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Help! 
 How Do I Evaluate and Apply the 
Numerous Guidelines for Low Back 
  Pain; a Practical and Informed 
     Approach for Clinicians.

    Elaine Lonnemann PT, DPT, MSc, OCS, FAAOMPT
                   Tim Wideman PT
                Steven Kamper PT, PhD
        Chad Cook PT, PhD, MBA, OCS, FAAOMPT
Elaine Lonnemann PT, DPT, OCS, 
                       FAAOMPT


Tim Wideman PT


           Steven Kamper PT, PhD




      Chad Cook PT, PhD, MBA, OCS, FAAOMPT
Introduction to Guidelines


Define             Locate 


                 Consistencies 
Identify         & Differences
Clinical Practice Guidelines
Designed to support the decision‐making processes in 
patient care 

   Content is based on a systematic review 
              of clinical evidence  
Clinical Practice Guidelines
To describe appropriate care based on the 
best available scientific evidence and 
broad consensus
 To reduce inappropriate variation in 
                                    practice
 To provide or promote:
     a rational basis for referral 
     focus for continuing education 
     promote efficient use of resources
     focus for quality control
     highlight shortcomings of existing 
             literature 
     suggest appropriate future research 
Reviews of Clinical Practice Guidelines 
                on LBP



                          2010
                2006
       2001
2001 Systematic Review of 
               Clinical Practice Guidelines
                                   Koes BW, Van Tulder MW, Ostelo R et al

Clinical guidelines for the management of low back pain 
in primary care: an international comparison. 
11 countries 
  generally similar recommendations regarding the diagnostic 
  classification and therapeutic interventions 
  Consistent features 
       early and gradual activation of patients
       discouragement of prescribed bed rest
       recognition of psychosocial factors as risk factors for chronicity
  Discrepancy 
       exercise therapy, spinal manipulation, muscle relaxants, and 
        patient information
2010
   An Updated Overview of Clinical Guidelines for the 
Management of Non‐Specific Low Back Pain in Primary Care
                            Koes, van Tulder, Cung‐Wei, 
                             Macedo, McAuley, Maher

                         Criteria
Target group –             Languages:  English, 
primary health care        German, Finnish, Spanish, 
professionals              Norwegian, or Dutch
                                One per country
LBP Guidelines 2010
            13 Individual Countries 
2 International Clinical Guidelines from Europe

                      NO
  CAN                      FI


   US




                                        AU


                                             NZ
Guidelines from 2010
1. Australia, National Health and Medical Research Council (2003) 
2. Austria, Center for Excellence for Orthopaedic Pain Management Speising (2007)
3. Canada, Clinic on Low back Pain in Interdisciplinary Practice (2007) 
4. Europe, COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain 
    in Primary Care 1 (2004) 
5. Europe, COST B13 Working Group on Guidelines for the Management of Chronic Low Back 
    Pain in Primary Care (2004) 
6. Finland, Working group by the Finnish Medical Society Duodecim and the Societas Medicinae
    Physicalis et Rehabilitationis Fenniae. Duodecim (2008) 
7. France, Agence Nationale d’Accreditation et d’Evaluation en Sante (2000) 
8. Germany, Drug Committee of the German Medical Society (2007) 
9. Italy, Italian Scientific Spine Institute (2006) 
10. New Zealand, New Zealand Guidelines Group (2004) 
11. Norway, Formi & Sosial‐og helsedirectorated (2007) 
12. Spain, the Spanish Back Pain Research Network (2005) 
13. The Netherlands, The Dutch Institute for Healthcare Improvement (CBO) (2003) 
14. United Kingdom, National Health Service (2008) 
15. United States, American College of Physicians and the American Pain Society (2007) 
2010
 An Updated Overview of Clinical Guidelines for Low Back Pain

                              Koes, van Tulder, Cung‐Wei, 
                               Macedo, McAuley, Maher

Similarities:
   – Diagnostic classification (diagnostic triage) 
   – Diagnostic and therapeutic interventions 
Differences:
   – Spinal manipulation and drug treatment 
     for acute and chronic low back pain.
T   Scientific evidence is 
H        the same.            The guidelines are 
     Recommendations           measured by the 
E
      for diagnosis and       same instrument?
    treatment should be 
C   the same, are they?
H         Yes     No               Yes    No

A
L                             The individuals on 
L           All                  the guideline 
     Recommendations           committees are 
E
    from Guidelines are        similar from one 
N     Evidence Based?         committee to the 
G                                    next?
          Yes     No
E                                 Yes    No
A Practical and Informed Approach
            to Evaluate & Apply
PEDro                                      Physio‐pedia
    – http://www.pedro.org.au/                 – http://www.physio‐
    – Low Back Pain AND Practice Guidelines       pedia.com/Lumbo‐
                                                  Pelvic_Guidelines
National Guideline Clearinghouse               – Lumbo‐pelvic Guidelines
    – www.guideline.gov
    – low back pain                          Guidelines International Network
                                                 – http://www.g‐i‐n.net/
                                                 – Low back pain
National Institute for Health and Clinical Excellence 
(NICE) 
                                               IFOMPT Clinical Guidelines
    – www.nice.org.uk                              – Link to page
    – low back pain
Physiotherapy Evidence Database
http://www.pedro.org.au/
– pain, practice guidelines, combined with AND


                                    www.nice.org.uk
                                     low back pain
National Guideline Clearinghouse 

www.guideline.gov
– low back pain
Guidelines International Network




http://www.g‐i‐n.net/about‐g‐i‐n
NICE




   Guidelines Manual 2009
www.nice.org.uk/guidelinesmanual
Evaluating Guidelines                    The benefits of 
                                            guidelines are only 
                                              as good as the 
                                               quality of the 
                                            practice guidelines 
                                                themselves

Agree II (2003) 
Appraisal of Guidelines, Research and Evaluation
   a tool that assesses the methodological rigor and 
   transparency in which a practice guideline is developed

www.agreetrust.org
www.agreetrust.org/?o=1397
Guyatt et al. 
Grades of                Strength of Evidence
Recommendation
A   Strong evidence      A preponderance of level I and/or level II studies support the 
                         recommendation. This must include at least 1 level I study
B   Moderate evidence A single high‐quality randomized controlled trial or a 
                      preponderance of level II studies support the 
                      recommendation
C   Weak evidence        A single level II study or a preponderance of level III and IV 
                         studies including statements of consensus by content experts 
                         support the recommendation
D   Conflicting evidence Higher‐quality studies conducted on this topic disagree with 
                         respect to their conclusions. The recommendation is based 
                         on these conflicting studies
E   Theoretical/foundat A preponderance of evidence from animal or cadaver 
    ional evidence      studies, from conceptual models/principles or from basic 
                        sciences/bench research support this conclusion
F   Expert opinion       Best practice based on the clinical experience of the 
                         guidelines development team
Mexico        France
USA‐15                                                  Finland
Canada 3                                                              Austria
UK‐6
Europe‐4
                  39 Guidelines                         Norway
                                                        Italy 
                                                                      Spain 
                                                                      Australia
                                                        Netherlands   New Zealand
                                                        Germany




                    UK             Finland
                     6     4 Netherlands
     3                        Germany        France
             15        1                      Austria
                        Italy
         1




