A COMMON APPROACH

ALEX SANCHEZ-VIVAR

Developing Evidence-BasedGuidelines for Health Protection

- An overview of the process -

Developing Evidence-BasedGuidelines for Health Protection

- An overview of the process -

Moriarty: “Everything I have to say has already crossed your mind.”

Sherlock: “Probably my answer has crossed yours.”

Moriarty: “Everything I have to say has already crossed your mind.”

Sherlock: “Probably my answer has crossed yours.”

Presentation OverviewPresentation Overview Presentation OverviewPresentation Overview

1. Intro: the Health Protection Network (HPN)

2. Why does Evidence-Based Practice matter to us? Rationale & background

3. A systematic approach to produce guidance for HP in ScotlandDevelopment of evidence-based guidelines

1. Intro: the Health Protection Network (HPN)

2. Why does Evidence-Based Practice matter to us? Rationale & background

3. A systematic approach to produce guidance for HP in ScotlandDevelopment of evidence-based guidelines

1. The Health Protection Network (HPN) in Scotland

1. The Health Protection Network (HPN) in Scotland

The Health Protection Network (HPN) is a network of existing professional organisations and networks in the health protection community across Scotland.

It aims to promote, sustain, and coordinate good practice.

The HPN does this by adopting, promoting and disseminating a systematic approach to develop evidence-based guidelines, as well as by ensuring an appropriate workforce development plan is in place and complied with.

MEMBERSHIP • Scottish CPHM (CD/EH) Group• Health Protection Nurses Specialist (Scotland) Network (HPNS) • Health Protection Scotland (HPS) • Infection Prevention Society (IPS) • The Royal Environmental Health Institute of Scotland (REHIS) • Scottish Infection Research Network (SIRN) • Scottish Microbiology Virology Network (SMVN) and the Scottish Clinical Virology Consultants Group (SCVG)• Scottish Public Health Network (ScotPHN) • Society of Chief Officers of Environmental Health (SoCOEH) • Health Protection Education Programme (HPS/NES) • Public Representative

• Why does evidence-based practice matter to us?

Rise of Evidence-Based Medicine

• First described in 1992• A new approach to teaching medicine• A “revolution” in medical practice• Other “evidence-based” approaches: ethics,

psychotherapy, occupational therapy, dentistry, nursing, and librarianship

Factors Driving EBM

• Overwhelming size of the literature• Inadequacy of textbooks• Difficulty synthesizing evidence and

translating into practice• Increased number of RCTs• Available computerized databases• Reproducible evidence strategies

Sackett DL et al; Churchill Livingstone, 2000

Definition of EBM

• “The integration of best research evidence with clinical expertise and patient values.”

Steps of EBM

• Convert the need for info. into an answerable question

• Track down the best evidence• Critically appraise that evidence• Integrate the appraisal with one’s clinical

expertise and the individual patient• Evaluate

Sackett DL. EBM: how to practice and teach EBM. Churchill Livingstone 2000

Critique of EBM

• De-emphasizes patient values• Doesn’t account for individual variation• Devalues clinical judgment• Leads to therapeutic nihilism

Development of EBPH

• Jenicek (1997) published a review discussing epidemiology, EBM, EBPH

• Epidemiology described as the foundation of both EBM and EBPH

• EBPH unique in using complex interventions with multiple community and societal issues

Jenicek M. J Epidemiol 1997;7:187-97

Definition of EBPH (1)

• “EBPH is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of communities and populations in the domain of health protection, disease prevention, health maintenance and improvement.”

Jenicek (1997)

Strong evidence supports that…

“teaching is not effective on Friday afternoons”

Strong evidence supports that…

“teaching is not effective on Friday afternoons”

• Trust? – sourceTrust? – source

• Evidence – Identified and synthesised?Evidence – Identified and synthesised?

• Recommendations link with the evidence?Recommendations link with the evidence?

• Validation Validation improve practice? improve practice? implementation implementation

Interpretation of Interpretation of ““communications”communications”

“Half of what we are taught as medical students will in ten years have been shown to be wrong. The trouble is, none of teachers knows which half.”

