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Showing papers in "JAMA in 1996"


Journal ArticleDOI
28 Aug 1996-JAMA
TL;DR: For RCTs to ultimately benefit patients, the published report should be of the highest possible standard and should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial.
Abstract: THE RANDOMIZED controlled trial (RCT), more than any other methodology, can have a powerful and immediate impact on patient care. Ideally, the report of such an evaluation needs to convey to the reader relevant information concerning the design, conduct, analysis, and generalizability of the trial. This information should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial. Accurate and complete reporting also benefits editors and reviewers in their deliberations regarding submitted manuscripts. For RCTs to ultimately benefit patients, the published report should be of the highest possible standard. For editorial comment see p 649. Evidence produced repeatedly over the last 30 years indicates a wide chasm between what a trial should report and what is actually published in the literature. In a review of 71 RCTs with negative results published between 1960 and 1975, the authors reported that the vast

3,197 citations


Journal ArticleDOI
25 Dec 1996-JAMA
TL;DR: Results from secondary end-point analyses support the hypothesis that supplemental selenium may reduce the incidence of, and mortality from, carcinomas of several sites and require confirmation in an independent trial of appropriate design before new public health recommendations regarding seenium supplementation can be made.
Abstract: Objective. —To determine whether a nutritional supplement of selenium will decrease the incidence of cancer. Design. —A multicenter, double-blind, randomized, placebo-controlled cancer prevention trial. Setting. —Seven dermatology clinics in the eastern United States. Patients. —A total of 1312 patients (mean age, 63 years; range, 18-80 years) with a history of basal cell or squamous cell carcinomas of the skin were randomized from 1983 through 1991. Patients were treated for a mean (SD) of 4.5 (2.8) years and had a total follow-up of 6.4 (2.0) years. Interventions. —Oral administration of 200 μg of selenium per day or placebo. Main Outcome Measures. —The primary end points for the trial were the incidences of basal and squamous cell carcinomas of the skin. The secondary end points, established in 1990, were all-cause mortality and total cancer mortality, total cancer incidence, and the incidences of lung, prostate, and colorectal cancers. Results. —After a total follow-up of 8271 person-years, selenium treatment did not significantly affect the incidence of basal cell or squamous cell skin cancer. There were 377 new cases of basal cell skin cancer among patients in the selenium group and 350 cases among the control group (relative risk [RR], 1.10; 95% confidence interval [CI], 0.95-1.28), and 218 new squamous cell skin cancers in the selenium group and 190 cases among the controls (RR, 1.14; 95% CI, 0.93-1.39). Analysis of secondary end points revealed that, compared with controls, patients treated with selenium had a nonsignificant reduction in all-cause mortality (108 deaths in the selenium group and 129 deaths in the control group [RR, 0.83; 95% CI, 0.63-1.08]) and significant reductions in total cancer mortality (29 deaths in the selenium treatment group and 57 deaths in controls [RR, 0.50; 95% CI, 0.31-0.80]), total cancer incidence (77 cancers in the selenium group and 119 in controls [RR, 0.63; 95% CI, 0.47-0.85]), and incidences of lung, colorectal, and prostate cancers. Primarily because of the apparent reductions in total cancer mortality and total cancer incidence in the selenium group, the blinded phase of the trial was stopped early. No cases of selenium toxicity occurred. Conclusions. —Selenium treatment did not protect against development of basal or squamous cell carcinomas of the skin. However, results from secondary end-point analyses support the hypothesis that supplemental selenium may reduce the incidence of, and mortality from, carcinomas of several sites. These effects of selenium require confirmation in an independent trial of appropriate design before new public health recommendations regarding selenium supplementation can be made.

2,780 citations


Journal ArticleDOI
16 Oct 1996-JAMA
TL;DR: The basis for recommendations constituting the reference case analysis, the set of practices developed to guide CEAs that inform societal resource allocation decisions, and the content of these recommendations are described.
Abstract: Objective. —To develop consensus-based recommendations for the conduct of cost-effectiveness analysis (CEA). This article, the second in a 3-part series, describes the basis for recommendations constituting the reference case analysis, the set of practices developed to guide CEAs that inform societal resource allocation decisions, and the content of these recommendations. Participants. —The Panel on Cost-Effectiveness in Health and Medicine, a nonfederal panel with expertise in CEA, clinical medicine, ethics, and health outcomes measurement, was convened by the US Public Health Service (PHS). Evidence. —The panel reviewed the theoretical foundations of CEA, current practices, and alternative methods used in analyses. Recommendations were developed on the basis of theory where possible, but tempered by ethical and pragmatic considerations, as well as the needs of users. Consensus Process. —The panel developed recommendations through 21/2 years of discussions. Comments on preliminary drafts prepared by panel working groups were solicited from federal government methodologists, health agency officials, and academic methodologists. Conclusions. —The panel's methodological recommendations address (1) components belonging in the numerator and denominator of a cost-effectiveness (C/E) ratio; (2) measuring resource use in the numerator of a C/E ratio; (3) valuing health consequences in the denominator of a C/E ratio; (4) estimating effectiveness of interventions; (5) incorporating time preference and discounting; and (6) handling uncertainty. Recommendations are subject to the "rule of reason," balancing the burden engendered by a practice with its importance to a study. If researchers follow a standard set of methods in CEA, the quality and comparability of studies, and their ultimate utility, can be much improved.

2,368 citations


Journal ArticleDOI
24 Jul 1996-JAMA
TL;DR: There are striking similarities across countries in patterns of major depression and of bipolar disorder and the differences in rates for major depression across countries suggest that cultural differences or different risk factors affect the expression of the disorder.
Abstract: Objective. —To estimate the rates and patterns of major depression and bipolar disorder based on cross-national epidemiologic surveys. Design and Setting. —Population-based epidemiologic studies using similar methods from 10 countries: the United States, Canada, Puerto Rico, France, West Germany, Italy, Lebanon, Taiwan, Korea, and New Zealand. Participants. —Approximately 38 000 community subjects. Outcome Measures. —Rates, demographics, and age at onset of major depression and bipolar disorder. Symptom profiles, comorbidity, and marital status with major depression. Results. —The lifetime rates for major depression vary widely across countries, ranging from 1.5 cases per 100 adults in the sample in Taiwan to 19.0 cases per 100 adults in Beirut. The annual rates ranged from 0.8 cases per 100 adults in Taiwan to 5.8 cases per 100 adults in New Zealand. The mean age at onset shows less variation (range, 24.8-34.8 years). In every country, the rates of major depression were higher for women than men. By contrast, the lifetime rates of bipolar disorder are more consistent across countries (0.3/100 in Taiwan to 1.5/100 in New Zealand); the sex ratios are nearly equal; and the age at first onset is earlier (average, 6 years) than the onset of major depression. Insomnia and loss of energy occurred in most persons with major depression at each site. Persons with major depression were also at increased risk for comorbidity with substance abuse and anxiety disorders at all sites. Persons who were separated or divorced had significantly higher rates of major depression than married persons in most of the countries, and the risk was somewhat greater for divorced or separated men than women in most countries. Conclusions. —There are striking similarities across countries in patterns of major depression and of bipolar disorder. The differences in rates for major depression across countries suggest that cultural differences or different risk factors may affect the expression of the disorder.