                                                                Australia


                                                                      New Zealand
Additional Guidelines Since 2008
2012
   ICSI:  Adult acute and subacute low back pain. 1994 Jun (revised 2012 Jan). NGC:008959 Institute for Clinical Systems 
   Improvement ‐ Nonprofit Organization. (USA‐Minn)
2011
   APTA‐Orthopaedic Section (2011) Low Back Pain: Clinical Practice Guidelines Linked to the International Classification of 
   Functioning, Disability, and Health.
   ACR Appropriateness Criteria® low back pain. 1996 (revised 2011). NGC:008863 American College of Radiology ‐ Medical 
   Specialty Society
   MQIC: Management of acute low back pain. 2008 Mar (revised 2011 Sep). [NGC Update Pending] NGC:008744 Michigan 
   Quality Improvement Consortium ‐ Professional Association.
   WLDI:  Low back ‐ lumbar & thoracic (acute & chronic). 2003 (revised 2011 Mar 14). NGC:008517 Work Loss Data Institute ‐
   For Profit Organization. US CA
   NASS: Diagnosis and treatment of degenerative lumbar spinal stenosis. 2002 (revised 2011). NGC:008766 North American 
   Spine Society ‐ Medical Specialty Society
   Practice Guidelines for the management of low back pain.  Mexico.  Surgery and Surgeons 2011. 70; 286‐302
   Clinical guidelines for the physiotherapy management of persistent Low Back Pain (LBP): Exercise ‐ Part One (1 of 2) from the 
   Chartered Society of Physiotherapy, UK. (2009)
   Clinical guidelines for the physiotherapy management of persistent Low Back Pain (LBP): Exercise ‐ Part One (2 of 2) from the 
   Chartered Society of Physiotherapy, UK. (2009)
   Clinical guidelines for the physiotherapy management of persistent Low Back Pain (LBP): Manual Therapy ‐ Part Two (1 of 2) 
   from the Chartered Society of Physiotherapy, UK. (2009)
   Clinical guidelines for the physiotherapy management of persistent Low Back Pain (LBP): Manual Therapy ‐ Part Two (2 of 2) 
   from the Chartered Society of Physiotherapy, UK. (2009)
2010
   UMHS:  Acute low back pain. 1997 (revised 2010 Jan). NGC:008009 University of Michigan Health System
All guidelines recommend a diagnostic triage
Patients are classified as having 
     1. non‐specific low back pain
     2. suspected or confirmed serious pathology 
            ‘Red Flag’ conditions such as tumor, infection 
            or fracture 
     3. radicular syndrome 
Additional Guidelines Since 2008
2009
   ASIPP:  Comprehensive evidence‐based guidelines for interventional techniques in the management of chronic spinal pain. 2003 
   (revised 2009 Jul‐Aug). NGC:007428 American Society of Interventional Pain Physicians ‐ Medical Specialty Society. 
   IHE:  Guideline for the evidence‐informed primary care management of low back pain. 2009 Mar. [NGC Update Pending] 
   NGC:007704 Institute of Health Economics ‐ Nonprofit Research Organization; Toward Optimized Practice ‐ State/Local 
   Government Agency ‐‐CAN
   NICE: Low back pain. Early management of persistent non‐specific low back pain. 2009 May. NGC:007269 National Collaborating 
   Centre for Primary Care ‐ National Government Agency‐UK
   AOA:  American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back 
   pain. 2009 Jul. NGC:007504 American Osteopathic Association ‐ Professional Association. US
   ICA:  Practicing Chiropractors' Committee on Radiology Protocols (PCCRP) for biomechanical assessment of spinal subluxation in 
   chiropractic clinical practice. 2009. NGC:007250 International Chiropractors Association ‐ Medical Specialty Society.
2008
   UK:  United Kingdom, National Health Service (2008)Back Pain (Low) with Sciatica  (2008)‐ UK Link
   CCGPP:  Chiropractic management of low back disorders: report from a consensus process. 2008 Nov‐Dec. NGC:007127 Council 
   on Chiropractic Guidelines & Practice Parameters ‐ Professional Association. US SC
   NASS Diagnosis and treatment of degenerative lumbar spondylolisthesis. 2008. NGC:006568 North American Spine Society ‐
   Medical Specialty Society.
   ICA:  Best practices & practice guidelines. 2008. NGC:007125 International Chiropractors Association ‐ Medical Specialty Society. 
   US‐VA
   CPCA‐Diagnostic imaging practice guidelines for musculoskeletal complaints in adults ‐ an evidence‐based approach. Part 3: spinal 
   disorders. 2008 Jan. NGC:006703 Canadian Protective Chiropractic Association ‐ Professional Association
   Finland:  Malmivaara A, Erkintalo M, Jousimaa J, Kumpulainen T, Kuukkanen T, Pohjolainen T, Seitsalo S, O¨ sterman H (2008) 
   Aikuisten alaselka¨sairaudet. (Low back pain among adults. An update within the Finnish Current Care guidelines). Working group 
   by the Finnish Medical Society Duodecim and the Societas Medicinae Physicalis et Rehabilitationis, Fenniae. Duodecim 124:2237–
   2239
   Italy:  Negrini S, Giovannoni S, Minozzi S et al (2006) Diagnostic therapeutic flow‐charts for low back pain patients: the Italian 
   clinical guidelines. Euro Medicophys 42(2):151–170
Diagnostic Procedures should focus on
  – identification of red flags
  – exclusion of specific diseases 
     (sometimes including radicular syndrome) 
  – Red flags      2000‐2008                         2009‐2012
                   age at onset (<20 or >55 years)   History of Cancer or HIV
                   significant trauma                Failure to improve with 
                                                     conservative care
                   unexplained weight loss           No relief with bed rest
                   widespread neurologic changes     Cauda Equina signs
                                                     Severe unremitting pain 
                                                     worsening of pain
None recommend routine use of imaging
Imaging recommended 
at the initial visit only for suspected serious 
  pathology 
  – (Australian, European) 
where the proposed treatment (manipulation) 
 requires the exclusion of a specific cause of 
 low back pain (French). 
 Imaging is sometimes recommended where 
  sufficient progress is not being made 
  – Time cut‐off varies from 4 to 7 weeks 
  – Often recommend MRI in cases with red flags 
    (European, Finland, Germany)
 All mention psychosocial factors
 Neurologic screening (not always detailed)
   –   Strength testing
   –   Reflexes
   –   Sensation
   –   SLR
Some guidelines did not distinguish between 
non‐specific low back pain and radicular 
syndrome.
  The Australian and New Zealand guidelines 


Symptom Duration
  – What is acute, sub‐acute, chronic & recurrent?
Yellow Flags
 The German guideline classifies a group of patients who 
  are at risk for chronicity, based on ‘yellow flags’.
 Variation in the amount of details given about how to 
  assess ‘yellow flags’ or the optimal timing of the 
  assessment. 
 The Canadian and the New Zealand guidelines provide 
  specific tools for identifying yellow flags and clear 
  guidelines for what should be done once yellow flags 
  are identified.
Recommended physical examination and tests
  – limit the examination to a neurological screen 
    (European)
  – more comprehensive musculoskeletal and 
    neurological examination
     • inspection, range of motion/spinal mobility, palpation, 
       and functional limitation
Topics to follow
Psychosocial Risk Factors for Pain‐Related 
  Disability and Current Clinical Practice 
                Guidelines
                  1 October 2012

               Timothy H. Wideman
                     PT, PhD
           Post‐Doctoral Research Fellow
             Johns Hopkins University
Ambiguity related to psychosocial 
        factors in current CPG

• Most Clinical Practice Guidelines (CPG) 
  recommend screening for psychosocial risk 
  factors for pain‐related disability (e.g. yellow 
  flags)
• Considerable variance in 
  – How recommended screening is performed
  – Whether interventions that target risk factors are 
    are recommended   
Objectives

• Provide a brief introduction to psychosocial 
  factors
• Review how psychosocial factors are 
  addressed in the literature
• Highlight recent (exciting!) findings
• Relate this ongoing research to previous 
  Clinical Practice Guidelines
Physical Therapy versus Mental Health 



                 Most Patients with Back Pain




 Physical therapy traditionally focuses on biomechanical factors 
For most patients, recovery from back pain is influenced by both 
     while mental health professionals focus on psychosocial 
               biomechanical and psychosocial factors
                                factors
                                                Main & George; PTJ 2011
Psychologically Informed Physical 
             Therapy




Aims to broadly integrate psychosocial factors into clinical 
                          practice           Main & George; PTJ 2011
Psychologically Informed Physical 
             Therapy




   Does not aim to replace clinical expertise in 
psychopathology or psychiatric illness (i.e. we are not 
    psychologists; aims to chart a middle ground)
                                       Main & George; PTJ 2011
What are psychosocial factors?

