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5 Advancing State-of-the-Art Treatment and Prevention In the previous chapters, the committee has reviewed in detail the National Institutes of Health's (NIH) portfolio of research on cancer among ethnic minority and medically underserved populations and, pursuant to the study charge, has commented on the adequacy and comprehensiveness of this portfolio in addressing the cancer research needs of these populations. The committee has reviewed the priority-setting processes at NIH that underlie decisions regarding resource allocation and the areas of scientific inquiry that are emphasized. Ultimately, however, the utility of this research in reducing cancer incidence and mortality and increasing rates of survivorship among ethnic minority and medically underserved populations is dependent upon NIH's ability to bring the fruits of such research to affected communities. This includes the application and testing of new knowledge in field-based clinical and prevention trials and the dissemination of research findings to community-based health care providers, to organizations engaged in cancer prevention, and to members of affected communities. Accordingly, this chapter addresses two aspects of the study charge: It conducts ''an examination of how well research results are communicated and applied to cancer prevention and treatment programs for minority and medically underserved communities"; and It assesses "the adequacy of NIH procedures for equitable recruitment and retention of minority and medically underserved populations in clinical trials."
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This chapter begins with an assessment of NIH's efforts to include ethnic minority and medically underserved populations in NIH-sponsored cancer treatment and prevention trials. Particular attention is paid to the unique issues involved in recruiting these populations and retaining them in clinical trials, given the high quality of care generally afforded to patients enrolled in clinical trials and the importance of testing hypotheses with diverse populations to ensure the generalizability of findings. Next, the chapter reviews the strategies that NIH uses to disseminate information regarding cancer research to ethnic minority and medically underserved populations, their providers, and community-based health organizations. Recruitment and Retention of Ethnic Minority and Medically Underserved Participants in Clinical Cancer Research Clinical research forms the backbone of scientific advancements in medicine. New medications, preventive and rehabilitative interventions, and other innovations must be tested under the rigorous conditions of clinical trial research to understand whether these applications will work effectively, under what conditions they will work, and whether patients will be exposed to unintended harmful effects. Because patients are monitored closely under most clinical trial protocols, they often receive a higher quality of medical care and follow-up than patients who are not enrolled in clinical trials. This holds true even among patients in clinical trials assigned to "no-treatment" or "placebo" control groups in randomized trials. Ethnic minority and medically underserved populations, however, have historically not participated in clinical trial research at rates proportional to participation rates among middle- and upper-income whites. Many factors may underlie this disparity. Examples of historical abuse of ethnic minorities in research abound; most researchers, and in particular, many in African-American communities, point to the Tuskegee syphilis experiment as a significant source of minority mistrust of the scientific establishment. In that study, federal researchers followed approximately 400 lower-income African-American men in rural Macon County, Alabama, who were infected with syphilis to study the natural history of the disease. Left untreated, syphilis can cause a host of life-threatening medical and cognitive complications. Yet, despite the availability of treatments such as penicillin, these men were denied treatment and were not informed of their infection. When news of the study became public in 1972, the study was abruptly halted, and the federal government and other public and private research
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entities began developing a series of procedures designed to protect the rights of human subjects participating in research. Efforts to obtain informed consent and protect participants in clinical trials, however, may have resulted in the exclusion of ethnic minority and medically underserved populations from some clinical trial settings. Many researchers found recruitment of these populations into clinical trials to be challenging; some researchers who were unaccustomed to working with ethnic minorities as potential research subjects encountered difficulties in obtaining their informed consent for participation in trials, whereas other researchers may have been too cautious in attempting to protect research subjects from unethical behaviors (Durso, 1997). Such attitudes may have furthered the gap of mistrust between the scientific community and ethnic minority communities. Some researchers dismissed the possibility of recruiting research subjects from ethnic minority communities altogether, citing difficulties in recruitment. Mistrust of the scientific community among ethnic minority populations is also heightened by well-publicized claims concluding that African Americans and other minority groups are genetically inferior to whites, despite the repudiation of such work by large segments of the scientific community. Publications such as Richard Hernnstein and R.J. Murray's, The Bell Curve, which argues that African Americans are intellectually inferior to whites and Asians as a result of genetic differences between these groups, may reinforce the perception of many ethnic minorities that the "scientific establishment" views them as inferior and less deserving of high-quality medical care (Durso, 1997). Similarly, a large body of evidence indicates that African Americans and other minorities receive a lower intensity of medical and surgical care (Sullivan, 1991), reinforcing this view-point. Structural issues within the health care research industry also pose challenges to the recruitment of ethnic minority and medically underserved individuals. Many urban, low-income, uninsured, underinsured, or ethnic minority individuals receive treatment in large public hospitals, as opposed to private hospitals or university-affiliated research hospitals. The latter often capture a larger share of federal research dollars. Increasingly, time and financial constraints prevent many physicians working in public hospital settings from participating in research projects and enrolling their patients as subjects. Researchers working with lower-income and minority communities may also face greater costs in conducting research as a result of the need to address financial barriers to participation in clinical trials. Recruitment often requires more than placing ads in newspapers; researchers must expend resources to build relationships with community groups and hire outreach personnel. Clinical trial participants often must visit a doctor's
