A dietitian-delivered group nutrition program leads to reductions in dietary fat, serum cholesterol, and body weight: the Worcester Area Trial for Counseling in Hyperlipidemia (WATCH).

OBJECTIVE: To assess the effectiveness of a dietitian-based nutrition counseling and education program for patients with hyperlipidemia. DESIGN: A 4-session program implemented as a complement to a randomized physician-delivered intervention. SUBJECTS/SETTING: From 12 practice sites of the Fallon Clinic, 1,162 subjects with hyperlipidemia were recruited, 645 of whom had data sufficient for our primary analyses. INTERVENTION: Two individual and 2 group sessions conducted over 6 weeks. MAIN OUTCOME MEASURES: Total and saturated fat levels; serum low-density lipoprotein cholesterol levels; and body weight, measured at baseline and after 1 year. STATISTICAL ANALYSES: Multiple linear regression was used to evaluate changes in outcome measures. RESULTS: After 1 year, there were significant reductions in outcome measures for subjects attending 3 or 4 nutrition sessions vs subjects attending fewer than 3 sessions or those never referred to a nutrition session. Reductions (mean +/- standard error) in saturated fat (measured as percent of energy) were 2.7 +/- 0.5%, 2.1 +/- 0.5%, and 0.3 +/- 0.1%, respectively. These reductions correspond to roughly a 22% relative change from baseline in those attending 3 or 4 sessions. Corollary reductions were observed for total fat (measured as percent of energy): 8.2 +/- 1.4%, 5.0 +/- 1.4%, and 0.7 +/- 0.4%; low-density lipoprotein cholesterol: 0.48 +/- 0.11 mmol/L, 0.13 +/- 0.11 mmol/L, and 0.02 +/- 0.03 mmol/L; and body weight: 4.5 +/- 0.9 kg, 2.1 +/- 0.8 kg, and 1.1 +/- 0.2 kg. The specified changes were additive to those of the physician-delivered intervention. APPLICATIONS/CONCLUSIONS: This investigation provides empirical data demonstrating the effectiveness of a dietitian-delivered intervention in the care of patients with hyperlipidemia.

Effect of physician-delivered nutrition counseling training and an office-support program on saturated fat intake, weight, and serum lipid measurements in a hyperlipidemic population: Worcester Area Trial for Counseling in Hyperlipidemia (WATCH).

OBJECTIVE: To evaluate the effectiveness of a training program for physician-delivered nutrition counseling, alone and in combination with an office-support program, on dietary fat intake, weight, and blood low-density lipoprotein cholesterol levels in patients with hyperlipidemia. PARTICIPANTS AND METHODS: Forty-five primary care internists at the Fallon Community Health Plan, a central Massachusetts health maintenance organization, were randomized by site into 3 groups: (1) usual care; (2) physician nutrition counseling training; and (3) physician nutrition counseling training plus an office-support program. Eleven hundred sixty-two of their patients with blood total cholesterol levels in the highest 25th percentile, having previously scheduled physician visits, were recruited. Physicians in groups 2 and 3 attended a 3-hour training program on the use of brief patient-centered interactive counseling and the use of an office-support program that included in-office prompts, algorithms, and simple dietary assessment tools. Primary outcome measures included change at 1-year of follow-up in percentage of energy intake from saturated fat; weight; and blood low-density lipoprotein cholesterol levels. RESULTS: Improvement was seen in all 3 primary outcome measures, but was limited to patients in group 3. Compared with group 1, patients in group 3 had average reductions of 1.1 percentage points in percent of energy from saturated fat (a 10.3% decrease) (P = .01); a reduction in weight of 2.3 kg (P<.001); and a decrease of 0.10 mmol/L (3.8 mg/dL) in low-density lipoprotein cholesterol level (P = .10). Average time for the initial counseling intervention in group 3 was 8.2 minutes, 5.5 minutes more than in the control group. CONCLUSION: Brief supported physician nutrition counseling can produce beneficial changes in diet, weight, and blood lipids.

Effectiveness of antihyperlipidemic drug management in clinical practice.

