Thomas G. Hurley

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.

The effect of dietary exposures on recurrence and mortality in early stage breast cancer

We studied the effect of diet and body weight on recurrence and death in 472 women diagnosed with early-stage breast cancer in 1982–1984. From Cox proportional hazards regression models we found that the strongest effects were observed in premenopausal women. For example, after accounting for disease stage and age, reported baseline consumption (times/day) of butter, margarine, and lard (risk ratio (RR)=1.67; 95% confidence interval (CI)=1.17–2.39) and beer (drinks/day) (RR=1.58; 95% CI=1.15–2.17) increased the risk of recurrence. There also appeared to be an increased risk associated with consumption of red meat, liver, and bacon, corresponding to about a doubling of risk for each time per day that foods in this category were consumed (RR=1.93; 95% CI=0.89–4.15). Relative body weight increased risk at the rate of 9% (RR=1.09; 95% CI=1.02–1.17) for each kg/m2 (equivalent to about 5.8 pounds for a woman 5′4″ tall). For death, the results were similar, but relative weight was more strongly associated, increasing risk by 12% per kg/m2 (RR=1.12; 95% CI=1.03–1.22).

Change in women's diet and body mass following intensive intervention for early-stage breast cancer

OBJECTIVEnTo determine the effectiveness of an intensive dietary intervention on diet and body mass in women with breast cancer.nnnDESIGNnRandomized clinical trial.nnnSUBJECTSn172 women aged 20 to 65 years with stage I or II breast cancer.nnnINTERVENTIONnA 15-session, mainly group-based and dietitian-led nutrition education program (NEP) was compared to a mindfulness-based stress reduction clinic program (SRC); or usual supportive care (UC).nnnMAIN OUTCOME MEASURESnDietary fat, complex carbohydrates, fiber, and body mass were measured.nnnSTATISTICAL ANALYSISnIn addition to descriptive statistics, analysis of variance was conducted to test for differences according to intervention group.nnnRESULTSnOf the 157 women with complete dietary data at baseline, 149 had complete data immediately postintervention (at 4 months) and 146 had complete data at 1 year. Women randomized to NEP (n = 50) experienced a large reduction in fat consumption (5.8% of energy as fat) at 4 months and much of this reduction was preserved at 1 year (4.1% of energy) (both P < .0002) vs no change in either SRC (n = 51) or UC (n = 56). A 1.3-kg reduction in body mass was evident at 4 months in the NEP group (P = .003) vs no change in the SRC and UC groups. Women who had higher-than-average expectations of a beneficial effect of the intervention experienced larger changes.nnnAPPLICATIONSnDietitians use of group nutrition interventions appear to be warranted. Increasing their effectiveness and maintaining high levels of adherence may require additional support, including the involvement of significant others, periodic individual meetings, or group booster sessions.

A randomized, multicenter trial of weight-adjusted intravenous heparin dose titration and point-of-care coagulation monitoring in hospitalized patients with active thromboembolic disease

BACKGROUNDnTherapy with intravenous unfractionated heparin improves clinical outcome in patients with active thromboembolic disease, but achieving and maintaining a therapeutic level of anticoagulation remains a major challenge for clinicians.nnnMETHODSnA total of 113 patients requiring heparin for at least 48 hours were randomly assigned at 7 medical centers to either weight-adjusted or non-weight-adjusted dose titration. They were separately assigned to either laboratory-based or point-of-care (bedside) coagulation monitoring.nnnRESULTSnWeight-adjusted heparin dosing yielded a higher mean activated partial thromboplastin time (aPTT) value 6 hours after treatment initiation than non-weight-adjusted dosing (99.9 vs 78.8 seconds; P =.002) and reduced the time required to exceed a minimum threshold (aPTT >45 seconds) of anticoagulation (10.5 vs 8.6 hours; P =.002). Point-of-care coagulation monitoring significantly reduced the time from blood sample acquisition to a heparin infusion adjustment (0.4 vs 1.6 hours; P <.0001) and to reach the therapeutic aPTT range (51 to 80 seconds) (16.1 vs 19.4 hours; P =.24) compared with laboratory monitoring. Although a majority of patients participating in the study surpassed the minimum threshold of anticoagulation within the first 12 hours and reached the target aPTT within 24 hours, maintaining the aPTT within the therapeutic range was relatively uncommon (on average 30% of the overall study period) and did not differ between treatment or monitoring strategies.nnnCONCLUSIONSnWeight-adjusted heparin dosing according to a standardized titration nomogram combined with point-of-care coagulation monitoring using the BMC Coaguchek Plus System represents an effective and widely generalizable strategy for managing patients with thromboembolic disease that fosters the rapid achievement of a desired range of anticoagulation. Additional work is needed, however, to improve on existing patient-specific strategies that can more effectively sustain a therapeutic state of anticoagulation.

