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					Evidence-Based Practice
     Resources for the Busy Clinician
                           06.08.2006




   Lorrie Ippensen Vreeman, PT, DPT
Clinical Assistant Professor of Physical Therapy – Indiana University
      Pediatric Physical Therapist – Clarian Health; Firsts Steps
               Objectives
• At the end of this session you should
  be able to:
  –   Explain the significance of EBP
  –   Follow the EBP process to answer your
      clinical questions
What is EBP and Why all the
          Hype?
                                                What Is EBP?
         “The conscientious, explicit, and judicious
           use of current best evidence in making
            decisions about the care of individual
             patients. The practice of EBM means
           integrating individual clinical expertise
               with the best available external
            evidence from systematic research.”



*   Sackett DL, Rosenberg WM, et al. Evidence based medicine: what it is and what it isn’t. BMJ 1996;312(13):71-72
       Why all the Hype?
• Justification
  – The cost-conscious healthcare
    environment
  – Care that is effective and efficient
  – Professional responsibility
                    PTs’ Perspective on EBP
     •           Generally positive view of EBP
     •           Interested in increasing skills and amount
                 of evidence
     •           Reported use of databases to search
                 literature was related to computer access
             –        Home > Work
             –        Practice setting-dependant
     •           Lack of time was the greatest reported
                 barrier


•   Jette DU, Bacon K, et al. Evidence-based practice: beliefs, attitudes, knowledge, and behaviors of physical therapists. Phys Ther.
    2003;83(9):786-805.
      Clinical Decision-Making

• Clinicians have daily questions about
  practice
• To answer our questions and best serve
  our patients, we need strategies
  – To assist in critical appraisal
  – To use the literature to inform our practice
     Journeys Beyond the Horizon
           Jules M Rothstein, PT, PhD, FAPTA
             32nd Mary McMillan Lecture


“If you care for your patients, don’t you
 want to know whether your interventions
really work? The only way we can know is
  through clinical trials with controls. In a
very real sense, we, like other health care
    professionals, abuse the trust of our
 patients when we give the impression of
       knowing more than we do.”
The EBP Process
                    The EBP Process
                              Patient              Monitor
                             Problem:           literature for
     Interpret                  EBP            new evidence
evidence relative             begins
    to patient               and ends
     problem                   here!


                                                 Formulate
                                                  Clinical
   Critically                                     Question
appraise level
 of evidence
                       Conduct search:
                      systematic review   Identify type of
                         &/or Primary         question:
                           literature        diagnosis,
                                             prognosis,
                                            intervention
    Formulating the Clinical Question

    • Construct an answerable clinical
      question that asks for specific knowledge
      about managing patients with a disorder
    • Four components:
       –   Patient, population or problem
       –   Intervention
       –   Comparison intervention (if appropriate)
       –   Clinical outcome


•   Evidence Based Medicine: How to Practice and Teach EBM. Sackett et al. 2000
 Identify Type of Clinical Question
• Clarifying the type of evidence sought
  –   Clinical findings
  –   Etiology
  –   Clinical manifestations of disease
  –   Differential diagnosis
  –   Diagnostic tests
  –   Prognosis
  –   Therapy/intervention
  –   Prevention
  –   Experience and meaning
  –   Self-improvement
 Identify Type of Clinical Question

• Diagnosis
  – How well does this test distinguish people
    with and without the condition of interest?
• Prognosis
  – What is the likelihood that an individual will
    have a specific outcome?
• Intervention
  – Do people who have this treatment have
    better outcomes?
                            Conducting the Search

    • Search strategy – tracking down info
          –     Asking an expert
          –     Checking reference lists in textbooks
          –     Checking your files
          –     Using a bibliographic database
                   • Ovid Technologies
                   • Evidence-based Medicine Reviews
                   • Cochrane Library
                   • MEDLINE/PubMed®


•   Oxman AD. Sackett DL. Guyatt GH. Users' guides to the medical literature. I. How to get started. The Evidence-Based Medicine Working Group. JAMA. 1993;270(17):2093-5,5
•   http://www.apta.org/AM/Template.cfm?Section=Research&TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=24480
    Critically Appraising the Literature

    • First question applied to an article once
      tracked down:
          – “are the results of this article valid?”
    • Two key guides to assess validity for
      primary studies and integrative studies

