Fragmento

The purpose of pharmacological and non-pharmacological medical interventions are maintenance of good health, delay pathology and rehabilitate patients with disability. Because any intervention have the risk of adverse effects, physicians have to weigh benefits against harms before deciding the best treatment for the patient condition, a practice of rational prescription supported by high-quality evidence from randomized clinical trials and meta-analysis. Non-rational prescription of therapeutic interventions could result in severe adverse reactions. These unwanted effects could lead to increased patient visits to emergency rooms, prolonged hospitalizations, disability, loss of productivity days and patient death. Adverse reactions increase health care system costs and often lead to legal actions against physicians, hospitals, and pharmaceutical companies. The evaluation of scientific evidence supporting the use of medical treatments interventions depends on the existence of clear, complete and transparent descriptions of the study design, patient recruitment processes, statistical methods used for data analysis, results and conclusions. Prospective registration of clinical trials (i.e.: before the recruitment of the first patient) in a public registry (e.g. ClinicalTrials.gov and controlled-trials.com) is a necessary process to improve the transparency of interventional studies. Disclosure of agreements between the sponsor and the principal investigators, restricting in some way the publication of the study results, should also be appropriately informed in the process of the study registration. Authors must also provide a declaration of competing interests during the publication of the study. For this purpose, the International Committee of Medical Journal Editors (ICJME) have a standard conflict of interests form: http:// www.icmje.org/coi_instructions.html.

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2014-05-28   |   247 visitas   |   Evalua este artículo 0 valoraciones

Vol. 44 Núm.4. Octubre-Diciembre 2013 Pags. 243-246 Colomb Med 2013; 44(4)