RESUMO
PURPOSE: Magnetic resonance imaging (MRI) is a high-cost imaging modality, and an optimized encounter ideally provides high-quality care, patient satisfaction, and capacity utilization. Our purpose was to assess the effectiveness of team training and its impact on patient show-up and completion rates for their MRI examinations. MATERIALS AND METHODS: A total of 97,712 patient visits from three tertiary academic medical centers over 1-year intervals were evaluated, totaling 49,733 visits at baseline and 47,979 after training. Each center's MRI team received team training skill training including advanced communication and team training techniques training. This training included onsite instruction including case simulation with scenarios requiring appropriate behavioral and communicative interventions. Orientation and training also utilized customized online tools and proctoring. The study completion rate and patient show-up rate during consecutive year-long intervals before and after team training were compared to assess its effectiveness. Two-sided chi-square tests for proportions using were applied at a 0.05 significance level. RESULTS: Despite differing no-show rates (5-22.2%) and study incompletion rates (0.7-3.7%) at the three academic centers, the combined patients' data showed significant (P < 0.0001) improvement in the patients' no-show rates (combined decreases from 11.2% to 8.7%) and incompletion rates (combined decreases from 2.3% to 1.4%). CONCLUSION: Our preliminary results suggest training of the imaging team can improve the no-show and incompletion rates of the MRI service, positively affecting throughput and utilization. Team training can be readily implemented and may help address the needs of the current cost-conscious and consumer-sensitive healthcare environment. J. MAGN. RESON. IMAGING 2016;44:1040-1047.
Assuntos
Competência Clínica/estatística & dados numéricos , Eficiência Organizacional/estatística & dados numéricos , Consentimento Livre e Esclarecido/psicologia , Capacitação em Serviço/estatística & dados numéricos , Imageamento por Ressonância Magnética/estatística & dados numéricos , Pacientes não Comparecentes/estatística & dados numéricos , Equipe de Assistência ao Paciente/estatística & dados numéricos , Centros Médicos Acadêmicos/estatística & dados numéricos , Humanos , Consentimento Livre e Esclarecido/estatística & dados numéricos , Imageamento por Ressonância Magnética/psicologia , Pacientes não Comparecentes/psicologia , Conforto do Paciente/estatística & dados numéricos , Estados UnidosRESUMO
BACKGROUND: The threshold model represents an important advance in the field of medical decision-making. It is a linchpin between evidence (which exists on the continuum of credibility) and decision-making (which is a categorical exercise - we decide to act or not act). The threshold concept is closely related to the question of rational decision-making. When should the physician act, that is order a diagnostic test, or prescribe treatment? The threshold model embodies the decision theoretic rationality that says the most rational decision is to prescribe treatment when the expected treatment benefit outweighs its expected harms. However, the well-documented large variation in the way physicians order diagnostic tests or decide to administer treatments is consistent with a notion that physicians' individual action thresholds vary. METHODS: We present a narrative review summarizing the existing literature on physicians' use of a threshold strategy for decision-making. RESULTS: We found that the observed variation in decision action thresholds is partially due to the way people integrate benefits and harms. That is, explanation of variation in clinical practice can be reduced to a consideration of thresholds. Limited evidence suggests that non-expected utility threshold (non-EUT) models, such as regret-based and dual-processing models, may explain current medical practice better. However, inclusion of costs and recognition of risk attitudes towards uncertain treatment effects and comorbidities may improve the explanatory and predictive value of the EUT-based threshold models. CONCLUSIONS: The decision when to act is closely related to the question of rational choice. We conclude that the medical community has not yet fully defined criteria for rational clinical decision-making. The traditional notion of rationality rooted in EUT may need to be supplemented by reflective rationality, which strives to integrate all aspects of medical practice - medical, humanistic and socio-economic - within a coherent reasoning system.
