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1.
Am Heart J ; 224: 148-155, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32402701

RESUMO

BACKGROUND: Multiple modern Indian hospitals operate at very low cost while meeting US-equivalent quality accreditation standards. Though US hospitals face intensifying pressure to lower their cost, including proposals to extend Medicare payment rates to all admissions, the transferability of Indian hospitals' cost advantages to US peers remains unclear. METHODS: Using time-driven activity-based costing methods, we estimate the average cost of personnel and space for an elective coronary artery bypass graft (CABG) surgery at two American hospitals and one Indian hospital (NH). All three hospitals are Joint Commission accredited and have reputations for use of modern performance management methods. Our case study applies several analytic steps to distinguish transferable from non-transferable sources of NH's cost savings. RESULTS: After removing non-transferable sources of efficiency, NH's residual cost advantage primarily rests on shifting tasks to less-credentialed and/or less-experienced personnel who are supervised by highly-skilled personnel when perceived risk of complications is low. NH's high annual CABG volume facilitates such supervised work "downshifting." The study is subject to limitations inherent in case studies, does not account for the younger age of NH's patients, or capture savings attributable to NH's negligible frequency of re-admission or post-acute care facility placement. CONCLUSIONS: Most transferable bases for a modern Indian hospital's cost advantage would require more flexible American states' hospital and health professional licensing regulations, greater family participation in inpatient care, and stronger support by hospital executives and clinicians for substantially lowering the cost of care via regionalization of complex surgeries and weekend use of costly operating rooms.


Assuntos
Ponte de Artéria Coronária/economia , Doença da Artéria Coronariana/cirurgia , Procedimentos Cirúrgicos Eletivos/economia , Custos Hospitalares , Medicare/economia , Transferência de Pacientes/economia , Doença da Artéria Coronariana/economia , Feminino , Humanos , Índia , Masculino , Estados Unidos
2.
Ann Oncol ; 17(6): 986-9, 2006 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16533874

RESUMO

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.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Neoplasias Ósseas/fisiopatologia , Neoplasias Ósseas/secundário , Difosfonatos/uso terapêutico , Imidazóis/uso terapêutico , Dor/prevenção & controle , Neoplasias da Próstata/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Difosfonatos/administração & dosagem , Humanos , Imidazóis/administração & dosagem , Infusões Intravenosas , Masculino , Medição da Dor , Placebos , Neoplasias da Próstata/patologia , Ácido Zoledrônico
3.
Ann Oncol ; 16(4): 579-84, 2005 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-15734776

RESUMO

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.


Assuntos
Neoplasias Ósseas/patologia , Neoplasias Ósseas/secundário , Neoplasias da Próstata/patologia , Qualidade de Vida , Idoso , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
4.
Theor Med Bioeth ; 24(4): 329-44, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-14620488

RESUMO

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.


Assuntos
Ensaios Clínicos Fase I como Assunto/ética , Compreensão , Consentimento Livre e Esclarecido/ética , Pacientes/psicologia , Relações Médico-Paciente/ética , Neoplasias do Colo/tratamento farmacológico , Neoplasias do Colo/psicologia , Feminino , Humanos , Linguística , Neoplasias Hepáticas/tratamento farmacológico , Neoplasias Hepáticas/psicologia , Neoplasias Hepáticas/secundário , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/psicologia , Neoplasias Pulmonares/secundário , Pessoa de Meia-Idade , Medição de Risco , Resultado do Tratamento , Incerteza
5.
Bone Marrow Transplant ; 31(3): 205-10, 2003 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-12621482

RESUMO

We performed an economic analysis of data from 180 women in a clinical trial of conventional-dose chemotherapy vs high-dose chemotherapy plus stem-cell transplantation for metastatic breast cancer responding to first-line chemotherapy. Data on resource use, including hospitalizations, medical procedures, medications, and diagnostic tests, were abstracted from subjects' clinical trial records. Resources were valued using the Medicare Fee Schedule for inpatient costs at one academic medical center and average wholesale prices for medications. Monthly costs were calculated and stratified by treatment group and clinical phase. Mean follow-up was 690 days in the transplantation group and 758 days in the conventional-dose chemotherapy group. Subjects in the transplantation group were hospitalized for more days (28.6 vs 17.8, P=0.0041) and incurred higher costs (US dollars 84055 vs US dollars 28169) than subjects receiving conventional-dose chemotherapy, with a mean difference of US dollars 55886 (95% CI, US dollars 47298-US dollars 63666). Sensitivity analyses resulted in cost differences between the treatment groups from US dollars 36528 to US dollars 75531. High-dose chemotherapy plus stem-cell transplantation resulted in substantial additional morbidity and costs at no improvement in survival. Neither the survival results nor the economic findings support the use of this procedure outside of the clinical trial setting.


