On September 18-19, 2000, the U.S. Department of Health and Human Services (HHS) convened a conference on the next generation of research in maternal health. It focused on issues related to the content, quality, and use of maternal health services.
Participants urged HHS agencies to enhance the maternal health research infrastructure by developing improved data standards and systems.
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Acknowledgments
Summary
Conference Summary Report
Background
Prenatal Care: Current Context and Key Issues
Specific Issues and Research Needs
Scope, Content, and Outcomes of Care
Models for Delivering Interventions
Special Populations
Quality of Care
Data and Information Needs
Translating Research into Practice
Getting Started: A Dialogue with Senior HHS Officials
Conclusion
Recommendations
Content of Maternal Health Care
Quality of Maternal Health Care
Disparities in Access, Use, and Delivery of Services
Intervention Models
Data and Information Needs
Translating Research into Practice
Training
References
Appendix A: Meeting Agenda
Appendix B: List of Participants
Appendix C: Listing of Recent Prenatal Care Research Sponsored by HHS
We are grateful for the contributions of Carolina Reyes, M.D. At the time of this meeting, she was a Senior Scholar-in-Residence with the Agency for Healthcare Research and Quality (AHRQ). Dr. Reyes provided tremendous leadership in conceptualizing and convening this meeting.
The meeting was the product of shared interests and resources from several components of the U.S. Department of Health and Human Services (HHS)—the first HHS-wide meeting on maternal health care in about 10 years.
We thank Christine Schmidt, M.P.A., in the Office of the Assistant Secretary for Planning and Evaluation (OASPE); Carolyn Clancy, M.D., and Lisa Simpson, M.B., B.Ch., of the Agency for Healthcare Research and Quality (AHRQ); Doris Barnette, M.S.W., of the Health Resources and Services Administration (HRSA); Sumner Yaffe, M.D., of the National Institute of Child Health and Human Development, National Institutes of Health (NICHD/NIH); and Lynne Wilcox, M.D., M.P.H., of the Centers for Disease Control and Prevention (CDC) for their commitment to development of a coordinated, interagency research agenda in maternal health.
The planning committee benefited from the advice and assistance of many people. Agency representatives included:
Marcy L. Gross
Project Director and Senior Advisor on Women's Health
AHRQ
Andrea Pernack, M.P.H.
Co-Project Director and Health Policy Analyst
Office of the Assistant Secretary for Planning and
Evaluation, HHS
Caroline Taplin, M.P.H.
Senior Policy Analyst
Office of the Assistant Secretary for Planning and
Evaluation, HHS
Peter Van Dyck, M.D., M.P.H.
Associate Administrator
Health Resources and Services Administration
We also thank Lawrence Bartlett, Ph.D., Director, Health Systems Research, Inc. (HSR), Washington, DC, for his help in planning the meeting and facilitating the discussion; Kate Lynch Machado, also of HSR, who managed meeting logistics; and Rania Awad, who provided meeting notes and draft proceedings.
We are also immensely grateful to the distinguished speakers and panel members who contributed their time and expertise. They are listed in Appendix B.
A 1985 Institute of Medicine (IOM) report of the Committee to Study the Prevention of Low Birthweight promoted the enrollment of all pregnant women into a system of prenatal care as a national policy to reduce the risk of low birthweight (Institute of Medicine, 1985). This report was followed by congressional initiatives that expanded Medicaid eligibility to include pregnant women.
The policy actions sparked by the IOM report were based on the premise that increasing early initiation and adequate use of prenatal care would reduce the risk of low birthweight (LBW) and preterm birth, thus resulting in lower infant mortality rates (Alexander and Howell, 1997). Although prenatal care continues to be widely touted as an effective approach to reducing low birthweight and preterm births, a decade of further research has raised questions about the impact of prenatal care on LBW rates. As a result, the Department of Health and Human Services (HHS) decided to re-examine its maternal health care research agenda.
