standOff. When we have changed our mind. Some entries in the table begin with a word in capitals and the reason for it. EVIDENCE CORRECTED — the finding still stands, but we had quoted the wrong sentence from the paper, and the quotation has been replaced with the right one. RETRACTED — the entry itself was wrong; it stays on the page, marked, with the reason, rather than being deleted. WITHDRAWN AND REPLACED — the entry was wrong, and a corrected version of it appears in the entries below. Each mark carries its own reason, in brackets, because the reasons differ from one entry to the next. An entry we have WITHDRAWN is removed from this page and kept in the record, with its reason. A line reading Audit and a date is a later re-reading of the entry against its whole sentence: DOUBTFUL means it was kept, and the reason says what is loose about it. Quotation marks inside the tagger's sentence. Where a tag is the tagger's own sentence, a phrase in quotation marks inside it is borrowed from the paper — the tagger's wording around it is not. The paper's own sentence is the evidence quote shown on the same row, so the borrowing can be checked against the thing borrowed from without leaving this page. Nothing inside quotation marks anywhere on this page is ours: if it is quoted, it is the paper's. Whose words a concept carries. A concept entry records a term the paper itself uses, so the term, the sense given for it, and its evidence are the paper's own words, quoted where the paper fixes them. This is the opposite of a sense entry in the tag table, which is the tagger's sentence about how the paper uses a term. Where a concept entry could not be grounded in the paper's words, the entry says so on its own row.| second reading | alternatives | an independent re-reading of a facet, recorded whether or not it agrees |
| relation to other work | claim_relations | how this paper stands to another: agrees, contradicts, extends, qualifies |
| claim type | claim_type | the shape of the claim: existence, mechanism, method, critique, prediction, null |
| concept edge | concept_edges | an asserted relation between two concepts, with the sentence asserting it |
| concept | concepts | an idea the paper works with, quoted where the paper uses it |
| content tag | content_tags | a finding, definition, quantity, statistic or variable named in the paper |
| limitation | limitations | what the paper says its evidence cannot support |
| mechanism | mechanisms | how the reported effect is said to come about |
| method | method | how the paper produced its evidence |
| object of study | object_of_study | what the paper is about — the thing it investigates |
| phenomenon | phenomenon | the effect or regularity under study |
| sense | senses | a distinct use of a term, quoted where the paper fixes it |
| transfer | transfers | a method or concept carried in from another field |
| unrecordable relation | unhoused_relations | a relation the paper asserts that this vocabulary cannot express, with the reason |
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 Schulz and colleagues describe the 2010 version of the CONSORT Statement, which updates the previous reporting guideline based on new methodological evidence and accumulated experience. Introduction transfersconcepts↗concepts↗concepts↗concepts↗concepts↗sensesconcept_edgesRandomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. alternativesHowever, content_tagsrandomised trials can yield biased results if they lack methodological rigour [1] . object_of_studyTo 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] . claim_relationsclaim_relationsThat lack of adequate reporting fuelled the development of content_tags↗content_tags↗the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6] , [7] , [8] . limitationscontent_tagsWhile 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. claim_relationsConsequently, we organised a CONSORT Group meeting to update the 2001 statement [6] , [7] , [8] . We introduce here the result of that process, CONSORT 2010. Intent of CONSORT 2010 claim_typeconcepts↗concepts↗sensessensesconcept_edgescontent_tagscontent_tagsThe 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↗concepts↗concepts↗sensesOther trial designs, such as cluster randomised trials and non-inferiority trials, require varying amounts of additional information. CONSORT extensions for these designs, [11] , [12] and other CONSORT products, can be found through the CONSORT website ( http://www.consort-statement.org ). concepts↗sensesconcept_edgesAlong 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. 10.1371/journal.pmed.1000251.g001 Figure 1 Flow diagram of the progress through the phases of a parallel randomised trial of two groups (that is, enrolment, intervention allocation, follow-up, and data analysis). (For a downloadable version of this diagram see Figure S1 or the CONSORT website.) 