterm·mth Group, an international and eclectic group of clinical trialists, statisticians, epidemiologists, and biomedical editors. The CONSORTterm·mth Executive (KFS, DGA, DM) strives for a balance of established and emerging researchers. The membership of the group is dynamic. As our work expands in response to emerging projects and needed expertise, we invite new members to contribute. As such, CONSORTterm·mth continually assimilates new ideas and perspectives. That process informs the continually evolving CONSORTterm·mth statement. Over time, CONSORTterm·mth has garnered much support. More than 400 journals, published around the world and in many languages, have explicitly supported the CONSORTterm·mth statement. Many other healthcare journals support it without our knowledge. Moreover, thousands more have implicitly supported it with the endorsement of the CONSORTterm·mth statement by the International Committee of Medical Journal Editorsterm·dom ( http://www.icmje.org ). Other prominent editorial groups, the Council of Science Editors and the World Association of Medical Editors, officially support CONSORTterm·mth. That support seems warranted: when used by authors and journals, CONSORTterm·mth seems to improve reporting. [9] Development of CONSORTterm·mth 2010date Thirty one members of the CONSORTterm·mth 2010date Group met in Montebello, Canada, in January 2007 to update the 2001 CONSORTterm·mth statement. In addition to the accumulating evidence relating to existing checklistterm·mth items, several new issues had come to prominence since 2001. Some participants were given primary responsibility for aggregating and synthesising the relevant evidence on a particular checklistterm·mth item of interest. Based on that evidence, the group deliberated the value of each item. As in prior CONSORTterm·mth versions, we kept only those items deemed absolutely fundamentalterm to reporting a randomised controlled trialterm·mth. 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 instructions 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 consensusterm on their value cautions against inclusion at this point. The CONSORTterm·mth 2010date Statement thus addresses the minimum criteriaterm, although that should not deter authors from including other information if they consider it important. After the meeting, the CONSORTterm·mth Executive convened teleconferences and meetings to revise the checklistterm·mth. After seven major iterationsterm, a revised checklistterm·mth was distributed to the larger group for feedback. With that feedback, 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 statement. The CONSORTterm·mth Executive then drafted an updated explanation and elaborationterm·mth manuscript, with assistance from other members of the larger group. The substance of the 2007 CONSORTterm·mth meeting provided the material for the update. The updated explanation and elaborationterm·mth manuscript was distributed to the entire group for additions, deletions, and changes. That final iterative process converged to the CONSORTterm·mth 2010date Explanation and Elaborationterm·mth. [13] Changes in CONSORTterm·mth 2010date The revision process resulted in evolutionary, not revolutionary, changesterm to the checklistterm·mth ( Table 1 ), and the flow diagramterm·mth was not modified except for one word ( Figure 1 ). Moreover, because other reporting guidelinesterm·mth augmenting the checklistterm·mth 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, an entirely new item number at the end of the checklistterm·mth, 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 CONSORTterm·mth website contains a side by side comparison of the 2001 and 2010date versions. Box 1. Noteworthy General Changes in CONSORTterm·mth 2010date 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 appraisalterm by breaking some items into sub-items. Many journals expect authors to complete a CONSORTterm·mth checklistterm·mth indicating where in the manuscript the items have been addressed. Experience with the checklistterm·mth noted pragmatic difficulties when an item comprised multiple elementsterm. 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 checklistterm·mth, but might have reported only eligibility in the paper, for example, and not reported the settings and locations. CONSORTterm·mth 2010date relieves obfuscations and forces authors to provide page numbers in the checklistterm·mth for both eligibility and settings. Box 2. Noteworthy Specific Changes in CONSORTterm·mth 2010date Statement Item 1b (title and abstract)— We added a sub-item on providing a structured summary of trial design, methods, results, and conclusions and referenced the CONSORTterm·mth for abstracts article [21] . Item 2b (introduction)— We added a new sub-item (formerly item 5 in CONSORTterm·mth 2001) on “Specific objectives or hypotheses”. Item 3a (trial design)— We added a new item including this sub-item to clarify the basic trial design (such as parallel group, crossover, cluster) and the allocation ratioterm·var. Item 3b (trial design)— We added a new sub-item that addresses any important changes to methods after trial commencementterm, with a discussion of reasons. Item 4 (participants)— Formerly item 3 in CONSORTterm·mth 2001. Item 5 (interventions)— Formerly item 4 in CONSORTterm·mth 2001. We encouraged greater specificity by stating that descriptions of interventions should include “sufficient details to allow replicationterm” [3] . Item 6 (outcomes)— We added a sub-item on identifying any changes to the primary and secondary outcome (endpoint) measures after the trial started. This followed from empirical evidenceterm that authors frequently provide analyses of outcomes in their published papers that were not the prespecified primary and secondary outcomesterm in their protocolsterm·mth, while ignoring their prespecified outcomes (that is, selective outcome reportingterm·dom). [4] , [22] We eliminated text on any methods used to enhance the quality of measurements. Item 9 (allocation concealment mechanismterm·def)— We reworded this to include mechanism in both the report topic and the descriptor to reinforce that authors should report the actual steps taken to ensure allocation concealmentterm rather than simply report imprecise, perhaps banal, assurances of concealmentterm. Item 11 (blindingterm·mth)— We added the specification of how blindingterm·mth was done and, if relevant, a description of the similarity of interventions and procedures. We also eliminated text on “how the success of blindingterm (masking) was assessed” because of a lack of empirical evidenceterm supporting the practice as well as theoretical concerns about the validity of any such assessment [23] , [24] . Item 12a (statistical methods)— We added that statistical methods should also be provided for analysis of secondary outcomes. Sub-item 14b (recruitment)— Based on empirical research, we added a sub-item on “Why the trial ended or was stopped” [25] . Item 15 (baseline data)— We specified “A table” to clarify that baseline and clinical characteristics of each group are most clearly expressed in a table. Item 16 (numbers analysed)— We replaced mention of “intention to treatterm·mth” analysis, a widely misused term, by a more explicit request for information about retaining participants in their original assigned groups [26] . Sub-item 17b (outcomes and estimation)— For appropriate clinical interpretability, prevailing experience suggested the addition of “For binary outcomes, presentation of both relative and absolute effect sizesterm is recommended” [27] . Item 19 (harmsterm·dom)— We included a reference to the CONSORTterm·mth paper on harmsterm·dom [28] . Item 20 (limitations)— We changed the topic from “Interpretation” and supplanted the prior text with a sentence focusing on the reporting of sources of potential bias and imprecision. Item 22 (interpretation)— We changed the topic from “Overall evidence.” Indeed, we understand that authors should be allowed leeway for interpretation under this nebulous heading. However, the CONSORTterm·mth Group expressed concerns that conclusions in papers frequently misrepresented the actual analytical results and that harmsterm·dom were ignored or marginalised. Therefore, we changed the checklistterm·mth item to include the concepts of results matching interpretationsterm and of benefits being balanced with harmsterm. Item 23 (registration)— We added a new item on trial registrationterm·mth. Empirical evidenceterm supports the need for trial registrationterm·mth, and recent requirements by journal editors have fostered compliance [29] . Item 24 (protocolterm·mth)— We added a new item on availability of the trial protocolterm. Empirical evidenceterm suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocolterm·mth. [4] , [22] Hence, availability of the protocolterm·mth can instigate adherence to the protocolterm before publication and facilitate assessment of adherence after publication. Item 25 (funding)— We added a new item on funding. Empirical evidenceterm points toward funding sourceterm sometimes being associated with estimated treatment effectsterm [30] . Implications and Limitations We developed CONSORTterm·mth 2010date to assist authors in writing reports of randomised controlled trialsterm·key, editors and peer reviewers in reviewing manuscripts for publication, and readers in critically appraising published articles. The CONSORTterm·mth 2010date Explanation and Elaborationterm·mth provides elucidation and context to the checklistterm·mth items. We strongly recommend using the explanation and elaborationterm·mth in conjunction with the checklistterm·mth to foster complete, clear, and transparent reportingterm and aid appraisal