    Rapidly screen abstracts
    Choose 1-2 articles most likely to provide a
     valid answer
    Reduce literature to a manageable size
•   Oxman AD. Sackett DL. Guyatt GH. Users' guides to the medical literature. I. How to get started. The Evidence-Based Medicine Working Group. JAMA. 1993;270(17):2093-5,5
•   http://www.apta.org/AM/Template.cfm?Section=Research&TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=24480
    Critically Appraising the Literature
                                                                         Validity




•   Oxman AD. Sackett DL. Guyatt GH. Users' guides to the medical literature. I. How to get started. The Evidence-Based Medicine Working Group. JAMA. 1993;270(17):2093-5,
    Critically Appraising the Literature

    • Validity
          – Lots of subtypes                                                                                                      Diagnosis
                                                                                                                                  Prognosis
    • Reliability                                                                                                                 Examples

          – Inter vs intra rater

                                                                                                                          Intervention
    • Levels of Evidence                                                                                                  Examples




•   Oxman AD. Sackett DL. Guyatt GH. Users' guides to the medical literature. I. How to get started. The Evidence-Based Medicine Working Group. JAMA. 1993;270(17):2093-5,5
•   http://www.apta.org/AM/Template.cfm?Section=Research&TEMPLATE=/CM/ContentDisplay.cfm&CONTENTID=24480
       Critically Appraising the Literature

       • Levels of Evidence (LOE)
                – Help clinicians critically appraise literature
                – Stratifies study designs based on level of
                  confidence that a clinician can have in
                  applying study’s results to an individual
                  patient
                – Certain studies are given a greater level of
                  confidence because they rigorously
                  address bias and confounding factors


All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
       Critically Appraising the Literature
                             Levels of Evidence for Interventions
       1a                     Systematic reviews of RCTs
       1b                     Individual RCTs with narrow CI
       2a                     Systematic reviews of cohort studies
       2b                     Individual cohort studies and low-quality RCTs
       3a                     Systematic reviews of case-controlled studies
       3b                     Case-controlled studies
       4                      Case series and poor quality cohort and case-
                              controlled studies
       5                      Expert opinion
All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
                                                                  Level 1b
    • Randomized Controlled Trial (RCT)
             –     Randomization into groups
             –     Experimental group and Control group
             –     Blinding of subjects and researchers
             –     Groups are followed up for the outcomes of
                   interest




All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
                                                                  Level 2b
    • Cohort Study (and low quality RCT)
             – Identification of two groups (cohorts) of
               patients
                      • One received exposure of interest
                      • One did not
             – Follow cohorts forward for outcome of
               interest
             – Observational study design
                      • Outcomes are observed as they occur


All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
                                                                  Level 3b
    • Case-Control Study
             – Identifying patients who have outcome of
               interest (cases)
             – Control patients without the same outcome
             – Look back (retrospective) to see if they had
               the same exposure of interest




All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
                                                                      Level 4
    • Case Series/ Case Report (and low
      quality cohort and case-control)
             – Report on series of patients with outcome of
               interest
             – No control group




All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
                                                                      Level 5
    • Expert Opinion




All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
Clinical Implications
   EBM in Practice
                    The EBP Process
                              Patient              Monitor
                             Problem:           literature for
     Interpret                  EBP            new evidence
evidence relative             begins
    to patient               and ends
     problem                   here!


                                                 Formulate
                                                  Clinical
   Critically                                     Question
appraise level
 of evidence
                       Conduct search:
                      systematic review   Identify type of
                         &/or Primary         question:
                           literature        diagnosis,
                                             prognosis,
                                            intervention
        Using the EBP Process
                  Example 1
• Patient History:
  – 7 y.o. boy with diagnosis of Spastic
    Diplegia Cerebral Palsy
  – Enjoys fishing, hiking, playing baseball
  – Seen for PT since 18 months of age
  – PT frequency decreased; then put on hold
     • Increased involvement in community activities
     • Missed appointments
  – Referred for reexamination 2º to new
    difficulties playing baseball
         Using the EBP Process
                 Patient Problem
• Patient Examination Findings:
  – Ambulation
     • (B) solid AFOs and Loftstrand crutches
     • Crouch gait; reduced step length; 50% normal velocity
  – ROM [AROM < PROM]
     • Decreased (B) hip extension 0-10º
     • Decreased (B) knee extension -15º
     • Decreased (B) ankle dorsiflexion 0-10º
  – Strength
     • Hip extensors 2+/5
     • Hip flexors 3/5
     • Knee extensors 2/5
     • Ankle dorsiflexors 2+/5
       Using the EBP Process
             Patient Problem
• Patient / Family Goal:
  – Develop more normalized gait pattern in
    order to participate in community
    baseball league
    • Maintain upright stance when batting
    • Increase speed of gait
                                     Using the EBP Process
                Formulating the Clinical Question
    • Does strength training improve
      walking function of
      children with cerebral palsy?

