Norberto Chávez-Tapia Departamento de Investigación Biomédica Fundación Clínica Médica Sur
Estudios de intervención
Validez y aplicabilidad
Cochrane system Sequence generation Low risk of bias, if the allocation sequence was generated by a computer or random number table. Drawing of lots, tossing of a coin, shuffling of cards, or throwing dice were also considered as adequate if a person who was not otherwise involved in the recruitment of participants performed the procedure Allocation concealment Low risk of bias, if the allocation of patients involved a central independent unit, on-site locked computer, identically appearing numbered drug bottles or containers prepared by an independent pharmacist or investigator, or sealed envelopes. Incomplete outcome data Low risk of bias, if there were no post-randomisation drop-outs or withdrawals. Selective outcome reporting Low risk of bias, considering that most of the included trials were made before of the obligatory registration on randomised controlled trials databases, and the pre-specified outcomes are not available. The following outcomes were considered fundamental as outcome to avoid selective reporting; a) mortality, b) response rate, and c) adverse events. Blinding Low risk of bias, if the trial was described as double blind and the method of blinding involved identical placebo or active drugs.
¿Sesgo?
Desenlaces relevantes Clínicamente significativo Objetivo primario versus objetivo secundario Deselances compuestos
Tipo de pacientes
Significado clínico vs. Significado estadístico Al paciente no le interesa el valor de P Un valor de P más pequeño no significa mas efectividad Valorar el tipo desenlace y su magnitud % RR u OR NNT Post-hoc
¿Es posible? Protocolo Sentido biológico y clínico Disponible Contaminación y co-intervención
Inclusión de pacientes Intención a tratar Peor escenario posible (Error tipo 2, excesivo escepticismo) Por protocolo, pacientes elegibles, etc.