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Biomedical subjects

J Concato

Publications and source records attributed to J Concato.

At least 19 recordsLinked to original sources

Unwillingness of rheumatoid arthritis patients to risk adverse effects.

OBJECTIVE: To evaluate patient willingness to accept the risk of adverse effects (AEs) commonly associated with arthritis medications. METHODS: Rheumatoid arthritis patients were asked to rate their willingness to take a medication associated with 17 specific AEs using a visual analogue scale. RESULTS: We interviewed 100 patients. Eighty-one were currently using one or more disease-modifying anti-rheumatic drugs (DMARDs) and 29 had previously experienced AEs related to DMARDs. Seventy-five stated that they were doing very well or well with respect to their arthritis compared with other people their age. Thirty-five per cent of those interviewed were unwilling to accept the risk of cosmetic changes, 38% were unwilling to accept the risk of temporary discomfort and 45% were unwilling to accept the risk of major toxicity. Patients who had previously experienced AEs were more willing to accept the risk of cosmetic changes (83 vs. 58%, P=0.02), temporary discomfort (79 vs. 55%, P=0.02) and major toxicity (83 vs. 44%, P=0.001) compared with those who had not previously experienced AEs. CONCLUSIONS: Many rheumatoid arthritis patients are very concerned about potential drug toxicity. However, risk adversity appeared to be attenuated by past experience with AEs. Our results suggest that certain patients, especially those with milder disease activity, might be reluctant to accept commonly used arthritis medications if they are fully informed of their potential toxicity.

Adult↗

Effect of non-insulin-dependent diabetes mellitus on myocardial insulin responsiveness in patients with ischemic heart disease.

BACKGROUND: Patients with non-insulin-dependent diabetes mellitus (NIDDM) exhibit poor clinical outcomes from myocardial ischemia. This may reflect an impairment in their cardiac insulin-response system. METHODS AND RESULTS: We used AV balance and intracoronary infusion techniques to compare the intrinsic cardiac responsiveness to insulin in 26 coronary disease patients with (n=13) and without (n=13) NIDDM. During fasting, NIDDM hearts demonstrated lower fractional extraction of glucose from arterial plasma than controls (1.0+/-0.5% versus 2.1+/-0.5%, P<0.05) despite higher circulating insulin levels (26+/-5 versus 13+/-4 microU. mL, P<0.05). This was compensated for by higher circulating glucose levels, so that net cardiac glucose uptake in the 2 groups was equivalent (5.2+/-1.1 versus 5.3+/-1.1 micromol. min). Intracoronary insulin infusion produced an approximately 3-fold increase in fractional extraction and net uptake of glucose across the heart in both groups (to 3.7+/-0.4% and 18.3+/-3.5 micromol. min in NIDDM and to 5.4+/-0.7% and 17.7+/-4.3 micromol. min in controls) accompanied by an approximately 30% increase in net lactate uptake, suggesting preserved insulin action on both glucose uptake and glucose oxidation in the NIDDM heart. In nondiabetics, insulin consistently increased coronary blood flow, but this effect was absent in NIDDM. CONCLUSIONS: In contrast to their peripheral tissues and coronary vasculature, the myocardium of patients with NIDDM expresses a competent insulin-response system with respect to glucose metabolism. This suggests that insulin resistance is mediated at the level of individual organs and that different mechanisms are involved in muscle and vascular tissue.

Angiography↗

Preference for disclosure of information among patients with rheumatoid arthritis.

OBJECTIVE: To quantify preference for disclosure of information among patients with rheumatoid arthritis (RA) and to examine sex-specific correlates of information preference. METHODS: We interviewed patients with RA and assessed preference for disclosure of information using 4 questions from the previously validated "Information Preference Seeking Scale." Three questions addressed preference for disclosure of side effects and 1 question addressed preference for disclosure of therapeutic options. Associations between preference for information and patient characteristics were examined using stepwise multiple linear regression. RESULTS: One hundred RA patients (mean age 68+/-12 years; 73% female) were interviewed; 89 respondents agreed or strongly agreed with all 4 statements reflecting a preference for full disclosure, and an additional 8 respondents agreed or strongly agreed with 3 of the 4 statements. The mean score (+/- SD) for information preference was 86+/-13, on a scale from 0 to 100 where 100 reflected a strong preference for full disclosure. In bivariate analyses, female sex and current employment were associated with stronger preferences for being informed (mean score for women 88+/-11, for men 80+/-15 [P = 0.02]; for employed 92+/-11, for unemployed 84+/-13 [P = 0.04]). Multivariate sex-specific analyses demonstrated that current employment and higher education level were positively associated with preference for disclosure among women and men, respectively. CONCLUSION: The results of our survey suggest that RA patients want to be fully informed about the risks associated with medications and about alternative options. The challenge remaining for rheumatologists is how to effectively communicate the risks and benefits related to the many options that are currently available for RA patients.