             –     Patient, population or problem
             –     Intervention
             –     Comparison intervention (if appropriate)
             –     Clinical outcome


All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
         Conduct the Search
• Using a bibliographic • Using a bibliographic
  database                database
  – Ovid Technologies
     • MEDLINE            – PubMed®
     • CINAHL
• Keywords searched: • Keywords searched:
  – Cerebral palsy        – Cerebral palsy
  – Strength training     – Strength training
  – Function              – Function
• Combined searches • Combined searches
         Conduct the Search
            Ovid Technologies




• Results of Ovid databases
  – 14 articles found
    • Duplicates removed  8 articles
       Conduct the Search
          Ovid Technologies
• 3 studies seemed appropriate to my
  patient:
        Conduct the Search
                  PubMed®




• Results of PubMed®
  – 21 articles found
       Conduct the Search
               PubMed®
• 5 articles seemed appropriate
Functional outcomes of strength training
       in spastic cerebral palsy.
• 6-week strength training program
• Examined:
   – Isometric strength of 8 mm groups (B) LE w/ hand-held
     dynamometer
   – 3-D gait analysis at free and fast speeds
   – Gross Motor Function Measure (GMFM)
   – Energy expenditure during gait
• Results:
   – Significant strength gains in the muscles targeted
   – Higher gait velocity
   – Greater capacity to walk faster
   – Improvement in GMFM Dimension 5 (walking, running,
     jumping)
   – No change in energy expenditure
   – Asymmetry in strength improved in hemiplegia
A qualitative analysis of the benefits of strength
 training for young people with cerebral palsy.

• Studied (+) and (-) outcomes of a home-
  based strength-training program
• Results:
  – Overwhelmingly positive outcomes
     • Perceptions of improved strength, flexibility, posture,
       walking, and the ability to negotiate steps
     • Psychological benefits of increased well-being and
       improved participation in school/leisure activities
  – Only minor negative responses
     • Equipment
     • Need for parental involvement
A randomized clinical trial of strength training
    in young people with cerebral palsy.
 • Home-based, six-week strength-training
   program on LE strength and physical activity
 • Spastic diplegic cerebral palsy
 • 10 in control group; 11 experimental
 • Results:
    – Experimental group increased their lower limb
      strength at 6 weeks and at a follow-up 12 weeks
      later
    – At 6 weeks, trends were also evident for improved
      scores in Gross Motor Function Measure
      dimensions D and E for standing, running and
      jumping, and faster stair climbing
                   Study selected for review
       Critically Appraising the Literature

    • Levels of Evidence – Level 1b
    • Randomized Controlled Trial (RCT)
             –     Randomization into groups
             –     Experimental group and Control group
             –     Blinding of researchers
             –     Groups were followed up for the outcomes
                   of interest




All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
Critically Appraising the Literature

• Are the results of the intervention trial
  valid?
  – Main Questions to answer:
     • Was the assignment of patients to interventions
       randomized? And was the randomization
       concealed?         Yes
     • Was follow-up of patients sufficiently long and
       complete?          Yes
     • Were all patients analyzed in the groups which
       they were randomized?           Yes
Critically Appraising the Literature

• Are the results of the intervention trial
  valid?
  – Finer points to address:
     • Were patients and clinicians kept blind to
       intervention?       Yes
     • Were the groups treated equally apart from
       the treatment?      Yes
     • Were the groups similar at the start of the trial?
                             Yes
  Interpret Evidence Relative to
         Patient Problem
• With support of valid evidence:
  – Children with CP can improve mm performance
    & gait
  – No adverse effects of strength training
• Decision was made:
  – Provide strength training protocol for pt to meet
    his goals
     • Home-based program 1x/day; 3 days/wk
        – (B) heel raises; half squats, step ups
        – Resistance added to backpack
        – 3 sets of 8-10 reps
     • Outcomes
        – Force production of LE through dynamometry
        – Gait velocity
     • Return to clinic at 2 wks to adjust/educate PRN
     • Continue to monitor monthly for 3 months
                    The EBP Process
                              Patient              Monitor
                             Problem:           literature for
     Interpret                  EBP            new evidence
evidence relative             begins
    to patient               and ends
     problem                   here!


