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The multiple risk factor intervention trial in the U.S. A summary of results at four years in special intervention and usual care men.

Four-year results of the Multiple Risk Factor Intervention Trial indicate that an integrated approach to lifestyle modification of multiple risk factors is feasible and achieves significant lowering of risk factors compared with a group referred to usual medical care. The greatest changes and differences were in cigarette smoking. The hypertension treatment result met design predictions in the Special Intervention (SI) group. However, at 4 years the difference between groups was less than predicted, primarily due to unanticipated effectiveness of treatment of elevated pressures in the Usual Care (UC) group, reflecting recent secular changes in hypertension detection and control in the U.S. Similarly, the serum cholesterol net fall in the SI compared to UC group was 59% of goal, in part because of an unanticipated reduction in the UC group. The risk factor differences between groups were considerable, even though in some areas short of initial design expectations. The most serious consequence of a less than anticipated difference in risk characteristics between groups is an effective loss of power to detect significant differences in major disease endpoints. A further major benefit from the study has been the demonstration of the ability to have diverse scientific disciplines work effectively together in the long-term preventive management of healthy but high-risk men.

Adult↗

Relationship between baseline risk factors and coronary heart disease and total mortality in the Multiple Risk Factor Intervention Trial. Multiple Risk Factor Intervention Trial Research Group.

The relationship between selected baseline risk factors and subsequent coronary heart disease (CHD) death and total mortality among participants in the Multiple Risk Factor Intervention Trial (MRFIT) was studied in order to determine whether the three risk factors used to identify high-risk men for the trial were associated with CHD death; whether other risk factors measured at baseline, especially lipoprotein cholesterol levels, were associated with CHD and total mortality; and whether there were any differences between special intervention (SI) and usual care (UC) participants in the relationship of the specific levels of risk factors to CHD or total mortality. The three main risk factors (blood cholesterol, cigarette smoking, and diastolic blood pressure) and age were significantly associated with CHD mortality; age, diastolic blood pressure, and cigarette smoking were associated with total mortality. The risk score based on the multiple logistic equation developed from the Framingham Study was also strongly associated with CHD mortality. When the joint associations of selected baseline risk factors with CHD and total mortality were considered, age, diastolic blood pressure, cigarette smoking, and low- and high-density lipoprotein cholesterol were significantly associated with CHD mortality; age, cigarette smoking, and low-density lipoprotein cholesterol were positively associated with total mortality. Systolic blood pressure significantly improved the prediction of CHD mortality for SI and UC men when it was added to a regression model that included age, diastolic blood pressure, cigarettes smoked per day, body mass index, and lipoprotein levels, but improved the prediction of total mortality only for SI men. In similar analyses, serum thiocyanate improved the prediction of both CHD and total mortality for UC men. Among SI men the improved prediction gained by considering serum thiocyanate was less pronounced and not significant for CHD death. This latter finding may be due in part to the changes made in smoking behavior by SI participants during the course of the study. The estimated regression coefficients for CHD and total mortality endpoints were not significantly different between the SI and UC groups.

Adult↗

Interventions in consultation-liaison psychiatry: the development of a schema and a checklist for operationalized interventions.

A literature review and pilot investigations reveal that (ward-) management consultation-liaison (C/L) psychiatry recommendations are infrequent and unsystematically used. Furthermore, the communication with the operational group as defined by Meyer and Mendelson is not sufficiently activated. The major focus of the consultation is the first contact, but follow-up is infrequent. With the exception of biologic recommendations and disposition, chart notes by psychiatric consultants do not sufficiently specify the actions to be taken by the ward staff in a general hospital. A schema for the systematic organization of the intervention was developed. A checklist of operationalized C/L interventions is reported. This combination provides a tool for the systematic use of strategic ward management and discharge recommendations. Its basic structure is currently integrated in MICRO CARES [Hammer et al, SCAMC]. The impact on clinical care, education, and research is described.

Adjustment Disorders↗

Using mindfulness-based therapeutic interventions in psychiatric nursing practice--part I: Description and empirical support for mindfulness-based interventions.