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office or clinic regularly, which for some entails transportation and child-care costs, which typically are not covered by federal research grants. Some research programs have offered meals as a means of assisting low-income patients' participation. Thus, the combination of historical experience and unequal access to health care has created a dynamic of mistrust on the part of ethnic minority and medically underserved communities and, in many quarters, resignation to low levels of minority participation in clinical research among investigators and health practitioners. From a scientific perspective, however, it is critical to include diverse populations in clinical trials to ensure that research findings are generalizable to the entire population. (As discussed in Chapter 4, Zora Kramer Brown provides an example of the dangers involved when scientists and public health officials attempt to generalize research findings from relatively homogeneous study populations to broad, more diverse populations.) From a social justice perspective, it is important that research supported by taxpayer dollars be inclusive of and applicable to the diverse populations of the United States. To address these needs, NIH and the U.S. Congress worked to develop standards in the late 1980s and early 1990s that mandated the participation of women and ethnic minorities in federally supported human subjects research. In 1993, as part of the NIH Revitalization Act (P.L. 103–43), Congress passed legislation that called for (1) the inclusion of women, ethnic minorities, and subpopulations into clinical trials; (2) the inclusion of adequate numbers of women and ethnic minorities for performance of valid analyses; (3) preventing cost from being an applicable reason for the exclusion of these groups; (4) a determination of the circumstances under which inclusion of these groups may be inappropriate; and (5) clinical trials and outreach programs to be designed and executed in ways that encourage recruitment and retention of women and ethnic minorities (Penn, 1996). This legislation was designed to ensure that biomedical and behavioral research results are applicable to all affected populations and include detailed information about the effects of gender, racial, and socioeconomic factors that might influence the development and outcomes of cancer. In response to the law, guidelines for inclusion were developed and published (US. Department of Health and Human Services, 1994), and a 1-year comment period was provided. The policy states that women and ethnic minorities and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects unless there is a clear and compelling justification that the inclusion of these groups is inappropriate with respect to the health of the subjects or the purpose of the research. NIH policy also demands that
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studies be designed to allow valid analyses to be performed (i.e., to detect a significant difference that is of clinical or public health importance on the basis of scientific data). Investigators are required to report on actual accrual and inclusion of women and minorities in progress reports and for supplementary grant applications. In the future, reporting on intent to recruit will also be mandated. A computerized tracking system that enables NIH institutes to report on the actual number of ethnic minorities and women included in NIH-sponsored research studies has been developed. The NIH Revitalization Act did not, however, address the many practical and ethical concerns that affect recruitment of ethnic minorities into clinical trials. As noted above, the cost of research may vary, with some populations being more costly to recruit into clinical trials. Balancing cost considerations with the need for fair recruitment into clinical trials can be challenging and can involve trade-offs that constrain researchers. Another concern is the applicability of results of studies with the general population to each of the relevant subpopulations. If certain groups of individuals are not included in clinical trials, then the principle of justice would support the need for a remedy to this situation. This leads to a separate concern: whether it is ethical to target the recruitment of ethnic minorities into clinical trials. Targeted studies are based on the conceptual framework that individuals differ on the basis of gender, "race" or ethnicity, culture, age, and other factors. However, these studies also raise the concern that the researchers who are involved in these studies believe that there are biological differences among the "races," a concept that is controversial (see Chapter 2). In certain cases, such assumptions that individuals differ are reasonable, such as in the evaluation of biological differences in the context of genetic conditions or in behavioral studies, especially if the behavioral studies address institutional racism that is associated with outcome differences between ethnic minorities and nonminorities. Finally, trust is an important consideration in recruitment efforts. Much existing evidence indicates that African Americans are less trusting of clinical research efforts than whites. No data are available indicating whether low-income whites share this mistrust. These concerns are not unreasonable, given the large degree of evidence indicating the lower intensities of medical and surgical care for African Americans. NIH Efforts to Increase Participation of Minority and Medically Underserved Groups in Clinical Trials The National Cancer Institute (NCI) has reported on several initiatives that have been used to increase the participation of ethnic minority populations and groups with low levels of literacy in clinical trials.