2,245 citations


Journal ArticleDOI
18 Sep 1996-JAMA
TL;DR: RHC was associated with increased mortality and increased utilization of resources, and these findings justify reconsideration of a randomized controlled trial of RHC and may guide patient selection for such a study.
Abstract: Objective —To examine the association between the use of right heart catheterization (RHC) during the first 24 hours of care in the intensive care unit (ICU) and subsequent survival, length of stay, intensity of care, and cost of care Design —Prospective cohort study Setting —Five US teaching hospitals between 1989 and 1994 Subjects —A total of 5735 critically ill adult patients receiving care in an ICU for 1 of 9 prespecified disease categories Main Outcome Measures —Survival time, cost of care, intensity of care, and length of stay in the ICU and hospital, determined from the clinical record and from the National Death Index A propensity score for RHC was constructed using multivariable logistic regression Case-matching and multivariable regression modeling techniques were used to estimate the association of RHC with specific outcomes after adjusting for treatment selection using the propensity score Sensitivity analysis was used to estimate the potential effect of an unidentified or missing covariate on the results Results —By case-matching analysis, patients with RHC had an increased 30-day mortality (odds ratio, 124; 95% confidence interval, 103-149) The mean cost (25th, 50th, 75th percentiles) per hospital stay was $49300 ($17000, $30500, $56600) with RHC and $35700 ($11 300, $20600, $39200) without RHC Mean length of stay in the ICU was 148 (5,9, 17) days with RHC and 130 (4,7, 14) days without RHC These findings were all confirmed by multivariable modeling techniques Subgroup analysis did not reveal any patient group or site for which RHC was associated with improved outcomes Patients with higher baseline probability of surviving 2 months had the highest relative risk of death following RHC Sensitivity analysis suggested that a missing covariate would have to increase the risk of death 6-fold and the risk of RHC 6-fold for a true beneficial effect of RHC to be misrepresented as harmful Conclusion —In this observational study of critically ill patients, after adjustment for treatment selection bias, RHC was associated with increased mortality and increased utilization of resources The cause of this apparent lack of benefit is unclear The results of this analysis should be confirmed in other observational studies These findings justify reconsideration of a randomized controlled trial of RHC and may guide patient selection for such a study

1,986 citations


Journal ArticleDOI
22 May 1996-JAMA
TL;DR: Hypertension was the most common risk factor for CHF, and it contributed a large proportion of heart failure cases in this population-based sample, and Preventive strategies directed toward earlier and more aggressive blood pressure control are likely to offer the greatest promise for reducing the incidence of CHF and its associated mortality.
Abstract: Objective. —To study the relative and population-attributable risks of hypertension for the development of congestive heart failure (CHF), to assess the time course of progression from hypertension to CHF, and to identify risk factors that contribute to the development of overt heart failure in hypertensive subjects. Design. —Inception cohort study. Setting. —General community. Participants. —Original Framingham Heart Study and Framingham Offspring Study participants aged 40 to 89 years and free of CHF. To reflect more contemporary experience, the starting point of this study was January 1, 1970. Exposure Measures. —Hypertension (blood pressure of at least 140 mm Hg systolic or 90 mm Hg diastolic or current use of medications for treatment of high blood pressure) and other potential CHF risk factors were assessed at periodic clinic examinations. Outcome Measure. —The development of CHF. Results. —A total of 5143 eligible subjects contributed 72422 person-years of observation. During up to 20.1 years of follow-up (mean, 14.1 years), there were 392 new cases of heart failure; in 91% (357/392), hypertension antedated the development of heart failure. Adjusting for age and heart failure risk factors in proportional hazards regression models, the hazard for developing heart failure in hypertensive compared with normotensive subjects was about 2-fold in men and 3-fold in women. Multivariable analyses revealed that hypertension had a high population-attributable risk for CHF, accounting for 39% of cases in men and 59% in women. Among hypertensive subjects, myocardial infarction, diabetes, left ventricular hypertrophy, and valvular heart disease were predictive of increased risk for CHF in both sexes. Survival following the onset of hypertensive CHF was bleak; only 24% of men and 31% of women survived 5 years. Conclusions. —Hypertension was the most common risk factor for CHF, and it contributed a large proportion of heart failure cases in this population-based sample. Preventive strategies directed toward earlier and more aggressive blood pressure control are likely to offer the greatest promise for reducing the incidence of CHF and its associated mortality. (JAMA. 1996;275:1557-1562)

1,843 citations


Journal ArticleDOI
17 Jul 1996-JAMA
TL;DR: Low fitness is an important precursor of mortality and the protective effect of fitness held for smokers and nonsmokers, those with and without elevated cholesterol levels or elevated blood pressure, and unhealthy and healthy persons.
Abstract: Objective. —To quantify the relation of cardiorespiratory fitness to cardiovascular disease (CVD) mortality and to all-cause mortality within strata of other personal characteristics that predispose to early mortality. Design. —Observational cohort study. We calculated CVD and all-cause death rates for low (least fit 20%), moderate (next 40%), and high (most fit 40%) fitness categories by strata of smoking habit, cholesterol level, blood pressure, and health status. Setting. —Preventive medicine clinic. Study Participants. —Participants were 25 341 men and 7080 women who completed preventive medical examinations, including a maximal exercise test. Main Outcome Measures. —Cardiovascular disease and all-cause mortality. Results. —There were 601 deaths during 211 996 man-years of follow-up, and 89 deaths during 52 982 woman-years of follow-up. Independent predictors of mortality among men, with adjusted relative risks (RRs) and 95% confidence intervals (Cls), were low fitness (RR, 1.52; 95% CI, 1.28-1.82), smoking (RR, 1.65; 95% CI, 1.39-1.97), abnormal electrocardiogram (RR, 1.64; 95% CI, 1.34-2.01), chronic illness (RR, 1.63; 95% CI, 1.37-1.95), increased cholesterol level (RR, 1.34; 95% CI, 1.13-1.59), and elevated systolic blood pressure (RR, 1.34; 95% CI, 1.13-1.59). The only statistically significant independent predictors of mortality in women were low fitness (RR, 2.10; 95% CI, 1.36-3.21) and smoking (RR, 1.99; 95% CI, 1.25-3.17). Inverse gradients were seen for mortality across fitness categories within strata of other mortality predictors for both sexes. Fit persons with any combination of smoking, elevated blood pressure, or elevated cholesterol level had lower adjusted death rates than low-fit persons with none of these characteristics. Conclusions. —Low fitness is an important precursor of mortality. The protective effect of fitness held for smokers and nonsmokers, those with and without elevated cholesterol levels or elevated blood pressure, and unhealthy and healthy persons. Moderate fitness seems to protect against the influence of these other predictors on mortality. Physicians should encourage sedentary patients to become physically active and thereby reduce the risk of premature mortality.