Finding effective nursing interventions for the treatment of mental illness is a major concern for advanced practice psychiatric nurses (APPN). Increasingly, innovative psychotherapeutic treatment modalities are being used for the treatment of individuals with serious mental illness. One such innovative approach, mindfulness-based therapeutic interventions, has been shown to relieve distress for individuals with medical and psychiatric illnesses. In part one of this two-part article, the investigators describe principle concepts of mindfulness, review current research in the usefulness of mindfulness practice for treatment of psychiatric illnesses, and outline the theoretical basis for this treatment modality, including mindfulness-based cognitive therapy (MBCT). In Part II, the writers detail the therapy phases of MBCT and present a clinical case in which an advance practice psychiatric nurse integrates mindfulness-based psychotherapeutic approaches into her treatment. This clinical case may inform future clinical nursing research and advanced psychiatric nursing practice.

Cognitive Behavioral Therapy↗

Health-related quality of life after interventional or conservative strategy in patients with unstable angina or non-ST-segment elevation myocardial infarction: one-year results of the third Randomized Intervention Trial of unstable Angina (RITA-3).

OBJECTIVES: We sought to compare the effects of an early interventional strategy (IS) versus a conservative strategy (CS) on health-related quality of life (HRQOL) in patients with non-ST-segment elevation acute coronary syndromes (ACS). BACKGROUND: The third Randomized Intervention Trial of unstable Angina (RITA-3) evaluated early IS (n = 895) versus CS (n = 915). We report one-year results of the RITA-3 trial concerning HRQOL. METHODS: The patients' HRQOL was assessed with the Short Form-36 (SF-36) and Seattle Angina Questionnaire (SAQ) at four-month and one-year follow-up, and the EuroQOL Visual Analogue Scale (EQ-VAS) and EuroQOL 5-Dimensional Classification (EQ-5D) also measured at baseline. Analysis was performed using the two-sample t test and analysis of co-variance. RESULTS: Mean changes from baseline EQ-VAS scores were better for IS than for CS at four months (treatment difference of 3.0, p < 0.001) and one year (2.3, p < 0.01). The EQ-5D utility scores were also higher for IS at four months (treatment difference: 0.036, p < 0.01) and at one year (0.016, p = 0.20). For SF-36, IS scored significantly better at four months for physical function, physical role function, emotional role function, social function, vitality, and general health. The SAQ scores for exertional capacity, anginal stability and frequency, treatment satisfaction, and disease perception were better for IS at four months. These treatment differences were present but attenuated by one-year follow-up. Improvements in HRQOL for IS could be attributed to improvements in anginal symptoms. CONCLUSIONS: In patients with non-ST-segment elevation ACS, an early IS provides greater gains in HRQOL, as compared with CS, mainly due to improvements in angina grade.

Adult↗

Use of bivalirudin during percutaneous coronary intervention in patients with diabetes mellitus: an analysis from the randomized evaluation in percutaneous coronary intervention linking angiomax to reduced clinical events (REPLACE)-2 trial.

OBJECTIVES: The objective of this study was to confirm that the efficacy and safety of percutaneous coronary intervention (PCI) in diabetic patients are not compromised by a bivalirudin-based antithrombotic strategy. BACKGROUND: Previous studies have shown a survival benefit with use of platelet glycoprotein (GP) IIb/IIIa inhibitors in diabetic patients undergoing PCI. The Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial showed the non-inferiority of a strategy of bivalirudin with provisional GP IIb/IIIa inhibition compared with routine GP IIb/IIIa inhibition. The relative efficacy of these two strategies in diabetic patients has not been studied. METHODS: We evaluated the diabetic patients enrolled in the REPLACE-2 trial to assess the impact of these antithrombotic strategies on the short- and long-term outcome after PCI. RESULTS: The REPLACE-2 trial enrolled 1,624 diabetic patients and 4,368 non-diabetic patients. Compared with non-diabetic patients, diabetic patients had similar short-term outcome but higher mortality at 1 year (3.06% vs. 1.85%, p = 0.004). There was no difference in short-term or long-term ischemic events among the diabetic patients randomized to the two arms. Specifically, the 1-year mortality rate was non-significantly lower in the bivalirudin arm, suggesting no differential survival impact of the two strategies (2.3% vs. 3.9%). There was less minor bleeding in the bivalirudin arm in diabetic patients (12.6% vs. 24.4%, p < 0.001), whereas no difference was seen in the incidence of major bleeding (3.0% vs. 3.3%, p = 0.69). CONCLUSIONS: Compared with routine GP IIb/IIIa inhibition, the use of bivalirudin with provisional GP IIb/IIIa inhibitors in diabetic patients is associated with no differences in clinical outcomes at 30 days, a trend toward lesser mortality at 1 year, and a reduction in minor bleeding.