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Outreach efforts to inform ethnic minority groups and populations with low literacy levels about clinical trials include versions of the NCI publication What Are Clinical Trials all About? in Spanish and in a version for people with low literacy levels, and a Spanish-language version of the videotape Patient to Patient: Cancer Clinical Trials and You. Fact sheets on cancer prevention and treatment studies have been developed in both English and Spanish. Similarly, a new training program for health professionals that addresses common patient concerns about the trial process, from initial decision making to trial participation and follow-up was developed in English and Spanish. To address the increasing complexity of the informed-consent process, representatives from NCI, the Office of Protection from Research Risks, and the Food and Drug Administration have organized a working group charged with developing recommendations to make the informed-consent process more understandable. Informed-consent documents are lengthy, complex, and often difficult to understand, thereby hindering the process of providing accurate information to potential subjects. The working group developed recommendations for an informed-consent template and sample consent documents that are undergoing field testing. NCI's Cancer Therapy Evaluation Program provided supplemental funding in fiscal year (FY) 1997 for 5 of the 11 Clinical Trials Cooperative Groups (see below for description) as part of an initiative to increase the accrual of ethnic minority populations. Funds were used to support focus groups and educational opportunities for ethnic minority health professionals, to advertise and support outreach efforts in ethnic minority communities, to hire translators, and to conduct other community-based education efforts. To increase the number of ethnic minority patients enrolled in Community Clinical Oncology Programs (CCOPs), NCI developed the Minority-Based Community Clinical Oncology Programs (MBCCOPs) in 1990. The MBCCOP involve more than 300 physicians and eight program sites located in areas with large minority populations, such as San Juan, Puerto Rico; Mobile, Alabama; Honolulu, Hawaii; and San Antonio, Texas. The NIH Office of Research on Minority Health (ORMH; see Chapter 3) has provided funding to the NCI Cancer Center Program to support programs and personnel to increase the accrual of ethnic minorities in cancer center trials. These funds have supported the hiring of personnel involved in minority recruitment efforts, such as translators, data managers, bilingual patient liaisons, and others and have supported activities such as the development of recruitment brochures specifically targeted to ethnic minority patients. Finally, NCI has sponsored several conferences to promote strategies for the development and sharing of information among investigators to
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increase ethnic minority accrual. NCI released a request for applications in 1996 to support regional conferences on the recruitment and retention of ethnic minorities in clinical trials. Eleven such conferences were funded to address particular issues for investigators and patient populations at each locality. These regional conferences followed a national conference entitled Recruitment and Retention of Minority Participants Clinical Cancer Research, held in Washington, D.C., that was cosponsored by the American Cancer Society (ACS), the Oncology Nursing Society, the NIH Office of Research on Women's Health, and ORMH, among others. A monograph of the conference proceedings outlining specific needs and strategies for recruitment and retention of ethnic minority and underserved populations was published by NCI (see Box 5-1). Ethnic Minority Accrual in NIH-Sponsored Trials As noted in Chapter 3, NCI sponsors approximately 500 clinical trials, including those of the Clinical Trials Cooperative Groups and CCOP, intramural clinical trials, and trials conducted at NCI-funded cancer centers. The Clinical Trials Cooperative Group Program performs more than half of the NCI-sponsored trials, conducting approximately 900 of the 1,500 trials. Thirteen cooperative groups that included participants from 194 universities and 1,839 hospitals and more than 23,700 physicians were funded in 1977. CCOP links community-based physicians with Clinical Trials Cooperative Groups and cancer centers for cancer prevention and treatment trials. More than 50 community-based programs in 30 states, nine cooperative groups, and three cancer centers were funded in 1997 and involved more than 300 hospitals and 3,300 physicians. Finally, NCI sponsors four large cancer prevention trials, described in greater detail below and in Chapter 3: the atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intra-epithelial lesions (LSIL) Triage Study (ALTS) of cervical cancer screening, evaluation, and management; the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial; the Prostate Cancer Prevention Trial (PCPT); and the Breast Cancer Prevention Trial (BCPT). The levels of ethnic minority accrual in these trial groups are summarized below. Except in a few instances as noted below, NCI and the trial groups did not report on accrual by socioeconomic status or other indicators of medically underserved populations. Determinations of whether the level of accrual of ethnic minorities into trials is proportionate to cancer burden can typically be accomplished by comparing the percentage of cancer diagnoses among racial and ethnic groups in the U.S. population within a given time frame and the percentage of minority enrollment within trials for each cancer studied. Such
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BOX 5-1 Factors Affecting Ethnic Accrual and Inclusion of Minorities in Research In January 1996, the National Cancer Institute (NCI), in conjunction with the National Cancer Advisory Board, the American Cancer Society, the Oncology Nursing Society, and the National Institutes of Health (NIH) Office of Research on Women's Health and Office of Research on Minority Health, organized a conference entitled "Recruitment and Retention of Minority Participants in Clinical Cancer Research." The 2-day conference brought together national experts on minority health and clinical trials research to share perspectives and strategies to improve the rate of inclusion of ethnic minorities in research. The proceedings of the conference were published by NCI (National Cancer Institute, 1996d). In the Executive Summary, conference participants concluded that the achievement of equity in clinical trials will require that four goals be met: there must be professional and institutional commitment to increasing minority participation; data on the cancer burden in subpopulations must be collected and made available; there must be more research on the accrual and retention process in a whole range of clinical trials, with specific attention paid to accessibility, education, communication, and attitudes of participants, physicians, and communities; and there must be minority participation not only in clinical trials, but also in the conduct of clinical trials (National Cancer Institute, 1996d). The committee supports the findings and recommendations of the five conference panels, some of which are summarized below with respect to specific issues and populations. ETHICAL ISSUES IN RECRUITMENT OF MINORITY PARTICIPANTS Three ethical principles should guide the behavior of individuals who conduct clinical research, particularly with respect to oversight by institutional review boards (IRBs), according to Nancy Kass of Johns Hopkins University. These ethical principles are respect for autonomy, beneficence, and justice. Occasionally, these principles conflict with each other, which requires priorities to be considered. CULTURAL ADAPTATIONS FOR OVERCOMING BARRIERS Native Americans Cultural factors significantly affect the recruitment of Native Americans into clinical trials, according to Linda Burhansstipanov, Director of