10.1371/journal.pmed.1000251.t001 Table 1 CONSORT 2010 checklist of information to include when reporting a randomised trial (for a downloadable version of this checklist see Text S1 or the CONSORT website). * Section/Topic Item No Checklist 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 CONSORT for abstracts [21] , [31] ) Introduction Background and objectives 2a Scientific background and explanation of rationale 2b Specific objectives or hypotheses Methods Trial design 3a content_tags↗Description of trial design (such as parallel, factorial) including allocation ratio 3b Important changes to methods after trial commencement (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 replication, 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 size 7a content_tags↗content_tags↗How sample size was determined 7b When applicable, explanation of any interim analyses and stopping guidelines Randomisation: Sequence generation 8a Method used to generate the random allocation sequence 8b Type of randomisation; details of any restriction (such as blocking and block size) Allocation concealment mechanism 9 content_tags↗Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), content_tags↗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 Blinding 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 randomisation, 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 content_tags↗For each primary and secondary outcome, results for each group, and content_tags↗the estimated effect size and its precision (such as 95% confidence interval) 17b content_tags↗For binary outcomes, presentation of both absolute and relative effect sizes is recommended Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms [28] ) Discussion Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Generalisability 21 Generalisability (external validity, applicability) of the trial findings Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Other information Registration 23 Registration number and name of trial registry Protocol 24 Where the full trial protocol 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 CONSORT 2010 Explanation and Elaboration [13] for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials [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 checklist, see http://www.consort-statement.org . concepts↗concepts↗concepts↗concepts↗unhoused_relationssensesconcept_edgesDiligent 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 limitationsdoes not include recommendations for designing, conducting, and analysing trials. content_tagsIt 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. Moreover, CONSORT can help researchers in designing their trial. Background to CONSORT phenomenonconcepts↗concepts↗concepts↗unhoused_relationssensesEfforts 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. mechanismscontent_tagscontent_tagsMore 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. We add, drop, or modify items based on that evidence and the recommendations of the CONSORT Group, an international and eclectic group of clinical trialists, statisticians, epidemiologists, and biomedical editors. The CONSORT Executive (KFS, DGA, DM) strives for a balance of established and emerging researchers. The membership 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, CONSORT continually assimilates new ideas and perspectives. That process informs the continually evolving CONSORT statement. Over time, CONSORT has garnered much support. content_tagscontent_tagscontent_tagsMore than 400 journals, published around the world and in many languages, have explicitly supported the CONSORT statement. Many other healthcare journals support it without our knowledge. concept_edgesMoreover, 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 ). Other prominent editorial groups, the Council of Science Editors and the World Association of Medical Editors, officially support CONSORT. That support seems warranted: content_tagswhen used by authors and journals, CONSORT seems to improve reporting. [9] Development of CONSORT 2010 method↗concepts↗concepts↗concepts↗sensessensescontent_tagscontent_tagsThirty 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. limitationsMoreover, 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. mechanismsOther 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. limitationsThe CONSORT 2010 Statement thus addresses the minimum criteria, although that should not deter authors from including other information if they consider it important. concepts↗sensesAfter the meeting, the CONSORT Executive convened teleconferences and meetings to revise the checklist. content_tagscontent_tagsAfter 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. [13] Changes in CONSORT 2010 limitationsconcepts↗sensesThe 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 ). mechanismsMoreover, 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. Box 1. Noteworthy General Changes in CONSORT 2010 Statement We simplified and clarified the wording, such as in items 1, 8, 10, 13, 15, 16, 18, 19, and 21. We improved consistency of style across the items by removing the imperative verbs that were in the 2001 version. concepts↗concepts↗unhoused_relationssensesWe 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. mechanismsCONSORT 2010 relieves obfuscations and forces authors to provide page