Although randomized clinical trials have convincingly shown the efficacy of antihyperlipidemic drugs, both discontinuation of antihyperlipidemic drugs and failure to achieve goal lipid levels would be expected to attenuate the effect of these drugs on reducing the rates of hospitalization for coronary events. This study compares the rates of hospitalization and low-density lipoprotein cholesterol (LDL-C) levels during and after discontinuation of antihyperlipidemic drug therapy. A retrospective cohort study was conducted among 2369 patients at 2 health maintenance organizations (HMOs) during the period 1988 to 1994. Rates of coronary heart disease (CHD)-related hospitalization and non-CHD-related hospitalization and the LDL-C levels between 14 and 180 days after the initiation or discontinuation of drug therapy were compared for periods of antihyperlipidemic drug use and nonuse. The rate ratio for CHD hospitalization during periods of antihyperlipidemic drug use compared with periods of nonuse was 1.02 (95% CI, 0.74 to 1.40), excluding the first 6 months after initiation or discontinuation and controlling for patient sex, age, history of CHD, hypertension, diabetes, and HMO site. By contrast, the adjusted rate ratio was 0.70 (95% CI, 0.61 to 0.80) for non-CHD hospitalization. The percentage of patients with a history of CHD who achieved LDL-C levels <130 mg/dL was 27% < or =6 months after initiation of antihyperlipidemic drug therapy compared with 18% during gaps in drug therapy (P = 0.04). This study failed to demonstrate the effectiveness of lipid-lowering therapy in reducing CHD hospitalizations in community settings, apparently because most recipients either discontinued therapy or failed to achieve the desired LDL-C reduction while receiving therapy. These results indicate the need for interventions to improve patient compliance and management of lipid disorders.

Relationship between leisure-time physical activity and selected dietary variables in the Worcester Area Trial for Counseling in Hyperlipidemia.

We evaluated the relationship between Leisure-time Physical Activity (LTPA) and selected dietary variables in the Worcester Area Trial for Counseling in Hyperlipidemia. Subjects were males (N = 425) and females (N = 494) of mean age 49.8 and 48.4 yr, respectively. Dietary data were collected using a 7-d (7DDR) and a 24-h dietary recall (24HR), and LTPA information was obtained along with the 7DDR. Subjects were categorized into four levels of LTPA (0-29 (N = 548), 30-60 (N = 98), 61-120 (N = 137), and > or = 121 min.wk-1 (N = 136)). Results from ANOVA revealed that active subjects (LTPA > or = 30 min.wk-1) consumed fewer servings per week of meats, fried foods, sweets, and 2-4% milk and more servings of fruits, vegetables, low fat dairy products, and 0-1% milk than did inactive subjects (LTPA = 0-29 min.wk-1). Comparison of selected 7DDR-derived macro- and micronutrients revealed that active individuals consumed a lower fat and a more micronutrient dense diet than their more inactive counterparts. These findings were not materially altered by adjustment for age, gender, education, and smoking. Finally, the 7DDR results were confirmed in analyses of the 24HR data in a slightly smaller group of subjects (N = 756). The present findings have implications for etiologic investigations on outcomes that have both LTPA and diet as risk factors, and for targeting public health interventions.

Gender differences in social desirability and social approval bias in dietary self-report.

Social desirability (the tendency to respond in such a way as to avoid criticism) and social approval (the tendency to seek praise) are two prominent response set biases evident in answers on structured questionnaires. These biases were tested by comparing nutrient intakes as estimated from a single 24-hour diet recall interview (24 HR) and a 7-day dietary recall (7DDR). Data were collected as part of the Worcester Area Trial for Counseling in Hyperlipidemia, a randomized, physician-delivered nutrition intervention trial for hypercholesterolemic patients conducted in Worcester, Massachusetts, from 1991 to 1995. Of the 1,278 total study subjects, 759 had complete data for analysis. Men overestimated their fat and energy intakes on the 7DDR as compared with the 24HR according to social approval: One unit increase in the social approval score was associated with an overestimate of 21.5 kcal/day in total energy intake and 1.2 g/day in total fat intake. Women, however, underestimated their dietary intakes on the 7DDR relative to the 24HR according to social desirability: One unit increase in the social desirability score was associated with an underestimate of 19.2 kcal/day in energy intake and 0.8 g/day in total fat. The results from the present study indicate that social desirability and social approval biases appear to vary by gender. Such biases may lead to misclassification of dietary exposure estimates resulting in a distortion in the perceived relation between health-related outcomes and exposure to specific foods or nutrients. Because these biases may vary according to the perceived demands of research subjects, it is important that they be assessed in a variety of potential research study populations.

