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Biomedical subjects

F E Harrell

Publications and source records attributed to F E Harrell.

At least 19 recordsLinked to original sources
PubMed1992

High and low strength nonsynchronized shocks given during canine ventricular tachycardia.

UNLABELLED: Cardioversion shocks given during ventricular tachycardia may cause ventricular fibrillation or acceleration of ventricular tachycardia, or arrest the tachycardia. A recently proposed theory may explain why the former two phenomena may occur. Briefly, this theory states that potential gradient shock fields of a critical strength delivered to tissue with a critical degree of refractoriness will cause circulating wave fronts of ventricular activation ("rotors") manifest as ventricular arrhythmia. We tested this theory by delivering nonsynchronized shocks 50% higher than defibrillation threshold or 50% lower than defibrillation threshold during 275 episodes of ventricular tachycardia in eight dogs with 5- to 7-day-old myocardial infarcts. Shocks stronger than the defibrillation threshold are likely to create shock fields in the ventricles everywhere stronger than this critical value, and therefore would not generate rotors. Shocks less strong than the defibrillation threshold may create shock fields within the ventricles that include the critical value, and therefore cause rotors if given when critically refractory tissue is present. Nonsynchronized shocks were used to increase the likelihood of encountering tissue with a critical degree of refractoriness. Ventricular fibrillation or acceleration of ventricular tachycardia occurred following 83 of 138 (60%) low strength shocks and following 20 of 137 (14.6%) high strength shocks. The pooled odds ratio for induction of ventricular fibrillation or accelerated ventricular tachycardia after low strength shocks as compared to high strength shocks was 8.9. CONCLUSION: when given during ventricular tachycardia, low strength shocks are much more likely to cause ventricular fibrillation or accelerated ventricular tachycardia than are high strength shocks (P less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1992

Observational comparison of event-free survival with medical and surgical therapy in patients with coronary artery disease. 20 years of follow-up.

BACKGROUND: The purpose of this study was to describe the long-term event-free survival patterns of patients with significant coronary artery disease treated medically versus patterns of those treated surgically and to evaluate the factors associated with improved event-free survival. METHODS AND RESULTS: We studied the results of 5,824 patients undergoing medical and surgical therapy for ischemic heart disease from 1969 to 1984, with follow-up to 1991. Events considered for this evaluation were nonfatal myocardial infarction or cardiovascular death. The Cox proportional hazards model was used to determine factors differentially affecting surgical event-free survival. The survival benefits previously reported for bypass surgery in this population were largely preserved when event-free survival was examined. The two factors associated with significant event-free survival benefits for surgically treated patients were more severe coronary artery disease and a more recent surgery data. Patients with more severe coronary obstruction had a greater relative improvement with surgery in event-free survival than did patients with less severe anatomic disease. Event-free survival with surgery progressively improved over the period of the study and, by 1984, was significantly better than medical therapy for most patient subgroups. Patients with poor prognosis because of risk factors such as older age, severe angina, or left ventricular dysfunction had a risk reduction with surgery proportional to their overall risk under medical therapy. CONCLUSIONS: Higher-risk patients with more severe disease (due to either coronary disease or other risk factors and age) should be considered for coronary revascularization because it is in these patients that coronary artery bypass graft surgery has the greatest impact in reducing future cardiovascular events.

Cardiac Catheterization↗
PubMed1991

Prognostic value of a treadmill exercise score in outpatients with suspected coronary artery disease.