• Pain‐related psychosocial factors can be broadly 
  construed as thoughts, feelings and related 
  behaviours that are associated with pain
• Yellow (psychological), blue (occupational) and black 
  (social systems) flags tap different aspects of 
  psychosocial factors
• Many types and measures…
Psychosocial factors: 
       Some Constructs and Measures
• Measures
   – Virtually all self‐report
• Common psychosocial constructs
   – Pain‐Related Fear
   – Pain Catastrophizing
   – Pain‐related Self‐Efficacy
   – Depression
How do psychosocial factors relate to 
         our clinical outcomes?
• Predictors
   – Baseline measures that influence outcome regardless of tx. 
   – E.g. High baseline depression predicts poor outcome following tx.
• Moderators
   – Baseline measures that influence relationship between specific 
     intervention and outcome
   – E.g. Baseline fear influence efficacy of spinal manipulation
• Mediators
   – Treatment‐related change in measure is related to outcome
   – E.g. Pain catastrophizing mediates exercise and psychosocial tx.
                                                Hill & Fritz; PTJ 2011
The challenge of addressing psychological factors 
             within clinical practice

 • Despite calls to address risk factors within
 clinical management, significant barriers exist:
   • Not all patients require psychosocial risk factor 
   interventions
   • Assessment of multiple risk factors can be time 
   consuming and resource intensive
   • Choosing a treatment that targets psychosocial 
   factors can be challenging
New Research that facilitates the integration of 
  psychosocial factors into clinical practice




                                 Hill et al., Lancet 2011
The STarT Back Tool: A Strategy for facilitating risk 
      factor assessment within Primary Care

• 9‐item prognostic screening tool used to quantify risk 
complexity of patients’ with back pain
• Uses single items to represent different risk constructs (physical 
and psychosocial)
The STarT Back Tool: A Strategy for facilitating risk 
     factor assessment within Primary Care
Scores on the STarT Screening Tool Can 
           be Used to Classify Risk

• Risk classification based on 
STarT Scores:
   • Low: 3 or less
   • Medium: 4 or more; low 
   psychosocial risk
   • High: 4 or more; high 
   psychosocial risk
Risk Stratified Care: A Strategy for Integrating STarT
       Back Scores into Primary Care Settings




                Figure from : www.keele.ac.uk/sbst/
Risk Stratified Care: Treatment Content

Low risk
• 30 minute reassurance 
intervention

Medium Risk
• Physical therapy

High Risk
• Psychologically‐informed 
physical therapy

                              Figure from : www.keele.ac.uk/sbst/
Components of Psychologically Informed,
           High Risk Intervention

• Goal: address pain‐related thoughts and feelings in all 
aspects of treatment (subjective exam to clinical 
intervention)
• Not prescriptive with respect to psychosocial 
interventions
   • Activity monitoring and goal setting
   • Graded activity
   • Thought monitoring and restructuring
                                    Main et al., Physiotherapy 2012
Testing the efficacy of Risk Stratified Care: 
 A double armed Randomized Controlled Trial




Design
• 1500 adults with back pain 
• Randomized into best practice (un‐stratified) or Risk‐Stratified 
Care (reassurance, PT, psych‐informed PT)
                                               Hill et al., Lancet 2011
Testing the efficacy of Risk Stratified Care: 
   A double armed Randomized Controlled Trial


       Unstratified          Stratified Based on Risk


      Best Practice
• MD +/‐
   • PT, Psych, OT…
STarT Back RCT (Hill et al., Lancet 2011) 

Results (12 month follow‐up)
• Patients in risk stratified group had lower levels of 
self‐report disability
• Risk Stratified care was more cost‐effective than best 
practice 
Implications
• Strategy for integrating screening and treatment of 
psychosocial factors into physical therapy

                                        Hill et al., Lancet 2011
Relationship Between Psychosocial Research and 
                 Current CPG

• Clinical Practice Guidelines don’t reflect the 
detail and nuance that is reflected in primary 
psychosocial research (nor should they)
• CPGs lag behind primary research 
• Research answering some of your clinical 
questions may not be addressed in most recent 
CPGs
Strategies for exploring research that is not 
   addressed in Clinical Practice Guidelines


• Remember levels of evidence
  • Risk stratified care currently has level 2 
  evidence
• Can start by look for high quality reviews
  • Physical Therapy 2011; Volume 91; Issue 5; 
  An excellent special issue on psychosocial 
  factors
How can I learn more about psychosocial 
                factors?


• Take a course
  • Keele university offers online courses ( 
  http://www.keele.ac.uk/sbst/ )
• Come to our workshop in 200 AB at 4:15 today!
Summary

• Growing literature suggests that modifiable 
psychosocial factors influence our treatment
• We can improve treatment by adopting a 
psychologically‐informed approach
• Investigating primary research may help answer 
clinical questions not addressed in current clinical 
practice guidelines
Thank you!
Clinical Practice Guidelines  LBP 
                Interventions

Steve Kamper
EMGO+ Institute, VU University, Amsterdam 
George Institute for Global Health, University of Sydney
National Health and Medical Research Council, Australia
Why are you here?
• You don’t know what to do when someone with LBP 
  pain comes into your clinic?
• You want to know what you should be doing?
• At some point funders are only going to pay for 
  guideline‐based care?
• You want to learn something about how to 
  find/interpret guidelines? 
                                      Why?
• How do you decide what to do with your patients?
What are guidelines?
• Synthesis of the best available evidence
• Medline
  – 75 RCTs/day
  – 11 SRs/day


• Physio (2005‐12)
    •   8912 RCTs
    •   2624 SRs
Not just an issue of volume
  “… before the subject could be set in a clear and 
    proper light, it was necessary to remove a great 
    deal of rubbish” James Lind                1753


• Relevance
• Quality
• Effect
What are guidelines for?
• To describe appropriate care based on the best 
  available scientific evidence and broad 
  consensus
                        – Ensure best available care
                   – Reduce inappropriate variation
Why are there so many guidelines?
• 1 body of evidence → 39 guidelines
• How can the same evidence be interpreted so 
  differently?
• Are they all necessary?

