7
Health Services Research In Cancer Care

What is Health Services Research?

Health services research is a multidisciplinary field that investigates the structure, processes, and effects of health care services (Box 7.1). Such research informs critical decisions by government officials, corporate leaders, clinicians, health plan managers, and consumers making choices about health care or health insurance. The National Cancer Policy Board (NCPB), in an effort to understand how resources for research are applied to questions regarding the quality of cancer care, undertook a review of the status of cancer-related health services research. This chapter first describes publication trends in cancer-related health services research and then summarizes support for health services research within the following organizations:

Federally Sponsored Research

  • Department of Health and Human Services National Institutes of Health (National Cancer Institute) Agency for Health Care Policy and Research Health Care Financing Administration Centers for Disease Control and Prevention
  • Department of Defense
  • Department of Veterans Affairs

Privately Sponsored Research

  • American Cancer Society
  • Foundations (e.g., Robert Wood Johnson Foundation)

Although these organizations are not the only sponsors of cancer-related health services research, they represent the major funding sources for such research. Excluded from this review is health services research supported by health plans, insurers, pharmaceutical companies, and other private organizations. Much of the research in these settings is proprietary.



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--> 7 Health Services Research In Cancer Care What is Health Services Research? Health services research is a multidisciplinary field that investigates the structure, processes, and effects of health care services (Box 7.1). Such research informs critical decisions by government officials, corporate leaders, clinicians, health plan managers, and consumers making choices about health care or health insurance. The National Cancer Policy Board (NCPB), in an effort to understand how resources for research are applied to questions regarding the quality of cancer care, undertook a review of the status of cancer-related health services research. This chapter first describes publication trends in cancer-related health services research and then summarizes support for health services research within the following organizations: Federally Sponsored Research Department of Health and Human Services National Institutes of Health (National Cancer Institute) Agency for Health Care Policy and Research Health Care Financing Administration Centers for Disease Control and Prevention Department of Defense Department of Veterans Affairs Privately Sponsored Research American Cancer Society Foundations (e.g., Robert Wood Johnson Foundation) Although these organizations are not the only sponsors of cancer-related health services research, they represent the major funding sources for such research. Excluded from this review is health services research supported by health plans, insurers, pharmaceutical companies, and other private organizations. Much of the research in these settings is proprietary.

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--> BOX 7.1 What Is Health Services Research? The Institute of Medicine defines health services research as: a multidisciplinary field of inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services to increase knowledge and understand the structure, processes, and effects of health services for individuals and populations. Several features of this definition are worth noting. First, health services research is a multidisciplinary field that draws from many academic and clinical disciplines such as economics, epidemiology, biostatistics, nursing, and medicine. Its boundaries are imprecise, particularly as they relate to policy and management studies and clinical research. A clinical trial, for example, could be categorized as health services research if the effectiveness of a health care technology or intervention was assessed in a ''real-world'' rather than in an ideal or highly controlled setting. Second, the reference to basic and applied research underscores the fact that health services research involves both questions about fundamental individual, organizational, and system behaviors and questions of direct practical interest to public and private decision makers. Third, by referring to both knowledge and understanding, the definition stretches the boundaries of the field to include work of a theoretical or conceptual nature. Finally, the definition includes research that can have either a group-or an individual-level focus. SOURCE: IOM, 1995. Health services research can be defined broadly to include behavioral and psychological research (e.g., assessments of individuals' preferences in health care), evaluations of programs that may fall outside the purview of the traditional health care system (e.g., school-based health programs), and randomized controlled clinical trials (e.g., studies of the effectiveness of health care technologies in situations representative of community practice). The National Cancer Policy Board accepted a broad definition of health services research and for this review applied the rubric used by the National Library of Medicine to select projects for inclusion in its health services research database (i.e., HSRProj) (Box 7.2). Status of Cancer-Related Health Services Research Publications Evaluating trends in research publications is one way to assess the level of activity within a discipline. A resource for tracking such studies is the National Library of Medicine (NLM) Medline bibliographic database, which stores information about individual citations including index terms used to characterize each article (articles are indexed according to a dictionary of medical subject headings called MESH terms).

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--> The volume of cancer-related health services research articles appears to have been relatively stable during the 1980s, but increased sharply in the 1990s according to Medline searches from 1980 to 1997. In 1997, there were more than 1,200 articles indexed that addressed health services research issues related to cancer (Figure 7.1). Although the number of health services research citations increased during this period, by 1997 they represented less than 3 percent of all cancer-related citations indexed in the medical literature (Figure 7.2). These trends reflect publications in English, but not necessarily articles written by U.S. investigators. Much of the literature reviewed in Chapter 5 was conducted in the United Kingdom and is represented here. Figures 7.1 and 7.2 therefore reflect trends in the general medical literature, not necessarily trends in the United States. These trends must be interpreted with caution because they may reflect changes in the way MESH headings are applied to index the literature rather than real increases in cancer-related health services research. BOX 7.2 Topics in Health Services Research Health services research may address, or be conducted for the purposes of understanding or improving, areas such as the following: need and demand for health care; availability and accessibility of health care; utilization of health care; patient preferences (e.g., for treatments, providers, settings); patient compliance with treatment; organization and delivery of health care (e.g., managed care versus fee for service); health care workforce; financing of health care (e.g., public and private third-party payment, capitation); costs, cost-effectiveness, cost-benefit, and other economic aspects of health care; patient and population health status or quality of life; outcomes of health care technologies and interventions; practice patterns and diffusion of technologies or interventions; quality assurance programs and techniques; guidelines, standards, and criteria for health care; health care administration and management; health education and patient instruction; health professions education; health planning and forecasting; legal and regulatory changes affecting the health care system (e.g., antitrust laws); data and information needed for health care decision making (e.g., report cards); and clinical trials (including randomized controlled trials) of the effectiveness of health care technologies or interventions. SOURCE: HSRProj, 1998.