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the Native American Cancer Research Program in Denber, Colorado. Relevant considerations include insurance, poverty, racial identification, and distrust of science and research, especially by underserved and underrepresented population. IRB processes are very different for Native Americans, especially with respect to considerations of the protection of individuals and sovereignty. Although the Native American health care system provides excellent access to care, the rate of survival from cancer for this group is the poorest among all ethnic groups. Informed-consent forms and procedures may serve as a barrier to recruitment, as the language commonly used in such forms and procedures may be considered offensive by some Native Americans. In many cases, the informed-consent process is poorly understood by Native Americans. In addition, body language and styles of interaction between researchers and potential research subjects may affect recruitment. Other factors including intonation are important. Among this population, fear of research is real and telephone recruitment is generally unhelpful. Involvement of the community elders is important in studies among Native Americans. Face-to-face recruitment is likely to be the most successful strategy. Incentives, such as food for research subjects' children or grandchildren, and other rewards are being tested, but they have yet to show results. Although programs such as the Native Sisters (a social and emotional support system) have been implemented, their success is limited. Tribal beliefs are difficult to change, and protocols are often inflexible. The result is that it may take three times as long to recruit Native Americans into clinical trials. African Americans As described by Carolyn Harvey, cultural variations in communication styles also affect the recruitment of African Americans to clinical trials. Linear models of information are preferred among whites, with an emphasis on written messages. In contrast, among African Americans, a cyclical model of consent and information is important, with information being disseminated through real-life situations rather than statistics or written messages. African Americans are more likely to communicate via a church or an interactive educational session and often need the freedom to respond and interrupt during a teaching session. African Americans may also require flexibility and are responsive to nonverbal aspects of communication, accounting for the importance of tone, inflection, and body language. A model for this approach has been developed in East Texas (the Visible Messenger Model), where people who are known, trusted, and accountable in the community are recruited to provide cancer awareness messages.
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Asians/Pacific Islanders As outlined by Marjorie Kagawa-Singer, among Asians/Pacific Islanders many factors are barriers to recruitment, including structural concerns (such as a wide range of fluencies in English), cultural considerations (e.g., different conceptions of health and fear of preventive interventions), and cultural differences (decisions are made by family conference and often take a long time). Confidentiality is also a concern because these individuals often require the town elder to participate in the consent process, representing a breach of confidentiality. Written consent forms are off-putting to the patients. Successful strategies include the use of research team members familiar with Asian and Pacific Island cultures. Allocation of adequate lead times with focus groups is also required, because additional services are often needed. Hispanics As outlined by Edward Trapido, Hispanics consist of individuals of diverse races and ethnicities, with many subpopulations. Differences exist with subpopulations according to culture, language, religion, race, age, gender, family role, education, and length of time in the United States. Focus groups consisting of individuals from Miami revealed several important beliefs of the Hispanic participants: physicians did not communicate well with patients; the medical staff was insensitive to their culture and language; they had not been well informed about their cancer; many felt that physicians had financial interests in prescribing surgery or advising enrollment in surgical trials; chemotherapy would bring on certain death; physicians were concerned that patients would not follow up with care; communication difficulties were common when physicians preferred to speak English, even if the patient understood the language (even if the patient's native language was Spanish); patients were often not asked to participate in the trials; and the participants had a high level of concern over Medicare fraud, inconsistent public health policies, the commercialization of medicine, and the need to involve pharmacists and nurses in the process. Other cultural considerations include a sense of fatalism. Patients are often not told their diagnosis to spare them from pain. General recommendations of this panel included the following: recognize variability and diversity within and among ethnic groups; include provisions for transportation and family coverage; train more community members to work in clinical research; stress the importance of enrollment in trials to the family;