Assuntos
Tomada de Decisão Clínica/métodos , Diagnóstico , Gerenciamento Clínico , Medicina Baseada em Evidências/métodos , Lógica , Padrões de Prática Médica , Humanos , Modelos TeóricosRESUMO
BACKGROUND: There are no randomized controlled trials to inform the decision of which cranial radiation therapy (CRT) strategy to apply to pediatric patients with T-cell acute lymphoblastic leukemia (ALL). PROCEDURE: We performed a decision analysis using a Markov model in which we compared the life expectancy and quality-adjusted life expectancy when administering one of three CRT strategies to a cohort of patients with T-cell ALL: (1) omission of CRT for all patients; (2) CRT only for those with evidence of leukemic involvement in the central nervous system at diagnosis (therapeutic strategy); or (3) CRT for all (prophylactic strategy). RESULTS: When considering plausible event-free survival rates and late mortality after cure for groups of pediatric patients with T-cell ALL, the strategies of omitting CRT, administering therapeutic CRT, and administering prophylactic CRT result in similar short-term (7-year) survival. When considering the increased contribution of deaths from late effects, the strategy of prophylactic CRT is associated with lower life expectancy when compared to the other two strategies. The Monte Carlo probabilistic sensitivity analysis demonstrated that the strategy of prophylactic CRT was the preferred strategy only 5% of the time. CONCLUSIONS: Similar short-term survival may be expected when comparing the strategies of total omission of CRT, therapeutic CRT, and prophylactic CRT for patients with T-cell ALL. Long-term survival is likely inferior for the strategy of prophylactic CRT. The synthesis of nonrandomized trials and the application of decision analysis can help inform complex decision making in pediatric oncology.
Assuntos
Irradiação Craniana/mortalidade , Técnicas de Apoio para a Decisão , Recidiva Local de Neoplasia/radioterapia , Leucemia-Linfoma Linfoblástico de Células T Precursoras/radioterapia , Anos de Vida Ajustados por Qualidade de Vida , Idoso , Criança , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Cadeias de Markov , Recidiva Local de Neoplasia/mortalidade , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias , Leucemia-Linfoma Linfoblástico de Células T Precursoras/mortalidade , Leucemia-Linfoma Linfoblástico de Células T Precursoras/patologia , Prognóstico , Taxa de SobrevidaRESUMO
To provide an update on recent revisions to Evaluation of Genomic Applications in Practice and Prevention (EGAPP) methods designed to improve efficiency, and an assessment of the implications of whole genome sequencing for evidence-based recommendation development. Improvements to the EGAPP approach include automated searches for horizon scanning, a quantitative ranking process for topic prioritization, and the development of a staged evidence review and evaluation process. The staged process entails (i) triaging tests with minimal evidence of clinical validity, (ii) using and updating existing reviews, (iii) evaluating clinical validity prior to analytic validity or clinical utility, (iv) using decision modeling to assess potential clinical utility when direct evidence is not available. EGAPP experience to date suggests the following approaches will be critical for the development of evidence based recommendations in the whole genome sequencing era: (i) use of triage approaches and frameworks to improve efficiency, (ii) development of evidence thresholds that consider the value of further research, (iii) incorporation of patient preferences, and (iv) engagement of diverse stakeholders. The rapid advances in genomics present a significant challenge to traditional evidence based medicine, but also an opportunity for innovative approaches to recommendation development.