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--> Figure 7.1 Medline citations for cancer-related health services research, 1980-1997. Research citations  were identified in the NLM's Medline database using the MESH heading "neoplasms"  (for cancer) and any one of the following major MESH headings "health services research,"  ''quality of health care," and "quality assurance." The last terms encompass cancer citations  addressing guideline adherence, outcomes and process assessment, accreditation, and health  planning. Only articles published in English are counted. Figure 7.2 Medline citations for cancer-related health services research as a percentage of all  cancer citations, 1980-1997. Percentages were calculated as the number of cancer-related  health services research citations (as described in Figure 7.1) divided by the total number  of citations identified using the "neoplasms" MESH term alone, for each given year. Only articles  published in English are counted.

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--> Research Support A more direct way to assess the status of U.S.-based cancer-related health services research is to describe topics of investigation and levels of research spending. There is no one comprehensive source of information on health services research support, and as part of its review, the National Cancer Policy Board relied on the following sources: information catalogued in the HSRProj database (Health Services Research Project database) maintained by the National Library of Medicine—this database includes brief descriptions of ongoing extramural research sponsored by federal and state agencies, foundations, and other organizations; listings of research projects provided by some organizations (e.g., National Cancer Institute, Agency for Health Care Policy and Research, American Cancer Society); review of annual reports of research arms of certain agencies (e.g., the Department of Veterans Affairs); review of agency web sites (e.g., Department of Defense); informal contacts with agency representatives known to be involved in health services research (e.g., Health Care Financing Administration, Centers for Disease Control and Prevention); and meetings with senior agency representatives (i.e., Agency for Health Care Policy and Research, National Cancer Institute). Despite the best efforts of the Board, the description of the nation's cancer-related health services research portfolio that follows may under-or over-estimate the actual level of research. Organizations varied in how they defined health services research and consequently, there is likely some inconsistency in what was included (or excluded) as a health services research activity. Furthermore, some health services research activities may have been missed because of limitations of research tracking systems. The review is limited to currently active research projects for most organizations. Federally Sponsored Research Department of Health and Human Services The Department of Health and Human Services (DHHS) includes the Public Health Service (PHS), which in turn oversees several sites that house cancer research: the National Institutes of Health (NIH), the Agency for Health Care Policy and Research (AHCPR), and the Centers for Disease Control and Prevention (CDC). Within DHHS, the Health Care Financing Administration (HCFA), which is organizationally parallel to the PHS, also supports applied cancer research. DHHS reports to Congress each year about the amount it spends on a number of health-related areas, including cancer (McGeary, 1999).

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--> Ã The National Cancer Institute (NCI), one of the National Institutes of Health is the largest single provider of funds for cancer research ($2.4 billion in FY 1997). AHCPR estimated it spent $3.9 million for research on health costs, quality, and outcomes related to cancer (out of a research budget of $95 million). HCFA spends enormous amounts on cancer—$16.7 billion in FY 1997—mostly on medical services and care, but it has a small program of research (see below)· CDC estimated that it spent $185 million on cancer-related programs in FY 1997. The categories included breast and cervical cancer ($139.7 million), cancer registries ($22.3 million), other chronic diseases ($8.1 million), infectious diseases ($450,000), environmental health ($1.7 million), and occupational safety and health ($12.7 million). All categories do not represent research programs For example, the breast and cervical cancer program is an early detection program aimed at underserved populations. Deleting this program and assuming the rest of the activities are research would leave $45.3 million. National Institutes of Health National Cancer Institute. Cancer Surveillance Research Program. Many of NCI's health services research activities are housed in the Division of Cancer Control and Population Sciences, Cancer Surveillance Research Program (CSRP). CSRP develops information systems and methods needed to conduct cancer surveillance research and makes these resources available to investigators throughout the research community. The linked Medicare-SEER (Surveillance, Epidemiology, and End Results) database, for example, is now widely used to answer cancer-related health services research questions (www.dccps.ims.nci.nih.gov/ARB/SEERMedicare). CSRP-sponsored research evaluates trends in cancer related to risk factors, health behaviors, and health services and assesses the influence of these factors on cancer burden (e.g., cancer incidence, morbidity, mortality, survival)· The division sponsors research related to patterns of care, diffusion of new technologies, cost of cancer care, and methodology and modeling. Examples of health services research supported by the division include the following (Edwards, 1998a, b): Patterns of Care studies: SEER data are used to describe the dissemination of state-of-the-art cancer treatment and explanatory factors for variation in patterns of care. First conducted in 1987, samples of cases from SEER were obtained in 1988, 1989, 1990, 1991, 1995, and 1996. Currently, data are being collected on cases diagnosed in 1997 with cancer of the head and neck, cervix, childhood brain stem, and ductal carcinoma in situ of the breast. In previous years, cancer sites assessed have included: in situ and early-stage breast, colorectal, ovarian, urinary bladder, melanoma, non-small-cell lung, and childhood cancers. Annual budgets for the past three funding years ranged from $575,000 to $690,000 per year. Prostate cancer outcomes study: A longitudinal survey of 3,500 men with prostate cancer is underway regarding quality of life measured at 6 and 12 months and at 5 years following diagnosis (data collection to be completed in 1999). Practice patterns are also being assessed. Breast Cancer Surveillance Consortium (a national mammography screening and outcomes database): The performance of mammography screenings (i.e., its sensitivity, specific-