BACKGROUND: The treadmill exercise test identifies patients with different degrees of risk of death from cardiovascular events. We devised a prognostic score, based on the results of treadmill exercise testing, that accurately predicts outcome among inpatients referred for cardiac catheterization. This study was designed to determine whether this score could also accurately predict prognosis in unselected outpatients. METHODS: We prospectively studied 613 consecutive outpatients with suspected coronary disease who were referred for exercise testing between 1983 and 1985. Follow-up was 98 percent complete at four years. The treadmill score was calculated as follows: duration of exercise in minutes--(5 x the maximal ST-segment deviation during or after exercise, in millimeters)--(4 x the treadmill angina index). The numerical treadmill angina index was 0 for no angina, 1 for nonlimiting angina, and 2 for exercise-limiting angina. Treadmill scores ranged from -25 (indicating the highest risk) to +15 (indicating the lowest risk). RESULTS: Predicted outcomes for the outpatients, based on their treadmill scores, agreed closely with the observed outcomes. The score accurately separated patients who subsequently died from those who lived for four years (area under the receiver-operating-characteristic curve = 0.849). The treadmill score was a better discriminator than the clinical data and was even more useful for outpatients than it had been for inpatients. Approximately two thirds of the outpatients had treadmill scores indicating low risk (greater than or equal to +5), reflecting longer exercise times and little or no ST-segment deviation, and their four-year survival rate was 99 percent (average annual mortality rate, 0.25 percent). Four percent of the outpatients had scores indicating high risk (less than -10), reflecting shorter exercise times and more severe ST-segment deviation; their four-year survival rate was 79 percent (average annual mortality rate, 5 percent). CONCLUSIONS: The treadmill score is a useful and valid tool that can help clinicians determine prognosis and decide whether to refer outpatients with suspected coronary disease for cardiac catheterization. In this study, it was a better predictor of outcome than the clinical assessment.

Adult↗
PubMed1991

Using ordinal logistic regression to estimate the likelihood of colorectal neoplasia.

The utility of ordinal logistic regression in the prediction of colorectal neoplasia was demonstrated in a group of 461 consecutive patients undergoing colonoscopy in a community practice. One hundred twenty-nine patients had adenomatous polyps and 34 had colorectal adenocarcinoma. An ordinal logistic regression model developed in a random subset (292 patients) identified five predictors of colorectal neoplasia. Colorectal neoplasia risk could be predicted using the patient's age, sex, hematocrit, fecal occult blood test result and indication for colonoscopy. The risk of colorectal neoplasia in the remaining subset of patients (169) could be reliably estimated from the model. Ordinal logistic regression analysis in this select group of patients can accurately estimate the likelihood of colorectal neoplasia. Because the generalizability of our findings are unknown, the model should not be applied to other patients. However, application of this technique to an unselected group of patients not already referred for colonoscopy could provide unbiased estimates of colorectal neoplasia risk in individual patients.

Adenocarcinoma↗
PubMed1991

Determinants of early versus late cardiac death in patients undergoing coronary artery bypass graft surgery.

Most analyses of risk factors affecting survival after coronary artery bypass graft surgery have not differentiated among factors that influence early and late survival. For this reason, a multiphase model was applied to survival data from 2,967 patients undergoing a first coronary artery bypass graft at the Duke University Medical Center between 1969 and 1984. There were 709 deaths during follow-up to 19.6 years. The data were analyzed using a multivariable survival model that separates the underlying hazard function into as much as three different phases, each incorporating separate risk factors. Two distinct phases were detected. One phase dominated early survival (0-1 year), and the second phase dominated late survival (greater than 1 year). Surgery performed earlier in our experience was associated with elevated risk of dying in both phases but with different magnitudes, whereas lower ejection fraction, greater extent of coronary disease, older age, conduction abnormality, and history of hypertension were associated with elevated risk of dying similarly in both phases (p less than 0.05). Severity of angina symptoms and lower weight were associated with an elevated risk of dying only in the early phase (p less than 0.05; because few of the patients were obese, estimates of the relative risk of morbid obesity could not be estimated), whereas vascular disease, diabetes, and extent of myocardial damage were associated with an elevated risk of dying only in the late phase (p less than 0.05). These data illustrate both the differential influence of risk factors over time and the importance of multiphase models.

Cohort Studies↗
PubMed1991

Estimating the likelihood of severe coronary artery disease.

PURPOSE: To determine which clinical characteristics obtained by a physician during an initial clinical examination are important for estimating the likelihood of severe coronary artery disease, and to determine whether estimates based on these characteristics remain valid when applied prospectively and in different patient groups. PATIENTS AND METHODS: We examined clinical characteristics predictive of severe disease in 6,435 consecutive symptomatic patients referred for suspected coronary artery disease between 1969 and 1983. RESULTS: Eleven of 23 characteristics were important for estimating the likelihood of severe coronary artery disease. A model using these characteristics accurately estimated the likelihood of severe disease in an independent sample of 2,342 patients referred since 1983. The model also accurately estimated the prevalence of severe disease in large series of patients reported in the literature. CONCLUSIONS: These findings suggest that the clinician's initial evaluation can identify patients at high or low risk of anatomically severe coronary artery disease. Cost-conscious quality care is encouraged by identifying patients at higher risk for severe coronary artery disease who are most likely to benefit from further evaluation.