numbers in the checklist for both eligibility and settings. Box 2. Noteworthy Specific Changes in CONSORT 2010 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 CONSORT for abstracts article [21] . Item 2b (introduction)— We added a new sub-item (formerly item 5 in CONSORT 2001) on “Specific objectives or hypotheses”. concepts↗concepts↗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↗Item 6 (outcomes)— We added a sub-item on identifying any changes to the primary and secondary outcome (endpoint) measures after the trial started. content_tagsThis followed from empirical evidence that content_tags↗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). [4] , [22] We eliminated text on any methods used to enhance the quality of measurements. concepts↗concepts↗sensesItem 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↗sensesItem 11 (blinding)— We added the specification of how blinding was done and, if relevant, a description of the similarity of interventions and procedures. content_tagsWe 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] . 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)— mechanismsconcepts↗sensesWe replaced mention of content_tags↗“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↗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” [27] . Item 19 (harms)— We included a reference to the CONSORT paper on harms [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. concepts↗concepts↗sensesItem 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↗concepts↗concepts↗concepts↗unhoused_relationsunhoused_relationsItem 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. content_tagsItem 25 (funding)— We added a new item on funding. Empirical evidence points toward content_tags↗funding source sometimes being associated with estimated treatment effects [30] . Implications and Limitations sensesWe 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. limitationslimitationscontent_tagsCONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature. [2] Most of the items from the CONSORT 2010 Statement, however, pertain to all types of randomised trials. Nevertheless, some types of trials or trial situations dictate the need for additional information in the trial report. When in doubt, authors, editors, and readers should consult the CONSORT website for any CONSORT extensions, expansions (amplifications), implementations, or other guidance that may be relevant. claim_relationsconcept_edgesThe 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] The explicit goal of all these initiatives is to improve reporting. content_tags↗The Enhancing the Quality and Transparency of Health Research (EQUATOR) Network will facilitate development of reporting guidelines and help disseminate the guidelines: http://www.equator-network.org provides information on all reporting guidelines in health research. concepts↗sensessensesWith CONSORT 2010, we again intentionally declined to produce a rigid structure for the reporting of randomised trials. mechanismsclaim_relationsconcept_edgesIndeed, 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. sensesAuthors 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↗concepts↗concepts↗unhoused_relationssensesCONSORT urges completeness, clarity, and transparency of reporting, which simply reflects the actual trial design and conduct. limitationsHowever, 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. limitationsconcepts↗concepts↗concepts↗concepts↗unhoused_relationssensesconcept_edgesconcept_edgesMoreover, 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. limitationsThus, CONSORT 2010 is not intended as an instrument to evaluate the quality of a trial. content_tagsNor 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. claim_relationsCONSORT 2010 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 CONSORT may do so by registering on the CONSORT website. If a journal supports or endorses CONSORT 2010, it should cite one of the original versions of CONSORT 2010, the CONSORT 2010 Explanation and Elaboration, and the CONSORT website in their “Instructions to authors.” We suggest that authors who wish to cite CONSORT should cite this or another of the original journal versions of CONSORT 2010 Statement, and, if appropriate, the CONSORT 2010 Explanation and Elaboration. [13] . All CONSORT material can be accessed through the original publishing journals or the CONSORT website. Groups or individuals who desire to translate the CONSORT 2010 Statement into other languages should first consult the CONSORT policy statement on the website. concepts↗concepts↗unhoused_relationssensesWe 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. Supporting Information Figure S1 Flow diagram 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 CONSORT 2010 checklist 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.
Relations on this page carry a quotation for the claim. Where a relation was separately evidenced — and so tested against the vocabulary for its type — the row says so; 4 of 9 relations here carry that mark. The rest are the tagger’s reading of the sentence quoted beside them.