    Chad will solve this
    mystery and more
Which guideline?
• Something to be aware of: Confirmation bias
What to read and what to toss
• Strategies
   – Roll a dice
   – Believe everything (doesn’t solve the problem)
   – Believe nothing (cuts down the required reading)
   – Read a summary (Bouwmeester 2009, Koes 2010, 
    Dagenais 2010, Pillastrini 2012)
  – Determine the quality yourself
What makes a good* guideline?
* A guideline you can believe in
• Methodological quality – certain rules regarding 
  how guideline is developed and written
• Analogy: RCT quality
  –   Randomised allocation
  –   Blinding
  –   Follow‐up rates
  –   Appopriate statistics and reporting
Guideline quality
• Appraisal of Guidelines for 
  Research and Evaluation: AGREE
  – Instrument for assessing guideline 
    quality
  – 6 domains (23 items), users manual
• Probably not feasible to apply yourself 
• Work in progress
How AGREE works
•   Each question (23) is scored on a scale from 
    1=Strongly disagree... to 7=strongly agree
    e.g. Q.3. (Scope and Purpose)
       “The population (patients, public etc) to whom the 
    guideline is meant to apply is specifically described”

•   The score is a percentage of the maximum (7 on 
    every question) in each domain
•   No threshold good / bad
AGREE II*
1.   Scope and purpose
2.   Stakeholder involvement
3.   Rigour of development
4.   Clarity of presentation
5.   Applicability
6.   Editorial independence

* Like AGREE I except better
1. Scope and purpose
• Explicit definition of: 
  – Objectives
  – Health question
  – Population
Why?
  – So you know if you’re reading the right book
2. Stakeholder involvement
• All the relevant professions represented
• Includes views of patients
• Target users identified

Why?
 – Minimise bias along professional grounds, 
    ensure patient‐centredness
3. Rigour of development
• How the evidence is located and synthesised
• How the recommendations are linked to the 
  evidence
• External peer‐review

Why?
 – Prevent cherry‐picking from the literature
4. Clarity of presentation
• Specific and unambiguous recommendations
• Different Mx options clearly presented
• Key recommendations easy to find

Why?
 – It’s no use to you if you can’t find the message
5. Applicability
• Advice for translation into practice
• Barriers to, and resources necessary for 
  implementation

Why?
 – Recommendations are only useful if they 
    make it to the patient
6. Editorial independence
• Funding body doesn’t influence the content
• Competing interests of the developers are 
  outlined

Why?
 – People have a funny way of being influenced 
    when there is money involved (money > 
    science)
Guidelines then and now (last 10‐12 years)
• Getting better over time
• Good parts: Clarity and Rigour of development
• Poor parts: Stakeholder involvement, 
  Applicability and Editorial independence
• Recommendations are becoming more 
  consistent
Guideline treatment for LBP
1. Reassurance and activity advice
  – No serious injury, resume activities, self‐care
2. Medication
  – Paracetamol, then NSAIDs, then others
3. Exercise
  – Not for acutes, supervised for chronics
4. Spinal Manipulative Therapy
  – Short trial in the absence of improvement
Other stuff
• Don’ts
  – Routine x‐ray, bedrest, electrotherapies (esp. 
    chronics), lumbar supports
• Unclears
  – Massage, acupuncture, traction
• Subgroups
  – Not yet established
Summary
•   Why are you are reading the Guidelines?
•   Offer a convenient synthesis of evidence
•   Not all are created equal
•   Be aware of your confirmation bias
•   Guideline quality – AGREE criteria
•   Guidelines are getting better and more 
    consistent
How Low Back Pain Guidelines are 
   Influenced by socio‐cultural, 
 historical, economic factors, and 
              discipline
   Chad Cook PT, PhD, MBA, FAAOMPT
          Chair and Professor
           Walsh University
Guidelines are Not Infallible
  Let’s consider how these are made
  • 1. Expert consensus.
  • 2. Outcomes based
  • 3. Preference based (Outcomes 
    based combined with patient 
    based)
  • 4. Evidence Based (what we are 
    used to)
Scazitti D. Evidence‐based guidelines: application to clinical practice. Phys Ther. 2001 
Oct;81(10):1622‐8.
Potential Influences
•   Socio‐Cultural
•   Historical
•   Economic factors
•   Discipline‐oriented
Cultural Factors
• Consider Professional Culture 
   – Surgical Checklist
• Consider Socioeconomic Culture
   – Preference based (Outcomes based combined with patient 
     based)
   – French guidelines for Physiotherapy and LBP
• for subacute, recurrent and chronic low back pain: 
  Physiotherapy is an important part of treatment, but 
  there is no evidence in support of specific protocols 
  specifying the number and frequency of sessions. The 
  expert panel proposed 10‐15 sessions after the initial 
  diagnostic assessment. These should take account of the 
  patient’s expectations and include patient education.
Historical Considerations
• Evidence changes
• Professions change their 
  roles
• Expectations change
Historical Treatment of Low Back Pain
Historical Treatment of Low Back Pain
U.S. Agency for Health Care Policy and Research 
    Guidelines for Acute Low Back Pain (1994)
Condition       NSAIDS    Tylenol   Physical    Thrust     Shoe     A “few” 
                                    Agents                Insoles   days rest


Recommended
                  X         X                    X
Optional
                                      X          X          X          X


“Comfort is often a patient's first concern.” 


http://www.chirobase.org/07Strategy/AHCPR/ahcprclinician.html
Early Guidelines Among Practitioners 
               was Not Popular
 • “The rumbling backfire is 
   that the U.S. Government 
   document, which is 
   intended as a practice 
   guideline for routine acute 
   back care, will come to 
   haunt us as a practice 
   standard for all back care.”

De Jong RH. Backfire: AHCPR guideline for acute low back pain. J S C Med Assoc. 1995;91:465‐8.
Economic Factors
• Rarely, are cost effectiveness components 
  considered in LBP guidelines development 
  (Koes et al., Eur Spine J, 2010 )
• Many create guidelines as a mechanism to 
  adapt to societal, cultural, legal, or economic 
  realities of their countries. (Dagenais et al., 
  Spine J, 2010)
The Primary Care Provider as the 
        Economic Gatekeeper
• All guidelines are geared 
  toward initiation of care 
  from a primary care 
  provider (Dagenais et al., 
  Spine J, 2010). 
• That role takes different 
  forms in different 
  countries and cultures
Big Deal?
Yes, it is a big deal
• Most clinical practice guidelines that are 
  endorsed by a national association involves 
  authors representative of that association 
  (Dagenais et al. 2010)
Multi‐Disciplinary Guidelines
Mono‐disciplinary Guidelines
Mono‐Disciplinary Guidelines
 • Clinical guidelines created by a 
   specific group (e.g., physical 
   therapists)
 • Mono‐disciplinary guidelines 
   are more likely to be 
   consensus‐based as well as 
   biased, especially in areas 
   where evidence is weak and 
   discipline self interest is strong

Breen et al. Eur J Spine. 2006;15:641‐647.
Mono‐Disciplinary Guidelines




Breen et al. Eur J Spine. 2006;15:641‐647.
When is it OK?
 • When the mono‐disciplinary guidelines is 
   reflective of the multidisciplinary guidelines
 • Unique context areas
 • When issues not specific to multidisciplinary 
   guidelines are factors
 • When more detail is needed in a given area 
   (e.g., we recommend exercise for LBP)


Breen et al. Eur J Spine. 2006;15:641‐647.
When is it not OK?
 • When there is no multi‐disciplinary parent
 • When authors or others benefit commercially 
   or professionally from writing the guidelines
 • When language is used that confuses the 
   public
 • When the focus is on access to care, not 
   interventions


Breen et al. Eur J Spine. 2006;15:641‐647.
Examples
• Physical Therapist          • Chiropractic 
  Guidelines                    Guidelines            • Osteopathic 
  (Manipulation)                (Manipulation)          Guidelines 
• Thrust manipulative and  • There was little 
                                                        (Manipulation)
  non‐thrust mobilization       evidence for the use  • Other areas……
  procedures can also be used                           what??
  to improve spine and hip      of manipulation for 
  mobility and reduce pain      other conditions 
  and disability in patients    affecting the low 
  with subacute and chronic     back, and very few 
  low back and back‐related     papers to support a 
  lower extremity pain. A
                                higher rating 
                                (Rating: C).

