Clinical Practice Guidelines Initiative
André Bussières, DC, PhD CCRF Professorship in Rehabilitation Epidemiology
Assistant Professor, School of Physical and Occupational Therapy Faculty of Medicine, McGill University
Professeur, Département Chiropratique, UQTR
Thank you for helping improve patient care
8h30
• Review mission and scope of the Guideline Initiative
• Agree to respective roles within the GDG
9h30 - Breakout Groups B (3 small groups):
• Scope of the low back pain (LBP) Assessment guideline
• Analytical Framework for the LBP Assessment guideline
10h00– Nutrition Break
10h15
• Patient preference and values (15 min)
• Review the SR proposal for the LBP Assessment CPG, 30 min
• Discuss results from the search strategy, 15 min (Fadi)
11h15
• Discuss missing elements, and need to undertake additional SR(s), 30 min
• Outline plan for undertaking the SR(s) and developing the CPG, 45 min
• Timeline for 1) conducting the SR(s); 2) developing CPG recommendations, 15 min
• Assigning of tasks and responsibilities, 15 min
13h00 - Closing remarks - André
North Atlantic Research Collaboration (NARC)
• Professional associations in Canada, Denmark, Norway, Sweden, Switzerland, and the UK.
• Education/Research/Clinical Practice Guidelines
– Share a common desire to work together in the development and the implementation of clinical guidelines.
To improve patient outcomes by developing
strategies to promote uptake of evidence-based
information on musculoskeletal disorders among
chiropractors, patients and leaders/decision makers
1. Clinical Practice Guidelines (CPGs)
2. Knowledge Translation (KT)
Guideline Initiative Overall goals
Knowledge to Action Framework
(I Graham et al. 2013, with permission)
Guideline Dissemination/Implementation Group
• Dr. André Bussières (Chair)
• Dr Kent Stuber (Co-Chair)
• Dr Sara Ahmed
• Fadi Al Zoubi (PhD Student)
• Dr Simon Brockhusin (DC, MD
Student)
• Dr Danica Brousseau
• Dr Brian Budgell
• Shawn Davis
• Dr Simon French
• Dr Bob Grisdale
• Dr Diane Grondin (PhD student)
• Dr Monika Kastner
• Dr Tue Secher Jensen
• Dr Jeff Quon
• Dr Sandy Sajko
• Dr Aliki Thomas
• Dr Tony Tibbles
• Dr Vic Weatherall
Observer: Dr. Ayla Azad (OCA)
Com Spec: Ronda Parks (CCA)
Project Manager: Sareekha Singh
Clinical Practice Guidelines
• Statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options
(Institute of Medicine. Standards for Developing Trustworthy Clinical
Practice Guidelines, March 2011)
Individual clinical expertise
(experience, judgment)
Patient’s values and expectations
Best available external clinical
evidence from systematic
research
Developing guideline recommendations
Circumstances/clinical context
Clinical decision
Literature search
Evidence for using Guidelines?
• Guideline dissemination and implementation strategies can encourage practitioners to conform to utilize best practices and lead to improvements in care.
(Lugtenberg 2009, Grimshaw 2006, Solomon 1998, Giguère 2012)
Goals of this meeting
Understand the mission and the scope of the Guideline Initiative
Conflict-of-interest disclosure
Establishing guideline group processes:
Communications, expectations, roles as GDG members, training
Using tools: AGREE II; appraisal tool(s), RevMan, GRADE, GDT, etc.
Determine the scope of the LBP Assessment guideline
Analytical Framework and key questions
Patient preference & values
Discuss the systematic review proposal
Set the timelines: conducting the review; developing recommendations
Tasks/responsibilities
Deliverables
MACRO: A cogent plan for the systematic reviews(s) and guideline on Treatment-Based classification System Guideline for adult with LBP with a roadmap and timeline for actions
MICRO: Assignments for each member of the GDG towards completion of the macro tasks described above.
Composition
• Oversight committee: Oversee overall CPG development process. Advise on guideline topic selection, CPG scope and key questions, group membership;
• The Editor and Chair;
• Working group: experts & methodologists to synthesize evidence: Information specialist, evidence review team, health economist (where feasible), GRADE approach advisor. May include ISAC and CCRF members;
• Guideline panel to develop recommendations Clinical experts, frontline clinicians;
Leader/decision maker
Patient representative (consumers) for consultation;
• Secretariat: to provide administrative support.
