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1.
Ann Oncol ; 17(6): 986-9, 2006 Jun.
Article in English | MEDLINE | ID: mdl-16533874

ABSTRACT

BACKGROUND: Zoledronic acid reduces skeletal-related events associated with prostate cancer and has long-term efficacy in pain outcomes. Findings of treatment group differences in pain early in treatment are less reliable. We used a recently recommended analytic approach to examine the effect of zoledronic acid on pain. MATERIALS AND METHODS: In a trial of zoledronic acid (n = 214) versus placebo (n = 208), we used the Brief Pain Inventory to assess pain at baseline, 3 weeks, 6 weeks and every 6 weeks thereafter for a total of 60 weeks. We used a modified longitudinal rank test to determine whether clinically meaningful changes in pain were related to treatment group. RESULTS: Seventy-six of 214 patients (35.5%) receiving zoledronic acid and 62 of 208 patients (29.8%) receiving placebo completed the 60-week visit (P = 0.22). In all 11 pain assessments, patients receiving zoledronic acid reported more favorable, clinically meaningful changes in pain scores. Overall, patients receiving zoledronic acid had a 33% chance of a favorable response, compared with 25% for patients receiving placebo (P = 0.04; 95% CI 0.5% to 15.6%). CONCLUSIONS: Zoledronic acid was more likely than placebo to be associated with clinically meaningful reductions in pain. Thus, zoledronic acid may help to avert the pain experienced by patients with progressing metastatic disease secondary to prostate cancer.


Subject(s)
Bone Density Conservation Agents/therapeutic use , Bone Neoplasms/physiopathology , Bone Neoplasms/secondary , Diphosphonates/therapeutic use , Imidazoles/therapeutic use , Pain/prevention & control , Prostatic Neoplasms/physiopathology , Aged , Aged, 80 and over , Diphosphonates/administration & dosage , Humans , Imidazoles/administration & dosage , Infusions, Intravenous , Male , Pain Measurement , Placebos , Prostatic Neoplasms/pathology , Zoledronic Acid
2.
Ann Oncol ; 16(4): 579-84, 2005 Apr.
Article in English | MEDLINE | ID: mdl-15734776

ABSTRACT

BACKGROUND: We examined the clinical relevance of skeletal-related events (SREs) for health state preferences, pain and health-related quality of life in patients with advanced prostate cancer and a history of bone metastases. PATIENTS AND METHODS: Data were from a clinical trial of zoledronic acid versus placebo in the treatment of SREs associated with advanced prostate cancer metastatic to bone. Patients (n=248) were included if they experienced an SRE during the study. Outcome measures were assessed at fixed intervals. We used mixed-effects models to estimate changes in outcomes after each patient's first SRE. RESULTS: There were clinically meaningful and statistically significant declines in physical well-being after: radiation and pathologic fractures; functional well-being after radiation; and emotional well-being after radiation and pathologic fractures. There also were meaningful and significant declines in preference and utility scores after radiation and fracture. Pain intensity declined after radiation, but not after other SREs; no other pain measure changed substantively. CONCLUSIONS: SREs have important and significant effects on measures of health-related quality of life in men with prostate cancer. Treatments that prevent SREs may not demonstrate corresponding effects on outcomes if the effects of SREs occur between scheduled outcome assessments. Implications for trial design are discussed.


Subject(s)
Bone Neoplasms/pathology , Bone Neoplasms/secondary , Prostatic Neoplasms/pathology , Quality of Life , Aged , Humans , Male , Randomized Controlled Trials as Topic/methods
3.
Theor Med Bioeth ; 24(4): 329-44, 2003.
Article in English | MEDLINE | ID: mdl-14620488

ABSTRACT

The ethical treatment of cancer patients participating in clinical trials requires that patients are well-informed about the potential benefits and risks associated with participation. When patients enrolled in phase I clinical trials report that their chance of benefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type (e.g., "On average, 5 out of every 100 patients will benefit") can be confused with expressions of uncertainty of the belief type (e.g., "The chance that I will benefit is about 80%"). Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subserve multiple speech acts, some of which may be indirect. For example, a patient reporting a high expected benefit may be reporting a belief about the future, reassuring family members, and/or attempting to improve his or her outcome by a public assertion of optimism. These sources of linguistic confusion should be considered in judging whether the patient's reported expectation is grounds for a bioethical concern that there has been a failure in the informed consent process.


