Systematic reviews of adverse effects and other topics not – yet – covered by the Cochrane Collaboration

Systematic Reviews of Adverse Effects and Other Topics Not Yet Covered by Cochrane Reviews Gerald Gartlehner Donau-Universität Krems, Department für Evidenzbasierte Medizin und Klinische Epidemiologie Symposium anlässlich des 10-jährigen Bestehens des Deutschen Cochrane Zentrums 2. April 2008

Objectives ,[object Object],[object Object],[object Object]

Benefits Harms A systematic review emphasizing only benefits is likely to lead to biased conclusions

Cochrane Reviews Underemphasize Adverse Effects ,[object Object],[object Object]

[object Object],[object Object]

RCTs and Adverse Effects – Major Issues ,[object Object],[object Object],[object Object]

Inadequate Assessment and Reporting ,[object Object],[object Object],[object Object],[object Object],[object Object]

Example: Second-generation Antidepressants ,[object Object],[object Object],[object Object],Gartlehner et al. Comparative Effectiveness Review No 7: Agency for Healthcare Research and Quality. January 2007

Reporting of Sexual Adverse Events in RCTs of Antidepressants

Mean Incidence of Sexual Adverse Events in RCTs

Mean Incidence of Sexual Adverse Events in Observational Studies

Methodological Limitations of RCTs to Assess Harms ,[object Object],[object Object],[object Object]

Methodological limitations of RCTs to assess adverse effects ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Publication Bias: Antidepressants in Children ,[object Object],[object Object],[object Object],(Whittington et al. Lancet 2004; 363: 1341-45)

How can the limitations be overcome? ,[object Object],[object Object],[object Object],[object Object]

“ Observational studies” refers to a broad range of study designs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Case reports ,[object Object],[object Object],[object Object]

Observational Studies and Confounding ,[object Object],[object Object],[object Object]

Asymptomatic Carotid Artery Surgery Trial (ACAS) ,[object Object]

Applicability - What Decision Makers Need To Know ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

APPLICABILITY ( external validity, generalizability) Can I apply results to my population of interest? Can it work (under ideal circumstances)? Will it work (in real life)?

How can we facilitate the assessment of applicability? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Criteria to distinguish efficacy from pragmatic trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],(Gartlehner et al. A simple and valid tool distinguished efficacy from effectiveness studies. J Clinical Epidemiology 2006; 56:1040-1048)

Summary ,[object Object],[object Object],[object Object]

Systematic reviews of adverse effects and other topics not – yet – covered by the Cochrane Collaboration

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