Development and testing of a seven-day dietary recall

Using multiple 24-hr recalls (24HR) we tested the Seven Day Dietary Recall (7DDR) developed to assess nutrient exposures, especially lipids, in dietary interventions and other clinical trials requiring measurement of effect over moderate time periods. A total of 261 individuals in three studies completed a 7DDR at the end of a 3- to 5-week period during which 3 to 7 24HR were telephone-administered on randomly selected days. One of these studies and data from one additional study (total n = 678) allowed us to test the ability of the 7DDR to predict serum lipid changes in an intervention setting. In correlation and linear regression analyses, high levels of agreement between 7DDR and 24HR were obtained. For total energy: r = 0.67 and b = 0.69, and for total fat intake (g/day): r = 0.67 and b = 0.80. When 7 days of 24HR were available agreement tended to be higher. For total energy: r = 0.69 and b = 0.95, and for total fat (g/day): r = 0.71 and b = 1.04. Data derived from the 7DDR and fit to the Keys and Hegsted equations closely predicted actual changes in total serum cholesterol (within 15% and 10%, respectively). The 7DDR is a relatively easily administered, sensitive method to assess short-term changes in dietary fat consumption in individuals.

A comparison of selected nutrient intakes derived from three diet assessment methods used in a low-fat maintenance trial.

OBJECTIVEnIn the vast majority of surveys and research in humans, dietary data are obtained from self-reports: recalls; records; or historical methods, usually food frequency questionnaires (FFQ). This study provides a rare opportunity to compare data derived from all three methods.nnnDESIGNnA crossover study of dietary fat in which data were collected using an average of 11.4 food records and 11.7 24-h diet recalls. Using simple subtraction and correlation, energy and nutrient intakes derived from the three methods were compared to each other and with those derived from a single FFQ. Analysis of variance was used to evaluate sources of variability in nutrient intakes estimated from the individual days of records and recalls.nnnSETTINGnAn independent, free-standing medical research institute.nnnSUBJECTSn13 men who were compliant with study procedures.nnnRESULTSnFFQ-derived estimates of energy and nutrient intake were highest (e.g. 1967 kcal versus 1858 kcal and 1936 kcal for the records and recalls, respectively). Mean differences in energy and nutrient intakes and their variances were lowest and correlation coefficients highest in comparing the records and recalls (e.g. for fat the mean difference was 5.0 g, and r = 0.85). Analysis of variance of individual days of record- and recall-derived data (n = 300) revealed that there was no effect due to either method (record or recall) or the sequence of administration.nnnCONCLUSIONSnResults of this study indicate that the FFQ overestimated dietary intake. Energy and nutrient results obtained from the records and recalls were interchangeable. However, based on smaller SDs around the means, it appears that the recalls may perform slightly better in estimating dietary intake in groups such as these well-educated, highly compliant men.

Thrombin Generation After the Abrupt Cessation of Intravenous Unfractionated Heparin Among Patients With Acute Coronary Syndromes Potential Mechanisms for Heightened Prothrombotic Potential

OBJECTIVESnThe purpose of this study was to determine the mechanistic basis for thrombin generation and increased prothrombotic potential after the abrupt cessation of intravenous (i.v.) unfractionated heparin among patients with acute coronary syndromes.nnnBACKGROUNDnA rebound increase in prothrombotic potential has been observed biochemically and clinically after the abrupt cessation of unfractionated heparin (UFH) among patients with acute coronary syndromes. Although the mechanism is unknown, tissue factor and the extrinsic coagulation cascade, both operative in atherosclerotic vascular disease and arterial thrombosis, are thought to be centrally involved.nnnMETHODSnIn a single-center, pilot study, 30 patients with either unstable angina or non-ST segment elevation myocardial infarction who had received a continuous i.v. infusion of UFH for 48 h were randomly assigned to: 1) abrupt cessation, 2) i.v. weaning over 12 h or 3) subcutaneous weaning over 12 h.nnnRESULTSnThrombin generation (prothrombin fragment 1.2) was evident within 1 h of UFH cessation, increased progressively (by nearly two-fold) at 24 h (p = 0.002) and correlated inversely with tissue factor pathway inhibitor concentration (r = -0.61). Thrombin generation was greatest among patients randomized to abrupt cessation (1.6-fold increase at 24 h) and least in those with i.v. weaning.nnnCONCLUSIONSnThrombin generation after the abrupt cessation of UFH may represent a drug-induced impairment of physiologic vascular thromboresistance in response to locally generated tissue factor. A dosing strategy of abbreviated i.v. weaning attenuates but does not prevent heparin rebound among patients with acute coronary syndromes.

CORONARY ARTERY SMOKING INTERVENTION STUDY (CASIS) : 5-YEAR FOLLOW-UP

The authors compared the effect of a behavioral multicomponent smoking cessation special intervention (SI) to an advice-only intervention (AO) on smoking status at 5 years for smokers with coronary disease (n = 160). Regression analyses revealed an interaction between intervention type and disease severity such that patients in the SI group with greater degrees of coronary artery disease showed significantly higher cessation rates (odds ratio = 344 for 3-vessel disease in the SI vs. AO, p = .01). Factors predicting maintained abstinence included having 12 or more years of education, contemplating quitting smoking or being ready to begin action to quit at baseline, and having a higher self-efficacy score.