Aged↗

Determinants of adoption of cognitive behavioral interventions in a hospital setting: example of a minimal-contact smoking cessation intervention for cardiology wards.

OBJECTIVE: The aim of our study was to identify the psychological and organizational determinants of adopting a smoking cessation intervention in cardiology wards, using the Integrated Change Model (I-Change Model) as the theoretical basis. METHODS: A cross-sectional survey by means of questionnaires was conducted among the heads of all 121 cardiology wards in Dutch hospitals, of whom 77 (64%) responded. RESULTS: Adopters had a significantly lower level of formalization and more nurses working on the ward. Adopters also had a significantly more positive attitude towards working with the intervention, perceived more positive social influences from their direct environment and had higher self-efficacy. Psychological determinants explained adoption to a greater extent than organizational determinants did. CONCLUSION: It is very important to take psychological factors into account when studying the adoption of preventive innovations and developing diffusion strategies. PRACTICE IMPLICATIONS: Programs for dissemination of preventive innovations in a hospital setting should primarily focus on psychological characteristics like social influence and self-efficacy.

Adult↗

Interventional study of diltiazem in dilated cardiomyopathy: a report of multiple centre clinical trial in China. Chinese Cooperative Group of Diltiazem Intervention Trial in Dilated Cardiomyopathy.

The aim of this study was to determine the interventional effects of diltiazem on autoantibody mediated myocardial damage in dilated cardiomyopathy (DCM). 221 patients with DCM in 16 hospitals were included in the multiple centre clinical trial from January 1995 to November 1996, using the diltiazem or placebo based on the background therapy for heart failure. Patients were randomly divided into groups for a single blind trial, followed by observation for an average of 7.4 months. After treatment, the heart function of 84% of patients in the diltiazem group recovered to grade I or II, but this occurred for 64% of patients in the placebo group. Heart-thorax ratio was decreased from 0.59+/-0.07 to 0.56+/-0.07 and the left ventricular end-diastolic dimension (LVEDd) from 65.40+/-8.60 mm to 61.12+/-9.86 mm, the left ventricular ejection fraction (EF) was increased from 35.75+/-10.78% to 42.52%+/-11.41% (P<0.01) in the diltiazem group (n=114). The above parameters were not significantly changed in the placebo group (n=107). Mortality was 3.5% in the diltiazem group and 11.2% in the placebo group (P<0.05). Further analysis also shows that LVEDd were reduced and EF were obviously elevated in patients with DCM of LVEDd <70 mm, but the above parameters weren't improved in patients of LVEDd >70 mm. The study suggests that diltiazem is safe and effective in the treatment of DCM, the action mechanism might be intervention in antibody-mediated myocardial damage and protection of myocardium. Diltiazem is suitable for the treatment of the early stage in DCM.

Adult↗

Beef HACCP: intervention and non-intervention systems.

While there are several generic beef HACCP documents available to the beef industry, these lack sufficient detail to be of any use other than as a general guide to HACCP. A document which clearly identifies and provides a sound scientific basis for potential critical control points (CCPs') and details critical limits, monitoring and corrective actions is clearly required. The objective of this paper is to provide such information. A detailed description of CCPs' for two different HACCP systems (an intervention and a non-intervention system) are presented and the advantages and disadvantages of each are discussed. Individual beef plants may then make an informed choice as to which HACCP system is most suitable for them and have all the specific information required for effective implementation.

Abattoirs↗

The new interventional centre--a multidisciplinary R&D clinic for interventional radiology and minimal access surgery.