                                                 Formulate
                                                  Clinical
   Critically                                     Question
appraise level
 of evidence
                       Conduct search:
                      systematic review   Identify type of
                         &/or Primary         question:
                           literature        diagnosis,
                                             prognosis,
                                            intervention
        Using the EBP Process
                 Example 2
• Patient History:
  – 6 y.o. girl with diagnosis of Spastic Diplegia
    Cerebral Palsy
  – Enjoys riding her bike, dancing and dolls
  – Seen for PT since 12 months of age for ~6
    wks at a time as needed
  – Referred for reexamination 2º to starting
    Kindergarten at new school
        Using the EBP Process
             Patient Problem
• Patient Examination Findings:
  – Ambulation
    • (B) solid AFOs and posterior walker
    • Crouch gait; reduced step length
  – PROM
    • Decreased (B) hip extension -10º
    • Decreased (B) knee extension -10º
    • Decreased (B) ankle dorsiflexion -10º
  – Plantar flexor spasticity
    • Modified Ashworth score of 3
       Using the EBP Process
             Patient Problem
• Patient / Family Goal:
  – Develop more normalized gait pattern in
    order to negotiate new school
    environment
    • Decrease spasticity
    • Increase ROM of PFs
     Formulating the Clinical Question

  • Construct an answerable clinical
    question that asks for specific knowledge
    about managing patients with a disorder
  • Four components:
         –   Patient, population or problem
         –   Intervention
         –   Comparison intervention (if appropriate)
         –   Clinical outcome


Evidence Based Medicine: How to Practice and Teach EBM. Sackett et al. 2000
                Formulating the Clinical Question
                           Example 1
    • Does serial casting improve
      passive ankle dorsiflexion in
      children with cerebral palsy better than
      serial casting combined with Botox?

             –     Patient, population or problem
             –     Intervention
             –     Comparison intervention (if appropriate)
             –     Clinical outcome

All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
          Conduct the Search
• Using a bibliographic • Using a bibliographic
  database                database
  – Ovid Technologies
       • MEDLINE          – PubMed®
       • CINAHL
• Keywords searched: • Keywords searched:
  –   Cerebral palsy      –   Cerebral palsy
  –   Serial Casting      –   Serial Casting
  –   Range of Motion     –   Range of Motion
  –   Botulinum Toxin     –   Botulinum Toxin
• Combined searches • Combined searches
        Conduct the Search




• Results
  – 11 articles found
        Conduct the Search




• Results
  – 4 articles found
      Conduct the Search
• 4 studies seemed appropriate:
        Conduct the Search
                  PubMed®




• Results of PubMed®
  – 8 articles found
        Conduct the Search
                  PubMed®




• Results of PubMed®
  – 3 articles found
       Conduct the Search
               PubMed®
• 3 articles seemed appropriate
 Serial casting vs combined intervention with
  botulinum toxin A and serial casting in the
   treatment of spastic equinus in children.
• Design:
  – Retrospective; low quality cohort study
• Purpose:
  – Whether botox before serial casting vs
    serial casting alone was associated with
    changes in:
    • Number of weeks necessary to reach desired
      DF ROM
    • Number of degrees of DF ROM gained per
      week of casting
 Serial casting vs combined intervention with
  botulinum toxin A and serial casting in the
   treatment of spastic equinus in children.
• Results:
  – Fewer weeks required to reach goal of 15-
    20º DF for group receiving botox
  – Group receiving botox had significantly
    greater increase in ROM per week
Efficacy of botulinum toxin A, serial casting, and
    combined treatment for spastic equinus: a
             retrospective analysis.
• Design:
  – Retrospective; low quality cohort study
• Purpose:
  – What is the relative impact of botox,
    casting, or combined intervention of pts
    with contractures and spasticity?
  – Is casting superior to botox in improving
    ROM and does botox administered before
    casting improve ROM gained with
    casting?
Efficacy of botulinum toxin A, serial casting, and
    combined treatment for spastic equinus: a
             retrospective analysis.
• Results:
  – Combined group showed a significantly
    greater increase in PROM in comparison
    to botox alone (mean 17º vs 5º)
  – Casting alone showed significantly greater
    increase in PROM in comparison with
    botox alone (mean 15º vs 5º)
  – Change in ROM after casting with and
    without botox was not significantly
    different
Botulinum toxin as an adjunct to serial casting
   treatment in children with cerebral palsy.

