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Strengthening Research in Academic OB/GYN Departments (1992)

Chapter: EXECUTIVE SUMMARY

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Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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EXECUTIVE SUMMARY

Many people in the biomedical research community, including those who fund research and those who conduct it, have detected what they believe to be signs of weakness in the research capabilities of academic departments of obstetrics and gynecology (OB/GYN).

If weakness, indeed, exists, its implications would be extensive, both for present and future generations: research that might be undertaken in these departments has great potential for improving the health of women of all ages and the outcomes of pregnancy, and for reducing health care expenditures for such conditions as the sequelae of low birth weight. This gives a sense of urgency to questions about OB/GYN research capabilities. Below are a few examples of large-scale problems that could be ameliorated by a strengthened OB/GYN research capability:

  • the percentage of infants who are born weighing less than 2,000 grams, which has remained at about 7 percent throughout the 1980s;

  • pregnancy-induced hypertension, which complicates about 2.6 percent of all deliveries and increases the risk of poor outcomes for both mother and child;

  • ectopic pregnancies, which have increased every year since 1970 and have a fatality rate of 42 per 1,000 cases;

  • infertility, which affects about 10 percent of married couples who want children; and

  • an epidemic of sexually transmitted diseases that include 4 million cases annually of chlamydial infection and 24 million people in the United States infected with human papillomavirus, many types of which are associated with cervical carcinomas and severe dysplasia.

To address the question of whether the field of OB/GYN lacks a sufficiently vigorous research capability, the National Institute of Child Health and Human

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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Development asked the Institute of Medicine to convene a study committee. The committee took OB/GYN research to mean research that would be most advantageously conducted in academic departments of OB/GYN, whether for reasons of patient availability, locus of expertise, or because of the particular concerns of the physicians in the specialty. At the heart of this activity are investigators who are trained in the specialty of OB/GYN but who often work alongside physicians from other specialties and investigators trained in basic science.

An integral part of the background to the study is widespread distress about the general state of clinical investigation and the diminishing interest and participation of physicians in research. Thus, other clinical specialties confront many of the difficulties that OB/GYN departments face in generating and sustaining research manpower. Although the committee's charge was confined to finding ways of advancing and strengthening OB/GYN research, to the extent that the solutions recommended here are helpful to other disciplines, there may be additional benefits from this study.

The committee viewed its charge as encompassing three major tasks:

  • developing indicators of the research strengths of academic departments of OB/GYN to assess whether a problem exists;

  • examining the causes of problems or the barriers to improvement and identifying possible solutions; and

  • developing a research agenda for OB/GYN that would both contribute to the resolution of the question of whether a problem in OB/GYN research exists and provide priorities for future research.

The committee used several mechanisms to gather the information necessary to fulfill its charge. It held four meetings of the full committee and established two task forces, one on NIH and the other on the research agenda. To learn about the concerns of the OB/GYN academic research community, the committee sent letters to all chairs of academic OB/GYN departments in the United States and Canada; it received replies from 50 individuals, some of whom responded as representatives of leading OB/GYN professional societies. The committee also commissioned background papers and authorized interviews of a wide array of knowledgeable individuals.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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The Current Situation

Data on total federal support of research or research training in academic departments of OB/GYN were not available, but the committee was able to examine detailed data on NIH support:

  • NIH funding of research in academic departments of OB/GYN increased from $16.1 million in 1978 to $46.5 million in 1989, representing an increase of 180 percent in current dollars and 43 percent in constant dollars. However, the increase in the proportion of total NIH resources going to OB/GYN departments was very small. More importantly, departments of OB/GYN continued to receive a small share (7.5 percent in 1989) of the funds of the National Institute of Child Health and Human Development (NICHD)—the institute that provides the majority of funds from NIH to departments of OB/GYN and that has a mandate to improve reproductive health.

  • Between 1980 and 1989, OB/GYN had a low success rate, compared with other departments, in securing funding for its NIH grant applications. Success rates were 37.6 percent for internal medicine, 33.4 percent for radiology, 31.0 percent for pediatrics, and 28.5 percent for surgery—but only 26.5 percent for OB/GYN.

  • Physicians in departments of OB/GYN made a particularly poor showing. Not only did they submit relatively few applications, but their success rate was lower than that of Ph.D.s from OB/GYN departments and of M.D.s in the four comparison departments noted above.

  • There were relatively few applications for or awards of NIH training and career development awards to departments of OB/GYN, particularly for physicians. It is estimated that only 50 physicians in departments of OB/GYN received NIH research training or career development support between 1980 and 1989—a finding that bodes ill for the future of OB/GYN research manpower.

  • Initiation of the Reproductive Scientist Development Program is a promising sign. This program provides postresidency or postsubspecialty fellowship support for two or three years of training in a basic science laboratory. Grantees thereafter spend three years, with at least 75 percent of that time in research, as junior faculty in the sponsoring department of OB/GYN. The program, which generally accepts three individuals per year, is funded jointly by NIH, OB/GYN professional groups, and industry.

Information on support of research and research training by the private sector provides a less complete but equally disturbing picture, particularly with

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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regard to training future generations of investigators. Industry contributed $19.3 million to research in departments of OB/GYN in 1990. It is not known how this level of funding compares with that of past years. In earlier decades. organizations such as the Josiah Macy, Jr., Rockefeller, Ford, and Mellon foundations played an important role both in supporting research and training and in providing early support for the careers of many of today's most prominent investigators in OB/GYN. Today, however, these foundations have withdraw or radically reduced their support of research in reproduction and of the training of young investigators who intend to pursue careers in reproductive research. Private-sector support of training for young investigators now comes mainly from industry and from OB/GYN professional associations and their foundations. It is estimated that six to eight physician/scientists each year are recipients of major training support from these sources.

The pattern of NIH and private funding confirms what knowledgeable individuals have known for a long time: only a handful of the nation's academic departments of OB/GYN host the kind of research enterprise that provides a truly vibrant environment for research training. There are several specific grounds for this statement. Only me departments reported receiving more than $2 million in federal funds in 1990. The involvement in research by faculty of departments of OB/GYN is low by two measures: the percentage of M.D.s and M.D./Ph.D.s who are principal investigators on NIH or Alcohol, Drug Abuse, and Mental Health Administration grants, compared with other clinical departments; and the proportion of M.D.s and M.D./Ph.D.s who spent more than 20 percent of their time in research activities in 1990 compared with departments of internal medicine in 1983. (This last is admittedly a poor comparison both because of the different time periods and because the procedural demands of OB/GYN make it more like a department of surgery than a department of medicine; however, it is the only department for which comparison data are available.) Finally, there are large numbers of women at the lower academic levels of departments of OB/GYN whose full participation and productivity in research is not likely to occur unless attention is paid to their special requirements, which may include flexible work arrangements and extended time to tenure.