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promote the balance of spirituality, faith, medicine, and science; and adapt the language in written and oral communications to the patient. PUBLIC AND PROVIDER EDUCATION Approaching Community Physicians Worta McKaskill-Stevens points out that community physician involvement in cooperative trials is needed. The National Medical Association (22,000 minority physicians, two-thirds of whom are primary care providers) is working closely with the Eastern Cooperative Oncology Group to develop a protocol-specific patient brochure. The text includes sections on IRBs and who the participants are, and a layperson is on the IRB. It provides general information for clinical trials. Recruiting Asian Americans for Smoking Cessation Research Moon Chen, Jr., points out that researchers are challenged to recruit Asian Americans if they overlook the tremendous diversity within Asian-American populations. The majority of Asian Americans are foreign born (especially true with regard to the Southeast Asian populations in the United States), thereby posing linguistic barriers to recruitment. There is a relative dearth of research information on these populations, which is especially alarming given the high rate of health risk behaviors such as smoking (for example, 57 percent of Southeast Asian males in the San Francisco Bay area smoke). A research project in Ohio solicited community support and hired workers from Asian ethnic groups to find study samples via the telephone book and home visits, in part to establish rapport for a long-term relationship instead of simply collecting data. Similarly, educational outreach efforts in California proved successful when antismoking messages were tailored to particular groups and were presented by use of outdoor billboards and educational classes in settings where community members gather. Successful Recruitment of African-American Men: The DEED Program Isaac Powell describes the Detroit Education and Early Detection (DEED) program, which studied prostate-specific antigen changes among African-American men enrolled in a prostate cancer screening program. Researchers assessed these men's attitudes toward the health care system and found that fear of a positive diagnosis was a significant barrier to participation (many men held fatalistic attitudes toward a diagnosis
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of treatment may be facilitated (or impeded) by physician and practice setting characteristics such as specialty, affiliation with a CCOP hospital, time in practice, professional centrality (level of participation in cancer information networks), solo practice, and number of colon cancer patients (McAfee et al., 1996). Health behavior is complex, however, and any given behavior often exists among a constellation of other behaviors. One study looked at this relationship in two ways. The researchers compared women 50 to 70 years of age who had received three screening examinations—a clinical breast examination (CBE), mammography, and Pap smear—in the previous 2 years with those who had not received all three examinations. They also compared women who had a Pap smear and at least one breast screening examination (i.e., a mammogram or a CBE) in the previous 2 years with women who were underscreened. Black women were more likely to use screening services in the office setting (i.e., BCE and Pap smear), without a corresponding use of mammography. Nevertheless, more black women than white women received a routine Pap smear in combination with a CBE, a very positive trend with respect to the successful diffusion of at least two screening procedures among older black women. The data suggest that barriers to mammography screening remain even among women who are screened by a CBE and a Pap smear. The researchers point out the need to educate both primary care physicians and their patients that the various components of preventive health are equally necessary and inter-related (Pearlman et al., 1996). What Works Many different dissemination and implementation strategies are available; however, traditional passive dissemination methods (for example, publication in professional journals or mailing of practice recommendations to health care professionals) are generally ineffective. Greater attention needs to be given to coordinating active dissemination and implementation strategies to ensure effective professional practice (Grimshaw, 1996). A variety of methods, such as the use of letters of invitation, community mobilization, and mobile service delivery, can be used to increase levels of participation in screening programs (Bryant, 1996). Long-term, ongoing community participation and coalition building in all phases of the research are essential to generating community acceptance of innovative and effective interventions (Matsunaga et al., 1996; Suarez et al., 1993; Ward et al., 1993). In an example not related to cancer per se (i.e., nursing education and the use of enteral feeding catheters), nurses' primary source of knowledge about the subject was clinical practice (56.9 percent) and consultation
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with peers (21.7 percent); only 19 percent had received in-service training on the topic. Although written guidelines from the agency varied considerably, two factors significantly associated with use of the guidelines were (1) assistance from pertinent ancillary and support staff and (2) attendance at a relevant seminar or in-service training program. Among their conclusions, the researchers note that research-based guidelines and a more formal means of dissemination of information to clinical staff are needed (Belknap et al., 1997). The diffusion of new technology is significantly affected by coverage and reimbursement decisions. Medical innovation may improve the quality of health care but may also increase the cost of health care delivery. The Medicare program has a significant influence on the coverage policies of public and private third-party payers. This influence is especially visible in coverage and reimbursement decisions for cancer-related diagnostic procedures and systems. Coverage for these procedures and systems is not widespread because payers have not been convinced of the clinical usefulness of the assays (Logue, 1993). Clinical practice guideline dissemination or implementation processes have had mixed results. Variables that affect the adoption of guidelines include the quality of the guidelines, the characteristics of the targeted health care professionals, the characteristics of the practice setting, incentives, regulations, and patient-related factors. Specific strategies fall into two categories: primary strategies involving mailing or publication of the actual guidelines and secondary interventional strategies that reinforce the guidelines. Such intervention can be weak (e.g., didactic, traditional continuing medical education and mailings), moderately effective (e.g., audit and feedback, especially concurrent feedback, targeted to specific providers and delivered by peers or opinion leaders), and relatively strong (e.g., reminder systems, academic detailing, and multiple interventions). The evidence shows serious deficiencies in the adoption of clinical practice guidelines in practice. Future implementation strategies must overcome this failure by considering the forces and variables that influence practice and by using methods that are practice and community based rather than didactic (Davis and Taylor-Vaisey, 1997). Following implementation of a legislative mandate requiring the dissemination of practice guidelines regarding deliveries by cesarean section to obstetric physicians, one study found that the guideline certification program did not accelerate the consistent but gradual downward trend in deliveries by cesarean section that had already been evident in the 3 prior years. The data did suggest a possible greater effect on repeat cesarean deliveries more than on primary cesarean deliveries. The date of guideline implementation reported by hospitals was not related to any systematic change in observed cesarean delivery rates. The researchers conclude that
