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.
ContributorsNicola Harman - University of Liverpool
Paula Williamson - University of Liverpool
Sarah Gorst - University of Liverpool
Stella Huyshe-Shires - Lyme Disease Action
Disease Category: Infectious disease
Disease Name: Lyme disease
Age Range: 18 - 99
Sex: Either
Nature of Intervention: Drug
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Researchers
- 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.