Subject(s)
Clinical Trials, Phase I as Topic/ethics , Comprehension , Informed Consent/ethics , Patients/psychology , Physician-Patient Relations/ethics , Colonic Neoplasms/drug therapy , Colonic Neoplasms/psychology , Female , Humans , Linguistics , Liver Neoplasms/drug therapy , Liver Neoplasms/psychology , Liver Neoplasms/secondary , Lung Neoplasms/drug therapy , Lung Neoplasms/psychology , Lung Neoplasms/secondary , Middle Aged , Risk Assessment , Treatment Outcome , Uncertainty
4.
Bone Marrow Transplant ; 29(2): 159-64, 2002 Jan.
Article in English | MEDLINE | ID: mdl-11850711

ABSTRACT

Filgrastim alone and sequential sargramostim and filgrastim have been shown to be more effective than sargramostim alone in the mobilization of CD34(+) cells after myelosuppressive chemotherapy (MC). We sought to compare costs and resource use associated with these regimens. Data were collected prospectively alongside a multicenter, randomized trial of filgrastim, sargramostim, and sequential sargramostim and filgrastim. Direct medical costs were calculated for inpatient and outpatient visits and procedures, including administration of growth factors and MC. We followed 156 patients for 30 days or until initiation of high-dose chemotherapy. The main outcome measures were resource use and costs of inpatient and outpatient visits, platelet and red blood cell transfusions, antibiotic use, and apheresis procedures. Hospital admissions, red blood cell transfusions, and use of i.v. antibiotics were significantly more common in the sargramostim group than in the other treatment arms. In univariate and multivariable analyses, total costs were higher for patients receiving sargramostim alone than for patients in the other groups. Mean costs in multivariable analysis for the filgrastim and sequential sargramostim and filgrastim arms were not significantly different. Filgrastim alone and sequential sargramostim and filgrastim are less costly than sargramostim alone after MC, as well as therapeutically more beneficial.


Subject(s)
Antineoplastic Agents/economics , Drug Costs , Granulocyte Colony-Stimulating Factor/economics , Granulocyte-Macrophage Colony-Stimulating Factor/economics , Adult , Antineoplastic Agents/therapeutic use , Breast Neoplasms/therapy , Costs and Cost Analysis , Drug Costs/statistics & numerical data , Drug Therapy, Combination , Female , Filgrastim , Granulocyte Colony-Stimulating Factor/therapeutic use , Granulocyte-Macrophage Colony-Stimulating Factor/therapeutic use , Health Care Costs/statistics & numerical data , Humans , Immunosuppressive Agents/economics , Immunosuppressive Agents/therapeutic use , Lymphoma/therapy , Male , Middle Aged , Randomized Controlled Trials as Topic , Recombinant Proteins
5.
Am Heart J ; 142(3): 516-9, 2001 Sep.
Article in English | MEDLINE | ID: mdl-11526367

ABSTRACT

BACKGROUND/OBJECTIVE: Our purpose was to evaluate the effectiveness of reperfusion therapy among elderly paced patients with acute myocardial infarction (MI). Current guidelines make no recommendation for the use of reperfusion therapy among patients who have a paced rhythm during MI. METHODS: We evaluated 1954 Medicare beneficiaries 65 years and older treated for acute MI between 1994 and 1996 who had a paced rhythm for use of reperfusion therapy. Use of reperfusion therapy was evaluated for associations with outcomes by logistic regression and Cox proportional hazards models incorporating propensity score analysis. RESULTS: Reperfusion therapy was used in 171 (8.8%) patients; 70 were treated with primary PTCA and 101 with thrombolytic therapy. Patients who received reperfusion therapy had 30-day mortality rates similar to those who did not receive reperfusion (26.3% vs 25.7%, P =.87). Multivariate adjustment for mortality risk factors and treatment propensity indicated no survival benefit associated with reperfusion therapy at 30 days (relative risk [RR] 1.07, 95% confidence interval [CI] 0.77-1.43) or long-term follow-up (hazard ratio [HR] 0.86, 95% CI 0.68-1.10). Mortality risks varied by type of reperfusion therapy. Patients treated with primary percutaneous transluminal coronary angioplasty were at comparable risk of mortality at 30 days (RR 0.73, 95% CI 0.40-1.23) but at lower risk at long-term follow-up (HR 0.60, 95% CI 0.40-0.88). Mortality risks were unchanged among patients treated with thrombolytics at 30 days (RR 1.32, 95% CI 0.92-1.79) and long-term follow-up (HR 1.08, 95% CI 0.82-1.43). CONCLUSION: We find suggestive evidence that primary percutaneous transluminal coronary angioplasty provides a long-term survival benefit in the treatment of elderly patients with acute MI who have a paced rhythm.


