Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Apr-Jun;13(2):77-81.
doi: 10.4103/picr.PICR_64_20. Epub 2021 Jan 8.

Completeness of reporting and outcome switching in trials published in Indian journals from 2017 to 2019: A cross-sectional study

Kiran Warrier  1 , C R Jayanthi  1
Affiliations

Completeness of reporting and outcome switching in trials published in Indian journals from 2017 to 2019: A cross-sectional study

Kiran Warrier et al. Perspect Clin Res. 2022 Apr-Jun.

Abstract

Context: Randomized controlled trials (RCTs) are among the cornerstones for generation of high-quality clinical evidence. However, incomplete or biased reporting of trials can hamper the process of review of trials and their results. Outcome switching, intentional, or otherwise leads to biased reporting and can result in false inferences.

Aims: The aim of this study was to analyze the completeness of reporting Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and detect if outcome switching had occurred.

Settings and design: This cross-sectional study was conducted in the department of pharmacology.

Methods: Online editions of journals published by the Indian association of medical specialties from 2017 to 2019 were accessed, and the full-text versions of the published RCTs in them were downloaded. Reporting of each item in the CONSORT checklist was recorded. The effect of trial registration and CONSORT endorsement on reporting of key methodological parameters was also determined. Protocols of registered trials were accessed, and the outcome switching was assessed.

Statistical analysis used: Descriptive statistics were used to summarize the data.

Results: Average completeness of reporting has significantly improved from 2017 to 2019. Major areas of underreporting were generalizability, protocol availability, trial registration, date of recruitment, allocation concealment, and the patient flow diagram. CONSORT endorsing journals had worse, whereas registered trials had better reporting of key methodological indicators. No overt switching of outcomes was observed in 84 out of 86 registered trials where trial protocols were available online for comparison.

Conclusions: Quality of clinical trial reporting in the Indian medical journals has improved but remains inadequate. CONSORT nonendorsement prevents completeness of trial reporting.

Keywords: Consolidated Standards of Reporting Trials 2010; Indian medical journals; outcome switching; quality of reporting.

PubMed Disclaimer

Conflict of interest statement

There are no conflicts of interest.

Similar articles

See all similar articles

Cited by

References

    1. Johansen M, Thomsen SF. Guidelines for Reporting Medical Research: A Critical Appraisal. Int Sch Res Notices 2016. 2016 1346026. - PMC - PubMed
    1. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:869. - PMC - PubMed
    1. Kane RL, Wang J, Garrard J. Reporting in randomized clinical trials improved after adoption of the CONSORT statement. J Clin Epidemiol. 2007;60:241–9. - PubMed
    1. Altman DG, Moher D, Schulz KF. Harms of outcome switching in reports of randomised trials: CONSORT perspective. BMJ. 2017;356:j396. - PubMed
    1. Goenka L, Rajendran S, Arumugam K, Rani J, George M. The assessment of the quality of randomized controlled trials published in Indian medical journals. Perspect Clin Res. 2019;10:79. - PMC - PubMed