Adult↗

A nested case-control study of the effectiveness of screening for prostate cancer: research design.

Although prostate-specific antigen (PSA) and digital rectal examination (DRE) are commonly used to screen for prostate cancer, available data do not confirm that either test improves survival. This report describes the methodological aspects of a nested case-control study addressing the question of whether PSA screening, with or without DRE, is effective in increasing survival. Potential sources of bias are discussed, as well as corresponding strategies used to avoid them. Results are expected in the year 2002.

Case-Control Studies↗

Risk adjustment for older hospitalized persons: a comparison of two methods of data collection for the Charlson index.

To compare Charlson indices based on chart data and ICD-9 data for agreement overall and on rating specific comorbid conditions, and to compare mortality risks associated with these indices. Prospective cohort study. Six general medicine wards at Yale-New Haven Hospital. 524 consecutive patients who had no clinical evidence of delirium at enrollment, admitted between November 6, 1989 and July 31, 1991, aged 70 years or older. Death within 1 year of the index hospital admission date. Scores using the chart-based data were significantly higher than those using ICD-9 data. About half of the individual conditions showed fair-to-good agreement between the two scores, whereas the other half showed poor agreement. A comparison of mortality prediction indicated that the weightings assigned to individual comorbidities differed substantially from those used in Charlson's original index. While mortality prediction of each individual index was comparable, the ICD-9 and chart indices contributed independently to mortality prediction in the presence of the other. Low agreement between Charlson scores based on the two methods of data collection and their cumulative contribution to mortality prediction suggest that these indices may include different information. Our results suggest that the original Charlson index may not provide optimal risk adjustment for elderly general medicine samples. We suggest development of an empirically-derived index of comorbid conditions and weights may be warranted for older general medical patients.

Aged↗

Injury related infant death: the impact of race and birth weight.

OBJECTIVE: To examine the effect of race and birth weight independent of other sociodemographic factors on injury related infant death using national data. SETTING: Infants born in the United States to mothers who were white (non-Hispanic), African American, Mexican American, and Native American. METHODS: Linked infant birth and death data from the National Center for Health Statistics for 1989-91 were analyzed to calculate unadjusted and adjusted odds ratios for death due to homicide or unintentional injury within the first year of life. In addition to maternal race and birth weight, the risk of death was adjusted for maternal age, prenatal care, maternal education, paternal education, marital status, birth order, interval since last pregnancy, smoking during pregnancy, and alcohol intake during pregnancy. RESULTS: Among 10.7 million births during 1989-91, 821 homicides and 2397 unintentional deaths were reported in infants. Relative to whites, African Americans were at highest risk for homicides (unadjusted and adjusted odds ratios = 3.6 (95% confidence interval = 3.1 to 4.2) and 1.6 (1.3 to 1.9), respectively) and Native Americans at highest risk for unintentional injuries (unadjusted and adjusted odds ratios = 3.8 (3.0 to 4.8) and 2.1 (1.7 to 2.6), respectively). After accounting for other sociodemographic factors, Mexican American infants appeared protected from injury (adjusted odds ratio = 0.7 (0.6 to 1.0) for homicides and 0.7 (0.6 to 0.8) for unintentional injuries). An inverse effect of birth weight was seen-as birth weight decreased, risk of homicides and unintentional injuries increased. After adjustment for the sociodemographic factors, very low birthweight babies were still at substantially increased risk of homicides with an odds ratio of 2.1 (1.4 to 3.1) and unintentional injuries with an odds ratio of 2.9 (2.4 to 3.7). CONCLUSIONS: Using a large national data-set, the effect of race as a risk factor for fatal infant injuries was mostly explained by birth weight and other sociodemographic factors. Preventable risk factors need to be identified for African Americans and Native Americans, in particular. Birth weight is an important independent risk factor; very low birthweight babies should be monitored for both homicide and unintentional injury.