Subject(s)
Angioplasty, Balloon, Coronary , Myocardial Infarction/therapy , Myocardial Reperfusion , Age Factors , Aged , Aged, 80 and over , Electrocardiography , Female , Humans , Male , Medicare , Myocardial Infarction/pathology , Retrospective Studies , Survival Analysis , Treatment Outcome , United States
6.
Nephrol Dial Transplant ; 16(5): 1028-33, 2001 May.
Article in English | MEDLINE | ID: mdl-11328911

ABSTRACT

BACKGROUND: Immunosuppressive therapy with cyclosporin A has substantially improved clinical outcomes for renal transplantation. Whether basiliximab (a chimeric monoclonal antibody) demonstrates economic and quality-of-life advantages over other induction therapies has not yet been shown. METHODS: A multi-centre open-label clinical trial was conducted among renal transplant recipients in the US, in which patients were randomized into two induction therapy regimens: basiliximab and antithymocyte globulin (ATG) as part of a quadruple immunosuppressive regimen. Medical resources used and a EuroQol visual analogue scale (VAS) rating of quality of life were collected prospectively for the 135 dosed subjects for a period of 1 year post-treatment. We analysed the differences between treatment groups in 1-year costs and 1-year quality-adjusted survival. We also conducted a post hoc analysis of outcomes among the subgroup of patients identified as high risk. RESULTS: A significant difference was observed in first-year post-treatment costs (basiliximab, $45857; ATG, $54729; difference, $8872 (95% CI, $1169 to $16573). The savings from basiliximab can be attributed to the less expensive induction therapy (basiliximab, $2378; ATG, $8670; difference, $6292 (95% CI, $5165 to $7419)) and other savings during the initial hospitalization totalling $2609. One-year quality-adjusted survival was the same in both groups (basiliximab, 81.5; ATG, 81.1; difference, 0.45 (95% CI, -5.9 to 6.8)). The results of the post hoc analysis of the 48 high-risk patients were comparable to the analysis of all patients. CONCLUSIONS: These results demonstrate lower first-year post-treatment costs in renal-transplant recipients receiving basiliximab compared to ATG with no differences in quality-adjusted survival. The results also suggest similar differences among high-risk subjects.


Subject(s)
Antibodies, Monoclonal/economics , Antibodies, Monoclonal/therapeutic use , Antilymphocyte Serum/economics , Antilymphocyte Serum/therapeutic use , Drug Costs , Immunosuppressive Agents/therapeutic use , Kidney Transplantation , Quality of Life , Recombinant Fusion Proteins , Basiliximab , Economics , Female , Humans , Male , Middle Aged , Risk Factors , Survival Analysis
7.
J Soc Psychol ; 141(1): 101-10, 2001 Feb.
Article in English | MEDLINE | ID: mdl-11294145

ABSTRACT

The authors presented, as a case study of methodological challenges in cross-cultural research, E. S. Bogardus's (1925) Social Distance Scale, which requires respondents to indicate the social distance between themselves and others. The meaningfulness of the scale depends on the assumption that respondents believe that the magnitude of social distance increases as one moves through the social categories of family member, friend, neighbor, coworker, and citizen. The authors tested this assumption for English Canadian, French Canadian, Jewish, Indian, Algerian, and Greek participants, all 1st-generation immigrants in Montreal. The participants rated their willingness to associate with members of each of the other ethnic groups in 5 social categories. The percentage of respondents in each sample whose data conformed to the prediction ranged from 63.7% to 98.0%, with English Canadian, French Canadian, and Jewish respondents providing responses most consistent with the predicted pattern. The Indian and Algerian respondents' data were the least consistent with the predicted pattern, especially when rating members of their own ethnic groups.


Subject(s)
Cultural Diversity , Emigration and Immigration , Ethnicity/psychology , Psychological Distance , Adult , Female , Humans , Male , Personality Assessment , Quebec
8.
Ann Intern Med ; 134(8): 644-51, 2001 Apr 17.
Article in English | MEDLINE | ID: mdl-11304104