1,751 citations


Journal ArticleDOI
17 Jul 1996-JAMA
TL;DR: Sudden death in young competitive athletes usually is precipitated by physical activity and may be due to a heterogeneous spectrum of cardiovascular disease, most commonly hypertrophic cardiomyopathy.
Abstract: Objective. —To develop clinical, demographic, and pathological profiles of young competitive athletes who died suddenly. Design. —Systematic evaluation of clinical information and circumstances associated with sudden deaths; interviews with family members, witnesses, and coaches; and analyses of postmortem anatomic, microscopic, and toxicologic data. Participants and Setting. —A total of 158 sudden deaths that occurred in trained athletes throughout the United States from 1985 through 1995 were analyzed. Main Outcome Measures. —Characteristics and probable cause of death. Results. —Of 158 sudden deaths among athletes, 24 (15%) were explained by noncardiovascular causes. Among the 134 athletes who had cardiovascular causes of sudden death, the median age was 17 years (range, 12-40 years), 120 (90%) were male, 70 (52%) were white, and 59 (44%) were black. The most common competitive sports involved were basketball (47 cases) and football (45 cases), together accounting for 68% of sudden deaths. A total of 121 athletes (90%) collapsed during or immediately after a training session (78 cases) or a formal athletic contest (43 cases), with 80 deaths (63%) occurring between 3PMand 9PM. The most common structural cardiovascular diseases identified at autopsy as the primary cause of death were hypertrophic cardiomyopathy (48 athletes [36%]), which was disproportionately prevalent in black athletes compared with white athletes (48% vs 26% of deaths; P =.01), and malformations involving anomalous coronary artery origin (17 athletes [13%]). Of 115 athletes who had a standard preparticipation medical evaluation, only 4 (3%) were suspected of having cardiovascular disease, and the cardiovascular abnormality responsible for sudden death was correctly identified in only 1 athlete (0.9%). Conclusions. —Sudden death in young competitive athletes usually is precipitated by physical activity and may be due to a heterogeneous spectrum of cardiovascular disease, most commonly hypertrophic cardiomyopathy. Preparticipation screening appeared to be of limited value in identification of underlying cardiovascular abnormalities.

1,633 citations


Journal ArticleDOI
15 May 1996-JAMA
TL;DR: Renal failure appears to increase the risk of developing severe nonrenal complications that lead to death and should not be regarded as a treatable complication of serious illness.
Abstract: Objective. —To determine if the high mortality in acute renal failure is explained by underlying illnesses (comorbidity). Design. —Cohort analytic study. Setting. —An 826-bed general hospital providing primary, secondary, and tertiary care. Patients. —From 16248 inpatients undergoing radiocontrast procedures between 1987 and 1989, we identified 183 index subjects who developed contrast media—associated renal failure (defined as an increase in serum creatinine level of at least 25%, to at least 177 μmol/L [2 mg/dL], within 2 days of receiving contrast material) and 174 paired subjects, matched for age and baseline serum creatinine level, who underwent similar contrast procedures without developing renal failure. Main Outcome Measure. —Death during hospitalization. Results. —The mortality rate in subjects without renal failure was 7%, compared with 34% in the corresponding index subjects with renal failure (odds ratio, 6.5;P Conclusions. —The high mortality rate in acute renal failure is not explained by the underlying conditions alone. Renal failure appears to increase the risk of developing severe nonrenal complications that lead to death and should not be regarded as a treatable complication of serious illness. (JAMA. 1996;275:1489-1494)

1,418 citations


Journal ArticleDOI
18 Sep 1996-JAMA
TL;DR: RHC was associated with increased mortality and increased utilization of resources, and these findings justify reconsideration of a randomized controlled trial of RHC and may guide patient selection for such a study.
Abstract: Objective To examine the association between the use of right heart catheterization (RHC) during the first 24 hours of care in the intensive care unit (ICU) and subsequent survival, length of stay, intensity of care, and cost of care. Design Prospective cohort study. Setting Five US teaching hospitals between 1989 and 1994. Subjects A total of 5735 critically ill adult patients receiving care in an ICU for 1 of 9 prespecified disease categories. Main outcome measures Survival time, cost of care, intensity of care, and length of stay in the ICU and hospital, determined from the clinical record and from the National Death Index. A propensity score for RHC was constructed using multivariable logistic regression. Case-matching and multivariable regression modeling techniques were used to estimate the association of RHC with specific outcomes after adjusting for treatment selection using the propensity score. Sensitivity analysis was used to estimate the potential effect of an unidentified or missing covariate on the results. Results By case-matching analysis, patients with RHC had an increased 30-day mortality (odds ratio, 1.24; 95% confidence interval, 1.03-1.49). The mean cost (25th, 50th, 75th percentiles) per hospital stay was $49 300 ($17 000, $30 500, $56 600) with RHC and $35 700 ($11 300, $20 600, $39 200) without RHC. Mean length of stay in the ICU was 14.8 (5, 9, 17) days with RHC and 13.0 (4, 7, 14) days without RHC. These findings were all confirmed by multivariable modeling techniques. Subgroup analysis did not reveal any patient group or site for which RHC was associated with improved outcomes. Patients with higher baseline probability of surviving 2 months had the highest relative risk of death following RHC. Sensitivity analysis suggested that a missing covariate would have to increase the risk of death 6-fold and the risk of RHC 6-fold for a true beneficial effect of RHC to be misrepresented as harmful. Conclusion In this observational study of critically ill patients, after adjustment for treatment selection bias, RHC was associated with increased mortality and increased utilization of resources. The cause of this apparent lack of benefit is unclear. The results of this analysis should be confirmed in other observational studies. These findings justify reconsideration of a randomized controlled trial of RHC and may guide patient selection for such a study.