Assuntos
Medicina Baseada em Evidências , Genoma Humano , Genômica , Sequenciamento de Nucleotídeos em Larga Escala , Testes Genéticos , Humanos , Revisão por Pares , Garantia da Qualidade dos Cuidados de SaúdeRESUMO
BACKGROUND: Dual processing theory of human cognition postulates that reasoning and decision-making can be described as a function of both an intuitive, experiential, affective system (system I) and/or an analytical, deliberative (system II) processing system. To date no formal descriptive model of medical decision-making based on dual processing theory has been developed. Here we postulate such a model and apply it to a common clinical situation: whether treatment should be administered to the patient who may or may not have a disease. METHODS: We developed a mathematical model in which we linked a recently proposed descriptive psychological model of cognition with the threshold model of medical decision-making and show how this approach can be used to better understand decision-making at the bedside and explain the widespread variation in treatments observed in clinical practice. RESULTS: We show that physician's beliefs about whether to treat at higher (lower) probability levels compared to the prescriptive therapeutic thresholds obtained via system II processing is moderated by system I and the ratio of benefit and harms as evaluated by both system I and II. Under some conditions, the system I decision maker's threshold may dramatically drop below the expected utility threshold derived by system II. This can explain the overtreatment often seen in the contemporary practice. The opposite can also occur as in the situations where empirical evidence is considered unreliable, or when cognitive processes of decision-makers are biased through recent experience: the threshold will increase relative to the normative threshold value derived via system II using expected utility threshold. This inclination for the higher diagnostic certainty may, in turn, explain undertreatment that is also documented in the current medical practice. CONCLUSIONS: We have developed the first dual processing model of medical decision-making that has potential to enrich the current medical decision-making field, which is still to the large extent dominated by expected utility theory. The model also provides a platform for reconciling two groups of competing dual processing theories (parallel competitive with default-interventionalist theories).
Assuntos
Técnicas de Apoio para a Decisão , Medição de Risco/métodos , Cognição , Lógica Fuzzy , Humanos , Modelos Psicológicos , Modelos Estatísticos , Variações Dependentes do Observador , Avaliação de Processos e Resultados em Cuidados de SaúdeRESUMO
This chapter about antithrombotic therapy for valvular heart disease is part of the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Grade 1 recommendations are strong and indicate that the benefits do, or do not, outweigh risks, burden, and costs. Grade 2 suggests that individual patient values might lead to different choices (for a full understanding of the grading see Guyatt et al, CHEST 2008; 133[suppl]:123S-131S). Among the key recommendations in this chapter are the following: for patients with rheumatic mitral valve disease complicated singly or in combination by the presence of atrial fibrillation (AF), previous systemic embolism, or left atrial thrombus, we recommend vitamin K antagonist (VKA) therapy (Grade 1A). For patients with rheumatic mitral valve disease and normal sinus rhythm, without left atrial enlargement, we do not suggest antithrombotic therapy unless a separate indication exists (Grade 2C). For patients with mitral valve prolapse (MVP), not complicated by AF, who have not had systemic embolism, unexplained transient ischemic attacks, or ischemic stroke, we recommend against antithrombotic therapy (Grade 1C). In patients with mitral annular calcification complicated by systemic embolism or ischemic stroke, we recommend antiplatelet agent (APA) therapy (Grade 1B). For patients with isolated calcific aortic valve disease, we suggest against antithrombotic therapy (Grade 2C). But, for those with aortic valve disease who have experienced ischemic stroke, we suggest APA therapy (Grade 2C). For patients with stroke associated with aortic atherosclerotic lesions, we recommend low-dose aspirin (ASA) therapy (Grade 1C). For patients with cryptogenic ischemic stroke and a patent foramen ovale (PFO), we recommend APA therapy (Grade 1A). For patients with mechanical heart valves, we recommend VKA therapy (Grade 1A). For patients with mechanical heart valves and history of vascular disease or who have additional risk factors for thromboembolism, we recommend the addition of low-dose aspirin ASA to VKA therapy (Grade 1B). We suggest ASA not be added to long-term VKA therapy in patients with mechanical heart valves who are at particularly high risk of bleeding (Grade 2C). For patients with bioprosthetic heart valves, we recommend ASA (Grade 1B). For patients with bioprosthetic heart valves and additional risk factors for thromboembolism, we recommend VKA therapy (Grade 1C). For patients with infective endocarditis, we recommend against antithrombotic therapy, unless a separate indication exists (Grade 1B).
