The development of a core outcome set for clinical trials of the management of Lyme disease

Lyme disease (borreliosis) is the most prevalent tick borne disease in the United States and Western Europe. A UK review of available evidence for the management of Lyme disease concluded that the quality of evidence was low and that there was heterogeneity in the outcomes assessed. The development of a core outcome set for trials of the management of Lyme disease may help to address the issue of outcome heterogeneity and will also identify outcomes that are the most important to both clinicians and patients.


Nicola Harman - University of Liverpool
Paula Williamson - University of Liverpool
Sarah Gorst - University of Liverpool
Stella Huyshe-Shires - Lyme Disease Action

Further Study Information

Current Stage: Ongoing
Date: April 2021 - May 2022
Funding source(s): Lyme Disease Action

Health Area

Disease Category: Infectious disease

Disease Name: Lyme disease

Target Population

Age Range: 18 - 99

Sex: Either

Nature of Intervention: Drug

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Researchers

Study Type

- COS for clinical trials or clinical research


- Consensus meeting
- Delphi process
- Systematic review

The core outcome set will be developed in three stages. Systematic reviews of randomised controlled trials and the qualitative literature will identify a list of outcomes that will form the basis of a two round online Delphi survey. The online Delphi survey will ask stakeholders to rate outcomes on their importance for inclusion in a core outcome set. The results of the Delphi survey will then be discussed and ratified at an online consensus meeting.

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