The National Hospital wanted to coordinate and promote the development of new minimally invasive procedures by structuring collaboration and communication across traditional speciality boundaries. To achieve this, a new hospital department has been established, a 'neutral ground' for working with such clinical applications in multi-disciplinary teams with surgeons, radiologists, cardiologists etc., individually composed for the type of intervention to be performed. The Interventional Centre also represents a full fusion of a modern radiology department with a state-of-the-art operating department, securing the use of relevant imaging technologies, aseptic conditions and options of converting any 'key-hole' procedure to open, conventional surgery within minutes. The Centre represents a new organizational model for such activities. It is also a technology centre, a common 'tool-box' securing better access and higher quality for the use of advanced radiological and surgical technology in our hospital.

Hospital Departments↗

[Ventilation in laryngeal laser-surgical interventions using superimposed high frequency jet ventilation (SHFJV)--a further revision of jet ventilation technique for laryngeal interventions].

In laser surgery of the larynx the surgeon and the anaesthesist have to compete for the limited space available. The surgeon requiring good visibility and an undisturbed operating area whereas the anesthetist has to ensure sufficient ventilation of the patient. Further, complications of anaesthesia and laser must be avoided. These requirements are met by using the jet-tube (jet-laryngoscope) with two integrated nozzles applying simultaneously low- and high-frequency jet-ventilation giving the surgeon total access to the area operated on, and at the same time enables safe ventilation of the patient. Of 334 operations with the tubeless ventilation technique 76 cases were laser surgical interventions. In 6 patients stenoses were enlarged. The average duration of the jet-ventilation was 25 +/- 10 minutes. The maximum duration of a laser surgical intervention was 140 minutes. The age distribution of the patients was 18 months to 82 years. In all patients pulmonary gas exchange was satisfactory. We believe that the advantage of the tubeless jet-ventilation is: optimal visibility and surgical freedom for the surgeon, no time limitation, even in very severe stenoses. Since no volatile anaesthetics or any type of endotracheal tube are applied there is no danger of interaction with the laser when using the SHFJV via the jet-laryngoscope. Application of the tubeless jet-ventilation technique is however limited if patients suffer from severe pulmonary obstruction; likewise highly obese patients and patients in whom massive bleeding occurs are not amenable to tubeless jet-ventilation.

Adult↗

Relation of changes in dietary lipids and weight, trial years 1-6, to changes in blood lipids in the special intervention and usual care groups in the Multiple Risk Factor Intervention Trial.

For men in the special intervention (SI) group of the Multiple Risk Factor Intervention Trial, the average decrease in serum total cholesterol was 16.9 mg/dL (6.7%); for men in the usual care (UC) group, the average decrease was 9.7 mg/dL (3.8%). The difference between the two groups for plasma total cholesterol was 6.2 mg/dL. Plasma low-density-lipoprotein (LDL) cholesterol decreased 10.6 mg/dL (6.6%) in SI men and 5.4 mg/dL (3.4%) in UC men. Mean weight losses were 3.0 lb (1.36 kg) and 0.1 lb (0.05 kg) for SI and UC men, respectively. Change in blood total cholesterol was directly related to baseline concentration; for men with serum total cholesterol > or = 220 mg/dL, those in the SI group decreased their total cholesterol by 7.8% (design goal: 10%) and those in the UC group by 4.8% (expected: 0%). Change in dietary lipid intake (summarized by the Keys score) for SI men was significantly related to changes in blood total cholesterol, LDL cholesterol, and triglyceride, but not to change in high-density-lipoprotein (HDL) cholesterol. Controlled for weight change, coefficients for Keys score change were smaller but remained significantly related to each blood lipid except HDL cholesterol. Weight loss was associated with favorable effects on all blood lipids. Influences of change in diet and weight on blood lipids were quantitatively less for hypertensive men for serum total cholesterol, HDL cholesterol, and triglyceride than for nonhypertensive men. Nonsmokers had greater decreases than smokers in blood total cholesterol, LDL cholesterol, and triglyceride.

Body Mass Index↗

Adherence to dietary recommendations in the special intervention group in the Multiple Risk Factor Intervention Trial.