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--> ity, predictive value) in a community setting is being evaluated in eight sites across the country as part of a congressionally mandated study under the Mammography Quality Standards Act of 1992. The major objectives of the consortium are to enhance understanding of the accuracy, cost, and quality of breast cancer screening; to foster collaborative research among consortium participants; to assess factors associated with variations in mammography practice, accuracy, and subsequent diagnostic evaluation; and to provide a foundation for the conduct of clinical and basic science research that can improve understanding of breast cancer etiology and prognosis. By the year 2000, the consortium will have data on nearly 3.2 million screening mammographic examinations and more than 24,000 breast cancer cases. Through 1999, total funding for the consortium is $17.2 million (NCI provides 85-90 percent of the total funding, with the remainder coming from CDC and the DoD). An additional $31 million for the period FY 2000 through FY 2004 will support the extramural research effort. The SEER-Medicare database: This is a collaborative effort of the NCI, the SEER registries, and HCFA to create a large population-based source of information for cancer-related epidemiologic and health services research. The database links cases in SEER cancer registries to claims records in Medicare's administrative database. The currently available linked file includes all Medicare data through 1994 for persons diagnosed with cancer through 1993. An update of the linkage, which will incorporate SEER cancer cases diagnosed in 1994-1996, will be completed in 1999. The SEER-Medicare data offer an opportunity to examine patterns of care prior to the diagnosis of cancer, during the period of initial diagnosis, and during long-term follow-up. Topics that can be addressed with the linked database include patterns of care for specific cancers, the use of health services, and the costs of treatment. There is also the potential for longitudinal surveillance of the health care of persons with cancer. These data can be used to assess health care directed toward the prevention of disease or disability, as well as the restoration or maintenance of health (Edwards, 1997). Active projects using the linked SEER-Medicare database include analyses of trends in treatment of in situ breast cancer; total lifetime payments for elderly cancer patients; differences in patterns of care and cancer survival between health maintenance organizations (HMOs) and fee-for-service (FFS) providers; breast cancer treatment patterns and trends; prostate cancer detection practices; and trends and variations in initial treatment for early-stage prostate cancer. HMO Cancer Research Network. The purpose of the Cancer Research Network (CRN) is to encourage the expansion of collaborative cancer research among health care provider organizations that are oriented to community care; have access to large, stable, and diverse patient populations; and are able to take advantage of existing integrated databases that can provide patient-level information relevant to research studies on cancer control and to cancer-related population studies. Beginning in 1999, NCI will fund the first CRN project—a consortium of 10 large, not-for-profit, research-oriented HMOs. The CRN will conduct four main projects (Martin Brown, Head, Health Services and Economics Section, Applied Research Branch, Cancer Surveillance Re-

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--> search Program, Division of Cancer Control and Population Sciences, NCI, personal communication, December 16, 1998): The development of an administrative infrastructure to support research collaboration, data quality, and integrity and to develop methods and organizational approaches to increase the participation of managed care patients in NCI-approved clinical trials. The infrastructure will include a data-coordinating center and expert teams to provide organized scientific input in the areas of biostatistics, health economics, survey measures, pharmacoepidemiology, genetics, clinical trials management, and survivorship. A study of the efficacy, reach, adherence to, and quality of delivery of smoking cessation programs in HMO practice settings. A study of late-stage breast and invasive cervical cancer cases to elucidate the patient, provider, and system factors that contribute to preventing advanced disease. A study of the effectiveness of the commonly used strategies of frequent mammography or prophylactic mastectomy, to prevent fatal breast cancer among women at increased risk for breast cancer. Funding for this four-year extramural grant is approximately $4 million per year, with a total award of approximately $16 million. The division has established an Outcomes Research Section to examine outcomes measures used in clinical trials and to monitor the national burden of cancer. The section will support research in the areas of measurement of quality of life, cost, and quality of care. Aspects of clinical trial organization and financing will also be addressed (e.g., integrating trials into routine care) (Martin Brown, Head, Health Services and Economics Section, Applied Research Branch, Cancer Surveillance Research Program, Division of Cancer Control and Population Sciences, NCI, personal communication, December 16, 1998). Office of Cancer Survivorship. In 1996, NCI established the Office of Cancer Survivorship to develop and support a research agenda that explores the long-and short-term physical and psychological effects of cancer and its treatment. The office has provided $4 million to supplement existing cooperative agreements, grants, and contracts. An additional $700,000 was committed by the Susan Komen Foundation. Investigator-initiated research will be funded with an additional $3 million per year for five years. Most of the research funded to date has focused on treatment complications (e.g., effects of cancer treatment on gonadal function and reproductive health) and quality-of-life issues (e.g., quality of life for adult survivors of childhood leukemia), but a few awards have addressed health services research issues (e.g., medical care costs of cancer). Box 7.3 shows prioritized areas of research for the Office of Cancer Survivorship. Health services research supported by the NCI is shown for breast cancer in Box 7.4, other cancer sites in Box 7.5, and other general research (i.e., not cancer-site specific) in Box 7.6. Several other NIH institutes have supported extramural health services research (Table 7.1).

