1. Criterios de selección -1
EFICACIA
Taller se selección de medicamentos en SSR
Conferencia nº 4.1
Albert Figueras

2. ¿Qué significa eficacia?

3. 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.0009479
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0009479

4. 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.0009479
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0009479

8. 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

9. 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

10. 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?

11. 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?

12. Does the Measurement Matter? Is It Reproducible? Accurate?
How Are Missing Data Addressed?
Do the Design and Methods Conform to
the Prestudy Guidelines?
How Good Are the Results?

13. 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)