1 Division of Public Health Practice, Department of Community and Preventive Medicine, University of Rochester, Rochester, NY.
2 Center for Maternal and Child Health, SUNY Upstate Medical University, Syracuse, NY.
3 New York State Department of Health, Albany, NY.
Received for publication July 2, 2001; accepted for publication April 18, 2002.
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ABSTRACT |
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informed consent; medical informatics; perinatal care; population surveillance; pregnancy; registries
Abbreviations: Abbreviation: WIC, Special Supplemental Nutrition Program for Women, Infants, and Children.
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INTRODUCTION |
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As electronic birth registration systems become more commonplace in the United States, the electronic sharing of data for purposes other than the original intent for which the data were collected is increasing (4). For example, immunization registry systems can be prepopulated with birth information from electronic birth certificate systems (5). Further, these systems can be augmented with data input from clinical databases with information about prenatal care history, risks, and demographic information (69). The sharing of data for multiple purposes reduces redundancy and potentially increases accuracy by consolidating the data functions into a few systems and increasing the utility of these systems (1012).
The use of birth registries for research purposes is appealing in that such databases often contain information on large populations, can contain cases of rare diseases or conditions, and can be used for the selection of cases and controls for studies where primary data collection would prove expensive or impossible. Therefore, the completeness of these registries is important to avoid, or at least to understand, potential bias in the databases. Users of registries that require consent for inclusion do not typically have access to the entire population offered the opportunity to participate, and understanding the bias in such a database can be difficult.
The development of data consent and access policies has not necessarily kept pace with the technologic advances that encourage access to surveillance data (13). As more systems require consent by participants to share their information for these multiple purposes, users must be aware of the potential epidemiologic biases that could be introduced into the data sets available for sharing or analyses. Participation in projects that require personal information is not random: The likelihood of consenting can vary strongly with other variables, such as demographic characteristics, language, and understanding of system uses (14). In fact, these demographic characteristics are also associated with poor receipt of prenatal care (15) such that women who might be at highest risk (i.e., those with poor prenatal care adequacy) might also be most likely to refuse to consent to share data. Further, the very attitudinal barrier that may prevent some women from accessing care may also be reflected in their refusal to share their information with other clinical and public health sources.
Because access to record-level birth information is oftentimes desirable for determining program eligibility (e.g., Medicaid enrollment), for providing denominator or population bases for health and social registries (e.g., immunization), and for evaluations of maternal and child health programs, the potential bias introduced by nonrandom participation becomes important. The usefulness and completeness of registries are contingent upon the representativeness of the records contained within them, which, in turn, is a function of consent. Families are frequently suspicious of these requests for consent to share information publicly, and refusal to consent to share information with public sources may reflect underlying educational, societal, and philosophic issues (14).
We evaluated the determinants of consenting to share birth information with public users of electronic perinatal data system information in central New York State. In addition, we evaluated the association between prenatal care and prenatal program participation with refusal to share information as a reflection of an attitude of "nonparticipation" in public programs.
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MATERIALS AND METHODS |
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Electronic birth certificate information is included in the Regional Perinatal Data System for all women delivering a livebirth within the 14-county region. The data contained within this system include the contents of the electronic birth certificate (e.g., details of the birth, demographics, medical complications, risks of the mother) and also selected quality improvement information (e.g., breastfeeding intentions, exercise during pregnancy, genetic testing offered). Further, as part of the quality improvement component of the data collection process, each woman is asked to consent to share information from the Regional Perinatal Data System electronically with three sources: 1) her obstetric provider, 2) her infants pediatric provider, and 3) the Central New York Immunization Registry.
Only women who explicitly provided consent or who explicitly refused consent were included in this analysis. Women whose infants died or were placed in foster care or with adoption services were excluded from this analysis, because they did not have equal opportunity to provide consent. Further, women who did not respond to the consent question were excluded (1.7 percent, 1.7 percent, and 1.9 percent did not respond to consent for sharing data with obstetric providers, pediatric providers, and the immunization registry, respectively). In total, 76,602 women responded to the consent question to share data with their obstetric providers, 76,597 women responded to the question to share data with their pediatric providers, and 76,441 women responded to the question to share data with the immunization registry.