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--> BOX 7.3 Prioritized Areas of Research for the Office of Cancer Survivorship (OCS) OCS has, to date, focused its research agenda on the issues of survivors who are at least two years post-treatment, because research data has been lacking for this group of individuals. Little information has been available about long-term cancer survivors (5-, 10-, and 15-year survivors) and the types of problems they face. OCS also aims to increase awareness of survivor issues among medical professionals and the general public. Prioritized areas of research include: prevalence of physiological and psychological long-term effects of cancer and its treatment, the risk of second cancers and the relationship between patients' risk levels and previous exposures, treatment received, and genetic predisposition, prevention and treatment of second cancers associated with treatment, issues related to reproductive and sexual functioning, the risk of cardiac disease in adults treated for childhood cancers and how to prevent this delayed treatment effect, the impact of cancer treatment on renal and cognitive function, effects of treatment on offspring of cancer survivors, treatment of premature menopause (e.g., with hormone replacement) and its effect on quality of life and the risk of recurrence, comparisons of cancer survivors with non-cancer patients to assess undesirable outcomes that could be prevented, either during the course of therapy or after therapy is completed, interventions to prevent long-term problems, behavior modification, patient education, surveillance and follow-up care for cancer survivors, and the economic impact of cancer. A number of survivor groups have been overlooked in studies to date, these include patients with certain diagnoses, survivors representing various ethnic and socioeconomic groups, and the elderly. In addition, longitudinal survivorship studies have been lacking and instrumentation has been inadequate to measure quality of life over time. SOURCE: Meadows A., presentation at the President's Cancer Panel, June 2, 1998.

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--> BOX 7.4 Current Extramural Health Services Research Projects on Breast Cancer Supported by NCI Prevention and Screening: Breast and cervical screening--older, low-income, rural women Increasing compliance with mammography guidelines Reducing barriers to the use of breast cancer screening Empowering physicians to improve breast cancer screening Increasing breast screening among rural minority women Improving breast and cervical cancer screening Maximizing mammography participation--a randomized trial Increasing breast screening among nonadherent women Promoting mammography screening in North Dakota Barriers to abnormal mammogram follow-up Mammography referral in primary care Breast cancer education through organized labor Mammographic practice and performance in the population Interventions for breast cancer screening behaviors Pilot for a community mammography and tumor registry Breast cancer surveillance (four projects) Cost-effectiveness analysis of breast cancer control for African Americans Case-control study of mammography Evaluating mammography claims data Public health study of mammogram interpretation Population-based approach to increase mammography use Follow-up evaluation of breast screening program project Breast and cervical cancer screening among Filipina women Treatment: Data sources and patterns of care for breast cancer Multilevel compliance model of breast treatments Breast cancer patterns of care and morbidity Home-based moderate exercise for breast cancer patients Hierarchical modeling for assessing breast cancer care Breast cancer treatment protocols for Hawaii minorities Breast and Cervical Cancer Intervention Study Adjustment to breast cancer Patient barriers to breast cancer clinical trials Breast conserving surgery for the elderly Home care training for younger breast cancer patients Managing uncertainty--self-help in breast cancer Promoting self-help--underserved women with breast cancer Breast cancer in young women--population-based approach SOURCES: Brenda Edwards, Associate Director, CSRP, DCCPS, National Cancer Institute, personal communication to Maria Hewitt, November 1998; http://www.nih.gov/grants/guide/pa; Martin Brown, Head, Health Services and Economics Section, Applied Research Branch, CSRP, DCCPS, NCI, personal communication to Maria Hewitt, December 1998; HSRProj, 1998.

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--> BOX 7.5 Current Extramural Health Services Research Projects on Cancers Other than Breast Cancer Supported by NCI Prevention and Screening: Prevention and control of skin cancer Cost-effectiveness of human papillomavirus screening for cervical cancer Abnormal Pap smears--what is cost-effective management? Single-visit cervical cancer prevention program Improving colorectal cancer screening Adding new fecal occult blood tests to sigmoidoscopy Enhancing diagnostic evaluation in colorectal cancer screening Treatment: Prostate cancer in relation to vasectomy Cost-effectiveness of lung cancer chemotherapy Data resource for analyzing blood and marrow transplants Medical decision making in bone marrow transplantation Determinants of access to pediatric cancer care Minimally invasive surgery in children with cancer Staging and monitoring musculoskeletal sarcomas Pain relief in pancreatic cancer Minimal access surgery for pancreatic cancer Cancer and leukemia Group B--Minnesota Oncology Group Rehabilitation of patients with head and neck cancer CCSP in head and neck cancer rehabilitation Psychosocial factors in adjustment of bone marrow transplant survivors SOURCES: Brenda K. Edwards, Division of Cancer Control and Population Sciences, National Cancer Institute, personal communication to Maria Hewitt, November 1998; http://www.nih.gov/grants/ guide/pa; Martin Brown, Head, Health Services and Economics Section, Applied Research Branch, CSRP, DCCPS, NCI, personal communication to Maria Hewitt, December 1998; HSRProj, 1998. BOX 7.6 Current Extramural General Health Services Research Projects Supported by NCI Prevention and Cancer Control (Including Early Detection): Community randomized trial of Hispanic cancer prevention Cancer control in North American Chinese women Community trial to increase cancer screening adherence Mujeres Protease/Women Protect Yourself--cancer screening Cancer control among Hispanic women--a research proposal Promoting cancer prevention among Vietnamese immigrants Increasing cancer screening in poor and minority women