This record holds no controls. A layer is empty when the tagger recorded nothing in it — which is not the same as the paper having nothing to record.
| facet | tag | field | conf. | whose words |
|---|---|---|---|---|
| object_of_study | How randomised controlled trials should be reported, and what changed in the 2010 revision of the standard. | object_of_study | the paper's words | |
| claim_type | method | claim_type | the paper's words | |
| phenomenon | reporting of randomised controlled trials | phenomenon | the paper's words | |
| method | expert-consensus also in: expert-consensus | method | the paper's words | |
| mechanisms | Item numbers were deliberately preserved through the revision because other guidelines point at them - identifiers must be stable when other things reference them | mechanisms[0] | the tagger's words | |
| mechanisms | Items are admitted or dropped on empirical evidence about whether the practice affects bias, not on what seems desirable | mechanisms[1] | the tagger's words | |
| mechanisms | 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 | mechanisms[2] | the tagger's words | |
| mechanisms | A misused term was replaced by a description of the thing it was supposed to denote, rather than being redefined | mechanisms[3] | the tagger's words | |
| mechanisms | The standard governs content and explicitly not form, because a rigid format was tried and failed | mechanisms[4] | the tagger's words | |
| mechanisms | An ongoing database of methodological studies supplies the evidence for each revision, so the guideline updates from accumulating research rather than from opinion | mechanisms[5] | the tagger's words | |
| limitations | CONSORT covers reporting only, not the design, conduct, or analysis of trials what this limits: everything outside reporting: the statement DOES NOT INCLUDE RECOMMENDATIONS FOR DESIGNING, CONDUCTING and analysing trials | limitations[0] | the tagger's words | |
| limitations | A reporting guideline may induce some authors to report what the guideline asks for rather than what they actually did. what this limits: 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 | limitations[1] | the tagger's words | |
| limitations | The statement covers reporting only and gives no guidance on how trials should be designed or conducted. what this limits: the same scope as limitations[0] - reporting only, not design or conduct | limitations[2] | the tagger's words | |
| limitations | The checklist is not a trial-quality appraisal instrument and must not be turned into a quality score. what this limits: 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 | limitations[3] | the tagger's words | |
| limitations | Scope is restricted mainly to the two-group parallel design; other designs need extensions. what this limits: 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 | limitations[4] | the tagger's words | |
| limitations | Built for the two-group parallel trial, with other designs needing extensions duplicate of: limitations[4] · what this limits: the same scope as limitations[4] - other designs need published extensions | limitations[5] | the tagger's words | |
| limitations | The checklist is a minimum, not a description of good reporting what this limits: 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 | limitations[6] | the tagger's words | |
| limitations | Items fundamental to a trial may still be absent from the checklist if another mechanism already enforces them what this limits: 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 | limitations[7] | the tagger's words | |
| limitations | Two revisions on from 1996 and reporting remains inadequate in many trials what this limits: 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 | limitations[8] | the tagger's words | |
| limitations | The revision is described as evolutionary rather than revolutionary, so it inherits whatever the earlier versions got wrong what this limits: 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 | limitations[9] | the tagger's words | |
| transfers | the randomized controlled trial methodology (randomization / experimental design from statistics) as the gold standard for evaluating medical interventions | transfers[0] | the tagger's words | |
| concepts | intention to treat also in: intention to treat | concepts[9] | 0.95 | the paper's words |
| concepts | gold standard also in: gold standard | concepts[21] | 0.95 | the paper's words |
| concepts | lack methodological rigour also in: lack methodological rigour | concepts[22] | 0.95 | the paper's words |