Accidents↗

Randomized, controlled trials, observational studies, and the hierarchy of research designs.

BACKGROUND: In the hierarchy of research designs, the results of randomized, controlled trials are considered to be evidence of the highest grade, whereas observational studies are viewed as having less validity because they reportedly overestimate treatment effects. We used published meta-analyses to identify randomized clinical trials and observational studies that examined the same clinical topics. We then compared the results of the original reports according to the type of research design. METHODS: A search of the Medline data base for articles published in five major medical journals from 1991 to 1995 identified meta-analyses of randomized, controlled trials and meta-analyses of either cohort or case-control studies that assessed the same intervention. For each of five topics, summary estimates and 95 percent confidence intervals were calculated on the basis of data from the individual randomized, controlled trials and the individual observational studies. RESULTS: For the five clinical topics and 99 reports evaluated, the average results of the observational studies were remarkably similar to those of the randomized, controlled trials. For example, analysis of 13 randomized, controlled trials of the effectiveness of bacille Calmette-Guérin vaccine in preventing active tuberculosis yielded a relative risk of 0.49 (95 percent confidence interval, 0.34 to 0.70) among vaccinated patients, as compared with an odds ratio of 0.50 (95 percent confidence interval, 0.39 to 0.65) from 10 case-control studies. In addition, the range of the point estimates for the effect of vaccination was wider for the randomized, controlled trials (0.20 to 1.56) than for the observational studies (0.17 to 0.84). CONCLUSIONS: The results of well-designed observational studies (with either a cohort or a case-control design) do not systematically overestimate the magnitude of the effects of treatment as compared with those in randomized, controlled trials on the same topic.

Anticholesteremic Agents↗

Claims of equivalence in medical research: are they supported by the evidence?

BACKGROUND: Most clinical studies are done to show comparative superiority, but many reports now claim equivalence between the investigated entities. These assertions may not always be supported by the methods used and the results obtained. PURPOSE: To assess the justification and support for claims of clinical or therapeutic equivalence in medical journals. DATA SOURCES: A search of MEDLINE for articles published from 1992 through 1996. STUDY SELECTION: From 1209 citations that contained the word equivalence in the title or abstract or contained the Medical Subject Heading therapeutic equivalency, we excluded 1121 studies reporting nonoriginal research, purely laboratory or other nonhuman research, and studies in which equivalence was not the main claim. The remaining 88 eligible papers were evaluated for five methodologic attributes. DATA SYNTHESIS: Only 45 (51%) of the 88 reports were specifically aimed at studying equivalence; the others either tried to show superiority or did not state a research aim. The quantitative distinctions regarded as "equivalent" ranged from 0% to 21% for direct increments and from 0% to 76% for proportionate differences. An equivalence boundary was set and confirmed with an appropriate statistical test in only 23% of reports. In 67% of reports, equivalence was declared after a failed test for comparative superiority, and in 10%, the claim of equivalence was not statistically evaluated. The sample size needed to confirm results had been calculated in advance for only 33% of reports. Sample size was 20 patients per group or fewer in 25% of reports. CONCLUSIONS: Many studies of clinical equivalence do not set boundaries for equivalence. Claims of "difference" or "similarity" are often made not by thoughtful examination of the data but by tests of statistical significance that are often misapplied or accompanied by inadequate sample sizes. These methodologic flaws can lead to false claims, inconsistencies, and harm to patients.

Humans↗

Alcohol exposure and health services utilization in older veterans.

