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Year : 2019  |  Volume : 10  |  Issue : 4  |  Page : 145-147

The CONSORT statement and its impact on quality of reporting of trials

Department of Anaesthesiology, Tata Memorial Centre, Mumbai, Maharashtra, India

Date of Web Publication9-Oct-2019

Correspondence Address:
Dr. Priya Ranganathan
Department of Anaesthesiology, Tata Memorial Centre, Ernest Borges Road, Parel, Mumbai - 400 012, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.PICR_143_19

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How to cite this article:
Ranganathan P. The CONSORT statement and its impact on quality of reporting of trials. Perspect Clin Res 2019;10:145-7

How to cite this URL:
Ranganathan P. The CONSORT statement and its impact on quality of reporting of trials. Perspect Clin Res [serial online] 2019 [cited 2021 May 9];10:145-7. Available from: https://www.picronline.org/text.asp?2019/10/4/145/268717

A well-designed and adequately powered randomized controlled trial (RCT) is considered the gold standard for evaluating the efficacy of new treatments. However, in addition to good science and methodology, proper reporting of RCTs is essential to allow readers to appraise the validity of trial findings. Reporting of RCTs is facilitated by guidelines such as the Consolidated Statement of Reporting Trials (CONSORT).[1] The CONSORT checklist for reporting trials serves as a template for authors, reviewers, and editors to ensure uniformity and enhance the quality of reporting of trials.

One element of the CONSORT checklist is the flow diagram, which describes the flow of participants through the different phases of a trial, i.e., assessment for eligibility, enrolment, allocation of intervention, follow-up, and data analysis. This information is crucial to determine the validity of the trial results. The number of participants eligible for the trial tells the reader about the generalizability of the results (external validity). The number of participants available at each stage during the trial ensures that the exclusion of participants at any stage of the trial is unbiased (internal validity). A study by Egger et al. showed that the use of a flow diagram was associated with improved overall completeness of reporting of flow of participants in a study.[2]

In this journal, Shaikh et al. compare the reporting of CONSORT flow diagrams in RCTs in a national and an international pharmacology journal.[3] Despite both journals mandating the use of the CONSORT guidelines, they found that fewer RCTs published in the Indian journal included the CONSORT flow diagram; even among studies that included the flow diagram, adherence to some items was incomplete.

The results of Shaikh et al.'s study are comparable to several other studies. As far back as 1998, Egger et al. showed that there was wide variation in the reporting of flow diagrams in RCTs published in six major journals.[2] Toerien et al., in a review of 133 RCTs published in 2004, found that post-randomization data was reported adequately, but information regarding participant eligibility was poor.[4] Hopewell et al. found that only 56% of RCTs published in core clinical journals on PubMed in 2009 included a flow diagram.[5] However, the studies by Shaikh et al. and Hopewell et al. were limited by the fact that they focused on the use of flow diagrams and did not look at whether the same data were reported in the text or tables (which is an acceptable alternative as per the CONSORT checklist).

How did the concept of guidelines for reporting of studies begin? In the 1990s, two publications highlighted the sub-optimal quality of reporting of trials.[6],[7] At the same time, expert committees consisting of editors and trialists came up with checklists of recommended items for improving uniformity in the reporting of trials.[8],[9] Subsequently, these two initiatives were combined to form the CONSORT statement.[10] The CONSORT statement was first described in 1996 and then revised in 2001 and 2010. Since then, the CONSORT statement has progressed to include extensions for different types of studies and translations in various languages.[10] Studies done across the world in several fields of medicine have examined adherence to CONSORT and have found that the adoption of the guidelines has resulted in better quality of reporting of trials.[11],[12],[13],[14] However, there is scope for further improvement as, despite the availability of the guidelines, reporting has been shown to be incomplete.[13],[14]

Does journal endorsement of CONSORT affect the quality of reporting of trials? Currently, 585 journals have endorsed the use of the CONSORT statement.[10] Both the journals chosen in Shaikh et al.'s paper recommended the use of the CONSORT statement in their instructions to authors; however, despite this endorsement, reporting was less than ideal. Hopewell et al. found that there was a large difference in the reporting of the participant flow diagram between trials published in journals that endorsed and did not endorse the CONSORT statement (62% versus 29%); however, it is interesting to note that even in the journals that endorsed the use of the CONSORT statement, reporting was not complete.[5] Stevens et al. looked at whether journal endorsement of various reporting guidelines (excluding CONSORT) impacted adherence to reporting; they found inadequate evidence to suggest that journal endorsement of a reporting guideline improved the quality of reporting.[15]

