ts-med conferencia 4.1: criterios de selección -1 eficacia
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Criterios de selección -1EFICACIA
Taller se selección de medicamentos en SSRConferencia nº 4.1
Albert Figueras
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¿Qué significa eficacia?
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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
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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
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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
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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
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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?
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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?
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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?
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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)