A Change in the Trend of Quality Reporting in Leprosy Trials: A Systematic Review

Author:

Thangaraju Pugazhenthan1ORCID,Sheth Pranav Gaurangbhai1ORCID,Velmurugan Hemasri1ORCID,Venkatesan Sajitha2ORCID,Balan Aravind Kumar3ORCID

Affiliation:

1. Department of Pharmacology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India

2. Department of Microbiology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India

3. Department of Pharmacology, Pondicherry Institute of Medical Sciences, Pondicherry, India

Abstract

Background: Leprosy is a communicable disease caused by bacteria Mycobacterium leprae. Despite all attempts, it has not been eradicated in several underdeveloped nations since the start of the antibiotic age. It's a social issue as well as a stigmatised disease. Due to these restrictions, randomised controlled trials in leprosy confront numerous obstacles, which are reflected in the quality of study reporting. Objectives: The objective of this study is to use the Consolidated Standard for Reporting Trials (CONSORT) 2010 checklist to assess the quality of leprosy trial reporting. Methods: We assess the quality of reporting of randomised control trials on leprosy conducted after 2010 in the PubMed database, using the CONSORT checklist 2010. Second, we compare the quality of RCT reporting before and after the release of the CONSORT guidelines in 2010. Results: A total of 19 full-text eligible articles were examined and included in the final list of articles, which were then evaluated further. 4 out of 19 trials had a compliance percentage of more than 75%. 6 out of 19 trials had compliance percentage of 50% to 75%. 9 trials had a compliance percentage of below 50%. Highest compliance was 86.48% and the lowest compliance was 32.43%. When compared with trials before 2010, we could see an improvement in some criteria showing a statistically significant rise in comparison with trials conducted before 2010. Conclusion: Leprosy is still a concern in developing countries, which have failed to eradicate the disease despite their best efforts and resources. The compliance of leprosy related RCTs has improved since the introduction of the CONSORT guidelines, but the quality of reporting still remains on the lower side.

Publisher

Bentham Science Publishers Ltd.

Subject

Microbiology (medical),Pharmacology,Molecular Medicine,General Medicine

Reference29 articles.

1. WHO Leprosy. 2021. Available from:

2. National Health Portal. 2021. Available from:

3. Global leprosy (hansen disease) update, 2020: Impact of COVID-19 on the global leprosy control. Weekly epidemiological record 2021,9 September; 96: 421-44.

4. Grossman J.; Mackenzie F.J.; The randomized controlled trial: Gold standard, or merely standard? Perspect Biol Med 2005,48(4),516-534

5. Schulz K.F.; Altman D.G.; Moher D.; CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. BMC Med 2010,8(7),604-612

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