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Data and Information Needs

One overriding concern of participants was the lack of a solid body of data that would provide the foundation for conducting much-needed research. More sophisticated methods for collecting data about the prenatal experience are needed to be able to associate particular interventions with outcomes in a scientifically sound manner. They argued that current data are outdated, uncontrolled, biased, and observational.

Some participants argued that some good data are already available, but the data are not linked together in some type of comprehensive system. Each data system (e.g., Medicaid data, administrative data) is insufficient in and of itself, so there needs to be a way of bringing all the systems together. They also noted that the assessment of prenatal care quality rests on having a comprehensive, nationwide electronic medical record, but costs and other implications have not been fully examined. Participants also noted that since practitioners are already required to keep records, Federal efforts could examine how to link the records electronically to allow for analysis using standardized data.

Participants also noted that in prenatal care, social strategies (e.g., Medicaid expansions) have far outpaced the knowledge base (e.g., knowledge about effectiveness of interventions). The efficacy of many of the original aspects of prenatal care was never rigorously established, nor have there been periodic assessments of the scientific evidence for prenatal care practice standards as prenatal care evolved. Participants agreed that a more systematic way is needed to evaluate interventions as they are developed.

Therefore, participants offered the following suggestions for future research:

  • Standardize key data elements, measures, definitions, and fields and validate existing data systems to determine which are useful for research.
  • Initiate a collaborative perinatal study to gather and analyze obstetric and pediatric information from selected hospitals across the country.
  • Develop a primary clinical information database linked to secondary data (e.g., administrative data, managed care ambulatory data) for a standardized clinical database for the continuum of reproductive health to link with outcomes, financial, and registry databases. Examine the cost-effectiveness (and other implications) of an electronic medical record.
  • Use Medicaid data to study the role of Medicaid in family planning and abortion services.
  • Collect better data via vital records, longitudinal studies on prenatal care, and other services to women to better explain population risk.
  • Expand the medical component of the national standard birth certificate, fetal death certificate, and infant and maternal death certificates, making them electronically available. Teach institutions to use these data to establish benchmarks.
  • Develop and evaluate measurement tools and monitoring systems for maternal health, maternal outcomes, and health services support.
  • Develop and systematically validate practice guidelines across all areas of women's lives for use by internists, family practitioners, and obstetricians, including prenatal care guidelines for high-risk and vulnerable populations.
  • Observe how data elements are linked to outcomes by studying centers of practice that use computerized systems incorporating ACOG standards for measuring quality of care.
  • Initiate demonstration projects to collect primary data based on a minimum data set and integrate data into a clinical information system.
  • Develop national normative data of sentinel events or rate-based indicators that have already been described and stratified by age and race/ethnicity and use these to develop a consensus for standardized measures for case-mix adjustment.
  • Combine data into a repository of clinical and administrative data and use the data to develop a methodology to link structure-process variables with outcomes of interest.

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Translating Research Into Practice

Carolyn Clancy, M.D., Director of AHRQ's Center for Outcomes and Effectiveness Research, initiated a discussion about mechanisms and strategies for building partnerships to facilitate translation of research-based evidence. She reviewed mechanisms through which existing evidence could be evaluated and disseminated, including:

  1. AHRQ-supported Evidence-based Practice Centers (EPCs), which review and synthesize existing evidence on specific clinical topics.
  2. The Cochrane Collaboration, which has a group that evaluates effective obstetrical practices.
  3. AHRQ's Excellence Centers for Eliminating Disparities, which is a grant program that has the goal of strengthening the science base for evaluating and implementing strategies to eliminate differences in outcomes and health status in minorities for six specific conditions.

Dr. Clancy noted that there is an opportunity to explore issues related to infant mortality. What remains to be known is how researchers can work with representatives of different professional organizations first to prioritize a research agenda and then throughout the research project.

In response, participants suggested establishing a better partnership between the practice community and the practice evaluation community, perhaps through an ongoing consensus conference that would provide a better link between the evaluation of practices and the ultimate practices themselves. This type of mechanism could facilitate the dissemination of information about harmful or ineffective interventions. This mechanism would be greatly enhanced if the EPCS or other centers for evidence synthesis could function as a virtual knowledge base for findings, publications, and decisions that are current.

One participant raised the point that although prenatal care is constantly being examined by various groups, it is a haphazard examination. If too many groups are examining prenatal care from too many perspectives and make many different kinds of recommendations, improvements in quality and/or outcomes will not be achieved. Therefore, a forum could be beneficial in bringing together the medical and public health communities so an ongoing dialogue can be established.

