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Lectura critica ensayo clínico SPRINT

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Critical appraisal : A Randomized Trial of Intensive versus Standard Blood-Pressure Control

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Lectura critica ensayo clínico SPRINT

  1. 1. lectura critica ensayo clínico SPRINT New Engl J Med. November 9, 2015DOI: 10.1056/NEJMoa1511939 por Rafael Bravo Toledo
  2. 2. P: Pacientes mayores de 50 años, TA de 130 a 180 mmHg con alto riego cardiovascular, sin diabetes en total 9361 pacientes ( se señala lo que se considera alto riego cardiovascular y además otros criterios de inclusión y exclusión) I: Objetivo TA < 120 mmHg C: Objetivo TA < 140 mmHg O: tasa menor de Infarto agudo de miocardio, síndrome coronario agudo, insuficiencia cardiaca, ictus, mortalidad de origen cardiovascular. Como variables secundarias se estudiaron todas las que componían la variable primaria de forma individual, más mortalidad por cualquier causa y una variable compuesta de la variable primaria o mortalidad por cualquier causa. Pregunta en formato PICO del ensayo clínico SPRINT
  3. 3. Lo más importante en un ensayo clínico es que los grupos sean iguales sean iguales en cuanto factores pronósticos con respecto al resultado que se va evaluar validez del ensayo clínico
  4. 4. • Comienzan con el mismo pronóstico – La asignación de los pacientes al tratamiento ¿se hizo de manera aleatoria? – La aleatorización ¿se realizó de forma oculta? es decir se ocultó la asignación a los grupos allocatión concealment – Eran similares los grupos al inicio del ensayo • Se mantuvo este equilibrio durante la duración del estudio – ¿Fueron los pacientes, médicos y personal evaluador de los resultados estudio "ciegos" con respecto al tratamiento administrado? • Se mantuvo el equilibrio cuando se termino el estudio – Se realiza un seguimiento completo y exhaustivo de todos los pacientes hasta el final del estudio? rafael bravo toledo 4
  5. 5. rafael bravo toledo 5
  6. 6. 1- La asignación de los pacientes al tratamiento ¿se hizo de manera aleatoria? rafael bravo toledo 6
  7. 7. 2- La aleatorización, ¿se realizó de forma oculta? es decir se oculto la asignación a los grupos. rafael bravo toledo 7 ?? allocatión concealment
  8. 8. 3- ¿Eran similares los grupos al inicio del ensayo rafael bravo toledo 8 Página 6
  9. 9. 4-¿Fueron los pacientes, médicos y personal evaluador de los resultados estudio "ciegos" con respecto al tratamiento administrado? rafael bravo toledo 9
  10. 10. 5-¿Se realiza un seguimiento completo y exhaustivo de todos los pacientes hasta el final del estudio? rafael bravo toledo 10
  11. 11. 5-¿Se realiza un seguimiento completo y exhaustivo de todos los pacientes hasta el final del estudio? Página 5 rafael bravo toledo 11
  12. 12. 5-¿Se realiza un seguimiento completo y exhaustivo de todos los pacientes hasta el final del estudio? 12 Discontinued intervention refers to participants who discontinued the study treatment but did not withdraw consent or become lost to follow-up.
  13. 13. rafael bravo toledo 13
  14. 14. 6¿Fueron analizados en los grupos a los que se les asigno en la distribución aleatoria? Análisis por intención de tratar. rafael bravo toledo 14
  15. 15. lectura critica ensayo clínico SPRINT Resultados del ensayo clínico
  16. 16. rafael bravo toledo 16
  17. 17. rafael bravo toledo 17
  18. 18. rafael bravo toledo 18 Shown are the cumulative hazards for the primary outcome (a composite of myocardial infarction, acute coronary syndrome, stroke, heart failure, or death from cardiovascular causes) (Panel A) and for death from any cause (Panel B). The inset in each panel shows the same data on an enlarged y axis. CI denotes confidence interval. Primary Outcome and Death from Any Cause
  19. 19. rafael bravo toledo 19 Calculadora EVALMED ≥30% reduction in estimated GFR to <60 ml/min/1.73 m
  20. 20. rafael bravo toledo 20 http://www.curingmedicare.com/#!The-SPRINT-Blood-Pressure-Study-Small- Numbers-Questionable-Significance/c1q8z/5643e9520cf2708e00169405 The SPRINT Blood Pressure Study: Small Numbers, Questionable Significance November 12, 2015
  21. 21. rafael bravo toledo 21 http://www.curingmedicare.com/#!The-SPRINT-Blood-Pressure-Study-Small-Numbers-Questionable-Significance/c1q8z/5643e9520cf2708e00169405
  22. 22. ¿Se consideraron todos los resultados importantes para el paciente? rafael bravo toledo 22
  23. 23. ¿Se pueden aplicar los resultados a la asistencia de mi paciente? ¿Son mis pacientes muy diferentes a los que participaron en el estudio? rafael bravo toledo 23
  24. 24. ¿Los beneficios potenciales superan a los inconvenientes y efectos adversos de este tratamiento? rafael bravo toledo 24 ??
  25. 25. goals in hypertension • our current concept of hypertension is insufficient to determine who benefits from blood-pressure lowering or how far to lower blood pressure. • So what are the most pressing issues in blood pressure research? I’d say they are (a) the identification of those who do not need to take drugs and (b) the best way to share decisions with individuals about treatment based on accurate personal estimates of benefit and harm. http://www.nejm.org/doi/full/10.1056/NEJMe1513301 http://blogs.bmj.com/bmj/2015/11/16/richard-lehmans-journal-review-16-november-2015/

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