PUBMED and the EVIDENCE-BASED UNIVERSE http://nnlm.gov/training/pubmedebm/

1. PUBMED and the EVIDENCE-BASED UNIVERSEhttp://nnlm.gov/training/pubmedebm/ Holly Ann Burt Outreach and Exhibits Coordinator NN/LM GMR

2. objectives • By the end of this class, attendees will be able to: • Define evidence based research, identify process steps and know where the library services fit • Recognize types of studies and understand how they related to levels of evidence • Formulate literature searches to find such evidence • Know where to go for additional information

3. Agenda • Introduction • Just What IS Evidence Based? • Studies, Studies, Studies • Taking it to the Next Level • To Literature and Beyond • Evidence-Based MeSH • MeSH Terms, Subsets, Clinical Queries • Critical Appraisal

4. JUST WHAT ISEVIDENCE BASED?

5. Terminology • Evidence-Based Medicine (EBM) • Evidence-Based Practice (EBP) • Evidence-Based Practice in xxx (EBPx) • Evidence-Based Health Care (EBHC) • Evidence-Based Nursing (EBN) • Evidence-Based Public Health (EBPH) • Evidence Based Library and Information Practice (EBLIP) • Research Based Evidence (RBE)

6. Definitions Evidence-based medicine requires the integration of the best research evidence with our clinical expertise and our patient’s unique values and circumstances. Patient Values Best research evidence Clinical Expertise EBM Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-based medicine: how to practice and teach EBM 3d ed. London: Churchill Livingstone, 2005

7. Definitions Evidence-Based Public Health (EBPH): The process of systematically finding, appraising and using contemporaneous clinical and community research findings as the basis for decisions in public health. Jenicek M, Stachenko S. Evidence-based public health, community medicine, preventive care. Med Sci Monit. 2003 Feb;9(2):SR1-7.

8. Definitions Evidence-Based Practice: A way of providing health care that is guided by a thoughtful integration of the best available scientific knowledge with clinical expertise. This approach allows the practitioner to critically assess research data, clinical guidelines, and other information resources in order to correctly identify the clinical problem, apply the most high-quality intervention, and re-evaluate the outcome for future improvement. NLM MeSH 2009

9. Steps in Evidence Based Research Asking answerable questions Finding the best evidence Critically appraising the evidence Applying a decision Evaluation Heneghan C, Badenoch D. Evidence-based medicine toolkit. 2d ed. Malden, MA: Blackwell, 2007

10. Step 1 • Asking answerable questions – focused, searchable, clinical • PICO • Patient, Problem, Population (subjects) • Intervention or therapy – may include coalition-building and/or collaborative programs (study groups) • Comparison, Control, Context (study groups) • Outcome (results)

11. Step 2 • Finding the best evidence with which to answer the question through structured searches and understanding the literature • Primary Studies • Clinical trials • Randomized Controlled Trials • Multicenter studies • Secondary (synthesized, summarized) Studies • Reviews • Meta-analyses

12. Step 3 • Critically appraising the evidence for its validity (closeness to the truth), impact (size of the effect) and applicability (usefulness in clinical practice) • Is it valid? • Is it important? • Can it help?

13. Step 4 • Applying a decision - Combining findings to make a recommendation, placing the evidence into context, incorporating recommendation into a specific patient situation, clinical setting or organization • How much will it help a patient or population? • Does it meet their values and goals? • Is it cost-effective?

14. Step 5 • Evaluation - Determining and measuring the effectiveness of the practice change over time • How could it be done better next time? • What is the outcome of using (or not using) particular information and its impact on clinical practice?

15. STUDIES, STUDIES, STUDIES

16. STUDIESResearch Design Research Analytical Descriptive Observational Experimental Correlational Qualitative Study Interview Cohort Randomized Clinical Trial Case Studies/Reports Case-Control Non-Randomized Clinical Trial Cross Sectional Community Trial Cambron JA. Study Design. Lombard: National University of Health Sciences; 2008.

