The socio-political transformations occurred during modern times generated a radical shift in self-perception of individuals. They no longer see themselves as subjects. Religious and political paternalism have become extinct, and now people demand to be recognized as autonomous individuals capable of deliberation. The term, citizen, becomes stronger and they themselves ask to be heard and respected as active participants in shaping social reality. The practice of medicine is not indifferent to these processes and the atavistic model (the genetic condition that is inherited from past generations) which applies to the paternalistic, clinical relationship, where the professional, due to their qualifications and based on welfare, decided what was best for the patient, started to crumble. Now, the patient requires an active recognition of their autonomy, which entails a new way of exercising the clinical setting through dialogue and deliberation. This new patient-citizen initiative, which is subject to rights and duties, requires self-judgment in various medical scenarios that determine one’s health. In this scenario, informed consent arises, and although autonomy is often stated to be the principle behind it, which states that decision- making related to health must respect the subjectivity of the patient, it needs, as an integral process of other principals, generators of early duties in the other protagonist of the clinical setting: the clinician. Non-maleficence and justice constitute the framework that determines the limitations of the range of decisions to make, between professional and patient.
Early ductal decompression in the treatment of acute biliary pancreatitis with ampullary obstruction is controversial. The objective of this study is to determine the methodological quality, internal and external validity of the article of Acosta et al. (2006), that compares the effectiveness of early ductal decompression versus conservative management in acute biliary pancreatitis with ampullary obstruction. Acosta et al., article was subjected to a therapy User’s Guide. Subsequently its methodological quality was analyzed applying 3 instruments; MINCIR therapy, CONSORT and SIGN. The application of these instruments was performed independently by four researchers, trained in critical analysis of the literature and clinical epidemiology. The article is not oriented to a definite question. It has a random assignment of participants, but these were not properly considered until the end of the study. It has 16 points of MINCIR scale (cut-off of the methodological quality construct is 18). Fulfills with only 10 of the 21 items of CONSORT. All the instruments used put in evidence similar methodological weaknesses that lead to questioning of the internal and external validity of the study, a fact that in turn makes questioning the logic of the applicability of this protocol.
Early ductal decompression in the treatment of acute biliary pancreatitis with ampullary obstruction is controversial. The objective of this study is to determine the methodological quality, internal and external validity of the article of Acosta et al. (2006), which compares the effectiveness of early ductal decompression versus conservative management in acute biliary pancreatitis with ampullary obstruction. Acosta et al. (2006), article was subjected to a therapy User’s Guide. Subsequently its methodological quality was analyzed applying 3 instruments; MINCIR therapy, CONSORT and SIGN. The application of these instruments was performed independently by four researchers, trained in critical analysis of the literature and clinical epidemiology. The article is not oriented to a definite question. It has a random assignment of participants, but these were not properly considered until the end of the study. It has 16 points of MINCIR scale (cut-off of the methodological quality construct is 18). It complies with only 10 of the 21 items of CONSORT. All instruments used put into evidence similar methodological weaknesses that lead to questioning of the internal and external validity of the study, a fact that in turn questions the logic of the applicability of this protocol.
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