Delitto et al. JOSPT. 2012;42(4):A1‐A57.    http://www.ccgpp.org/delphi.pdf   http://www.ccgpp.org/delphi.pdf
More Examples (CPRs)?
• Physical         • Chiropractic   • Osteopathic
  Therapy
• Discussion on    • Not            • Not 
  2 pages            mentioned        mentioned
  dedicated to 
  this
Conflict of Interests
 • In recognition of the impact that COI have on 
   guidelines, the Association of American 
   Medical Colleges, the Institute of Medicine, 
   and US, pan‐European, British, and French 
   government authorities have included more 
   robust policies for reporting and selection of 
   expert committees. 



Jones et al. Conflict of interest ethics…….Ann Intern Med. 2012;156: 809‐816.
Why?
• Conflicts of interest (62% of 
  guidelines creators had a 
  vested interest in the 
  diagnostic or interventional 
  guidelines they advocate)
• Some guidelines involve 
  findings as high as 87‐90% 
  (Jones et al., Ann Intern Med, 
  2012)                             Trust me……

• Top deficient findings in the 
  Agree II guidelines 
Example
• American Pain Society                     • American Society of 
  (APS)                                       Interventional Pain 
                                              Physicians (ASIPP)




 Chou et al.. Guideline Warfare…. J Pain. 2011;12:833‐839.

 Manchikanti et al. A critical review…… Pain Physician. 2010;13:E141‐E174.
How are We Supposed to Know This 
             Stuff
Agree II Guidelines
• The Appraisal of Guidelines for Research & 
  Evaluation (AGREE) Instrument was developed 
  to address the issue of variability in the quality 
  of practice guidelines. 
  http://www.agreetrust.org/about‐
  agree/introduction1/
The Tool
• 23 items organized into the original 6 quality 
  domains: 
  – i) scope and purpose; 
  – ii) stakeholder involvement; 
  – iii) rigor of development; 
  – iv) clarity of presentation; 
  – v) applicability; 
  – vi) editorial independence.
  – 700 publications have used the tool
Thank You

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Low back pain guidelines IFOMPT 2012

  • 1. Help!  How Do I Evaluate and Apply the  Numerous Guidelines for Low Back  Pain; a Practical and Informed  Approach for Clinicians. Elaine Lonnemann PT, DPT, MSc, OCS, FAAOMPT Tim Wideman PT Steven Kamper PT, PhD Chad Cook PT, PhD, MBA, OCS, FAAOMPT
  • 2. Elaine Lonnemann PT, DPT, OCS,  FAAOMPT Tim Wideman PT Steven Kamper PT, PhD Chad Cook PT, PhD, MBA, OCS, FAAOMPT
  • 3. Introduction to Guidelines Define  Locate  Consistencies  Identify  & Differences
  • 4. Clinical Practice Guidelines Designed to support the decision‐making processes in  patient care  Content is based on a systematic review  of clinical evidence  
  • 5. Clinical Practice Guidelines To describe appropriate care based on the  best available scientific evidence and  broad consensus To reduce inappropriate variation in  practice To provide or promote: a rational basis for referral  focus for continuing education  promote efficient use of resources focus for quality control highlight shortcomings of existing  literature  suggest appropriate future research 
  • 7. 2001 Systematic Review of  Clinical Practice Guidelines Koes BW, Van Tulder MW, Ostelo R et al Clinical guidelines for the management of low back pain  in primary care: an international comparison.  11 countries  generally similar recommendations regarding the diagnostic  classification and therapeutic interventions  Consistent features   early and gradual activation of patients  discouragement of prescribed bed rest  recognition of psychosocial factors as risk factors for chronicity Discrepancy   exercise therapy, spinal manipulation, muscle relaxants, and  patient information
  • 8. 2010 An Updated Overview of Clinical Guidelines for the  Management of Non‐Specific Low Back Pain in Primary Care Koes, van Tulder, Cung‐Wei,  Macedo, McAuley, Maher Criteria Target group – Languages:  English,  primary health care  German, Finnish, Spanish,  professionals Norwegian, or Dutch One per country
  • 9. LBP Guidelines 2010 13 Individual Countries  2 International Clinical Guidelines from Europe NO CAN FI US AU NZ
  • 10. Guidelines from 2010 1. Australia, National Health and Medical Research Council (2003)  2. Austria, Center for Excellence for Orthopaedic Pain Management Speising (2007) 3. Canada, Clinic on Low back Pain in Interdisciplinary Practice (2007)  4. Europe, COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain  in Primary Care 1 (2004)  5. Europe, COST B13 Working Group on Guidelines for the Management of Chronic Low Back  Pain in Primary Care (2004)  6. Finland, Working group by the Finnish Medical Society Duodecim and the Societas Medicinae Physicalis et Rehabilitationis Fenniae. Duodecim (2008)  7. France, Agence Nationale d’Accreditation et d’Evaluation en Sante (2000)  8. Germany, Drug Committee of the German Medical Society (2007)  9. Italy, Italian Scientific Spine Institute (2006)  10. New Zealand, New Zealand Guidelines Group (2004)  11. Norway, Formi & Sosial‐og helsedirectorated (2007)  12. Spain, the Spanish Back Pain Research Network (2005)  13. The Netherlands, The Dutch Institute for Healthcare Improvement (CBO) (2003)  14. United Kingdom, National Health Service (2008)  15. United States, American College of Physicians and the American Pain Society (2007) 
  • 11. 2010 An Updated Overview of Clinical Guidelines for Low Back Pain Koes, van Tulder, Cung‐Wei,  Macedo, McAuley, Maher Similarities: – Diagnostic classification (diagnostic triage)  – Diagnostic and therapeutic interventions  Differences: – Spinal manipulation and drug treatment  for acute and chronic low back pain.
  • 12. T Scientific evidence is  H the same. The guidelines are  Recommendations  measured by the  E for diagnosis and  same instrument? treatment should be  C the same, are they? H Yes No Yes No A L The individuals on  L All  the guideline  Recommendations  committees are  E from Guidelines are  similar from one  N Evidence Based? committee to the  G next? Yes No E Yes No
  • 13. A Practical and Informed Approach to Evaluate & Apply PEDro Physio‐pedia – http://www.pedro.org.au/ – http://www.physio‐ – Low Back Pain AND Practice Guidelines pedia.com/Lumbo‐ Pelvic_Guidelines National Guideline Clearinghouse  – Lumbo‐pelvic Guidelines – www.guideline.gov – low back pain Guidelines International Network – http://www.g‐i‐n.net/ – Low back pain National Institute for Health and Clinical Excellence  (NICE)  IFOMPT Clinical Guidelines – www.nice.org.uk – Link to page – low back pain
  • 16.
  • 17.
  • 19. NICE Guidelines Manual 2009 www.nice.org.uk/guidelinesmanual
  • 20. Evaluating Guidelines The benefits of  guidelines are only  as good as the  quality of the  practice guidelines  themselves Agree II (2003)  Appraisal of Guidelines, Research and Evaluation a tool that assesses the methodological rigor and  transparency in which a practice guideline is developed www.agreetrust.org www.agreetrust.org/?o=1397
  • 21. Guyatt et al.  Grades of  Strength of Evidence Recommendation A Strong evidence A preponderance of level I and/or level II studies support the  recommendation. This must include at least 1 level I study B Moderate evidence A single high‐quality randomized controlled trial or a  preponderance of level II studies support the  recommendation C Weak evidence A single level II study or a preponderance of level III and IV  studies including statements of consensus by content experts  support the recommendation D Conflicting evidence Higher‐quality studies conducted on this topic disagree with  respect to their conclusions. The recommendation is based  on these conflicting studies E Theoretical/foundat A preponderance of evidence from animal or cadaver  ional evidence studies, from conceptual models/principles or from basic  sciences/bench research support this conclusion F Expert opinion Best practice based on the clinical experience of the  guidelines development team
  • 22. Mexico France USA‐15 Finland Canada 3 Austria UK‐6 Europe‐4 39 Guidelines Norway Italy  Spain  Australia Netherlands New Zealand Germany UK  Finland 6 4 Netherlands 3 Germany        France 15 1 Austria Italy 1 Australia New Zealand
  • 23. Additional Guidelines Since 2008 2012 ICSI:  Adult acute and subacute low back pain. 1994 Jun (revised 2012 Jan). NGC:008959 Institute for Clinical Systems  Improvement ‐ Nonprofit Organization. (USA‐Minn) 2011 APTA‐Orthopaedic Section (2011) Low Back Pain: Clinical Practice Guidelines Linked to the International Classification of  Functioning, Disability, and Health. ACR Appropriateness Criteria® low back pain. 1996 (revised 2011). NGC:008863 American College of Radiology ‐ Medical  Specialty Society MQIC: Management of acute low back pain. 2008 Mar (revised 2011 Sep). [NGC Update Pending] NGC:008744 Michigan  Quality Improvement Consortium ‐ Professional Association. WLDI:  Low back ‐ lumbar & thoracic (acute & chronic). 2003 (revised 2011 Mar 14). NGC:008517 Work Loss Data Institute ‐ For Profit Organization. US CA NASS: Diagnosis and treatment of degenerative lumbar spinal stenosis. 2002 (revised 2011). NGC:008766 North American  Spine Society ‐ Medical Specialty Society Practice Guidelines for the management of low back pain.  Mexico.  Surgery and Surgeons 2011. 70; 286‐302 Clinical guidelines for the physiotherapy management of persistent Low Back Pain (LBP): Exercise ‐ Part One (1 of 2) from the  Chartered Society of Physiotherapy, UK. (2009) Clinical guidelines for the physiotherapy management of persistent Low Back Pain (LBP): Exercise ‐ Part One (2 of 2) from the  Chartered Society of Physiotherapy, UK. (2009) Clinical guidelines for the physiotherapy management of persistent Low Back Pain (LBP): Manual Therapy ‐ Part Two (1 of 2)  from the Chartered Society of Physiotherapy, UK. (2009) Clinical guidelines for the physiotherapy management of persistent Low Back Pain (LBP): Manual Therapy ‐ Part Two (2 of 2)  from the Chartered Society of Physiotherapy, UK. (2009) 2010 UMHS:  Acute low back pain. 1997 (revised 2010 Jan). NGC:008009 University of Michigan Health System
  • 24. All guidelines recommend a diagnostic triage Patients are classified as having  1. non‐specific low back pain 2. suspected or confirmed serious pathology  ‘Red Flag’ conditions such as tumor, infection  or fracture  3. radicular syndrome 
  • 25. Additional Guidelines Since 2008 2009 ASIPP:  Comprehensive evidence‐based guidelines for interventional techniques in the management of chronic spinal pain. 2003  (revised 2009 Jul‐Aug). NGC:007428 American Society of Interventional Pain Physicians ‐ Medical Specialty Society.  IHE:  Guideline for the evidence‐informed primary care management of low back pain. 2009 Mar. [NGC Update Pending]  NGC:007704 Institute of Health Economics ‐ Nonprofit Research Organization; Toward Optimized Practice ‐ State/Local  Government Agency ‐‐CAN NICE: Low back pain. Early management of persistent non‐specific low back pain. 2009 May. NGC:007269 National Collaborating  Centre for Primary Care ‐ National Government Agency‐UK AOA:  American Osteopathic Association guidelines for osteopathic manipulative treatment (OMT) for patients with low back  pain. 2009 Jul. NGC:007504 American Osteopathic Association ‐ Professional Association. US ICA:  Practicing Chiropractors' Committee on Radiology Protocols (PCCRP) for biomechanical assessment of spinal subluxation in  chiropractic clinical practice. 2009. NGC:007250 International Chiropractors Association ‐ Medical Specialty Society. 2008 UK:  United Kingdom, National Health Service (2008)Back Pain (Low) with Sciatica  (2008)‐ UK Link CCGPP:  Chiropractic management of low back disorders: report from a consensus process. 2008 Nov‐Dec. NGC:007127 Council  on Chiropractic Guidelines & Practice Parameters ‐ Professional Association. US SC NASS Diagnosis and treatment of degenerative lumbar spondylolisthesis. 2008. NGC:006568 North American Spine Society ‐ Medical Specialty Society. ICA:  Best practices & practice guidelines. 2008. NGC:007125 International Chiropractors Association ‐ Medical Specialty Society.  US‐VA CPCA‐Diagnostic imaging practice guidelines for musculoskeletal complaints in adults ‐ an evidence‐based approach. Part 3: spinal  disorders. 2008 Jan. NGC:006703 Canadian Protective Chiropractic Association ‐ Professional Association Finland:  Malmivaara A, Erkintalo M, Jousimaa J, Kumpulainen T, Kuukkanen T, Pohjolainen T, Seitsalo S, O¨ sterman H (2008)  Aikuisten alaselka¨sairaudet. (Low back pain among adults. An update within the Finnish Current Care guidelines). Working group  by the Finnish Medical Society Duodecim and the Societas Medicinae Physicalis et Rehabilitationis, Fenniae. Duodecim 124:2237– 2239 Italy:  Negrini S, Giovannoni S, Minozzi S et al (2006) Diagnostic therapeutic flow‐charts for low back pain patients: the Italian  clinical guidelines. Euro Medicophys 42(2):151–170
  • 26. Diagnostic Procedures should focus on – identification of red flags – exclusion of specific diseases  (sometimes including radicular syndrome)  – Red flags 2000‐2008 2009‐2012 age at onset (<20 or >55 years) History of Cancer or HIV significant trauma Failure to improve with  conservative care unexplained weight loss  No relief with bed rest widespread neurologic changes  Cauda Equina signs Severe unremitting pain  worsening of pain
  • 27. None recommend routine use of imaging Imaging recommended  at the initial visit only for suspected serious  pathology  – (Australian, European)  where the proposed treatment (manipulation)  requires the exclusion of a specific cause of  low back pain (French). 
  • 28.  Imaging is sometimes recommended where  sufficient progress is not being made  – Time cut‐off varies from 4 to 7 weeks  – Often recommend MRI in cases with red flags  (European, Finland, Germany)  All mention psychosocial factors  Neurologic screening (not always detailed) – Strength testing – Reflexes – Sensation – SLR
  • 30. Yellow Flags  The German guideline classifies a group of patients who  are at risk for chronicity, based on ‘yellow flags’.  Variation in the amount of details given about how to  assess ‘yellow flags’ or the optimal timing of the  assessment.   The Canadian and the New Zealand guidelines provide  specific tools for identifying yellow flags and clear  guidelines for what should be done once yellow flags  are identified.
  • 31. Recommended physical examination and tests – limit the examination to a neurological screen  (European) – more comprehensive musculoskeletal and  neurological examination • inspection, range of motion/spinal mobility, palpation,  and functional limitation
  • 33. Psychosocial Risk Factors for Pain‐Related  Disability and Current Clinical Practice  Guidelines 1 October 2012 Timothy H. Wideman PT, PhD Post‐Doctoral Research Fellow Johns Hopkins University
  • 34. Ambiguity related to psychosocial  factors in current CPG • Most Clinical Practice Guidelines (CPG)  recommend screening for psychosocial risk  factors for pain‐related disability (e.g. yellow  flags) • Considerable variance in  – How recommended screening is performed – Whether interventions that target risk factors are  are recommended   
  • 35. Objectives • Provide a brief introduction to psychosocial  factors • Review how psychosocial factors are  addressed in the literature • Highlight recent (exciting!) findings • Relate this ongoing research to previous  Clinical Practice Guidelines
  • 36. Physical Therapy versus Mental Health  Most Patients with Back Pain Physical therapy traditionally focuses on biomechanical factors  For most patients, recovery from back pain is influenced by both  while mental health professionals focus on psychosocial  biomechanical and psychosocial factors factors Main & George; PTJ 2011
  • 37. Psychologically Informed Physical  Therapy Aims to broadly integrate psychosocial factors into clinical  practice Main & George; PTJ 2011
  • 38. Psychologically Informed Physical  Therapy Does not aim to replace clinical expertise in  psychopathology or psychiatric illness (i.e. we are not  psychologists; aims to chart a middle ground) Main & George; PTJ 2011
  • 39. What are psychosocial factors? • Pain‐related psychosocial factors can be broadly  construed as thoughts, feelings and related  behaviours that are associated with pain • Yellow (psychological), blue (occupational) and black  (social systems) flags tap different aspects of  psychosocial factors • Many types and measures…
  • 40. Psychosocial factors:  Some Constructs and Measures • Measures – Virtually all self‐report • Common psychosocial constructs – Pain‐Related Fear – Pain Catastrophizing – Pain‐related Self‐Efficacy – Depression
  • 41. How do psychosocial factors relate to  our clinical outcomes? • Predictors – Baseline measures that influence outcome regardless of tx.  – E.g. High baseline depression predicts poor outcome following tx. • Moderators – Baseline measures that influence relationship between specific  intervention and outcome – E.g. Baseline fear influence efficacy of spinal manipulation • Mediators – Treatment‐related change in measure is related to outcome – E.g. Pain catastrophizing mediates exercise and psychosocial tx. Hill & Fritz; PTJ 2011
  • 42. The challenge of addressing psychological factors  within clinical practice • Despite calls to address risk factors within clinical management, significant barriers exist: • Not all patients require psychosocial risk factor  interventions • Assessment of multiple risk factors can be time  consuming and resource intensive • Choosing a treatment that targets psychosocial  factors can be challenging
  • 44. The STarT Back Tool: A Strategy for facilitating risk  factor assessment within Primary Care • 9‐item prognostic screening tool used to quantify risk  complexity of patients’ with back pain • Uses single items to represent different risk constructs (physical  and psychosocial)
  • 45. The STarT Back Tool: A Strategy for facilitating risk  factor assessment within Primary Care
  • 46. Scores on the STarT Screening Tool Can  be Used to Classify Risk • Risk classification based on  STarT Scores: • Low: 3 or less • Medium: 4 or more; low  psychosocial risk • High: 4 or more; high  psychosocial risk
  • 47. Risk Stratified Care: A Strategy for Integrating STarT Back Scores into Primary Care Settings Figure from : www.keele.ac.uk/sbst/
  • 49. Components of Psychologically Informed, High Risk Intervention • Goal: address pain‐related thoughts and feelings in all  aspects of treatment (subjective exam to clinical  intervention) • Not prescriptive with respect to psychosocial  interventions • Activity monitoring and goal setting • Graded activity • Thought monitoring and restructuring Main et al., Physiotherapy 2012
  • 50. Testing the efficacy of Risk Stratified Care:  A double armed Randomized Controlled Trial Design • 1500 adults with back pain  • Randomized into best practice (un‐stratified) or Risk‐Stratified  Care (reassurance, PT, psych‐informed PT) Hill et al., Lancet 2011
  • 51. Testing the efficacy of Risk Stratified Care:  A double armed Randomized Controlled Trial Unstratified Stratified Based on Risk Best Practice • MD +/‐ • PT, Psych, OT…
  • 52. STarT Back RCT (Hill et al., Lancet 2011)  Results (12 month follow‐up) • Patients in risk stratified group had lower levels of  self‐report disability • Risk Stratified care was more cost‐effective than best  practice  Implications • Strategy for integrating screening and treatment of  psychosocial factors into physical therapy Hill et al., Lancet 2011
  • 53. Relationship Between Psychosocial Research and  Current CPG • Clinical Practice Guidelines don’t reflect the  detail and nuance that is reflected in primary  psychosocial research (nor should they) • CPGs lag behind primary research  • Research answering some of your clinical  questions may not be addressed in most recent  CPGs
  • 54. Strategies for exploring research that is not  addressed in Clinical Practice Guidelines • Remember levels of evidence • Risk stratified care currently has level 2  evidence • Can start by look for high quality reviews • Physical Therapy 2011; Volume 91; Issue 5;  An excellent special issue on psychosocial  factors
  • 55. How can I learn more about psychosocial  factors? • Take a course • Keele university offers online courses (  http://www.keele.ac.uk/sbst/ ) • Come to our workshop in 200 AB at 4:15 today!
  • 56. Summary • Growing literature suggests that modifiable  psychosocial factors influence our treatment • We can improve treatment by adopting a  psychologically‐informed approach • Investigating primary research may help answer  clinical questions not addressed in current clinical  practice guidelines
  • 58. Clinical Practice Guidelines  LBP  Interventions Steve Kamper EMGO+ Institute, VU University, Amsterdam  George Institute for Global Health, University of Sydney National Health and Medical Research Council, Australia
  • 59. Why are you here? • You don’t know what to do when someone with LBP  pain comes into your clinic? • You want to know what you should be doing? • At some point funders are only going to pay for  guideline‐based care? • You want to learn something about how to  find/interpret guidelines?  Why? • How do you decide what to do with your patients?
  • 60. What are guidelines? • Synthesis of the best available evidence • Medline – 75 RCTs/day – 11 SRs/day • Physio (2005‐12) • 8912 RCTs • 2624 SRs
  • 61. Not just an issue of volume “… before the subject could be set in a clear and  proper light, it was necessary to remove a great  deal of rubbish” James Lind 1753 • Relevance • Quality • Effect