1,385 citations


Journal ArticleDOI
22 May 1996-JAMA
TL;DR: The absence of a decline in the prevalence of hypertension indicates an urgent need for primary prevention by weight control, exercise, and reduced salt and alcohol intake and the urgency and choice of therapy of existing hypertension should be based on the multivariate cardiovascular risk profile that more appropriately targets hypertensive persons for treatment and prevention of cardiovascular sequelae.
Abstract: Objective. —To examine the prevalence, incidence, predisposing factors for hypertension, its hazards as an ingredient of the cardiovascular risk profile, and the implications of this information for prevention and treatment. Methods. —Prospective longitudinal analysis of 36-year follow-up data from the Framingham Study of the relation of antecedent blood pressure to occurrence of subsequent cardiovascular morbidity and mortality depending on the metabolically linked burden of associated risk factors. Results. —Hypertension is one of the most prevalent and powerful contributors to cardiovascular diseases, the leading cause of death in the United States. There is, on average, a 20 mm Hg systolic and 10 mm Hg diastolic increment increase in blood pressure from age 30 to 65 years. Isolated systolic hypertension is the dominant variety. There is no evidence of a decline in the prevalence of hypertension over 4 decades despite improvements in its detection and treatment. Hypertension contributes to all of the major atherosclerotic cardiovascular disease outcomes increasing risk, on average, 2- to 3-fold. Coronary disease, the most lethal and common sequela, deserves highest priority. Hypertension clusters with dyslipidemia, insulin resistance, glucose intolerance, and obesity, occurring in isolation in less than 20%. The hazard depends on the number of these associated metabolically linked risk factors present. Coexistent overt cardiovascular disease also influences the hazard and choice of therapy. Conclusion. —The absence of a decline in the prevalence of hypertension indicates an urgent need for primary prevention by weight control, exercise, and reduced salt and alcohol intake. The urgency and choice of therapy of existing hypertension should be based on the multivariate cardiovascular risk profile that more appropriately targets hypertensive persons for treatment and prevention of cardiovascular sequelae. ( JAMA . 1996;275:1571-1576)

Journal ArticleDOI
10 Jan 1996-JAMA
TL;DR: Mortality for patients hospitalized with CAP was high and was associated with characteristics of the study cohort, pneumonia etiology, and a variety of prognostic factors.
Abstract: Objective. —To systematically review the medical literature on the prognosis and outcomes of patients with community-acquired pneumonia (CAP). Data Sources. —A MEDLINE literature search of English-language articles involving human subjects and manual reviews of article bibliographies were used to identify studies of prognosis in CAP. Study Selection. —Review of 4573 citations revealed 122 articles (127 unique study cohorts) that reported medical outcomes in adults with CAP. Data Extraction. —Qualitative assessments of studies' patient populations, designs, and patient outcomes were performed. Summary univariate odds ratios (ORs) and rate differences (RDs) and their associated 95% confidence intervals (Cls) were computed to estimate a summary effect size for the association of prognostic factors and mortality. Data Synthesis. —The overall mortality for the 33148 patients in all 127 study cohorts was 13.7%, ranging from 5.1% for the 2097 hospitalized and ambulatory patients (in six study cohorts) to 36.5% for the 788 intensive care unit patients (in 13 cohorts). Mortality varied by pneumonia etiology, ranging from less than 2% to greater than 30%. Eleven prognostic factors were significantly associated with mortality using both summary ORs and RDs: male sex (OR=1.3; 95% Cl, 1.2 to 1.4), pleuritic chest pain (OR=0.5; 95% Cl, 0.3 to 0.8), hypothermia (OR=5.0; 95% Cl, 2.4 to 10.4), systolic hypotension (OR=4.8; 95% Cl, 2.8 to 8.3), tachypnea (OR=2.9; 95% Cl, 1.7 to 4.9), diabetes mellitus (OR=1.3; 95% Cl, 1.1 to 1.5), neoplastic disease (OR=2.8; 95% Cl, 2.4 to 3.1), neurologic disease (OR=4.6; 95% Cl, 2.3 to 8.9), bacteremia (OR=2.8; 95% Cl, 2.3 to 3.6), leukopenia (OR=2.5; 95% Cl, 1.6 to 3.7), and multilobar radiographic pulmonary infiltrate (OR=3.1; 95% Cl, 1.9 to 5.1). Assessments of other clinically relevant medical outcomes such as morbid complications (41 cohorts), symptoms resolution (seven cohorts), return to work or usual activities (five cohorts), or functional status (one cohort) were infrequently performed. Conclusions. —Mortality for patients hospitalized with CAP was high and was associated with characteristics of the study cohort, pneumonia etiology, and a variety of prognostic factors. Generalization of these findings to all patients with CAP should be made with caution because of insufficient published information on medical outcomes other than mortality in ambulatory patients. ( JAMA . 1995;274:134-141)

Journal ArticleDOI
11 Dec 1996-JAMA
TL;DR: This study confirms that lymphatic mapping is technically possible in the patient with breast cancer and that the Histologic characteristics of the SLN probably reflect the histologic characteristicsof the rest of the axillary lymph nodes.
Abstract: Objective. —To identify the sentinel lymph node(s) (SLN[s]) (the first node[s] draining the primary tumor in the regional lymphatic basin) in patients with invasive breast cancer and to test the hypothesis that the histologic characteristics of the SLN predict the histologic characteristics of the remaining lymph nodes in the axilla. Design. —A prospective trial. Participants. —Sixty-two patients with newly diagnosed invasive breast cancers. Intervention. —Patients underwent intraoperative lymphatic mapping using a combination of a vital blue dye and filtered technetium-labeled sulfur colloid. The SLN was identified and removed, followed by a definitive cancer operation, including a complete axillary node dissection. Main Outcome Measure. —The metastatic distribution in the axilla was determined in patients with occult nodal disease. Results. —The SLN was successfully identified in 57 (92%) of 62 patients using the 2 lymphatic mapping procedures. After localization, 18 patients (32%) were found to have metastatic disease, and the SLN tested positive in all 18 patients. There were no "skip" metastases, defined as an SLN that tested negative with higher nodes that tested positive. In 12 (67%) of 18 patients with metastatic disease, the SLN was the only site of disease. The metastatic distribution significantly favored SLN involvement. Among subjects with discordant nodal involvement, the probability of observing the distribution of SLN involvement by chance is very small (P Conclusions. —This study confirms that lymphatic mapping is technically possible in the patient with breast cancer and that the histologic characteristics of the SLN probably reflect the histologic characteristics of the rest of the axillary lymph nodes. The procedure also allows the pathologist to focus the histologic examination on 1 or 2 nodes, potentially increasing the yield of positive dissections and the accuracy of staging.

