The role of community review in evaluating the risks of human genetic variation research.

The practicality and moral value of community review of human genetic research has become a focus of debate. Examples from two Native American communities are used to address four aspects of that debate: (1) the value of community review in larger, geographically dispersed populations; (2) the identification of culturally specific risks; (3) the potential conflict between individual and group assessments of research-related risks; and (4) the confusion of social categories with biological categories. Our experiences working with these two communities suggest that: (1) successful community review may require the involvement of private social units (e.g., families); (2) culturally specific implications of genetic research may be identifiable only by community members and are of valid concern in their moral universes; (3) community concerns can be incorporated into existing review mechanisms without necessarily giving communities the power to veto research proposals; and (4) the conflation of social and biological categories presents recruitment problems for genetic studies. These conclusions argue for the use of community review to identify and minimize research-related risks posed by genetic studies. Community review also can assist in facilitating participant recruitment and retention, as well as in developing partnerships between researchers and communities.

Cancer incidence among American Indians and Alaska Natives, 1980 through 1987.

OBJECTIVES: This study uses Indian Health Service inpatient data to estimate cancer incidence among American Indians and Alaska Natives. METHODS: Hospital discharge data for 1980 through 1987 were used to identify cases of cancer for 21 sites in women and 18 sites in men. Estimates of incidence were directly standardized to data from the Surveillance, Epidemiology, and End Results Program for the same time frame. RESULTS: Cancers of the gallbladder, kidney, stomach, and cervix show generally high rates among many American Indian and Alaska Native communities, and cancers of the liver and nasopharynx are high in Alaska. Of the relatively common cancers in Whites, American Indians and Alaska Natives experience lower rates for cancers of the breast, uterus, ovaries, prostate, lung, colon, rectum, and urinary bladder and for leukemia and melanoma. Variation among geographic areas and among tribal groups is observed for many important cancer sites. CONCLUSIONS: This study demonstrates significant variations of cancer rates among American Indians and Alaska Natives, with important implications for Indian Health Service cancer control programs. The study also supports the potential use of hospital discharge data for estimating chronic disease among diverse American Indian and Alaska Native communities.

Use of CT scans for the investigation of headache: a report from ASPN, Part 1.

BACKGROUND: Clinicians in the Ambulatory Sentinel Practice Network (ASPN) order computed tomography (CT) scans for approximately 3% of patients with headache. This study was undertaken to provide information about the reasons for ordering CT scans and the results obtained. METHODS: Weekly return cards were used to collect data on every patient for whom a CT scan was ordered to investigate a headache during a 19-month period. Copies of CT reports were reviewed, and a chart audit was performed to collect further clinical information whenever an intracranial tumor, subarachnoid hemorrhage (SAH), or subdural hematoma (SDH) was reported. RESULTS: Clinicians in 58 practices ordered 349 CT scans. Only 52 patients (15%) had abnormalities noted on neurological examination. Most CT scans were ordered because the clinician believed that a tumor (49%) or an SAH (9%) might be present. Fifty-nine (17%) were ordered because of patient expectation or medicolegal concerns. Of the 293 reports reviewed, 14 indicated that a tumor, an SAH, or an SDH was present. Two of the 14 (14%) were false positives. Forty-four (15%) of the reports noted incidental findings of questionable significance. CONCLUSIONS: Because there are no clear guidelines for the use of CT for the investigation of headache, physicians must exercise good clinical judgment in their attempts to identify treatable disease in a cost-effective manner. ASPN clinicians made selective use of CT scans based on a combination of factors that included physician and patient concerns. CT was an imperfect tool in this setting. Most of the positive results represented false positives or incidental findings that could have led to adverse effects and additional costs.

Detection of intracranial tumors, subarachnoid hemorrhages, and subdural hematomas in primary care patients: a report from ASPN, Part 2.