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--> cal, psychosocial, behavioral, sociocultural, and environmental sciences: nursing, occupational health, alternative therapies, public health and policy, and economics. In FY 1993-1994 the program applied the recommendations of the Institute of Medicine and focused on traditional research and infrastructure (IOM, 1997). In FY 1996, the program deemphasized traditional awards to fund innovative "idea awards" and clinical translational research. The BCRP also offers training support, such as predoctoral, postdoctoral, sabbatical, and career development awards. Prostate cancer: Between FY 1997 and 1999, $135 million has been appropriated to the Prostate Cancer Research Program for basic and clinical research. The goals of the program are to pursue breakthrough ideas and approaches, prepare new scientists, encourage established investigators, and promote prostate cancer public awareness and education among the public. The program encourages innovative, multi-institutional, and multidisciplinary research and has funded new investigator awards, idea development awards, and minority population-focused training awards. Ovarian cancer: Between FY 1997 and 1999, $27.5 million has been appropriated to the Ovarian Cancer Research Program. To date, comprehensive, multidisciplinary, preventive center grants have been funded to foster the development of a sustained national ovarian cancer research enterprise. Extramural research identified in HSRProj is shown in Box 7.9. BOX 7.9 Current Extramural Health Services Research Projects Funded by DoD General Utilization of a national clinical trials infrastructure to evaluate breast cancer patient outcomes of importance in determining priorities for new care reform A randomized clinical trial to evaluate advanced nursing care for women with newly diagnosed breast cancer Decision modeling of psychosocial and clinical factors in assessing treatment alternatives for lobular carcinoma in situ Adding data accessibility and rule-based targeting data collection to the California cancer reporting system for breast cases Massachusetts cancer control evaluation project Development of a stochastic simulation model of the cost-effectiveness of promoting breast cancer screening Special sabbatical for training in health decision sciences with application to breast cancer treatment evaluation Prostate Cancer Role of African-American churches in prostate cancer prevention Unbiased outcome estimates for conservative versus aggressive treatment of early-stage prostate cancer from retrospective data: an instrumental variables approach Assessing patient values toward prostate cancer genetic screening

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--> The effects of supportive and nonsupportive behaviors on the quality of life of prostate cancer patients and their spouses Value-based decision making in prostate cancer early detection Microsimulation model of the benefits and costs of prostate cancer screening and treatment Breast Cancer Prevention: Psychoeducational group intervention for women at increased risk for breast cancer Breast cancer information system designed to foster increased proactive prevention activities among minority populations Screening: Breast cancer screening by physical examination: a randomized clinical trial in the Philippines Facility inreach strategy to promote annual mammography Regional breast cancer screening network Evaluation of multiple outcall intervention to increase screening mammography use among low-income and minority women Treatment: Surveillance after initial treatment for breast cancer: a population-based study of variation in outcomes of care Follow-up care for older women with breast cancer Cost-effectiveness of alternative treatments for local breast cancer in the elderly Managing menopausal symptoms in breast cancer survivors Psychoeducational group intervention for women at increased risk for breast cancer Role of physician gender in variation in breast cancer care Effects of meditation-based stress reduction in younger women with breast cancer Psychological intervention for women with breast cancer Other: Emotional processing and expression in breast cancer patients: effects on health and psychological adjustment Multigenerational breast cancer risk factors in African-American women Knowledge and beliefs regarding breast cancer among elderly Puerto Rican women Linkage of molecular and epidemiological breast cancer investigations with treatment data: a specialized registry Establishment of the Fox Chase network breast cancer risk registry Enhancing positive reactions to breast cancer risk appraisal Methodology for case-control studies of breast cancer Effects of a comprehensive coping strategy on clinical outcomes in breast cancer bone marrow transplant patients and primary caregiver SOURCES: HSRProj 1998; S. Young-McCaughan, Deputy Director for Research Programs, CDMRP, personal communication to Maria Hewitt, December 1998.

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--> Department of Veterans Affairs The Department of Veterans Affairs (VA) Office of Research and Development supports intramural biomedical, rehabilitation, and health services research. Health services research focuses on conditions that are common among veterans, including cancer (especially prostate and lung). Recent initiatives have addressed factors affecting the delivery of health care such as managed care; the implementation of clinical practice guidelines; ethnic, cultural, and gender issues; continuity of care, and patient-centered care. VA support for cancer-related health services research totaled $9.5 million in fiscal years 1997 and 1998. Eleven Centers of Excellence have been established to link health services research to patient and administrative needs and to provide technical expertise in certain areas, for example, the measurement of chronic disease outcomes, health economics, and tobacco use and cessation. Studies of cancer treatments, chronic pain, and end-of-life care are being conducted as part of the VA's quality improvement program, the Quality Enhancement Research Initiative (QUERI). The VA is supporting two clinical trials with health services research components: PIVOT, a randomized trial comparing radical prostatectomy versus palliative expectant management for the treatment of clinically localized prostate cancer (other sponsors include NCI and AHCPR); and A VA cooperative trial to assess whether 18-F-Fluorideoxyglucose Positron Emission Tomography (PET) imaging can be used to accurately determine if solitary pulmonary nodules are malignant. The trial will assess the costs and benefits of this technology (e.g., avoidance of unnecessary procedures). In 1998, the VA's Office of Research and Development began collaborating with the Department of Defense for studies on prostate diseases including prostate cancer. Other VA intramural health services research is shown in Box 7.10. BOX 7.10 Intramural Health Services Research Projects, Department of Veterans Affairs General Assessing pain control in acute and chronically ill patients Implementation of clinical practice guidelines for smoking cessation The use of nurses to improve cancer patient pain outcomes Prostate Cancer Impact of education on prostate cancer screening decisions Prospective study of patient preferences for prostatic cancer treatment Familial patterns in prostate cancer Effectiveness of screening for prostatic cancer Effects of age and race on prostate cancer outcomes Differences in patterns of care, risk factors, and health-related knowledge and beliefs among African-American and white men