Journal ArticleDOI
20 Mar 1996-JAMA
TL;DR: A simple predictive model based on the presence of five precipitating factors can be used to identify elderly medical patients at high risk for delirium and increase progressively from low-risk to high-risk groups in all directions.
Abstract: Objective. —To prospectively develop and validate a predictive model for delirium based on precipitating factors during hospitalization, and to examine the interrelationship of precipitating factors and baseline vulnerability. Design. —Two prospective cohort studies, in tandem. Setting. —General medical wards, university teaching hospital. Patients. —For the development cohort, 196 patients aged 70 years and older with no delirium at baseline, and for the validation cohort, 312 comparable patients. Main Outcome Measure. —New-onset delirium by hospital day 9, defined by the Confusion Assessment Method diagnostic criteria. Results. —Delirium developed in 35 patients (18%) in the development cohort. Five independent precipitating factors for delirium were identified: use of physical restraints (adjusted relative risk [RR], 4.4; 95% confidence interval [CI], 2.5 to 7.9), malnutrition (RR, 4.0; 95% CI, 2.2 to 7.4), more than three medications added (RR, 2.9; 95% CI, 1.6 to 5.4), use of bladder catheter (RR, 2.4; 95% CI, 1.2 to 4.7), and any iatrogenic event (RR, 1.9; 95% CI, 1.1 to 3.2). Each precipitating factor preceded the onset of delirium by more than 24 hours. A risk stratification system was developed by adding 1 point for each factor present. Rates of delirium for low-risk (0 points), intermediate-risk (1 to 2 points), and high-risk groups (≥3 points) were 3%, 20%, and 59%, respectively (P Conclusions. —A simple predictive model based on the presence of five precipitating factors can be used to identify elderly medical patients at high risk for delirium. Precipitating and baseline vulnerability factors are highly interrelated and contribute to delirium in independent, substantive, and cumulative ways. (JAMA. 1996;275:852-857)

Journal ArticleDOI
23 Oct 1996-JAMA
TL;DR: Recommendations for the reporting of cost-effective analyses intended to improve the quality and accessibility of CEA reports are proposed to enhance the transparency of study methods, assist analysts in providing complete information, and facilitate the presentation of comparable cost-effectiveness results across studies.
Abstract: Objective. —This article, the third in a 3-part series, describes recommendations for the reporting of cost-effective analyses (CEAs) intended to improve the quality and accessibility of CEA reports. Participants. —The Panel on Cost-Effectiveness in Health and Medicine, a nonfederal panel with expertise in CEA, clinical medicine, ethics, and health outcomes measurement, convened by the US Public Health Service. Evidence. —The panel reviewed the theoretical foundations of CEA, current practices, alternative methods, published critiques of CEAs, and criticisms of general CEA methods and reporting practices. Consensus Process. —The panel developed recommendations through 21/2 years of discussions. Comments on preliminary drafts were solicited from federal government methodologists, health agency officials, and academic methodologists. Conclusion. —These recommendations are proposed to enhance the transparency of study methods, assist analysts in providing complete information, and facilitate the presentation of comparable cost-effectiveness results across studies. Adherence to reporting conventions and attention to providing information required to understand and interpret study results will improve the relevance and accessibility of CEAs.

Journal ArticleDOI
09 Oct 1996-JAMA
TL;DR: Recommendations apply to analyses intended to inform the allocation of health care resources across a broad range of conditions and interventions to improve the comparability and quality of studies.
Abstract: Objective: To develop consensus-based recommendations guiding the conduct of cost-effectiveness analysis (CEA) to improve the comparability and quality of studies. The recommendations apply to analyses intended to inform the allocation of health care resources across a broad range of conditions and interventions. This article, first in a 3-part series, discusses how this goal affects the conduct and use of analyses. The remaining articles will outline methodological and reporting recommendations, respectively. Participants: The Panel on Cost-Effectiveness in Health and Medicine, a nonfederal panel with expertise in CEA, clinical medicine, ethics, and health outcomes measurement, was convened by the US Public Health Service (PHS). Evidence: The panel reviewed the theoretical foundations of CEA, current practices, and alternative procedures for measuring and assigning values to resource use and health outcomes. Consensus process: The panel met 11 times during 2 1/2 years with PHS staff and methodologists from federal agencies. Working groups brought issues and preliminary recommendations to the full panel for discussion. Draft recommendations were circulated to outside experts and the federal agencies prior to finalization. Conclusions: The panel's recommendations define a "reference case" cost-effectiveness analysis, a standard set of methods to serve as a point of comparison across studies. The reference case analysis is conducted from the societal perspective and accounts for benefits, harms, and costs to all parties. Although CEA does not reflect every element of importance in health care decisions, the information it provides is critical to informing decisions about the allocation of health care resources.

Journal ArticleDOI
18 Sep 1996-JAMA
TL;DR: Findings indicate that nonfasting triglyceride levels appear to be a strong and independent predictor of future risk of MI, particularly when the total cholesterol level is also elevated.
Abstract: Objective. —To test whether a predominance of small, dense low-density lipoprotein (LDL) particles and elevated triglyceride levels are independent risk factors for myocardial infarction (MI). Design. —Nested case-control study with prospectively collected samples. Setting. —Prospective cohort study. Participants. —Blood samples were collected at baseline (85% nonfasting samples) from 14916 men aged 40 to 84 years in the Physicians' Health Study. Main Outcome Measurements. —Myocardial infarction diagnosed during 7 years of follow-up. Results. —Cases (n=266) had a significantly smaller LDL diameter (mean [SD], 25.6 [0.9] nm) than did controls (n=308) matched on age and smoking (mean [SD], 25.9 [8] nm; P P r =-0.71), and a high direct correlation with high-density lipoprotein cholesterol (HDL-C) level (r=0.60). We observed a significant multiplicative interaction between triglyceride and total cholesterol (TC) levels ( P =.01). After simultaneous adjustment for lipids and a variety of coronary risk factors, LDL particle diameter was no longer a statistically significant risk indicator, with a relative risk (RR) of 1.09 (95% confidence interval [CI], 0.85-1.40) per 0.8-nm decrease. However, triglyceride level remained significant with an RR of 1.40 (95% CI, 1.10-1.77) per 1.13 mmol/L (100-mg/dl) increase. The association between triglyceride level and MI risk appeared linear across the distribution; men in the highest quintile had a risk about 2.5 times that of those in the lowest quintile. The TC level, but not HDL-C level, also remained significant, with an RR of 1.80 (95% CI, 1.44-2.26) per 1.03-mmol/L (40-mg/dL) increase. Conclusions. —These findings indicate that nonfasting triglyceride levels appear to be a strong and independent predictor of future risk of MI, particularly when the total cholesterol level is also elevated. In contrast, LDL particle diameter is associated with risk of MI, but not after adjustment for triglyceride level. Increased triglyceride level, small LDL particle diameter, and decreased HDL-C levels appear to reflect underlying metabolic perturbations with adverse consequences for risk of MI; elevated triglyceride levels may help identify high-risk individuals.