BACKGROUND: The initial diagnosis of intracranial tumor, subarachnoid hemorrhage (SAH), and subdural hematoma (SDH) can be difficult. This study was undertaken to determine the incidence and presenting signs and symptoms of these disorders in primary care settings, and to determine whether a more aggressive investigative strategy for patients with headache is justifiable. METHODS: Weekly return cards and a chart audit were used to collect data over a 19-month period on every patient who had a new diagnosis of intracranial tumor, SAH, or SDH. Age and sex reports were collected annually. RESULTS: Twenty-five new tumors, 17 SAHs, and 8 SDHs were reported in 58 practices (a rate of 12/100,000 patients per year). Only one half of these patients had headaches, and no abnormalities were found on neurological examination of many. Diagnosis was delayed in only four patients with headache caused by a brain tumor and in three patients with SAHs. Diagnosis was delayed in two of the latter because of false-negative CT scans. CONCLUSIONS: Although clinical findings and CT scans are not reliable indicators, clinicians are able to detect the majority of these rare conditions without undue delay by selecting a small subset of patients for further investigation. More extensive use of CT scans appears to be a weak strategy to improve detection of these serious disorders, as increased use would lead to increased health care costs and unintended adverse effects, and provide little benefit.

Screening for diabetic retinopathy in a clinical setting: a comparison of direct ophthalmoscopy by primary care physicians with fundus photography.

BACKGROUND: Type II diabetes mellitus is a major health problem among Native Americans, and diabetic retinopathy is a frequent complication of this disease. Screening for retinopathy can identify early disease and prevent major vision loss, but the most cost-effective screening method has not yet been determined. METHODS: In a rural clinic that served more than 400 Native Americans with diabetes, we compared the accuracy of referrals made based on two screening methods: ophthalmoscopy by trained primary care physicians and seven-view nonstereoscopic, mydriatic fundal photography read by two general ophthalmologists and a retinal specialist. Patients in whom abnormal findings were detected by either screening method were then referred to a general ophthalmologist for further evaluation. RESULTS: Two hundred forty-three examinations were performed and 83 referrals made. Both screening methods had high sensitivity for referring patients with retinopathy that required treatment or follow-up sooner than 1 year (100% for direct ophthalmoscopy by primary care physicians, 94% for the general ophthalmologist photography readers, and 100% for the retinal specialist reader). The calculated costs of screening by direct ophthalmoscopy and by retinal photography were 64% less and 44% to 35% less, respectively, than the cost of yearly ophthalmological examinations by ophthalmologists. CONCLUSIONS: Careful screening for treatable diabetic eye disease by trained primary care physicians proved to be a clinically acceptable, cost-effective strategy. Screening methods for diabetic retinopathy should be evaluated based on the absolute sensitivity, specificity, and predictive values of their ability to correctly refer patients rather than their diagnostic accuracy.

Diabetic complications among American Indians of Washington, Oregon, and Idaho. Prevalence of retinopathy, end-stage renal disease, and amputations.

OBJECTIVE: To estimate the prevalence of severe diabetic complications. RESEARCH DESIGN AND METHODS: We surveyed the data systems of the IHS and local care providers to identify all AI/AN people with any of three diabetic complications: retinopathy needing one or more laser treatments, ESRD needing dialysis, and one or more LEAs. We calculated prevalence rates that were sex-age adjusted to the U.S. population for total sample, each community, gender, and culture area. RESULTS: Of the population-based complete sample with diabetes, 1.7% had retinopathy, 1% ESRD, and 4% LEA. Complication rates among the culture areas were not statistically different. The LEA rate among diabetic men (5.8%) was higher than that among women (2.3%). The odds ratio was 2.2 (95% CI 1.2-4.2). One community had an extraordinarily high LEA rate of 16%. CONCLUSIONS: This study showed that IHS can use its data systems to estimate prevalence of diabetic complications and identify population groups with higher prevalence rates. The data led the IHS clinic with the high LEA rate to start a program to prevent amputations. We suggest quality assurance activities based on the methods of this study.

Designing and evaluating diabetes education material for American Indians.