Committee Findings

All pertinent data, as well as the impressions gathered by the committee in interviews and from responses by OB/GYN department chairs to a request for

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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information, indicate present as well as potential future weakness in the research capabilities of academic departments of OB/GYN. In particular, there is cause for acute concern about the research capabilities of physicians in such departments: too few are entering research, and those who do are often not competitive with their Ph.D. colleagues or with physicians in other disciplines. More ominously, the future is compromised because there are too few centers of excellence in OB/GYN research that can serve as research training grounds, and because the level of support for the next generation of investigators is not sufficient to sustain, let alone expand, existing research capabilities. Although it is appropriate for many departments of OB/GYN to preserve their clinical focus, it is also important to expand the number of departments that are competitive players in the research arena, so that OB/GYN can fulfill its potential for improving the health of women.

Findings Related to Career Choices

It is vital for the health of the OB/GYN research enterprise that individuals with the talent and inclination for research be identified early and that obstacles to their growth as investigators be diminished. In particular, since women represent nearly half of all OB/GYN residents and are therefore a very significant component of the pool from which investigators are drawn, it is important that they not be lost to research because of the particular obstacles they face. These include coping with pregnancy and childcare during crucial early faculty years; isolation from traditional information and support networks that guide young investigators; and a dearth of women role models and mentors.

  • OB/GYNs who intend to pursue a career in research must complete a four-year residency, usually followed by two to three years of subspecialty fellowships. It is difficult, however, to interleave research training with clinical training; as a result, these physicians are not equipped with the methodological tools for research nor with the basic science knowledge that would allow them to undertake investigation in the molecular aspects of biology—if that is where their interests lie. Acquiring this knowledge requires at least two to three years. Many in the field have noted that much of the education of the generalist OB/GYN is wasted when an individual selects a subspecialty. Some specialties have made arrangements that allow those destined for an academic career to reduce the time needed to complete clinical and research training. The committee found that the extended duration of training for a physician

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×

investigator in OB/GYN and the difficulties of interleaving clinical and research training deter some individuals who would otherwise enter a research career. As a result, there is an urgent need to reexamine OB/GYN residency and subspecialty training requirements to decrease the total time needed to tram academicians.

  • OB/GYN, like other clinical departments, loses investigators because of the discrepancy between practice and academic income. Data show little difference in this income discrepancy between OB/GYN and other specialties, but a young academician (under the age of 36) earns only approximately 80 percent of the earnings of his or her peers in practice. The experience of many academicians is that this gap (particularly if combined with high debt) deters some potential investigators. A heartening note for OB/GYN is that the specialty choices of women physicians may be driven less by income than by other considerations, suggesting that they may be less deterred from investigation by the difference between academic and practice income if their other needs are met.

  • Debt, when combined with the many other deterrents to an investigative career, does result in the loss of talented individuals from the pool of OB/GYN investigators. Although there is little information on the role of debt in the decision to enter a career in investigation, analysis of the income needed to repay various levels of debt shows that entry-level academic salaries—let alone training and fellowship stipends—do not allow for comfortable repayment of the average debt accrued by the time an individual enters OB/GYN residency. Furthermore, anecdotes abound of individuals in OB/GYN who are unable to pursue an inclination for research because of the burden of debt. The income that OB/GYNs can expect from practice would make debt repayment less burdensome and practice an attractive alternative.

Findings Related to NIH and Other External Support

Although the weakness of OB/GYN research stems in part from factors within the discipline, external factors also play a role. The committee therefore deliberated over what might have caused foundations to decrease their support of research and training in reproductive science, and whether there might be factors at NIH that work against OB/GYN research.

  • In the past, foundation support (e.g., from the Mary R. Markle, Josiah Macy Jr., Rockefeller, Ford, Mellon foundations), was an important factor in the OB/GYN research enterprise and in the training and development of today's

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×

OB/GYN investigators and academic leaders. These foundations have either withdraw from or substantially diminished such support. The committee found cause for alarm in this decline—which appeared to be the result of changes in foundation leadership, changes in the magnitude of government support, and a sense that the interests of OB/GYN investigators do not sufficiently meld with the interests of the foundations.

  • The absence of an OB/GYN intramural program at NIH places OB/GYN at a disadvantage in several ways. In particular, an outstanding training and research environment is lost. Efforts by individuals in the OB/GYN community and by Congress have resulted in welcome moves to establish intramural programs in OB/GYN at NICHD and the National Cancer Institute (NCI). The effectiveness of these efforts points to the importance of leaders of the discipline engaging themselves in endeavors to advance OB/GYN research.

  • OB/GYN is funded primarily by NICHD, whose principal focus is not OB/GYN and whose staffing reflects this lack of emphasis on the reproductive sciences. As a result, OB/GYN lacks the strength that a focal point within the NIH provides, and it also lacks NIH leaders for whom enhancing the field is a high priority. This, too, puts the discipline at a disadvantage.

  • OB/GYN is sparsely represented on NIH study sections—in 1989, only 3 members of NIH initial review groups listed OB/GYN as their area of expertise, compared with 21 in surgery, 19 in pediatrics, 124 in dentistry, and 117 in internal medicine. Despite this lack of representation, however, there is no evidence that applications from OB/GYN receive unbalanced reviews. Scientific Review Administrators possess valuable knowledge that could enable investigators to improve their grant applications.

Findings Relating to Departments of OB/GYN

There is a pervasive sense among chairs of departments of OB/GYN that they operate in an environment in which it is particularly difficult to conduct research. For example, high salaries must be paid to recruit OB/GYNs into academia. In 1990, average salaries for M.D. assistant professors in OB/GYN departments were $121,500, and them are reports that today $150,000 is needed to recruit newly qualified subspecialists. These salaries can only be supported if practice income is substantial; faculty must therefore spend significant time in clinical activities—often at the expense of investigation. The need to generate income to support high salaries also makes it difficult to protect the time of young faculty to allow them to gain the experience necessary to become independent investigators. Added to this financial burden is the fact that many

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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OB/GYN departments provide large amounts of uncompensated care. The committee thus concluded the following:

  • Academic departments of OB/GYN face particular difficulties in establishing the infrastructure for research and expanding their research capability.

  • Two central problems are the need for clinical income to support salaries and the difficulty of sustaining young investigators until they become independent.

  • Most importantly, chairs of OB/GYN departments play a pivotal role in establishing the importance of research in a department, securing external support and providing internal leadership. Three critical areas for their leadership are ensuring a cross-subsidy of research by clinical income, recruitment of promising investigators, and establishing research collaboration with other departments.

Findings Related to Professional Organizations

The professional organizations of a discipline play a role in informing members of the discipline, and others, of the priorities and values of the discipline and in enlisting members in efforts to further those priorities. Thus, OB/GYN professional organizations have considerable opportunities to encourage young people who may be considering research careers, to assert to the discipline the importance of supporting research, and to ensure that influential groups and decision makers are apprised of the potential social and financial return on investment in OB/GYN research.

  • The ethos of a discipline determines its direction. In the case of OB/GYN, the discipline has not developed a critical mass of leaders for whom the advancement of research within the specialty is a high priority. This lack reflects the small number of academic departments of major research status: 38 departments receive no federal research funds; 10 departments receive 50 percent of the NIH funds that are directed to departments of OB/GYN; and there is substantial agreement among knowledgeable people that between 6 and 12 departments can be counted as serious research centers.

  • There has been a recent surge of interest in research to improve the health of women. This is reflected in a major new research initiative proposed by Bernadine Healy, director of NIH, the establishment at NIH of the Office of Research on Women's Health, and an array of legislative proposals from

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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Congress. The emerging realization of a need to foster research on issues related to women's health offers an unprecedented opportunity to make the case for the role of OB/GYN research in women's health and the need to support OB/GYN research. However, this opportunity will be missed unless vocal OB/GYN leaders emerge.

  • Despite what appears to be a generally gloomy picture, several encouraging events have occurred in the area of OB/GYN research. Organizations are supporting the training of investigators through such programs as the Reproductive Scientist Development Program and the James Kennedy Fellowship Award. In addition, the American College of Obstetricians and Gynecologists (ACOG) and other OB/GYN groups have become engaged with groups concerned about strengthening women's health research. Interest in stimulating research has also been expressed by the Council of University Chairs of the Association of Professors of Gynecology.

  • There are lessons to be learned from activities undertaken by other specialties that are attempting to stimulate interest in research. One such example is the Office of Research of the American Psychiatric Association, which undertakes numerous activities to promote research.

Committee Recommendations

The committee concluded that, in order to accomplish the proposed agenda of important research it is necessary to strengthen the OB/GYN research enterprise. The highest priority should be the building of physician research manpower so that more departments of OB/GYN would be able to successfully compete for research support. The committee therefore focused its recommendations on ways of recruiting and sustaining OB/GYNs in investigative careers, and on developing research capabilities in departments that have the potential to become first-rank centers of OB/GYN research.

The committee was also acutely aware of the interaction between research manpower and the research funding needed to strengthen investigation. First-rate investigators must be given time to develop, but this cannot occur in the absence of adequate funds to support their work. Similarly, funds will be forthcoming only if first-rate investigators are available to use them. Therefore, in addition to recommendations to strengthen physician research manpower, the committee considered strategies that would result in increased funding for OB/GYN research. Investigation in a particular field will thrive only if those who fund research are knowledgeable about its importance. The research agenda that constitutes Chapter 6 of this report therefore emphasizes the

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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significance of the proposed research to the prevention, cure, or amelioration of major health problems. In addition, the committee encourages OB/GYN leaders to educate decision makers and to stimulate support for OB/GYN research.

The committee was aware that many of the problems being confronted by the discipline are also faced by other clinical departments that are trying to develop or sustain clinical investigation. This does not lessen the problems for OB/GYN. Moreover, each clinical discipline has unique characteristics that must be accommodated in arriving at solutions to its problems.

No one entity bears total responsibility for this effort. Rather, the following recommendations are directed toward those in positions of leadership at NIH and in foundations, in the departments of OB/GYN, and, most importantly, in the profession of OB/GYN itself. This is the main source from which must flow the leadership that is the prerequisite for development of a strong research community. The committee's conviction that members of the discipline of OB/GYN must play leading roles in strengthening support for research in the profession itself and in the organizations that fund training and research underlies many of the following recommendations.

Recommendations for NIH and NICHD

  • NICHD program staff should exercise to the fullest extent possible their ability to target training support to expand the number of research training opportunities for physicians in OB/GYN. The committee also recommends that NICHD tailor another career development award to OB/GYN physicians. Because of the importance of the program, NICHD should continue to sustain the Reproductive Scientist Development Program.

  • Institutes at NIH whose missions include areas of science to which OB/GYN contributes should affirm their commitment to reproductive health and ensure its appropriate priority in their programs. The committee believes that there is an urgent need for changes that emphasize the importance of OB/GYN research. Actions that would help overcome some of the problems OB/GYN research now confronts might include the National Institute of Child Health and Human Development's changing its name to signal to the public and institute staff its commitment to and responsibility for reproductive health. NICHD could also recognize the importance of programs in reproductive health by establishing the position of deputy director for reproductive health or by appointing a board-certified OB/GYN to the position of deputy director. Further actions that might be considered by NICHD include increased representation of

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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OB/GYN on its staff, and the development of requests for applications (RFAs) on high-priority OB/GYN research topics identified in institute plans.

  • NIH should develop a system to track OB/GYNs who are receiving federal training and career development support.

Recommendations for Other External Support

  • Congress should ensure the success of recent initiatives to establish intramural programs in OB/GYN by appropriating the necessary funds. Leaders of the profession of OB/GYN have the responsibility to educate and inform those in decision-making positions about the importance and promise of an intramural program of OB/GYN research.

  • Decision makers in foundations that are concerned with the development of scientific personnel—or with population problems, women's health, cancer, pregnancy outcomes, and other topics that OB/GYN is well positioned to address—should be aware of the role that their support of training and research could play at this crucial time in the development of OB/GYN research.

  • A foundation should set up a program to assist the advancement of potential research leaders. The Markle Scholars Program and other efforts to develop academic leaders should be examined to determine which of their characteristics should be replicated.

Recommendations for Which Multiple Groups Have Responsibility

  • The committee recommends that a program to alleviate the burden of debt (e.g., loan forgiveness, deferral of repayment, targeted fellowships or awards that eliminate the need to recur further debt, etc.) be established for physicians qualified in the specialty of OB/GYN who have demonstrated a serious intention to pursue a career in research. Program costs will not be large and should be home by a consortium of OB/GYN professional associations, the pharmaceutical industry, academic departments of OB/GYN, and the Public Health Service.

  • Professional groups and other private-sector organizations that support the Reproductive Scientist Development Program should ensure its stability through a long-term commitment of resources.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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Recommendations for Departments of OB/GYN

  • Chairs of departments of OB/GYN should make a serious commitment to augment their research capabilities and to vigorously engage in informing medical school leaders and OB/GYN faculty of the potential of investment in research and research training. This commitment should also extend to accommodating the nonfinancial working needs of investigators, to facilitate and ensure their continued involvement in research.

  • In particular, OB/GYN department leaders should pursue ways to ameliorate the stresses that attend the life of women in science. Every effort should be made to find women mentors and role models for women investigators. In addition, chairs in institutions in which no provisions exist for extending time to tenure for individuals with pressing personal commitments should engage the institution's decision-making groups in an effort to initiate such a policy.

  • The committee recommends three specific strategies for increasing research activities: (1) increase the clinical income used to support research; (2) conduct important epidemiological and behavioral research that is relevant to OB/GYN; and (3) create interdepartmental research linkages.

  • To ensure the dissemination of knowledge about NIH grant processes, and to enable applicants to improve their applications and make full use of the many NIH funding mechanisms, members of academic departments of OB/GYN and members of professional societies concerned with OB/GYN research should explore all avenues of communication with NIH staff.