Journal ArticleDOI
20 Nov 1996-JAMA
TL;DR: It is suggested that genotype-phenotype correlations do exist and, if made reliably absolute, could prove useful in the future in clinical management with respect to screening, surveillance, and prophylaxis, as well as provide insight into the genetic effects of particular mutations.
Abstract: Objective. —Multiple endocrine neoplasia type 2 (MEN 2) is an autosomal dominant disorder. The 3 recognized subtypes include MEN 2A, characterized by medullary thyroid carcinoma (MTC), pheochromocytoma (pheo), and hyperparathyroidism (HPT); MEN 2B, by MTC, pheo, and characteristic stigmata; and familial MTC (FMTC), by the presence of MTC only. The purpose of this study was to establish the relationship between specific mutations and the presence of certain disease features in MEN 2 which could help in clinical decision making. Design. —Correlative survey study of 477 MEN 2 families. Setting. —Eighteen tertiary referral centers worldwide. Patients. —A total of 477 independent MEN 2 families. Main Outcome Measures. —Association between the position and type of germline mutation in the RET proto-oncogene and the presence or absence of MTC, pheo, HPT, and/or other features in a family. Results. —There is a statistically significant association between the presence of any mutation at a specific position (codon 634) and the presence of pheo and HPT. The presence of a specific mutation, CGC at codon 634, has yet to be associated with FMTC. Conversely, mutations at codons 768 and 804 are thus far seen only with FMTC, while codon 918 mutation is MEN 2B-specific. Rare families with both MEN 2 and Hirschsprung disease were found to have MEN 2-specific codon mutations. Patients with Hirschsprung disease presenting with such mutations should be monitored for the possible development of MEN 2 tumors. Conclusions. —This consortium analysis suggests that genotype-phenotype correlations do exist and, if made reliably absolute, could prove useful in the future in clinical management with respect to screening, surveillance, and prophylaxis, as well as provide insight into the genetic effects of particular mutations.

Journal ArticleDOI
13 Mar 1996-JAMA
TL;DR: The CATCH intervention was able to modify the fat content of school lunches, increase moderate-to-vigorous physical activity in PE, and improve eating and physical activity behaviors in children during 3 school years.
Abstract: grade intervention including school food service modifications, enhanced physical education (PE), and classroom health curricula. Twenty-eight additional schools received these components plus family education. Main Outcome Measures.\p=m-\Atthe school level, the two primary end points were changes in the fat content of food service lunch offerings and the amount of moderate-to-vigorous physical activity in the PE programs. At the level of the individual student, serum cholesterol change was the primary end point and was used for power calculations for the study. Individual level secondary end points included psychosocial factors, recall measures of eating and physical activity patterns, and other physiologic measures. Results.\p=m-\Inintervention school lunches, the percentage of energy intake from fat fell significantly more (from 38.7% to 31.9%) than in control lunches (from 38.9% to 36.2%)(P<.001 ). The intensity of physical activity in PE classes during the Child and Adolescent Trial for Cardiovascular Health (CATCH) intervention increased significantly in the intervention schools compared with the control schools (P<.02). Self-reported daily energy intake from fat among students in the intervention schools was significantly reduced (from 32.7% to 30.3%) compared with that among students in the control schools (from 32.6% to 32.2%) (P<.001). Intervention students reported significantly more daily vigorous activity than controls (58.6 minutes vs 46.5 minutes; P<.003). Blood pressure, body size, and cholesterol measures did not differ significantly between treatment groups. No evidence of deleterious effects of this intervention on growth or development was observed. Conclusion.\p=m-\TheCATCH intervention was able to modify the fat content of school lunches, increase moderate-to-vigorous physical activity in PE, and improve eating and physical activity behaviors in children during 3 school years.

Journal ArticleDOI
23 Oct 1996-JAMA
TL;DR: Recommendations for the reporting of cost-effective analyses intended to improve the quality and accessibility of CEA reports are proposed to enhance the transparency of study methods, assist analysts in providing complete information, and facilitate the presentation of comparable cost-effectiveness results across studies.
Abstract: Objective This article, the third in a 3-part series, describes recommendations for the reporting of cost-effective analyses (CEAs) intended to improve the quality and accessibility of CEA reports. Participants The Panel on Cost-Effectiveness in Health and Medicine, a nonfederal panel with expertise in CEA, clinical medicine, ethics, and health outcomes measurement, convened by the US Public Health Service. Evidence The panel reviewed the theoretical foundations of CEA, current practices, alternative methods, published critiques of CEAs, and criticisms of general CEA methods and reporting practices. Consensus process The panel developed recommendations through 2 1/2 years of discussions. Comments on preliminary drafts were solicited from federal government methodologists, health agency officials, and academic methodologists. Conclusions These recommendations are proposed to enhance the transparency of study methods, assist analysts in providing complete information, and facilitate the presentation of comparable cost-effectiveness results across studies. Adherence to reporting conventions and attention to providing information required to understand and interpret study results will improve the relevance and accessibility of CEAs.

Journal ArticleDOI
13 Nov 1996-JAMA
TL;DR: The number and proportion of Americans living with chronic conditions, and the magnitude of their costs, including direct costs (annual personal health expenditures) and indirect costs to society (lost productivity due to chronic conditions and premature death) are determined.
Abstract: Objectives. —To determine (1) the number and proportion of Americans living with chronic conditions, and (2) the magnitude of their costs, including direct costs (annual personal health expenditures) and indirect costs to society (lost productivity due to chronic conditions and premature death). Design. —Analysis of the 1987 National Medical Expenditure Survey for prevalence and direct health care costs; indirect costs based on the 1990 National Health Interview Survey andVital Statistics of the United States. Setting. —US population. Participants. —For the estimate of prevalence and direct costs, the National Medical Expenditure Survey sample of persons who reported health conditions associated with (1) use of health services or supplies or (2) periods of disability. Interventions. —None. Main Outcome Measures. —The number of persons with chronic conditions, their annual direct health care costs, and indirect costs from lost productivity and premature deaths. Results. —In 1987, 90 million Americans were living with chronic conditions, 39 million of whom were living with more than 1 chronic condition. Over 45% of non-institutionalized Americans have 1 or more chronic conditions and their direct health care costs account for three fourths of US health care expenditures. Total costs projected to 1990 for people with chronic conditions amounted to $659 billion—$425 billion for direct health care costs and $234 billion in indirect costs. Conclusions. —The prevalence and costs of chronic conditions as a whole have rarely been estimated. Because the number of persons with limitations due to chronic conditions is more regularly reported in the literature, the total prevalence of chronic conditions has perhaps been minimized. The majority of persons with chronic conditions are not disabled, nor are they elderly. Chronic conditions affect all ages. Because persons with chronic conditions have greater health needs at any age, their costs are disproportionately high.