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--> Prostate cancer-case controlled study of African-American versus white men, VA versus private sector Quality of life and patient utility for veterans with prostate cancer Breast Cancer Breast cancer among women veterans Other Cancers VA marrow transplantation: potential demand, resource use, effectiveness Posttreatment management options for lung cancer patients Evaluation of compliance in colorectal tumor postoperative screening An evaluation of the risk factors for colon cancer and determination of follow-up intervals for screening Teledermatology: Diagnosing dermatologic lesions by digital imaging Comprehensive outcomes of nonmelanoma skin cancer SOURCE: Department of Veterans Affairs, Office of Research and Development, Mary Jones, personal communication to Maria Hewitt, January 7, 1999. Private Organizations Funding Research American Cancer Society The American Cancer Society (ACS) is the largest non-government funder of cancer research in the United States ($93.4 million in 1996) (McGeary, 1999). Intramural Research Programs Department of Epidemiology and Surveillance Research. Assessment of the Quality of Treatment Data. The ACS in collaboration with the American College of Surgeons and three state cancer registries (Illinois, Kentucky, Louisiana) is evaluating the completeness and quality of treatment data for patients with colon cancer. Different approaches to collecting data from both hospital and outpatient settings will be assessed with the aim of estimating the proportion of colon cancer patients who receive optimal treatment, given the stage of their disease at diagnosis. Data acquired in a more timely fashion could be used by clinicians, individual hospitals, and state health department officials as benchmarks to gauge the quality of care provided. Success in this feasibility study could lead to the study of other cancer sites in additional states. Funding for this feasibility study is less than $100,000 (P. Wingo, Department of Epidemiology and Surveillance Research, American Cancer Society, personal communication to Maria Hewitt, October 1998).

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--> Patterns of Care Study. The ACS is analyzing the National Hospital Discharge Surveys from 1988 to 1995 to describe patterns of use of inpatient surgical procedures for treating cancers of the lung, colorectum, prostate, and female breast, by age, race, gender, and geographic region. This is an intramural research activity of the Department of Epidemiology and Surveillance Research (P. Wingo, Department of Epidemiology and Surveillance Research, American Cancer Society, personal communication to Maria Hewitt, October 1998). Behavioral Research Center. Although not designed as health services research initiatives per se, several activities within ACS's Behavioral Research Center could have applications to health services research (ACS, 1998). Population-Based Surveys of Cancer Survivors. The Behavioral Research Center is conducting two large population-based surveys of cancer survivors at a cost of $2 million for the pilot phases (Baker, VP Behavioral Research, ACS, personal communication to Maria Hewitt, October 1997). The first is the "Study of Cancer Survivors—Incidence." This survey of up to 100,000 cancer survivors is underway in a pilot phase and is designed as a 10-year prospective study of survivors enrolled within the first year after diagnosis of any one of the ten most common cancers (i.e., prostate, female breast, lung, colorectal, urinary bladder, non-Hodgkin's lymphoma, skin melanoma, uterine, kidney, ovarian). A population-based sample is being selected from area cancer registries in sufficient numbers to provide state-level estimates. The major aim of the survey is to examine the behavioral, psychosocial, treatment, and support factors that influence quality of life and survival of cancer patients. The survey is being fielded on a pilot basis in four states (Iowa, Minnesota, Wisconsin, Georgia), and plans are to extend the study to other states that have adequate cancer registration and an interest in participating. The survey includes a number of scales that have been validated (e.g., problems in daily living, physical and mental health functioning, problems with work) along with basic information about the cancer (type of cancer), treatment, health insurance, and site of health care. It should be possible, therefore, to examine quality-of-life issues by insurance or site of care, controlling for type of cancer (although it is unclear what information on comorbidity will be available). The second survey is the "Study of Long-Term Cancer Survivors—Prevalence." This survey is a cross-sectional study of 6,000 long-term survivors (i.e., those who are 5, 10, and 15 years beyond diagnosis) of six cancers (prostate, breast, colorectal, bladder, melanoma, uterine). There will be 1,000 respondents for each type of cancer. Twenty-seven states have registries that were established in 1983 or earlier, and four SEER metro area registries also meet this requirement, which is necessary to identify 15-year survivors. Only 12 state registries and all four SEER registries have complete data (85 percent complete) for 1983, 1988, and 1993. Complementary Therapies. Surveys of complementary therapies (e.g., acupuncture, visualization, yoga) have been conducted to determine the extent to which people with cancer are using these unconventional treatments and what their impact is on quality of life. In addition, surveys of oncology physicians, nurses, and social workers have been completed regarding the extent to which providers are aware of commonly used complementary therapies and whether they are supportive of cancer patients' use of these therapies.

