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Linking Data from a Population-Based Assisted Reproductive Technology Registry to Vital Statistics Data:. Encouraging Results from a CDC-Massachusetts Department of Public Health Collaborative Project NAPHSIS/NCHS Joint Meeting Bruce Cohen, PhD June 2007. Background

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Linking Data from a Population-Based Assisted Reproductive Technology Registry to Vital Statistics Data:

Encouraging Results from a CDC-Massachusetts Department of Public Health Collaborative Project

NAPHSIS/NCHS Joint Meeting

Bruce Cohen, PhD

June 2007


Presentation outline

Background Technology Registry to Vital Statistics Data:

Evaluation of ART reporting on the birth certificate

Characteristics of mothers using ART

Associations between ART and maternal and perinatal outcomes

Future direction for linkage of fertility clinic data and birth certificates

Presentation Outline


Background
Background Technology Registry to Vital Statistics Data:

  • Use of ART has steadily increased over the past decade, and accounts for 1% of all live-born children in the USA

  • Safety concerns demand large-scale studies of adverse outcomes of ART

  • Whereas the ART registry maintained by CDC can be used to address certain outcomes (e.g., multiple gestation, pre-term delivery), its scope is limited (e.g., poor data on birth defects, no data on infant mortality)

  • Massachusetts state law mandates health insurance coverage of ART, and fertility assistance now accounts for about 3% of all live-born children in that state (based on birth certificate data)

  • Massachusetts has considerable experience with research based on record linkage


Objectives of the linkage project
Objectives of the Linkage Project Technology Registry to Vital Statistics Data:

  • To link information from CDC’s assisted reproductive technology (ART) surveillance data files with Massachusetts state birth records

  • To create a population-based dataset of ART mother-infant pairs including data on circumstances surrounding conception and delivery and data on maternal and infant outcomes

  • To compare infants conceived using ART and their mothers with other Massachusetts infants and their mothers


Study population
Study Population Technology Registry to Vital Statistics Data:

The study population was drawn from MA birth certificate data base:

  • infants born in 1997-2000

  • maternal residency listed as MA.

  • birth occurred in MA, RI, CT, NH

    N=158,229 deliveries and 161,539 total infants in 1997-1998

    N=158,771 deliveries and 162,260 total infants in 1999-2000

    Information abstracted: demographic characteristics, prenatal care use, maternal history, pregnancy complications, delivery outcomes and complications


Study population1
Study Population Technology Registry to Vital Statistics Data:

Data from live births reported to ART Registry were linked to the study population if:

  • ART treatment was in a MA or RI clinic (11 clinics total)

  • Infant(s) born in 1997-1998, 1999-2000

  • Maternal residency at time of ART listed as MA or unknown.

    N=2703 deliveries and 3704 total infants in 1997-1998;

    N=3330 deliveries and 4494 total infants in 1999-2000;

    Information abstracted: patient history, ART treatment information, ART outcome information


Data linkage strategy
Data Linkage Strategy Technology Registry to Vital Statistics Data:

STAGE 1:

  • link ART record to birth record using mother’s date of birth and infant’s date of birth

  • further evaluate potential matches using ancillary variables -- plurality, parity and birth weight

    STAGE 2:

  • further linkage by maternal name for a portion of records -- ART record names obtained through follow-up with ART clinics


Stage 1 linkage results
Stage 1 Linkage Results Technology Registry to Vital Statistics Data:


Final linkage results
Final Linkage Results Technology Registry to Vital Statistics Data:


For additional details on linkage methods and 1997 1998 results
For additional details on linkage methods Technology Registry to Vital Statistics Data:and 1997-1998 results:

Sunderam S, Schieve LA, Cohen B, et al.: Linking Birth and Infant Death Records With Assisted Reproductive Technology Data: Massachusetts, 1997–1998.Maternal and Child Health Journal, 2005: 9, 1 – 11


Evaluation of art reporting on the ma birth certificates background
Evaluation of ART Reporting on the MA Birth Certificates: Background

  • Massachusetts is one of the first states that collect information on assisted reproductive technology (ART) and fertility during use via the birth certificate, started in 1996

  • ART information was extracted by hospital staff from medical records, recorded on the birth certificates, then sent to the state Registry of Vital Records as part of the routine data transmission.

  • The completeness and quality of reporting has not been systematically evaluated, thus limiting the potential of use in our surveillance and research work related to the assisted reproductive technology.


Massachusetts birth certificate medical worksheet questions
Massachusetts Birth Certificate BackgroundMedical Worksheet Questions


Research questions
Research Questions Background

  • How consistent is the ART information reported on the Massachusetts birth certificate with ART reported in ART Registry?

  • What are the predictors of checking off the ART variable on the Massachusetts birth certificate ?