Journal ArticleDOI
09 Oct 1996-JAMA
TL;DR: The authors in this article developed consensus-based recommendations guiding the conduct of cost-effectiveness analysis (CEA) to improve the comparability and quality of studies, which apply to analyses intended to inform the allocation of health care resources across a broad range of conditions and interventions.
Abstract: Objective. —To develop consensus-based recommendations guiding the conduct of cost-effectiveness analysis (CEA) to improve the comparability and quality of studies. The recommendations apply to analyses intended to inform the allocation of health care resources across a broad range of conditions and interventions. This article, first in a 3-part series, discusses how this goal affects the conduct and use of analyses. The remaining articles will outline methodological and reporting recommendations, respectively. Participants. —The Panel on Cost-Effectiveness in Health and Medicine, a nonfederal panel with expertise in CEA, clinical medicine, ethics, and health outcomes measurement, was convened by the US Public Health Service (PHS). Evidence. —The panel reviewed the theoretical foundations of CEA, current practices, and alternative procedures for measuring and assigning values to resource use and health outcomes. Consensus Process. —The panel met 11 times during 21/2 years with PHS staff and methodologists from federal agencies. Working groups brought issues and preliminary recommendations to the full panel for discussion. Draft recommendations were circulated to outside experts and the federal agencies prior to finalization. Conclusions. —The panel's recommendations define a "reference case" costeffectiveness analysis, a standard set of methods to serve as a point of comparison across studies. The reference case analysis is conducted from the societal perspective and accounts for benefits, harms, and costs to all parties. Although CEA does not reflect every element of importance in health care decisions, the information it provides is critical to informing decisions about the allocation of health care resources.

Journal ArticleDOI
26 Jun 1996-JAMA
TL;DR: Arthur Frank, a sociologist at the University of Calgary, has survived several diseases and has joined what he terms the "remission society," people who have been sick and are now well but who can never be completely cured.
Abstract: In At the Will of the Body: Reflections on Illness , Arthur Frank gave a moving account of his own troubles. Now, in The Wounded Storyteller he writes of the need (obligation, really) for sick persons to tell their stories in order to clarify their own illnesses. For Frank, the wounded healer and the wounded storyteller often turn out to be the same person; the tales of sickness give it meaning and create "empathic bonds" between the teller and listener (or reader). A sociologist at the University of Calgary, Frank has survived several diseases, from heart trouble to cancer and more. In that way he has joined what he terms the "remission society," people who have been sick and are now well but who can never be completely cured. In this group he includes people in "cardiac rehab" programs, those recovered from any cancer, people with chronic diseases, and even victims

Journal ArticleDOI
21 Feb 1996-JAMA
TL;DR: Low linguistic ability in early life was a strong predictor of poor cognitive function and Alzheimer's disease in late life.
Abstract: Objective. —To determine if linguistic ability in early life is associated with cognitive function and Alzheimer's disease in late life. Design. —Two measures of linguistic ability in early life, idea density and grammatical complexity, were derived from autobiographies written at a mean age of 22 years. Approximately 58 years later, the women who wrote these autobiographies participated in an assessment of cognitive function, and those who subsequently died were evaluated neuropathologically. Setting. —Convents in the United States participating in the Nun Study; primarily convents in the Milwaukee, Wis, area. Participants. —Cognitive function was investigated in 93 participants who were aged 75 to 95 years at the time of their assessments, and Alzheimer's disease was investigated in the 14 participants who died at 79 to 96 years of age. Main Outcome Measures. —Seven neuropsychological tests and neuropathologically confirmed Alzheimer's disease. Results. —Low idea density and low grammatical complexity in autobiographies written in early life were associated with low cognitive test scores in late life. Low idea density in early life had stronger and more consistent associations with poor cognitive function than did low grammatical complexity. Among the 14 sisters who died, neuropathologically confirmed Alzheimer's disease was present in all of those with low idea density in early life and in none of those with high idea density. Conclusions. —Low linguistic ability in early life was a strong predictor of poor cognitive function and Alzheimer's disease in late life. (JAMA. 1996;275:528-532)

Journal ArticleDOI
28 Jul 1996-JAMA
TL;DR: All Americans should engage in regular physical activity at a level appropriate to their capacity, needs, and interest, and children and adults alike should set a goal of accumulating at least 30 minutes of moderate-intensity physical activity on most, and preferably, all days of the week.
Abstract: OBJECTIVE To provide physicians and the general public with a responsible assessment of the relationship between physical activity and cardiovascular health. PARTICIPANTS A non-Federal, nonadvocate, 13-member panel representing the fields of cardiology, psychology, exercise physiology, nutrition, pediatrics, public health, and epidemiology. In addition, 27 experts in cardiology, psychology, epidemiology, exercise physiology, geriatrics, nutrition, pediatrics, public health, and sports medicine presented data to the panel and a conference audience of 600. EVIDENCE The literature was searched through Medline and an extensive bibliography of references was provided to the panel and the conference audience. Experts prepared abstracts with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. CONSENSUS PROCESS The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in open forum and the scientific literature. The panel composed a draft statement that was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. CONCLUSIONS All Americans should engage in regular physical activity at a level appropriate to their capacity, needs, and interest. Children and adults alike should set a goal of accumulating at least 30 minutes of moderate-intensity physical activity on most, and preferably, all days of the week. Most Americans have little or no physical activity in their daily lives, and accumulating evidence indicates that physical inactivity is a major risk factor for cardiovascular disease. However, moderate levels of physical activity confer significant health benefits. Even those who currently meet these daily standards may derive additional health and fitness benefits by becoming more physically active or including more vigorous activity. For those with known cardiovascular disease, cardiac rehabilitation programs that combine physical activity with reduction in other risk factors should be more widely used.

Journal ArticleDOI
18 Dec 1996-JAMA
TL;DR: Low-dose diuretic-based (chlorthalidone) treatment is effective in preventing major CVD events, cerebral and cardiac, in both non-insulin-treated diabetic and nondiabetic older patients with ISH.
Abstract: Objective. —To assess the effect of low-dose, diuretic-based antihypertensive treatment on major cardiovascular disease (CVD) event rates in older, non-insulintreated diabetic patients with isolated systolic hypertension (ISH), compared with nondiabetic patients. Design. —Double-blind, randomized, placebo-controlled trial: the Systolic Hypertension in the Elderly Program (SHEP). Setting. —Multiple clinical and support centers in the United States. Paticipants. —a total of 4736 men and women aged 60 years and older at baseline with ISH (systolic blood pressure [BP], ≥160 mm Hg; diastolic BP, Intervention. —The active treatment group received a low dose of chlorthalidone (12.5-25.0 mg/d) with a step-up to atenolol (25.0-50.0 mg/d) or reserpine (0.05-0.10 mg/d) if needed. The placebo group received placebo and any active antihypertensive drugs prescribed by patient's private physician for persistently high BP. Main Outcome Measures. —The 5-year rates of major CVD events, nonfatal plus fatal stroke, nonfatal myocardial infarction (MI) and fatal coronary heart disease (CHD), major CHD events, and all-cause mortality. Results. —The SHEP antihypertensive drug regimen lowered BP of both diabetic and nondiabetic patients, with few adverse effects. For both diabetic and nondiabetic patients, all outcome rates were lower for participants randomized to the active treatment group than for those randomized to the placebo group. Thus, 5-year major CVD rate was lower by 34% for active treatment compared with placebo, both for diabetic patients (95% confidence interval [CI], 6%-54%) and nondiabetic patients (95% CI, 21%-45%). Absolute risk reduction with active treatment compared with placebo was twice as great for diabetic vs nondiabetic patients (101/1000 vs 51/1000 randomized participants at the 5-year follow-up), reflecting the higher risk of diabetic patients. Conclusion. —Low-dose diuretic-based (chlorthalidone) treatment is effective in preventing major CVD events, cerebral and cardiac, in both non-insulin-treated diabetic and nondiabetic older patients with ISH.