Dr Sydney Burrell, Dean of Harvard Medical School (2000)

Health Care / Medical Sciences Literature -Health Care / Medical Sciences Literature -

Good Practice GUIDELINES

“Systematically developed statements to assist practitioner and patient (public) decisions about appropriate public health interventions for specific circumstances”

Derived from: Institute of Medicine Committee to Advise the Public Health Service on Clinical Practice Guidelines. Clinical Practice Guidelines: Directions for a new program. Washington DC: National Academy Press, 1990.

Concepts

What makes a good guideline?

“Should provide extensive, critical and well-balanced information on the benefits and limitations of various interventions so that the practitioner can carefully judge individual cases”

Derived from: Subcommittee of WHO. Summary of the 1993

WHO. BMJ 1993; 307: 1541-1546

Concepts

Concepts

Guidelines Purpose

“To make explicit recommendations with a definite intent to influence what physicians do”

Derived from: Hayward RSA, Wilson MC, Tunis SR, Bass EB,

Guyatt G, for the Evidence-Based Medicine Working Group. Users’ guides to the Medical Literature. VIII How to use Clinical Practice Guidelines. A Are the

Recommendations Valid? JAMA 1995< 274> 570-574

What makes a good guideline?

• Valid• Reproducible• Cost-effective• Representative / multidisciplinary• Clinically applicable• Flexible • Clear • Reviewable• Amenable to clinical audit

Criteria

NHS Executive. Clinical Guidelines. Leeds: NHSE, 1996

Potential benefits of Good Practice Guidelines

• For the public / patients

• For healthcare professionals

• For healthcare systems

Adapted from Woolf SH et al. Potential benefits, limitations and harms of clinical guidelines. BMJ 1999: 318: 527-530

Potential benefits for patients / the public

Better quality of care

Improve health outcomes

Improve consistency of care

Inform patients / public about what health professionals should be doing

Empower public to make more informed choices

Influence public policy

Promote distributive justice

Potential benefits for healthcare professionals

Better quality of management decisions

Reassure healthcare professionals that practice / intervention is appropriate

Provide explicit recommendations to guide care / public health interventions

Reduce outdated, ineffective or wasteful practice

Support quality improvement initiatives

Inform the research agenda by highlighting gaps in evidence

Potential benefits for healthcare systems

Improve efficiency

Optimise value for money

Demonstrate adherence to guidelines may improve public image

What can GUIDELINES offer to improve the standard of practice?

• Provide clear statements and standards for the delivery of care/service locally• Clarify roles and responsibilities• Support the implementation of evidence-based practice• Promotes high quality, effective care / service• Support risk assessment and management• Provide opportunities for the public to become involved in developing services• Provide a source of information for the CG Committee• Provide audit information• Promote high quality record keeping

How are evidence-based guidelines developed?

1. Identifying and refining the subject area of a guideline

2. Running guideline development groups

3. Identifying and assessing the evidence

4. Translating evidence into a clinical practice guideline

5. Reviewing and updating guidelines

Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Developing guidelines. BMJ 1999: 42: 67-81

COMPOSITION OF THE GUIDELINE DEVELOPMENT GROUP

DEFINE RESOURCE CONSEQUENCES

CONSULTATION & PEER REVIEW

EDIT & PUBLICATION

FORMULATION OF AUDIT & PEER REVIEW

FORMATION OF RECOMMENDATIONS & GRADING

IDENTIFICATION & EVALUATION OF EVIDENCE

TOPIC SELECTION & SCOPE

HPS GUIDELINES Development Proposal

CPD

SELECTION OF GUIDELINE TOPICS

FORMATION OF RECOMMENDATIONS

CONSULTATION AND PEER REVIEW

PRESENTATION AND DISSEMINATION

LOCAL IMPLEMENTATION

SYSTEMATIC LITERATURE REVIEW

COMPOSITION OF THE GUIDELINE DEVELOPMENT GROUP

AUDIT AND REVIEW

ORGANISATION OF GUIDELINE DEVELOPMENT

SIGN GUIDELINES

Scottish Intercollegiate Guidelines Network. SIGN 50: A Guideline developers’ handbook, Edinburgh, March 2004