This paper describes the methods used to develop and evaluate diabetes education material for American Indians and Alaska Natives living in Washington, Oregon, and Idaho. Reading skills of individuals and readability of a sample of existing diabetic education material were measured. Using the Wide Range Achievement Test to measure reading skills, the authors found that 66% of the sample read at a 5th "grade" or higher level. Readability of a sample of available diabetic education material was found to be, on average, at the 10th "grade" level. Diabetes education booklets targeted to a 5th to 7th "grade" level were developed and assessed for acceptability and comprehension. Final evaluation, using the close procedure, showed that 62% of the target audience understood the messages in the booklets. A comprehensive assessment process was found to be useful in developing effective diabetes education material for Indian communities.

Diabetes in American Indians of Washington, Oregon, and Idaho.

The prevalence of diabetes among 29,000 American Indians living on or near 10 reservations in the Pacific Northwest was established from clinical data sources. The age- and sex-adjusted prevalence rate in 1987 was three times higher [95% confidence interval (CI) 2.8-3.1] than the comparable United States rate in 1980. The age-adjusted prevalence for women was 1.3 times that for men (95% CI 1.2-1.4). The prevalence varied by culture area. Reservation communities whose principal tribe came from the Great Basin culture area had 3.6 times more diabetes than found in the U.S. as a whole. Reservation communities whose principal tribe was from the Plateau culture had 3.0 times more diabetes than found in the U.S., and those from the Northwest Coast culture had 1.9 times more diabetes than found in the U.S. The reasons for these variations are unknown and warrant investigation.

Patients with new headache in primary care: a report from ASPN.

From a consecutive series of 3,847 headache patients, 1,331 patients who made first visits for new headache to 120 primary care physicians were studied for usual care over a 14-month period. Either tension or vascular headache was the initial diagnosis in 23.8 percent and 12.8 percent of patients, respectively. Nearly one half (47.8 percent) were classified as having headaches other than tension or vascular. A total of 15.3 percent of headaches were undiagnosed or were regarded as a mixture of traditional diagnostic designations. At first visit, most patients (76.6 percent) were managed without diagnostic tests. Drugs were prescribed for 73.6 percent, and advice was given for 58.6 percent. Only 2.0 percent of patients had computerized tomographic scanning ordered at first visit, although at least 46 percent met National Institutes of Health criteria, a finding with potential economic consequences of at least $2 billion. These findings suggest the need for reevaluation of diagnostic categories for headache, reevaluation of strategies for headache management, and further investigations of headache in primary care patients.

The dietary management of non-insulin-dependent diabetes mellitus in the obese patient.

This article reviews current research about the pathogenesis of obese NIDDM relevant to its dietary management. It summarizes the findings about four dietary interventions: fasting; very low-calorie diets; hypocaloric balanced-deficit diets; and variation of constituents within a diet. The review recommends a specific primary care strategy: induce an extended remission of NIDDM in the obese patient in the short-term; and treat the cause of NIDDM and the behaviors that promote obesity in the long-term with group competition programs.

Pelvic inflammatory disease in primary care.

The Ambulatory Sentinel Practice Network (ASPN) conducted an observational study of pelvic inflammatory disease (PID) in the primary care setting. During 14 months from 1982 to 1983, 38 practices in 16 states and two Canadian provinces reported 384 first visits for patients with PID. PID, as diagnosed by the clinicians in ASPN, was less severe than other published clinical descriptions of PID. Fewer patients had fever, palpable adnexal masses, and extensive tenderness than reported in other series. Although 43% of patients met published recommendations for hospitalization, the clinicians hospitalized only 9% on the initial visit, similar to the hospitalization rate by office gynecologists in a national study. Whether this management represented optimal care in the primary care setting is unknown. If office based physicians in the United States admitted to the hospital all PID patients who met current recommendations for hospitalization, the added annual cost could exceed $1.2 billion. Given both the serious clinical consequences of PID and the enormous financial implications of different clinical strategies, there is a compelling need to investigate the diagnosis and management of PID in primary care.

The Ambulatory Sentinel Practice Network: purpose, methods, and policies.

The Ambulatory Sentinel Practice Network (ASPN) is a network of primary health care practices across the United States and Canada offering (1) a laboratory for the study of populations under the care of primary care providers, and (2) surveillance of primary care problems and services. This paper reports the methods and policies developed and used by ASPN to conduct studies and describes the initial sentinel practices.