The following other suggestions for future research were offered:

  • Support research and education to create a culture in which policymakers, providers, payers, patients, and legislators recognize the value of evidence-based practice.
  • Develop a process for periodically revisiting the evidence and a mechanism for disseminating what is known about both effective and ineffective interventions.
  • Require that grants propose a plan for the dissemination of research findings and provide funding for dissemination activities.
  • Identify appropriate methodologies for dissemination research.
  • Develop stronger interagency communication and cooperation and work with the private sector where cooperation would lead to better initial designs for studies, analyses, and applications.
  • Promote the concept of a virtual knowledge base in maternal health which posts (possibly on the Internet) findings as they are published, as well as standards, guidelines, and results of consensus conferences.
  • Coordinate and regularly update best practices by linking and synthesizing information from ACOG, AHRQ, the Health Resources and Services Administration (HRSA), and the Centers for Medicare & Medicaid Services (CMS).
  • Develop a mechanism for training the next generation of clinical scientists to conduct health services research.

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Getting Started: A Dialogue with Senior HHS Officials

During the concluding session of the conference, a representatives from each of the sponsoring Federal agencies discussed their agency's interest and related activities in the area of maternal health care and highlighted particular issues or research questions that are important to their own agency.

Doris Barnette, M.S.W., noted that HRSA, sometimes called the "access agency," links with safety net providers and funds more than 700 community health centers and 2,100 National Health Services Corps physicians. Between these two groups, 11-12 million patients are served, many of whom are pregnant women and even more of whom are in the preconception/interconceptional phase. Ms. Barnette noted that HRSA has developed a strategic plan for dealing with disparities in health care, but although the plan sets forth strategies, it lacks detail on specific activities. She identified the following as key questions the agency hopes to answer:

  • Are there specific activities and services that are needed, along with more global actions like increasing access, to eliminate disparities?
  • Is there a sense among participants that a major investment of new funds will be necessary? If so, Federal agencies will require help from the medical, academic, and other communities to justify this.
  • How can providers be encouraged to change ineffective or harmful behaviors, and what is the best way to communicate with isolated rural providers?
  • Where do program evaluations fit into the evidence? Are they considered at all?
  • How can patient preferences be better understood?
  • What are the implications of managed care on the content of care and the delivery of services?

Lynne Wilcox, M.D., M.P.H., of the Centers for Disease Control and Prevention (CDC), the "prevention" agency, noted that the CDC is involved in two activities that are relevant to the discussion:

  • Public health monitoring/surveillance.
  • Prevention research.

A data system that is currently in use is the Pregnancy Risk Assessment Monitoring System (PRAMS), which is designed to capture population-level information that can be used by programs to design appropriate responses to maternal and child health issues within their State. The CDC also convened a conference last year to examine maternal morbidity issues and how to capture this type of information on a population level and across health systems, to determine the Nation's status with regard to maternal morbidity. To address issues of disparity, Dr. Wilcox emphasized that not only issues of mortality must be considered, but also morbidity (which affects many more women). Some of the important questions that she raised were:

  • What can help explain disparities in outcomes?
  • What are appropriate interventions taken in the context of an individual woman' lifestyle (i.e., community-based experience)?
  • How may the discussion of maternal health be bridged with the broader women's health discussion?

Dr. Clancy explained that AHRQ will publish the first ever national report on the quality of health care in 2003. She noted that the Agency will have to arrive at some consensus regarding quality measures before then, possibly by looking into mechanisms for bringing together practitioners and public health experts to develop quality indicators for high-priority conditions. She also raised the following questions important to AHRQ:

  • Where does investigator-initiated research fit into the forthcoming agenda? AHRQ needs guidance from professional organizations on how to advertise maternal health services research opportunities to the clinical community in order to build the talent for carrying out maternal health services research.
  • Why do disparities in maternal health care exist, and what is the reason(s) for those disparities?
  • What errors occur in maternal health, and what are the possible strategies to reduce those errors?

Sumner Yaffe, M.D., of the National Institute of Child Health and Human Development (NICHD), which the National Institutes of Health component dedicated to maternal and neonatal research, noted that NICHD has two broad-based ongoing efforts in the area of maternal health:

  • Studying the epidemiology of birth defects.
  • Studying the molecular mechanisms underlying the detection of birth defects.