The objective of this study was to determine if increased alcohol exposure is associated with greater use of health services among older veterans. A total of 129 older veterans (> or =65 years old), receiving longitudinal care in a Veterans' Administration primary care clinic, were followed retrospectively for up to 42 months. Subjects were screened at baseline for problem drinking with the CAGE or the quantity-frequency questions from the Alcohol Use Disorders Identification Test (QF-AUDIT), and stratified by exposure into three categories: abstainers, social drinkers, and problem drinkers. Outcomes included total outpatient clinic visits, laboratory tests, radiologic and other technologic procedures, as well as acute care hospitalizations. For all subjects (N = 129), no association was found between alcohol exposure and use of any outpatient services. Among CAGE-screened (n = 62) abstainers, social drinkers, and problem drinkers, significant differences were found in the median number of laboratory tests (7.3 vs. 3.4 vs. 7.1, P = 0.004) and hospitalizations (0.3 vs. 0.0 vs. 0.3, P = 0.001) per patient year of follow-up. No exposure-outcome associations were present, however, among QF-AUDIT-screened subjects (n = 67). We were unable to demonstrate a consistent relationship between alcohol exposure and health services utilization. The effects of alcohol on older veterans' use of health services varied with the method used to measure alcohol exposure. Additional studies are needed to determine whether multiple, or possibly new, measures can more precisely define the health effects of alcohol in older populations.

Aged↗

Treatment decisions for localized prostate cancer: asking men what's important.

OBJECTIVE: To identify what factors men consider important when choosing treatment for prostate cancer, and to assess why men reject watchful waiting as a treatment option. PARTICIPANTS: One hundred two consecutive men with newly diagnosed localized prostate cancer identified from hospital and community-based urology practice groups. MEASUREMENTS: Patients were asked open-ended questions about likes and dislikes of all treatments considered, how they chose their treatment, and reasons for rejecting watchful waiting. The interviews were conducted in person, after the men had made a treatment decision but before they received the treatment. MAIN RESULTS: The most common reasons for liking a treatment were removal of tumor for radical prostatectomy (RP) (n = 15), evidence for external beam radiation (EBRT) (n = 6), and short duration of therapy for brachytherapy (seeds) (n = 25). The most frequently cited dislikes were high risk of incontinence for RP (n = 46), long duration of therapy for EBRT (n = 29), and lack of evidence for seeds (n = 16). Only 12 men chose watchful waiting. Fear of future consequences, cited by 64% (n = 90) of men, was the most common reason to reject watchful waiting. CONCLUSION: In discussing treatment options for localized prostate cancer, clinicians, including primary care providers, should recognize that patients' decisions are often based on specific beliefs regarding each therapy's intrinsic characteristics, supporting evidence, or pattern of complications. Even if patients do not recall a physician recommendation against watchful waiting, this option may not be chosen because of fear of future consequences.

Aged↗

Cervical cancer practice patterns and appropriateness of therapy.

OBJECTIVE: This study was undertaken (1) to describe practice patterns for treatment of cervical cancer on a national scale, including patient characteristics associated with receiving appropriate versus inappropriate therapy, and (2) to determine whether mortality rate differences exist between patients who were treated appropriately and those who were treated inappropriately. STUDY DESIGN: We defined treatment appropriateness in cases of cervical cancer according to general recommendations for therapy for each International Federation of Gynecology and Obstetrics stage. In an analysis of data obtained from the Surveillance, Epidemiology, and End Results Program for 1988 through 1994 we determined the associations of patient demographic characteristics and tumor characteristics with treatment appropriateness. The association between treatment appropriateness and overall mortality for as long as 7 years of follow-up was adjusted for age; marital status; Surveillance, Epidemiology, and End Results Program location; International Federation of Gynecology and Obstetrics stage of disease; lymph node status; tumor grade; and histologic classification. RESULTS: Overall 90% of all patients were found to have received appropriate therapy. Important variables significantly associated with being treated inappropriately versus appropriately included age <40 years, positive nodal status, and International Federation of Gynecology and Obstetrics stage IB disease. Important variables significantly associated with receiving no therapy versus receiving appropriate therapy were age >/=60 years, International Federation of Gynecology and Obstetrics stage IV disease, positive nodal status, and unknown nodal status. In a comprehensive model that included demographic factors and tumor characteristics, the adjusted hazard ratio for mortality among patients who were treated inappropriately versus appropriately was 0.87 (95% confidence interval, 0.70-1.09). The adjusted hazard ratio for mortality among patients who did not receive therapy versus those who were treated appropriately was 2.92 (95% confidence interval, 2.44-3.48). CONCLUSIONS: In an analysis of data from a tumor registry, cervical cancer practice patterns were generally found to follow accepted treatment guidelines. Appropriateness of therapy did not vary widely according to demographic variables. Although patients who received no therapy had an elevated risk of death with respect to that of patients who were treated appropriately, patients who were treated inappropriately had a mortality rate similar to that among those who were treated appropriately (perhaps because of limitations in Surveillance, Epidemiology, and End Results Program data). Results of this preliminary study suggest a need for further research on effectiveness of cervical cancer therapies in the general population.

