The document discusses two important issues that are often not fully addressed in Cochrane reviews: adverse effects and applicability of findings. It notes that many Cochrane reviews underemphasize adverse effects and that randomized controlled trials have limitations for assessing harms. Observational studies can provide supplemental information on harms. The document also discusses how applicability of findings to real-world settings can be better assessed through improved reporting of factors like population characteristics, interventions, and outcomes. A standardized approach is needed to distinguish efficacy from pragmatic trials.

1. 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

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

9. Reporting of Sexual Adverse Events in RCTs of Antidepressants

10. Mean Incidence of Sexual Adverse Events in RCTs

11. Mean Incidence of Sexual Adverse Events in Observational Studies

21. 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)?