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EBP: WHERE ARE WE?

EBP: WHERE ARE WE?. Jay Rosenbek, Ph.D. Professor and Chair Dept of Communicative Disorders Jrosenbe@phhp.ufl.edu. USUAL EXPECTATIONS. Review all the literature Hold it up to one of the scales of level of evidence Pronounce that we are making progress but could do better. NO NEED.

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EBP: WHERE ARE WE?

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  1. EBP: WHERE ARE WE? Jay Rosenbek, Ph.D. Professor and Chair Dept of Communicative Disorders Jrosenbe@phhp.ufl.edu

  2. USUAL EXPECTATIONS • Review all the literature • Hold it up to one of the scales of level of evidence • Pronounce that we are making progress but could do better

  3. NO NEED • VA and many of people in this room compiled the data • And its available on several web sites

  4. EXAMPLES • ANCDS in cooperation with the VA undertook to generate EBP guidelines • Goal was • Assisting clinicians in decision-making about the management of specific populations through “guidelines” based on research evidence

  5. SITE • ANCDS.ORG

  6. SAMPLE CONTENT • VPI management • Spaced-retrieval practice • Spasmodic dysphonia • Respiratory phonatory systems in dysarthria • Speech supplementation technologies

  7. USE • Source of the studies • And their evaluation • And other research needs in the area

  8. ALTERNATIVE • Evaluate EBP • Rather than using EBP to evaluate our profession

  9. DEFINITION • EBP is the “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients” Sackett, Richardson, Rosenberg, Haynes. Evidence-based Medicine. Churchill Livingstone, 1998 This is the usual definition

  10. SOMETIMES NEGLECTED • “The practice of evidence-based medicine means integrating individual clinical experience with the best available external evidence from systematic research”

  11. NEARLY ALWAYS NEGLECTED • “If you want to practice EBM, merge it with becoming the best history taker and clinical examiner you can be, incorporate it into becoming the most thoughtful diagnostician and therapist you can become and consolidate it in your evolution into an effective, efficient, caring and compassionate clinician”

  12. DISTORTIONS • RCT data are the only data worth considering • Its cookbook care dictated by MBAs

  13. EVIDENCE • Not all RCTs are equal • Primary outcomes can be the wrong ones • At least one study of weight assisted gait training showed no effect on an outcome that actually had nothing to do with functional walking

  14. MORE TO POINT • RCTs are not always available • Not always necessary • AND • Other data can inform clinical practice

  15. RECALL PHASES OF RESEARCH • Robey is responsible for importing into profession the idea of phases of research • An excellent reference is: Robey, R.R. (2004). The five-phase model for clinical-outcome research. J. Commun dis, 37, 401-411 • Well known so only use to make other points

  16. PHASE I • Identifying a therapeutic effect • Determine if effect is present in response to tx • Get estimate of its magnitude

  17. DANGER • Robey’s stuff is now widely known • Widely known often translates into old hat • But the first requirement of phase one is critical

  18. IDENTIFYING THE THERAPEUTIC EFFECT • Reflexively SLPs have turned to impairment measures most frequently • Probably fine in the first days of a profession and of a treatment • Perhaps less fine later on and sometimes even in the beginning

  19. WHAT ARE OPTIONS? • Several model driven ones • WHO for example

  20. International Classification of Functioning, Disability and Health (ICF) HEALTHSTATE BODY FUNCTIONS & STRUCTURES ACTIVITY PARTICIPATION PERSONAL FACTORS ENVIRONMENTAL FACTORS

  21. BODY STRUCTURE/FUNCTION • The usual impairment and clinician/diagnostician oriented evaluations

  22. ACTIVITY/PARTICIPATION • Enclosed in box because difficult to distinguish • However the differences can be operationally defined

  23. ACTIVITY • Execution of a task or action by an individual (WHO, 2001) • Shows capacity and identifies a person’s “highest probably level of functioning” • Usually implies a standard environment

  24. PARTICIPATION • Involvement in a life situation (WHO, 2001) • Reveals performance in person’s present environment

  25. CONTEXTUAL FACTORS • Environmental • Personal

  26. ENVIRONMENTAL • Physical • Social • Attitudinal • Environments in which person lives life

  27. PERSONAL • Gender • Race • Age fitness • Lifestyle • Habits • Experience • Education • Etc

  28. INTERACTION • These two interact with body function and structure • Most important for us: they influence how a person will do with rehab • And: they may should influence rehab focus