In September 2000, HHS convened a conference to discuss the next generation of research in maternal health care, with a focus on issues related to the content, quality, and use of maternal health care services. Five components in HHS—the Agency for Healthcare Research and Quality (AHRQ), the Office of the Assistant Secretary for Planning and Evaluation (OASPE), the Health Resources and Services Administration (HRSA), the National Institute for Child Health and Human Development (NICHD), and the Centers for Disease Control and Prevention (CDC)—cosponsored the meeting. It brought together experts from different parts of the system to identify research gaps and priorities and to suggest how to turn those research needs into questions.
The overall objectives for the meeting were to:
The report presents a summary of the conference. The meeting agenda is presented in Appendix A, and a list of participants appears in Appendix B. A listing of recent research projects sponsored by HHS agencies is presented in Appendix C.
In his opening presentation, "Are We Ready to Assess the Content of Prenatal Care?" Milton Kotelchuk, Ph.D., M.P.H., reviewed many of the key issues that led to the need for this conference. He noted the confusion over what is meant by "prenatal care," a concept that has been enlarged from being a strictly medical (obstetrical) visit to become a public health intervention. This shift resulted in new issues related to access, changing content, and new theories of causation around poor birth outcomes.
Over the last decade, the definition of prenatal care has been expanded to include other ancillary services occurring during the antenatal period (e.g., nutrition, education, and psychosocial services). Alternate sources of prenatal intervention also have begun to receive attention (e.g., the impact of outreach workers, family members, and the community in providing prenatal services and information). Today, the expanded focus is on maternal health care, a concept that encompasses preconception, prenatal, and postnatal care. So from an initial focus on preventing maternal mortality, the role of prenatal care has progressed to encompass:
Dr. Kotelchuk also discussed the three major factors leading to changes in health policy:
He emphasized that in the late 1980s and early 1990s, there was a consensus across the public health community and the Federal Government that the knowledge base was sufficient for developing a series of public interventions related to prenatal care (e.g., Medicaid expansions, Healthy Start). Unfortunately, the efficacy of many of the original components of prenatal care was never rigorously established, nor have there been periodic reviews of the evidence for standards.
Most of the recent research has focused on the relationship between prenatal care use and low birthweight, ignoring the number of alternative outcomes that may be affected by prenatal care. Some of the questions raised by Dr. Kotelchuk include:
A subsequent presentation by Robert Goldenberg, M.D., "Pre-Term Birth: Next Steps After the Low Birthweight PORT Study," focused on one of many possible prenatal outcomes: preterm birth. Although preterm births account for just 10 percent of total births, preterm birth is a factor in 75 percent of perinatal mortality and 50 percent of neurologic handicap.
In 1992, the Agency for Healthcare Research and Quality funded a Patient Outcomes Research Team (PORT) study to examine low birthweight in minority and other high-risk women (Patient Outcomes Research Team, 1998). Dr. Goldenberg noted that the PORT's outcomes of interest were not only preterm birth, but also included the relationship between low birthweight and preterm births and maternal/fetal mortality, long-term handicap, and severe neonatal morbidity.
Focusing on all of these outcomes, the PORT researchers reviewed the research on 11 common interventions thought to have an impact on reducing the incidence of preterm birth. These interventions included: prenatal care, risk screening, nutrition counseling, bed rest, hydration, home uterine activity monitoring, and caloric, protein, and/or iron supplementation. The PORT researchers concluded that there was no evidence to support the usefulness of any of these interventions in reducing rates of preterm birth.
Although prenatal care was found to substantially reduce the rate of stillbirths and term neonatal mortality, it had no or only marginal effects on preterm birth rates or survival rates of low birthweight infants. The lesson learned from this experience is that before other interventions are adopted, there first should be evidence on the effectiveness, ineffectiveness, or harm of the intervention in relation to a specific outcome.
To achieve this, the field of maternal health care would benefit from the development and adoption of a rigorous approach to evaluating new evidence, interventions, and/or technology. Among the specific research questions identified as critically important were the following:
These and other presentations made during the meeting generated significant discussion on a range of topics. These discussions, including suggestions for specific research topics and questions, are summarized here.
Participants agreed that while the relationship between use of prenatal care and low birthweight is almost always the exclusive focus of research, there are a number of alternative perinatal outcomes that may be modified by prenatal care and are in need of further investigation. These include maternal and fetal mortality, severe neonatal morbidity, and long-term handicap.
