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Core modules

What to expect?. Core modules. Introduction Finding out relevant literature General guidelines for literature appraisal Abstract and Introduction appraisal Methods and Results appraisal 1 - Patients and procedures

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Core modules

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  1. What to expect? Core modules • Introduction • Finding out relevant literature • General guidelines for literature appraisal • Abstract and Introduction appraisal • Methods and Results appraisal 1 - Patients and procedures • Methods and Results appraisal 2 - Data collection/management and descriptive analysis • Methods and Results appraisal 3 - Inferential analysis • Discussion and Conclusions appraisal

  2. CONSORT statement

  3. CONSORT statement Moher JAMA 2001

  4. CONSORT statement Moher JAMA 2001

  5. STARD guidelines

  6. STARD guidelines

  7. QUADAS guidelines

  8. QUADAS guidelines Whiting BMCMRM 2003

  9. QUOROM statement

  10. MOOSE

  11. MOOSE Stroup JAMA 2000

  12. MOOSE

  13. The EBM 3-step approach Appraising and using an article from the medical literature in three steps: Step 1 – Are the results of the study (internally) valid? Step 2 – What are the results? Step 3 – How can I apply these results to patient care?

  14. Articles about therapy • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Were pts randomized? • Was randomization concealed? • Were pts analyzed in the groups to which they were randomized? • Were pts in the treatment and control groups similar with respect to known prognostic factors? • Did experimental and control groups retain a similar prognosis after the study started? • Were pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete?

  15. Articles about therapy • What are the results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? • How can I apply the results to patient care? • Were the study patients similar to my patient? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs?

  16. Articles about therapy

  17. Articles about therapy • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Were pts randomized? • Was randomization concealed? • Were pts analyzed in the groups to which they were randomized? • Were pts in the treatment and control groups similar with respect to known prognostic factors? • Did experimental and control groups retain a similar prognosis after the study started? • Were pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete?

  18. Articles about therapy Ardissino JAMA 2004

  19. Articles about therapy • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Were pts randomized? • Was randomization concealed? • Were pts analyzed in the groups to which they were randomized? • Were pts in the treatment and control groups similar with respect to known prognostic factors? • Did experimental and control groups retain a similar prognosis after the study started? • Were pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete?

  20. Articles about therapy Ardissino JAMA 2004

  21. Articles about therapy • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Were pts randomized? • Was randomization concealed? • Were pts analyzed in the groups to which they were randomized? • Were pts in the treatment and control groups similar with respect to known prognostic factors? • Did experimental and control groups retain a similar prognosis after the study started? • Were pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete?

  22. Articles about therapy Ardissino JAMA 2004

  23. Articles about therapy • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Were pts randomized? • Was randomization concealed? • Were pts analyzed in the groups to which they were randomized? • Were pts in the treatment and control groups similar with respect to known prognostic factors? • Did experimental and control groups retain a similar prognosis after the study started? • Were pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete?

  24. Articles about therapy Ardissino JAMA 2004

  25. Articles about therapy • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Were pts randomized? • Was randomization concealed? • Were pts analyzed in the groups to which they were randomized? • Were pts in the treatment and control groups similar with respect to known prognostic factors? • Did experimental and control groups retain a similar prognosis after the study started? • Were pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete?

  26. Articles about therapy Ardissino JAMA 2004

  27. Articles about therapy • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Were pts randomized? • Was randomization concealed? • Were pts analyzed in the groups to which they were randomized? • Were pts in the treatment and control groups similar with respect to known prognostic factors? • Did experimental and control groups retain a similar prognosis after the study started? • Were pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete?

  28. Articles about therapy Ardissino JAMA 2004

  29. Articles about therapy • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Were pts randomized? • Was randomization concealed? • Were pts analyzed in the groups to which they were randomized? • Were pts in the treatment and control groups similar with respect to known prognostic factors? • Did experimental and control groups retain a similar prognosis after the study started? • Were pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete?

  30. Articles about therapy Ardissino JAMA 2004

  31. Articles about therapy • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Were pts randomized? • Was randomization concealed? • Were pts analyzed in the groups to which they were randomized? • Were pts in the treatment and control groups similar with respect to known prognostic factors? • Did experimental and control groups retain a similar prognosis after the study started? • Were pts aware of group allocation? • Were clinicians aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete?

  32. Articles about therapy Ardissino JAMA 2004

  33. Articles about therapy • What are the results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? • How can I apply the results to patient care? • Were the study patients similar to my patient? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs?

  34. Articles about therapy

  35. Articles about therapy • What are the results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? • How can I apply the results to patient care? • Were the study patients similar to my patient? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs?

  36. Articles about therapy

  37. Articles about therapy • What are the results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? • How can I apply the results to patient care? • Were the study patients similar to my patient? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs?

  38. Articles about therapy

  39. Internal validity appraisalaccording to The Cochrane Collaboration • 4 MAIN TYPE OF BIAS POTENTIALLY UNDERMINING RCTs • Ascertainment bias • Non-uniform adjudication of events • Attrition bias • Non-uniform follow-up or compliance to treatment • Performance bias • Non-uniform performance of corollary treatments • Selection bias • The non-random allocation of pts one of the treatment groups http://www.cochrane.org

  40. Articles about harm • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Did the investigators demonstrate similarity in all known determinants of outcome; did they adjust for differences in the analysis? • Were exposed patients equally likely to be identified in the two groups? • Did experimental and control groups retain a similar prognosis after the study started? • Were the outcomes measured in the same way in the groups being compared? • Was follow-up sufficiently complete?

  41. Articles about harm • What are the results? • How strong is the association between exposure and outcome? • How precise is the estimate of the risk? • How can I apply the results to patient care? • Were the study patients similar to the patient under consideration in my practice? • Was the duration of follow-up adequate? • What was the magnitude of risk? • Should I attempt to stop the exposure?

  42. Articles about harm Graham Lancet 2005

  43. Articles about harm • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Did the investigators demonstrate similarity in all known determinants of outcome; did they adjust for differences in the analysis? • Were exposed patients equally likely to be identified in the two groups? • Did experimental and control groups retain a similar prognosis after the study started? • Were the outcomes measured in the same way in the groups being compared? • Was follow-up sufficiently complete?

  44. Articles about harm Graham Lancet 2005

  45. Articles about harm • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Did the investigators demonstrate similarity in all known determinants of outcome; did they adjust for differences in the analysis? • Were exposed patients equally likely to be identified in the two groups? • Did experimental and control groups retain a similar prognosis after the study started? • Were the outcomes measured in the same way in the groups being compared? • Was follow-up sufficiently complete?

  46. Articles about harm Graham Lancet 2005

  47. Articles about harm • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Did the investigators demonstrate similarity in all known determinants of outcome; did they adjust for differences in the analysis? • Were exposed patients equally likely to be identified in the two groups? • Did experimental and control groups retain a similar prognosis after the study started? • Were the outcomes measured in the same way in the groups being compared? • Was follow-up sufficiently complete?

  48. Articles about harm Graham Lancet 2005

  49. Articles about harm • Are the results valid? • Did experimental and control groups begin the study with a similar prognosis? • Did the investigators demonstrate similarity in all known determinants of outcome; did they adjust for differences in the analysis? • Were exposed patients equally likely to be identified in the two groups? • Did experimental and control groups retain a similar prognosis after the study started? • Were the outcomes measured in the same way in the groups being compared? • Was follow-up sufficiently complete?

  50. Articles about harm Graham Lancet 2005

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