ABSTRACT

BACKGROUND: A paced rhythm can mask the electrocardiographic features of an acute myocardial infarction, complicating timely recognition and treatment. OBJECTIVE: To evaluate characteristics, treatment, and outcomes among patients presenting with paced rhythms during myocardial infarction. DESIGN: Retrospective cohort study. SETTING: U.S. acute care hospitals. PATIENTS: 102 249 Medicare beneficiaries at least 65 years of age who were treated for acute myocardial infarction between 1994 and 1996. MEASUREMENTS: Provision of three treatments for acute myocardial infarction (emergent reperfusion, aspirin, and beta-blockers), death at 30 days, and long-term follow-up. RESULTS: 1954 patients (1.9%) presented with paced rhythms during myocardial infarction. These patients were older; were predominantly male; and had higher rates of congestive heart failure, diabetes, and previous infarction. They were significantly less likely to receive emergent reperfusion (relative risk [RR], 0.27 [95% CI, 0.22 to 0.33]), aspirin (RR at admission, 0.91 [CI, 0.88 to 0.94]; RR at discharge, 0.87 [CI, 0.83 to 0.92]), and beta-blockers at admission (RR, 0.89 [CI, 0.82 to 0.96]). In addition, there was a trend toward decreased use of beta-blockers at discharge (RR, 0.91 [CI, 0.76 to 1.06]). Crude mortality rates were higher among patients with paced rhythms than among those without at 30 days (25.8% vs. 21.3%; P = 0.001) and at 1 year (47.1% vs. 36.1%; P = 0.001). Among patients with paced rhythms, risk for death at 30 days decreased after adjustment for illness severity and decreased use of therapy (RR, 1.03 [CI, 0.93 to 1.14]). Patients with paced rhythms remained at additional risk for long-term mortality (hazard ratio, 1.12 [CI, 1.06 to 1.18]). CONCLUSIONS: Patients with paced rhythms were less likely than those without to receive treatment for acute myocardial infarction and had poorer short- and long-term outcomes. However, this mortality risk diminished after adjustment for treatment. This suggests that improved recognition and treatment of myocardial infarction may improve outcomes, particularly in the short term.


Subject(s)
Cardiac Pacing, Artificial , Myocardial Infarction/diagnosis , Myocardial Infarction/therapy , Adrenergic beta-Antagonists/therapeutic use , Aged , Aged, 80 and over , Angioplasty, Balloon, Coronary , Aspirin/therapeutic use , Female , Fibrinolytic Agents/therapeutic use , Follow-Up Studies , Hospital Mortality , Humans , Male , Myocardial Infarction/mortality , Myocardial Infarction/physiopathology , Proportional Hazards Models , Regression Analysis , Retrospective Studies , Thrombolytic Therapy , Treatment Outcome
9.
Am Heart J ; 141(1): 47-54, 2001 Jan.
Article in English | MEDLINE | ID: mdl-11136486

ABSTRACT

BACKGROUND: Although second- and third-degree heart block (HB) are common conduction disorders associated with acute myocardial infarction (MI), patient characteristics and HBs association with outcomes, particularly among the elderly, remain poorly defined. METHODS: We evaluated 106,780 Medicare beneficiaries aged 65 years and older treated for acute MI between January 1994 and February 1996 for development of HB. HB and non-HB patients were compared by univariate analysis, and the influence of HB on outcomes was evaluated by unadjusted and multiple logistic regression. RESULTS: HB was documented in 5048 (4.7%) patients; 1646 presented with HB and 3402 developed HB during hospitalization. HB was more common among patients with inferior infarctions than anterior infarctions (7.3% vs 3.0%, P =.001), particularly the cohort of patients with inferior MI treated with reperfusion therapy (8.3%). HB patients had higher rates of in-hospital mortality (29.6% vs. 17.5% vs. non-HB patients, P =.001). After adjustment for demographic and clinical factors, HB remained an independent predictor of in-hospital mortality (relative risk [RR] 1.41, 95% confidence interval [CI] 1. 34-1.48), but HB had no prognostic significance at 1 year among hospital survivors (RR 0.94, 95% CI 0.88-1.01). Mortality risks varied on the basis of MI location. Both anterior MI (RR 1.46, 95% CI 1.30-1.63) and inferior MI (RR 1.52, 95% CI 1.39-1.66) patients with HB had increased risks of in-hospital mortality. There was a trend toward increased mortality among patients with anterior MI (RR 1.15, 95% CI 0.99-1.32) at 1 year, whereas those with inferior MI were at lower risk (RR 0.83, 95% CI 0.75-0.98). CONCLUSIONS: HB is a common complication of acute MI in elderly patients, particularly among patients with inferior MIs who received reperfusion therapy. HB is independently associated with short-term but not long-term mortality.


