Norberto Chvez-Tapia Departamento de Investigacin Biomdica Fundacin Clnica Mdica Sur

Estudios de intervencin

Validez y aplicabilidad

Cochrane system
Sequence generation
Low risk of bias, if the allocation

Incomplete outcome data

Low risk of bias, if there were no

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

post-randomisation drop-outs or withdrawals. 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. described as double blind and the method of blinding involved identical placebo or active drugs.

Selective outcome reporting

Low risk of bias, considering that

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.

Blinding
Low risk of bias, if the trial was

Sesgo?

Desenlaces relevantes
Clnicamente significativo
Objetivo primario versus objetivo secundario Deselances compuestos

Tipo de pacientes

Significado clnico vs. Significado estadstico

Al paciente no le interesa el valor de P Un valor de P ms pequeo no significa mas

efectividad Valorar el tipo desenlace y su magnitud

%
RR u OR NNT

Post-hoc

Es posible?
Protocolo
Sentido biolgico y clnico Disponible Contaminacin y co-intervencin

Inclusin de pacientes
Intencin a tratar Peor escenario posible (Error tipo 2, excesivo escepticismo) Por protocolo, pacientes elegibles, etc.