Criterios de selección -1EFICACIA

Taller se selección de medicamentos en SSRConferencia nº 4.1

Albert Figueras

¿Qué significa eficacia?

Figure 4. Changes in abstract reporting over time.

Brunoni AR, Tadini L, Fregni F (2010) Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology. PLoS ONE 5(3): e9479. doi:10.1371/journal.pone.0009479http://www.plosone.org/article/info:doi/10.1371/journal.pone.0009479

Figure 6. Changes in study methodology over time (1).

Brunoni AR, Tadini L, Fregni F (2010) Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology. PLoS ONE 5(3): e9479. doi:10.1371/journal.pone.0009479http://www.plosone.org/article/info:doi/10.1371/journal.pone.0009479

Elementos a tener en cuenta:

- diseño del ensayo clínico - aleatorización y enmascaramiento - comparador- variables

- tipo de análisis de resultados (intención de tratar / por protocolo)

- ....

- relevancia de los resultados

Sources of bias to check for in a randomised controlled trial.

Greenhalgh T BMJ 1997;315:305-308

©1997 by British Medical Journal Publishing Group

Question 1: Was the study original?

Question 2: Whom is the study about?

Question 3: Was the design of the study sensible?

Question 4: Was systematic bias avoided or minimised?

Question 5: Was assessment “blind”?

Question 6: Were preliminary statistical questions dealt with?

Are These Subjects Like My Patients?

What Happened to the Subjects? Did They Drop Out? Why?

Is the Study Design Biased?

Does the Study Include an Intention-to-Treat Analysis?

Is This a Test of Superiority? Equivalence? Noninferiority?

Do the Design and Methods Conform to the Prestudy Guidelines?

How Good Are the Results?

How Are Missing Data Addressed?

Does the Measurement Matter? Is It Reproducible? Accurate?

Más allá del ensayo clínico:

- revisión sistemática (resumen de estudios primarios que usan métodos explícitos y reproducibles) Por ejemplo, las revisiones de la Cochrane Coll.

- metanálisis (síntesis matemática del resultados de estudios primarios que analizan la misma hipótesis de la misma manera)