Assuntos
Fibrinolíticos/uso terapêutico , Doenças das Valvas Cardíacas/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Aspirina/administração & dosagem , Aspirina/uso terapêutico , Medicina Baseada em Evidências , Fibrinolíticos/administração & dosagem , Doenças das Valvas Cardíacas/complicações , Humanos , Inibidores da Agregação Plaquetária/administração & dosagem , Medição de Risco , Fatores de Risco , Vitamina K/antagonistas & inibidoresRESUMO
This chapter describes the system used by the American College of Chest Physicians to grade recommendations for antithrombotic and thrombolytic therapy as part of the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Clinicians need to know if a recommendation is strong or weak, and the methodologic quality of the evidence underlying that recommendation. We determine the strength of a recommendation by considering the balance between the desirable effects of an intervention and the undesirable effects (incremental harms, burdens, and for select recommendations, costs). If the desirable effects outweigh the undesirable effects, we recommend that clinicians offer an intervention to typical patients. The uncertainty associated with the balance between the desirable and undesirable effects will determine the strength of recommendations. If we are confident that benefits do or do not outweigh harms, burden, and costs, we make a strong recommendation in our formulation, Grade 1. If we are less certain of the magnitude of the benefits and risks, burden, and costs, and thus their relative impact, we make a weaker Grade 2 recommendation. For grading methodologic quality, randomized controlled trials (RCTs) begin as high-quality evidence (designated by "A"), but quality can decrease to moderate ("B"), or low ("C") as a result of poor design and conduct of RCTs, imprecision, inconsistency of results, indirectness, or a high likelihood for reporting bias. Observational studies begin as low quality of evidence (C) but can increase in quality on the basis of very large treatment effects. Strong (Grade 1) recommendations can be applied uniformly to most patients. Weak (Grade 2) suggestions require more judicious application, particularly considering patient values and preferences and, when resource limitations play an important role, issues of cost.
Assuntos
Fibrinolíticos/uso terapêutico , Guias de Prática Clínica como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Terapia Trombolítica , HumanosRESUMO
BACKGROUND: Some hospitals have instituted voluntary electronic error reporting systems (e-ERSs) to gather data on medical errors, adverse events, near misses, or environmental issues in a peer review-protected environment. An e-ERS allows for real-time review, oversight, and intervention and provides insight into hospital processes in need of modification to reduce the likelihood of adverse hospital events. In a descriptive study of a standardized, Web-based reporting system, the reporting practices of physicians and nurses were compared. METHODS: Twenty-nine acute care hospitals and one long-term care organization implemented an e-ERS between August 2000 and December 2005. The reporting system consisted of a secure, Web-based portal available on all hospital computers. Events were classified by the level of impact on the patient using a standard classification scheme. All reports that occurred from August 2000 through January 2006 were analyzed in aggregate analyses. Hospitals and patients were de-identified to study investigators. RESULTS: Some 266,224 events were reported over 7.3 million inpatient days--1 event per 27.5 days. Physicians were the reporters of 1.1% of total events, nurses 45.3%, and other hospital employees 53.6%. Physicians were more likely to be the reporter for events that caused permanent harm, near death, or death of a patient (p < .01). Nurses were more likely to be the reporter for events that caused no or temporary harm (p < .01). DISCUSSION: Physicians reported a narrower spectrum of events than nurses; they were more likely to report as the impact of events on patients increased but less likely to report fatal events. Nurses' reporting remained stable across impact levels. Differences exist between whether nurses and physicians report events; physicians must be encouraged to increase their reporting of adverse events.
