Low-fat dietary pattern and risk of invasive breast cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.

CONTEXT: The hypothesis that a low-fat dietary pattern can reduce breast cancer risk has existed for decades but has never been tested in a controlled intervention trial. OBJECTIVE: To assess the effects of undertaking a low-fat dietary pattern on breast cancer incidence. DESIGN AND SETTING: A randomized, controlled, primary prevention trial conducted at 40 US clinical centers from 1993 to 2005. PARTICIPANTS: A total of 48,835 postmenopausal women, aged 50 to 79 years, without prior breast cancer, including 18.6% of minority race/ethnicity, were enrolled. INTERVENTIONS: Women were randomly assigned to the dietary modification intervention group (40% [n = 19,541]) or the comparison group (60% [n = 29,294]). The intervention was designed to promote dietary change with the goals of reducing intake of total fat to 20% of energy and increasing consumption of vegetables and fruit to at least 5 servings daily and grains to at least 6 servings daily. Comparison group participants were not asked to make dietary changes. MAIN OUTCOME MEASURE: Invasive breast cancer incidence. RESULTS: Dietary fat intake was significantly lower in the dietary modification intervention group compared with the comparison group. The difference between groups in change from baseline for percentage of energy from fat varied from 10.7% at year 1 to 8.1% at year 6. Vegetable and fruit consumption was higher in the intervention group by at least 1 serving per day and a smaller, more transient difference was found for grain consumption. The number of women who developed invasive breast cancer (annualized incidence rate) over the 8.1-year average follow-up period was 655 (0.42%) in the intervention group and 1072 (0.45%) in the comparison group (hazard ratio, 0.91; 95% confidence interval, 0.83-1.01 for the comparison between the 2 groups). Secondary analyses suggest a lower hazard ratio among adherent women, provide greater evidence of risk reduction among women having a high-fat diet at baseline, and suggest a dietary effect that varies by hormone receptor characteristics of the tumor. CONCLUSIONS: Among postmenopausal women, a low-fat dietary pattern did not result in a statistically significant reduction in invasive breast cancer risk over an 8.1-year average follow-up period. However, the nonsignificant trends observed suggesting reduced risk associated with a low-fat dietary pattern indicate that longer, planned, nonintervention follow-up may yield a more definitive comparison. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.

Improving management of obesity in primary care: cluster randomised trial.

OBJECTIVE: To evaluate a training programme intended to improve the management of obesity, delivered to general practice teams. DESIGN: Cluster randomised trial. SETTING: Northern and Yorkshire region of England. PARTICIPANTS: 44 general practices invited consecutively attending obese adults to participate; 843 patients attended for collection of baseline data and were subsequently randomised. INTERVENTION: 4.5 hour training programme promoting an obesity management model. MAIN OUTCOME MEASURES: Difference in weight between patients in intervention and control groups at 12 months (main outcome measure) and at 3 months and 18 months; change in practitioners' knowledge and behaviour in obesity management consultations. RESULTS: Twelve months after training the patients in the intervention group were 1 (95% confidence interval--1.9 to 3.9) kg heavier than controls (P = 0.5). Some evidence indicated that practitioners' knowledge had improved. Some aspects of the management model, including recording weight, target weight, and dietary targets, occurred more frequently in intervention practices after the training, but in absolute terms levels of implementation were low. CONCLUSION: A training package promoting a brief, prescriptive approach to the treatment of obesity through lifestyle modification, intended to be incorporated into routine clinical practice, did not ultimately affect the weight of this motivated and at risk cohort of patients.

Waiting for organ transplantation: results of an analysis by an Institute of Medicine Committee.

One of the most visible and contentious issues regarding the fairness of the original system of organ procurement and allocation is the argument that it resulted in great disparities in the total amount of time a patient waited for an organ (i.e. the time from registration at a transplantation center to transplant), depending on where he or she lived. In an attempt to resolve this debate, Congress charged the National Academy of Sciences, Institute of Medicine to perform an independent study of the original system and proposed rule changes. In an analysis of approximately 68,000 transplant waiting list records, the committee developed several conclusions and recommendations largely specific to liver transplantation policies. The purpose of this paper is to describe both the results of the study and the statistical foundations of the mixed-effects multinomial logistic regression model that led to the committee's conclusions.