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

Pugazhenthan Thangaraju1, Pranav Gaurangbhai Sheth1, Hemasri Velmurugan1

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

Infectious Disorders Drug Targets
|February 27, 2023
PubMed
Abstract

Insights

Leprosy randomized controlled trials (RCTs) show improved reporting quality since 2010. However, overall reporting quality for this stigmatized disease remains suboptimal, necessitating further enhancements.

Area of Science:

  • Medical Research
  • Clinical Trials
  • Infectious Diseases

Background:

  • Leprosy, caused by Mycobacterium leprae, persists as a significant public health and social issue in underdeveloped nations.
  • Randomized controlled trials (RCTs) for leprosy face unique challenges due to the disease's social stigma and complex nature.
  • Despite advances, leprosy eradication efforts remain hampered, highlighting the need for robust clinical trial data.

Approach:

  • This study evaluated the reporting quality of leprosy RCTs published after 2010.
  • The Consolidated Standard for Reporting Trials (CONSORT) 2010 checklist was employed for assessment.
  • Reporting quality was compared between trials published before and after the CONSORT 2010 guidelines.

Key Points:

  • Nineteen eligible leprosy RCTs were analyzed.
  • Reporting compliance varied, with only 4 trials exceeding 75% adherence to CONSORT guidelines.
  • A statistically significant improvement in reporting quality was observed for trials published after 2010 compared to those before.
  • The highest compliance reached 86.48%, while the lowest was 32.43%.

Conclusions:

  • While the CONSORT guidelines have led to improved reporting of leprosy RCTs, the overall quality remains insufficient.
  • Further efforts are needed to enhance the quality of scientific reporting for leprosy clinical trials.
  • Addressing reporting deficiencies is crucial for advancing leprosy control and eradication strategies.
Keywords:
Leprosyantibioticschronic infectioushypo-pigmentionmultidrug therapyrespiratory tract

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