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How can we improve the reliability and transparency of published medical research

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US Cochrane Center
US Cochrane Center

This document discusses several issues that undermine confidence in published medical research: 1. Poor methodology, selective reporting, and biased interpretation of results are common problems. 2. Reporting is often inadequate, omitting key details about how studies were designed and conducted. 3. Peer review is limited and cannot guarantee scientifically sound papers. Readers should be cautious in their interpretation.

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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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How can we improve the reliability and transparency of published medical research

  • 1. How much confidence can we have in published medical research? Doug Altman Centre for Statistics in Medicine University of Oxford
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  • 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)
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  • 14. [Chan et al, JAMA 2004]
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  • 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
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  • 41. Perrone et al, Eur J Cancer 2008
  • 42. Perrone et al, Eur J Cancer 2008
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