Role of the GDG
1. Scope of the guideline and criteria for the best evidence synthesis (oversight committee, GAC, Editor, ISAC, GDG, GAC)
2. Conducts the review (working group)
3. Develop recommendations (Guideline panel, working groups, Chair, Editor)
4. Publish the review & guidelines (Editor, Chair, guideline
working group)
5. Update the guidelines (Editor, Chair, GDG)
Role of the GDG
1. Scope and criteria for the best evidence synthesis
Contribute to preparation of the scope
Help construct the review questions (using PICO – Patient, Intervention, Comparison, Outcomes
2. Review the evidence
3. Search, (information specialist), Screen, Select, Assess evidence Select studies (screen all the scientific abstracts; carry out detailed reviews of the articles that were considered)
Assess risk of bias (i.e., quality of evidence)
Assess cost-effectiveness (where feasible)
Develop the evidence tables which formed the basis for the conclusions and recommendations
4. Developing recommendations
Develop the guideline recommendations (GRADE or NICE)?
Respond to comments received during consultation and agree on necessary changes to the guideline
Help develop “key messages” and implementation tools
Writing full version of the guideline • describes the link between evidence and recommendation
• describes the trade-off between: – benefits and harm of the intervention,
– economic considerations where feasible,
– the quality of the evidence,
– patient preference,
– implementation issues
Writing short version ‘Practitioners’ guide’, and ‘patient guide’ where applicable
Role of the GDG
Role of the GDG
5. Publish systematic reviews and guidelines (Editor, Chair, guideline working group)
6. Update the guidelines (Editor, Chair, GDG)
Stage Role Timing*
Selection of topic Stakeholder Panel administered by Guideline Advisory
Committee (GAC); final decision from Guideline Steering
Committee (GSC) referred to Editor and GDG
10 mo
Advertise and recruit chair of GDG
Advertise and recruit GDG members
Editor
Editor and chair 1mo
Develop first draft of scope(why it is needed, what it will
not cover, outcome measures, PICO)
Committee members and Stakeholder register interest
Scope consultation
Redraft scope and respond to comments
GSC, GAC, Editor, chair, GDG
Members of External Review and GIG consulted
Editor, chair, and GDG
6 mo
Guideline development(using the AGREE instrument) Review
• Literature search
• Critical appraisal (risk of bias)
• Health economic modeling
Develop recommendations
Write first draft of guideline
Editor administers and provides technical support to GDG
(directs and advises)
Information specialist (McGill University)
Working group and Editor
Working group and Editor
Guideline panel, Editor, Chair
Editor, GDG
16 mo (varies by topics)
(meet every 4-6 weeks
online or by phone, meet
physically 1-2 times)
Consultation phase External Review Group submits comments 4-8 wk
Prepare implementation support tools Guideline Implementation Group Ongoing from start
Redraft CPG, respond to External Review comments Editor and GDG 6 wk
Validation phase • Review Panel checks guideline (members of the
External Review Group and ISAC)
• Prepublication check
• Final corrections made to guideline
• Approve final draft
Editor administers Review Panel;
Review Panel submit comments
Editor, GDC and Chair respond to comments
Oversight committee/GAC reviews responses to comments
Editor, GDG and Chair make final corrections
ISAC, GSC approve final draft
12 wk
Publish guideline and costing tool (if possible) Editor, Chair, GSC 2.5 y from start
Launch implementation tools Editor, GIG, GSC, Stakeholders 5-10 wk after publication
Check whether guideline needs updating Editor, GDG,GAC, ISAC 3-5 y after publication
Characteristics of Quality CPGs Conference on Guideline Standardization (Rosenfeld 2013)
1. Overview material: Structured abstract (release date, status, and print and e-sources)
2. Focus: Condition and intervention/service/technology
3. Goal: What is this CPG expected to achieve, rationale for topic
4. Users/setting: For who, where
5. Target population: Patients, exclusion criteria
6. Developer: Org. plus author names/credentials
7. Funding source: Who sponsored, their role, any conflict of interest
8. Evidence collection: Search strategy, dates, databases, filters
9. Grading criteria: Evidence quality, strength of recommendation
Characteristics of Quality CPGs Conference on Guideline Standardization (Rosenfeld 2013)
10. Evidence synthesis: How evidence was used to create recommendations
11. Prerelease review: How/who reviewed and/or tested CPG
12. Update plan: Expiration date; plans for updating
13. Definitions: Defines unfamiliar terms, those critical to correct application
14. Recommendations & rationale: Key action statements, explicit linkage to evidence
15. Benefits/harms/costs associated with recommendations
16. Patient preferences: Role in decisions (personal choice or values)
17. Algorithm: Graphical description of the stages and decisions in clinical care
18. Implementation: Anticipated barriers, tools, review criteria
Low back pain (LBP)
• The prevalence of chronic LBP increased three-fold from 3.9% (95%CI, 3.4%-4.4%) in 1992 to 10.2% (95%CI, 9.3%-11.0%) in 2006.