Dr. Yaffe emphasized that unless basic biological mechanisms of disease are well understood, any other data will not be particularly useful on their own. He highlighted the following ongoing and future activities of NICHD that are related to maternal and neonatal health care:

  • NICHD funds 13 centers, as part of its Maternal-Fetal Medicine Network, to study various factors involved in preterm delivery.
  • The Institute has partnered with the National Institute of Neurological Disorders and Stroke (NINDS) to study the beneficial effects of antenatal magnesium and partnered in the past with the National Heart, Lung, and Blood Institute (NHLBI) to study pediatric asthma.
  • NICHD plans to convene two joint conferences with the Food and Drug Administration (FDA) to examine what is known about the 2,000 drugs used during pregnancy and how these drugs can be properly studied for efficacy.

Beth Benedict, Dr.P.H., J.D., explained that the Centers for Medicare & Medicaid Services (CMS, at the time of this conference the Health Care Financing Administration [HCFA]), unlike many of its sister agencies, directs the majority of its research funds and efforts in response to congressional mandates. Dr. Benedict noted that CMS does not offer grants but primarily participates in cooperative agreements and contracts. The agency does, however, have a very strong intramural research group that works with other agencies on a women's health research agenda. CMS relies on other agencies and the private sector to move research initiatives forward.

Within CMS, there is a Center for State Medicaid Operations (which handles policies, demonstrations, and waivers) and a separate Office of Information Systems (which handles Medicaid data). CMS has already begun to convert Medicaid data files into research-ready formats.

Christine Schmidt, M.P.A., of the Office of the Assistant Secretary for Planning and Evaluation (OASPE) noted a number of similarities between the issues discussed at this meeting and other policy areas that OASPE is involved in. Ms. Schmidt commented that the abundance of issues and suggestions for research provided at the meeting were indicative of the complexity of the maternal health care arena. She highlighted some of the priority questions from the perspective of OASPE:

  • What is the future of e-health and information technology in general and in maternal health care?
  • What are the strategies for developing quality indicators?
  • What are the topics for data collection, and what are the best ways to collect data?
  • Are there stakeholders not present at the conference who should have been engaged in the discussion?

The meeting concluded with a further discussion of these interests and activities with participants and with the recognition that future interagency collaboration will be critical in developing a maternal health research agenda capable of enhancing the knowledge base and moving it forward.

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Conclusion

In an effort to develop a conceptual framework for the next generation of research on the quality, content, and use of maternal health care services, experts from various disciplines and representatives from five HHS agencies identified research gaps and priorities for research.

A call to develop a rigorous science knowledge base and to enhance the research infrastructure resonated throughout the discussion. The panel identified a rich array of priorities. It is hoped that with continued dedicated effort these recommendations will lay the groundwork for the next generation of research on maternal health.

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Recommendations

Following is a categorized, cumulative list of research priorities in maternal health as identified by conference participants.

Content of Maternal Health Care

  • Define the objectives of maternal health care services in relation to a range of specific outcomes.
  • Expand research on the impact of prenatal care to alternative outcomes beyond preterm delivery and low birthweight (e.g., maternal, perinatal, infant, and child mortality and morbidity, health behaviors, use of health care services).
  • Disentangle which specific content of care components within comprehensive prenatal care packages may be beneficial for targeted outcomes. Advance the use of randomized controlled trials for assessing the impact of these components.
  • Examine the recommendations of the Expert Panel on Content of Prenatal Care to determine which prenatal care interventions are supported with adequate evidence and which unproven interventions will require further research.
  • Reframe health care services to improve birth outcomes from an exclusive focus on prenatal care to a continuum of care starting at preconception through menopause, and fund more research on the full spectrum of women's experiences with reproductive health services.
  • Study the impact of reproductive health management during the continuum of maternal health care, focusing not only on the index pregnancy but also on subsequent pregnancies to determine if specific types of interventions have an impact on overall reproductive health.

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Quality of Maternal Health Care

  • Perform systematic evaluations of guidelines or proposed indicators and define optimal management and expected outcomes.
  • Foster efforts to periodically evaluate proposed prenatal care guidelines and standards.
  • Develop indicators across the continuum of care and across all provider levels.
  • Support networks and collaboration to foster sharing of data and resources, perform multimethod research design, and disseminate findings.
  • Identify the most effective communication and education practices for maternal health, and study how physician-patient communication affects satisfaction and other outcomes in different types of settings.
  • Develop potential quality indicators for conditions or services specific to maternal health care.
  • Develop and validate new methods for the measurement of quality in maternal health care, to include optimal outcomes, impact on subsequent pregnancies, and unconventional outcomes (e.g., decreased morbidity and developmental handicaps).
  • Examine how the coordination of obstetrical and primary care in different types of organizations affects quality of care.
  • Expand research on the adequacy of prenatal care use, including improving the current definition and measurement of adequate use, exploring normal use patterns, and defining adequate use for high-risk women.
  • Understand patient variation (e.g., attitudes, preferences, interpretation of informed consent), and develop tools to integrate patient satisfaction and expectations in measuring quality.
  • Explore the quality of maternal health care services from women's perspectives by simultaneously collecting quality/service data from both patients and their providers to identify differences in perspectives.
  • Create mechanisms and tools for providers that promote adherence to and use of standards.