  • Chairs of departments of OB/GYN should work with NIH staff to improve the success rate of applicants for FIRST (First Independent Research Support and Transition) awards.

Recommendations for Professional Organizations

  • The American Board of Obstetrics and Gynecology should immediately reexamine training requirements for generalists and subspecialists in OB/GYN to ascertain whether the training programs are unnecessarily long. A reduction in the time needed to obtain subspecialist status would allow those interested in pursuing a career in research and academic OB/GYN to achieve their goal more quickly than is possible today.

  • OB/GYN professional organizations should create opportunities for expanding research and for stimulating young members of the profession to view investigation as an exciting and valued activity. Useful mechanisms include

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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special sessions at annual meetings and providing funds for interested residents to attend such meetings. These organizations should combine resources to establish an office whose mission would be the encouragement of OB/GYN research.

  • OB/GYN professional organizations should expand their efforts to educate decision makers about the potential of OB/GYN research and the importance of accomplishing the research agenda laid out in this report.

  • The American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics should continue to include in their manpower survey questions on sources of research support received by departments of OB/GYN. This information will for the first time allow tracking of the level of research activity in departments of OB/GYN.

Recommendations for Leadership

  • Individuals with a strong interest in research should be represented in decision-making positions in leading OB/GYN professional organizations.

  • OB/GYN leaders should take the initiative in demonstrating to foundation and voluntary health agency trustees and other representatives, to leaders of professional associations, and to relevant foundations of industrial corporations, ways in which expanded support of training for OB/GYN investigators would be a worthwhile investment.

  • OB/GYN leaders should also seek additional research support from the types of organizations mentioned above.

  • Leaders of the profession of OB/GYN have the responsibility to educate and inform those in decision-making positions about the importance and promise of OB/GYN research.

  • OB/GYN leaders should also work with NIH staff to identify key issues and otherwise encourage OB/GYN research.

A Research Agenda for OB/GYN

The committee developed an agenda of OB/GYN research using the following criteria:

  • The research should contribute to the resolution of an important health problem.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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  • The research approach suggested should have promise.

  • The research should be conducted in departments of OB/GYN or in collaboration with members of such departments.

The research agenda serves two purposes: (1) its depth and breadth underscore the need to strengthen OB/GYN research capabilities so that the suggested research can be undertaken, and (2) it can be used as a guide to prospective funders. The implementation of this important research agenda will require more resources than are currently being used by OB/GYN researchers, and the shifting of resources to OB/GYN research.

During the period of this study, NIH initiated three activities that will result in research agendas that overlap many areas of the committee's work: the Pregnancy, Birth, and Infant Research Plan of the National Institute of Child Health and Human Development, a research agenda being developed by the Task Force on Opportunities for Research on Women's Health, and the development of a strategic plan that brought together a panel on reproductive biology and development and one on infant health and mortality. In light of these large-scale efforts, the committee felt that it would be duplicative to produce a comprehensive, detailed research agenda. Instead, individual committee members were asked to highlight areas of investigation that meet the criteria listed above and that exemplify the range of questions that might fruitfully be investigated. Because there were no committee members with expertise in the behavioral sciences, technology assessment, or outcomes analysis, the agenda outlined in the following sections does not sufficiently emphasize those areas. The committee therefore wishes to stress its opinion that departments of OB/GYN, in conjunction with individuals with relevant expertise, are well suited to undertake investigation of many topics related to behavior that affects reproductive health, the technologies used by the field of OB/GYN, and the outcomes of care provided by OB/GYNs. The large number of patients who receive care in the OB/GYN clinics of academic centers represents an opportunity for clinically relevant epidemiological research—including research on the efficacy of treatment, on the natural history of disease, and on the prevention of disease. Faculty of departments of OB/GYN, in collaboration with epidemiologists, sociologists, statisticians, and health services researchers, have the patient base and the discipline-specific interests needed to investigate questions that other disciplines are not likely to undertake. The committee also believes that the advantages of the patient base and knowledge that resides in departments of OB/GYN suggest that these departments should organize

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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and conduct clinical/epidemiological trials that are often now initiated by other departments.

Oocyte and Follicular Development in the Ovary

Follicular Formation

  • Elucidation of the events responsible for the transformation of endodermal cells into germ cell elements.

  • Understanding of the forces responsible for guiding the germ cell toward the proper location in the future ovary.

  • Clarification of the cellular origins of the somatic follicular cells.

  • Analysis of the cellular mechanism or mechanisms responsible for the initiation of meiosis and for its arrest at the prophase stage of the first division.

  • Improved understanding of the role of putative intraovarian paracrine and autocrine regulators.

Follicular Atresia

  • Understanding of the molecular events responsible for determining follicular fate.

  • Development of a reliable, reproducible experimental model for improved understanding of the atretic process.

  • Understanding of the apoptotic nature of the atretic process and, in particular, of the ionic events that appear to trigger the molecular enzymatic events.

  • Focused investigation of potential putative intraovarian regulators concerned with the atretic process.

Follicular Recruitment, Selection, and Dominance

  • Development of more specific markers capable of predicting the general well-being of the follicle in question and most importantly the quality of the resident oocyte.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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  • Improved understanding of existing known cytokine and growth factor regulators and the elucidation of the potential role of as yet unrecognized peptides.

Corpus Luteum Function

• It would be interesting to determine if the block to cell proliferation involves known genes associated with suppression of cell growth (perhaps one or more of the recently discovered tumor-suppressor genes, such as the retinoblastoma, or RB) or new examples of similarly functional genes.

Leukocytes, Cytokines, and Ovarian Function

• Determine the physiological role of immune system-derived products on ovarian function.

Fertilization

  • Continued investigation of the role of maturation-promoting factor(s) in the reinitiation of meiosis and the continuation of egg maturation.

  • Continued investigation of the molecular biology of sperm chromatin processes.

  • Continued investigation of the biochemical composition of cortical granules and the significance of cortical granule dehiscence prior to sperm-egg fusion, as well as their general role in the fertilization process.

  • Determination of the physiology and biochemistry of germinal vesicle breakdown.

  • Further investigation of the molecular events and physiology of the formation of maternal and paternal pronuclei.

  • Determination of the physiology and biochemistry of male and female pronuclei (envelopes) breakdown and the re-condensation of their chromosomes.

  • Continued investigation of the molecular biology of the zona proteins and their significance to sperm binding. Particular questions include how zona proteins are related to the slow block to polyspermy, and how sperm receptors are inactivated.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
  • Continued investigation of the fast block to polyspermy following the sperm-egg fusion.

  • Investigation of the biophysics of sperm-egg-cortical granule fusion.

  • Continued investigation of the molecular biology of sperm capacitation.

  • Continued investigation of the molecular biology of the acrosome reaction with an emphasis on understanding the significance of the hydrolytic enzymes and their role in the general process of fertilization.

