The Unequal Burden of Cancer An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved (1999) / Chapter Skim
Currently Skimming:
5 Advancing State-of-the-Art Treatment and Prevention
5 Advancing State-of-the-Art Treatment and Prevention
Pages 187-229
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 187... ...
This includes the application and testing of new knowledge in f~eld-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." 187
|
From page 188... ...
This holds true even among patients in clinical trials assigned to "no-treatment" or "placebo" control croups in randomized trials. 0 1 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.
|
From page 189... ...
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.
|
From page 190... ...
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.
|
From page 191... ...
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)
|
From page 192... ...
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.
|
From page 193... ...
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.
|
From page 199... ...
and nonexistent for others (e.g., rural medically underserved populations) , as discussed in Chapter 2.
|
From page 200... ...
The committee therefore interprets the proportionality of ethnic minority participation in clinical trials with caution. Sufficient data are not available from NCI to evaluate clinical trial accrual for medically underserved populations.
|
From page 201... ...
(1996) found that overall, younger patients tend to be heavily represented in Clinical Trials Cooperative Groups, because slightly less than half of trial participants are under age 50 years, even though more than 85 percent of cancer diagnoses occur among people 50 years of age or older.
|
From page 202... ...
Where data on expected incidences are available, these are reported, but the committee urges caution in their interpretation. Percent accrual of ethnic minorities in each trial group in 1997 is depicted in Figures 5-1 and 5-2.
|
From page 203... ...
POG enrolls 31 percent minority females and 34 percent minority males, including 14 and 15 percept female and male Hispanics, respectively; 11 and 14 percent female and male African Americans, respectively; and 4 and 3 percent female and male Asian Americans, respectively (Figure 5-1~. Bleyer et al.
|
From page 204... ...
Among the pediatric specialty clinical trial groups, NWTS and IRS appeared to have a high level of representation of ethnic minority patients, with 38 percent of females and 34 percent of males enrolled in NWTS identified as ethnic minorities and 30 percent of females and 36 percent of males enrolled in IRS identified as ethnic minorities. More than half of the ethnic minority females in NWTS were African American (20 percent overall)
|
From page 205... ...
(1998) found that the elderly were significantly under-accrued in breast, colon and rectal, and lung cancer trials, while African Americans were significantly under-accrued in lymphoma trials (7 percent accrual in SWOG, compared with 11 percent of African Americans among all lymphoma cases during the same period)
|
From page 206... ...
Overall, the Clinical Trials Cooperative Groups appear to accrue ethnic minority populations in clinical trials at rates proportional to the rates of cancer among those groups. When examined by specific trial groups and types of cancers, however, there appear gaps in accrual that serve to suppress overall ethnic minority accrual.
|
From page 207... ...
In addition, the numbers of ethnic minorities brought into clinical trials via MBCCOPs between June 1996 and February 1997 are small: although data are missing for one of the eight MBCCOPs, the seven remaining groups brought only an additional 215 ethnic minority patients into treatment trials and 102 ethnic minority patients into prevention trials. Overall, 79 percent of the patients enrolled in MBCCOP treatment trials were ethnic minorities, whereas 58 percent of the subjects enrolled in prevention trials were ethnic minorities.
|
From page 208... ...
To increase the rate of accrual of ethnic minorities, two screening centers focused on the recruitment of ethnic minorities were to be added in 1998, in addition to a new center cosponsored by the Centers for Disease Control and Prevention (CDC) to focus on the recruitment of African Americans.
|
From page 209... ...
accrual of all ethnic minority groups, with the exception of Pacific Islanders, lags behind the percentage of these individuals diagnosed with prostate, lung, colorectal, and ovarian cancers in the United States, according to figures from NCI. NCI reports that among Americans ages 55 to 74 years, the proportion of African Americans diagnosed with prostate, lung, colorectal, and ovarian cancer is 8.7 percent; similarly, the proportions for Hispanics, Asian Americans, and American Indians/Alaska Natives are 3.3, 8.6, and 0.5 percent, respectively.
|
From page 210... ...