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Disparities in Access, Use, and Delivery of Services

  • Expand research to explore the varying impact of prenatal care on diverse populations as defined by medical, demographic, cultural, and socioeconomic characteristics, and use multi-level statistical modeling techniques to determine how each of these factors independently affects perinatal outcomes.
  • Develop methods to find variations or "pockets" of high rates of adverse outcomes, researching the reasons for the concentrated poor outcomes and evaluating targeted interventions to reduce the high rates.
  • Investigate the consequences on women's maternal health of being born and raised in communities segregated on the basis of socioeconomic status, race, and/or ethnicity.
  • Examine whether there are racial and ethnic disparities in the advice, content, or quality of care provided by health care professionals and how to enhance cultural sensitivity among providers.
  • Identify factors that drive higher rates of prematurity and other adverse outcomes in black women.
  • Identify and measure how structural phenomena like social, economic, and power inequalities (e.g., racism) directly influence health outcomes.
  • Examine the relationship between social determinants and population-level determinants in preterm delivery.
  • Examine social, biological, economic, and environmental contributors to racial and ethnic disparities in maternal and infant outcomes.
  • Examine the various barriers that keep women from entering systems of care.

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Intervention Models

  • Focus on the social determinants of maternal health, including screening and interventions for domestic violence and substance abuse.
  • Develop better interventions (and evaluations of interventions) for multifaceted problems (e.g., behavioral, social, biological, cultural) arising in a diversity of communities.
  • Examine what influences women's health knowledge and behaviors (e.g., where they get their information) and identify the types of care different groups of women prefer.
  • Research the impact of social marketing strategies (e.g., talk shows, soap operas) on various behaviors.
  • Improve the training of alternative types of providers (e.g., nurses, midwives) to provide care to women.

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Data and Information Needs

  • Standardize key data elements, measures, definitions, and fields.
  • Develop demonstrations of information systems for health services research at the local, regional, and national levels to determine the feasibility and barriers to implementing such systems.
  • Initiate a second Collaborative Perinatal Study that would gather obstetric and pediatric information from selected hospitals across the country.
  • Develop a primary clinical information database linked to secondary data (e.g., administrative data, managed care ambulatory data).
  • Use Medicaid data to study the role of Medicaid in family planning and abortion services.
  • Validate existing data and clinical data systems to determine whether their quality is sufficient for use in research.
  • Collect better data via vital records, longitudinal studies on prenatal care, and other services to women in a way that helps to explain and quantify population risk.
  • Improve data quality for monitoring and surveillance, including improved reporting.
  • Provide resources for a standardized clinical database for the continuum of reproductive health to link with outcomes, financial, and registry databases and examine the cost-effectiveness (and other implications) of an electronic medical record.
  • Expand the medical component of the national standard birth certificate, fetal death certificate, and infant and maternal death certificates, making them electronically available. Teach institutions to use these data to establish benchmarks.
  • Develop and evaluate measurement tools and monitoring systems for maternal health, maternal outcomes, and health services support.
  • Develop and systematically validate practice guidelines across all area of women's lives for use by internists, family practitioners, and obstetricians.
  • Develop prenatal care guidelines for high-risk and vulnerable populations.
  • Observe how data elements are linked to outcomes by studying centers of practice that use computerized systems incorporating ACOG standards for measuring quality of care.
  • Initiate a demonstration project to collect primary data based on a minimum data set into a clinical information system.
  • Develop national normative data of sentinel events or rate-based indicators that have already been described and stratified by age and race/ethnicity and use these to develop a consensus for standardized measures for case-mix adjustment.
  • Combine data into a repository of clinical and administrative data and use the data to develop a methodology to link the structure-process variables to outcomes of interest.

Return to Contents

Translating Research into Practice

  • Support research and create a culture, through education, where policymakers, providers, payers, patients, and legislators have an understanding and appreciation of the value of evidence-based practice.
  • Develop a process for periodically revisiting the evidence and a mechanism for disseminating what is known about both effective and ineffective interventions.
  • Require that grant applications include a proposed plan for the dissemination of research findings, and provide funding for such dissemination activities.
  • Determine the appropriate methodological approaches to conducting dissemination research.
  • Develop stronger interagency communication and cooperation, and work with the private sector where cooperation could lead to better initial designs for studies, analyses, and applications.
  • Promote the concept of a virtual knowledge base in maternal health which posts (possibly on the Internet) findings as they are published, as well as standards, guidelines, and results of consensus conferences.
  • Coordinate and regularly update best practices by linking and synthesizing information from ACOG, AHRQ, HRSA, and CMS.