| concepts | biased results also in: biased results | concepts[23] | 0.95 | the paper's words |
| concepts | complete, clear, and transparent information | concepts[24] | 0.95 | the paper's words |
| concepts | reporting quality also in: reporting quality | concepts[25] | 0.95 | the paper's words |
| concepts | 25 item checklist also in: 25 item checklist | concepts[26] | 0.95 | the paper's words |
| concepts | individually randomised, two group, parallel trials | concepts[27] | 0.95 | the paper's words |
| concepts | cluster randomised trials also in: cluster randomised trials | concepts[28] | 0.95 | the paper's words |
| concepts | non-inferiority trials also in: non-inferiority trials | concepts[29] | 0.95 | the paper's words |
| concepts | additional information also in: additional information | concepts[30] | 0.95 | the paper's words |
| concepts | published examples of transparent reporting | concepts[31] | 0.95 | the paper's words |
| concepts | Diligent adherence also in: Diligent adherence | concepts[32] | 0.95 | the paper's words |
| concepts | clarity, completeness, and transparency of reporting | concepts[33] | 0.95 | the paper's words |
| concepts | Transparent reporting also in: Transparent reporting | concepts[34] | 0.95 | the paper's words |
| concepts | deficiencies in research also in: deficiencies in research | concepts[35] | 0.95 | the paper's words |
| concepts | CONSORT database also in: CONSORT database | concepts[36] | 0.95 | the paper's words |
| concepts | empirical evidence also in: empirical evidence | concepts[37] | 0.95 | the paper's words |
| concepts | evidence base also in: evidence base | concepts[38] | 0.95 | the paper's words |
| concepts | items deemed absolutely fundamental also in: items deemed absolutely fundamental | concepts[39] | 0.95 | the paper's words |
| concepts | minimum criteria also in: minimum criteria | concepts[40] | 0.95 | the paper's words |
| concepts | lack of empirical evidence or any consensus | concepts[41] | 0.95 | the paper's words |
| concepts | seven major iterations also in: seven major iterations | concepts[42] | 0.95 | the paper's words |
| concepts | evolutionary, not revolutionary, changes | concepts[43] | 0.95 | the paper's words |
| concepts | specificity of appraisal also in: specificity of appraisal | concepts[44] | 0.95 | the paper's words |
| concepts | multiple elements also in: multiple elements | concepts[45] | 0.95 | the paper's words |
| concepts | important changes to methods after trial commencement | concepts[46] | 0.95 | the paper's words |
| concepts | sufficient details to allow replication | concepts[47] | 0.95 | the paper's words |
| concepts | prespecified primary and secondary outcomes | concepts[48] | 0.95 | the paper's words |
| concepts | actual steps taken to ensure allocation concealment | concepts[49] | 0.95 | the paper's words |
| concepts | assurances of concealment also in: assurances of concealment | concepts[50] | 0.95 | the paper's words |
| concepts | success of blinding also in: success of blinding | concepts[51] | 0.95 | the paper's words |
| concepts | relative and absolute effect sizes also in: relative and absolute effect sizes | concepts[52] | 0.95 | the paper's words |
| concepts | results matching interpretations also in: results matching interpretations | concepts[53] | 0.95 | the paper's words |
| concepts | benefits being balanced with harms also in: benefits being balanced with harms | concepts[54] | 0.95 | the paper's words |
| concepts | availability of the trial protocol also in: availability of the trial protocol | concepts[55] | 0.95 | the paper's words |
| concepts | adherence to the protocol also in: adherence to the protocol | concepts[56] | 0.95 | the paper's words |
| concepts | funding source also in: funding source | concepts[57] | 0.95 | the paper's words |
| concepts | estimated treatment effects also in: estimated treatment effects | concepts[58] | 0.95 | the paper's words |
| concepts | rigid structure also in: rigid structure | concepts[59] | 0.95 | the paper's words |
| concepts | potential drawback also in: potential drawback | concepts[60] | 0.95 | the paper's words |
| concepts | report fictitiously also in: report fictitiously | concepts[61] | 0.95 | the paper's words |
| concepts | trial registers also in: trial registers | concepts[62] | 0.95 | the paper's words |
| concepts | designing and conducting randomised trials | concepts[63] | 0.95 | the paper's words |
| concepts | quality score also in: quality score | concepts[64] | 0.95 | the paper's words |
| concepts | ensuing scrutiny also in: ensuing scrutiny | concepts[65] | 0.95 | the paper's words |