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the mere dissemination of practice guidelines by a state agency may not achieve either the magnitude or the specificity of the desired results without an explicit and thorough guideline implementation program. Simple legislative mandates may therefore be ineffective when multiple initiatives are already achieving the desired outcomes (Studnicki et al., 1997). What is Needed In the area of clinical trials, formal overviews or meta-analyses are now widely accepted as reliable means of evaluating the evidence from multiple trials that have assessed a particular form of therapy. Such analyses can have many benefits: the results are particularly clear and therefore have substantial public health impact, the areas of statistical and medical agreement on the evidence can be defined, and the areas of uncertainty (and hence future research priorities) can be clarified prior to the dissemination of the results (Sandercock, 1993). It has been argued that cancer has lagged behind many other areas of medicine in pursuing outcomes research and management (Weeks and Pfister, 1996). For more than 20 years, studies have documented the substantial geographic variability in medical practice around the United States and have found that such variability is often driven by nonmedical factors. Outcomes management has several key components: the development and implementation of guidelines; measurement, pooling, and dissemination of clinical and outcomes data; and refinement of guidelines on the basis of an analysis of those data. In the case of the National Comprehensive Cancer Network (NCCN), the goal of outcomes research within NCCN member institutions is to pool and analyze selected patterns of care and outcomes data, ultimately creating a uniform outcomes measurement system to monitor guideline compliance (Weeks and Pfister, 1996). Further research, however, is required to determine optimal dissemination strategies and evaluate the impacts of these guidelines (Levine et al., 1996). In workplace environments, there is also a need for better assessment of the effectiveness of information dissemination, along with greater understanding of the barriers to implementation of the information by workers and management and improved hazard surveillance (Fine, 1995). From the perspective of theory, several gaps regarding diffusion and dissemination should be considered: (1) research, in terms of better understanding of efficacious treatment and alternative treatments as well as prevention; (2) clinical practices, in that practitioners may not be up to date on diagnostic practices, which can be addressed through medical and continuing medical education; and (3) communication, both from the doctor's perspective and from that of the patient, such that health consumers need to be trained in how the medical system works and on how to
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participate actively in their own care (Bourque, 1996). Arguably, the epidemiologic knowledge of health care workers, media, decision makers, and the general public has improved, and all groups are aware of the main cancer risk factors. Direct assessment of primary prevention activities has proved to be very difficult because many years may pass between the time that the level of exposure to a carcinogen is reduced and the time that the consequences in terms of public health are observed (Hill, 1996). Although the development of treatment guidelines has evolved a somewhat systematic framework, further research is required to determine optimal dissemination strategies and to evaluate the impacts of these guidelines (Levine et al., 1996). Dissemination and diffusion are complex, long-term endeavors, even within a single institution with multiple sites. In one study that used the context of continuous quality improvement, the intervention arms of the study were training, consultation, networking, and reinforcement for internal multidisciplinary teams as they work through a structured process to understand and improve their clinic's process for providing preventive services. Training alone lasted up to 9 months (Solberg et al., 1996). Given the danger of overloading health care providers with new guidelines, there needs to be a timed strategy for their introduction. Dissemination of guidelines alone is not enough without an appropriate implementation strategy that may require marketing of new ideas to change practice (Forrest et al., 1996). NCI Cancer Information Dissemination Practices Of the information supplied to the committee, ethnic minority or medically underserved populations were rarely the targets of specific dissemination activities. The information in general reflect a varied picture of the dissemination process. For instance, consensus development panels are convened to expedite transfer of new knowledge and "medical technologies into the practice of medicine for the benefit of patients." However, one study related to follow-up of a consensus conference on prostate cancer treatment failed to note any consequent change in recommended therapies (Sherman et al., 1992). Clinical Alerts can have an immediate impact on the treatment of certain segments of patient populations (Johnson et al., 1994). Community Clinical Trials Networks can also be used to increase access to cancer care. However, success rates vary with organizational and management styles, the clarity of the goal statement, adequacy of funding, and so forth (Kaluzny et al., 1995b). The Cancer Information Service as a Dissemination Tool NCI's CIS is a successful mechanism for cancer information dissemination.
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According to NCI, the service received 500,000 calls in 1996. In one survey, users tended to be generally very satisfied with the communications from their treating physicians, had strong information needs, and preferred to participate in their treatment plans (Manfredi et al., 1993). However, in that study, 80 percent of the respondents were patients; that is, it was not clear how well CIS disseminates cancer prevention, screening, and early detection guidelines before diagnosis. In addition, no data on the minority status of the users were available. In addressing these questions, CIS provided the information presented in Tables 5-1 and 5-2. It should be noted that the committee did not formally analyze these data statistically. However, Table 5-1 indicates that less than 15 percent of calls to the CIS telephone service were from minorities, TABLE 5-1 Race or Ethnicity of Callers to CIS Telephone Service (1997) Race or Ethnic Category Percentage of Callers Percentage of U.S. Population Asians or Pacific Islanders 2.1 3.6 Black (non-Hispanic) 6.0 12.1 Hispanic 4.5 10.7 Native American/Alaska Native 0.9 0.9 White (non-Hispanic) 85.0 72.3 Other/mixed 1.6 NOTE: Data are for calls to the CIS telephone service (1-800-4-CANCER) in 1997. SOURCE: National Cancer Institute. TABLE 5-2 Subjects of Inquiry to CIS Telephone Service Subject Percentage of Callers Prevention/risk 4.9 Screening/diagnosis 6.2 Treatment 35.1 Psychosocial 3.3 Site information 19.8 Organizations 5.5 Health professionals 8.1 Support Services 8.5 Other 8.6 NOTE: Data are for calls to the CIS telephone service (1-800-4-CANCER) in 1997. SOURCE: National Cancer Institute.
