TS-med Conferencia 4.1: Criterios de selección -1 EFICACIA

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TS-med Conferencia 4.1: Criterios de selección -1 EFICACIA

  1. 1. Criterios de selección -1 EFICACIA Taller se selección de medicamentos en SSR Conferencia nº 4.1 Albert Figueras
  2. 2. ¿Qué significa eficacia?
  3. 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 ofResearch in Psychopharmacology. PLoS ONE 5(3): e9479. doi:10.1371/journal.pone.0009479http://www.plosone.org/article/info:doi/10.1371/journal.pone.0009479
  4. 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 ofResearch in Psychopharmacology. PLoS ONE 5(3): e9479. doi:10.1371/journal.pone.0009479http://www.plosone.org/article/info:doi/10.1371/journal.pone.0009479
  5. 5. 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
  6. 6. 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
  7. 7. 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?
  8. 8. 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?
  9. 9. 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?
  10. 10. 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 deestudios primarios que analizan la misma hipótesisde la misma manera)

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