| concepts | well conducted trials also in: well conducted trials | concepts[66] | 0.95 | the paper's words |
| concepts | evolving guideline also in: evolving guideline | concepts[67] | 0.95 | the paper's words |
| concepts | perpetual reappraisal also in: perpetual reappraisal | concepts[68] | 0.95 | the paper's words |
| unhoused_relations | Transparent reporting → deficiencies in research Transparent reporting reveals research deficiencies; exposes is absent from the eight relation types. | unhoused_relations[0] | 0.95 | the tagger's words |
| unhoused_relations | CONSORT database → evidence base The CONSORT database provides the evidence base for statement updates; provides-basis-for is absent from the governed types. | unhoused_relations[1] | 0.95 | the tagger's words |
| unhoused_relations | specificity of appraisal → multiple elements Breaking multi-element items into sub-items enhances appraisal specificity; improves-through-splitting is absent from the eight types. | unhoused_relations[2] | 0.95 | the tagger's words |
| unhoused_relations | 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. | unhoused_relations[3] | 0.95 | the tagger's words |
| unhoused_relations | funding source → estimated treatment effects Funding source is sometimes associated with estimated treatment effects; associated-with is absent from the eight types. | unhoused_relations[4] | 0.95 | the tagger's words |
| unhoused_relations | 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. | unhoused_relations[5] | 0.95 | the tagger's words |
| unhoused_relations | ensuing scrutiny → well conducted trials Scrutiny rewards well-conducted trials and penalizes poorly conducted ones; rewards/penalizes is absent from the edge registry. | unhoused_relations[6] | 0.95 | the tagger's words |
| unhoused_relations | evolving guideline → perpetual reappraisal An evolving guideline requires perpetual reappraisal; requires is absent from the eight types. | unhoused_relations[7] | 0.95 | the tagger's words |
| senses | CONSORT - the 2001 version: the previous statement, whose item numbers survive into the new one | senses[0] | 1.0 | the tagger's words |
| senses | CONSORT - the 2010 version: this paper plus its 25-item checklist and flow diagram, the three together being the statement | senses[1] | 1.0 | the tagger's words |
| senses | the standard - as governing CONTENT: what must be addressed somewhere in the article | senses[2] | 1.0 | the tagger's words |
| senses | the standard - as NOT governing FORM: the group explicitly declines to prescribe structure, citing a rigid format that failed | senses[3] | 1.0 | the tagger's words |
| senses | intention to treat - the term, withdrawn from the checklist because practitioners use it for different things | senses[4] | 1.0 | the tagger's words |
| senses | Randomized controlled trial as gold standard - only when design, conduct, and reporting are all appropriate | senses[5] | 0.95 | the tagger's words |
| senses | CONSORT 2010 core scope - 25-item checklist plus flow diagram, focused on individually randomized two-group parallel trials | senses[6] | 0.95 | the tagger's words |
| senses | CONSORT extension - additional information required for cluster and non-inferiority designs | senses[7] | 0.95 | the tagger's words |
| senses | Explanation and Elaboration - item rationale, methodological background, and published reporting exemplars | senses[8] | 0.95 | the tagger's words |
| senses | Checklist adherence - explicit reporting improves clarity and exposes research deficiencies without directly prescribing conduct | senses[9] | 0.95 | the tagger's words |
| senses | CONSORT evidence base - a monitored database of more than 700 methodological studies used for updates | senses[10] | 0.95 | the tagger's words |
| senses | Minimum criteria - only absolutely fundamental reporting items, with exclusions when evidence or consensus is lacking | senses[11] | 0.95 | the tagger's words |
| senses | Consensus iteration - seven major checklist revisions followed by larger-group feedback and explanation-document convergence | senses[12] | 0.95 | the tagger's words |
| senses | Evolutionary revision - wording, style, specificity, and sub-items changed while the checklist lineage remained stable | senses[13] | 0.95 | the tagger's words |
| senses | Sub-item specificity - separate page locations prevent one reported element from hiding another omitted element | senses[14] | 0.95 | the tagger's words |
| senses | Allocation concealment reporting - actual implementation steps rather than generic assurances | senses[15] | 0.95 | the tagger's words |
