Core Outcome Set development for LEPtospirosis trials (COS-LEP): a study protocol to develop a core outcome set for the evaluation of clinical therapeutic interventions for human leptospirosis
2025

Developing a Core Outcome Set for Leptospirosis Trials

publication Evidence: moderate

Author Information

Author(s): Lee Nathaniel, Smith Chris, Bailey Robin, Ariyoshi Koya, Smith Sarah, Black Nick, Edwards Tansy

Primary Institution: London School of Hygiene & Tropical Medicine

Hypothesis

The study aims to develop a core outcome set (COS) for leptospirosis research to standardize outcome measures in clinical trials.

Conclusion

The establishment of a core outcome set will help harmonize leptospirosis treatment research and improve the quality of evidence for future clinical trials.

Supporting Evidence

  • Leptospirosis is a significant public health concern due to its global distribution and high mortality.
  • The study aims to standardize outcome measures to improve the comparability of clinical trials.
  • Current treatment research for leptospirosis lacks established outcome measures.

Takeaway

This study is trying to create a list of important things to measure when treating leptospirosis, so that all doctors and researchers can agree on what to look for.

Methodology

The study will use a systematic review, qualitative interviews, a Delphi survey, and a consensus meeting to develop the COS.

Potential Biases

There may be risks of bias in outcome reporting due to the subjective nature of qualitative data collection.

Limitations

The study may face challenges in participant recruitment and achieving consensus across diverse stakeholder groups.

Participant Demographics

Participants will include healthcare providers, researchers, policymakers, and individuals affected by leptospirosis.

Digital Object Identifier (DOI)

10.1186/s13063-024-08713-6

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