Evidence-Based Practice Introduction to methods and searching for Librarians

1. Evidence-Based PracticeIntroduction to methods and searching for Librarians Ann McKibbon MLS PhD McMaster University mckib@mcmaster.ca

2. Have fun Stretch your minds Make clinical decisions Ask questions and make comments Make mistakes and say dumb things Develop some new skills Stop me for breaks Rules for the day

3. Morning Agenda Introduction to EBM EBM and the question EBM and searching/retrieval Categories of care How are the similar How are they different EBM and the article Types of articles What makes a “good’ one

4. Agenda How they differ? What makes them strong? How do I find them? Therapy Diagnosis Prognosis Etiology/harm Systematic reviews

5. Current Working (Pragmatic) Definition …a set of tools, resources, and procedures …for finding current best evidence from research …and applying this evidence …for decision making with respect to the care of individual patients (EBM, EBN, EBD, EBHC) the care of groups of people (EBPublic Health) the running of your library (EBL) raising your child (EBParenting) …taking into account the situation, culture, resources, and common sense

6. Historical Roots of EBP Daniel—first clinical trial with Shadrack, Meshack, and Abednigo The results? At the end of 10 days, they "appeared better and fatter than all the young men who had been eating the royal rations" (v:15), and …the king found them in learning and wisdom to be "ten times better than all the magicians and enchanters in his whole kingdom" (vs:18-19).

7. Ibn Sina (981-1037) Rules of drug evaluation The drug must have a specific defined mode of action It must be tested on a well defined disease The time of action must be observed The effect of the drug must been seen to occur consistently in many cases The experimentation must be done on the human body (horses or lions may react differently than a human)

8. Historical Roots of EBP Lind—scurvy Late 1700s 12 sailors Dramatic results Slow implementation

9. Osler—Information It is astonishing with how little reading a doctor can practice medicine, but it is not astonishing how badly he may do it.

10. Historical Roots of EBP First randomized trial --not enough drug in UK --George Orwell not eligible for trial

11. EB Health Care—First Version Patient Evidence Clinical Expertise

12. EB Health Care—New Version Clinical Circumstances Clinical Experience Patient preferences Evidence and actions

13. 5 Steps of EBHC • Framing the question appropriate to the needs of the patient • Finding the evidence • Evaluating the evidence (critical appraisal) • Making and doing the decision • Evaluation of the whole process

14. Critical appraisal Three-step process • Find out how good (strong) the evidence is (assessment of the methods) • Find out what the results are and how strong they are • Figure out how our patient (or patient group) and settings matches with the study patients and setting

15. Critical appraisal Go to first page of supplemental package Pictorial representation of the EB process from a clinical perspective Most of the steps are done intuitively and not on paper

16. Why our searching skills are important

17. New Awareness of the Importance of Evidence and Difficulties to Find/Accumulate Systematic reviews and meta-analyses Presence of search strategies a measure of quality Expert searching—have we lost our edge? Seeing a true collaboration (work as equals) Searching and data management Cochrane and Campbell Collaborations, DARE Librarians full members with own sections on methods CADTH, AHRQ and Technology Assessment As above (Jessie McGowan) Guidelines and Care Maps Librarians true partners (Ruth Holst) Professional Societies hire librarians/contract for services CFPC, CMA, ACOG, AAN

18. Need for new information tools and techniques Books and book-like products Clinical Evidence has much librarian input—searching etc PIER from ACP Summary Journals ACP Journal Club, EBM, EBN Web pages and sites MEDLINEPLUS and Go Local implementations Provide sites and production New products OVID EBM Reviews and other aggregated services PubMED Clinical Queries BMJUpDates+ New services

19. New Respect for our Abilities/Collections Grants Preparation, editing of grants Teaching of grant writing skills (Wessel & Pitt modules) Institutional Review Boards Membership Standards (Kate Oliver) New service opportunities Scherrer and publication process Code Yellow—Library 911 Teaching EBM workshops in Hamilton and Denver Limited only by our Imagination Ability to recognize and create opportunities

20. Clinical Research Move now to looking at clinical research… …the kind of research that is strong enough and applicable enough for use in making/changing clinical decisions

21. Clinical Research • Question based—once question formed • Methods • Observation • Manipulation/experimental • Which is stronger to do? • Which is easier to do? • Do we need both? • Why?

22. Observational or Experimental? • What is the process that elderly people go through as they come to terms with living in an assisted living arrangement? • Does yoga improve fatigue levels in people recovering from cancer? • How effective is this appetite reducing drug in relation to exercise? • Do suduku puzzles protect me from developing Alzheimer disease? • What is my life expectancy now that you have told me I have ALS? • Is this blood test as effective as stomach biopsy at telling me that I have celiac disease?