| senses | Blinding assessment - report how blinding was done, but do not require an unsupported success test | senses[16] | 0.95 | the tagger's words |
| senses | Interpretation discipline - conclusions should match results and balance benefits against harms | senses[17] | 0.95 | the tagger's words |
| senses | CONSORT audience - authors, editors, reviewers, and readers using the checklist with its Explanation and Elaboration | senses[18] | 0.95 | the tagger's words |
| senses | Content without rigid form - address every item with detail while retaining journal and field structure | senses[19] | 0.95 | the tagger's words |
| senses | Reporting-guideline gaming - guidance can elicit fictitious compliance, checked against protocols, registers, and regulators | senses[20] | 0.95 | the tagger's words |
| senses | Reporting versus trial quality - CONSORT elicits disclosure but is neither a design prescription nor a quality-score instrument | senses[21] | 0.95 | the tagger's words |
| senses | Evolving CONSORT - perpetual reappraisal from criticism, experience, and accumulating evidence | senses[22] | 0.95 | the tagger's words |
| alternatives | phenomenon: reporting of randomised controlled trials a second reading reaching the same value. Recorded: reporting of randomised controlled trials — note: a second reading reaching the same value from a different sentence. Not applied - a person decides. | alternatives.phenomenon | the tagger's words | |
| claim_relations | extends → CONSORT 2001 statement | claim_relations[1] | the tagger's words | |
| claim_relations | builds-on → original 1996 CONSORT (Consolidated Standards of Reporting Trials) statement and its 2001 revision | claim_relations[2] | the tagger's words | |
| claim_relations | extends → the 2001 CONSORT statement, which this revises and replaces | claim_relations[3] | the tagger's words | |
| claim_relations | extends → the original 1996 CONSORT statement | claim_relations[4] | the tagger's words | |
| claim_relations | supports → the reporting guidelines for systematic reviews, diagnostic and observational studies that took CONSORT as their model | claim_relations[5] | the tagger's words | |
| claim_relations | critiques → SORT, the rigid-format reporting attempt | claim_relations[6] | the tagger's words | |
| concept_edges | CONSORT —operationalised-as→ checklist strength of the relation: 1 | concept_edges[0] | the tagger's words | |
| concept_edges | CONSORT —is-a→ reporting guidelines strength of the relation: 1 also in: CONSORT · reporting guidelines | concept_edges[2] | the tagger's words | |
| concept_edges | CONSORT —contrasted-with→ SORT strength of the relation: 1
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. | concept_edges[3] | the tagger's words | |
| concept_edges | explanation and elaboration —part-of→ CONSORT strength of the relation: 1 also in: explanation and elaboration · CONSORT | concept_edges[4] | the tagger's words | |
| concept_edges | International Committee of Medical Journal Editors —causes→ CONSORT strength of the relation: 0.9
Audit 2026-09-28: DOUBTFUL - read against its span and kept, but the committee ENDORSED CONSORT; causes is the wrong type for an endorsement. | concept_edges[11] | the tagger's words | |
| concept_edges | lack methodological rigour —causes→ biased results the relation itself is separately evidenced · strength of the relation: 1 · note: The paper directly says trials can yield biased results if they lack methodological rigor. also in: lack methodological rigour · biased results | concept_edges[14] | 0.95 | the tagger's words |
| concept_edges | Diligent adherence —causes→ clarity, completeness, and transparency of reporting the relation itself is separately evidenced · strength of the relation: 1 · note: Checklist adherence is stated to facilitate reporting clarity, completeness, and transparency. | concept_edges[15] | 0.95 | the tagger's words |
| concept_edges | CONSORT —distinct-from→ designing and conducting randomised trials the relation itself is separately evidenced · strength of the relation: 1 · note: CONSORT explicitly excludes recommendations for designing and conducting trials. | concept_edges[16] | 0.95 | the tagger's words |
| concept_edges | checklist —distinct-from→ quality score the relation itself is separately evidenced · strength of the relation: 1 · note: The paper explicitly says the checklist is not appropriate for constructing a quality score. also in: checklist · quality score | concept_edges[17] | 0.95 | the tagger's words |
| content_tags | 25 — size of the CONSORT reporting checklist | content_tags.quantities[0] | the tagger's words | |