Adult↗
PubMed1990

Effect of Type A behavior on exercise test outcome in coronary artery disease.

The outcome of the diagnostic exercise test depends on such patient-related factors as age, maximum exercise heart rate, exercise time and severity of the underlying coronary artery disease (CAD). This study examined the hypothesis that type A behavior would affect the amount of effort expended, as indicated by the exercise time and the maximum heart rate achieved, thereby resulting in differences in exercise test outcome. A total of 1,260 patients with suspected CAD, all of whom had coronary angiography, a structured interview to assess type A behavior and a treadmill exercise test, participated. Of these patients, 818 (65%) had significant CAD, and 852 (68%) were type A. There were no differences between type A and B patients in either maximum heart rate or total exercise time. Among both type A and B subjects, 36% of treadmill tests were positive. Exercise test sensitivity was similar for both groups (69% for type A vs 72% for type B, p = 0.39). Similarly, specificity was similar for both groups (87% for type A vs 80% for type B, p = 0.09). Results did not change after using logistic regression to control for potential confounding factors. Thus, type A behavior does not need to be taken into account when interpreting exercise test outcome.

Adult↗
PubMed1990

Clinical judgment and therapeutic decision making.

Clinical decision making is under increased scrutiny due to concerns about the cost and quality of medical care. Variability in physician decision making is common, in part because of deficiencies in the knowledge base, but also due to the difference in physicians' approaches to clinical problem solving. Evaluation of patient prognosis is a critical factor in the selection of therapy, and careful attention to methodology is essential to provide reliable information. Randomized controlled clinical trials provide the most solid basis for the establishment of broad therapeutic principles. Because randomized studies cannot be performed to address every question, observational studies will continue to play a complementary role in the evaluation of therapy. Randomized studies in progress, meta analyses of existing data, and increased use of administrative and collaborative clinical data bases will improve the knowledge base for decision making in the future.

Cardiology↗
PubMed1990

Cardiac rupture, mortality and the timing of thrombolytic therapy: a meta-analysis.

This study examined the relation between the risk of cardiac rupture and the timing of thrombolytic therapy for acute myocardial infarction. To test the hypothesis that cardiac rupture is prevented by early thrombolytic therapy but is promoted by late treatment, randomized controlled trials of thrombolytic agents for myocardial infarction were pooled. A logistic regression model including 58 cases of cardiac rupture among 1,638 patients from four trials showed that the odds ratio (treated/control) of cardiac rupture was directly correlated with time to treatment (p = 0.01); at 7 h, the odds ratio was 0.4 (95% confidence limits 0.17 to 0.93); at 11 h, it was 0.93 (0.53 to 1.60) and at 17 h, it was 3.21 (1.10 to 10.1). Analysis of data from the Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI) trial independently confirmed the relation between time to thrombolytic therapy and risk of cardiac rupture (p = 0.03). Analysis of 4,692 deaths in 44,346 patients demonstrated that the odds ratio of death was also directly correlated with time to treatment (p = 0.006); at 3 h, the odds ratio for death was 0.72 (0.67 to 0.77); at 14 h, it was 0.88 (0.77 to 1.00) and at 21 h, it was 1 (0.82 to 1.37). Thrombolytic therapy early after acute myocardial infarction improves survival and decreases the risk of cardiac rupture. Late administration of thrombolytic therapy also appears to improve survival but may increase the risk of cardiac rupture.

Drug Administration Schedule↗
PubMed1990

Statistical methods in SUPPORT.

The analysis and interpretation of the data collected in SUPPORT provide great potential for understanding the relationships among treatment choices, patient and physician values and preferences, perceptions about the risks and benefits of treatments, institutional characteristics, and outcomes (as measured by quality of life, survival, and satisfaction). The complicated analyses required to elucidate these relationships will pose many technical challenges in dealing with longitudinal observational data collected from seriously ill patients at multiple sites. Major challenges include the handling of incomplete data, proper parameterization of treatment effects, strategies to avoid various potential biases, validating predictive models, and constructing endpoints that combine survival with quality of life. Within the structure of the SUPPORT study, mechanisms have been established to guide the analyses and to ensure their quality and validity.