Assuntos
Antineoplásicos/economia , Neoplasias da Mama/terapia , Transplante de Células-Tronco/economia , Adulto , Antineoplásicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/economia , Neoplasias da Mama/patologia , Estudos de Coortes , Custos e Análise de Custo , Relação Dose-Resposta a Droga , Economia Hospitalar , Feminino , Humanos , Pessoa de Meia-Idade , Metástase Neoplásica , Seleção de Pacientes , Reprodutibilidade dos Testes , Estados Unidos
6.
Bone Marrow Transplant ; 29(2): 159-64, 2002 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-11850711

RESUMO

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.


Assuntos
Antineoplásicos/economia , Custos de Medicamentos , Fator Estimulador de Colônias de Granulócitos/economia , Fator Estimulador de Colônias de Granulócitos e Macrófagos/economia , Adulto , Antineoplásicos/uso terapêutico , Neoplasias da Mama/terapia , Custos e Análise de Custo , Custos de Medicamentos/estatística & dados numéricos , Quimioterapia Combinada , Feminino , Filgrastim , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Fator Estimulador de Colônias de Granulócitos e Macrófagos/uso terapêutico , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Imunossupressores/economia , Imunossupressores/uso terapêutico , Linfoma/terapia , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes
7.
Support Care Cancer ; 9(7): 545-51, 2001 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-11680835

RESUMO

Our goal was to calculate resource use associated with administration of zoledronic acid, compared with pamidronate, as palliative care for patients with metastatic bone lesions. We conducted a time-and-motion study of therapy administration at each of three outpatient chemotherapy infusion sites participating in clinical trials of zoledronic acid and pamidronate. We developed a data-collection instrument to record all staff effort and patient resource use in drug administration. The main outcome measures were (a) direct costs of therapy administration per patient and (b) opportunity benefits expressed as the availability of resources gained per year. The average visit time for patients receiving the study dose of zoledronic acid, 4 mg, was 1 h, 6 min, compared to 2 h, 52 min for patients receiving a 90-mg dose of pamidronate. Infusion time accounted for much of the difference. In the base-case analysis, total direct costs per patient were $728 for zoledronic acid and $776 for pamidronate. The opportunity benefit for infusion of zoledronic acid vs pamidronate in the base case was 1.8 chairs per day, or 426 chairs per 240-workday year. Results were sensitive to changes in infusion facility size, days of operation, and average number of patients treated. Shorter infusion time associated with the administration of zoledronic acid, compared with pamidronate, yields substantial time savings for patients, as well as opportunity benefits for outpatient oncology facilities.


Assuntos
Antineoplásicos/economia , Neoplasias Ósseas/tratamento farmacológico , Neoplasias Ósseas/secundário , Difosfonatos/economia , Imidazóis/economia , Cuidados Paliativos/economia , Antineoplásicos/uso terapêutico , Custos e Análise de Custo , Difosfonatos/uso terapêutico , Farmacoeconomia , Humanos , Imidazóis/uso terapêutico , Pamidronato , Estudos de Tempo e Movimento , Ácido Zoledrônico
8.
Am Heart J ; 142(3): 516-9, 2001 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-11526367

RESUMO

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.


