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T A Schwartz

Publications and source records attributed to T A Schwartz.

7 recordsLinked to original sources

Gender differences in survival in advanced heart failure. Insights from the FIRST study.

BACKGROUND: Previous natural history studies in broad populations of heart failure patients have associated female gender with improved survival, particularly in patients with a nonischemic etiology of ventricular dysfunction. This study investigates whether a similar survival advantage for women would be evident among patients with advanced heart failure. METHODS AND RESULTS: The study analysis is based on the Flolan International Randomized Survival Trial (FIRST) study which enrolled 471 patients (359 men and 112 women) who had evidence of end-stage heart failure with marked symptoms (60% NYHA class IV) and severe left ventricular dysfunction (left ventricular ejection fraction 18+/-4.9%). A Cox proportional-hazards model, adjusted for age, gender, 6-minute walk, dobutamine use at randomization, mean pulmonary artery blood pressure, and treatment assignment, showed a significant association between female gender and better survival (relative risk of death for men versus women was 2.18, 95% CI 1.39 to 3.41; P<0.001). Although formal interaction testing was negative (P=0.275), among patients with a nonischemic etiology of heart failure, the relative risk of death for men versus women was 3.08 (95% CI 1.56 to 6.09, P=0.001), whereas among those with ischemic heart disease, the relative risk of death for men versus women was 1.64 (95% CI 0.87 to 3.09, P=0.127). CONCLUSIONS: Women with advanced heart failure appear to have better survival than men. Subgroup analysis suggests this finding is strongest among patients with a nonischemic etiology of heart failure.

Aged↗

Technical factors of CT angiography studied with a carotid artery phantom.

PURPOSE: To evaluate scanning parameters (conventional versus spiral CT, section thickness, and pitch) and vessel orientation in the performance of CT angiography. METHODS: Conventional CT and 1.0-, 1.5-, and 2.0-pitch spiral CT acquisitions of a carotid phantom designed with vessels oriented parallel to the z-axis, 45 degrees oblique, and perpendicular to the z-axis were obtained with section thicknesses of 2, 4, and 8 mm. The phantom contained 32 vessels with 0% to 100% stenoses. Normal and stenotic luminal diameters were measured and the number of artifacts was assessed. RESULTS: No overall difference was observed among conventional and spiral CT acquisitions obtained with pitches of 1.0, 1.5, and 2.0. With thicker sections, CT angiographic accuracy decreased and artifacts increased. The three-vessel orientations were relatively comparable in accuracy in terms of the percentage of stenosis measured. Vessels parallel to the z-axis suffered less artifactual degradation. Unique artifacts, such as luminal distortion and beam hardening, were observed in vessels oriented at 45 degrees and perpendicular to the z-axis. CONCLUSION: Use of thinner sections with vessels oriented parallel to the z-axis optimizes CT angiographic quality. There is no apparent degradation with the use of spiral CT, and a pitch of 1.5 or 2.0 provides results equivalent to 1.0-pitch spiral studies.

Brain Ischemia↗

Analysis of interobserver and intraobserver variability in CT tumor measurements.