This chapter presents findings on adherence to the Multiple Risk Factor Intervention Trial eating pattern by special intervention participants, on the basis of measures other than the 24-h dietary recall and blood cholesterol concentrations. These additional assessments included subjective ratings by a nutritionist, used during follow-up years 1 and 2, and a food record rating that was calculated from a 3-d food record, used during years 3-6. An additional tool used during the latter part of the trial was a checklist for evaluating degree of shortfall of the participant's diet from recommendations, level of motivation toward adherence, and factors in the social environment potentially influencing dietary behavior. Subjective ratings and food record ratings indicated that approximately 40-65% of participants were good or excellent adherers, with declines in these percentages over time. There were consistent strong relations between these ratings and change in serum cholesterol. Checklist evaluations gave similar overall findings, with about one-half to three-quarters of participants rated positively on infrequency of deviation from the eating pattern, motivation, and conducive environment. Several baseline traits predicted adherence. Adherence was better in older participants, in white than in black men, in nondrinkers, in those with fewer stressful life events, in those eating away from home less often, in less overweight men (although heavier participants exhibited greater changes in serum cholesterol, perhaps reflecting their poorer baseline diets), in those with higher serum cholesterol and diastolic blood pressure, and in nonsmokers.

Clinical Trials as Topic↗

Relation of dietary carbohydrates to blood lipids in the special intervention and usual care groups in the Multiple Risk Factor Intervention Trial.

This chapter explores relations between reported intake of dietary carbohydrates and measurements of plasma lipids at baseline and during trial years 1-6 of the Multiple Risk Factor Intervention Trial. With control for dietary lipids, alcohol, and other factors, total carbohydrate intake at baseline was inversely related to baseline plasma total cholesterol and high-density-lipoprotein (HDL) cholesterol; starch and other simple carbohydrates were unrelated to plasma lipids and sucrose was inversely related to HDL cholesterol. During trial years 1-6, men assigned to the special intervention group increased their intake of starch and other simple carbohydrates as they decreased their fat intake, and lowered their intakes of refined and processed sucrose. Total carbohydrate intake of these men was inversely related to total, low-density-lipoprotein (LDL), and HDL cholesterol. Starch and sucrose intakes were also inversely related to HDL cholesterol. In contrast, intake of other simple carbohydrates was directly related to HDL, and inversely related to plasma total and LDL cholesterol. For men in the highest quintile of intake of other simple carbohydrates compared with men in the lowest quintile, plasma total cholesterol was lower by 3.6 mg/dL, LDL cholesterol was lower by 4.3 mg/dL, and HDL cholesterol was higher by 1.6 mg/dL. Findings were generally similar for men in the usual care group.

Dietary Carbohydrates↗

Relation of dietary fiber to blood lipids in the special intervention and usual care groups in the Multiple Risk Factor Intervention Trial.

This chapter addresses relations between intake of fiber--total, soluble, and insoluble--and blood lipids in the Multiple Risk Factor Intervention Trial through use of baseline data (single measurement), averages of four to five 24-h recalls and blood lipid determinations collected during annual follow-up examinations, and change from baseline to follow-up. No significant associations were observed at baseline. Consistent highly significant inverse associations were seen in analyses of follow-up measurements. Results from change data were of intermediate strength and consistency. These variations were in all likelihood due to the low reliability of a single 24-h recall at baseline for determination of dietary intake and change in intake for individuals. From follow-up data, plasma total and low-density-lipoprotein (LDL) cholesterol concentrations were lower by approximately 5 mg/dL for men in the special intervention group in quintile 5 of total fiber intake (25 g/d) compared with men in quintile 1 (8 g/d), after adjustment for average body mass index and intake of alcohol, saturated and polyunsaturated fatty acids, and dietary cholesterol. Results were similar for men in the usual care group. There were no adverse effects on high-density-lipoprotein cholesterol, nor any consistent associations with plasma triglycerides. Thus, increasing dietary fiber can provide additional reduction in blood total and LDL cholesterol and consequent improvement in the lipid profile, over and above the beneficial effects of a fat-modified diet.

Clinical Trials as Topic↗

Relation of body mass and alcohol, nutrient, fiber, and caffeine intakes to blood pressure in the special intervention and usual care groups in the Multiple Risk Factor Intervention Trial.

