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Validity of diagnosis and procedure codes for identifying neural tube defects in infants.
Cheetham, T Craig; Dublin, Sascha; Pocobelli, Gaia; Bobb, Jennifer F; Andrade, Susan; Hechter, Rulin C; Portugal, Cecilia; Munis, Mercedes; Albertson-Junkans, Ladia; Salgado, Gladys; Wong, Lawrence; Maarup, Timothy J; Carroll, Kecia; Griffin, Marie R; Raebel, Marsha A; Smith, David; Li, De-Kun; Pawloski, Pamala A; Toh, Sengwee; Taylor, Lockwood; Hua, Wei; Dinatale, Miriam; Ceresa, Carrie; Trinidad, James P; Boudreau, Denise M.
Affiliation
  • Cheetham TC; Chapman University - School of Pharmacy, Irvine, California, USA.
  • Dublin S; Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
  • Pocobelli G; Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
  • Bobb JF; Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
  • Andrade S; Meyers Primary Care Institute & University of Massachusetts Medical School, Worcester, Massachusetts, USA.
  • Hechter RC; Kaiser Permanente Department of Research & Evaluation, Pasadena, California, USA.
  • Portugal C; Kaiser Permanente Department of Research & Evaluation, Pasadena, California, USA.
  • Munis M; Kaiser Permanente Department of Research & Evaluation, Pasadena, California, USA.
  • Albertson-Junkans L; Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
  • Salgado G; Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
  • Wong L; The Permanente Medical Group, Clinical Genetics, Oakland, California, USA.
  • Maarup TJ; Southern California Permanente Medical Group, Genetics Department, Downey, California, USA.
  • Carroll K; Department of Pediatrics, Vanderbilt University Medical School, Nashville, Tennessee, USA.
  • Griffin MR; Department of Health Policy, Vanderbilt University Medical School, Nashville, Tennessee, USA.
  • Raebel MA; Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado, USA.
  • Smith D; Kaiser Permanente Northwest, Center for Health Research, Portland, Oregon, USA.
  • Li DK; Division of Research, Kaiser Permanente Northern California, Oakland, California, USA.
  • Pawloski PA; HealthPartners Institute, Bloomington, Minnesota, USA.
  • Toh S; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Research Institute, Boston, Massachusetts, USA.
  • Taylor L; CDER, Food and Drug Administration, Office of Surveillance and Epidemiology, Silver Spring, Maryland, USA.
  • Hua W; CDER, Food and Drug Administration, Office of Surveillance and Epidemiology, Silver Spring, Maryland, USA.
  • Dinatale M; Division of Pediatric and Maternal Health, CDER, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ceresa C; Division of Pediatric and Maternal Health, CDER, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Trinidad JP; CDER, Food and Drug Administration, Office of Surveillance and Epidemiology, Silver Spring, Maryland, USA.
  • Boudreau DM; Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
Pharmacoepidemiol Drug Saf ; 29(11): 1489-1493, 2020 11.
Article in En | MEDLINE | ID: mdl-32929845
ABSTRACT

PURPOSE:

The use of validated criteria to identify birth defects in electronic healthcare databases can avoid the cost and time-intensive efforts required to conduct chart reviews to confirm outcomes. This study evaluated the validity of various case-finding methodologies to identify neural tube defects (NTDs) in infants using an electronic healthcare database.

METHODS:

This analysis used data generated from a study whose primary aim was to evaluate the association between first-trimester maternal prescription opioid use and NTDs. The study was conducted within the Medication Exposure in Pregnancy Risk Evaluation Program. A broad approach was used to identify potential NTDs including diagnosis and procedure codes from inpatient and outpatient settings, death certificates and birth defect flags in birth certificates. Potential NTD cases were chart abstracted and confirmed by clinical experts. Positive predictive values (PPVs) and 95% confidence intervals (95% CI) are reported.

RESULTS:

The cohort included 113 168 singleton live-born infants 55 960 infants with opioid exposure in pregnancy and 57 208 infants unexposed in pregnancy. Seventy-three potential NTD cases were available for the validation analysis. The overall PPV was 41% using all diagnosis and procedure codes plus birth certificates. Restricting approaches to codes recorded in the infants' medical record or to birth certificate flags increased the PPVs (72% and 80%, respectively) but missed a substantial proportion of confirmed NTDs.

CONCLUSIONS:

Codes in electronic healthcare data did not accurately identify confirmed NTDs. These results indicate that chart review with adjudication of outcomes is important when conducting observational studies of NTDs using electronic healthcare data.
Subject(s)
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Neural Tube Defects Type of study: Diagnostic_studies / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Female / Humans / Infant / Pregnancy Language: En Journal: Pharmacoepidemiol Drug Saf Journal subject: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2020 Document type: Article Affiliation country: Estados Unidos

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Neural Tube Defects Type of study: Diagnostic_studies / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Female / Humans / Infant / Pregnancy Language: En Journal: Pharmacoepidemiol Drug Saf Journal subject: EPIDEMIOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2020 Document type: Article Affiliation country: Estados Unidos
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