Comparing food intake using the Dietary Risk Assessment with multiple 24-hour dietary recalls and the 7-Day Dietary Recall.

The Dietary Risk Assessment (DRA) is a brief dietary assessment tool used to identify dietary behaviors associated with cardiovascular disease. Intended for use by physicians and other nondietitians, the DRA identifies healthful and problematic dietary behaviors and alerts the physician to patients who require further nutrition counseling. To determine the relative validity of this tool, we compared it to the 7-Day Dietary Recall (an instrument developed to assess intake of dietary fat) and to the average of 7 telephone-administered 24-hour dietary recalls. Forty-two free-living subjects were recruited into the study. The 7-Day Dietary Recall and DRA were administered to each subject twice, at the beginning and the end of the study period, and the 24-hour recalls were conducted during the intervening time period. Correlation coefficients were computed to compare the food scores derived from the 3 assessment methods. Correlations between the DRA and 7-Day Dietary Recall data were moderate (r = .47, on average, for postmeasures); correlations between the DRA and 24-hour recalls were lower. The ability of the DRA to assess dietary fat consumption and ease of administration make it a clinically useful screening instrument for the physician when counseling patients about dietary fat reduction.

Editorial: Evolution of direct thrombin antagonists: Acknowledging potential limitations

The pathobiology of acute myocardial infarction (MI) is known to involve occlusive coronary arterial thrombosis developing at sites of vessel wall injury and atheromatous plaque rupture [1-6]. Thrombus formation is driven by a complex cascade of dynamic processes that includes circulating coagulation proteins, platelets, erythrocytes, and leukocytes. There is clear evidence that thrombin, a 308 amino acid serine protease, plays a pivotal role in arterial thrombogenesis [7,8] and that biochemical markers of increased thrombin activity and generation, as measured in plasma, are associated with several unfavorable clinical outcomes, including incomplete coronary perfusion, reocclusion, recurrent myocardial ischemia, and death [9-14]. At the present time, heparin is the most widely used anticoagulant in patients with MI. It has been shown in clinical studies to reduce reocclusion following coronary thrombolysis with tissue plasminogen activator (tPA). However, in vitro studies suggest that heparins inability to inhibit clot-bound thrombin may limit significantly its role as an adjunctive agent. The search for an optimal adjunctive strategy has, therefore, turned to the investigation of direct thrombin antagonists [15-18]. Some have argued, however, that the effective prevention of thrombosis among patients with acute coronary syndromes in general, and with MI given thrombolytics in particular, can only be achieved by neutralizing the existing thrombotic stimulus, or at the very least inhibiting the coagulation cascade more proximally. In other words, prevent thrombin from being generated in the first place, rather than try to limit its activity after the fact. Naturally it follows to ask whether the available thrombin antagonists are capable of inhibiting thrombin generation and, if not, can they inhibit thrombin activity sufficiently to yield clinical benefit? In the Thrombolysis in Myocardial Infarction (TIMI) 5 study [19], patients received accelerated tPA, aspirin (160 mg), and either unfractionated heparin or the direct thrombin antagonist hirudin. The study drug was administered prior to thrombolytic initiation. The four ascending dose groups of hirudin were as follows: (1) 0.15 mg/kg intravenous bolus, followedby a 0.05 mg/kg/hr fixed infusion; (2) 0.1 mg/kg intravenous bolus, followed by a 0.01 mg/kg/hr fixed infusion; (3) 0.3 mg/kg intravenous bolus, followed by a 0.1 mg/kg/hr fixed infusion; (4) 0.6 mg/kg intravenous bolus, followed by a 0.2 mg/kg/hr fixed infusion. The hirudin infusion was not adjusted unless the activated partial thromboplastin time (aPTT) exceeded 150 seconds at the 24 hour sampling time point. In this instance, the infusion rate was reduced by one half. Heparin (Liquaemin, Organon) was given as a 5000 unit intravenous bolus followed by a 1000 U / h r infusion adjusted to maintain the aPTT between 65 and 90 seconds according to a bedside coagulation monitor (Coaguchek plus, Boehringer Mannheim). The study drug was administered for 96 hours. The mean levels of fibrinopeptide A (FPA), Thrombin-Antithrombin Complexes (TAT), and prothrombin activation fragment 1.2 (F1.2) were all elevated at baseline compared with normal laboratory reference values. The procoagulant markers, reflecting thrombin activity and generation, were increased to a similar degree in both treatment groups; however, mean F1.2 levels were slightly higher in heparin than hirudin-treated patients (1.1 ___ 0.5 nmol/1 and 0.9 _ 0.4 nmol/1, respectively, p = 0.8) (Table 1). Mean FPA levels decreased over time from an elevated baseline value. A decline by 60 minutes was evident in both treatment groups and reached statistical significance by 12 hours. Overall, FPA levels remained below baseline values at each subsequent sampling time point and did not differ significantly between heparin and hirudin-treated patients (Figure 1).