Emphasis was placed on the importance of identifying, very specifically, what prenatal care should be designed to achieve. A starting point could be to determine which specific prenatal interventions affect which specific outcomes. To fully understand the benefits of prenatal care on specific outcomes, the modifiable adverse outcomes that each component is intended to ameliorate must be specified.
The controversy over the effectiveness of prenatal care in preventing low birthweight also has broadened to embrace the difficulties in defining what constitutes adequate use of prenatal care. There are many content areas (both medical and social) that potentially can be incorporated into a comprehensive prenatal care package, but it simply is not feasible to include them all and achieve improvements in all the associated outcomes.
One of the challenges faced by researchers is that the purpose and content of prenatal care have changed (and continue to change) over time. Prenatal care has shifted from being a medical (obstetric) intervention to a much broader public health intervention where it now encompasses:
Another fundamental problem facing researchers is that the current standards of practice for prenatal care were established without randomized clinical trials to demonstrate the efficacy of many of the components. Conference participants seconded the opinion that there is a pressing need for more systematic research into the effectiveness of each of the many diverse components of prenatal care, using outcomes that can plausibly be modified through prenatal care services.
The discussion often returned to the idea of prenatal care being viewed as a platform that contains many specific components and interventions. To evaluate each specific intervention in an evidence-based manner, there must be a way to single out individual components of prenatal care that may be beneficial for targeted outcomes.
There also was an overwhelming consensus about the importance of moving beyond the traditional concept of prenatal care to integrating it into the broader concept of general women's health: what women need before they become pregnant (preconception care), through the pregnancy and delivery (prenatal care), and after delivery (postpartum care). Current interventions do not recognize that the prenatal period is not the only period of risk for adverse outcomes and therefore do not take advantage of all opportunities for prevention.
The following suggestions for future research were offered:
In the presentation, "A Critical Re-examination of Models of Intervention in Perinatal and Maternal Health," Vijaya Hogan, Dr.P.H., identified research strategies to better understand the impact of behavioral interventions during pregnancy for different groups of women and to assess their long-term value in prevention.
Numerous previous studies have noted that behavioral choices (e.g., smoking, diet, drug use) account for a significant portion of preventable fetal and maternal morbidity and mortality. Therefore, behavioral and social interventions offer great promise to reduce morbidity and mortality, but their potential to improve public health has not been fully tapped. An IOM report (Smedley and Syme, 2001) noted that although approximately 50 percent of mortality in the United States is attributable to behavioral factors, only 5 percent of all health care expenditures are directed at improving the way social and behavioral risks are addressed. When considered in the context of the slow progress in achieving desired outcomes, there is opportunity for reassessing current models of intervention.
According to the traditional model of addressing current known risks, the risk factor first must be identified, and then the effects of the risk factor must be mediated. Dr. Hogan noted that, unfortunately, many of the risk factors for preterm delivery are not readily accessible for intervention. Jack and Culpepper (1990) have classified prenatal risk type into:
In treating the effects of risk, the symptoms affecting the current pregnancy are eliminated, but the social context stays the same. In correcting the causes of risk, on the other hand, there can be a greater effect on clinical conditions because the context has been changed, removing a fundamental cause.
Targeting intervention strategies at individual women makes an incorrect assumption that their behaviors exist outside of a social context. In reality, there are several levels of influence on a woman's behavior, among them the family, social network, social environment, and health care providers. To be successful, any intervention strategy would need to account for all members of a woman's extended family network that she relies on for advice and material support.
Dr. Hogan proposed a multilevel approach that would first research and understand different levels of influence on behavior and then design and target a strategy to intervene on all those levels. She also suggested that intervention strategies should take full advantage of all periods of risk as opportunities for prevention: preconception, prenatal, during delivery, and postpartum.
The following related suggestions for future research were offered:
Special Populations
There is little definitive information on the extent to which individual components of standard prenatal care may be effective in reducing or preventing adverse pregnancy outcomes among different groups of women with special medical conditions and socioeconomic situations. However, there was general agreement among conference participants that the benefits of prenatal care may not be equal for all population subgroups and that there may be differences in use and outcomes based on socioeconomic, demographic, cultural, and medical risk factors. Indeed, participants were concerned about the biomedical, behavioral, social, and cultural factors that, singularly or in combination, are often found in diverse communities but about which little is known.