Journal ArticleDOI
18 Sep 1996-JAMA
TL;DR: In this article, a nested case-control study was conducted to investigate the prospective association of low-density lipoprotein (LDL) particle diameter with the incidence of fatal and nonfatal coronary artery disease.
Abstract: Objective. —To investigate the prospective association of low-density lipoprotein (LDL) particle diameter with the incidence of fatal and nonfatal coronary artery disease (CAD). Design. —A nested case-control study. Setting. —Cases and controls were identified from a population-based sample of men and women combining all of the 5 cross-sectional surveys conducted from 1979 to 1990 of the Stanford Five-City Project (FCP). Participants. —Incident CAD cases were identified through FCP surveillance between 1979 and 1992. Controls were matched by sex, 5-year age groups, survey time point, ethnicity, and FCP treatment condition. The sample included 124 matched pairs: 90 pairs of men and 34 pairs of women. Main Outcome Measures. —LDL peak particle diameter (LDL size) was determined by gradient gel electrophoresis on plasma samples collected during the cross-sectional surveys (stored at 70°C for 5-15 years). Established CAD risk-factor data were available from FCP baseline measurements. Results. —LDL size was smaller among CAD cases than controls (mean ±SD) (26.17±1.00nm vs 26.68±0.90nm;P Conclusion. —LDL size was significantly smaller in CAD cases than in controls in a prospective, population-based study. These findings support other evidence of a role for small, dense LDL particles in the etiology of atherosclerosis.

Journal ArticleDOI
14 Feb 1996-JAMA
TL;DR: The results suggest an inverse association between fiber intake and MI and suggest that fiber, independent of fat intake, is an important dietary component for the prevention of coronary disease.
Abstract: Objective. —To examine prospectively the relationship between dietary fiber and risk of coronary heart disease. Design. —Cohort study. Setting. —In 1986, a total of 43 757 US male health professionals 40 to 75 years of age and free from diagnosed cardiovascular disease and diabetes completed a detailed 131 -item dietary questionnaire used to measure usual intake of total dietary fiber and specific food sources of fiber. Main Outcome Measure. —Fatal and nonfatal myocardial infarction (Ml). Results. —During 6 years of follow-up, we documented 734 cases of Ml (229 were fatal coronary heart disease). The age-adjusted relative risk (RR) for total Ml was 0.59 (95% confidence interval [CI], 0.46 to 0.76) among men in the highest quintile of total dietary fiber intake (median, 28.9 g/d) compared with men in the lowest quartile (median, 12.4 g/d). The inverse association was strongest for fatal coronary disease (RR, 0.45; 95% CI, 0.28 to 0.72). After controlling for smoking, physical activity and other known nondietary cardiovascular risk factors, dietary saturated fat, vitamin E, total energy intake, and alcohol intake, the RRs were only modestly attenuated. A 10-g increase in total dietary fiber corresponded to an RR for total Ml of 0.81 (95% CI, 0.70 to 0.93). Within the three main food contributors to total fiber intake (vegetable, fruit, and cereal), cereal fiber was most strongly associated with a reduced risk of total Ml (RR, 071; 95% CI, 0.55 to 0.91 for each 10-g increase in cereal fiber per day). Conclusions. —Our results suggest an inverse association between fiber intake and Ml. These results support current national dietary guidelines to increase dietary fiber intake and suggest that fiber, independent of fat intake, is an important dietary component for the prevention of coronary disease. (JAMA. 1996;275:447-451)

Journal ArticleDOI
10 Jan 1996-JAMA
TL;DR: The evolution to patient-centered care in many areas of medicine is described, including patient care, health-related law, medical education, research, and quality assessment.
Abstract: American medicine is in the midst of a professional evolution driven by a refocusing of medicine's regard for the patient's viewpoint. Historically, medicine has been largely physician centered, but physicians have begun to incorporate patients' perspectives in ways that increasingly matter. Some call this shift "patient-centered" care. In support of the view that this refocusing reflects a broad professional shift, we describe the evolution to patient-centered care in many areas of medicine: patient care, health-related law, medical education, research, and quality assessment.

Journal ArticleDOI
04 Dec 1996-JAMA
TL;DR: A program of counseling and support can substantially increase the time spouse-caregivers are able to care for AD patients at home, particularly during the early to middle stages of dementia when nursing home placement is generally least appropriate.
Abstract: Objective. —To determine the long-term effectiveness of comprehensive support and counseling for spouse-caregivers and families in postponing or preventing nursing home placement of patients with Alzheimer disease (AD). Design. —Randomized controlled intervention study. Setting. —Outpatient research clinic in the New York City metropolitan area. Participants. —Referred, volunteer sample of 206 spouse-caregivers of AD patients who enrolled in the study during a 31/2-year period. All patients were living at home at baseline and had at least 1 relative living in the area. Intervention. —Caregivers in the treatment group were provided with 6 sessions of individual and family counseling within 4 months of enrollment in the study and were required to join support groups. In addition, counselors were available for further counseling at any time. Main Outcome Measure. —Time from enrollment of caregivers in the study to placement of the AD patients in a nursing home. Results. —Using Kaplan-Meier survival analysis, we estimated that the median time (weighted average of estimates for male and female caregivers) from baseline to nursing home placement of AD patients was 329 days longer in the treatment group than in the control group ( z =2.29; P =.02). The relative risk (RR) from a Cox proportional hazard model of nursing home placement (intent-to-treat estimate) after adjusting for caregiver sex, patient age, and patient income was 0.65 (95% confidence interval [CI], 0.45 to 0.94; P =.02), indicating that caregivers were approximately two thirds as likely to place their spouses in nursing homes at any point in time if they were in the treatment group than if they were in the control group. Treatment had the greatest effect on risk of placement for patients who were mildly demented (RR, 0.18; 95% CI, 0.04 to 0.77) or moderately demented (RR, 0.38; 95% CI, 0.17 to 0.82). Conclusions. —A program of counseling and support can substantially increase the time spouse-caregivers are able to care for AD patients at home, particularly during the early to middle stages of dementia when nursing home placement is generally least appropriate.