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proportionately less than the proportions of calls from whites. Given the disproportionate incidence of cancer among minority populations, one would hope for appropriately increased numbers of calls from affected groups. For instance, prostate cancer incidence and mortality rates are higher among African-American men than among white men. Compared with white women, African-American women have a lower incidence of breast cancer but higher rates of mortality from breast cancer (American Cancer Society, 1997, 1998). Table 5-2 indicates that treatment topics are addressed much more than are prevention and screening (C. Thomsen, CIS, personal communication, 1998). Scientific Journal Publications as a Tool for Dissemination NIH provided a list of 888 scientific journal publications related to cancer among minorities and medically underserved populations that have resulted from awards of programs of NIH in 1985. Having neither the actual publications nor their abstracts in hand, it was difficult to tell how much the articles were in fact related to cancer among ethnic minority and medically underserved populations. The committee therefore analyzed only the titles of the articles listed to determine the distribution of publications across racial and ethnic groups and the number of publications related to dissemination. It should be noted that the categorizations may underestimate references to ethnic minority and medically underserved populations in the articles listed. The committee examined whether the following specific terms actually appeared in the title: Multicultural: "race," "racial," "ethnic," "cultural,'' "multicultural" Not multicultural: no reference to any such terms at all or clearly indicating only a sample of white, Caucasian, or Anglo individuals. African American: "African American," "black." Hispanic: "Hispanic," "Latin/Latino/Latina," "Mexican," "Mexican American," or "Puerto Rican." Asian/Pacific: "Asian Islander," "Oriental," "Chinese," "Japanese," "Vietnamese," "Hawaiian." American Indian/Alaska Native: "Native American," "Alaska Native," "tribal." Related to dissemination: "screening," "education," "guidelines," "media," "disseminate/diffuse." An article was listed in more than one column if its title included more than one appropriate term, for example, "Hispanic" and "American
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Indian." As shown in Table 5-3, starting in 1995, there was a large increase in both the number of publications and the number of titles with some relation to dissemination compared with those in previous years. The reasons for these increases are not clear. For instance, more projects may have been funded, researchers may more frequently have published multiple articles that were based on the same numbers of projects, community and political activism may have increased pressure for both, or there may be other less obvious reasons worth investigating. Other Sources of Cancer Information NCI also made available approximately 600 publications and other informational resources. In its response to the Institute of Medicine, NCI listed several examples that are targeted to African-American, Hispanic, Native American, and multiethnic populations. However, no data on the proportion of all materials that are targeted to minority and medically underserved groups were available. The committee did not find any publication comparable to ACS's Cancer Facts & Figures—1997 (American Cancer Society, 1997), which provided a general comparison of the cancer-related needs of different racial and ethnic groups. NCI's computerized information systems have been designed to help physicians cope with the information explosion by translating the medical literature into usable forms that are accessible by computer and fax. Systems developed by NCI's International Cancer Information Center provide access to a comprehensive source of bibliographic citations on cancer research (the CANCERLIT database) and to current, peer-reviewed syntheses of state-of-the-art clinical information on cancer (the PDQ database [Hubbard et al., 1995]). However, programs such as the NIH Consensus Development Program and Physician Data Query system have not been shown to have major impacts on treatment patterns (Kosecoff et al., 1987; Lomas et al., 1989). A method that assesses how usage patterns for these programs and systems may vary between minority and nonminority physicians does not seem to exist. Admitting its lack of experience reaching high-risk populations, particularly those characterized by high proportions of socioeconomically disadvantaged individuals, ACS has begun to fund and provide technical assistance to community demonstration projects, followed by dissemination of model projects to selected ACS divisions with various resources and capabilities (e.g., outreach to high-risk populations, planning, program development, and evaluation) for replication (Corcoran and Robinson, 1994). Since January 1996, NCI has sponsored a series of regional conferences on the recruitment and retention of minorities in clinical trials, in part to promote interaction between community groups and researchers
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TABLE 5-3 Articles from NIH-Sponsored Programs Relative to Cancer and Cancer Information Dissemination Among Minority and Medically Underserved Populations by Key Terms in Title No. of Articles Key Term in Title Year Total Not Multicultural Multicultural 1997 110 50 28 1996 129 42 20 1995 119 55 13 1994 83 22 12 1993 62 27 27 1992 66 40 10 1991 63 33 2 1990 50 29 3 1989 38 15 5 1988 32 24 2 1987 33 16 2 1986 39 19 3 1985 64 31 8 Total 888 403 135 SOURCE: National Cancer Institute. to share strategies. There are plans for a future publication about what has been learned through this process. However, it is not clear how NCI identifies successful intervention programs and models or supports their replication. Also, it is not clear whether or how NCI addresses the problem of studying subgroups of target populations. Recommendations In Chapter 1 of this report, the committee poses a fundamental question: Is there a strategic plan for reducing the numbers of deaths from cancer among minority and medically underserved population? If there is a plan, when can results be expected? On the basis of the documentation that the committee reviewed, the committee concludes that such a strategic plan and schedule do not exist. Although NIH has devoted resources to the needs of special populations, with regard to dissemination there is a difference between the delivery of information and the impact of information. The committee could find little to no dissemination research or activities