Confounding Factors, Epidemiologic↗
PubMed1990

Prognostic value of radionuclide angiography in medically treated patients with coronary artery disease. A comparison with clinical and catheterization variables.

To evaluate the usefulness of multiple measures from rest and exercise radionuclide angiography (RNA) in predicting cardiovascular death and cardiovascular events (death or nonfatal myocardial infarction) and to assess the prognostic usefulness of the RNA relative to clinical and catheterization data, we studied 571 stable patients with symptomatic coronary artery disease who had upright rest/exercise first-pass RNA within 3 months of catheterization and were medically treated. With a median follow-up of 5.4 years, 90 patients have died from cardiovascular causes, and 147 patients have either died or suffered a nonfatal myocardial infarction. Using the Cox regression model and a preselected group of RNA variables, the most important RNA predictor of mortality was exercise ejection fraction (chi 2 = 81, p less than 0.00001). Neither rest ejection fraction nor the change in ejection fraction from rest to exercise contributed additional predictive information. Two other RNA study variables, the change in heart rate from rest to exercise and rest end-diastolic volume index, did contribute additional prognostic information to the exercise ejection fraction (chi 2 = 23, p less than 0.0001). Compared with noninvasive clinical data (history, physical examination, electrocardiogram, and chest radiograph), RNA variables were considerably more predictive of mortality (chi 2 = 71 [clinical variables] versus chi 2 = 104 [RNA]). Remarkably, the strength of the relation of RNA variables with mortality was equivalent to that of the set of catheterization variables previously demonstrated in our large angiographic population to be prognostically important (chi 2 = 104 [RNA] versus chi 2 = 102 [catheterization variables]). The RNA contained 84% of the information provided by clinical and catheterization descriptors combined. Furthermore, the RNA contributed significant additional prognostic information to the clinical and catheterization data (chi 2 = 13.6, p = 0.0035). For cardiovascular events, the relative prognostic usefulness of the RNA was similar, although relations with this outcome were generally weaker. Descriptors from the rest/exercise RNA exhibit a powerful relation with long-term outcomes and can be useful in defining risk, even when clinical and catheterization data are available.

Cardiac Catheterization↗
PubMed1990

Studies of gastric ulcer disease by community-based gastroenterologists.

A community-based group of gastroenterologists examined 623 patients (541 prospectively and 82 retrospectively) with endoscopically diagnosed gastric ulcer disease during a 12-month period. Patients averaged 60 years of age; the majority were women (62%). Women were less likely to smoke, abuse alcohol, and were more likely to present with abdominal pain (p less than 0.05). Whereas patients presenting with bleeding or requiring transfusion were less likely to complain of pain (p less than 0.05), they were more likely to be taking aspirin or nonsteroidal anti-inflammatory drugs and have prior history of bleeding (p less than 0.05). Patients with a prior history of ulcer disease were more likely to smoke, present with pain and use acetaminophen (p less than 0.05). Patients with large ulcers were more likely to bleed, present with pain, and obstruct (p less than 0.05). Multiple gastric ulcers were seen in patients taking aspirin or nonsteroidal anti-inflammatory drugs (p less than 0.05).

Abdominal Pain↗
PubMed1989

Clinical correlates and prognostic significance of type A behavior and silent myocardial ischemia on the treadmill.

Type A patients with coronary artery disease (CAD) tend to ignore or underreport symptoms, especially during challenging tasks such as the treadmill exercise test. To determine whether type A CAD patients might be more likely than type B patients to have silent ischemia during exercise and consequently a worse prognosis, 403 patients with stable CAD who had significant coronary disease on angiography, a positive Bruce protocol treadmill test and a structured interview to assess type A behavior were studied. Median follow-up time was 6 years. Type A patients were more likely to experience silent ischemia during exercise than were type B patients (35 vs 25%, p = 0.05). Patients with silent ischemia during exercise had a history of fewer anginal episodes/week, and type A patients with silent ischemia were less likely to have had a history of typical angina. However, using the Cox model, there were no significant differences in survival between type A patients and B patients with silent ischemia (4-year survival 86 vs 79%, p = 0.44) and no significant differences in survival between type A patients with silent ischemia and type A patients with symptomatic ischemia (6-year survival 86 vs 80%, p = 0.59). Similar results were obtained for infarction-free survival. Type A patients are more likely than type B patients to have silent ischemia during exercise, but long-term survival is not affected.