Assuntos
Angioplastia Coronária com Balão , Infarto do Miocárdio/terapia , Reperfusão Miocárdica , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Eletrocardiografia , Feminino , Humanos , Masculino , Medicare , Infarto do Miocárdio/patologia , Estudos Retrospectivos , Análise de Sobrevida , Resultado do Tratamento , Estados Unidos
9.
Bone Marrow Transplant ; 27 Suppl 2: S23-9, 2001 May.
Artigo em Inglês | MEDLINE | ID: mdl-11436117

RESUMO

Myelosuppressive chemotherapy is frequently used for mobilization of autologous CD34(+) progenitor cells into the peripheral blood for subsequent collection and support of high-dose chemotherapy. The administration of myelosuppressive chemotherapy is typically followed by a myeloid growth factor and is associated with variable CD34 cell yields and morbidity. The two most commonly used myeloid growth factors for facilitation of CD34 cell harvests are granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF). We performed a randomized phase III clinical trial comparing G-CSF, GM-CSF, and sequential administration of GM-CSF and G-CSF following administration of myelosuppressive chemotherapy. We evaluated CD34 yields, morbidity, and cost-effectiveness of the three cytokine schedules. One hundred and fifty-six patients with multiple myeloma, breast cancer, or lymphoma received cyclophosphamide with either paclitaxel or etoposide and were randomized to receive G-CSF 6 microg/kg/day s.c., GM-CSF 250 microg/m(2)/day s.c., or GM-CSF for 6 days followed by G-CSF until completion of the stem cell harvest. Compared with patients who received GM-CSF, patients who received G-CSF had faster recovery of absolute neutrophil count to 0.5 x 10(9) per liter (median of 11 vs14 days, P = 0.0001) with fewer patients requiring red blood cell transfusions (P= 0.008); fewer patients with fever (18% vs 52%, P = 0.001); fewer hospital admissions (20% vs 42%, P = 0.13); and less intravenous antibiotic therapy (24% vs 59%, P = 0.001). Patients who received G-CSF also yielded more CD34 cells (median 7.1 vs 2.0 x 10(6) kg per apheresis, P = 0.0001) and a higher percentage achieved 2.5 x 10(6) CD34 cells per kilogram (94% vs 78%, P = 0.21) and 5 x 10(6) CD34 cells per kilogram (88% vs 53%, P = 0.01) or more CD34 cells per kilogram with fewer aphereses (median 2 vs 3, P = 0.002) and fewer days of growth factor treatment (median 12 vs 14, P = 0.0001). There were no significant differences in outcomes between groups receiving G-CSF alone and the sequential regimen. After high-dose chemotherapy, patients who had peripheral blood stem cells mobilized with G-CSF or the sequential regimen received higher numbers of CD34 cells and had faster platelet recovery with fewer patients requiring platelet transfusions than patients receiving peripheral blood stem cells mobilized by GM-CSF. In summary, G-CSF alone is superior to GM-CSF alone for the mobilization of CD34(+) cells and reduction of toxicities following myelosuppressive chemotherapy. An economic analysis evaluating the cost-effectiveness of these three effective schedules is ongoing at the time of this writing.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Mobilização de Células-Tronco Hematopoéticas/métodos , Adulto , Idoso , Antígenos CD34/análise , Antígenos CD34/efeitos dos fármacos , Protocolos de Quimioterapia Combinada Antineoplásica/toxicidade , Remoção de Componentes Sanguíneos/normas , Fatores Estimuladores de Colônias/administração & dosagem , Fatores Estimuladores de Colônias/farmacologia , Análise Custo-Benefício , Esquema de Medicação , Feminino , Filgrastim , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Fator Estimulador de Colônias de Granulócitos/farmacologia , Fator Estimulador de Colônias de Granulócitos e Macrófagos/administração & dosagem , Fator Estimulador de Colônias de Granulócitos e Macrófagos/farmacologia , Mobilização de Células-Tronco Hematopoéticas/economia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Proteínas Recombinantes
10.
Nephrol Dial Transplant ; 16(5): 1028-33, 2001 May.
Artigo em Inglês | MEDLINE | ID: mdl-11328911

RESUMO

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.


Assuntos
Anticorpos Monoclonais/economia , Anticorpos Monoclonais/uso terapêutico , Soro Antilinfocitário/economia , Soro Antilinfocitário/uso terapêutico , Custos de Medicamentos , Imunossupressores/uso terapêutico , Transplante de Rim , Qualidade de Vida , Proteínas Recombinantes de Fusão , Basiliximab , Economia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Análise de Sobrevida
11.
Ann Intern Med ; 134(8): 644-51, 2001 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-11304104

RESUMO

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.


