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Experimentos clínicos aleatorizados são estudos onde se avalia comparativamente a eficácia de dois ou mais tratamentos. A aleatorização enquanto método de seleção dos tratamentos é um aspecto que gera várias críticas de cunho estatístico, bem como questionamentos relacionados à ética médica. A expressão equiparação individual foi introduzida por Freedman (1987) para descrever um estado de genuína incerteza de um pesquisador com relação aos méritos relativos de dois ou mais tratamentos. Em havendo equiparação, seria ético conduzir um experimento clínico aleatorizado. O dilema ético surge ao considerarmos os interesses individuais do paciente. A aleatorização quando utilizada na análise dos dados é o maior alvo das críticas, principalmente sob inferência bayesiana. Quando utilizada no planejamento apenas, a aleatorização é aceita e até mesmo recomendada por Kadane e Seidenfeld (1990). Kadane, Sedransk e Seidenfeld (Kadane, 1996), fazem uma proposta de um planejamento bayesiano (KSS), aleatorizando apenas tratamentos admissíveis para um paciente, de modo que seus imnteresses sejam considerados. Em conjunto com um grupo de anestesistas do Hospital Johns Hopkins, o Prof. Kadane conduziu um experimento clínico utilizando o planejamento bayesiano KSSEvaluating the efficacy of two treatments is the aim of randomized clinical trials. Randomization while a method for selecting treatments is very criticized by bayesian statisticians and also raises many ethical questions. the term individual equipoise was introduced by freedman (1987) to describe a state of genuine uncertainty of the investigator regarding the relative merits of the treatments under study. In having equipoise, it may be ethical to conduct any randomized clinical trial. The ethical dilemma arises when considering the patient's best interest. Randomizing to analyze data is not accepted in bayesian inference. When applied to the design only, randomization is accepted and even recommended by Kadane and Seidenfeld (1990). Kadane, Sedransk e Seidenfeld (Kadane, 1996) have proposed a bayesian design (KSS), which randomizes a treatment only if it is considered admissible to a patient. A clinical trial using the KSS design was conducted by Prof. Kadane, together with a group of anesthesiologists of Johns Hopkins Medical Institutuo

Secular trends in a population with ischemic heart disease admitted to the Instituto do Coração in São Paulo

OBJECTIVE: To assess the clinical and demographic characteristics of a population with ischemic heart disease admitted in the final decades of the 20th century. METHODS: This study retrospectively assessed patients hospitalized with ischemic heart disease divided into the following 2 groups: acute group - 11.181 patients with acute myocardial infarction admitted from 1/1/82 to 12/31/94; and chronic group - 4.166 patients undergoing coronary artery bypass graft surgery from 1/1/84 to 12/31/94. RESULTS: In the acute group, an increase in the percentage of females (from 22.7% to 27.7%, P<0.001) and diabetic individuals (from 12.4% to 17.5%, P<0.001) was observed, as was an increase in age (from 57.4±11.5 to 59.9±12.1 years, P<0.05). In-hospital mortality was greater among females (27.8% and 15.7%, P=0.001), among diabetic individuals (24.2% and 17.8%, P=0.001), and among the elderly (60.9±15.2 and 57.7±11.8 years, P=0.0001). In the chronic group, an increase in the percentage of females (from 17.5% to 27.2%, P=0.001) was observed, as was an increase in age (from 56.3±8.6 to 60.5±9.6 years, P=0.0001). In-hospital mortality was greater among females (8.3% and 5.8%, P<0.05) and among the elderly (58.1±9.1 and 62.1±7.9 years, P=0.0001). CONCLUSION: The characteristics of the population studied with ischemic heart disease point towards a worse prognosis, due to the greater percentages of females, older patients, and diabetic patients, groups known to have greater in-hospital mortality

Demographic characteristics of the population undergoing cine coronary angiography at the Instituto do Coração of the Medical School of USP from 1986 to 1995

OBJECTIVE: To obtain information about the profile and behavior of a population with ischemic heart disease undergoing cine coronary angiography and to determine disease severity. METHODS: Retrospective study assessing patients hospitalized at InCor from 1986 to 1995, in which the variables age, sex, and number of major coronary arteries with obstruction degree > 40% were analyzed. RESULTS: We studied 18,221 patients and observed a significant increase in the number of females (22.8% to 25.2%, P=0.001) and an increase in age (57.1±29.3 to 60.4±10.7 years, P=0.0001). A significant increase in the incidence of multivessel disease was observed, which was more frequent among males (69.2% and 64.5%) and among the older patients (59.8±9.8 and 56.8±10.7 years, P=0.0001). A reduction in the incidence of single-vessel disease was also observed (66.2% vs 69.2% and 33.8% vs 30.5%, respectively, P<0.0001). CONCLUSION: A change in the profile of the population studied was observed as follows: patients undergoing cine coronary angiography at InCor were older, had a greater number of impaired major coronary arteries, and the number of females affected increased, leading to indices suggestive of a poorer prognosis