  • Definition of the molecular events of the first cleavage, focusing on the involvement of cyclins. Continued focus on each of the fertilization events, keeping in mind a possible means of interruption as a contraceptive tactic.

Fetal Growth and Development

Embryology and Congenital Malformations

  • Investigation of the basis of genetic regulation of early embryogenic events, including the role of homeotic genes in both normal embryogenesis and in congenital malformations.

  • Characterization and study of embryologic mechanisms, including cell-cell interactions, cell migration, cell matrix interactions, and programmed cell death, all of which are important in normal and abnormal development. Development and exploitation of tissue and embryo culture techniques to examine developmental mechanisms and teratogenic influences on development including a study of drug-induced malformations as well as those resulting from conditions such as maternal diabetes or abnormal immune states.

  • Investigation of endocrine and growth factor signaling that modulates fetal growth and organ maturation—for example, the basis of actions of muellerian inhibitory factor (MIF) and androgens in regulating sex differentiation.

Fetal Growth and Placental Transport

  • Placental transport during normal development and under conditions in which nutrient flow is compromised.

  • The mechanisms by which specific disease states alter transport processes and the basic signaling mechanisms that regulate fetal growth and organ maturation. For example, infants of diabetic mothers with excessive

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×

substrate delivery and of large fetal size show a delay in organ maturation, whereas those with intrauterine growth restriction secondary to fetal malnutrition exhibit accelerated lung and brain maturation. The mechanisms underlying such changes are largely unknown.

  • Metabolic regulation during development.

Congenital Infection and Substance Abuse

  • Studies of mechanisms of maternal to fetal transmission of viruses.

  • Development of strategies to alter high-risk behaviors.

  • Investigation of pathogenesis of defects resulting from congenital infection.

  • Development of drug surveillance and treatment programs.

Perinatal Research

  • Investigation of what controls the signaling that induces lung maturation in preparation for the extrauterine environment.

  • Development of new therapies to induce maturation.

  • Investigation of the influences of maternal disease states and environmental insults on maturational events.

  • Refinement of techniques for fetal surveillance and the development of better indices for normal and abnormal function.

  • Development of new systems to deliver drugs, replacement hormone therapy, or nutrients to the fetus.

Epidemiological Research

  • How does prenatal care reduce perinatal morbidity?

  • How can we measure the effectiveness of social and behavioral interventions in changing high-risk behaviors that impair and limit fetal development?

  • How do specific obstetric interventions—for example, cesarian section and maternal nutritional supplementation—affect newborn outcomes?

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×

Preterm Labor

Preterm, Premature Rupture of the Fetal Membranes

  • Research must be directed to understanding the regulation of synthesis and degradation of the extracellular matrix of the fetal membranes and contiguous decidua parietalis.

  • It is suspected, but not established, that infection by way of the action of bacterial toxins (lipopolysaccharide, or LPS) may serve to initiate the formation of metalloproteinases that act upon the extracellular matrix of chorion laeve and amnion. We must ascertain if this is a mechanism by which fetal membrane rupture is commenced because if this is indeed the case, the condition is theoretically preventable.

Complications of Pregnancy That Compromise Fetal or Maternal Well-Being Independent of the Onset of Labor

  • Research is needed on the pathogenesis of pregnancy-associated hypertension.

  • Research must be directed toward defining the pathophysiology of the processes that mandate delivery prematurely even though independent of labor. Commonly, the obstetrician is faced with choosing between a deteriorating intrauterine environment for the fetus and the neonatal intensive care nursery for a sick newborn.

Preterm Onset of Labor

  • Information must be assembled to understand the fundamentals of the maintenance of pregnancy and the spontaneous initiation of parturition at term.

  • What are the physiological processes that effect such a stronghold on uterine contraction during human pregnancy?

  • How are these processes translated at the biomolecular level?

  • What is the role of the fetus in the maintenance of pregnancy and in the retreat from pregnancy maintenance at the end of normal gestation? It now seems very likely that retreat from pregnancy maintenance is the most likely choice of potential mechanisms for the initiation of spontaneous labor at term.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×

Therefore, we must define in great detail the processes that bring this remarkable situation about.

  • An understanding of the contractile properties of the uterus before and during pregnancy must be gained.

  • The role of Ca2+ channels and Ca2+ sequestration must be understood as these apply to the uterus of pregnancy.

  • The contribution of the unusual hormonal milieu of human pregnancy to the maintenance of uterine quiescence must be investigated. Before we can realistically address the causes of preterm labor, an understanding of these processes operative in normal human parturition at term must be acquired.

Preterm Labor and Infection

  • Research must be conducted to establish the role, if any, of infection in the preterm onset of labor.

  • An understanding of the cause or muses of preterm cervical dilatation is urgently needed.

  • The nature of the pathophysiology of the association with preterm labor and extrauterine infections also must be defined.

Contraception

  • Develop contraceptives that protect women against breast and cervical cancer.

  • Increase user satisfaction by offering contraceptors a wider array of choices.

  • Provide contraception for some underserved groups including men, lactating mothers, teenagers, and premenopausal women.

  • Develop contraceptives that protect women against sexually transmitted diseases (STDs).

Contraceptive Implants

  • Develop new drag delivery systems for steroids that would improve the pharmacokinetic profile to eliminate long-term tail-off of drug release once implants were sufficiently depleted of steroid as to be ineffective.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
  • Assess the carcinogenic and other long-term effects of progestins on the breast, cardiovascular system, and other organs.

  • Conduct and evaluate implants in clinical trials.

  • Conduct long-term studies on NORPLANT to determine the health benefits and risks of long-term, low-dose, progestin-only contraception compared with combined oral contraceptives.

  • Develop biodegradable implants that can be removed at any time and that do not have a long period of drug tail-off.

  • Conduct studies in lactating women with ST 1435.

Contraceptive Rings (CRs)

  • Determine the optimal steroid for use in different CRs.

  • Determine how much the hormone dose can be decreased without compromising effectiveness and safety.

  • Perform specialized phase 2 studies on CRs to determine whether vaginally administered steroids are different from orally administered steroids with respect to ovarian function; lipoprotein levels; metabolism; effects on cervical, uterine, and vaginal pathology; and carbohydrate metabolism.

  • Determine the long-term effects of CR use.

Transdermal Delivery

  • Determine what type of transdermal delivery will be most acceptable to women: high-tech patches vs. low-tech creams.

  • Conduct optimization of studies to select appropriate contraceptive steroids and their proper doses.

  • Determine subject-to-subject variability in absorption using pharmacokinetic studies.

  • Conduct local dermal irritation and toxicity studies. Conduct clinical studies for effectiveness.

Intrauterine Devices (IUDs)

  • Conduct behavioral studies to determine why women do not wish to use IUDs and why many health care workers will not insert them.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
  • Develop effective methods to identify, those women who are not good candidates for IUD use, that is, those who will have to discontinue IUD use because of bleeding and pain.

  • Develop IUDs that act as barriers to infection of the upper reproductive tract.