Assuntos
Estimulação Cardíaca Artificial , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/terapia , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão , Aspirina/uso terapêutico , Feminino , Fibrinolíticos/uso terapêutico , Seguimentos , Mortalidade Hospitalar , Humanos , Masculino , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/fisiopatologia , Modelos de Riscos Proporcionais , Análise de Regressão , Estudos Retrospectivos , Terapia Trombolítica , Resultado do Tratamento
12.
Health Econ ; 10(1): 27-37, 2001 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-11180567

RESUMO

OBJECTIVE: General health state classification systems, such as the EuroQol instrument, have been developed to improve the systematic measurement and comparability of health state preferences. In this paper we generate valuations for EuroQol health states using responses to this instrument's visual analogue scale made by patients enrolled in a randomized clinical trial evaluating tirilazad mesylate, a new drug used to treat subarachnoid haemorrhage. We then compare these valuations derived from patients with published valuations derived from responses made by a sample from the general public. METHODS: The data were derived from two sources: (1) responses to the EuroQol instrument from 649 patients 3 months after enrollment in the clinical trial, and (2) from a published study reporting a scoring rule for the EuroQol instrument that was based upon responses made by the general public. We used a linear regression model to develop an additive scoring rule. This rule enables direct valuation of all 243 EuroQol health states using patients' scores for their own health states elicited using a visual analogue scale. We then compared predicted scores generated using our scoring rule with predicted scores derived from a sample from the general public. RESULTS: The predicted scores derived using the additive scoring rules met convergent validity criteria and explained a substantial amount of the variation in visual analogue scale scores (R(2)=0.57). In the pairwise comparison of the predicted scores derived from the study sample with those derived from the general public, we found that the former set of scores were higher for 223 of the 243 states. Despite the low level of correspondence in the pairwise comparison, the overall correlation between the two sets of scores was 87%. CONCLUSIONS: The model presented in this paper demonstrated that scoring weights for the EuroQol instrument can be derived directly from patient responses from a clinical trial and that these weights can explain a substantial amount of variation in health valuations. Scoring weights based on patient responses are significantly higher than those derived from the general public. Further research is required to understand the source of these differences.


Assuntos
Atitude Frente a Saúde , Ensaios Clínicos como Assunto/métodos , Avaliação de Resultados em Cuidados de Saúde/métodos , Qualidade de Vida , Inquéritos e Questionários , Atividades Cotidianas , Feminino , Alocação de Recursos para a Atenção à Saúde , Nível de Saúde , Humanos , Masculino , Análise por Pareamento , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/economia , Análise de Regressão , Sensibilidade e Especificidade , Hemorragia Subaracnóidea/tratamento farmacológico
13.
Am J Cardiol ; 87(3): 272-7, 2001 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-11165959

RESUMO

Using data from a retrospective cohort study of Medicare beneficiaries hospitalized with an acute myocardial infarction (AMI), we evaluated the role of diabetes mellitus on 30-day and 1-year mortality. We classified subjects as nondiabetics, diabetics controlled with diet alone, diabetics receiving an oral hypoglycemic agent, and diabetics on insulin at time of admission. We compared baseline admission characteristics of subgroups using chi-square and Wilcoxon rank-sum tests and evaluated the effect of each diabetic state using sequential logistic models. We identified 80,832 nondiabetic patients, 9,862 diet-controlled diabetic patients, 14,664 diabetics receiving an oral hypoglycemic agent, and 12,241 diabetic patients on insulin therapy. Although mean age was similar among the groups, prevalence of hypertension, prior AMI, prior congestive heart failure, and prior revascularization were higher among diabetic patients, particularly those taking insulin. Diabetic patients, particularly those taking insulin, were less likely to receive aspirin and beta blockers and to undergo coronary revascularization. Diabetic patients had higher 30-day and 1-year mortality than nondiabetic patients. After adjustment for demographics, clinical and hospital characteristics, and treatment strategies, insulin-treated diabetics had the highest risk of mortality, followed by diabetics receiving oral hypoglycemic agents, followed by diet-controlled diabetics. Thus, diabetes is highly prevalent among elderly patients with an AMI. Mortality rates for these patients, particularly insulin-using diabetics, are higher than among their nondiabetic counterparts. Preventive and therapeutic strategies must be developed to ensure improved short- and long-term outcomes for elderly patients with diabetes and AMI.


