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      Evaluation of reporting of CONSORT flow diagrams in randomized controlled trials in a national and international pharmacology journal

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          Abstract

          Objective:

          To evaluate and compare the reporting of consolidated standard of reporting trial (CONSORT) flow diagrams in randomized controlled trials (RCTs) published in a national and international pharmacology journal.

          Methods:

          RCTs in an international pharmacology journal, European Journal of Clinical Pharmacology (EJCP), and a national journal, Indian Journal of Pharmacology (IJP), published from January 2014 to July 2016 were evaluated for reporting and completeness of CONSORT flow diagrams. A total of 138 articles (EJCP = 90; IJP = 48) were analyzed and compared.

          Results:

          Of 138 RCTs analyzed, 90 were from EJCP and 48 were from IJP. 76.6% (69/90) articles from EJCP and 37.5% (18/48) articles from IJP had reported the CONSORT flow diagram. Of these, 95.5% (66/69) had assessed for eligibility in EJCP and 88.8% (16/18) had reported the same in IJP. The number of participants excluded was reported in 86.9% (60/69) flow diagrams in EJCP and 83.3% (15/18) in IJP. 82.6% (57/69) flow diagrams in EJCP and 77.7% (14/18) in IJP had mentioned the details of randomization. Allocation of intervention was reported in 91.3% (63/69) flow diagrams in EJCP and 88.8% (16/18) in IJP. 60.8% (42/69) flow diagrams in EJCP and 44.4% (08/18) in IJP had mentioned the details of follow-up of participants. 95.5% (66/69) flow diagrams in EJCP and 94.4% (17/18) in IJP had mentioned details about analysis.

          Conclusion:

          In spite of both the journals, IJP and EJCP endorsing the CONSORT statement, a significant difference in the reporting of CONSORT flow diagrams in RCTs can be noted. The quality of reporting can be improved by stringent publication guidelines by the editors.

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          Most cited references8

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          Improving the quality of reporting of randomized controlled trials. The CONSORT statement.

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            The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.

            To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and flow diagram. The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
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              Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation.

              The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal. To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs. Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator). Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument. Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%; mean change, -22%; 95% CI, -38% to -6%). Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8). Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs.
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                Author and article information

                Journal
                Perspect Clin Res
                Perspect Clin Res
                PCR
                Perspectives in Clinical Research
                Wolters Kluwer - Medknow (India )
                2229-3485
                2229-5488
                Oct-Dec 2019
                : 10
                : 4
                : 168-171
                Affiliations
                [1]Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai, Maharashtra, India
                Author notes
                Address for correspondence: Dr. Asif Moeed Shaikh, Department of Pharmacology, Topiwala National Medical College and BYL Nair Charitable Hospital, Mumbai, Maharashtra, India. E-mail: asif1991xyz@ 123456gmail.com
                Article
                PCR-10-168
                10.4103/picr.PICR_73_18
                6801991
                31649866
                b908d0c7-711a-47e4-b0f3-74898cb32d7f
                Copyright: © 2019 Perspectives in Clinical Research

                This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

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                Original Article

                Medicine
                ejcp,ijp,thomas reuter impact factor
                Medicine
                ejcp, ijp, thomas reuter impact factor

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