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Systematic review and meta analysis applications in medication safety 2

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Systematic review and meta analysis applications in medication safety 2

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Systematic review and meta analysis applications in medication safety 2

  1. 1. Systematic Review and Meta-Analysis Applications in Medication Safety Hadeel Alkofide April 2017
  2. 2. Outline • Overview on systematic reviews (SR) and meta- analyses (MA) • Application of SR/MA on safety data • How to conduct a SR/MA on safety data?
  3. 3. Outline • Overview on systematic reviews (SR) and meta- analyses (MA) • Application of SR/MA on safety data • How to conduct a SR/MA on safety data?
  4. 4. “If only we knew what we know!” “Anything you can do…………. I can do meta!”
  5. 5. What are Reviews? Individual studies One review Why? - Complex issue - Small sample size in individual studies (increase precision) - Resolve discrepancies Narrative reviews Systematic reviews (SR) Meta-analyses (MA) of SR
  6. 6. How are SR and MA Conducted? PICO - Population - Intervention - Comparator - Outcome Define the question1 2 Search the literature - MEDLINE, EMBASE.. Etc. - Grey literature - Ask experts - Hand search 3 Pull articles/Screen abstracts - Apply inclusion/exclusion criteria 4 Read full paper - Apply inclusion/exclusion criteria 5 Data abstraction + assess quality of included studies 6 Conduct analysis i.e. perform Meta- Analysis
  7. 7. How SR/MA Rank Compared to other Designs? Systematic reviews and meta- analyses (of RCTs) Randomized controlled trials (RCT’s) Cohort studies Case-control studies Cross sectional studies Case reports King of the hill
  8. 8. What Questions can be Applied to SR/MA? • Used to summarize evidence in behavioral, social and health sciences • In health sciences SR/MA can be conducted on: Efficacy data Safety data Diagnostic tests Risk factors for diseases (epidemiological data) Economic evaluations
  9. 9. Outline • Overview on systematic reviews (SR) and meta- analyses (MA) • Application of SR/MA on safety data • How to conduct a SR/MA on safety data?
  10. 10. SR/MA on Adverse Events • Not as common as reviews on efficacy of interventions • One study showed that only 5% of published SRs were on adverse effects • Although the number of reviews ↑ over the years Golder et al. Journal of Clinical Epidemiology. 2013
  11. 11. Why Less Reviews on Medication Safety? • In clinical trials specifically, adverse events are poorly, and inconsistently reported • Difficulties in identifying relevant studies when using standard systematic searches techniques • Previously.. Lack of guidance on performing SR on harm New PRISMA checklist for safety data (2016) Huang et al. Pharmacoepidemiology and Drug Safety. 2011 PRISMA: Preferred Reporting Items for Systematic reviews and Meta-Analyses
  12. 12. Using Pharmacoepidemiological Studies in SR/MA of Safety Data • Pharmacoepidemiological studies: Observational studies Individuals are exposed to drugs without a method of assignment (non-interventional studies) Play a major role when conducting SR/MA on safety outcomes
  13. 13. Using Observational Studies vs RCTs • A study compared the estimates of adverse events derived from meta-analysis of RCTs vs. meta-analysis of observational studies: No difference in the pooled effect estimates of adverse events between the two study designs Golder et al. PLoS Medicine. 2011
  14. 14. Searching for Unpublished Studies • Is it that important to search the grey literature? Yes, especially when dealing with safety data
  15. 15. Adding Unpublished Reports • Number of additional trials available for meta-analyses when including unpublished reports Golder et al. PLoS Medicine. 2016
  16. 16. Quality of Published SR/MA on Safety Data • Comparison between the years of 2008 and 2010-11 showed no difference on quality of reporting over time (P=0.079) • Titles in fewer than half the reviews • Almost one third of reviews did not clearly define the adverse events reviewed Zorzela et al. BMJ. 2014
  17. 17. Outline • Overview on systematic reviews (SR) and meta- analyses (MA) • Application of SR/MA on safety data • How to conduct a SR/MA on safety data?
  18. 18. SR/MA on Adverse Events… Example Thomas et al. BMJ. 2015
  19. 19. SR/MA on Adverse Events… Example Thomas et al. BMJ. 2015
  20. 20. Conducting a SR/MA on Safety Data • Like any other review…. Mostly • Look carefully for unpublished studies • Include all study designs in your review when possible • Assess quality of studies, similarly as you would for efficacy data • Have a clear and reproducible search strategy
  21. 21. Thank You Questions

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