Generalizability in Two Clinical Trials of Lyme Disease
Author Information
Author(s): Cameron Daniel J
Primary Institution: Division of Medicine, First Medical Associates
Hypothesis
Do the selection factors in the trials affect the generalizability of the results to the overall Lyme disease population?
Conclusion
The trials conducted by Klempner et al. are not generalizable to the broader population of chronic Lyme disease patients.
Supporting Evidence
- The trials have been over-interpreted by the NIH and widely publicized.
- The treatment failure reported may be due to selecting patients who had undergone multiple unsuccessful treatments.
- The results of the trials are not generalizable to patients receiving treatment for chronic Lyme disease within 6 months of their initial presentation.
Takeaway
The study looked at two trials for Lyme disease and found that the results might not apply to all patients because the people in the trials were very specific.
Methodology
Epidemiologic review of the generalizability of two trials conducted by Klempner et al.
Potential Biases
The selection of patients with a long history of illness may have biased the results.
Limitations
The trials did not consider the impact of treatment delay or the characteristics of patients who might benefit from retreatment.
Participant Demographics
Patients were at least 18 years old with a history of Lyme disease and specific symptoms.
Digital Object Identifier (DOI)
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