Cholesterol-reduction intervention study (CRIS): a randomized trial to assess effectiveness and costs in clinical practice.

BACKGROUND: The 1988 US National Cholesterol Education Program Expert Panel Report recommended initial treatment with niacin or bile acid sequestrants, followed by other agents if needed, to lower low-density lipoprotein cholesterol (LDL-C) levels in hypercholesterolemic patients who require drug therapy. It is unknown how the effectiveness and costs of such an approach ("stepped care") compare in typical clinical practice to those of initial therapy with lovastatin. PATIENTS AND METHODS: We randomly assigned 612 patients, aged 20 to 70 years, who met 1988 National Cholesterol Education Program guidelines for drug treatment of elevated LDL-C level and had not previously used cholesterol-lowering medication, to either a stepped-care regimen or initial therapy with lovastatin (both n=306). The study, conducted at Southern California Kaiser Permanente, was designed to approximate typical practice: provider compliance with treatment plans was encouraged but not enforced, and patients paid for medication as they customarily would. RESULTS: At 1 year, the decline in mean LDL-C level was significantly greater among patients assigned to initial treatment with lovastatin (22% vs 15% for stepped care; P<.001), as was the number who attained goal LDL-C level (

The value of an elimination diet in the management of patients with ulcerative colitis.

Debate exists about the role of diet in both the aetiology and the management of ulcerative colitis. To examine the latter, a group of patients with documented ulcerative colitis was studied at the Groote Schuur Hospital Gastro-intestinal Clinic. A total of 18 subjects, 9 female and 9 male, were randomised into active or control groups and followed up weekly for 6 weeks. Subjects in the control group were asked to document but not alter their intake of food and drink. Those in the experimental group had their diets systematically manipulated to exclude foods that appeared to provoke symptoms. The symptoms, sigmoidoscopy and biopsy findings of all subjects were compared before and after. 'Remission' was defined as the passage of normal stools with absence of rectal bleeding. 'Improvement' was defined as a decrease in the number of diarrhoeal stools and/or a diminution of rectal bleeding. At the end of the trial the diet group displayed significantly fewer symptoms than did the controls (P = 0.009; Fisher's exact test). Sigmoidoscopic findings improved in 8 subjects in the diet group compared with 2 of the controls. Histological findings improved in 3 of the diet group as well as in 3 of the controls. There were no foods that provoked symptoms in all patients, though spiced and curried foods and fruits, especially grapes, melon and the citruses, commonly caused diarrhoea. In only 2 patients were symptoms reproduced consistently on reintroduction of a particular food, pork in 1 case and yellow cheese in another.

The insulin resistance atherosclerosis study (IRAS) objectives, design, and recruitment results.

The Insulin Resistance Atherosclerosis Study (IRAS) is the first epidemiologic study designed to assess the relationships between insulin resistance, insulinemia, glycemia, other components of the insulin resistance syndrome, and prevalent cardiovascular disease (CVD) in a large multiethnic cohort. Over 1600 men and women were recruited from four geographic areas to represent a range of glucose tolerance (normal, impaired, and diabetic) and ethnicity (hispanic, non-Hispanic white, and African-American). Insulin resistance was assessed directly using the frequently sampled intravenous glucose tolerance test with minimal model analysis. Intimal-medial carotid artery wall thickness, an indicator of atherosclerosis, was measured using B-mode ultrasonography. Prevalent CVD was assessed by questionnaire and resting electrocardiography. This report describes the design of the study and provides the recruitment results. Forthcoming cross-sectional analyses will help to disentangle the association between insulin resistance and CVD, apart from the concomitant hyperinsulinemia and related CVD risk factors.

Measuring the impact of patient counseling in the outpatient pharmacy setting: the research design of the Kaiser Permanente/USC patient consultation study.

This article describes the research method used to measure the impact of three alternative models of patient counseling in the outpatient pharmacy setting. The study was conducted in pharmacies operated by the Southern California region Kaiser Permanente Medical Care Program. Both random assignment and large-scale geographic area research designs were used. The presentation of the research design includes discussions of data collection and patient sampling methods; the measurement of patient outcomes, including measures of health care costs and utilization, patient functional status, and quality of life. Demographic data are presented for the study population, including an analysis of potential biased selection of patients electing to participate in random assignment. Data are also presented documenting potential selection bias across geographically determined treatment groups in the geographic area design arm. Finally, the article presents the analysis plan for the study and discusses study limitations.

A randomized trial of comprehensive geriatric assessment in the care of hospitalized patients.

