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