A longitudinal cohort study of childhood MMR vaccination and seizure disorder among American children

Geier, David A.; Geier, Mark R.

doi:10.1016/j.braindev.2020.09.001

Cited by 6 publications

(5 citation statements)

References 21 publications

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“…Outcomes, as described in previous studies, were identified from International Code for Disease, 9th revision (ICD-9) codes for rubella-related diagnoses (code: 056xxx) documented on claims for the children examined in this study. [4][5][6][7] Laboratory data confirming rubella diagnoses was not available in the IHRD. The onset of rubella infection was assumed to be the date of service for the first claim in chronological order with a rubella diagnosis.…”

Section: Discussionmentioning

confidence: 99%

“…The status of vaccination was determined for each cohort member examined from current procedural terminology (CPT) codes filed on claims, as described in previous studies. 4 , 5 Rubella vaccination (codes: 90706, 9947, W1942), MMR vaccine (codes: 90707, W1943), measles and rubella vaccine (codes: 90708, W1944), rubella and mumps vaccine (codes: 90709, W1945), measles, mumps, rubella, and varicella (MMRV) vaccine (code: 90710) were the CPT codes examined in this study. The vaccinated cohort examined in this study included only children receiving a single dose of MMR vaccine (codes: 90707, W1943) during the study period.…”

Section: Methodsmentioning

confidence: 99%

“…As described in previous studies, [4][5][6][7] non-identifiable healthcare records generated from the Florida Medicaid system compose the Independent Healthcare Research Database (IHRD). The Agency for Health Care Administration (AHCA) of the state of Florida provided the Florida Medicaid eligibility and claim files that were utilized to create the IHRD.…”

Section: Independent Healthcare Research Database (Ihrd)mentioning

confidence: 99%

“…The identification and selection methods of the cohort children examined were described in previous studies. [4][5][6][7]…”

Section: Study Participantsmentioning

confidence: 99%

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Childhood MMR Vaccination Effectiveness Against Rubella: A Longitudinal Cohort Study

Geier¹,

Geier²

2022

Global Pediatric Health

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The vaccine effectiveness (VE) of childhood measles-mumps-rubella (MMR) vaccine to reduce childhood rubella infections in the US during the 1990s/2000s was undertaken in a retrospective longitudinal cohort study. SAS and StatsDirect software were utilized to examine non-identifiable linked eligibility and claim healthcare records prospectively generated from the Florida Medicaid system in the Independent Healthcare Research Database (IHRD). A total of 33 839 children received a single MMR vaccination (vaccinated) and 44 154 children never received a rubella-containing vaccine (unvaccinated) were continuously eligible from 1990 to 2009 for Florida Medicaid within the first 10 years following birth. Cox proportional hazards models determined VE against diagnosed rubella (ICD-9 code: 056.xx). Children receiving MMR were at significantly reduced risk of rubella in unadjusted (VE = 80.7%, 95% confidence interval = 73.7%-85.8%) and adjusted (VE = 78.6%, 95% confidence interval = 70.8%-84.3%) models as compared to unvaccinated children. Between 1991 and 2009, in the combined vaccinated-unvaccinated cohort examined on a yearly basis, a significant inverse correlation between increasing MMR vaccine population coverage and a decreasing incidence rate of diagnosed rubella was observed. This first large-scale population epidemiological study supports the routine use childhood MMR vaccination to significantly reduce childhood rubella infections and also supports its ability to induce “herd immunity.” This study, coupled with a recently published epidemiological study showing childhood MMR vaccination significantly reduced measles infections, provide powerful epidemiological evidence strongly supporting MMR vaccination as an effective tool to improve public health.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Independent Healthcare Research Database (Ihrd)mentioning

confidence: 99%

“…The identification and selection methods of the cohort children examined were described in previous studies. [4][5][6][7]…”

Section: Study Participantsmentioning

confidence: 99%

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Childhood MMR Vaccination Effectiveness Against Rubella: A Longitudinal Cohort Study

Geier¹,

Geier²

2022

Global Pediatric Health

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“…As described previously in great detail, the IHRD contains de-identified healthcare records from the Florida Medicaid system [ 12 - 18 ]. Unique recipient identifier codes for each person allow for linkage of their eligibility and claim records.…”

Section: Methodsmentioning

confidence: 99%

Colon Cancer Risk Following Intestinal Clostridioides difficile Infection: A Longitudinal Cohort Study

Geier

2023

J Clin Med Res

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Background The gut microbiome may play an important role in the etiology and progression of colon cancer. The present hypothesis-testing study compared the colon cancer incidence rate among adults diagnosed with intestinal Clostridioides (formerly Clostridium) difficile (Cdiff) (the Cdiff cohort) to adults not diagnosed with intestinal Cdiff infection (the non-Cdiff cohort). Methods De-identified eligibility and claim healthcare records within the Independent Healthcare Research Database (IHRD) from a longitudinal cohort of adults (the overall cohort) enrolled in the Florida Medicaid system between 1990 through 2012 were examined. Adults with ≥ 8 outpatient office visits over 8 years of continuous eligibility were examined. There were 964 adults in the Cdiff cohort and 292,136 adults in the non-Cdiff cohort. Frequency and Cox proportional hazards models were utilized. Results Colon cancer incidence rate in the non-Cdiff cohort remained relatively uniform over the entire study period, whereas a marked increase was observed in the Cdiff cohort within the first 4 years of a Cdiff diagnosis. Colon cancer incidence was significantly increased (about 2.7-fold) in the Cdiff cohort (3.11 per 1,000 person-years) compared to the non-Cdiff cohort (1.16 per 1,000 person-years). Adjustments for gender, age, residency, birthdate, colonoscopy screening, family history of cancer, and personal history of tobacco abuse, alcohol abuse/dependence, drug abuse/dependence, and overweight/obesity, as well as consideration of diagnostic status for ulcerative and infection colitis, immunodeficiency, and personal history of cancer did not significantly change the observed results. Conclusions This is the first epidemiological study associating Cdiff with an increased risk for colon cancer. Future studies should further evaluate this relationship.

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Tree‐temporal scan statistics for safety signal detection in vaccine clinical trials

Haguinet,

Tibaldi,

Dessart

et al. 2024

Pharmaceutical Statistics

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The evaluation of safety is critical in all clinical trials. However, the quantitative analysis of safety data in clinical trials poses statistical difficulties because of multiple potentially overlapping endpoints. Tree‐temporal scan statistic approaches address this issue and have been widely employed in other data sources, but not to date in clinical trials. We evaluated the performance of three complementary scan statistical methods for routine quantitative safety signal detection: the self‐controlled tree‐temporal scan (SCTTS), a tree‐temporal scan based on group comparison (BGTTS), and a log‐rank based tree‐temporal scan (LgRTTS). Each method was evaluated using data from two phase III clinical trials, and simulated data (simulation study). In the case study, the reference set was adverse events (AEs) in the Reference Safety Information of the evaluated vaccine. The SCTTS method had higher sensitivity than other methods, and after dose 1 detected 80 true positives (TP) with a positive predictive value (PPV) of 60%. The LgRTTS detected 49 TPs with 69% PPV. The BGTTS had 90% of PPV with 38 TPs. In the simulation study, with simulated reference sets of AEs, the SCTTS method had good sensitivity to detect transient effects. The LgRTTS method showed the best performance for the detection of persistent effects, with high sensitivity and expected probability of type I error. These three methods provide complementary approaches to safety signal detection in clinical trials or across clinical development programmes. All three methods formally adjust for multiple testing of large numbers of overlapping endpoints without being excessively conservative.

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A longitudinal cohort study of childhood MMR vaccination and seizure disorder among American children

Cited by 6 publications

References 21 publications

Childhood MMR Vaccination Effectiveness Against Rubella: A Longitudinal Cohort Study

Childhood MMR Vaccination Effectiveness Against Rubella: A Longitudinal Cohort Study

Colon Cancer Risk Following Intestinal Clostridioides difficile Infection: A Longitudinal Cohort Study

Tree‐temporal scan statistics for safety signal detection in vaccine clinical trials

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