Subject(s)
Heart Block/epidemiology , Heart Block/etiology , Myocardial Infarction/complications , Age Factors , Aged , Female , Humans , Male , Prevalence , Prognosis
10.
Circulation ; 102(14): 1651-6, 2000 Oct 03.
Article in English | MEDLINE | ID: mdl-11015343

ABSTRACT

BACKGROUND: Although prompt treatment is a cornerstone of the management of acute myocardial infarction (AMI), prior studies have shown that one fourth of AMI patients arrive at the hospital >6 hours after symptom onset. It would be valuable to identify individuals at highest risk for late arrival, but predisposing factors have yet to be fully characterized. METHODS AND RESULTS: Data from the Cooperative Cardiovascular Project, involving Medicare beneficiaries aged >65 years hospitalized between January 1994 and February 1996 with confirmed AMI, were used to identify patients who presented "late" (>/=6 hours after symptom onset). Patient characteristics were tested for associations with late presentation by use of backward stepwise logistic regression. Among 102 339 subjects, 29.4% arrived late. Significant predictors of late arrival (odds ratio, 95% CI) included diabetes (1.11, 1.07 to 1.14) and a history of angina (1.32, 1.28 to 1.35), whereas prior MI (0.82, 0.79 to 0.85), prior angioplasty (0.80, 0.75 to 0.85), prior bypass surgery (0.93, 0.89 to 0.98), and cardiac arrest (0.52, 0.46 to 0. 58) predicted early presentation. Additionally, initial evaluation at an outpatient clinic (2.63, 2.51 to 2.75) and daytime presentation (1.67, 1.59 to 1.72) predicted late arrival. Finally, female sex, black race, and poverty, which were evaluated with an 8-level race-sex-socioeconomic status interaction term, were also risk factors for delay. CONCLUSIONS: Delayed hospital presentation is a common problem among Medicare beneficiaries with AMI. Factors associated with delay include not only clinical and logistical issues but also race, sex, and socioeconomic characteristics. Education efforts designed to hasten AMI treatment should be directed at individuals with risk factors for late arrival.


Subject(s)
Myocardial Infarction/physiopathology , Acute Disease , Aged , Emergency Medical Services , Female , Humans , Logistic Models , Male , Myocardial Infarction/epidemiology , Myocardial Infarction/genetics , Racial Groups , Risk Factors , Sex Factors , Social Class , Time Factors
11.
Circulation ; 102(6): 642-8, 2000 Aug 08.
Article in English | MEDLINE | ID: mdl-10931804

ABSTRACT

BACKGROUND: Race, sex, and poverty are associated with the use of diagnostic cardiac catheterization and coronary revascularization during treatment of acute myocardial infarction (AMI). However, the association of sociodemographic characteristics with the use of less costly, more readily available medical therapies remains poorly characterized. METHODS AND RESULTS: We evaluated 169 079 Medicare beneficiaries >/=65 years of age treated for AMI between January 1994 and February 1996 to determine the association of patient race, sex, and poverty with the use of medical therapy. Multivariable regression models were constructed to evaluate the unadjusted and adjusted influence of sociodemographic characteristics on the use of 2 admission (aspirin, reperfusion) and 2 discharge therapies (aspirin, beta-blockers) indicated during the treatment of AMI. Therapy use varied by patient race, sex, and poverty status. Black patients were less likely to undergo reperfusion (RR 0.84, 95% CI 0. 78, 0.91) or receive aspirin on admission (RR 0.97, 95% CI 0.96, 0. 99) and beta-blockers (RR 0.94, 95% CI 0.88, 1.00) at discharge. Female patients were less likely to receive aspirin on admission (RR 0.98, 95% CI 0.97, 0.99) and discharge (RR 0.98, 95% CI 0.96, 0.99). Poor patients were less likely to receive aspirin (RR 0.97, 95% CI 0. 96, 0.98) or reperfusion (RR 0.97, 95% CI 0.93, 1.00) on admission and aspirin (RR 0.98, 95% CI 0.96, 1.00), or beta-blockers (RR 0.95, 95% CI 0.91, 0.99) on discharge. CONCLUSIONS: Medical therapies are currently underused in the treatment of black, female, and poor patients with AMI.


Subject(s)
Black or African American , Health Services Misuse , Myocardial Infarction/therapy , Poverty , Sex Factors , White People , Aged , Aged, 80 and over , Female , Humans , Male , Myocardial Infarction/ethnology
12.
Am J Med ; 108(7): 561-6, 2000 May.
Article in English | MEDLINE | ID: mdl-10806285