Angina Pectoris↗
PubMed1989

Differential diagnosis of acute meningitis. An analysis of the predictive value of initial observations.

We analyzed data from the records of 422 patients with acute bacterial or viral meningitis. A cerebrospinal fluid (CSF) glucose level less than 1.9 mmol/L, a CSF-blood glucose ratio less than 0.23, a CSF protein level greater than 2.2 g/L, more than 2000 x 10(6)/L CSF leukocytes, or more than 1180 x 10(6)/L CSF polymorphonuclear leukocytes were individual predictors of bacterial infection with 99% certainty or better. Although any one of these tests could rule in bacterial meningitis with high probability, none could rule it out. To better predict whether a patient has bacterial vs viral infection, we developed a logistic multiple regression model using CSF-blood glucose ratio, total polymorphonuclear leukocyte count in CSF, age, and month of onset. This proved highly reliable when validated in an independent test sample, with an area under receiver operating characteristic curve of 0.97. The model should allow physicians to differentiate between acute viral and acute bacterial meningitis with greater accuracy.

Acute Disease↗
PubMed1989

Type A behavior and survival: a follow-up study of 1,467 patients with coronary artery disease.

Patients with documented coronary artery disease, admitted to Duke Medical Center between 1974 and 1980, were assessed for type A behavior pattern and were followed until 1984. The relation of type A behavior to survival was tested using data from coronary angiography to control for disease severity. Cox model regression analyses demonstrated an interaction (p less than 0.01) between type A behavior and an index of disease severity in the prediction of cardiovascular death. Among those with relatively poor left ventricular function, type A patients had better survival than type B. This difference was not present among patients with better prognoses. Type A behavior did not predict the subsequent incidence of nonfatal myocardial infarctions. Differential risk modification and differential selection into postinfarction status are possible explanations for the findings. These results need not conflict with the proposition that type A behavior plays a role in the pathogenesis of coronary artery disease.

Adult↗
PubMed1989

The evolution of medical and surgical therapy for coronary artery disease. A 15-year perspective.

To elucidate the factors associated with improved survival following coronary artery bypass surgery, we studied 5809 patients receiving medical or surgical therapy for coronary artery disease. Three factors were associated with a significant surgical survival benefit: more severe coronary disease, a worse prognosis with medical therapy, and a more recent operative date. Patients with more extensive coronary obstruction had the greatest improvement in survival. Patients with a poor prognosis because of factors such as older age, severe angina, or left ventricular dysfunction had a reduction in risk that was proportionate to their overall risk on medical therapy. Survival with surgery progressively improved over the study period and by 1984 surgery was significantly better than medical therapy for most patient subgroups. Thus, contemporary coronary revascularization is associated with improved longevity in many patients with ischemic heart disease, especially in those with adverse prognostic indicators.

Age Factors↗
PubMed1989

Randomized, double-blind comparison of famotidine with ranitidine in treatment of acute, benign gastric ulcer disease. Community-based study coupled with a patient registry.

A multicenter, double-blind, randomized controlled trial comparing the efficacy and safety of famotidine with ranitidine in the treatment of acute, benign gastric ulcer disease was coupled with a community-based gastric ulcer disease registry. One hundred ninety-five patients with endoscopically documented gastric ulcer disease were enrolled in the trial and randomly allocated to treatment with either famotidine 40 mg at bedtime or ranitidine 150 mg twice a day. Healing rates were similar in both groups: at four weeks 49% vs 48%, at six weeks 71% vs 69%, and at eight weeks 83% vs 81% for famotidine and for ranitidine, respectively. Pain relief, antacid tablet use, and adverse experiences were also similar in the two groups. Only 25% of patients entered in the gastric ulcer registry were enrolled in the trial. Given that patients with more severe or complicated gastric ulcer disease should be excluded from controlled trials of new drugs, the screening criteria used in the present study be excluded from findings being representative of a quarter of the patients seen in these practices. Therefore, coupling a patient registry with a clinical trial helps determine the applicability of its results. Famotidine 40 mg at bedtime is an effective and well-tolerated treatment of acute, benign gastric ulcer disease and is comparable in efficacy and safety to ranitidine 150 mg twice a day.

Clinical Trials as Topic↗