of published trial reports. CONSORTterm·mth 2010date focuses predominantly on the two group, parallel randomised controlled trialterm·mth, which accounts for over half of trials in the literature. [2] Most of the items from the CONSORTterm·mth 2010date Statement, however, pertain to all types of randomised trials. Nevertheless, some types of trials or trial situations dictate the need for additional informationterm in the trial report. When in doubt, authors, editors, and readers should consult the CONSORTterm·mth website for any CONSORTterm·mth extensions, expansions (amplifications), implementations, or other guidance that may be relevant. The evidence based approach we have used for CONSORTterm·mth also served as a model for development of other reporting guidelinesterm·mth, such as for reporting systematic reviews and meta-analyses of studies evaluating interventions, [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 (EQUATORterm·dom) Network will facilitate development of reporting guidelinesterm·mth and help disseminate the guidelines: http://www.equator-network.org provides information on all reporting guidelinesterm·mth in health research. With CONSORTterm·mth 2010date, we again intentionally declined to produce a rigid structureterm for the reporting of randomised trials. Indeed, SORTterm·mth [19] tried a rigid format, and it failed in a pilot run with an editor and authors. [20] 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 the structure of reporting. Authors should simply address checklistterm·mth 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. CONSORTterm·mth urges completeness, clarity, and transparency of reporting, which simply reflects the actual trial design and conduct. However, as a potential drawbackterm, a reporting guidelineterm·mth might encourage some authors to report fictitiouslyterm the information suggested by the guidance rather than what was actually done. Authors, peer reviewers, and editors should vigilantly guard against that potential drawbackterm and refer, for example, to trial protocolsterm·mth, to information on trial registersterm, and to regulatory agency websites. Moreover, the CONSORTterm·mth 2010date Statement does not include recommendations for designing and conducting randomised trialsterm. 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, CONSORTterm·mth 2010date is not intended as an instrument to evaluate the quality of a trial. Nor is it appropriate to use the checklistterm·mth to construct a “quality scoreterm.” 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 CONSORTterm·mth by journals and editorial groups, most authors should have to report transparently all important aspects of their trial. The ensuing scrutinyterm rewards well conducted trialsterm and penalises poorly conducted trials. Thus, investigators should understand the CONSORTterm·mth 2010date reporting guidelinesterm·mth before starting a trial as a further incentive to design and conduct their trials according to rigorous standards. CONSORTterm·mth 2010date 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 requested otherwise. Journals that do not currently support CONSORTterm·mth may do so by registering on the CONSORTterm·mth website. If a journal supports or endorses CONSORTterm·mth 2010date, it should cite one of the original versions of CONSORTterm·mth 2010date, the CONSORTterm·mth 2010date Explanation and Elaborationterm·mth, and the CONSORTterm·mth website in their “Instructions to authors.” We suggest that authors who wish to cite CONSORTterm·mth should cite this or another of the original journal versions of CONSORTterm·mth 2010date Statement, and, if appropriate, the CONSORTterm·mth 2010date Explanation and Elaborationterm·mth. [13] . All CONSORTterm·mth material can be accessed through the original publishing journals or the CONSORTterm·mth website. Groups or individuals who desire to translate the CONSORTterm·mth 2010date Statement into other languages should first consult the CONSORTterm·mth policy statement on the website. We emphasise that CONSORTterm·mth 2010date represents an evolving guidelineterm. It requires perpetual reappraisalterm and, if necessary, modifications. In the future we will further revise the CONSORTterm·mth material considering comments, criticisms, experiences, and accumulating new evidence. We invite readers to submit recommendations via the CONSORTterm·mth website. Supporting Information Figure S1 Flow diagramterm·mth of the progress through the phases of a parallel randomised trial of two groups (downloadable template document for researchers to re-use). (0.03 MB DOC) Click here for additional data file. Text S1 CONSORTterm·mth 2010date checklistterm·mth of information to include when reporting a randomised trial (downloadable template document for researchers to re-use). (0.11 MB DOC) Click here for additional data file.