ABSTRACT

PURPOSE: Although previous studies have examined race and sex differences in health care, few studies have investigated the possible role of physician bias. We evaluated the influence of race and sex on medical students' perceptions of patients' symptoms to determine if there are differences in these perceptions early in medical training. SUBJECTS AND METHODS: One-hundred sixty-four medical students were randomly assigned to view a video of a black female or white male actor portraying patients with identical symptoms of angina. We evaluated students' perceptions of the actors' health state (based on their assessment of quality of life) using a visual analog scale and a standard rating technique, as well as the type of chest pain diagnosis. RESULTS: Students assigned a lower value (indicating a less desirable health state) to the black woman than to the white man with identical symptoms [visual scale (mean +/- SD): 72 +/- 13 vs 67 +/- 12, P <0.02; standard gamble: 87 +/- 10 vs 80 +/- 15, P < 0.001). Nonminority students reported higher mean values for the white male patient (standard gamble: 89 +/- 8 vs 81 +/- 14 for the black female patient), whereas minority students' assessments did not differ by patient. Male students assigned a slightly lower value to the black female patient (standard gamble: 76 +/- 16 vs 87 +/- 10 for the white male patient). Students were less likely to characterize the black female patient's symptoms as angina (46% vs 74% for the white male patient, P = 0.001). CONCLUSIONS: The way that medical students perceive patient symptoms appears to be affected by nonmedical factors.


Subject(s)
Black People , Health Status , Quality of Life , Sex Factors , Students, Medical/statistics & numerical data , White People , Adult , Analysis of Variance , Female , Humans , Male , Surveys and Questionnaires , United States
13.
Am Heart J ; 139(4): 649-53, 2000 Apr.
Article in English | MEDLINE | ID: mdl-10740147

ABSTRACT

BACKGROUND: Women have worse outcomes after myocardial infarction and coronary revascularization. The explanations are likely multifactorial but may include smaller coronary artery size. Smaller luminal diameter has been confirmed angiographically; however, because of possible confounding effects of coronary remodeling, angiographically silent atherosclerosis, and body size, it is unclear if there is a true sex influence on arterial size. METHODS: We performed intravascular ultrasound on left main (LM) and proximal left anterior descending (LAD) coronary artery segments that were free of significant atherosclerosis in 50 men and 25 women. Arterial and luminal areas were measured by planimetry and corrected for body surface area. We evaluated associations between sex and coronary dimensions with univariate and then multiple linear regression analyses. RESULTS: Mean uncorrected LM and LAD arterial areas were smaller in women than in men (21.53 vs 26.95 mm(2), P <.001, and 14. 68 vs 19.94 mm(2), P =.002, respectively), as were mean LM and LAD luminal areas (15.94 vs 18.79 mm(2), P =.020, and 10.13 vs 12.71 mm(2), P =.036, respectively). In multivariate models accounting for body surface area and controlling for other factors, sex independently predicted corrected LM and LAD arterial area. In analyses that additionally controlled for plaque area, sex independently predicted corrected LAD luminal area. CONCLUSIONS: LM and LAD arteries are smaller in women, independent of body size. This suggests an intrinsic sex effect on coronary dimensions. Future studies should investigate underlying mechanisms because they may lead to novel therapeutic strategies and improved outcomes for women with coronary artery disease.


Subject(s)
Coronary Vessels/diagnostic imaging , Sex Characteristics , Ultrasonography, Interventional , Adult , Aged , Coronary Artery Disease/diagnostic imaging , Female , Humans , Hypertension/diagnostic imaging , Male , Middle Aged , Prognosis , Reference Values , Regression Analysis
14.
Circulation ; 101(9): 969-74, 2000 Mar 07.
Article in English | MEDLINE | ID: mdl-10704162

ABSTRACT

BACKGROUND: Although atrial fibrillation (AF) is a common complication of acute myocardial infarction (MI), patient characteristics and association with outcomes remain poorly defined in the elderly. METHODS AND RESULTS: We evaluated 106 780 Medicare beneficiaries > or =65 years of age from the Cooperative Cardiovascular Project treated for acute MI between January 1994 and February 1996 to determine the prevalence and prognostic significance of AF complicating acute MI in elderly patients. Patients were categorized on the basis of the presence of AF, and those with AF were further subdivided by time of AF (present on arrival versus developing during hospitalization). AF and non-AF patients were compared by univariate analysis, and logistic regression modeling was used to identify clinical predictors of AF. The influence of AF on outcomes was evaluated by unadjusted Kaplan-Meier survival curves and logistic regression models. AF was documented in 23 565 patients (22. 1%): 11 510 presented with AF and 12,055 developed AF during hospitalization. AF patients were older, had more advanced heart failure, and were more likely to have had a prior MI and undergone coronary revascularization. AF patients had poorer outcomes, including higher in-hospital (25.3% versus 16.0%), 30-day (29.3% versus 19.1%), and 1-year (48.3% versus 32.7%) mortality. AF remained an independent predictor of in-hospital (odds ratio [OR], 1. 21), 30-day (OR, 1.20), and 1-year (OR, 1.34) mortality after multivariate adjustment. Patients developing AF during hospitalization had a worse prognosis than patients who presented with AF. CONCLUSIONS: AF is a common complication of acute MI in elderly patients and independently influences mortality, particularly when it develops during hospitalization.