23. Publishing Wedge (therapy) Idea Idea development Laboratory Animal Early human Phase I Middle human Phase II Late human Phase III

24. Original studies Therapy Diagnosis Prognosis Etiology Clinical prediction guides Differential diagnosis Qualitative studies Syntheses Systematic reviews/ meta-analyses Clinical practice guidelines Economic studies Decision analyses Categories of clinical literature

25. Similarities across categories Done to answer legitimate and important problems and issues Meet standards • Ethical • Moral • Record keeping and reporting • Publishing standards and procedures

26. Similarities across categories • Question based • Preplanned • Comparative • Patients/participants • Results and statistics • Settings • Cultures/health care systems • Conflict of interest/disclosure statements • Funding sources

27. Clinical Question For young children, is a smoke detector/fire alarm that uses a recording of his or her mother’s voice more effective at awakening the child and shortening time to evacuation as compared to a standard tone-based smoke detector?

28. Settings • Important for assessment of match between patient and article • Most often primary care, tertiary care, hospital, office (UK surgery), nursing home, university medical center, chronic care facilities, home care • Compare the “typical” headache seen in above settings

29. Cultures/health care systems • For profit • Not for profit • Managed care • Health maintenance organizations • Medicare/Medicaid • Veterans Affairs Hospitals • Socialized medicine • Two tier vs. three tier

30. Health care systems—assignment What health care system does each country have? What “type” of research comes from each country? • Canada • Israel • Sweden • United Kingdom • Australia • The Netherlands • United States

31. Funding Sources • Complex and costly issue • Competing demands with “for profit” funders vs. “not for profit” funders • Kjaergard and Als-Nilesen showed that • “in pharmacological and nonpharmacological randomised controlled trials from 12 specialties financial competing interests were significantly associated with authors’ conclusions” • “personal, academic and political competing interests were not significantly associated with authors’ conclusions”.

32. Conflict of Interest Researchers or authors of the study or its report stand to gain (probably financially) from certain results of the study. Watch for this. Should be included in the article—usually at the end and in a small font.

33. Differences All articles same for a few features • Question based • Preplanned • Comparative • Patients/participants • Settings • Cultures/health care systems • Funding sources Then different….

34. Therapy

35. Therapy/Treatment • More of these types of studies than any other • Methodology is pretty well established for conducting trials and presenting results • Indexing (and retrieval) excellent

36. Alternate Names • Therapy/Treatment (medicine) • Intervention (nursing) • Prevention and control • Prevention • Primary prevention • Secondary prevention • Tertiary prevention • Quality improvement • Management???

37. How to do a Therapy Trial • 2 or more groups • Each group gets 1 intervention • All groups followed over time • At the end of the trial groups compared to assess outcomes

38. Things to Look for in a Therapy Trial Common sense Allocation concealment Random allocation Blinding Follow-up Sensible and important outcomes

39. Allocation Concealment Done before and during randomization No one with any influence on who goes into which group can have any knowledge of which group is next Differences among outcomes if this is not done—more favourable outcomes

40. Random Allocation You can randomize: • parts of people (e.g., arms, warts) • whole people • families • hospitals or wards (cluster) • towns

41. Methods for Random Allocation Best • Computer methods that do not allow for manipulation of randomization • An agency that has no involvement in patient recruitment such as a pharmacy department • An external trials office that entails calling into a central registration office and providing details of patient before the randomization is done • Sealed, opaque, consecutively numbered envelopes with external checking

42. Blinding Individuals involved in a study (e.g., patients, investigators, research staff) do not know who is assigned to treatment or control groups. Why: Individual expectations can influence study outcomes

43. Types of Blinding Single, double, triple blinding although many more could be listed Masked, dummy also used • Patients • Care providers • Study personnel • Data collectors • Outcome assessors • Data analysts • Report writers • Sponsors

44. Placebo To aid in blinding some trial participants may get something that is not really a treatment or for “real” • Sugar pill in vitamin C trials • Sham ultrasound in treating BPH and both real and sham kept “equivalent” by heating pads placed over treatment sites • Can be for assessors in addition to patient as in fake blood for patients in a scope vs full surgery trial

45. Follow-up Concerns the number of participants who completed the study Look for withdrawals, drop outs, or those who were lost 80% is magic number Common sense

46. Clinical Question Pain is a complex challenge at the best of times and is especially difficult for children. A hospital committee has been formed that wants to look at alternatives to simply increasing the doses of pain meds. Someone has suggested that video games may distract kids with substantial burns from thinking about their pain. Does the following article support this assertion?

47. MeSH Research Comparative study Clinical protocols Placebos* Feasibility studies Clinical trials as topic Pilot projects Clinical trials as topic, I-IV Research design* Multicenter studies Double-blind method* Randomized controlled trials Meta-analysis as topic Patient selection Treatment outcome Random allocation* Single-blind method Sample size

48. Publication Types Clinical trial Clinical trial, phase I Clinical trial, phase II Clinical trial, phase III Clinical trial, phase IV Randomized controlled trial Controlled clinical trial Multicenter study Meta-analysis

49. Subheadings Therapy (explodable) Surgery Radiotherapy Diet therapy Psychology Therapeutic use (explodable) Administration and dosage

50. Textwords Random: Double blind: Double-dummy Mask: Sham: Placebo: Control: trial: Efficacy Effectiveness