Assuntos
Erros Médicos/estatística & dados numéricos , Corpo Clínico Hospitalar , Recursos Humanos de Enfermagem Hospitalar , Gestão de Riscos/estatística & dados numéricos , Hospitais Filantrópicos , Humanos , Internet , Erros Médicos/prevenção & controle , Erros Médicos/normas , Aplicações da Informática Médica , Estados UnidosRESUMO
Most panels that develop clinical practice guidelines are poorly equipped to address resource allocation or cost issues associated with management options. This risks neglect, arbitrariness, lack of transparency, and methodological flaws in consideration of resource allocation. We provide recommendations for guideline panels to promote greater transparency and rigor. We suggest focusing on resource allocation issues for only a limited number of recommendations and provide criteria for selecting those in which economic considerations are likely to influence the direction or strength of the recommendation. Panels should involve a health economist to assist with the systematic review and critical interpretation of relevant economic analyses. They should carefully define the intended audience and may consider issuing alternative recommendations when available resources vary widely across target clinical settings. Targeting a limited number of recommendations for the consideration of resource allocation issues, and ensuring methodologically high-quality review, will best serve guideline panels, and the health-care providers and patients they hope to assist.
Assuntos
Guias de Prática Clínica como Assunto/normas , Pneumologia , Alocação de Recursos , Comitês Consultivos , Humanos , Estados UnidosRESUMO
OBJECTIVE: To describe the rate and types of events reported in acute care hospitals using an electronic error reporting system (e-ERS). DESIGN: Descriptive study of reported events using the same e-ERS between January 1, 2001 and September 30, 2003. SETTING: Twenty-six acute care nonfederal hospitals throughout the U.S. that voluntarily implemented a web-based e-ERS for at least 3 months. PARTICIPANTS: Hospital employees and staff. INTERVENTION: A secure, standardized, commercially available web-based reporting system. RESULTS: Median duration of e-ERS use was 21 months (range 3 to 33 months). A total of 92,547 reports were obtained during 2,547,154 patient-days. Reporting rates varied widely across hospitals (9 to 95 reports per 1,000 inpatient-days; median=35). Registered nurses provided nearly half of the reports; physicians contributed less than 2%. Thirty-four percent of reports were classified as nonmedication-related clinical events, 33% as medication/infusion related, 13% were falls, 13% as administrative, and 6% other. Among 80% of reports that identified level of impact, 53% were events that reached a patient ("patient events"), 13% were near misses that did not reach the patient, and 14% were hospital environment problems. Among 49,341 patient events, 67% caused no harm, 32% temporary harm, 0.8% life threatening or permanent harm, and 0.4% contributed to patient deaths. CONCLUSIONS: An e-ERS provides an accessible venue for reporting medical errors, adverse events, and near misses. The wide variation in reporting rates among hospitals, and very low reporting rates by physicians, requires investigation.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Internet , Erros Médicos , Gestão de Riscos , Gestão da Segurança/métodos , Programas Voluntários , Humanos , Enfermeiras e Enfermeiros/estatística & dados numéricos , Médicos/estatística & dados numéricosRESUMO
BACKGROUND: Mortality from invasive candidiasis is high. Low culture sensitivity and treatment delay contribute to increased mortality, but nonselective early therapy may result in excess costs and drug resistance. OBJECTIVE: To determine the cost-effectiveness of anti-Candida strategies for high-risk patients in the intensive care unit (ICU). DESIGN: Cost-effectiveness decision model. DATA SOURCES: Published data to 10 May 2005, identified from MEDLINE and Cochrane Library searches, ICU databases, expert estimates, and actual hospital costs. TARGET POPULATION: Patients in the ICU with suspected infection who have not responded to antibacterial therapy. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTIONS: Fluconazole, caspofungin, amphotericin B, or lipid formulation of amphotericin B given as either empirical or culture-based therapy and no anti-Candida therapy. OUTCOME MEASURES: Incremental life expectancy and incremental cost per discounted life-year (DLY) saved. RESULTS OF BASE-CASE ANALYSIS: Ten percent of the target population will have invasive candidiasis. Empirical caspofungin therapy is the most effective strategy but is expensive (295,115 dollars per DLY saved). Empirical fluconazole therapy is the most reasonable strategy (12,593 dollars per DLY saved) and decreases mortality from 44.0% to 30.4% in patients with invasive candidiasis and from 22.4% to 21.0% in the overall target cohort. RESULTS OF SENSITIVITY ANALYSIS: Empirical fluconazole therapy is reasonable for likelihoods of invasive candidiasis greater than 2.5% or fluconazole resistance less than 24.0%. For higher resistance levels, empirical caspofungin therapy is preferred. For low prevalences of invasive candidiasis, culture-based fluconazole is reasonable. For prevalences exceeding 60%, empirical caspofungin therapy is reasonable. For caspofungin to be reasonable at a prevalence of 10%, its cost must be reduced by 58%. LIMITATIONS: Less severe illness and limited use of broad-spectrum antimicrobial agents, typical of smaller hospitals, could result in a lower risk for invasive candidiasis. CONCLUSIONS: In patients in the ICU with suspected infection who have not responded to antibiotic treatment, empirical fluconazole should reduce mortality at an acceptable cost. The use of empirical strategies in low-risk patients is not justified.