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African American Hispanic Asian/Pacific Native American/ Alaska Native Dissemination 22 7 10 5 26 25 9 11 16 38 17 20 10 4 35 17 9 6 6 2 31 24 12 10 4 22 3 7 2 6 3 5 11 1 6 4 6 6 5 3 6 5 3 1 2 3 4 3 3 2 3 6 7 2 3 6 14 4 1 159 101 106 57 123 specifically targeting health care providers who come from minority and medically undeserved groups or who, regardless of their own backgrounds, serve those groups. As might be expected, much published research simply describes the results of specific projects or studies. There is little to no documentation of the long-term impacts of these studies for either health care providers or consumers at large. As a result, in the research literature, some investigators have begun to call for the use in dissemination of studies outcomes measurement approaches like those used in clinical studies. This may evolve into something like "clinical guidelines" for dissemination and diffusion. The overall recommendation of the committee is that NCI and NIH should develop a strategic plan and timetable to address the issues raised in this chapter. The strategic plan should use established cancer guidelines and recommendations in the areas of cancer prevention, screening and early detection, diagnosis, treatment, and follow-up. The strategic plan should provide a "gold standard" against which knowledge, attitudes, and behaviors can be benchmarked across various target populations of health
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care consumers and providers, regardless of racial, ethnic, or socioeconomic status. Recommendation 5-4: NCI should continue to assess its dissemination practices to identify effective cancer information delivery strategies among ethnic minority and medically underserved populations, revise and implement the strategic dissemination plan on the basis of the results of that research, and institute an ongoing system of monitoring to assess its effectiveness. As part of the strategic planning process, NCI and NIH should: Establish a formal reporting mechanism, perhaps through the National Cancer Advisory Board or the President's Cancer Panel, on the formulation and achievement of the strategic plan. Establish baseline data regarding dissemination research for both researchers and their target populations. For instance, ethnic group and gender data should be recorded regarding (1) the principal investigators submitting research proposals, (2) the principal investigators eventually funded to do research, (3) the populations targeted in research, and (4) the practical impact of funded research on those populations. This process should use scientifically appropriate methods that would not bias the application review process. Establish a more structured framework for disseminating cancer guidelines and recommendations both to health care consumers in ethnic minority and medically underserved communities and to the health care professionals who serve them. Among health care professionals, dissemination should target the continuum from undergraduate through postgraduate training and continuing education for those already in practice. Establish a more structured framework for monitoring the knowledge and application of cancer guidelines and recommendations by health care consumers and providers, noting differences in minority, nonminority, and medically underserved populations. Establish a framework in which implementation of guidelines by both consumers and providers can be planned. Summary The committee finds that the inclusion of minority and medically underserved populations in clinical trials and that the dissemination of information to minority and medically underserved communities and their health care providers is a critical link connecting scientific innovation with improvements in health and health care delivery. Enhancing this link is
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clearly within the purview of NCI and NIH. While many factors pose challenges to improvement (e.g., community mistrust), without a concerted effort to enhance this process, minority and medically underserved communities will continue to lag behind the American "majority" in benefiting from the tremendous recent scientific advancements and medical breakthroughs in cancer prevention, treatment, and control. The following recommendations were offered in this chapter: Recommendation 5-1: NIH and other federal agencies (particularly the Health Care Financing Administration) should continue to coordinate to address funding for clinical trials, particularly to address the additional diagnostic and therapeutic costs associated with prevention trials and third-party payment barriers associated with clinical treatment trials. Recommendation 5-2: NCI should continue to work with other appropriate federal agencies and institutional review boards to explore creative approaches to improving patients' understanding of research and encouraging them to provide consent to participate in research. These approaches should address cultural bias, mistrust, literacy, and other issues that may pose barriers to the participation of ethnic minority and medically underserved groups. Recommendation 5-3: NCI should report on the accrual and retention of ethnic minority and medically underserved populations in clinical trials using a consistent definition for medically underserved populations, including such characteristics as rural versus urban population, insurance status, socioeconomic status, and level of literacy. Recommendation 5-4: NCI should continue to assess its dissemination practices to identify effective cancer information delivery strategies among ethnic minority and medically underserved populations, revise and implement the strategic dissemination plan on this basis of the results of that research, and institute an ongoing system of monitoring to assess its effectiveness.
Representative terms from entire chapter: