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T J Wilt

Publications and source records attributed to T J Wilt.

53 records · Page 3Linked to original sources

The Prostate Cancer Intervention Versus Observation Trial (PIVOT).

The Prostate Cancer Intervention Versus Observation Trial (PIVOT) is a randomized trial designed to determine whether radical prostatectomy or expectant management provides superior length and quality of life for men with clinically localized prostate cancer. Conducted at Department of Veterans Affairs and National Cancer Institute medical centers, PIVOT will enroll over 1,000 individuals < 75 years of age. The primary study end point is all-cause mortality. Secondary outcomes include prostate cancer- and treatment-specific morbidity and mortality, health status, predictors of disease-specific outcomes, and cost-effectiveness. Within the first 3 years of enrollment, over 400 men have been randomized. Early analysis of participants' baseline characteristics indicate that enrollees are representative of men diagnosed with clinically localized prostate cancer throughout the United States. Therefore, results of PIVOT will be generalizable. These results are necessary in order to determine the preferred therapy for clinically localized prostate cancer.

Aged↗

Correlates and consequences of diffuse atherosclerosis in men with coronary heart disease. Veterans Affairs High-Density Lipoprotein Intervention Trial Study Group.

BACKGROUND: Peripheral atherosclerosis is a strong and independent predictor of mortality even in patients with known coronary heart disease. However, the prevalence, correlates, and potential adverse effects on quality of life associated with combined coronary heart disease and clinically evident cerebrovascular or lower-extremity atherosclerosis are not known. Identification of patients with "diffuse atherosclerosis" may enhance treatment of modifiable risk factors and alter therapeutic strategies. METHODS: We conducted a cross-sectional analysis of 2531 men younger than 73 years with coronary heart disease, low-density lipoprotein cholesterol levels of 3.62 mmol/L (140 mg/dL) or less, and high-density lipoprotein cholesterol level of 1.03 mmol/L (40 mg/dL) or less who were participating in Department of Veterans Affairs Cooperative Study 363 (the Veterans Affairs High-Density Lipo-protein Intervention Trial. Baseline demographic, medication, comorbidity, and atherosclerotic risk factor data were assessed by means of a standardized questionnaire. All plasma lipid levels were determined after a 12-hour fast by a central standardized lipid laboratory. Health status was determined by baseline reported symptoms, medical comorbidities, and the Psychological General Well-being Index. Clinically evident diffuse atherosclerosis was defined as a documented history of lower-extremity atherosclerosis or cerebrovascular disease. RESULTS: The mean age of all participants was 63.5 years. The mean plasma lipid values were as follows: total cholesterol, 4,52 mmol/L (174.6 mg/dL); high-density lipo-protein cholesterol, 0.81 mmol/L (31.5 mg/dL); low-density lipoprotein cholesterol, 2.88 mmol/L (111.2 mg/dL); and triglycerides, 1.81 mmol/L (160.6 mg/dL). Diffuse atherosclerosis was present in 525 (21%). Lower-extremity atherosclerosis was reported in 10%, while cerebrovascular disease was present in 13%. After controlling for other variables, the following factors were associated with the presence of diffuse atherosclerosis: increased age, being unmarried, being retired, having less than a high school education, increased alcohol use, hypertension, cigarette smoking, and diabetes. There was no association between lipid levels and the presence of diffuse atherosclerosis. After adjustment for age, race, and comorbidities, men with diffuse disease still had a reduced quality of life compared with men without diffuse atherosclerosis, as defined by having a greater number of clinical symptoms, lower psychological well-being scores, and more advanced or complicated coronary heart disease. CONCLUSIONS: Clinically evident diffuse atherosclerosis is common in men with coronary heart disease and low levels of high-density lipoprotein cholesterol. Because diffuse atherosclerosis is associated with a reduced quality of life and several modifiable risk factors, early detection and aggressive risk factor intervention appear justified.

Adult↗

Prevalence and correlates of symptomatic peripheral atherosclerosis in individuals with coronary heart disease and cholesterol levels less than 240 mg/dL: baseline results from the Cholesterol and Recurrent Events (CARE) Study.

PURPOSE: To determine the prevalence and correlates of symptomatic peripheral atherosclerosis in individuals with a history of myocardial infarction (MI) and cholesterol levels lower than 240 mg/dL. MATERIALS AND METHODS: A cross-sectional analysis was conducted at baseline of 4159 participants in the Cholesterol and Recurrent Events (CARE) Study. Symptomatic diffuse atherosclerosis was defined as a history of MI plus lower extremity or cerebrovascular atherosclerosis or claudication by Rose questionnaire. RESULTS: The prevalence of symptomatic diffuse atherosclerosis was 12.9%; 353 participants (8.5%) had lower extremity disease and 219 (5.3%) had cerebrovascular disease. After controlling for other variables, diffuse atherosclerosis was associated with age (Odds Ratio [OR] = 1.44 per ten-year increase), systolic blood pressure (OR = 1.13 per 10 mm Hg increase), a history of multiple myocardial infarctions (OR = 1.76), diabetes (OR = 1.76), hypertension (OR = 1.38), reduced exercise performance (OR = 1.55), current smoking status (OR = 2.87), and lower alcohol intake (OR = 0.97 per drink per week). There was no association with race, gender, or lipid levels. CONCLUSIONS: The presence of clinically evident diffuse atherosclerosis is common and is associated with several modifiable risk factors. Early identification of these individuals could affect treatment and clinical outcomes.

Anticholesteremic Agents↗

Distribution of lipids in 8,500 men with coronary artery disease. Department of Veterans Affairs HDL Intervention Trial Study Group.

In the present study we measured fasting lipid profiles in over 8,500 community-living men with coronary artery disease (CAD) to determine the distribution of lipid abnormalities in this population: 81% were white and 16% black; mean age 62.9 +/- 8 years; mean total cholesterol 214 +/- 41 mg/dl; low-density lipoprotein (LDL) cholesterol 140 +/- 37 mg/dl; high-density lipoprotein (HDL) cholesterol 39 +/- 11 mg/dl; and triglycerides 190 +/- 142 mg/dl. After adjusting for age, the only significant difference between blacks and whites was a higher HDL cholesterol in blacks (45 vs 38 mg/dl, p < 0.003). With use of cut points established by the National Cholesterol Education Program, 87% of subjects had high LDL cholesterol (> or = 100 mg/dl), 38% had low HDL cholesterol (< 35 mg/dl), and 33% had high triglycerides (> 200 mg/dl). We estimated that 42% of men with CAD would be definite candidates for cholesterol-lowering medication according to the National Cholesterol Education Program guidelines and that 41% of those in whom cholesterol-lowering medication would not be definitely indicated had low levels of HDL cholesterol. We conclude that (1) black men with CAD have substantially higher HDL cholesterol than white men, (2) almost 90% of male patients with CAD are candidates for dietary intervention and > 40% may need medications to lower LDL cholesterol, and (3) 40% of patients without a definite indication for cholesterol-lowering medications have low levels of HDL cholesterol.

Adult↗

The Prostate Cancer Intervention Versus Observation Trial: a randomized trial comparing radical prostatectomy versus expectant management for the treatment of clinically localized prostate cancer.

The Prostate Cancer Intervention Versus Observation Trial (PIVOT) is a randomized controlled trial sponsored by the Department of Veterans Affairs and the National Cancer Institute. PIVOT will enroll 2,000 participants from at least 80 Veterans Administration and National Cancer Institute medical centers. The purpose of PIVOT is to determine which of 2 strategies is superior for managing clinically localized prostate cancer (stage T1/T2NXM0) of all histological grades. Patients less than 75 years old will be randomized to either radical prostatectomy with early intervention for disease persistence/recurrence or expectant management with palliative therapy reserved for symptomatic or metastatic disease progression. Participants will be excluded if they have received prior therapy for prostate cancer (except transurethral resection of the prostate) or are judged not to be candidates for radical prostectomy. All patients with newly diagnosed prostate cancer will be recorded on the PIVOT screening log. Registry information will include patient age, race, prostate specific antigen level, clinical stage, histological tumor grade, initial therapy, and vital status. Patients meeting eligibility criteria will watch an information and randomization video tape developed for PIVOT. Participants will be randomized over a 3-year period and followed for a minimum of 12 years. Data collected at followup will include urological symptoms, disease and treatment related morbidity, and disease specific and overall quality of life. Evidence of symptomatic or asymptomatic disease persistence, recurrence or progression will be measured by questionnaire, physical examination, digital rectal examination, prostate specific antigen and annual bone scan. The primary study end point will be all cause mortality. Secondary outcomes will include prostate cancer and treatment specific morbidity and mortality rates, health status, predictors of disease specific outcomes and cost-effectiveness. PIVOT will provide a 90% power to detect a 15% relative decrease in all cause mortality and a 35% relative decrease in prostate cancer specific mortality rate by either treatment strategy.

Aged↗

The effect of fish oil supplements on blood pressure.

We conducted a double-blind, placebo-controlled crossover study to determine the effects of fish oil supplementation on blood pressure in middle-aged men. Subjects were randomly assigned to consume either 20 g of fish oil or safflower oil for 12 weeks and then consume the other oil for an additional 12 weeks after a 4-week washout period. We found no significant changes from the pretreatment value in systolic or diastolic blood pressure with the use of fish oil supplements. In addition, there were no significant differences in the posttreatment blood pressures comparing the fish and safflower oil phases of the study.

Blood Pressure↗

Distribution of lipid phenotypes in community-living men with coronary heart disease. High prevalence of isolated low levels of high-density lipoprotein cholesterol.

BACKGROUND: Risk factor modification, including treatment of dyslipidemias, has been recommended for the prevention of future coronary events in patients with coronary heart disease (CHD). Since the prevalence of various dyslipidemias among outpatients with CHD has not been well documented, the purpose of this study was to determine the frequency of specific lipid phenotypes among ambulatory men with CHD. METHODS: Lipid profiles were obtained in 255 men (mean age, 65.5 +/- 9.1 years) with CHD in three Veterans Affairs medical centers. Desirable levels of lipids were defined according to National Cholesterol Education Program guidelines as follows: low-density lipoprotein cholesterol (LDL-C) levels less than 3.36 mmol/L (130 mg/dL); high-density lipoprotein cholesterol (HDL-C) levels equal to or greater than 0.90 mmol/L (35 mg/dL); and triglyceride levels less than 2.83 mmol/L. RESULTS: Seventy-six percent of the group had one or more abnormalities on lipid profile: 51% had high LDL-C levels with or without abnormalities of HDL-C and/or triglyceride levels; 22% had low HDL-C levels with desirable levels of LDL-C; and 3% had hypertriglyceridemia without any cholesterol abnormalities. Normal lipid profiles were significantly more prevalent in subjects over the age of 65 years than in younger patients (40% vs 14%). CONCLUSIONS: These data suggest that (1) a high proportion of men with CHD have dyslipidemia, including 50% with LDL-C level elevations. For these men, the potential benefits of therapeutic intervention have been documented in clinical trials, although the cost-efficiency of wide-scale treatment has not been determined; (2) isolated hypertriglyceridemia is rare in this population; and (3) low HDL-C levels in association with desirable LDL-C levels are present in more than one fifth of male patients with CHD. Clinical trials focusing on this large group are urgently needed to determine whether efforts to raise HDL-C levels result in reduced cardiac morbidity and/or mortality.

Aged↗

Fish oil supplementation does not lower plasma cholesterol in men with hypercholesterolemia. Results of a randomized, placebo-controlled crossover study.