Subject(s)
Atrial Fibrillation/etiology , Myocardial Infarction/complications , Aged , Aged, 80 and over , Atrial Fibrillation/epidemiology , Cohort Studies , Female , Hospital Mortality , Hospitalization , Humans , Male , Myocardial Infarction/mortality , Myocardial Infarction/surgery , Myocardial Revascularization , Prevalence , Prognosis , Regression Analysis , Survival Analysis
15.
Med Care ; 38(4): 404-10, 2000 Apr.
Article in English | MEDLINE | ID: mdl-10752972

ABSTRACT

BACKGROUND: Although surrogate markers such as CD4 counts and viral burden (HIV-1 RNA) are predictive of AIDS-related disease progression, little is known about the relationship between changes in surrogate markers and health-related quality of life (HRQOL) outcomes. This study investigated how changes in CD4/mm3 and viral burden (RNA copies/mL) are related to changes in HRQOL as indexed by the Medical Outcomes Study HIV Health Survey (MOS-HIV-30). METHODS: Subjects were HIV-1-infected patients with CD4 counts <300/mm3 enrolled in a double-blind, randomized clinical trial of delavirdine. As part of the clinical protocol, patients completed the MOS-HIV-30, from which the Physical Health (PHS) and Mental Health (MHS) summary scores were used for analyses. HRQOL and surrogate marker data assessed up to 2 years after randomization were analyzed for a total of 1,112 patients. RESULTS: Individual patients' initial status (intercepts) and rates of change (slopes) over time for log CD4, log RNA, PHS, and MHS were estimated with the use of empirical Bayes. Early response to treatment correlated with HRQOL better for RNA than for CD4. However, the relationship between weekly change and HRQOL was stronger for CD4 than for RNA. CONCLUSIONS: Surrogate markers are significantly associated with HRQOL outcomes. Improvements in HRQOL over time are associated with lower initial viral load and with increases in CD4 counts. Limitations concerning the restricted variability of the change scores are addressed.


Subject(s)
CD4 Lymphocyte Count , HIV Infections/diagnosis , HIV-1 , Quality of Life , Viral Load , Adult , Aged , Anti-HIV Agents/therapeutic use , Delavirdine/therapeutic use , Didanosine/therapeutic use , Double-Blind Method , Drug Therapy, Combination , Female , HIV Infections/drug therapy , HIV Infections/psychology , Health Status Indicators , Humans , Male , Middle Aged , RNA, Viral/blood
16.
Arch Intern Med ; 159(19): 2263-70, 1999 Oct 25.
Article in English | MEDLINE | ID: mdl-10547165

ABSTRACT

BACKGROUND: Some physicians may resort to deception to secure third-party payer approval for patient procedures. Related physician attitudes, including willingness to use deception, are not well understood. OBJECTIVE: To determine physician willingness to deceive a third-party payer and physician attitudes toward deception of third-party payers. METHODS: A cross-sectional mailed survey was used to evaluate physician willingness to use deception in 6 vignettes of varying clinical severity: coronary bypass surgery, arterial revascularization, intravenous pain medication and nutrition, screening mammography, emergent psychiatric referral, and cosmetic rhinoplasty. We evaluated 169 board-certified internists randomly selected from 4 high- and 4 low-managed care penetration metropolitan markets nationwide for willingness to use deception in each vignette. RESULTS: Physicians were willing to use deception in the coronary bypass surgery (57.7%), arterial revascularization (56.2%), intravenous pain medication and nutrition (47.5%), screening mammography (34.8%), and emergent psychiatric referral (32.1%) vignettes. There was little willingness to use deception for cosmetic rhinoplasty (2.5%). Rates were highest for physicians practicing in predominantly managed care markets, for clinically severe vignettes, and for physicians spending less time in clinical practice. Physician ratings of the justifiability of deception varied by perspective and vignette. CONCLUSIONS: Many physicians sanction the use of deception to secure third-party payers' approval of medically indicated care. Such deception may reflect a tension between the traditional ethic of patient advocacy and the new ethic of cost control that restricts patient and physician choice in the use of limited resources.