This chapter presents analyses of relations of dietary variables to blood pressure, systolic (SBP) and diastolic (DBP), for men in the special intervention (SI) and usual care (UC) groups in the Multiple Risk Factor Intervention Trial. For each dietary factor, analyses were done at baseline, for trial years 1-6, and for change from baseline to years 1-6. Analyses were done for all participants and for men receiving or not receiving antihypertensive drug treatment and were controlled for age, race, education, serum cholesterol, smoking, special diet status, and (for specific nutrients) body mass index and alcohol intake. Nutrient data for trial years 1-6, which are based on four or five dietary recalls per man, are more reliable than the baseline or change data, which are based on only one recall. Therefore, this summary focuses on data for trial years 1-6, for SI and UC men pooled. Regression analyses confirmed direct independent relations of body mass index, alcohol intake, sodium, and ratio of sodium to potassium to SBP and DBP, and an inverse relation of potassium to SBP and DBP. Dietary starch was directly related to SBP and DBP; dietary saturated fatty acid and cholesterol and Keys score were directly related to DBP; dietary magnesium, fiber, and caffeine were inversely related to SBP and DBP; and dietary protein, polyunsaturated fatty acids, the ratio of polyunsaturated to saturated fatty acid, and other simple carbohydrates were inversely related to DBP. Method problems, all tending to produce underestimations, are also reviewed.

Alcohol Drinking↗

Relation of food and nutrient intakes to body mass in the special intervention and usual care groups in the Multiple Risk Factor Intervention Trial.

This chapter summarizes weight and body mass index findings of the Multiple Risk Factor Intervention Trial and then focuses on relations of food group and nutrient intakes to weight change during follow-up. Results were qualitatively similar for the special intervention (SI) and usual care groups. Weight change was related both to dietary composition averaged over follow-up recalls and to changes from baseline. Greater weight loss compared with little change or gain was related to greater reductions from baseline and lower percentages of energy reported at follow-up from refined sucrose, total fat, and saturated and monounsaturated fatty acids. Greater weight loss was also associated with greater reductions in and lower intakes of cholesterol and energy. In both groups, these patterns reflected lower percentages of energy from medium-fat dairy products, eggs, highly saturated visible fats, crackers and snacks, refined sugars and sweets, and additionally for SI men, lower percentages of energy from high-fat meats, dairy products, and baked goods and desserts. In both groups weight loss was related to increased or higher percentages of energy from total and non-sucrose simple carbohydrates, and to fiber intake, and for SI men, to higher percentages of energy from starch. These nutrient patterns involved higher percentages of energy from low-fat dairy products, breads and cereals, fruit, and vegetables, and for SI men, from low-fat baked goods and desserts. Overall, substantial weight loss was associated with a diet of lower energy density and with higher intakes of several essential micronutrients.

Body Mass Index↗

Relation of smoking at baseline and during trial years 1-6 to food and nutrient intakes and weight in the special intervention and usual care groups in the Multiple Risk Factor Intervention Trial.

This chapter describes dietary composition according to cigarette smoking status at baseline and changes in smoking status during follow-up for men in the special intervention (SI) and usual care (UC) groups of the Multiple Risk Factor Intervention Trial. Five patterns of smoking behavior were defined: 1) sustained nonsmoking, 2) early (years 1-2 of the trial) sustained quitting, 3) late (years 3-6 of the trial) sustained quitting, 4) recidivism, and 5) continued smoking. SI men who quit smoking showed greater favorable changes in dietary lipid composition and micronutrient intake than did continued smokers, and these changes were in many instances as great as favorable changes made by nonsmokers. On the other hand, SI men who quit smoking gained an average of 3.8 lb (1.7 kg), in contrast with nonsmokers who lost an average of 6.4 lb (2.9 kg). The gain by SI quitters was, however, less than that by UC quitters, who gained 6.5 lb (3.0 kg). Moreover, despite weight gain, net change in high-density-lipoprotein (HDL) cholesterol for SI quitters was positive. With the associated decrease in low-density-lipoprotein (LDL) cholesterol, early SI quitters had the most improvement in ratio of LDL to HDL among all subgroups. Thus, unfavorable nutritional patterns of smokers put them at double jeopardy regarding cardiovascular and other chronic diseases; additionally, long-term risks can be improved not only by smoking cessation but also by achievement of healthier eating patterns.

Body Weight↗