Assuntos
Antifúngicos/economia , Antifúngicos/uso terapêutico , Candidíase/tratamento farmacológico , Infecção Hospitalar/tratamento farmacológico , Anfotericina B/economia , Anfotericina B/uso terapêutico , Antibacterianos/uso terapêutico , Candidíase/epidemiologia , Caspofungina , Análise Custo-Benefício , Infecção Hospitalar/epidemiologia , Técnicas de Apoio para a Decisão , Equinocandinas , Fluconazol/economia , Fluconazol/uso terapêutico , Humanos , Unidades de Terapia Intensiva , Lipopeptídeos , Técnicas Microbiológicas , Peptídeos Cíclicos/economia , Peptídeos Cíclicos/uso terapêutico , Prevalência , Fatores de Risco , Sensibilidade e Especificidade , Resultado do TratamentoRESUMO
OBJECTIVES: We performed a meta-analysis of randomized trials comparing coronary artery bypass graft surgery (CABG) with percutaneous transluminal coronary angioplasty (PTCA) for the treatment of coronary artery disease, incorporating new trials and examining long-term outcomes. BACKGROUND: Previous meta-analyses of trials comparing CABG with PTCA have reported short- and intermediate-term outcomes, but since then longer term follow-up and newer trials have been published. METHODS: We performed a meta-analysis of 13 randomized trials on 7,964 patients comparing PTCA with CABG. RESULTS: We found a 1.9% absolute survival advantage favoring CABG over PTCA for all trials at five years (p < 0.02), but no significant advantage at one, three, or eight years. In subgroup analysis of multivessel disease, CABG provided significant survival advantage at both five and eight years. Patients randomized to PTCA had more repeat revascularizations at all time points (risk difference [RD] 24% to 38%, p < 0.001); with stents, this RD was reduced to 15% at one and three years. Stents also resulted in a significant decrease in nonfatal myocardial infarction at three years when compared with CABG. For diabetic patients, CABG provided a significant survival advantage over PTCA at 4 years but not at 6.5 years. CONCLUSIONS: Our results suggest that, when compared with PTCA, CABG is associated with a lower five-year mortality, less angina, and fewer revascularization procedures. For patients with multivessel disease, CABG provided a survival advantage at five to eight years, and for diabetics, a survival advantage at four years. The addition of stents reduced the need for repeat revascularization by about half.
