[Are authors allowed to make up what is valid when it comes to challenge and conflict of interest?].
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Biomedical subjects
Publications and source records attributed to Lars Werkö.
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A cornerstone in health care is the duty to inform patients not only of their right to partake in decisions about their care but also of the various options for treatment. This applies particularly in clinical research, for which the Helsinki Declaration has defined patients' rights. Informed consent is of great importance both in routine care and in clinical research. Directives defining informed consent in relation to clinical trials have been issued by The EU Commission. The Department of Health and Social Security in England has also published several documents governing patient consent. Even if information is given to the patient it is not always comprehended. In one study of cancer treatment about one third of the patients had misunderstood the information in certain respects.
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OBJECTIVE: Evolution of revascularization and medical therapy has increased the probability of improved survival in patients with stable angina. The present investigation tests the hypothesis that medical practice will generate lower mortality than randomly assigned bypass surgery in the European Coronary Surgery Study (ECSS) two decades earlier. METHOD: Using eligibility criteria of ECSS, a clinical decision strategy (CDS) cohort of 362 patients was selected from a nationwide study of medical practice in Sweden. Access to the individual data allowed common protocol design to compare 5-year mortality between CDS and surgical strategy of ECSS. RESULTS AND INTERPRETATION: CDS advised bypass surgery (BS) or percutaneous transluminal coronary angioplasty (PTCA) in 93% and medical treatment alone in 7%, while 94% of 394 patients randomized to surgery (Euro-S) in ECSS obtained BS. Operative mortality was 3.2% for Euro-S while no operative deaths occurred in CDS reflecting medical progress during two decades. However, the 5-year mortality for CDS decreased first when the risk ratio was adjusted for age, diabetes mellitus and hypertension (RR = 0.49 with 95% CI 0.26-0.93) p = 0.03 suggesting a need for improved comprehensive medical care.
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