1. Presented by: MahmoudAbdulhakam Drug Information,Guidelines, and HIPAALinda S. Tyler, PharmDUniversity of Utah Hospitals &Clinics, Salt Lake City, Utah

2. Compare and contrast types of guidelines Evaluate a clinical guideline Interpret information presented in meta analysis Describe ways to search PubMed more effectively Describe how HIPAA impacts patient care and research Types Objectives

3. Evidence based Consensus based Types ofClinical guidelines

4. AGREE instrument CASP tool Bandolier Evaluating Guidelines

5. Appraisal of Guidelines Research and Evaluation Collaboration International group 22 questions Evaluate on 4 point scale AGREE Instrument

6. Overall objective is specifically described Clinical question specifically described Patients to whom the guideline applies are specifically described Scope and purpose

7. Stakeholder involvement Relevant professional groups included Patients views and preferences Target users clearly defined Piloted with target users

8. Rigor of development Systematic methods used to find evidence Criteria for selecting evidence defined How recommendations made clearly described Benefits and risks evaluated Clear link between evidence and recommendations External review by experts prior to release Updating method provided

9. Clarity and presentation Specific and unambiguous Different options clearly presented Key recommendations easily identifiable Has tools for application

10. Applicability Organizational barriers discussed Cost implications considered Key review criteria for monitoring or auditing purposes

11. Editorial independence Independent from the funding body Conflicts of interested recorded Overall Assessment: Would you recommend these guidelines for use in practice?

12. Independent group based out of Oxford to promote evidence based medicine principles Essay on what makes a good guideline with two page checklist EBM glossary Bandolier

13. Agency for Healthcare Research and Quality (AHRQ) Catalog of guidelines Ability to compare guidelines you can Limit guidelines to : Guideline category: assessment of therapeutic effectiveness, counseling, diagnosis, education, evaluation, management, prevention, rehabilitation, screening, technology assessment, treatment Methods used to assess and analyze evidence Methods used to formulate recommendations Domain Implementation tools Guidelines with specific features Age, Sex Publication date National GuidelinesClearinghouse

14. View guidelines regarding: Points of comparisons View major recommendations View full text guideline

21. PubMed AHRQ guidelines.gov Cochrane Collaboration National Institute for Clinical Excellence Sources of clinical guidelines

22. ASCO ONS NCCN MASCC International Association for Hospice and Palliative Care Medicine (metasite) Sources of OncologyGuidelines

26. Identifying studies Selection bias Forest plots Heterogeneity Fixed vs random effects Data mutations Subgroups Sensitivity analysis Funnel plots Meta-analysis pearls

27. Address sample size, power ,and beta error issues that occur in individual studies Clear clinical question Why do a meta-analysis?

28. Find everything!! Search at least two appropriate databases Searches of ascendancy and descendancy Unpublished sources Language bias Identifying studies

29. How selected? Was quality assessed? Selection bias: May mean how studies selected! Selection studies

30. Patients Interventions Outcomes Study design Does it make sense tocombine studies?

31. Change continuous data to nominal data Patients who had at least 50% reduction in pain Patients whose BP was in normal range May mean loss of data so decide whether to use or not. Can calculate NNT off of nominal data Data mutations

32. Box (individual studies) ,Point estimate,Size of box: relative sample size Bar: confidence interval Diamond Vertical points: point estimate Horizontal points: confidence interval Forest plot

33. Forest plot

34. Qualitative • Quantitative • Cochran Q • I2 statistic Heterogeneity

35. Look at forest plot Are point estimates highly variable? Do confidence intervals overlap? Qualitative

36. Forest plot: assess overlap

37. Forest plot: significantheterogeneity

38. Only detect substantial difference. Based on Chi square statistic Null: variability is due to chance. P value of less than 0.1 or 0.05 significant heterogeneity Limitations Underpowered for studies with few patients Overpowered for large sample sizes Cochran Q

39. Help resolve issues of over and under power with Cochrane Q Percentage of variability across studies due to true treatment effect Variability across studies due to treatment effect 􀂋0% variability due to chance alone 􀂋0-25% low heterogeneity 􀂋25-50% moderate 􀂋>50% high 􀂋Confidence intervals I2 statistic

40. Fixed vs. random effect

41. Do they make sense? Confounding bias: Potential for confounding bias; can be misleading Fishing expeditions Subgroups may not reflect randomization Subgroups

42. Evaluate the impact of different decisions made in the conduct of study: What happens if poor quality studies are excluded? What happens if the follow-up(cohort) studies are evaluated separately and together? Sensitivity analysis

43. Plot effect size vs. sample size Used to asses publication and selection bias Funnel plots

44. Funnel plots

45. Funnel plots

46. Critical Appraisal Skills Program Tools developed by the Public Health Resource Unit of the NHS in Great Britain. Offers worksheets for evaluating systematic reviews, RCT, cohort, case-control, and economic studies. 10 questions Yes, No, can’t tell Tools for evaluating meta-analysesCASP Tools

47. Clearly-focused question • Right type of studies for question • Find relevant studies • Assess quality of studies • If combined, was it reasonable to do so? • Presenting results: are they clear? Main result easy to identify? • Are the results precise? • Generalizability: can you apply these results? • Were the important outcomes considered? • Should policy or practice change as a result of the review? Bandolier also has a guide for meta-analysis to help assess Use tool to answer: Screening questions Detailed questions

48. Advance search (formerly Set Limits): Preview—Index History:Gives you list of search progress-listed at the top of the advanced search Clipboard: stores articles selected Details: provides a translation for what was searched, were text words or MeSH headings used? Now in box to right of search • DRUG INFO:PubMed

49. I) Use indexing term. Finding the right search term is often a challenge especially in oncology. Pub Med software pretty flexible for using synonyms, but need to use the MeSH term to use subheadings. 2) Definitions of the indexing term 3) Can set subheadings 4) Can restrict to major topic headings only (Pub Med indexes an article by over 70 index terms-however, selects up to 12 as the "major" topic heading. 5) Can decide if want to "explode" term. MeSH is set up on a hierarchy. Indexers use the most specific term to capture the concept of the article 6) Lists synonyms 7) Diagram of the MeSH "tree", the hierarchy. Useful to find other terms that may be more specific for your search. MeSH Database: MeSH=Medical Subject Headings