• Results in significant burden to society with direct medical costs estimated between $12-90 billion, and indirect costs between $7-28 billion.
Definition
• Pain, muscle tension, or stiffness between the 12th rib and gluteal folds, with or without leg pain of either a specific or a non-specific origin.
“Diagnostic triage” Generally recommend by CPGs
1) LBP associated with nerve root pain,
2) Specific LBP,
3) Non-specific LBP (~ 90%):
• Acute LBP: pain with or without restriction of daily activities lasting up to 12 weeks,
• Chronic LBP: pain with or with restriction of daily activity lasting > 12 weeks.
Assessment and treatment of NSLBP
The ability to differentiate the exact source of "pain generators" remains challenging.
In the absence of a clear diagnosis, specific interventions cannot be prescribed.
This has led to a large body of literature evaluating “one-size-fits-all” approaches to treat patients in this category, despite their widely recognized heterogeneity.
Majid SR2010. Low back pain symptoms show a similar pattern of improvement following a wide range of primary
care treatments: a systematic review of RCTs
NSLBP symptoms seem to improve in a
similar pattern in clinical trials following
a wide variety of active as well as inactive
treatments.
It is important to explore factors other
than the treatment, that might influence
symptom improvement
Assessment and treatment of NSLBP
• Many factors can lead to the development of chronic LBP such as demographic (age and sex), environmental (e.g., workplace), and psychosocial factors (attitudes and beliefs).
• Identification of psychosocial risk factors (yellow flags) can help predict the risk of chronicity, long-term disability, and failure to return to work.
Stratified care approaches Treatment-based classifications systems
• The use of approaches leading to tailored treatment in primary health care posited to produce better clinical outcomes for NSLBP compared to usual care.
• Designed to assist clinicians with matching an initial treatment intervention strategy to patient’s clinical presentations.
– Clinical prediction rules are algorithm decision tools designed to help clinicians in determining a diagnosis, prognosis, or likely response to an intervention[26].
Rationale
The use of treatment-based classification systems can improve patient outcomes in the primary care setting (weak evidence)
Some of these systems have shown to significantly reduce levels of pain and disability in the short term (moderate effect size: 0.43) and in the long term (small effect size: 0.14).
The use of classification systems in clinical practice appears to be associated with lower costs and higher patient satisfaction
Stratified care approaches (adapted from Foster 2013)
Based on Treatment
Responsiveness Info drawn from aspects of the patient’s
history, findings from the physical examination and other test results to
match the patient to treatment based on the prediction of responsiveness to a
specific treatment. E studies developing and testing
Examples: clinical prediction rules (CPRs) for treatments such as manipulation,
exercice and traction.
Based on Mechanism Patients are matched to treatments based on underlying mechanisms, such as instability, fracture, pain mechanisms, or pathoanatomical cause. Treatments are targeted
towards the underlying mechanism(s). Ex.: the Pathoanatomic Based
Classification approach, Mechanical Diagnosis and Treatment approach
and the multi-dimensional classification system of O’Sullivan
Based on risk Info about a patient’s risk of persistent
disability, irrespective of underlying cause, is used to match treatment.
Examples: approaches that focus on particular prognostic factors (e.g.
psychosocial factors), single factors (e.g. fear avoidance) and a multi-domain
prognostic model (e.g. STarT Back)
ex.: the STarT Back questionnaire
• Growing evidence that a better identification of prognostic indicators leads to more effective, early preventive treatment for back pain in primary care [Bruyere 2012].
• STarT Back: A validated 9-item patient self-report questionnaire that classifies patients with LBP at low, medium or high-risk of poor prognosis for persistent non-specific LBP (also validated in Spanish and French).
• Large RCT demonstrated that the stratified care approach significantly reduced levels of disability and was cost-saving compared to the current best practice management approach [Hill 2011].