• Design:
  – Prospective, randomized trial
• Purpose:
  – Does botox increase efficacy of serial casting?
• Hypotheses: Pts who receive botox in combo
  with serial casting will have
  –   Significantly faster resolution of contracture
  –   Greater reduction of equinus during gait
  –   Greater reduction in spasticity
  –   Greater improvement in gross motor fxn
  –   Longer maintenance of benefits when compared
      to casting alone
Botulinum toxin as an adjunct to serial casting
   treatment in children with cerebral palsy.

• Subjects:
  – 23 children with CP
  – 12 boys; 11 girls
  – Mean age 7.1 ± 3.0 years
  – 9 with hemiplegia; 13 with diplegia; 1 with
    quadriplegia
  – All able to walk (4 used walker; 1 used
    forearm crutches)
• Exclusion:
  – Children with mixed CP, ataxia, athetosis
Botulinum toxin as an adjunct to serial casting
  treatment in children with cerebral palsy.

• Examined Baseline Measures:
  – ROM - goniometer
  – Spasticity – modified Ashworth
  – Gross Motor Function Measure dimensions
    C, D, and E
  – Computerized gait assessment (3 & 12
    mons reassessment)

  – Reassessments at 3, 6, 9, and 12 months
    after start of treatment
 Botulinum toxin as an adjunct to serial casting
   treatment in children with cerebral palsy.

• Results:
  – No diff b/t groups in duration of casting
    required to correct equinus contracture
    (>5º DF)
  – Both groups maintained significant
    improvement in PROM of DF t/o f/u
  – Casting and botox group had significant
    loss of PROM of DF when values at 6, 9, 12
    mons compared to 3 mons
  – Peak DF during stance and swing phases
    was significantly improved in both groups
    at 3 mons; only in the casting group at 12
    mons
 Botulinum toxin as an adjunct to serial casting
   treatment in children with cerebral palsy.
• Results:
  – PF spasticity was significantly decreased at
    3 mons in both groups; was significantly
    decreased at 6, 9, 12 mons only in casting
    group
  – Spasticity was significantly greater in
    casting and botox group than it was in
    casting only group at 6, 9, 12 mons
  – GMFM scores did not change significantly
    in either group at 3 mons; scores were
    significant for both groups starting at 6
    mons for both groups
                Study selected for review
       Critically Appraising the Literature

    • Levels of Evidence – Level 1b
    • Randomized Controlled Trial (RCT)
             –     Randomization into groups
             –     Experimental group and Control group
             –     Blinding of researchers
             –     Groups were followed up for the outcomes
                   of interest




All Evidence is Not Created Equal: A Discussion of the Levels of Evidence. APTA Website: PT Magazine. October 2003
Critically Appraising the Literature

• Are the results of the intervention trial
  valid?
  – Main Questions to answer:
     • Was the assignment of patients to interventions
       randomized? And was the randomization
       concealed?         Yes
     • Was follow-up of patients sufficiently long and
       complete?          Yes
     • Were all patients analyzed in the groups which
       they were randomized?           Yes
Critically Appraising the Literature

• Are the results of the intervention trial
  valid?
  – Finer points to address:
     • Were patients and clinicians kept blind to
       intervention?       Yes
     • Were the groups treated equally apart from
       the treatment?      Yes
     • Were the groups similar at the start of the trial?
                             Yes
  Interpret Evidence Relative to
         Patient Problem
• With support of valid evidence:
  – Use of botox to facilitate serial casting in
    treatment of fixed equinus contractures
    may hasten a recurrence of contracture,
    spasticity and equinus during gait
  – Combo of botox and casting may be
    more appropriate for pts with severe
    spasticity who do not tolerate casting well
    to minimize skin problems
  Interpret Evidence Relative to
         Patient Problem
• Decision was made:
  – Pt would receive serial casting weekly for
    ≤ 5 wks as tolerated to reach goal of >5º
    DF PROM
  – Once casting complete, pt to receive
    night splints positioned in max passive DF
    and appropriate AFOs
  – Pt would continue regular physical
    therapy

  – If no gains, then attempt Botox
       Take Home Messages
• Use the [best available] literature to
  inform your clinical practice
  –   Stand on the shoulders of giants
• Be strategic…follow the structured EBP
  process to keep you focused on the
  goal
• Integrate what you glean from the
  literature with your clinical expertise
  and your patient’s values
    Overcoming the Barriers
• Your thoughts…



• Journal Club Thoughts…
           Other Resources
•  Oxford Centre for Evidence Based Medicine
  – http://www.cebm.net/index.asp
• INAPTA website November 2005 meeting
   minutes
  – http://www.inapta.org/districts/INAPTAEBP.
     pdf