Although they agreed that a research agenda should address the "big picture" (i.e., the entire Nation), the agenda also should include outlying population "pockets" with major problems. These groups can be defined by ethnicity, subethnicity, locale, or a combination of factors.
There was some agreement as to the importance of carefully considering which subpopulations are studied and how conclusions are derived before translating one single study or intervention on a large scale to different populations where it may or may not have the same effect.
The following suggestions for future research were offered:
Quality of Care
A background paper prepared for the meeting by Carolina Reyes, at the time a visiting scholar at AHRQ, highlighted the fact that although there has been significant improvement in maternal and infant health over the last century, the last decade has shown a slow rate of improvement in maternal and perinatal mortality and morbidity. When considered in light of significant improvements in medical technology, this reinforces the need to place more emphasis on measuring and assessing the quality and outcomes associated with maternal health care.
Furthermore, usually there are many providers involved in a woman's care, which greatly increases the amount of data collected and shared. This reinforces the need for improved and more efficient mechanisms for information flow. Also, traditional perinatal health indicators are no longer sufficient to characterize the underlying problems presented by many pregnant women. Therefore, a quality management strategy is needed to ensure that the health care system will continue to evolve in a comprehensive manner and remain responsive to the individual needs of women.
A presentation by Kimberly Gregory, M.D., M.P.H., "Assessing Maternal Quality of Care," expanded the discussion on these points. She emphasized that the historical paradigm of adequacy of prenatal care being linked to maternal and perinatal mortality and low birthweight are no longer valid criteria as the sole determinants of quality of maternal health care. Poor quality, as defined by the Institute of Medicine (Chassin and Galvin, 1998), encompasses underuse (failure to provide a beneficial health service), overuse (service provided when potential for harm exceeds benefit), and misuse (when the appropriate service is given but a preventable complication occurs).
Dr. Gregory noted that although prenatal care quality indicators currently exist (e.g., Joint Commission on Accreditation of Healthcare Organizations [JCAHO] and American College of Obstetricians and Gynecologists [ACOG] measures), there are no measurements of their effectiveness or how often they are being used.
Several participants noted that there is little consensus regarding quality measures in obstetrics, due in part to a lack of consensus regarding the objectives of care. The adequacy of prenatal care is not easily measured because the definition of adequacy continues to evolve. The Kessner/IOM index (Kessner, Singer, Kalk, et al. 1973; Brown, 1988) and ACOG standards (ACOG, 1974) both define adequacy as the number of medical visits received. Participants emphasized that this definition is misleading because assuming that an increased number of visits is indicative of quality care misses an important confounder: that patients at highest risk for adverse outcomes often are the ones with the most visits. If future research is to enhance understanding about the benefits of prenatal care, the term "adequate care" must be better defined.
Measuring quality in terms of whether a patient receives the appropriate components of care also presents a challenge because, as discussed previously, there is no consensus on the appropriate content of prenatal care. Many content areas have changed considerably in the past decade (e.g., smoking cessation, HIV/AIDS, genetic testing, fetal monitoring). One participant proposed measuring quality of care in terms of whether services are delivered in an appropriate manner and whether patient satisfaction is achieved.
Addressing and improving quality of care also includes identifying and eliminating ineffective or harmful practices. Participants suggested that the examination of old practice models that have since been discredited could provide useful information on developing strategies to eliminate current harmful or ineffective interventions. Some participants suggested doing a cost-benefit analysis for practices that are suspected to be ineffective.
Other issues relate to quality focus on the use of maternal health care services. Three distinct issues affecting use of care were raised:
Participants noted that adequacy of prenatal care use indexes have been in use for nearly three decades, but much improvement is needed. For instance, current indexes of prenatal care use have problems in controlling for gestational age bias. The current measures also establish adequacy by relying on ACOG recommendations for low-risk mothers (ACOG, 1974). What is considered adequate care for women with high-risk conditions has not been fully explored. It remains unclear if the ACOG standard is the best choice to define adequate use.
The following suggestions for future research were offered: