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
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
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
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
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
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)
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
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
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!
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?
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
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
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.
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
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.
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