  • Develop hormone-releasing IUDs that will further reduce IUD side effects.

Oral Contraception

  • Study the long-term consequences of OCs, and determine the mechanism of action of mellatonin in women.

Barrier Methods

  • Select candidate compounds from results of previous screening tests on sperm and sexually transmitted diseases (STDs).

  • Test candidate compounds for evidence of antifertility effects and effectiveness against selected STDs in vitro. Prepare formulations (suitable for human use) of individual multiple compounds for animal tests. Test formulations in vitro.

  • Test selected formulations for evidence of effectiveness in animal model systems.

  • Prepare selected candidates for tests of effectiveness in humans.

  • Conduct comparative trials in humans.

Male Contraception

  • Determine whether luteinizing hormone-releasing hormone (LHRH) agonists or antagonists are the optimal component of a male method.

  • Develop long-term delivery systems for LHRH analogs.

  • Select an appropriate androgen for long-term administration, and develop an appropriate delivery system.

  • Conduct phase 1 and 2 clinical studies of the androgen and the LHRH analog.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
  • Investigate new approaches by developing methods that will interfere with the autocrine/paracrine control of germ cell maturation in the testis (a long-term objective).

Antifertility Vaccines

Sperm Antigens
  • Isolate a full-length cDNA thai encodes promising sperm proteins, and determine their nucleotide sequences.

  • Identify the nucleotide segment encoding the extracellular domain of membrane proteins and the entire sequence of secreted proteins; express such proteins in the baculovirus or similar expression system; and isolate expressed proteins for biological testing.

  • Study the effect of immunization with the recombinant proteins and/or synthetic polypeptides.

  • Produce a human dosage form, and test it in animals.

  • Perform trials in humans.

LHRH-Vaccine Used With or Without a Vaccine to the Luteinizing Hormone or FSH (Follicle Stimulating Hormone) Receptor
  • Conduct trials of the LHRH vaccine in animals and humans.

  • Prepare recombinant polypeptides of the luteinizing hormone (LH) and follicle stimulating hormone (FSH) receptors, and study their immunogenicity.

  • Prepare synthetic peptide segments of LH and FSH receptors corresponding to the hormone-binding and adenylate cyclase-stimulating domains, and conjugate the peptides with a carrier protein.

  • Establish immunogenicity of the LH and FSH receptor peptide segments by determining the interaction of antibodies developed against specific receptor peptide segments with the recombinant extracellular domain of the respective receptor, and with isolated ovarian and testicular membranes containing the LH and FSH receptors, respectively.

  • Immunize male and female rats with various combinations of LHRH-antigen and specific LH/FSH receptor peptide segments, and determine their effects on sex steroid production, gonadotropin secretion, spermatogenesis, ovulation, and fertility.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×

Medical Abortifacients

  • Identify an antiprogestin that can be used as a substitute for RU 486 in a new medical abortifacient.

  • Test combinations of an antiprogestin, anordrin analogs, progesterone synthesis inhibitors, and prostaglandins in pregnant animals to determine the lowest effective dosages in terminating pregnancy.

  • Determine the window of effectiveness during the postcoital period when the combined drugs could be most effectively administered.

  • Select the most promising combination of drugs for small-scale clinical trials, and perform the appropriate toxicology.

  • Develop an appropriate delivery system so that the drug combination could be administered in only one clinical visit.

  • Investigate the acceptability of new delivery systems to users and providers.

Infertility

  • A structured, comprehensive research program, including an epidemiologic description of the etiologies of infertility and basic research in cervical, tubal, and sperm development and function, would both expand our knowledge and the therapies available for infertile couples.

  • Specific disease processes associated with infertility, such as endometriosis and tubal adhesions, need investigation.

  • The new reproductive technologies of in vitro fertilization and gamete intrafallopian transfer (GIFT) offer a tremendous opportunity for understanding the specific cellular processes of human reproduction.

Epidemiology

  • Research is needed on the effect of chemical contaminants on sperm and oocyte function. In addition, more research on the effect of such substances as alcohol, tobacco, and drags on gametogenesis and fertilization is necessary.

  • Firm, normative data on normal fecundity and fertility, and a multitude of other reproductive issues, are needed for comparative data as the newer reproductive technologies continue to expand.

  • There is a need to ascertain the relationship between age and human (both male and female) fertility.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×

Cervical Physiology and Function

  • Research is needed to understand the physical and chemical properties of cervical mucus that facilitate sperm motility and to develop solid criteria for diagnostic tests of mucus function.

  • Study is needed of the relationship of cellular and antibody mediated immunologic function to normal sperm motility, as well as to the prevention of pelvic infection.

  • More research is needed to define normal cervical function and immunology with the goal of improved therapies for cervical factor infertility.

Fallopian Tube Function

  • New techniques must be developed to evaluate tubal function and to describe the specific etiologies of abnormal tubal function.

  • Studies are required to assess ciliary function and the role of muscular contractions in transporting the embryo into the uterus.

  • The area of steroid and growth factor interactions with tubal epithelium requires a major research commitment.

  • Normal implantation in the endometrium is modulated by a number of growth factors, and research into the role of growth factors in tubal function may provide important answers on the etiology and genesis of tubal ectopic pregnancies.

Endometriosis

  • Research is needed on the relationship of endometriosis to infertility.

  • Basic and clinical research into questions of who needs treatment and what is the best modality could yield an excellent societal return on investment.

Male Infertility

  • Research at the basic science level must be initiated before a true understanding of the causes and possible treatments of male infertility can be proposed.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
  • Research is needed into sperm-oocyte interaction, including details of fertilization and chromosome exchange, sperm acrosome reaction, sperm maturation, sperm metabolism, and detailed sperm morphology.

In Vitro Fertilization and New Reproductive Technologies

  • Research using appropriate animal model systems in the primate and research utilizing human follicular fluid, corona, and cumulus cells should investigate the molecular biology of human fertilization and early cell division.

  • Research should be conducted on the involvement of growth factors, activation of the embryonic genome, and metabolism in the very early embryo.

Premenstrual Syndrome

  • The metabolism and bioactions of progesterone and its metabolites are fruitful areas for research to define the biological muses of symptoms referred to as the premenstrual syndrome.

The Brain and Reproduction

  • The nature, specific localization, and mode of operation of the gonadtrophin-releasing hormone (GnRH) pulse generator must remain a critically important subject for intensive investigation at the systems, cellular, and subcellular levels.

  • While estradiol can initiate the preovulatory gonadotropin surge in the absence of changes in GnRH production, what actually happens during the normal menstrual cycle is not known and should be investigated.

  • The quantitative role of neuroendocrine deficits in the causation of infertility in women must be defined.

  • The mechanisms whereby ''stress'' inhibits the GnRH pulse generator and consequent ovarian function must be elucidated.

  • The mechanisms whereby lactation, severe exercise, and caloric deficits lead to amenorrhea and infertility must be characterized.