Return to Contents

Training

  • Develop a mechanism for training the next generation of maternal health clinical scientists to conduct health services research.

References

Alexander GR, Howell E. Preventing preterm birth and increasing access to prenatal care: Two important but distinct national goals. Am J Prevent Med 1997;13(4):290-1.

American College of Obstetricians and Gynecologists: Standards for Obstetric-Gynecologic Services. Chicago: ACOG, 1974.

Brown SS, editor. Prenatal care. Reaching mothers, reaching infants. Committee to Study Outreach for Prenatal Care, Institute of Medicine. Washington: National Academy Press; 1988.

Chassin MR, Galvin RW. The urgent need to improve health care quality. Institute of Medicine National Roundtable on Health Care Quality. JAMA 1998 Sep 16;280(11):1000-5.

Committee to Study the Prevention of Low Birth Weight, Institute of Medicine. Preventing low birth weight. Washington: National Academy Press; 1985.

Jack BW, Culpepper L. Prenatal care. J Am Board Fam Pract 1990;3(3):228-9.

Kessner DM, Singer J, Kalk CE, et al. Infant death: An analysis by maternal risk and health care. In: Contrasts in health status. Washington: National Academy Press; 1973.

Patient Outcomes Research Team. Low Birthweight in Minority and High-Risk Women (contract no. 290-92-0055). AHCPR Publication No. 98-N005. Rockville, MD: Agency for Healthcare Research and Quality; 1998.

Smedley BD, Syme SL, editors. Promoting health: Intervention strategies from social and behavioral research. Washington: National Academy Press; 2001.

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Appendix A. Meeting Agenda.

Monday, September 18, 2000

10:00 a.m. Welcome and Introductions
Carolina Reyes, Chair
Agency for Healthcare Research and Quality
Panel Members

10:30 a.m. Opening Remarks: Issues and Challenges
Christine Schmidt
Office of the Assistant Secretary for Planning and Evaluation
Lisa Simpson
Agency for Healthcare Research and Quality

10:50 a.m. Overview: Are We Ready to Assess the Content of Prenatal Care? Linking prenatal care to outcomes
Assessing use of prenatal care services

Milton Kotelchuck
School of Public Health, University of North Carolina
Greg Alexander
School of Public Health, University of Alabama at Birmingham
Unable to attend. His paper was presented by Milton Kotelchuck.
Panel Discussion

12:00 p.m. Lunch
Keynote: A National Perspective on Maternal Health

Margaret Hamburg
Assistant Secretary for Planning and Evaluation

1:30 p.m. Pre-term Birth: Next steps after the LBW Patient Outcomes
Research Team Study

Robert Goldenberg
University of Alabama at Birmingham
School of Medicine
Panel Discussion

2:40 p.m. A Critical Re-examination of Models of Intervention in Perinatal and Maternal Health
Vijaya Hogan
Centers for Disease Control and Prevention
Panel Discussion

4:00 p.m. Translating Research Into Practice Focusing on Priority Populations:
Health Care Outcomes and Effectiveness

Carolyn Clancy
Agency for Healthcare Research and Quality
Panel Discussion

5:15 p.m. Next Steps for the Panel
Carolina Reyes
Agency for Healthcare Research and Quality

Tuesday, September 19, 2000

8:00 a.m. Assessing Maternal Quality of Care
Definitions and Measures of Quality of Care

Kimberly Gregory
Cedars-Sinai Medical Center/UCLA
Panel Discussion

9:00 a.m. What Have We Missed?

9:30 a.m. Where Next? Priorities for the Next Generation of Research on Maternal Health Care Services
Panel Discussion on Content and Quality Issues

1:00 p.m. Research Priorities Continued
Panel Discussion on Access, Cost Benefit, and Use of Services

2:00-3:30 p.m. Speed Planning: Can We Get Started? An Action Plan in 90 Minutes:
Priorities, Strategies and Partnerships
Dialogue with Senior HHS Officials

Doris Barnette, HRSA
Christine Schmidt, OASPE
Lisa Simpson, AHRQ
Lynne Wilcox, CDC
Sumner Yaffe, NICHD
Panel Experts

3:30 p.m. Closing

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