OBJECTIVE: The purpose of this study was to evaluate the variability between radiologists interpreting thoracic and abdominal/pelvic CT scans in selecting specific sites of metastatic tumor for measurement (indicator lesions) and to assess interobserver and intraobserver variability in tumor measurement. MATERIALS AND METHODS: Three separate experienced radiologists were asked to review 24 combined thoracic and abdominal CT scans in patients with metastatic tumor. Each radiologist was asked to identify the indicator lesions representative of each patient's tumor bulk. In the second phase of the study, 105 specific foci on 26 combined thoracic and abdominal CT studies (including the original 24) were reviewed twice by the same three radiologists. Up to eight foci were randomly identified per patient, and each observer was asked to determine the slice with the maximum diameter for each tumor focus and to measure it in three dimensions (maximum diameter, its perpendicular, and length). RESULTS: A total of 132 tumor sites were present on the CT studies in phase I, all of which were chosen by at least one observer as an indicator lesion. Of the 116 of these that were separate and nonoverlapped, 57 (49%) were measured by only one observer, whereas 32 (28%) and 27 (23%) were measured by two or all three observers, respectively. Observers were more inclined to pick round or defined/well-defined lesions rather than irregular, oval, or poorly defined ones, although this tendency was not statistically significant. The second phase of the study showed considerable interobserver variability (15%) in CT tumor measurement, which was worse for poorly defined and irregular lesions. Intraobserver variability in measuring individual foci was less (6%). CONCLUSION: Radiologists interpreting thoracic and/or abdominal/pelvic CT scans for metastatic cancer should measure and report a significant number of each patient's tumor sites, especially larger ones in different anatomic areas. When interpreting a follow-up CT scan of a patient with metastatic cancer, the interpreting radiologist should remeasure the indicator lesions on the previous and on the follow-up CT scans, especially when the results will change the patient's treatment response category.

Abdominal Neoplasms↗

The front line health worker: selection, training, and performance.

Iranian villagers with basic literacy were recruited, selected, trained, and deployed as Village Health Workers (VHWs) to rural areas of Iran. VHW clinical visit records and activities logs were analyzed to determine levels and nature of effort achieved in the field. Within six months of deployment, the number of patient visits to VHW treatment services constituted 53% of the target population. Within ten months of deployment, the number of family planning acceptors rose from 8% to 21% of the population at risk. Improvements to water supplies have been effected in 50% of target villages. Sanitary improvements have been made to 35% of the houses and 88% of toilets in those villages. Demographic characteristics, class rank, and place of residence of VHWs appear unassociated with village differences in levels of achievement. However, availability of material resources and actual time spent by VHWs on the job may be factors influencing the differences in outcome between villages.

Allied Health Personnel↗

Applying sample survey methods to clinical trials data.

This paper outlines the utility of statistical methods for sample surveys in analysing clinical trials data. Sample survey statisticians face a variety of complex data analysis issues deriving from the use of multi-stage probability sampling from finite populations. One such issue is that of clustering of observations at the various stages of sampling. Survey data analysis approaches developed to accommodate clustering in the sample design have more general application to clinical studies in which repeated measures structures are encountered. Situations where these methods are of interest include multi-visit studies where responses are observed at two or more time points for each patient, multi-period cross-over studies, and epidemiological studies for repeated occurrences of adverse events or illnesses. We describe statistical procedures for fitting multiple regression models to sample survey data that are more effective for repeated measures studies with complicated data structures than the more traditional approaches of multivariate repeated measures analysis. In this setting, one can specify a primary sampling unit within which repeated measures have intraclass correlation. This intraclass correlation is taken into account by sample survey regression methods through robust estimates of the standard errors of the regression coefficients. Regression estimates are obtained from model fitting estimation equations which ignore the correlation structure of the data (that is, computing procedures which assume that all observational units are independent or are from simple random samples). The analytic approach is straightforward to apply with logistic models for dichotomous data, proportional odds models for ordinal data, and linear models for continuously scaled data, and results are interpretable in terms of population average parameters. Through the features summarized here, the sample survey regression methods have many similarities to the broader family of methods based on generalized estimating equations (GEE). Sample survey methods for the analysis of time-to-event data have more recently been developed and implemented in the context of finite probability sampling. Given the importance of survival endpoints in late phase studies for drug development, these methods have clear utility in the area of clinical trials data analysis. A brief overview of methods for sample survey data analysis is first provided, followed by motivation for applying these methods to clinical trials data. Examples drawn from three clinical studies are provided to illustrate survey methods for logistic regression, proportional odds regression and proportional hazards regression. Potential problems with the proposed methods and ways of addressing them are discussed.

Clinical Trials as Topic↗