Assuntos
Angioplastia Coronária com Balão , Ponte de Artéria Coronária , Doença das Coronárias/mortalidade , Doença das Coronárias/terapia , Angioplastia Coronária com Balão/mortalidade , Ponte de Artéria Coronária/mortalidade , Doença das Coronárias/cirurgia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Análise de Sobrevida , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE: Women with a history of prior venous thromboembolism have an increased risk for recurrence during pregnancy. Although thromboprophylaxis reduces this risk, recent evidence suggests that, in many cases, prophylaxis can be safely withheld because the estimated recurrence risk is very low. The balance of risks and benefits in women with different recurrence risks has not been examined. METHODS: We developed a Markov state transition decision analytic model to compare prophylactic low molecular weight heparin to expectant management for pregnant women with a single prior venous thromboembolism. A lifetime time horizon and societal perspective were assumed. Input data were obtained by literature review. Outcomes were expressed as U.S. dollars per quality-adjusted life-year (QALY). RESULTS: For "low-risk" women with a prior venous thromboembolism associated with a transient risk factor and no known thrombophilic condition (recurrence risk 0.5%), expectant management was both more effective and less costly than prophylaxis. For "high-risk" women with prior idiopathic venous thromboembolism or known thrombophilic condition (recurrence risk 5.9%), prophylaxis was associated with a reasonable cost-effectiveness ratio (USD 38,700 per QALY) given a risk of bleeding complications <1.0% (base case 0.5%). CONCLUSION: For low-risk women with prior venous thromboembolism, expectant management during pregnancy leads to better outcomes than administration of prophylactic low molecular weight heparin. For high-risk women, antepartum thromboprophylaxis is a cost-effective use of resources.
Assuntos
Anticoagulantes/economia , Custos de Medicamentos , Heparina de Baixo Peso Molecular/economia , Complicações Cardiovasculares na Gravidez/prevenção & controle , Tromboembolia/prevenção & controle , Trombose Venosa/prevenção & controle , Anticoagulantes/uso terapêutico , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Feminino , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Cadeias de Markov , Gravidez , Complicações Cardiovasculares na Gravidez/economia , Anos de Vida Ajustados por Qualidade de Vida , Prevenção SecundáriaRESUMO
Differences between observational and randomized studies of the effects of menopausal hormone therapy (HT) on coronary heart disease (CHD) have been attributed to the fact that women who choose to use HT tend to be healthier than those who do not. Although this bias should affect all clinical outcomes with modifiable risk factors, estimates for stroke and pulmonary embolism were unaffected. The authors sought possible explanations for this isolated discrepancy in CHD findings. Unlike the randomized Women's Health Initiative (WHI) trial, the observational Nurses' Health Study (NHS) did not try to detect silent myocardial infarctions. Many women present with atypical ischemic symptoms. Hormone therapy users who believe that HT reduces CHD risks might not interpret ischemic symptoms as related to CHD, might not seek medical attention, and might present differently to their physicians, all of which could lead to more unrecognized myocardial infarctions among HT users in the NHS. In addition, persons completing death certificates and NHS physicians interpreting death certificates were not blinded to the use of HT. If persons assigning cause of death knew the patient had used HT and believed that HT prevented CHD, they might have been more likely to assign a condition other than CHD as the cause of death. If HT users were 20% less likely to have their infarctions recognized and their deaths attributed to CHD, a true increase in CHD due to HT use would appear to be a reduction in CHD. Combining these reporting biases with socioeconomic differences between users and nonusers could explain discrepancies. Beliefs held by patients, clinicians, and investigators might have affected the ascertainment of CHD outcomes in observational studies.
Assuntos
Doença das Coronárias/prevenção & controle , Terapia de Reposição Hormonal , Observação , Pós-Menopausa , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Viés , Doença das Coronárias/mortalidade , Feminino , Humanos , Modelos Estatísticos , Fatores de Risco , Fatores SocioeconômicosAssuntos
Cognição , Conflito de Interesses , Tomada de Decisões , Médicos/psicologia , Teoria da Decisão , Erros de Diagnóstico , Educação Médica Continuada/economia , Educação Médica Continuada/ética , Objetivos , Humanos , Lógica , Modelos Psicológicos , Médicos/economia , Estudantes de Medicina/psicologia , IncertezaRESUMO
This article about the grades of recommendation for antithrombotic and thrombolytic therapy is part of the Seventh American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines. Clinicians need to know whether a recommendation is strong or weak, and about the methodological quality of the evidence underlying that recommendation. We determine the strength of a recommendation by considering the trade-off between the benefits of a treatment, on the one hand, and the risks, burdens, and costs on the other. Here, as elsewhere, we assume that a recommended treatment will increase costs (we recognize this is not always the case, but for simplicity we will continue to make this assumption). If the benefits outweigh the risks, burdens, and costs, we recommend that clinicians offer a treatment to typical patients. The uncertainty associated with the trade-off between the benefits and the risks, burdens, and costs will determine the strength of the recommendations. If we are very certain that the benefits do, or do not, outweigh the risks, burdens, and costs, we make a strong recommendation (in our formulation, Grade 1). If we are less certain of the magnitude of the benefits and the risks, burdens, and costs, and thus of their relative impact, we make a weaker Grade 2 recommendation. We grade the methodological quality of a recommendation according to the following criteria. Randomized clinical trials (RCTs) with consistent results provide evidence with a low likelihood of bias, which we classify as Grade A recommendations. RCTs with inconsistent results, or with major methodological weaknesses, warrant Grade B recommendations. Grade C recommendations come from observational studies or from a generalization from one group of patients included in randomized trials to a different, but somewhat similar, group of patients who did not participate in those trials. When we find the generalization from RCTs to be secure, or the data from observational studies overwhelmingly compelling, we choose a Grade C+. When that is not the case, we designate methodological quality as Grade C.