Effect of training and a structured office practice on physician-delivered nutrition counseling: the Worcester-Area Trial for Counseling in Hyperlipidemia (WATCH).

We examined the effectiveness of a training program for physician-delivered nutrition counseling, alone and in combination with a structured office practice environment for nutrition management, on physicians' counseling practices. Forty-five primary care internists and 1,278 of their patients in the top quarter of the cholesterol distribution at a central Massachusetts health maintenance organization (the Fallon Clinic) were enrolled into a randomized controlled trial. Physicians were randomized by site into three conditions: (1) usual care, (2) physician nutrition counseling training, and (3) physician nutrition counseling training plus a structured office practice environment for nutrition management (prompts and the provision of lipid results and counseling algorithms). A randomly selected 325 patients were given a 10-item patient exit interview (PEI) assessing whether the physician provided advice; assessed past changes, barriers, and resources; negotiated specific plans and goals; provided patient materials; referred the patient to a dietitian; and developed plans for follow-up. Condition 3 physicians demonstrated significantly greater implementation of the nutrition counseling sequence than did physicians in either of the other two conditions (P < .0001). Referrals to nutrition services were markedly reduced in condition 2, despite PEI scores no different than those in condition 1. Higher PEI scores for patients seen by physicians in condition 3 were stable for as long as two years beyond training. Primary care internists, when provided with both training in counseling techniques and a supportive office environment, will carry out patient counseling appropriately. Training alone, however, is not sufficient and may be counterproductive. Medical Subject Headings (MeSH): hypercholesterolemia, diet therapy, coronary disease, health behavior, primary health care, medical education, managed care programs.

Discontinuations of antihyperlipidemic drug therapy: assessment by means of automated databases.

Discontinuations of drugs used in the treatment of chronic conditions such as hyperlipidemia often signal adverse drug effects or therapeutic ineffectiveness. Discontinuations of antihyperlipidemic drug therapy among 2369 patients were evaluated using the computerized files and written medical records of two health maintenance organizations (HMOs) in Massachusetts for the period 1988 to 1990. Three methods were assessed for the identification of potential discontinuations of drug therapy using the automated databases. Overall, 75% of discontinuations flagged by the automated databases were confirmed in the medical charts. (1) In new users, 618 of the 635 (97%) drugs identified as drug switches by the computerized HMO pharmacy files were confirmed as discontinuations by the medical charts. (2) Of 620 eligible HMO members 332 (54%) identified with greater than 6 months between the last refill for an antihyperlipidemic drug and the end of the study stopped the drug therapy according to the medical chart. (3) Of 219 eligible drug therapies flagged with an 'inactive' or with an 'omit' status in the clinical encounter files 198 (90%) were discontinued according to the medical chart. This study demonstrates the utility of clinical automated databases to facilitate the study of drug discontinuations in primary care settings, reducing the cost and the amount of time required for the evaluation.

Research collaboration between an HMO and an academic medical center: lessons learned.

Joint research ventures between health maintenance organizations (HMOs) and academic medical centers (AMCs) can strengthen both organizations from the research and patient care perspectives, by facilitating the exploration of views and cost-effective approaches to diagnoses and treatment. This article describes a research venture between the Fallon Healthcare System, a health maintenance organization (HMO), and the University of Massachusetts Medical Center, an academic medical center (AMC). This research venture, the Worcester Area Trial for Counseling Hyperlipidemia, was a four-year study in which 1,277 participants were recruited from 45 Fallon Clinic physician panels. The study targeted patients with blood cholesterol levels in the upper 25% of the cholesterol distribution. The different priorities and perspectives of the two institutions with regard to health care and research became more apparent as the study progressed. Eventually study personnel needed to re-examine the study objectives and each other's perspectives to accommodate these differences. This learning process showed that research ventures between HMOs and AMCs can prove mutually beneficial. An HMO can gain experience with large government-funded projects. AMCs can study managed care within a controlled setting. However, the differing priorities and perspectives of these institutions' organizational structures require that considerable attention be paid to their representatives' working relationships and perceptions.