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--> Barriers to Care. Plans are underway to conduct research on factors that inhibit or are barriers to the participation of minorities and other special populations in prevention programs, screening, clinical trials, and effective treatment. Extramural Research Program Very little ACS extramural research is devoted to health services research, even when broadly defined to include behavioral, psychosocial, and quality-of-life research. Information from the ACS on institutional, research, and training grants in effect as of September 1, 1998, indicates that less than 5 percent of the total $171,336,000 grant program is allocated to health services research (Box 7.11). The brief descriptions of research projects included in the grant summary list do not always provide sufficient detail to allow one to distinguish between health services and other kinds of research. Consequently, this list may under-or overestimate the level of health services research support. BOX 7.11 ACS Extramural Grant Program Health Services Research Support (as of September 1998) Breast Cancer Breast cancer recurrence: Promoting patient and family quality of life Community breast cancer screening Assessing and improving interval mammography screening Measuring quality of life utilities in BRCA1 and BRCA2 patients Psychological treatment of black women with breast cancer Telephone social support and education for adaptation to breast cancer Colon Cancer Identification and targeting of counties deficient in colon cancer screening Colorectal cancer prevention in rural black churches Prostate Cancer Development of the Cochrane Collaboration prostate cancer review Outcome studies of screening for prostate cancer Quality-of-life outcomes in men with localized prostate cancer Psychoeducational support groups for prostate cancer patients Patient utilities for health states in early-stage prostate cancer Quality of life and utilities for patients with prostate cancer

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--> A physical activity quality-of-life intervention in androgen-ablated prostate cancer Effect of computer-based support on prostate cancer treatment decisions Nursing's impact on quality of life post-prostatectomy Facilitating participation in a prostate cancer family risk assessment program Life assessment for prostate cancer decision models Prostate-specific antigen screening and mortality from prostate cancer Other Cancers Posttraumatic stress among mothers of children who survive cancer Other Development of cost-effective models of cancer care Conversations about cancer: understanding how families talk through illness Comparing treatments using the Q-twist methodology Cancer-related health behaviors of Vietnamese youth: longitudinal study Legal reforms: effects of cancer diagnosis, treatment costs, outcomes Message framing, persuasion, and cancer prevention/detection Improving pain control: patient and family education Coaching patients with cancer to report sensory pain experience SOURCE: ACS, 1998. Several other private organizations support cancer-related health services research to a limited extent (Table 7.2). TABLE 7.2 Current Extramural Health Services Research Projects Supported by Foundations or Private Organizations and Listed on HSRProj Organization Project Robert Wood Johnson Foundation Smoking and cancer screening: chronic disease prevention for older women   Supporting quality improvement and Joint Commission on Accreditation of Healthcare Organizations standard setting for pain management in hospitals   Research on cancer screening among Hispanic women United Hospital Fund Improving clinical care for early-stage breast cancer patients: changing physician practices Aetna, Inc. Preparing African-American men for decision making about prostate cancer and early detection   Using performance measures to motivate process improvement: a randomized trial   SOURCE: HSRProj 1998.

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--> The Cochrane Collaboration Although not strictly health services research, the Cochrane Collaboration is a not-for-profit international organization that ''aims to help people make well-informed decisions about healthcare by preparing, maintaining, and promoting the accessibility of systematic reviews of the effects of healthcare interventions'' (Box 7.12). Evidence reviewed comes from a number of sources, with an emphasis on published and unpublished randomized clinical trials. Since 1997, the Cochrane Cancer Network (http://www.canet.demon.co.uk) has coordinated the work of site-specific groups and plans to develop a database of all past and present controlled or randomized trials and systematic reviews in cancer. To date, the network has registered nearly 15,000 reports of controlled and randomized trials in cancer (www.canet.demon.co.uk). Cancer or cancer-related collaborative review groups that are registered or that are developing include: breast cancer, colorectal cancer, ear, nose, and throat disorders, eye cancer, gynecological cancer, head and neck cancer, hematological malignancies, liver cancer, lung cancer, oral cancer, pain, palliative, and supportive care, prostatic and urological cancers, skin cancer, stomach and pancreatic cancer, and tobacco addiction. The Cochrane Cancer Network is developing a specialized database for cancer, called the Cancer Library in Europe, which will serve as a comprehensive source of information about cancer for consumer groups and other members of the cancer community (http://www.canet.demon.co.uk). Key Findings Many public and private organizations are funding a diverse set of health services research topics, but with the information currently available, one cannot estimate total spending on cancer-related health services research. The best estimates suggest that it represents a very small share of total cancer research funding.

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--> BOX 7.12 The Cochrane Collaboration Health care professionals, consumers, researchers, and policy makers are overwhelmed with unmanageable amounts of information. In an influential book published in 1972, Archie Cochrane, a British epidemiologist, drew attention to our great collective ignorance about the effects of health care. He recognized that people who want to make more informed decisions about health care do not have ready access to reliable reviews of the available evidence. In 1987, the year before Cochrane died, he referred to a systematic review of randomized controlled trials (RCTs) of care during pregnancy and childbirth as "a real milestone in the history of randomized trials and in the evaluation of care," and suggested that other specialties should copy the methods used. In the same year, the scientific quality of many published reviews was shown to leave much to be desired. As Cochrane had emphasized, reviews of research evidence must be prepared systematically and they must be kept up-to-date to take account of new evidence. If this is not done, important effects of health care (good and bad) will not be identified promptly, and people using the health services will be ill-served as a result. In addition, without systematic, up-to-date reviews of previous research, plans for new research will not be well informed. As a result, researchers and funding bodies will miss promising-leads and will embark on studies asking questions that have already been answered. The Cochrane Collaboration Logo The Cochrane Collaboration logo illustrates a systematic review of data from seven randomized controlled trials, comparing one health care treatment with a placebo. Each horizontal line represents the results of one trial (the shorter the line, the more certain is the result); the diamond represents their combined results. The vertical line indicates the position around which the horizontal lines would cluster if the two treatments compared in the trials had similar effects; if a horizontal line touches the vertical line, it means that that particular trial found no clear difference between the treatments. The position of the diamond to the left of the vertical line indicates that the treatment studied is beneficial. Horizontal lines or a diamond to the right of the line would show that the treatment did more harm than good. This diagram shows the results of a systematic review of RCTs of a short, inexpensive course of a corticosteroid given to women about to give birth prematurely. The first RCT was reported in 1972. The diagram summarizes the evidence that would have been revealed had the available RCTs been reviewed systematically a decade later: it indicates strongly that corticosteroids reduce the risk of babies' dying from the complications of immaturity. By 1991, seven more trials had been reported, and the picture had become still stronger. This treatment reduces by 30 to 50 percent the odds that the babies of these women will die from the complications of immaturity. Because no systematic reviews of these trials were published until 1989, most obstetricians did not realize that the treatment was so effective. As a result, tens of thousands of premature babies probably suffered and died unnecessarily (and received more expensive treatment than was necessary). This is just one of many examples of the human costs resulting from failure to perform systematic, up-to-date reviews of RCTs of health care. SOURCE: The Cochrane Collaboration, 1999.