  • The mechanisms of action of a variety of modulators of GnRH pulse generator activity must be elucidated.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
  • It is now clear that the control of LH and FSH secretion by the pituitary gland is not the same. The role of activins and inhibins and other factors in the control of FSH secretion must be investigated in a physiological context.

  • The mechanisms that cause the inhibition of the GnRH pulse generator shortly after birth and its reawakening at the time of puberty remain a complete mystery. The initiation of puberty continues to be a central, unsolved problem in human biology.

  • The functional relationship between the hourly activation of the GnRH pulse generator and "hot flashes," synchronous events in postmenopausal women, should be a subject of concerted study with the aim of discovering the physiological basis of the phenomenon and its potential alleviation by alternatives to estrogen therapy.

Menopause

  • Long-term, prospective studies to evaluate the effects and side effects of combinations of estrogen and progestins in the treatment of postmenopausal women should be conducted.

  • Studies are needed to explain why very few postmenopausal women are treated with estrogen.

  • Studies are needed to discover and assess the risks of adding progestin to estrogen treatment.

Oncology

Ovarian Cancer

  • What are the factors that predispose the development of ovarian cancer?

  • What preventive measures can be identified that could be implemented on a wide scale?

  • Is there a cost-effective method for early detection, such as the development and refinement of sensitive vaginal ultrasound, that would greatly improve survival?

  • Which genetic alterations, if any, play a causative role in neoplastic transformation merits further investigation.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
  • Are there methods, including human minor clonogenic assay, which can provide useful information and important clues to guide therapists to the optimal form of chemotherapy for specific patients?

  • What new agents or new approaches can be developed to kill the cancer cell—for example, novel delivery systems or specialized treatment approaches such as the improved use of intraperitoneal therapy as well as the immunologic development of new biological response modifiers?

Uterine Neoplasms

  • Can transvaginal ultrasonography become a cost-effective tool for early uterine cancer detection, similar to the project described in the discussion on ovarian cancer?

  • Specialized treatment trials are needed to determine optimal methods for combining chemotherapy and radiation therapy, as well as chemotherapy and hormone manipulation, to enhance responses in survival.

  • What is the safety and risk of estrogen replacement therapy in those who have been successfully treated for uterine cancer?

Cervical Cancers

  • What is the influence of human immunodeficiency virus (HIV)-related immunosuppression upon the risk of cervical human papillomavirus (HPV) infection, cervical dysplasia and cervical neoplasia? This requires population studies.

  • Do HPV infections require therapy and if so, which types are needed to reduce the frequency of cervical cancer?

  • Can a methodology be developed to identify which "premalignant" cervical neoplastic conditions are at risk for progression?

  • What are the optimal intervals for cervical cytologic screening?

  • What are the optimal methods of treating various degrees of cervical intraepithelialaeoplasia, and which are most cost-effective?

  • What is the role of HPV in the genesis and progression of cervical neoplasia?

  • What characteristics (oncogene amplification, for example) can be identified that will reliably predict aggressive tumor behavior and thus provide the basis for improved initial treatment strategies?

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
  • How can the standard therapies of radiation or operation for cervical cancer be combined with newer modalities of chemotherapy or immunotherapy to improve survival?

  • What new strategies can be developed to improve the therapy of recurrent cervical cancer, which currently is almost uniformly fatal?

Vulvar Malignancies

  • Clinical trials are needed to establish efficacy and safety of new treatments.

  • What is the optimal method of therapy of premalignant lesions of the vulva, and can one identify which of these lesions actually require therapy? This should include investigation of rates of progression and regression, identification of lesions that require therapy, and determination of optimal screening intervals. Understanding the molecular biology of premalignant vulvar disease should help in this area of research.

Breast Cancer

  • What is the potential effect of oral contraceptives on pre- and postmenopausal breast cancer?

  • Does prolonged oral contraceptive use or early initiation of use (prior to age 20) alter the risk of the development of breast cancer?

  • Does prolonged estrogen replacement therapy alter the risk of breast cancer?

  • Does the addition of a progestin (protective for endometrial carcinoma) alter breast cancer risks?

  • Can estrogen replacement therapy be safely used in patients who have been successfully treated for breast cancer to avoid the morbidity of estrogen deprivation?

  • Does tamoxifen therapy for breast cancer alter the risk of endometrial neoplasia?

  • Can groups of high-risk and low-risk women be identified through metabolic hormonal investigation or through molecular studies such as those involving proto-oncogenes?

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×

Trophoblastic Disease

  • What are the effects on future fertility of successful chemotherapy of trophoblastic diseases?

  • What are the effects of chemotherapy in the mother on future genetic abnormalities in the offspring?

  • What improved treatment strategies can be developed to help patients who currently succumb to the disease?

  • What are the genetic or other muses that lead to the development of gestational trophoblastic diseases?

Sexually Transmitted Diseases

Prevent Sexually Transmitted Diseases by Developing Clinically Effective and Safe Vaccines

  • Basic research on the microbiology, immunology, and pathogenesis of STDs is essential to the eventual design and development of effective vaccines against them.

  • Development of prototypes of vaccines for use in the prevention of N. gonorrhoeae, C. trachomatis, HIV, and herpes simplex virus (HSV), is under way and should be intensified with additional resources.

  • The mucosal immune response to organisms that cause STDs is critical for the development of successful vaccines, which may stimulate both B- and T-cell limbs of the immune response. Consequently, detailed mapping and analysis of the epitomes of the proteins associated with STD organisms in eliciting immune response are necessary.

  • The mucosal immune system of the human female genital tract and its role in the prevention of infection and/or susceptibility to infection should be studied more intensely.

  • The function of the mucosal immune system, specifically antigen-processing, humoral, and cellular immune responses and the effects of hormones on these responses, should be studied.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×

Develop Cost-Effective Tests for Early Diagnosis of STDs

  • Develop simple, inexpensive, rapid STD detection methods that are accurate in both symptomatic and asymptomatic women. Highest priority in this area is the development of a test for chlamydial infections. Development of a similar test for vital STDs, such as HSV, HPV, and HIV, is also critical.

  • Investigate the safety and efficacy of experimental drugs antiviral against HIV and treatment of opportunistic infections in both pregnant and nonpregnant women.

  • Evaluate the efficacy of treatment regimens for pelvic inflammatory disease in relation to preservation of normal reproductive function. This will require a long-term multicenter trial to adequately assess long-term outcomes.

  • Develop improved methods to diagnose pelvic inflammatory disease (PID) and to identify women at high risk for reproductive sequelae. Accurate, noninvasive approaches must be developed, particularly to address the challenges posed by atypical infections. Virulence factors and immunologic markers should be sought that are predictive of postinfectious infertility or ectopic pregnancy.

Develop New Therapies Where Needed and New Cost-Effective Antibiotics That are Easily Administered and Sufficiently Acceptable to Maximize Compliance

  • Develop curative antiviral agents for infections with HPV, HSV, and HIV. Studies are also needed to better define the effect of existing palliative therapies on transmission and progression of their infections.

