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Validation of the Rule of 7's for Identifying Children at Low-risk for Lyme Meningitis
Aris Garro1, Robert A Avery2, Keri A Cohn3
1From the Pediatrics and Emergency Medicine, Rhode Island Hospital, Providence, Rhode Island.
Insights
The Rule of 7's effectively identifies children with low-risk Lyme meningitis, enabling outpatient management. This clinical prediction rule demonstrates a 100% negative predictive value for Lyme meningitis.
Area of Science:
- Pediatric Infectious Diseases
- Clinical Epidemiology
- Neurology
Background:
- Lyme meningitis is a significant concern in pediatric neurology.
- The Rule of 7's is a clinical prediction rule designed to identify low-risk children for Lyme meningitis.
- Validation of this rule is crucial for guiding clinical management.
Purpose of the Study:
- To validate the Rule of 7's in a broader population of children undergoing evaluation for Lyme disease.
- To assess the accuracy of the Rule of 7's in identifying Lyme meningitis.
Main Methods:
- A patient-level data meta-analysis was conducted, combining 2 prospective and 2 retrospective cohorts.
- Included were children aged 21 years or younger with cerebrospinal fluid pleocytosis evaluated for Lyme disease.
- Lyme meningitis was defined by positive 2-tier serology results.
Main Results:
- The study included 721 children with meningitis; 178 (24.7%) had Lyme meningitis.
- The Rule of 7's demonstrated a sensitivity of 98% and a negative predictive value of 100%.
- Specificity was 40%, indicating a high rate of false positives for identifying low-risk cases.
Conclusions:
- The Rule of 7's accurately identifies children at low risk for Lyme meningitis.
- This rule supports considering outpatient management for low-risk pediatric patients while awaiting diagnostic test results.
- The high negative predictive value suggests it is safe to rule out Lyme meningitis in children meeting the criteria.
Background:
The Rule of 7's classifies children as low-risk for Lyme meningitis with the absence of the following: ≥7 days of headache, any cranial neuritis or ≥70% cerebrospinal fluid mononuclear cells. We sought to broadly validate this clinical prediction rule in children with meningitis undergoing evaluation for Lyme disease.
Methods:
We performed a patient-level data meta-analysis of 2 prospective and 2 retrospective cohorts of children ≤21 years of age with cerebrospinal fluid pleocytosis who underwent evaluation for Lyme disease. We defined a case of Lyme meningitis with a positive 2-tier serology result (positive or equivocal first-tier enzyme immunoassay followed by a positive supplemental immunoblot). We applied the Rule of 7's and report the accuracy for the identification of Lyme meningitis.
Results:
Of 721 included children with meningitis, 178 had Lyme meningitis (24.7%) and 543 had aseptic meningitis (75.3%). The pooled data from the 4 studies showed the Rule of 7's has a sensitivity of 98% [95% confidence interval (CI): 89%-100%, I2 = 71%], specificity 40% (95% CI: 30%-50%, I2 = 75%), and a negative predictive value of 100% (95% CI: 95%-100%, I2 = 55%).
Conclusions:
The Rule of 7's accurately identified children with meningitis at low-risk for Lyme meningitis for whom clinicians should consider outpatient management while awaiting Lyme disease test results.
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