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--> Currently funded health services research is addressing important issues related to the quality of cancer care, for example, the impact of managed care, patterns of care, outcomes studies, issues in cancer survivorship, cancer control in minority communities, barriers to access to cancer care, cancer surveillance, pain management, and end-of-life care. NCI appears to be the primary sponsor of cancer-related health services research. The health services research budget is not known, but quality-related research appears to represent a very small fraction of the overall NCI research budget ($2.4 billion in FY 1997). AHCPR has a small budget ($171 million in 1999) and a limited but balanced (by cancer site) portfolio of extramurally funded cancer health services research. An estimated 6 percent of the research budget is spent on cancer-related health services research. AHCPR is developing an infrastructure for evidence synthesis and is disseminating information about clinical practice guidelines, both or which have relevance to cancer care. Analysts at NCI and HCFA are conducting important cancer-related health services research with the linked SEER-Medicare claims file. NCI and HCFA are attempting to assist new researchers and to promote familiarity with, and use of, this database. DoD is supporting breast, prostate, and ovarian cancer research through its Congressionally Directed Medical Research Programs, but very few of the awards are for health services research. Very few private organizations (e.g., foundations) appear to be funding cancer-related health services research. The American Cancer Society has an extramural research budget of $171 million of which 5 percent of support is devoted to health services research. The ACS is internally funding the development of two very large surveys of cancer survivors, which will provide valuable information about the experience of cancer, especially quality-of-life issues. The Cochrane Collaboration, an international organization devoted to synthesizing the results of clinical trials, has begun to organize groups based on cancer site. References American Cancer Society. 1998a. American Cancer Society Extramural Grants Programs in Effect September 1, 1998. Atlanta, GA: American Cancer Society. American Cancer Society. 1998b. Behavioral Research Center: Program Description and Progress Report. Atlanta, GA: American Cancer Society. Brown M. 1998. Head, Health Services and Economics Section, Applied Research Branch, Cancer Surveillance Research Program, personal communication to Maria Hewitt, December 16, 1998. The Cochrane Collaboration. 1999. http://hiru.mcmaster.ca/cochrane/default.htm. Edwards BK. 1997a. Associate Director, Cancer Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute. Presentation to National Cancer Policy Board. Washington, D.C. Edwards BK. 1997b Briefing Book prepared for National Cancer Policy Board. Updated by personal communication. Edwards, BK. 1998. Associate Director, Cancer Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, personal communication to Maria Hewitt, November 2, 1998. Eisenberg JM. 1998. AHCPR focuses on information for health care decision makers. Health Services Research 33 (4): 767-785.

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--> HSRProj Database (Health Services Research Project Database). 1998. http://www.ahsr.org. IOM (Institute of Medicine). 1995. Health Services Research.' Work Force and Educational Issues. Field MJ, Tranquada RE, Feasley JC, eds. Washington, D.C.: National Academy Press. IOM. 1997. A Review of the Department of Defense's Program for Breast Cancer Research. Committee to Review the Department of Defense's Breast Cancer Research Program. Washington, D.C.: National Academy Press. McGeary, M. 1999. Cancer Research Funding in the United States. Draft presented to National Cancer Policy Board, Washington, D.C. Riley GF, Potosky AL, Klabunde CN, et al. 1999. Stage at diagnosis and treatment patterns among older women with breast cancer: An HMO and fee-for-service comparison. Journal of the American Medical Association 281 (8):720-726. Stephenson J. 1997. Revitalized AHCPR pursues research on quality. Journal of the American Medical Association 278(19): 1557. U.S. Congress, Office of Technology Assessment. 1994. Identifying Health Technologies That Work: Searching for Evidence. OTA-H-608. Washington, D.C.: U.S. Government Printing Office. U.S. Department of Defense. 1998. Congressionally Directed Medical Research Programs: Prostate Cancer Research Program. http://cdmrp.army.mil/prostate. U.S. Department of Health and Human Services, Health Care Financing Administration. 1998. Active Projects Report: Research and Demonstration in Health Care Financing. Washington, D.C. U.S. Department of Veteran Affairs, Office of Research and Development. 1997. Refining Research Priorities: New Initiatives Meeting Veteran Needs. Washington, D.C.