17. STUDIESResearch Design – Descriptive • Investigator studies people and exposures in nature, observational • No control or comparison group • Studies • Correlational – statistical association between variables • Case studies – new diseases & treatments, etc. • Case report – documenting research’s experience • Case series – following a group over time • Cross sectional study – survey • Community Survey • Qualitative study– interview w/open-ended question • Migrant studies

18. STUDIESResearch Design – Observational Analytic • Investigator collects data without making changes to patient’s life or introducing treatments • Control/Comparison group, not randomized • Studies • Case Control – etiology; examine associations between disease/disorder/health issue and one or more risk factors • Cohort Study – measurement of one characteristic, outcome, or issues across two groups • Prospective Cohort • Retrospective Cohort • Time Series Study • Cross sectional – to determine prevalence

19. STUDIESResearch Design – Experimental • Investigator chooses and tests intervention, treatment or exposure • Decision as to group allocation can be by either random or non-random methods • Control and/or comparison group used • Note: Random allocation of subjects to is used to reduce selection bias by investigator and evenly allocate subjects on basis of known and unknown characteristics

20. STUDIESResearch Design – Experimental • Studies • Clinical trials • Non-randomized trials (quasi-experiment) • Interrupted time series • Randomized Controlled Trials (RCT) • Double-blind randomized trial • Single-blind randomized trial • Non-blind trial • Crossover trial (may also be observational) • Community trials – conducted directly through doctors and clinics • Laboratory trials

21. STUDIESRandomized Control Trial (RCT) • Gold standard – especially for therapy studies • Participants are randomly allocated into intervention (treatment) and control (placebo) • Phase I – Healthy subjects • Phase II – Small group • Phase III – Large group prior to marketing • Phases IV – Post-marketing study • Rigorous evaluation of a single variable • Seeks to falsify (rather than confirm) it’s own hypotheses • PubMed MeSH: Randomized Controlled Trial [PT]

22. CT Scan Cross Sectional Study My Brother Died of Stroke, Will I?Glasziou P. Why bother with evidence-based practice? Oxford: Centre For Evidence-based Medicine; 2010 Cohort Study Inception Cohort Study Survey Frequency Prognosis Risk Factors Treatments Randomised Trial Treatment Effect Symptoms Signs, Tests Cause(s) Past Current Future

23. Levels of Evidence Kramer BS. Weighing scientific evidence. Washington DC: National Academies Press; 2009

24. Taking it to the Next Level

25. Primary: original research Secondary: review articles Tertiary: textbooks, summaries Levels of Peer Reviewed Information Primary Secondary Tertiary Clark N, IT Applications of EBM Principles. Tallahassee, FL: Florida State University College of Medicine, 2003

26. Review • Review of a body of data that uses explicit methods to locate primary studies and explicit criteria to asses their quality • PubMed: Review [PT]

27. Systematic Review • Review of a body of data that uses explicit methods to locate primary studies and explicit criteria to asses their quality • PubMed: No separate MeSH heading; use the Systematic Review option in Clinical Queries

28. Meta-Analysis • Works consisting of studies using a quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc. • A statistical analysis combining or integrating the results of several independent clinical trials considered by the analyst to be “combinable” usually to the level of re-analysing the original data. Pooling, quantitative synthesis. • PubMed MeSH: Meta-Analysis [PT]

29. Secondary Sources Clark N, 2003

30. Levels of Evidence – 5S Straus S, Haynes RB. Managing evidence-based knowledge: the need for reliable, relevant and readable resources. CMAJ. 2009 April 28; 180(9): 942–945.

31. Systems, Summaries, Synopses • Systems: the ideal. A perfect evidence-based clinical information system would integrate and concisely summarize all relevant and important research evidence about a clinical problem and would automatically link, through an electronic medical record, a specific patient’s circumstances to the relevant information. • Summaries/Synopses. Synthesized by experts being extremely reliable and authoritative. Enough and exact information needed to support a clinical action. Removes the patient from the picture and practitioner from the primary literature. Lag between study results, analysis, publication and summary Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-based medicine: how to practice and teach EBM 3d ed. London: Churchill Livingstone, 2005

32. Type of Study Evidence Pyramid Clark N, 2003

33. However: • The types of studies that give the best evidence are different for the different types of questions • In every case, however the best evidence comes from studies where the methods used maximize the chance of eliminating bias Glasziou P, Del Mar C. Evidence-based practice workbook: Bridging the gap between healthcare research and practice. Malden, MA: Blackwell; 2007.

