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 →
The first block is for the primary paper and is the citation you should use in research work. The atlas-snapshot line only applies if you are specifically referring to this atlas’s reading of the paper on the date shown.
Primary citation
Johnson, Lorraine, Shapiro, Mira, Needell, Deanna, & Stricker, Raphael B (2024). Optimizing Exclusion Criteria for Clinical Trials of Persistent Lyme Disease Using Real-World Data.. Healthcare (Basel, Switzerland). https://doi.org/10.3390/healthcare13010020
BibTeX
@article{mecfsatlas-johnson-2024-optimizing-exclusion,
author = {Johnson, Lorraine and Shapiro, Mira and Needell, Deanna and Stricker, Raphael B},
title = {Optimizing Exclusion Criteria for Clinical Trials of Persistent Lyme Disease Using Real-World Data.},
journal = {Healthcare (Basel, Switzerland)},
year = {2024},
doi = {10.3390/healthcare13010020},
note = {PubMed: 39791627},
url = {https://www.mecfsatlas.com/evidence/johnson-2024-optimizing-exclusion},
}Atlas snapshot reference
ME/CFS Atlas. Generator v1 / Scanner v1.4 / policy v0.1. Accessed 2026-05-29. https://www.mecfsatlas.com/evidence/johnson-2024-optimizing-exclusion
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