Johnson, Lorraine, Shapiro, Mira, Needell, Deanna et al. · Healthcare (Basel, Switzerland) · 2024 · DOI
This study looked at the rules that researchers use to decide who can join clinical trials for persistent Lyme disease (PLD). The researchers found that current rules exclude about 90% of patients, making it very hard to find enough people for studies. By relaxing some of these rules—especially those that exclude people with coexisting conditions like fibromyalgia or fatigue—researchers could include many more patients (up to 64%) while still conducting valid research.
For ME/CFS patients, this study is relevant because ME/CFS and PLD have overlapping symptoms and are sometimes misdiagnosed or coexist. The findings suggest that overly restrictive trial criteria may exclude patients who could benefit from treatments and contribute to research that doesn't represent the real-world population. Better-designed eligibility criteria could lead to more inclusive, generalizable clinical trials and faster recruitment.
This study does not prove that any specific exclusion criterion should be eliminated—it evaluates the scientific justification for criteria and their practical impact on recruitment. It does not establish which comorbidities are truly contraindications versus which can safely coexist in trials. The study also does not determine whether loosening criteria would compromise data quality or internal validity of individual trials.
About the PEM badge: “PEM required” means post-exertional malaise was an explicit required diagnostic criterion for participant inclusion in this study — not that PEM was studied, observed, or discussed. Studies using criteria that do not require PEM (e.g. Fukuda, Oxford) are tagged “PEM not required”. How the atlas works →
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