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How much confidence can we have in published medical research?  Doug Altman Centre for Statistics in Medicine University of Oxford
Richard Horton Editor,  Lancet ,[object Object],[object Object]
John Ioannidis (Epidemiologist,   Greece) ,[object Object],[object Object]
Research and publication  ,[object Object],[object Object],[object Object],[object Object]
The purpose of a research article ,[object Object],[object Object],[object Object],[object Object]
Some major causes of bias ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
3 underlying major problems in medical research ,[object Object],[object Object],[object Object],[object Object]
Composite outcomes ,[object Object]
Post hoc specification ,[object Object],[object Object],[object Object],[object Object],[object Object]
Vasopressin vs epinephrine for out-of-hospital cardiopulmonary resuscitation [Wenzel et al,  NEJM  2004] ,[object Object],[object Object]
Wenzel et al,  NEJM  2004
Wenzel et al,  NEJM  2004 No mention in Methods of planning to look at subgroups Comparison of P values is wrong  No significant difference between 3 groups (interaction test)
Comparing trial publications with protocols ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[Chan et al,  JAMA  2004]
[Chan et al,  JAMA  2004]
Example ,[object Object],[object Object],Primary outcome: % with Score<3 at 1 year Primary outcome: % dead/dependent at 1 year P  0.05 Primary outcome: % with Score<3 at 1 yr Protocol P<0.05 Publication
Comparing trial publications with protocols  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Biased interpretation  ,[object Object],[object Object]
 
Doyle et al,  Arch Surg  2008
“ Patients who undergo liver transplantation at age 60 or above have 1-year and 5-year survival rates similar to those of younger patients …” No mention that the study was of hepatitis C positive patients
Doyle et al Effect of age of donor ,[object Object],[object Object],[object Object],[object Object]
Importance of transparent  reporting of research ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Evidence of poor reporting  ,[object Object],[object Object],[object Object]
519 Randomised trials published  in December 2000   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Poor reporting is a serious problem for systematic reviews and clinical guidelines  ,[object Object],[object Object],[object Object]
Other study types  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case-control studies ,[object Object],[object Object],[object Object]
Selective reporting ,[object Object],[object Object],[object Object]
Impact of poor reporting  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Whose fault is poor reporting? ,[object Object],[object Object],[object Object],[object Object],[object Object]
What can be done to improve research reports? ,[object Object],[object Object],[object Object],[object Object]
What can be done to improve research reports? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Transparency and reproducibility ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
An early call for guidance on reporting clinical trials (1950) ,[object Object],[object Object],[object Object]
The CONSORT Statement for reporting RCTs [Moher  et al,   JAMA/Annals/Lancet  2001] ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Goals of CONSORT ,[object Object],[object Object],[object Object],[object Object]
Impact of CONSORT ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Other guidelines ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
STROBE
Key aspects of reporting  guidelines  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Perrone et al,  Eur J Cancer  2008
Perrone et al,  Eur J Cancer  2008
EQUATOR:  E nhancing the  QUA lity and  T ransparency  O f health  R esearch   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
www.equator-network.org
EQUATOR Core Programme: Objectives  ,[object Object],[object Object],[object Object],[object Object],[object Object]
What does the poor quality of published studies tell us about peer review? ,[object Object],[object Object],[object Object],[object Object]
Some (partial) solutions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reproducible research
How much confidence can we have in published medical research? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 

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Doug Altman 15 Jan09 V4

  • 1. How much confidence can we have in published medical research? Doug Altman Centre for Statistics in Medicine University of Oxford
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.
  • 8.
  • 9.
  • 10.
  • 11. Wenzel et al, NEJM 2004
  • 12. Wenzel et al, NEJM 2004 No mention in Methods of planning to look at subgroups Comparison of P values is wrong No significant difference between 3 groups (interaction test)
  • 13.
  • 14. [Chan et al, JAMA 2004]
  • 15.
  • 16.
  • 17.
  • 18.  
  • 19. Doyle et al, Arch Surg 2008
  • 20. “ Patients who undergo liver transplantation at age 60 or above have 1-year and 5-year survival rates similar to those of younger patients …” No mention that the study was of hepatitis C positive patients
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.
  • 33.
  • 34.
  • 35.
  • 36.
  • 37.
  • 38.
  • 40.
  • 41. Perrone et al, Eur J Cancer 2008
  • 42. Perrone et al, Eur J Cancer 2008
  • 43.
  • 45.
  • 46.
  • 47.
  • 49.
  • 50.