34. Identifying the Best Study Introduction to Evidence Based Medicine. Chapel Hill, NC: Health Sciences Library, UNC-Chapel Hill. 2004.

35. EVIDENCE BASED MESH

36. Clinical Queries • Search by Clinical Study Category • Category • Etiology • Diagnosis • Therapy (default) • Prognosis • Clinical prediction • Scope • Narrow specific search • Broad sensitive search(default) • Systematic Reviews • Medical Genetics Searches

37. Special Queries • Comparative Effectiveness Research • Health Services Research (HSR) Queries • Research Reporting Guidelines and Initiatives • Veterinary Medicine/Animal Health

38. MeSH Terms • Evidence Based Practice [MH] (under Health Occupations) • Evidence-Based Dentistry • Evidence-Based Medicine (also listed under (Clinical Medicine) • Evidence-Based Emergency Medicine • Evidence-Based Nursing

39. MeSH Terms • Study Characteristics [PT] • Case Reports • Clinical Conference • Clinical Trial + • Comparative Study • Census Development Conference (CDC) • CDC, NIH • Evaluation Studies • In Vitro • Meta-Analysis • Multicenter Study • Scientific Integrity Review • Twin Study • Validation Studies

40. MeSH Terms • Clinical Trial [PT] (under Study Characteristics) • Clinical Trial, Phase I • Clinical Trial, Phase II • Clinical Trial, Phase III • Clinical Trial, Phase IV • Controlled Clinical Trial • Multicenter Study • Randomized Controlled Trial

41. MeSH Terms • Useful in text words - use [TW] • Blind • Mask • Random • Placebo • Efficacy • Effective • Crossover [mh] Cohort [mh]

42. Critical Appraisal

43. Critical Appraisal • Is the study valid? • Are the results important? • What were the results? • Will the results help me in caring for my patients? Questions depend on the type of study being appraised Heneghan C, Badenoch D. Evidence-based medicine toolkit. 2d ed. Malden, MA: Blackwell, 2007

44. Reporting Standards • CONSORT – Consolidated Standards of Reporting Trials • MOOSE – Meta-analysis of Observational Studies in Epidemiology • QUORUM – Quality of Reporting for Meta-analysis • STROBE – Strengthening the Reporting of Observations Studies in Epidemiology Brand RA. Standards of reporting: The CONSORT, QUORUM, and STROBE guidelines. ClinOrthopRelat Res. 2009 (467):1383-1394.

45. Critical Appraisal Example • de Haen M, Spigt MG, van Uden CJ, van Neer P, Feron FJ, Knottnerus A. Efficacy of duct tape vs placebo in the treatment of verrucavulgaris (warts) in primary school children. Arch PediatrAdolesc Med. 2006 Nov;160(11):1121-1125. http://archpedi.ama-assn.org/cgi/content/full/160/11/1121 • Van Cleave J, Kemper AR, Davis MM. Interpreting negative results from an underpowered clinical trial: warts and all. Arch PediatrAdolesc Med. 2006 Nov;160(11):1126-1129. http://archpedi.ama-assn.org/cgi/content/full/160/11/1126

46. For More Information Centre for Evidence-Based Medicine - CEMB: http://www.cebm.net/index.aspx?o=1157 EMB Tools (Centre for Health Evidence): http://www.cche.net/usersguides/ebm_tips.asp Tools to support evidence-informed decision making (Health-evidence.ca): http://www.health-evidence.ca/tools/ EPIQ - Critical Appraisal and Evidence-based Practice (University of Auckland): http://www.fmhs.auckland.ac.nz/soph/depts/epi/epiq/ebp.aspx

47. The End of the Beginning

48. PUBMED and the EVIDENCE-BASED UNIVERSEhttp://nnlm.gov/training/pubmedebm/ Holly Ann Burt Outreach and Exhibits Coordinator NN/LM GMR