  29. OTHER MODELS • Include that of the Institute of Medicine • With domains and relationships to person and environment

  30. The Enabling-Disabling Process Biology Environment Lifestyle and (Physical and Behavior social/ psychological) No Disabling Condition Pathology Functional Limitation Impairment Quality Of Life

  31. MODEL REPRESENTS INTERACTION OF INDIVIDUAL AND ENVIRONMENT

  32. TAKEN TOGETHER • Models help identify what classes of evaluation may be useful • And what targets of treatment may be appropriate

  33. EVALUATION • I believe we need a repertoire of measures • Across domains of impairment, functional status and QoL • Of course the one or more we use depend on treatment/experimental question

  34. HOWEVER • Impairmentmeasure from clinician’s point of view is not always appropriate

  35. SURROGATE END POINTS • These are usually physiologic measures such as decreased viral load, cholesterol, blood pressure, and maximum strength and articulatory precision • Fine for Phase I and II • Not fine for Phase III and IV

  36. FLEMING AND DEMETS, 1996 • “For phase 3 trials, the primary endpoint should be a clinical event relevant to the patient, that is, the event of which the patient is aware and wants to avoid” • This article could be required reading for rehabilitationists Ann Int Med, 1996, 125, 605-613

  37. MISLEADING • Failure to measure beyond impairment leads to wrong conclusions with financial and other practice implications • My favorite is late-life exercise • All the rage • Better strength, balance, etc • No change in function or QoL • Keysor, Jette, J Geron, 2001, 56

  38. MORE RATIONALE • “…treatment decisions based on comprehensive individual information are probably more accurate, more flexible, more rational” when based on repertoire of measures • Siegrist, Junge. Sco. Sci Med. 1989, 29, 463-468

  39. ANOTHER ISSUE • Buried in this discussion is a more contentious one • Measures from clinician versus patient’s point of view • Medical model has made us suspicious of the latter

  40. OUTCOMES MANAGEMENT • Defined as a “technology of patient experience” • Defined: “outcomes management is a technology of patient experience designed to help patients, payers, and providers make rational medical care-related decisions based on better insight into the effect of these choices on the patient’s life” • Ellwood NEJM, 1988, 318, 1549-1556

  41. ROLE IN REHAB • Outcome researchers must “inform rehabilitation scientists more thoroughly about the ecological limitations of their dependent measures or of the therapeutic interventions themselves” • Nadeau. A paradigm shift in neurorehabilitation. The Lancet, Neurology, 2002, 1, 126-130

  42. GOAL OF REHABILITATION • Restore best possible functional status and health-related quality of life • “Rehabilitation is a goal oriented and time limited process aimed at enabling an impaired person to reach an optimum mental, physical and/or social functional level” • Dural et al. Disability and Rehabilitation. 2003, 25, 318-323 • Can be mislead about success unless use a repertoire of responses

  43. THREE EXAMPLES • Impairment level measures of swallowing function have modest positive relationship to QoL as measured by SWAL-QOL • McHorney, et al. Dysphagia, 2006 • Tremor and rigidity not significantly correlated with life satisfaction in PD • Dural et al. Disability and Rehabilitation, 2003, 25, 318- • Some of our BRRC treatment studies are showing modest or no change in impairment but substantial change in family report of functional performance

  44. INTERPRETATIONS • Some measures are invalid • Measures, if psychometrically sound, sample different domains of experience/result of illness and rehabilitation

  45. BACK TO PHASES • Phase II purposes include • Refine outcome construct and identify valid and reliable measurement instruments • Refine the treatment protocol

  46. BACK TO EBP • Its not just about RCT • Single-case designs • Cohort studies • Case reports • Expert opinion all contribute

  47. USEFUL DISTINCTION • Best evidence possible • Best evidence available

  48. AND • Its not just about impairment domain measures • Depending on stage of research and research question other domains may contribute more

  49. AND ONE MORE • Clinical experience and insight are key components • Hence DBP will never be cookbook practice in the hands of our best clinicians

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