STUDY OBJECTIVE: To determine the effects of fish oil supplementation on plasma cholesterol in middle-aged men with isolated hypercholesterolemia. DESIGN: Randomized double-blind placebo-controlled (safflower oil) two-period crossover trial with 12-week treatment periods. SETTING: Outpatient general medicine clinic at a university-affiliated Veterans Affairs hospital. PATIENTS: Thirty-eight men with plasma cholesterol between 5.68 and 7.76 mmol/L (220 to 300 mg/dL), triglyceride levels less than 3.39 mmol/L (300 mg/dL), and free of coexisting diseases. INTERVENTIONS: Fish oil and placebo (safflower oil) supplementation. After basal measurements and a 4-week lead-in period, twenty 1-g capsules of either fish oil or placebo oil were provided for 12 weeks (period 1). After a 4-week washout phase participants then received the other oil for an additional 12 weeks (period 2). MEASUREMENTS AND MAIN RESULTS: Blood was drawn at the beginning and end of each study period and analyzed for levels of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, apolipoprotein A1, and apolipoprotein B. Low-density lipoprotein (LDL) cholesterol was calculated using the Friedewald equation. Total and LDL cholesterol increased from the before treatment values by 4.8% and 9.1%, respectively, after ingestion of fish oil. Compared with placebo, LDL cholesterol was significantly higher (4.5 compared with 4.1 mmol/L, P = 0.01) and triglycerides lower (1.3 compared with 1.8 mmol/L, P = 0.01) after fish oil. Total and HDL cholesterol and apolipoprotein A1 and B levels did not differ. CONCLUSIONS: Fish oil supplements do not lower plasma cholesterol levels in middle-aged men with hypercholesterolemia without elevated triglycerides. They should not be recommended as a method to lower plasma cholesterol in these patients.

Adult↗

Physician performance and patient perceptions during the rectal examination.

OBJECTIVE: To describe internal medicine residents' training and performance as well as patients' attitudes and knowledge regarding the rectal examination. DESIGN: Descriptive survey of university-trained internal medicine residents and general medicine clinic patients. SETTING: General internal medicine residents' longitudinal clinic at a university-affiliated Veterans Affairs Medical Center. PATIENTS/PARTICIPANTS: Ambulatory male veterans attending their general internal medicine clinic, all of whom were over the age of 40 years and had previously had a rectal examination (n = 100), as well as all second- and third-year University of Minnesota internal medicine residents (n = 78) were surveyed using a self-administered questionnaire. MEASUREMENTS AND MAIN RESULTS: Residents differed in their training in, practice of, and understanding of indications for the rectal examination. Little formal instruction regarding patient comfort had been provided to residents, and many residents had never received supervised instruction in the rectal examination. Patients frequently were uncertain about why the examination had been performed, lacked understanding of the results of the examination, and often had preferences for examination comfort measures that differed from those utilized by their physicians. CONCLUSIONS: Increased supervised instruction in the rectal examination in medical training programs is recommended. This should emphasize not only appropriate indications for this procedure but also attention to patient communication and comfort.

Adult↗

Effect of written and computerized decision support aids for the U.S. Agency for Health Care Policy and Research depression guidelines on the evaluation of hypothetical clinical scenarios.

OBJECTIVE: The objective of this study was to compare the effects of written and computerized decision support aids (DSAs) based on U.S. Agency for Health Care Policy and Research depression guidelines. METHODS: Fifty-six internal medicine residents were randomized to evaluate clinical scenarios using either a written or a computerized DSA after first assessing scenarios without a DSA. The paired difference between aided and unaided scores was determined for diagnostic accuracy, treatment selection, severity and subtype classification, antipsychotic use, and mental health consultations. RESULTS: Diagnostic accuracy with the written DSA increased from 64% to 73%, and with the computerized DSA decreased from 67% to 64% (P=0.0065). Residents using the computerized DSA (vs. no DSA) requested fewer consultations (65% vs. 52%, P=0.028). In post hoc analysis, the written DSA increased sensitivity (66% to 89%, P<0.001) and the computerized DSA improved specificity (66% to 86%, P=0.0020) but reduced sensitivity (67% to 49%, P = 0.011). CONCLUSIONS: A written DSA improved diagnostic accuracy, whereas a computerized DSA did not. However, the computerized DSA improved specificity and reduced mental health consultations.