| content_tags | 700 — empirical studies underpinning the guideline | content_tags.quantities[1] | the tagger's words | |
| content_tags | 400 — journals explicitly endorsing the statement | content_tags.quantities[2] | the tagger's words | |
| content_tags | 31 — group members who met to update the statement | content_tags.quantities[3] | the tagger's words | |
| content_tags | 7 — revision rounds before distribution | content_tags.quantities[4] | the tagger's words | |
| content_tags | 25 item checklist — the size of the 2010 instrument | content_tags.quantities[5] | the tagger's words | |
| content_tags | Thirty one members — the size of the 2007 revision meeting | content_tags.quantities[6] | the tagger's words | |
| content_tags | More than 700 studies — the methodological evidence base underpinning the revisions | content_tags.quantities[7] | the tagger's words | |
| content_tags | More than 400 journals — explicit institutional uptake | content_tags.quantities[8] | the tagger's words | |
| content_tags | seven major iterations — how many drafts the checklist went through after the meeting | content_tags.quantities[9] | the tagger's words | |
| content_tags | over half of trials — share of the literature using the two-group parallel design the standard targets | content_tags.quantities[10] | the tagger's words | |
| content_tags | trials lacking methodological rigour can yield biased results | content_tags.findings[0] | the tagger's words | |
| content_tags | CONSORT adoption appears to improve reporting quality | content_tags.findings[1] | the tagger's words | |
| content_tags | the statement governs reporting only, not trial design or conduct | content_tags.findings[2] | the tagger's words | |
| content_tags | the checklist must not be turned into a trial quality score about this quote: 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] | the tagger's words | |
| content_tags | those statements improved reporting quality for some randomised trials, yet many trial reports still remain inadequate | content_tags.findings[4] | the tagger's words | |
| content_tags | authors frequently analyse outcomes that were not their pre-specified ones while ignoring those that were | content_tags.findings[5] | the tagger's words | |
| content_tags | assessment of blinding success was dropped for lack of evidence that it works | content_tags.findings[6] | the tagger's words | |
| content_tags | funding source is sometimes associated with the estimated treatment effect, which is why funding became an item | content_tags.findings[7] | the tagger's words | |
| content_tags | more than 400 journals have explicitly supported the CONSORT statement | content_tags.findings[8] | the tagger's words | |
| content_tags | allocation ratio also in: allocation ratio | content_tags.variables[0] | the tagger's words | |
| content_tags | sample size also in: sample size | content_tags.variables[1] | the tagger's words | |
| content_tags | effect size also in: effect size | content_tags.variables[2] | the tagger's words | |
| content_tags | funding source also in: funding source | content_tags.variables[3] | the tagger's words | |
| content_tags | CONSORT also in: CONSORT | content_tags.definitions[0] | the tagger's words | |
| content_tags | allocation concealment also in: allocation concealment | content_tags.definitions[1] | the tagger's words | |
| content_tags | intention to treat about this quote: 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. also in: intention to treat | content_tags.definitions[2] | the tagger's words | |
| content_tags | CONSORT also in: CONSORT | content_tags.definitions[4] | the tagger's words | |
| content_tags | selective outcome reporting also in: selective outcome reporting | content_tags.definitions[5] | the tagger's words | |
| content_tags | allocation concealment mechanism also in: allocation concealment mechanism | content_tags.definitions[6] | the tagger's words | |
| content_tags | EQUATOR also in: EQUATOR | content_tags.definitions[7] | the tagger's words | |
| content_tags | confidence-interval also in: confidence-interval | content_tags.statistics[0] | the tagger's words | |
| content_tags | effect-size also in: effect-size | content_tags.statistics[1] | the tagger's words | |
| content_tags | sample-size also in: sample-size | content_tags.statistics[2] | the tagger's words |
Tags that could not be placed in the text:
What was deliberately not tagged, and why, is recorded per paper by the tagger. Where a paper has no such record, this page says so rather than implying that nothing was declined.