Tx targeted at Psychological risk factors
and/or Stratified care approaches
Tx targeted at Psychological risk factors
and/or Stratified care approaches
Low Back Pain
KQ1 KQ1
Low risk
Risk of
delayed
recovery
Risk of
delayed
recovery
KQ2 KQ2 KQ3
Usual care*
KQ1 (Key Question) = Physical factors (Red flags) KQ2 = Do interventions aimed at improving psychological risk factors at baseline assessments (screening) improve patient outcomes compared to no screening (usual care)? KQ3 = Do stratified care approaches to guide conservative care improve patient outcomes compared to usual care? * Usual care: Manual therapy, exercise, motor control, cognitive, etc.
LOW BACK PAIN Low Risk Patients: Assessment
Relevant history,
assessment of
comorbidities and of
physical,
psychological
and social factors
Options
Severity Duration Recurrence Chronicity Disability Cost-effectiveness System performance (wait time, cost, etc.) Harm
Diagnostic Triage Investigation Treatment Outcome
Education Advice
Reassurance
Education Advice
Reassurance
Multidisciplinary pain
management programs,
surgery
Multidisciplinary pain
management programs,
surgery
Includes
focused
physical
exam
KQ3
Primary objectives
To estimate the extent to which treatment-based classification systems, in comparison with usual care, alter the time course of recovery for pain and disability among people undergoing conservative care for non-specific LBP, presenting with or without leg pain.
KQ3
Secondary objectives
Identify the range of reliability estimates reported for these classification systems
Estimate if and how cost-effectiveness has been tested,
Appraise the quality of evidence (risk of bias),
Identify the existent gaps in the current literature and to recommend research avenues.
1 Low Back Pain/ (14380)
2 (low* adj3 back pain).tw. (18368)
3 low* backache*.tw. (194)
4 Sciatica/ (4273)
5 Sciatica.tw. (3459)
6 (low* adj3 (spine pain or spinal pain)).tw. (20)
7 low* back disorder*.tw. (333)
8 or/1-7 (27752)
9 triage.mp. or Triage/ (13391)
10 Critical Pathways/ (4518)
11 Critical path*.mp. (6082)
12 Decision Support Techniques/ (12080)
13 clinical path*.mp. (11656)
14 clinical prediction rule*.mp. (692)
15 decision rule*.mp. (2072)
16 care path*.mp. (1701)
17 (assessment adj1 (system* or algorithm* or approach* or model* or guide*).mp. (13976)
18 decision guide*.mp. (75)
19 prediction guide*.mp. (45)
20 classification.mp. (203714)
21 subgroup*.mp. (135166)
22 prognostic model*.mp. (1995)
23 prediction model*.mp. (5943)
24 stratif*.mp. (92715)
25 or/9-24 (477179)
26 8 and 25 (1569)
Milestone Tasks Project Month
12 1 2 3 4 5 6 7 8 9 10 11
Literature Search
Review Titles/abstracts Select papers
Critical appraisal
Data extraction
Reliability estimates and Cost-effectiveness
Evidence tables, Grading
Evidence synthesis (2nd Face to Face meeting)
Draft: Systematic Review(s) and Guideline
External review/Revise
KT and Practitioner Guide (3rd face to face meeting)
LBP Assessment Guideline Development - Project Outline
Project Month: 12= Dec 2013; 1= Jan 2014
Conf call: working Gr
Conf call: working Gr+ Pannel
Ministry of Finance of Ontario
• Meeting with Dr Pierre Côté DC, PhD, Canada Research Chair
– Multimillion dollar financial support to conduct systematic reviews on minor traumatic injuries and produce recommendations for the Ministry.
– 15 systematic reviews completed
– 12 more expected by June 2014
Darlow SR2013. The association between health care professional attitudes and beliefs and the attitudes and beliefs, clinical management, and outcomes of patients
with low back pain: A systematic review
• Strong evidence that HCP beliefs about back pain are associated with the beliefs of their patients.
• Moderate evidence:
– HCPs with a biomedical orientation or elevated fear avoidance beliefs are more likely to advise patients to limit work and physical activities, and are less likely to adhere to treatment guidelines.
– HCP attitudes/beliefs are associated with patient education and bed rest recommendations.
– HCP fear avoidance beliefs are associated with reported sick leave prescription and that a biomedical orientation is not associated with the number of sickness certificates issued for LBP.
The four questions of our patient-centered outcomes research definition
• “Given my personal characteristics, conditions, and preferences, what should I expect will happen to me?”
• “What are my options, and what are the potential benefits and harms of those options?”
• “What can I do to improve the outcomes that are most important to me?”
• “How can clinicians and the care delivery systems they work in help me make the best decisions about my health and health care?”
Pcori