Adult↗

Beyond diagnosis: patient mix and challenges to patient care in ambulatory training sites.

BACKGROUND: Educational experiences in ambulatory medicine vary by site. PURPOSE: To evaluate variations in patient mix and challenges in patient care at 3 ambulatory training sites. METHOD: Patients (n=123) receiving care at a VA medical center (VA), an urban academic medical center's primary care center (PCC), and a community group practice (CGP) were evaluated. RESULTS: Patients at the VA (n=55), compared with those at the PCC (n=44) and the CGP (n=24), were older, more likely to be male, and white (all P<0.05). Patients at the VA and the PCC reported difficulty with functional and health status more frequently than those at the CGP (all P<0.05). Common medical diagnoses varied across sites and comorbidity scores were > or = 2 in 48% of VA subjects compared with 16% at the PCC and 29% at the CGP (P<0.05). Challenges most frequently cited were administrative issues at the VA (44%), patient-physician communication at the PCC (39%), and medical decisions at the CGP (50%) (P<0.05). CONCLUSIONS: Ambulatory training sites can differ greatly with respect to characteristics beyond diagnosis. Plans for increased and improved ambulatory training of internal medicine residents should include attention to these issues to ensure exposure to an adequate patient spectrum.

Academic Medical Centers↗

Prostate specific antigen: a useful screening test?

The role of prostate specific antigen (PSA) as a screening test for prostate cancer is controversial. Proponents of screening emphasize that early detection can lead to discovery of organ-confined disease and the potential for cure. Opponents point to the lack of credible evidence that screening is associated with a decrease in mortality. In addition, population-based screening (with subsequent diagnosis and treatment in many men) can be associated with considerable morbidity and mortality in the context of a disease that is often not fatal. This report examines the limitations of PSA as a screening test and supports an approach using "verbal informed consent" to identify patients who should be tested.

Humans↗

Validation of a staging system for evaluating prognosis in prostate cancer.

BACKGROUND: The purposes of our research were to validate a previously published clinical-anatomic staging system for evaluating prognosis in prostate cancer and to explore the predictive ability of additional factors. METHODS: All patients diagnosed with prostate cancer by physicians affiliated with Yale-New Haven Hospital during 1991 were eligible for the study. Patient and tumor characteristics at baseline were extracted from medical records with up to five-year follow-up for mortality. The original system was validated using Cox proportional hazards analysis and conjunctive consolidation. Prostate specific antigen (PSA) and Gleason score were also explored as factors to be included in an updated staging system. RESULTS: Five-year survival was 76% among 121 patients included in the study. The original staging system, when applied to the current cohort, was validated: Five-year survival ranged from 100% (low-risk) to 27% (high-risk). PSA and Gleason score were associated with survival but did not change results substantially in this population. CONCLUSION: By predicting distinct mortality outcomes in men with prostate cancer, prognostic staging systems can be used to help patients and physicians make informed treatment decisions.

Adult↗

Clinical epidemiological quality in molecular genetic research: the need for methodological standards.

CONTEXT: A genetic basis has been identified for many medical conditions and some molecular tests have been commercialized. However, little attention has been given to the quality of clinical epidemiology in molecular studies. OBJECTIVE: To examine the clinical epidemiological quality of recent publications on molecular genetic analysis. DESIGN: Cross-sectional study of original research articles published in 1995, identified by manually searching 4 general clinical journals. Of 83 articles identified, 40 were selected for analysis; these 40 discussed molecular genetic techniques, studied 10 or more patients, and had inferential conclusions. MAIN OUTCOME MEASURE: Compliance of the selected articles with 7 methodological standards for clinical epidemiological science (reproducibility, objectivity, delineation of case group, adequacy of spectrum in case group, delineation of comparison group, adequacy of comparison group, and quantitative summary of results). RESULTS: Among the 40 inferential articles that studied 10 or more patients, only 5 (12.5%) complied with all 7 applicable standards, and 10 (25.0%) complied with all but 1 standard, whereas 25 articles (62.5%) failed to comply with 2 or more standards and 9 (22.5%) failed 4 or 5 standards. Most articles did not comply with standards for reproducibility (n = 25, 62.5%) or objectivity (n = 27, 67.5%); however, the majority of articles did comply with standards for adequacy of case group (n = 35, 87.5 %), adequacy of comparison group (n = 35, 87.5%), and quantitative summary of results (n = 36, 90%). CONCLUSIONS: Despite major laboratory advances in molecular genetic analysis, our data suggest that reported applications in clinical journals often have troubling omissions, deficiencies, and lack of attention to the different, but necessary, principles of clinical epidemiological science. Without suitable attention to fundamental methodological standards, the expected benefits of molecular genetic testing may not be achieved.