Decision Support Systems, Clinical↗

Educating men about prostate cancer screening. A randomized trial of a mailed pamphlet.

CONTEXT: Although evidence-based guidelines recommend that physicians inform men about prostate cancer screening, the most efficient way to do this is not known. OBJECTIVE: To evaluate whether a mailed educational pamphlet affected men's knowledge about early detection of prostate cancer. DESIGN: Randomized, controlled trial. SETTING: Primary care clinic of the Minneapolis VA Medical Center. PATIENTS: 342 men at least 50 years of age who responded to a mailed survey (overall response rate, 68%) and did not report a history of prostate cancer. INTERVENTION: "Early Prostate Cancer" pamphlet mailed to patients in the intervention group 1 week before their scheduled clinic appointments. OUTCOME MEASURES: Patients' responses to a survey mailed 1 week after their clinic appointments; prostate-specific antigen (PSA) testing determined from electronic medical records. RESULTS: Respondents were predominantly elderly white men (mean age, 71 years; 90% white) with chronic illnesses (48% described their health as "fair" or "poor"). Men who received the educational pamphlet were better informed than men in the usual care group, as measured by correct responses to the following three questions about prostate cancer screening: the natural history of prostate cancer (32% vs. 24%; P = 0.10), whether treatment lengthens lives of men with early prostate cancer (56% vs. 44%; P = 0.04), and accuracy of PSA testing (46% vs. 27%; P < 0.008). The overall proportion of correctly answered questions was greater in the intervention group (45% vs. 32%; P < 0.001). Testing for PSA in the year after the index clinic appointments did not differ significantly between the intervention group and the usual care group (31% vs. 37%; P > 0.2). CONCLUSIONS: Male veterans are poorly informed about the potential benefits and risks of prostate cancer screening. Although our mailed educational pamphlet enhanced knowledge only modestly, it was an inexpensive and easily implemented intervention.

Aged↗

Cholesterol awareness after case-finding: do patients really know their cholesterol numbers?

BACKGROUND: Patients who are informed of their cholesterol status have been shown to take steps subsequently to reduce their risks for coronary heart disease. Accordingly, as part of a population-based strategy to reduce disease burden due to high cholesterol, the National Cholesterol Education Program (NCEP) recommends that physicians tell all patients their cholesterol test results in a clear, understandable manner and encourage all patients, regardless of their risk factor status, to reduce their fat intake. OBJECTIVES: Our objective was to assess compliance with these NCEP recommendations at a 432-bed, Midwestern, university-affiliated VA Medical Center. METHODS: We surveyed, within a year of their cholesterol measurement, 250 randomly selected men and women who had had their cholesterol checked by physician order between January 1993 and 1994. Survey results were validated against laboratory data. RESULTS: Approximately one third of the men and women said their cholesterol had not been checked, and about one half said they had not been told their test results. Only 59% knew their cholesterol status, and only 19% accurately recalled their cholesterol number. More than half did not remember receiving dietary advice. Female gender and more years of education were correlated with cholesterol awareness on both bivariable and multivariable analyses (adjusted odds ratio [OR] = 2.00, 95% confidence intervals [CI] = 1.10, 3.67 and OR = 2.62, 95% CI = 1.43, 4.78, respectively). Respondents were more likely to accurately recall their cholesterol number if they remembered being told their test results or remembered receiving dietary advice (OR = 7.70, 95% CI = 2.04, 29.0 and OR = 2.65, 95% CI = 1.15, 6.07, respectively). CONCLUSIONS: We conclude that compliance with the NCEP population-based guidelines is poor. Physicians should endeavor to improve patients' awareness of their cholesterol status and be more diligent in prescribing dietary therapy.

Adult↗