Variable definitions
Women were defined as having "refused consent" if they refused to share information with their obstetric providers, their infants pediatric provider, and/or the Central New York Immunization Registry. Prenatal care participation was assessed using the Adequacy of Prenatal Care Utilization Index, which quantifies the timing and volume of prenatal visits (16). Finally, participation in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) among women with Medicaid coverage was assessed. All women with Medicaid coverage in New York State are eligible to receive WIC services (17).
Statistical methods
Odds ratios were generated to assess the magnitude and direction of the association between selected risk factors and womens consent to share information as the outcome of interest. Potential confounders in these associations were defined as variables that were at least marginally (p < 0.10) associated with both the predictor and the outcome. The crude odds ratios were subsequently adjusted for these confounders using logistic regression. The 95 percent confidence intervals around these adjusted odds ratios were used to identify statistical significance. The odds of participation in the WIC program were calculated among only Medicaid recipients. SPSS V10.0 software (SPSS, Inc., Chicago, Illinois) was used for analysis.
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RESULTS |
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Table 2 presents associations between prenatal service usage (prenatal care and WIC) and refusal to consent to share data. Refusing to share data with clinical providers and with the immunization registry was significantly more common as the trimester of prenatal care entry increased. Women with no prenatal care were twice as likely as were women with first trimester care to refuse to share data with all sources. Further, women for whom prenatal care information was missing were significantly more likely to not share their data. Moreover, women who were eligible for WIC services but who did not receive WIC assistance were significantly more likely to not share their information with clinical providers or the immunization registry.
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DISCUSSION |
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In central New York, women were more likely to refuse to share their data with a public immunization registry than they were to refuse to share data with their clinical providers. This increased likelihood of refusal could in fact reflect suspicion or anxiety related to government-supported use of personal health information, or it may reflect a lack of information provided to women on the uses and purposes of the information shared with the immunization registry. Women with access to more information about the use of data are more likely to consent to participate in data collection and sharing (18, 19). In addition, correlation of consent refusal with sociodemographic variables may reflect 1) language barriers to the consent process, as has been found in other studies (20), 2) difficulty in understanding the purposes for such sharing (18, 19), or 3) increased suspicion or concern about the use of personal information for other uses (21).
Similarly, women without insurance, women who accessed prenatal care late or not at all, and eligible women who did not use WIC services were more likely to not share data. These latter associations remained even after controlling for the confounding effects of sociodemographic variables. That this association between poor or lack of prenatal program participation and refusal to share data remained after controlling for confounding variables suggests that there may be attitudinal barriers common to both. For example, there may be a "culture of nonparticipation" that reflects women who do not participate in public systems (programmatic or electronic) because of suspicions of public services, lack of awareness of the utility of services, or systemic barriers to services. The clustering of the women in these categories may be multimodal in that some women may refuse public participation because of language barriers evidenced by the higher rates of refusal to share data and to participate in prenatal care among foreign-born women, or perhaps well-informed women actively refuse participation for other reasons (evidenced by higher refusal rates among older and better educated women). The reasons why older women and women with more education may refuse consent are unclear but potentially may reflect a population that is resistant to electronic surveillance, does not perceive a need for the data to be shared, or purposefully does not participate in community programs.
Womens participation in public and clinical systems as reflected by their willingness to share data is not random. Differential consent rates by important sociodemographic and attitudinal characteristics may reflect larger systemic and cultural factors. That women with poorer use of prenatal services are not reflected in clinical and public registries could prove a substantial barrier to public health departments and clinicians charged with providing direct services as a result of such data sharing. Further, the use of such registries for research purposes (such as selection of cases and controls and selection for participation in studies) or for descriptive epidemiologic purposes could be problematic in that the registries do not include all populations equally, leading to potential bias in the resulting studies.
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ACKNOWLEDGMENTS |
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NOTES |
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REFERENCES |
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