  • Evaluate PID treatment regimens for efficacy in preserving normal reproductive function, as well as for ability to achieve clinical and microbiological resolution of acute infection. This will require a multicenter clinical trial, with support for a minimum of 7 to 10 years, to permit adequate assessment of relevant long-term outcomes. The role of adjunctive PID therapy using anti-inflammatory or immunomodulating agents to reduce long-term sequelae should also be examined.

  • Conduct further studies to document the safety and efficacy of STD/HIV regimens during pregnancy.

  • Evaluate the safety and efficacy of experimental antiviral drugs against HIV and treatment of opportunistic infections in both pregnant and nonpregnant women.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
  • Expand community research programs for treatment of HIV, and identify mechanisms to increase access to care, particularly for low-income women.

  • Develop an understanding of the nature of pathogen-cell interactions, especially virus attachment and entry, in order to formulate effective strategies for interruption of transmission. Natural history studies of HPV infection and the influence of the immune system are critically important in attempts to prevent the development of cervical cancer.

  • Encourage therapeutic studies of STDs that specifically address efficacy and safety as well as compliance and cost.

  • Develop inexpensive, accessible therapeutics that can be used reliably by women who must frequently manage multiple responsibilities (e.g., family, job) despite declining health.

  • Evaluate and develop clinical trial recruitment and retention procedures to facilitate enrollment and follow-up of women (e.g., access to primary medical care, child care, transportation to clinic sites, as well as other support services).

  • Review clinical trial eligibility criteria in ongoing studies, specifically, inclusion/exclusion criteria that may be too restrictive and thus prohibit the participation of women (e.g., definitions of active drug use, pregnancy, anemia, elevated liver enzymes, etc.).

  • Study and develop better barrier/contraceptive methods (e.g., condoms vs. female-controlled methods) and viricides that are effective, safe, and acceptable to women; especially needed are methods that can be controlled by women and that may be used without detection by their sexual partners.

Clarify the Natural History of Genital Infections

  • Describe the full spectrum of HIV-related illnesses and malignancies in women to fully evaluate current AIDS case definitions and standards of medical care for women.

  • Establish prospective cohorts of women to determine the natural history and clinical presentation of HIV infection in women. Factors that affect the progression to AIDS among HIV-infected women should be identified, and the types of opportunistic infections that occur in women should be studied more intensively. Clinical, virologic, and immunologic markers of disease progression should be evaluated to the female-specific endpoints of disease progression,

  • To better understand, prevent, and treat HI infection in women, conduct studies to address the frequency and factors responsible for transmission

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×

of HIV to women with specific focus on STDs, stage of disease, hormonal influence, and age.

  • Continue studies on the frequency and factors responsible for transmission of HIV from mother to child, and evaluate the use of therapy that prevents transmission.

  • Initiate detailed studies on the impact of STD infections on HIV transmission and the impact of HIV on STD infections. For example, detailed studies on HPV infection in HIV-infected women should be conducted to determine the impact of HIV on HPV in the subsequent development of cervical cancer.

  • Define the factors and mechanisms that alter risk of disease progression, such as HPV infection and its association with premalignant and malignant lesions of the genital tract. Epidemiologic studies are necessary to further define the factors required for initiation versus potentiation of typical cell growth.

  • Conduct epidemiological and basic studies to better define the risk factors and biological mechanisms that influence progression of HPV infection to anogenital neoplasia. Urgently needed are HPV natural history studies that examine the roles of vital type and immune status.

  • Examine the mucosal immune system of the human female genital tract, its relationship to other mucosal immune systems, and its role in the prevention of STDs and HIV infection. Specifically, antigen-processing, humoral, and cellular immune responses and the effects of hormones on the responses should be studied.

  • Define the chronology and the host and pathogen factors involved in ascent of lower tract organisms into the endometrium and fallopian tubes, and subsequent tubal scarring. Development of improved animal models for PID would greatly facilitate this research.

  • Determine the clinical and microbiological spectrum, the frequency, and the natural history of atypical PID. Seroepidemiological studies of infertile women and women with tubal pregnancies strongly suggest that atypical or subclinical PID is responsible for a substantial proportion of these disorders.

Define Behaviors Associated with the Acquisition and Spread of STDs

  • Investigate determinants of health care-seeking behavior in women, including the role of social networks and support systems in facilitating women's access to services.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
  • Develop a specific behavioral research agenda in STD prevention. Epidemiologic studies are needed to identify the type and prevalence of behaviors that put individuals at risk for transmission or progression of an STD.

  • Identify behavioral risk factors; this work would be facilitated by a national survey of sexual behavior.

  • Determine population rates for STDs, and conduct natural history studies for disease progression in specific, well-characterized populations.

  • Study the psychosocial needs of HIV-positive women and their family systems (traditional and nontraditional, including lesbian women) as they cope with the chronic, crisis-oriented, and usually fatal nature of HIV disease. Give special attention to adolescent psychosocial needs with emphasis on suicide prevention and support strategies.

Characterize the Role of STDs in Adverse Pregnancy Outcomes

  • Study factors such as the infecting pathogen, the stage of gestation during which infection occurs, chronicity of infection, and behavioral patterns such as drug abuse. Organisms should be specifically examined for virulence factors and for other markers associated with specific patterns of fetal or neonatal morbidity.

  • Conduct further studies to demonstrate whether drugs such as acyclovir and zidovudine are safe and effective for use during pregnancy.

  • Direct immunologic studies toward the protective immune responses during breastfeeding to identify the components in breast milk that axe primarily responsible for inhibition of specific pathogens.

  • Similarly, identify the role that breastfeeding plays in the transmission of certain infections such as HIV.

  • Examine such factors as chronicity of infection and stage of gestation during which infection occurs to identify specific pathogens. Improved understanding of the immunobiology of pregnancy and the use of both natural and artificial animal models of STDs in pregnancy are likely to be important to productive research in this area. In addition, organisms should be examined for virulence factors or other markers associated with specific patterns of fetal or neonatal morbidity.

Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
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Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
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Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
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Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
×
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Suggested Citation:"EXECUTIVE SUMMARY." Institute of Medicine. 1992. Strengthening Research in Academic OB/GYN Departments. Washington, DC: The National Academies Press. doi: 10.17226/1970.
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Strengthening Research in Academic OB/GYN Departments Get This Book
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Research conducted in academic departments of obstetrics and gynecology could result in substantial improvements in the health of women and the outcomes of pregnancy.

Strengthening Research in Academic OB/GYN Departments determines whether such departments are capable of fulfilling this promise. The committee finds that these departments have a poor track record in their ability to compete for research funds and in the extent to which their faculty contribute to research. Adding to the problem are factors that deter OB/GYNs from a research career and a dearth of dynamic research leaders in the profession.

The volume explores reasons for this situation and makes recommendations to counteract them. Also included is an agenda of needed research.

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