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The Next Generation of Research
Conference Summary
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.
Return to Contents
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:
-
Identify methods to evaluate the quality,
content, and use of maternal health care.
-
Identify mechanisms to increase the speed by
which research findings are disseminated and
transferred into practice, programs, and
policies.
-
Identify health services research efforts
necessary to build on and extend our
understanding of ways to prevent low
birthweight and preterm births.
-
Assess the cost-benefit and cost-effectiveness
of factors that promote and predict improved
outcomes related to low birthweight and
preterm births.
-
Identify research topics and strategies to assess
the impact of behavioral interventions during
pregnancy for different groups of women.
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.
Return to Contents
Prenatal Care: Current
Context and Key Issues
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:
-
The detection, treatment, and prevention of
adverse maternal, fetal, and infant outcomes.
-
The amelioration of adverse health behaviors
and socioeconomic conditions.
Dr. Kotelchuk also discussed the three major
factors leading to changes in health policy:
-
Changes in our knowledge base.
-
Social strategies.
-
Political will.
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:
-
What range of maternal and infant health
outcomes are we trying to influence?
-
What are the causal models underlying each
of the negative outcomes?
-
How can we measure the effects of
interventions on outcomes?
-
What range of maternal and antenatal health
services that should be considered
interventions?
-
Are any interventions associated with poor
outcomes?
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:
-
What strategies can be used for systematically
evaluating new interventions?
-
What mechanisms exist for increasing use of
effective interventions and eliminating
ineffective or harmful ones?
-
How do social and demographic factors affect
outcomes?
Return to Contents
Specific Issues and Research
Needs
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.
Scope, Content, and Outcomes of Care
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:
-
The detection, treatment, or prevention of
maternal, fetal, and infant outcomes.
-
The
amelioration of detrimental health behaviors and
socioeconomic conditions.
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:
-
Define the objectives of maternal health care
services in relation to a range of specific
outcomes and 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,
health care use).
-
Identify which specific content of care
components within comprehensive prenatal
care packages may be beneficial for targeted
outcomes. Advance the use of randomized
controlled trials to assess their impact.
-
Examine the recommendations of the IOM
Expert Panel on Content of Prenatal Care to
determine which prenatal care interventions
are supported with adequate evidence and
which unproven interventions require further
research.
-
Redefine the concept of health care to
improve birth outcomes from an exclusive
focus on prenatal care to a continuum of care,
starting at preconception and running
through menopause. 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, with a focus 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.
Return to Contents
Models for Delivering
Interventions
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:
-
Those factors mutable via changes in health
habits (e.g., diet, smoking).
-
Medical conditions not subject to change.
-
Medical conditions subject to change but for
which early detection and treatment can help
manage the risk.
-
Risks that cannot be changed by prenatal
intervention (e.g., age, race, previous
reproductive history).
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:
-
Focus on the social determinants of maternal
health, including screening and interventions
regarding domestic violence and substance
abuse.
-
Develop better interventions (and evaluations
of interventions) for complex problems (e.g.,
behavioral, social, biological, cultural) arising
in a diverse community.
-
Examine what factors influence women's
health knowledge and behaviors (e.g., Where
do they get their information?) and determine
the types of care different groups of women
prefer.
-
Study 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.
Return to Contents
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:
-
Expand research to explore the varying
impact of prenatal care on diverse
populations as defined by medical,
demographic, cultural, and socioeconomic
characteristics and use multilevel statistical
modeling techniques to determine how each
of these factors independently affects
perinatal outcomes.
-
Develop methods to find variations where
there are high rates of adverse outcomes,
determine why they occur, and evaluate
targeted interventions to reduce the high
rates.
-
Investigate the consequences for maternal
health of women who were 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.
-
Identify effective means 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 barriers that may keep women
from entering systems of care.
Return to Contents
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:
-
Defining and developing measures of prenatal
care use.
-
Assessing whether prenatal care or
maternal health care services are actually being
used.
-
Assessing whether adequate use
affects birth outcomes (or other maternal health
outcomes).
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:
-
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 allow
sharing of data and resources, permit
multimethod research designs, 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 obstetric
and primary care in different types of
organizations impacts on 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.
-
Explain 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 where disparities in perspectives exist.
-
Create mechanisms and tools for providers
that promote adherence to and use of
standards.
Return to Contents
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