Physician training for patient-centered nutrition counseling in a lipid intervention trial.

BACKGROUND: We examined the effect of a 3-hr training program on physicians' lipid intervention knowledge, attitudes, and skills. The program teaches physicians skills to conduct a brief dietary risk assessment and provide patient-centered counseling to enable patients with elevated lipids to change their dietary patterns. METHOD: The training is part of a randomized trial of lipid-lowering interventions, the Worcester Area Trial for Counseling in Hyperlipidemia. Primary care internists practicing in a health maintenance organization (HMO) were assessed, before and after training using questionnaires and audiotapes to document changes in knowledge about diet, attitudes about intervention, reported nutrition intervention practices, and counseling and assessment skills. Physicians also rated the value that they thought the training program had to them. RESULTS: After completion of the program the physicians' use of dietary counseling steps, as assessed by blinded evaluation of audiotaped physician-patient interactions, significantly increased (mean pre = 5.4, mean post = 9.2; t = 9.9; P < or = 0.001). In this regard, there were instances in the use of 7 of the 14 specific counseling steps. Physicians also demonstrated increases in self-perceived preparedness as measured by a 5-point scale (mean pre = 3.2, mean post = 4.0; t = 4.25; P < 0.001), confidence in having an effect (mean pre = 3.3, mean post = 3.9; t = 3.16; P < 0.01), perception that materials were available to aid intervention (mean pre = 2.7, mean post = 4.0; t = 5.29; P < 0.001), and perception that they have access to a nutritionist (mean pre = 3.5, mean post = 4.0; t = 2.63; P < 0.01). They rated the value of the program between very good and excellent. CONCLUSION: Results of this 3-hr educational program indicate that physicians in an HMO are responsive to the teaching of specialized skills deemed important for promoting health behavior change in their patients.

Discontinuation of antihyperlipidemic drugs--do rates reported in clinical trials reflect rates in primary care settings?

BACKGROUND: Discontinuation rates for drugs used to treat chronic conditions may affect the success of therapy. However, the discontinuation rates reported in clinical trials may not reflect those in primary care settings. METHODS: We conducted a cohort study using computerized research files and medical records on 2369 new users of antihyperlipidemic therapy at two health maintenance organizations (HMOs) from 1988 through 1990. The rates of drug discontinuation in these primary care settings were compared with the rates reported in clinical trials published from 1975 through 1993, located with the Medline data base. RESULTS: In the HMOs, the one-year probability of drug discontinuation was 41 percent for bile acid sequestrants (95 percent confidence interval, 38 to 44 percent), 46 percent for niacin (95 percent confidence interval, 42 to 51 percent), 15 percent for lovastatin (95 percent confidence interval, 11 to 19 percent), and 37 percent for gemfibrozil (95 percent confidence interval, 31 to 43 percent). For the bile acid sequestrants, niacin, and gemfibrozil, the risks of discontinuation were substantially higher in the HMOs than in randomized clinical trials, in which the summary estimates of this risk were 31 percent, 4 percent, and 15 percent, respectively, for trials of one year or longer. The rates of discontinuation in open-label studies were similar to those in the HMOs. CONCLUSIONS: The discontinuation rates reported in randomized clinical trials may not reflect the rates actually observed in primary care settings. The effectiveness and tolerability of antihyperlipidemic medications should be studied further in populations that typically use the agents.

Coronary artery dissection secondary to blunt chest trauma.

A 38-yr-old woman presented with an anterolateral myocardial infarction following blunt chest trauma sustained in a motor vehicle accident. Subsequent cardiac catheterization revealed a large left ventricular aneurysm and angiographic evidence of dissection of the proximal left anterior descending artery. Review of the literature and management are discussed.