Clinical Medicine↗

Differences in cervical cancer mortality among black and white women.

OBJECTIVE: To determine whether stage of disease and treatment patterns account for mortality differences between black and white women with cervical cancer. METHODS: Using data obtained from the Surveillance, Epidemiology, and End Results (SEER) Program for 1988-1994, we determined the associations between race and stage, and race and treatment. Racial differences in survival for up to 7 years of follow-up were adjusted for age, marital status, SEER location, International Federation of Gynecology and Obstetrics (FIGO) stage of disease, lymph node status, grade, histology, and treatment. RESULTS: Cumulative mortality was 36% (366 deaths in 1029 women) for black women and 24% (1215 deaths in 5021 women) for white women; unadjusted hazard ratio was 1.60 (95% confidence interval [CI] 1.43, 1.80). Black women were more likely to present with advanced disease than white women (43.8% compared with 34.8%). In a model adjusting for demographics and FIGO stage, the hazard ratio for black women compared with white women decreased to 1.35 (95% CI 1.19, 1.54). Treatment varied by race, with black women receiving surgery less often (33.5% compared with 48.2%, respectively) and radiation therapy more often (35.3% and 25.2%, respectively) than white women. In a comprehensive model including demographic factors, FIGO stage, other tumor characteristics, and treatment, the adjusted hazard ratio for mortality remained high for black women at 1.30 (95% CI 1.14, 1.48). CONCLUSION: Race remains an independent predictor of cervical cancer survival after accounting for age, stage of disease, treatment patterns, and other factors. Future studies should assess racial differences in clinical severity of disease, comorbidity, and socioeconomic status.

Adult↗

Alcohol use and functional disability among cognitively impaired adults.

BACKGROUND: The extent to which alcohol exposure increases risk for functional disability among older adults with cognitive impairment has not previously been assessed. OBJECTIVE: To examine the potential relationship between alcohol use and functional disability among older cognitively impaired adults. DESIGN: Retrospective medical record review. SETTING: Hospital-based geriatric assessment center. PARTICIPANTS: Two hundred forty-two consecutive participants with Mini-Mental Status Examination scores of < or = 24. MEASUREMENTS: Proxy-reported alcohol intake was classified in categories of never, former, light (< 1 drink/week), moderate (> or = 1 but < 14 drinks/week), and heavy (> or = 14 drinks/week) drinkers, and functional status was determined by proxy-reported performance in seven basic (BADL) and seven instrumental (IADL) activities of daily living (0 = poorest function and 14 = best function). RESULTS: Compared with never drinkers, moderate drinkers demonstrated higher mean BADL (12.2 vs 11.4, P = .033) and IADL scores (6.6 vs 5.6, P = .067), whereas heavy drinkers had higher BADL (12.8 vs 11.4, P = .019) but lower IADL scores (4.8 vs 5.6, P = .425). Former drinkers demonstrated both lower BADL (10.8 vs 11.4, P = .107) and IADL scores (3.9 vs 5.6, P = .011) compared with never drinkers. Evaluation of a potential dose-response effect was limited due to low numbers of light and heavy drinkers. CONCLUSIONS: Among cognitively impaired adults, moderate and heavy drinkers demonstrated better BADL function, whereas former drinkers had poorer IADL function, compared with never drinkers. Prospective studies that incorporate additional measures of exposure (e.g., cumulative lifetime consumption) and function (e.g., performance-based tests) may provide a more comprehensive understanding of alcohol's effects among older cognitively impaired adults.

Activities of Daily Living↗