  • 62. What are guidelines for? • To describe appropriate care based on the best  available scientific evidence and broad  consensus – Ensure best available care – Reduce inappropriate variation
  • 65. What to read and what to toss • Strategies – Roll a dice – Believe everything (doesn’t solve the problem) – Believe nothing (cuts down the required reading) – Read a summary (Bouwmeester 2009, Koes 2010,  Dagenais 2010, Pillastrini 2012) – Determine the quality yourself
  • 66. What makes a good* guideline? * A guideline you can believe in • Methodological quality – certain rules regarding  how guideline is developed and written • Analogy: RCT quality – Randomised allocation – Blinding – Follow‐up rates – Appopriate statistics and reporting
  • 67. Guideline quality • Appraisal of Guidelines for  Research and Evaluation: AGREE – Instrument for assessing guideline  quality – 6 domains (23 items), users manual • Probably not feasible to apply yourself  • Work in progress
  • 68. How AGREE works • Each question (23) is scored on a scale from  1=Strongly disagree... to 7=strongly agree e.g. Q.3. (Scope and Purpose) “The population (patients, public etc) to whom the  guideline is meant to apply is specifically described” • The score is a percentage of the maximum (7 on  every question) in each domain • No threshold good / bad
  • 69. AGREE II* 1. Scope and purpose 2. Stakeholder involvement 3. Rigour of development 4. Clarity of presentation 5. Applicability 6. Editorial independence * Like AGREE I except better
  • 70. 1. Scope and purpose • Explicit definition of:  – Objectives – Health question – Population Why? – So you know if you’re reading the right book
  • 71. 2. Stakeholder involvement • All the relevant professions represented • Includes views of patients • Target users identified Why? – Minimise bias along professional grounds,  ensure patient‐centredness
  • 72. 3. Rigour of development • How the evidence is located and synthesised • How the recommendations are linked to the  evidence • External peer‐review Why? – Prevent cherry‐picking from the literature
  • 73. 4. Clarity of presentation • Specific and unambiguous recommendations • Different Mx options clearly presented • Key recommendations easy to find Why? – It’s no use to you if you can’t find the message
  • 74. 5. Applicability • Advice for translation into practice • Barriers to, and resources necessary for  implementation Why? – Recommendations are only useful if they  make it to the patient
  • 75. 6. Editorial independence • Funding body doesn’t influence the content • Competing interests of the developers are  outlined Why? – People have a funny way of being influenced  when there is money involved (money >  science)
  • 76. Guidelines then and now (last 10‐12 years) • Getting better over time • Good parts: Clarity and Rigour of development • Poor parts: Stakeholder involvement,  Applicability and Editorial independence • Recommendations are becoming more  consistent
  • 77. Guideline treatment for LBP 1. Reassurance and activity advice – No serious injury, resume activities, self‐care 2. Medication – Paracetamol, then NSAIDs, then others 3. Exercise – Not for acutes, supervised for chronics 4. Spinal Manipulative Therapy – Short trial in the absence of improvement
  • 78. Other stuff • Don’ts – Routine x‐ray, bedrest, electrotherapies (esp.  chronics), lumbar supports • Unclears – Massage, acupuncture, traction • Subgroups – Not yet established
  • 79. Summary • Why are you are reading the Guidelines? • Offer a convenient synthesis of evidence • Not all are created equal • Be aware of your confirmation bias • Guideline quality – AGREE criteria • Guidelines are getting better and more  consistent
  • 80. How Low Back Pain Guidelines are  Influenced by socio‐cultural,  historical, economic factors, and  discipline Chad Cook PT, PhD, MBA, FAAOMPT Chair and Professor Walsh University
  • 81. Guidelines are Not Infallible Let’s consider how these are made • 1. Expert consensus. • 2. Outcomes based • 3. Preference based (Outcomes  based combined with patient  based) • 4. Evidence Based (what we are  used to) Scazitti D. Evidence‐based guidelines: application to clinical practice. Phys Ther. 2001  Oct;81(10):1622‐8.
  • 82. Potential Influences • Socio‐Cultural • Historical • Economic factors • Discipline‐oriented
  • 83. Cultural Factors • Consider Professional Culture  – Surgical Checklist • Consider Socioeconomic Culture – Preference based (Outcomes based combined with patient  based) – French guidelines for Physiotherapy and LBP • for subacute, recurrent and chronic low back pain:  Physiotherapy is an important part of treatment, but  there is no evidence in support of specific protocols  specifying the number and frequency of sessions. The  expert panel proposed 10‐15 sessions after the initial  diagnostic assessment. These should take account of the  patient’s expectations and include patient education.
  • 87. U.S. Agency for Health Care Policy and Research  Guidelines for Acute Low Back Pain (1994) Condition NSAIDS Tylenol Physical  Thrust Shoe  A “few”  Agents Insoles days rest Recommended X X X Optional X X X X “Comfort is often a patient's first concern.”  http://www.chirobase.org/07Strategy/AHCPR/ahcprclinician.html
  • 88. Early Guidelines Among Practitioners  was Not Popular • “The rumbling backfire is  that the U.S. Government  document, which is  intended as a practice  guideline for routine acute  back care, will come to  haunt us as a practice  standard for all back care.” De Jong RH. Backfire: AHCPR guideline for acute low back pain. J S C Med Assoc. 1995;91:465‐8.
  • 89. Economic Factors • Rarely, are cost effectiveness components  considered in LBP guidelines development  (Koes et al., Eur Spine J, 2010 ) • Many create guidelines as a mechanism to  adapt to societal, cultural, legal, or economic  realities of their countries. (Dagenais et al.,  Spine J, 2010)
  • 90. The Primary Care Provider as the  Economic Gatekeeper • All guidelines are geared  toward initiation of care  from a primary care  provider (Dagenais et al.,  Spine J, 2010).  • That role takes different  forms in different  countries and cultures
  • 91.
  • 93. Yes, it is a big deal • Most clinical practice guidelines that are  endorsed by a national association involves  authors representative of that association  (Dagenais et al. 2010)
  • 96. Mono‐Disciplinary Guidelines • Clinical guidelines created by a  specific group (e.g., physical  therapists) • Mono‐disciplinary guidelines  are more likely to be  consensus‐based as well as  biased, especially in areas  where evidence is weak and  discipline self interest is strong Breen et al. Eur J Spine. 2006;15:641‐647.
  • 98. When is it OK? • When the mono‐disciplinary guidelines is  reflective of the multidisciplinary guidelines • Unique context areas • When issues not specific to multidisciplinary  guidelines are factors • When more detail is needed in a given area  (e.g., we recommend exercise for LBP) Breen et al. Eur J Spine. 2006;15:641‐647.
  • 99. When is it not OK? • When there is no multi‐disciplinary parent • When authors or others benefit commercially  or professionally from writing the guidelines • When language is used that confuses the  public • When the focus is on access to care, not  interventions Breen et al. Eur J Spine. 2006;15:641‐647.
  • 100. Examples • Physical Therapist  • Chiropractic  Guidelines  Guidelines  • Osteopathic  (Manipulation) (Manipulation) Guidelines  • Thrust manipulative and  • There was little  (Manipulation) non‐thrust mobilization  evidence for the use  • Other areas…… procedures can also be used  what?? to improve spine and hip  of manipulation for  mobility and reduce pain  other conditions  and disability in patients  affecting the low  with subacute and chronic  back, and very few  low back and back‐related  papers to support a  lower extremity pain. A higher rating  (Rating: C). Delitto et al. JOSPT. 2012;42(4):A1‐A57.  http://www.ccgpp.org/delphi.pdf http://www.ccgpp.org/delphi.pdf
  • 101. More Examples (CPRs)? • Physical  • Chiropractic • Osteopathic Therapy • Discussion on  • Not  • Not  2 pages  mentioned mentioned dedicated to  this
  • 102. Conflict of Interests • In recognition of the impact that COI have on  guidelines, the Association of American  Medical Colleges, the Institute of Medicine,  and US, pan‐European, British, and French  government authorities have included more  robust policies for reporting and selection of  expert committees.  Jones et al. Conflict of interest ethics…….Ann Intern Med. 2012;156: 809‐816.
  • 103. Why? • Conflicts of interest (62% of  guidelines creators had a  vested interest in the  diagnostic or interventional  guidelines they advocate) • Some guidelines involve  findings as high as 87‐90%  (Jones et al., Ann Intern Med,  2012) Trust me…… • Top deficient findings in the  Agree II guidelines 
  • 104. Example • American Pain Society  • American Society of  (APS) Interventional Pain  Physicians (ASIPP) Chou et al.. Guideline Warfare…. J Pain. 2011;12:833‐839. Manchikanti et al. A critical review…… Pain Physician. 2010;13:E141‐E174.
  • 106. Agree II Guidelines • The Appraisal of Guidelines for Research &  Evaluation (AGREE) Instrument was developed  to address the issue of variability in the quality  of practice guidelines.  http://www.agreetrust.org/about‐ agree/introduction1/
  • 107. The Tool • 23 items organized into the original 6 quality  domains:  – i) scope and purpose;  – ii) stakeholder involvement;  – iii) rigor of development;  – iv) clarity of presentation;  – v) applicability;  – vi) editorial independence. – 700 publications have used the tool