BACKGROUND: Although many studies describe benefits from the comprehensive assessment of elderly patients by an interdisciplinary team (comprehensive geriatric assessment), the most supportive evidence for the process has come from programs that rely on specialized inpatient units and long hospital stays. We examined whether an inpatient geriatric consultation service might also be beneficial in a trial involving four medical centers of a group-practice health maintenance organization (HMO). METHODS: We conducted a randomized clinical trial with 2353 hospitalized patients 65 years of age or older in whom at least 1 of 13 screening criteria were present: stroke, immobility, impairment in any basic activity of daily living, malnutrition, incontinence, confusion or dementia, prolonged bed rest, recent falls, depression, social or family problems, an unplanned readmission to the hospital within three months of a previous hospital stay, a new fracture, and age of 80 years or older. Of the 1337 patients assigned to the experimental group, 1261 (94 percent) received a comprehensive geriatric assessment in the form of a consultation, with limited follow-up; the 1016 patients assigned to the control group received usual care. The functional and health status of the patients was measured at base line and 3 and 12 months later; survival was assessed at 12 months. Subgroups of patients who might be presumed to benefit from comprehensive assessment were also studied. RESULTS: The survival rate at 12 months was 74 percent in the experimental group and 75 percent in the control group. At base line, 3 months, and 12 months the scores of the two groups on measures of functional and health status were similar. The analysis of 16 subgroups did not identify any with either clearly improved functional status or improved survival. CONCLUSIONS: In this HMO, comprehensive geriatric assessment by a consultation team, with limited follow-up, did not improve the health or survival of hospitalized patients selected on the basis of screening criteria.

A randomized trial to assess effectiveness and cost in clinical practice: rationale and design of the Cholesterol Reduction Intervention Study (CRIS).

To compare the effectiveness and costs of two alternative approaches to the treatment of hypercholesterolemia, a prospective randomized trial is being undertaken at Southern California Kaiser Permanente, a large health maintenance organization. Six hundred and twelve patients with postdiet LDL cholesterol (LDL-C) levels in the range of 190-230 mg/dl (or 160-230 mg/dl for those with coronary heart disease or two or more coronary risk factors) were randomized to a stepped-care regimen (initial treatment with niacin followed by other agents if needed) or to initial use of lovastatin, an HMG-CoA reductase inhibitor. All patients are being followed for 1 year. The study seeks to approximate conditions of typical clinical practice: provider compliance with these plans of treatment is encouraged but not enforced and patients pay for medication as they customarily would. Principal outcomes of interest include the proportion of participants who achieve goal LDL-C at one year, the mean change in total cholesterol and LDL-C levels between baseline and the end of follow-up, and the costs of cholesterol-lowering therapy.

Rationale and design of a multi-center randomized trial of comprehensive geriatric assessment consultation for hospitalized patients in an HMO.

OBJECTIVE: To describe the evaluation of an interdisciplinary comprehensive geriatric assessment (CGA) consultation program for targeted hospitalized patients. DESIGN: Multi-center randomized clinical trial (RCT) at four hospitals where patients were randomly assigned to CGA consultation or usual care by the attending physician, and a non-equivalent control group (NCG) at two hospitals. SETTING: Six hospitals in a multi-specialty group practice model health maintenance organization (HMO). PARTICIPANTS: 3593 patients age 65 years or older meeting at least one of 13 inclusionary criteria at admission. INTERVENTION: Screening by hospital staff and standardized CGA consultation conducted by a nurse practitioner, social worker, and geriatrician at the four RCT hospitals. MAIN OUTCOME MEASURES: Functional and health status, mortality, rehospitalization, and cost-effectiveness of the CGA program at 1 year post-randomization; validation of targeting (inclusionary) criteria that identify subgroups of patients deriving benefit from CGA; and physician contamination (learning from CGA and changing treatment provided to control patients). CONCLUSIONS: A number of methodological issues need to be considered when conducting effectiveness trials of CGA. The concurrent design of a multi-center RCT, coupled with the NCG to determine physician contamination, is an innovative approach intended to determine more precisely the cost-effectiveness of CGA for frail hospitalized elderly persons. The large and heterogeneous patient population and the broad array of inclusionary criteria will permit the evaluation of the benefit of CGA for subgroups. All these features are intended to enhance the generalizability of study results.

Adolescent health care in a large multispecialty prepaid group practice. Who provides it and how well are they doing?

Adolescents are at risk for pregnancy, sexually transmitted diseases, suicide, homicide, accidents, and substance abuse. Adolescent medicine involves an overlap of many skills needed to provide routine medical care, as well as care for those conditions that require psychosocial assessment. We report the results of a mail survey covering care of this age group by practitioners of pediatrics, internal medicine, obstetrics and gynecology, family practice, and adolescent medicine in a large, multispecialty, prepaid group practice. The mail survey covered 10 areas of adolescent care. Adolescent medicine physicians expressed the highest level of perceived knowledge and competence in these areas, with family practitioners ranked second. More than 50% of internists and pediatricians felt only fair to poor competence for a variety of adolescent conditions, whereas a third of internists and pediatricians reported that they liked to care for adolescents. Physicians in all 4 of the primary care specialties reported a need for a teen health center for both consultation and education. These results are similar to those reported for pediatricians and primary care physicians in private practice and for residents in internal medicine.