Why is it that despite journal endorsement of reporting guidelines, studies continue to be poorly reported?First, many “CONSORT-endorsing” journals do not provide specific instructions to authors and only offer general recommendations for the reporting of studies.[16],[17],[18] Second, many journals mandate the inclusion of a CONSORT checklist at the time of manuscript submission; however, it has been shown that authors often use the wrong checklist extension and that there are discrepancies between the checklist and the actual manuscript.[19] Third, editorial staff and reviewers are not well informed regarding research methods and appropriate reporting guidelines for different types of studies. Cobo and González showed that one-third of manuscripts classified as trials by editorial staff were actually not trials.[20] In a study by Hirst and Altman, it was seen that reviewers had inadequate guidance regarding the use of checklists and guidelines.[21]

What can be done to improve this? Journals should be more exact in their submission requirements and provide explicit directives to authors, including details of specific CONSORT extensions for various types of studies.[16],[17],[18] Items such as the CONSORT flow diagram that are considered crucial elements of reporting can be made mandatory at the time of manuscript submission. Hopewell et al. have suggested the use of web-based programs to make it easier for authors to generate CONSORT-specific diagrams and charts.[16] Further, the onus of adhering to reporting guidelines should not rest with authors alone; editorial staff and reviewers need to be trained to actively promote the use of appropriate checklists for reporting studies. It will take a combined and concerted effort by everyone involved in the process of publication of biomedical research reports to enable such guidelines to achieve their objective of complete and transparent reporting.

   References Top

Schulz KF, Altman DG, Moher D; For the CONSORT Group. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. BMC Med 2010;8:18.  Back to cited text no. 1
Egger M, Jüni P, Bartlett C; CONSORT Group (Consolidated Standards of Reporting of Trials). Value of flow diagrams in reports of randomized controlled trials. JAMA 2001;285:1996-9.  Back to cited text no. 2
Shaikh AM, Mehta MM, Chawan VV. Evaluation of reporting of CONSORT flow diagrams in randomized controlled trials in a national and international pharmacology journal. Perspect Clin Res 2019;10:168-71.  Back to cited text no. 3
  [Full text]  
Toerien M, Brookes ST, Metcalfe C, de Salis I, Tomlin Z, Peters TJ, et al. Areview of reporting of participant recruitment and retention in RCTs in six major journals. Trials 2009;10:52.  Back to cited text no. 4
Hopewell S, Hirst A, Collins GS, Mallett S, Yu LM, Altman DG. Reporting of participant flow diagrams in published reports of randomized trials. Trials 2011;12:253.  Back to cited text no. 5
Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med 1987;317:426-32.  Back to cited text no. 6
Altman DG, Doré CJ. Randomisation and baseline comparisons in clinical trials. Lancet 1990;335:149-53.  Back to cited text no. 7
A proposal for structured reporting of randomized controlled trials. The standards of reporting trials group. JAMA 1994;272:1926-31.  Back to cited text no. 8
Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working group on recommendations for reporting of clinical trials in the biomedical literature. Ann Intern Med 1994;121:894-5.  Back to cited text no. 9
The CONSORT Group. The CONSORT Statement. Available from: http://www.consort-statement.org/. [Last accessed on 2019 Sep 08].  Back to cited text no. 10
Moher D, Jones A, Lepage L; CONSORT Group (Consolidated Standards for Reporting of Trials). Use of the CONSORT statement and quality of reports of randomized trials: A comparative before-and-after evaluation. JAMA 2001;285:1992-5.  Back to cited text no. 11
Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust 2006;185:263-7.  Back to cited text no. 12
Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: Comparative study of articles indexed in PubMed. BMJ 2010;340:c723.  Back to cited text no. 13
Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of the CONSORT statement impact the completeness of reporting of randomised controlled trials published in medical journals? A cochrane review. Syst Rev 2012;1:60.  Back to cited text no. 14
Stevens A, Shamseer L, Weinstein E, Yazdi F, Turner L, Thielman J, et al. Relation of completeness of reporting of health research to journals' endorsement of reporting guidelines: Systematic review. BMJ 2014;348:g3804.  Back to cited text no. 15
Hopewell S, Altman DG, Moher D, Schulz KF. Endorsement of the CONSORT statement by high impact factor medical journals: A survey of journal editors and journal 'instructions to authors'. Trials 2008;9:20.  Back to cited text no. 16
Hoffmann T, English T, Glasziou P. Reporting of interventions in randomised trials: An audit of journal instructions to authors. Trials 2014;15:20.  Back to cited text no. 17
Shamseer L, Hopewell S, Altman DG, Moher D, Schulz KF. Update on the endorsement of CONSORT by high impact factor journals: A survey of journal “Instructions to authors” in 2014. Trials 2016;17:301.  Back to cited text no. 18
Blanco D, Biggane AM, Cobo E, MiRoR network. Are CONSORT checklists submitted by authors adequately reflecting what information is actually reported in published papers? Trials 2018;19:80.  Back to cited text no. 19
Cobo E, González JA. Taking advantage of unexpected webCONSORT results. BMC Med 2016;14:204.  Back to cited text no. 20
Hirst A, Altman DG. Are peer reviewers encouraged to use reporting guidelines? A survey of 116 health research journals. PLoS One 2012;7:e35621.  Back to cited text no. 21


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