Assuntos
Diabetes Mellitus Tipo 2/mortalidade , Angiopatias Diabéticas/mortalidade , Insulina/administração & dosagem , Infarto do Miocárdio/mortalidade , Idoso , Idoso de 80 Anos ou mais , Causas de Morte , Diabetes Mellitus Tipo 2/tratamento farmacológico , Angiopatias Diabéticas/tratamento farmacológico , Dieta para Diabéticos , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/tratamento farmacológico , Prognóstico , Taxa de Sobrevida
14.
Am Heart J ; 141(1): 47-54, 2001 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-11136486

RESUMO

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.


Assuntos
Bloqueio Cardíaco/epidemiologia , Bloqueio Cardíaco/etiologia , Infarto do Miocárdio/complicações , Fatores Etários , Idoso , Feminino , Humanos , Masculino , Prevalência , Prognóstico
15.
Pharmacoepidemiol Drug Saf ; 10(5): 417-27, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11802588

RESUMO

OBJECTIVE: To utilize health services research techniques in developing an episode of care using an administrative data set. This method is demonstrated for an episodic clinical condition, migraine. DATA SOURCES: Medicaid administrative data set of 3,372 patients with a diagnosis of migraine (ICD-9-CM 346.0, 346.1) in the state of Pennsylvania between May 1990 and March 1992. STUDY DESIGN: The duration of a migraine episode was measured by assessing the magnitude of resource utilization and the proportion of patients with charges in the period after the index migraine as compared to the period before the index migraine. A confidence interval (CI) was developed around each measure using bootstrap techniques. DATA COLLECTION METHODS: All charge data were extracted daily for a 113-day observation period surrounding each index migraine in order to observe the duration of impact of a migraine diagnosis on resource utilization. PRINCIPAL FINDINGS: The lower limits of both the 95% and 99% CIs for the difference in charges are greater than 0 for three weeks. The lower limits of both CIs for the difference in the proportion of patients with charges are above 0 for six weeks. CONCLUSIONS: Our analysis demonstrates that a health services research framework can be used to define an episode of care for a chronic disease category such as migraine. This method can be used to evaluate episodes of care for clinical studies of limited or episodic conditions and to complement clinical expertise in developing time horizons for clinical trials.


Assuntos
Cuidado Periódico , Pesquisa sobre Serviços de Saúde/economia , Revisão da Utilização de Seguros/economia , Adulto , Feminino , Pesquisa sobre Serviços de Saúde/métodos , Pesquisa sobre Serviços de Saúde/estatística & dados numéricos , Humanos , Revisão da Utilização de Seguros/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/diagnóstico , Transtornos de Enxaqueca/economia , Transtornos de Enxaqueca/terapia , Fatores de Tempo
16.
J Am Med Womens Assoc (1972) ; 56(4): 151-4, 160, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11759782

RESUMO

Nearly twice as many women in the United States die of heart disease and stroke every year as die from all types of cancer. Several studies have shown that women are less likely than men to be referred for invasive cardiac procedures. Despite extensive literature documenting sex differences in invasive cardiac procedure use, few studies have investigated the ways in which sex may affect the patient and physician decision-making process in referrals for cardiac care. This paper presents a framework outlining 8 stages of the referral process and discusses the role sex plays in each one. This framework was adapted from one describing the influence of race on the referral process for invasive cardiac procedures. A representative sample of the literature is reviewed to describe the influence of sex at each stage.