Subject(s)
Attitude of Health Personnel , Conflict of Interest , Cost Control , Deception , Ethics, Medical , Insurance, Health, Reimbursement , Managed Care Programs , Patient Advocacy , Physicians , Analgesics/administration & dosage , Humans , Injections, Intravenous , Mammography , Psychiatry , Referral and Consultation , Resource Allocation , Surgical Procedures, Operative , United States
18.
Qual Life Res ; 8(1-2): 17-24, 1999.
Article in English | MEDLINE | ID: mdl-10457735

ABSTRACT

Little research has been conducted towards the development and evaluation of a measure of quality of life specific to head/brain injury populations. Accordingly, we examined responses to the Neurobehavioral Functioning Inventory in the context of a clinical trial for head injury patients (n = 655) conducted in 14 countries. To reduce the 66 item scale into a smaller number of composite scales, principal components analysis was conducted. Scales were constructed assessing four categories of symptoms: cognitive deficits, depression, aggression and somatization. The internal reliabilities (alpha coefficient) of the four scales were generally acceptable (range = 0.79-0.92). Scores on all four scales correlated significantly with patient-rated overall quality of life and all but the aggression scale correlated significantly with overall clinical severity. The need for more formal evaluation of this and other disease-specific measures is discussed.


Subject(s)
Craniocerebral Trauma/psychology , Health Status , Neuropsychological Tests/standards , Quality of Life , Surveys and Questionnaires/standards , Activities of Daily Living , Adult , Aggression/psychology , Analysis of Variance , Craniocerebral Trauma/physiopathology , Factor Analysis, Statistical , Female , Humans , Male , Mental Health , Reproducibility of Results , Severity of Illness Index
19.
Addict Behav ; 21(5): 615-32, 1996.
Article in English | MEDLINE | ID: mdl-8876761

ABSTRACT

Relations between adolescents' substance use and perceptions of their friends' substance use were examined cross-sectionally and longitudinally in a predominantly African-American school district. Fourth- and fifth-grade students were surveyed and tracked for 4 consecutive years. Cross-sectional samples included 3,073, 5,955, 7,701, and 6,616 students in years 1 to 4, respectively; the longitudinal sample included 1,802 students surveyed in every year. Self-reported substance use of friends and classmates also was assessed. Perceived friends' substance use had a stronger association with prior substance use than friends' self-reported substance use in every year. Perceived family use and classmates' self-reported use also made independent contributions to regression models. Longitudinal structural equation analyses indicated that perceived friends' use is more likely to be a product of an adolescent's previous substance use than a precursor of subsequent substance use. The findings contradict prevailing theories on the influence of peers on substance use.


Subject(s)
Black or African American/statistics & numerical data , Peer Group , Social Control, Informal , Social Perception , Substance-Related Disorders/epidemiology , Age Factors , Alcohol Drinking/epidemiology , Alcohol Drinking/psychology , Chi-Square Distribution , Child , Cross-Sectional Studies , Family Health , Female , Humans , Likelihood Functions , Longitudinal Studies , Male , Marijuana Smoking/epidemiology , Marijuana Smoking/psychology , Models, Psychological , Multivariate Analysis , Odds Ratio , Regression Analysis , Sampling Studies , Smoking/epidemiology , Smoking/psychology , Substance-Related Disorders/etiology , Urban Health
20.
J Stud Alcohol ; 57(3): 273-82, 1996 May.
Article in English | MEDLINE | ID: mdl-8709586

ABSTRACT

OBJECTIVE: This study investigated the prevalence of logical and estimation errors in a 4-year longitudinal survey of substance abuse for elementary and junior high school students. Logical errors occur when a subject reports having used a substance on one measurement occasion, but reports never having used the substance on a second measurement occasion. Estimation errors occur when a subject reports a lifetime frequency of use on a later survey that is less than the lifetime frequency of use reported for an earlier survey. METHOD: Substance abuse surveys were completed every year for four years by predominantly black District of Columbia students, beginning when the students were in 4th/5th grade, and ending when they were in 7th/8th grade. (Ns ranged from 5,671 to 6,421). Errors for alcohol, cigarette and marijuana use were calculated for every pair of years. Background characteristics such as demographic and academic performance variables were also assessed for each of the four years. RESULTS: Logical errors decreased for all substances as student got older, whereas estimation errors remained stable. Marijuana had the highest frequency of logical errors in every pair of years except one, and had the lowest frequency of estimation errors. Students who made errors in Years 1-2 were 1.64 times more likely to make errors again in Years 3-4. For some of the years, students who made any kind of error had lower school grades, were judged untrustworthy by their peers and were more likely to be males. CONCLUSIONS: The alarming prevalence of errors should be considered when conducting longitudinal substance abuse research. Several methods of dealing with these errors are reviewed. In most cases, the best a researcher can do is assess the error rates and report them.


Subject(s)
Cannabis , Substance-Related Disorders , Child , Humans , Longitudinal Studies , Research
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