Assuntos
Fibrinolíticos/uso terapêutico , Guias de Prática Clínica como Assunto , Terapia Trombolítica/métodos , Viés , Medicina Baseada em Evidências/estatística & dados numéricos , Fibrinolíticos/efeitos adversos , Humanos , Funções Verossimilhança , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Medição de Risco/estatística & dados numéricos , Terapia Trombolítica/efeitos adversosRESUMO
This chapter about antithrombotic therapy in native and prosthetic valvular heart disease is part of the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence Based Guidelines. Grade 1 recommendations are strong and indicate that the benefits do, or do not, outweigh risks, burden, and costs. Grade 2 suggests that individual patients' values may lead to different choices (for a full understanding of the grading see Guyatt et al, CHEST 2004; 126:179S-187S). Among the key recommendations in this chapter are the following: For patients with rheumatic mitral valve disease and atrial fibrillation (AF), or a history of previous systemic embolism, we recommend long-term oral anticoagulant (OAC) therapy (target international normalized ratio [INR], 2.5; range, 2.0 to 3.0) [Grade 1C+]. For patients with rheumatic mitral valve disease with AF or a history of systemic embolism who suffer systemic embolism while receiving OACs at a therapeutic INR, we recommend adding aspirin, 75 to 100 mg/d (Grade 1C). For those patients unable to take aspirin, we recommend adding dipyridamole, 400 mg/d, or clopidogrel (Grade 1C). In people with mitral valve prolapse (MVP) without history of systemic embolism, unexplained transient ischemic attacks (TIAs), or AF, we recommended against any antithrombotic therapy (Grade 1C). In patients with MVP and documented but unexplained TIAs, we recommend long-term aspirin therapy, 50 to 162 mg/d (Grade 1A). For all patients with mechanical prosthetic heart valves, we recommend vitamin K antagonists (Grade 1C+). For patients with a St. Jude Medical (St. Paul, MN) bileaflet valve in the aortic position, we recommend a target INR of 2.5 (range, 2.0 to 3.0) [Grade 1A]. For patients with tilting disk valves and bileaflet mechanical valves in the mitral position, we recommend a target INR of 3.0 (range, 2.5 to 3.5) [Grade 1C+]. For patients with caged ball or caged disk valves, we suggest a target INR of 3.0 (range, 2.5 to 3.5) in combination with aspirin, 75 to 100 mg/d (Grade 2A). For patients with bioprosthetic valves, we recommend vitamin K antagonists with a target INR of 2.5 (range, 2.0 to 3.0) for the first 3 months after valve insertion in the mitral position (Grade 1C+) and in the aortic position (Grade 2C). For patients with bioprosthetic valves who are in sinus rhythm and do not have AF, we recommend long-term (> 3 months) therapy with aspirin, 75 to 100 mg/d (Grade 1C+).