Asian Americans, Pacific Islanders, and Native Americans were slightly underrepresented in this study, according to national incidence data. As is the case with the CCOP and MBCCOP prevention trials, the committee finds that the rate of accrual of ethnic minorities into large NIH-sponsored prevention trials in most cases lagged behind that into treatment trials.
|
From page 211... ...
For example, studies with long-term survivors of pediatric cancers require patients to obtain third-party reimbursement for diagnostic tests such as cardiac echocardiography, which limits accrual of ethnic minorities and low-income populations into these long-term studies. In addition, Medicare and Medicaid health maintenance organization coverage of costs associated with enrollment in a clinical trial is poor and inconsistent, limiting the ability of populations covered by these plans to enter clinical trials.
|
From page 212... ...
As noted in several of the presentations at the NCI conference on recruitment and Retention of Minority Participants in Clinical Cancer Research (Box 5-1) , the informed-consent process should not be seen as a "barrier" to the recruitment of ethnic minority and underserved populations into clinical trials.
|
From page 213... ...
CHCs serve as primary care providers for more than 9 million low-income patients, many of whom are ethnic minority. NCI support for training, research, and data collection in these settings should be explored not only as a means of increasing the accrual of ethnic minority and medically underserved populations in clinical trials, but also as a point of information dissemination regarding cancer prevention and treatment.
|
From page 214... ...
Recommendation 5-3: NCI should report on Me accrual and retention of ethnic minority and medically undersexed populations in clinical trials using a consistent definition for medically underse~ved populations, Including such characteristics as rural versus urban population, insurance status, socioeconomic status, and level of literacy. DISSEMINATION OF RESEARCH FINDINGS TO ETHNIC MINORITY AND MEDICALLY UNDERSERVED COMMUNITIES As noted above, the committee is charged with reporting on "how well research results are communicated and applied to cancer prevention and treatment for minorities." The term research results is very vague, ranging from poster sessions at a conference and publications available through a MEDLINE search to clinical practice guidelines.
|
From page 215... ...
Related Literature on Ethnic Minority and Medically Underserved Populations The committee's review of the literature reveals that historically, federal, state, and local public health officials have failed to establish specific programs, guidelines, or initiatives to improve health service delivery for minority and medically underserved populations. Significantly, the literature also consistently reveals that ethnic minority and medically underserved individuals are more likely to receive less appropriate or less aggressive treatment for cancer once in the health care system, a fact that may contribute to disparities in cancer survival and mortality.
|
From page 216... ...
Few state public health agencies had developed culturally relevant cancer education materials for American Indians and Alaska Natives. Although the respondents directed chronic disease or cancer prevention and control programs in their states, many were unfamiliar with the cancer patterns or general health problems among American Indians and Alaska Natives (Michalek and Mahoney, 1994~.
|
From page 217... ...
incongruity of cancer screening guidelines with local standards, (2) insufficient specificity, (3)
|
From page 218... ...
In fact, significant differences in compliance with practice guidelines can be found between two large hospital providers of cancer services within the same medical community. In one study, a university hospital followed the guidelines more than a community hospital did both before and after publication of an NCI Clinical Alert regarding adjuvant therapy after primary treatment for node-negative breast cancer.
|
From page 219... ...
, 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.
|
From page 220... ...
. The evidence shows serious deficiencies in the adoption of clinical practice guidelines in practice.
|
From page 221... ...
Whcrt 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)
|
From page 222... ...
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 -- a Of the information supplied to the committee, ethnic minority or medically underserved populations were rarely the targets of specific dissemination activities.
|
From page 223... ...
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.
|
From page 224... ...
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.
|
From page 225... ...
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
|
From page 226... ...
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 populations? If there is a plan, when can results be expected?
|
From page 227... ...
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
|
From page 228... ...
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
|
From page 229... ...
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 undersexed 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.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.