Methods
Methods Background

  • Data sources: live-birth deliveries to MA resident mothers occurring in 1997-2000 in MA, NH, RI, and CT

  • Unit of analysis: live-birth deliveries

  • Use linked SART-BC records as “gold standard” for “true” ART births

  • Validity measures : sensitivity and specificity



Concordance of ART Information between the Massachusetts Birth Certificate and the SART Database, 1997-2000




Variation in sensitivity by hospital characteristics
Variation in Sensitivity by Kotelchuck Index Hospital Characteristics

  • Range of sensitivity by facility : 0-60+ %

  • Teaching hospitals: sensitivity > 60% in 3 out of 7

  • Non-teaching hospitals: sensitivity > 60% in 2 out of 49

  • Variation also observed by number of ART deliveries/year and hospital level


Summary comments
Summary/Comments Kotelchuck Index

  • While specificity of reporting ART on the birth certificates is high, the sensitivity is low

  • Results probably reflect experience of early stage of collecting ART information on the birth certificate in Massachusetts

  • Definitional differences could affect linkage rates: birth certificate response category includes non-invasive procedures--artificial insemination (AI) or intrauterine insemination (IUI) whereas CDC ART definition is “all treatments or procedures that include the handling of human oocytes and sperm for the purpose of establishing a pregnancy.  This includes, but is not limited to in vitro fertilization and transcervical embryo transfer, gamete intrafallopian transfer, zygote intrafallopian transfer, tubal embryo transfer, embryo cryopreservation, oocyte or embryo donation, and gestational surrogacy.  ART does not include assisted insemination using sperm from either a woman's partner or sperm donor.


Summary comments1
Summary/Comments Kotelchuck Index

  • Consider alternative reporting methods for ART on the birth certificate (PRAMS pilot testing indicated much higher response from MA mothers than recorded on birth certificate)

  • What are the implications of these results for the new revised certificate items? For research using these items?



Comparison groups
Comparison Groups in Massachusetts

The following slides use three comparison groups:

  • ART Births/Deliveries: Massachusetts births/deliveries linked to the CDC ART Registry (1.7%)

  • FA on BC: Evidence of fertility assistance on the birth certificate but not linked to the CDC ART registry (0.6%)

  • NO FA on BC: All other births or deliveries (97.8%)


Percentage of deliveries age 35 massachusetts 1997 2000
Percentage of Deliveries, Age in Massachusetts≥35, Massachusetts 1997-2000


Percentage of deliveries that are multiple births massachusetts 1997 2000
Percentage of Deliveries that are in MassachusettsMultiple Births, Massachusetts 1997-2000









Percentage of low birthweight infants massachusetts 1997 2000
Percentage of Low Birthweight Massachusetts 1997-2000Infants, Massachusetts 1997-2000


Percentage of multiple deliveries where plurality 3 massachusetts 1997 2000
Percentage of Massachusetts 1997-2000Multiple Deliveries where Plurality = 3+, Massachusetts 1997-2000

?


Summary
Summary Massachusetts 1997-2000

  • These linked data provide the first population-based assessment of the prevalence and characteristics of ART mothers in the US

  • Women who use other methods of fertility assistance are more similar to those who use ART than the general population, with some notable differences

  • These unadjusted data provide a preliminary, baseline snapshot and need to be examined more closely to fully understand the implications for public health practice


Associations between assisted reproductive technology and maternal and perinatal outcomes

Associations Between Massachusetts 1997-2000Assisted Reproductive Technology and Maternal and Perinatal Outcomes

Schieve LA, Cohen BB, Naninni A, Ferre C, Reynolds, MA, Zhang Z, Macaluso, M, and Wright V. “A Population-Based Study of Maternal and Perinatal Outcomes Associated with Assisted Reproductive Technology in Massachusetts.” Maternal Child Health J. March 8, 2007.


Summary1
Summary Massachusetts 1997-2000

  • After considering numerous potential confounding factors through sample restriction and matching, ART was associated with:

    • Pre-existing diabetes

    • Incompetent cervix

    • Pregnancy induced hypertension

    • Uterine bleeding

    • Placental abruption

    • Placenta previa

    • Preterm delivery

    • Very preterm delivery

    • Low birth weight

    • Infant not discharged home

  • Although confidence intervals overlapped 1.0, there was also a suggestion of increased risk among ART births for:

    • Gestational diabetes

    • Very low birth weight


Summary2
Summary Massachusetts 1997-2000

  • Findings of associations with pre-existing diabetes and incompetent cervix are supported by the literature. Both are conditions associated with infertility disorders treated with ART.

  • Findings of associations with pregnancy-induced hypertension, uterine bleeding placenta abruption, placenta previa (and marginal association with gestational diabetes) confirm and expand on previous studies by more fully considering potential confounders.

  • Negative finding for cesarean section contradicts several previous studies reporting association.

    • While C-section rates were high in women who conceived via ART in comparison to the general population of births in MA, ART does not appear to be the reason.

    • C-section rates for ART births were comparable to those observed in women who did not conceive with ART after matching on birth place and time, age, parity, and race/ethnicity.

  • Findings of associations with preterm and low birth weight also support previous studies.

    • Supplemental analysis in a subgroup without maternal health or labor and delivery complications suggests the increase in perinatal risk among ART births is not solely explained by maternal health factors.


Future directions
Future Directions Massachusetts 1997-2000

  • Update linkages for currently available data

  • Continue research using these data: extend etiologic and descriptive analyses

  • Explore linkages with other data sources such as hospital discharge data bases, birth defects registries…perhaps through PELL


Future directions1
Future Directions Massachusetts 1997-2000

  • Investigate limitations of linkage-based analyses (sensitivity analyses, potential for information/detection bias)

  • Explore the feasibility of augmented studies (nested follow-up, case-control studies)

  • Explore application of the linkage methods to other states with high ART prevalence


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