Assuntos
Atitude do Pessoal de Saúde , Atitude Frente a Saúde , Doenças Cardiovasculares/prevenção & controle , Identidade de Gênero , Relações Médico-Paciente , Padrões de Prática Médica/estatística & dados numéricos , Encaminhamento e Consulta/estatística & dados numéricos , Saúde da Mulher , Doenças Cardiovasculares/epidemiologia , Atenção à Saúde , Feminino , Humanos , Estados Unidos/epidemiologia
17.
Med Care Res Rev ; 57 Suppl 1: 162-80, 2000.
Artigo em Inglês | MEDLINE | ID: mdl-11092162

RESUMO

Coronary artery disease is the leading cause of death in the United States. Blacks are more likely than whites to experience premature disease, and they have poorer prognosis after acute myocardial infarction. Multiple studies have demonstrated that blacks are less likely to be referred for certain invasive cardiac procedures. Few studies have examined the effect of race on physician and patient decision making in referrals for cardiac procedures. The authors present a framework for the complex series of steps involved in obtaining invasive cardiac care. Patient race can affect each of these steps, and differences in physician and patient race may be a particular impediment to effective communication about symptoms and preferences and to the establishment of a therapeutic partnership. The potential role of communication in race-discordant physician-patient relationships suggests a need for more research in physician decision making and for efforts to promote cultural competency as a core component of medical education.


Assuntos
Angioplastia Coronária com Balão/estatística & dados numéricos , Negro ou Afro-Americano/psicologia , Negro ou Afro-Americano/estatística & dados numéricos , Cateterismo Cardíaco/estatística & dados numéricos , Ponte de Artéria Coronária/estatística & dados numéricos , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Aceitação pelo Paciente de Cuidados de Saúde/etnologia , Seleção de Pacientes , Padrões de Prática Médica/estatística & dados numéricos , Encaminhamento e Consulta/estatística & dados numéricos , Adulto , Idoso , Comunicação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Relações Médico-Paciente
18.
Circulation ; 102(14): 1651-6, 2000 Oct 03.
Artigo em Inglês | MEDLINE | ID: mdl-11015343

RESUMO

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.


Assuntos
Infarto do Miocárdio/fisiopatologia , Doença Aguda , Idoso , Serviços Médicos de Emergência , Feminino , Humanos , Modelos Logísticos , Masculino , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/genética , Grupos Raciais , Fatores de Risco , Fatores Sexuais , Classe Social , Fatores de Tempo
19.
Cancer ; 89(3): 561-73, 2000 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-10931455

RESUMO

BACKGROUND: Older women have high rates of breast carcinoma, and there are substantial variations in the patterns of care for this population group. METHODS: The authors studied 718 breast carcinoma patients age 67 years and older who were diagnosed with localized disease between 1995 and 1997 from 29 hospitals in 5 regions. Data were collected from patients, charts, and surgeons. Logistic regression analysis was used to evaluate determinants of treatment. RESULTS: Women who were concerned about body image were 1.8 times more likely (95% confidence interval [95% CI], 1.1-2.8) to receive breast conservation surgery and radiotherapy than women without this preference, controlling for other factors. In contrast, women who preferred receiving no therapy beyond surgery were 3.9 times more likely (95% CI, 2.9-6.1) to undergo mastectomy than other women, after considering other factors. Radiotherapy was omitted after breast conservation 3.4 times more often (95% CI, 2.0-5.6) among women age 80 years and older than among women ages 67-79 years, controlling for covariates. Black women tended to have radiotherapy omitted after breast conservation surgery 2.0 times more often (95% CI, 0.9-4.4) than white women (P = 0.09). Women age 80 years and older also were 70% less likely (odds ratio = 0.3; 95% CI, 0.1-0.8) to receive chemotherapy than women ages 67-79 years, controlling for health, functional status, and other covariates. CONCLUSIONS: After considering other factors, patient preferences and age were found to be associated with breast carcinoma treatment patterns in older women. Further research and training are needed to provide care for the growing population of older women that is both clinically appropriate and consonant with a woman's preferences.


Assuntos
Neoplasias da Mama/terapia , Participação do Paciente , Padrões de Prática Médica , Idoso , Análise de Variância , Neoplasias da Mama/psicologia , Estudos de Coortes , Feminino , Humanos , Modelos Logísticos
20.
Circulation ; 102(6): 642-8, 2000 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-10931804

RESUMO

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.


Assuntos
Negro ou Afro-Americano , Mau Uso de Serviços de Saúde , Infarto do Miocárdio/terapia , Pobreza , Fatores Sexuais , População Branca , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Infarto do Miocárdio/etnologia
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