PREPARE THE WORKPLAN

IDENTIFY THE EVIDENCE

REVIES AND GRADE THE EVIDENCE

CONSULTATION DRAFTS AND PEER REVIEW

FINAL GUIDELINE

FORMULATE THE CLINICAL QUESTIONS

FORM THE GUIDELINE DEVELOPMENT GROUP (GDG) AND MEETINGS

REVIEW AND UPDATE WITHIN AND AGREED TIMEFRAME

SCOPE THE GUIDELINE

CREATE GUIDELINE RECOMMENDATIONS

NICE

National Institute for Clinical Excellence. Guideline Development Methods. London, Feb 2004

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COMPOSITION OF THE GUIDELINE DEVELOPMENT GROUP

DEFINE RESOURCE CONSEQUENCES

CONSULTATION &PEER REVIEW

EDIT & PUBLICATION

FORMULATION OF AUDIT & PEER REVIEW

FORMATION OF RECOMMENDATIONS & GRADING

IDENTIFICATION & EVALUATION OF EVIDENCE

TOPIC SELECTION & SCOPE

CPD

HPS Proposal GUIDELINE DEVELOPMENT PROCESS

Subject

Groups

Evidence

Editing

Review

Health Health Protection Protection Network (HPN) Network (HPN) Guideline Guideline Development Development Framework Framework

2. A systematic approach to produce guidance for HP in ScotlandDevelopment of evidence-based guidelines

2. A systematic approach to produce guidance for HP in ScotlandDevelopment of evidence-based guidelines

1. Developing guidelines de novo

• Guidelines on Management of Legionella outbreaks and clusters in the community ( in collaboration with SIGN )

• Guidelines on Prophylaxis and Management of Rabies in Humans

2. Adapting existing guidelines

2.1. From a validated group of guidelines Guidelines on Risk Communication (appraisal of 7

guidelines)

2.2. Local adaptation of one validated guideline Guidelines on Tuberculosis (based on the NICE guidelines)

2.3. Review / revision of existing (older) local Scottish Guidance Guidance on managing E coli O157

1. Developing guidelines de novo

• Guidelines on Management of Legionella outbreaks and clusters in the community ( in collaboration with SIGN )

• Guidelines on Prophylaxis and Management of Rabies in Humans

2. Adapting existing guidelines

2.1. From a validated group of guidelines Guidelines on Risk Communication (appraisal of 7

guidelines)

2.2. Local adaptation of one validated guideline Guidelines on Tuberculosis (based on the NICE guidelines)

2.3. Review / revision of existing (older) local Scottish Guidance Guidance on managing E coli O157

“A guideline which fulfils all the institute's requirements

is like the Holy Grail: worth striving for,

but unattainable by mere mortals”

GENE FEDER, St Bartholomew's and the Royal London Medical College, 1993

“A guideline which fulfils all the institute's requirements

is like the Holy Grail: worth striving for,

but unattainable by mere mortals”

GENE FEDER, St Bartholomew's and the Royal London Medical College, 1993

Development of evidence-based guidelinesDevelopment of evidence-based guidelines

• A common methodology• A common methodology

• Validated (SIGN 50)• Validated (SIGN 50)

1. Topic selection and Scope

2. Completion of the GDG

3. Identification and evaluation of the evidence

• Appraisal tools (SIGN 50)

• AGREE instrument

4. Formulation of recommendations

5. Editing, publishing and implementing

1. Topic selection and Scope

2. Completion of the GDG

3. Identification and evaluation of the evidence

• Appraisal tools (SIGN 50)

• AGREE instrument

4. Formulation of recommendations

5. Editing, publishing and implementing

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Resources• Stakeholders capacity in harmony with business continuity• Training issues• Prioritisation criteria

Quality Assurance• Competence in search strategy / appraisal skills• Criteria to quality assure our own guidance

Pool of Evidence• Intrinsic limitations in the hierarchy of evidence• Interpretation of epidemiological evidence• Integration of extrapolated and induced evidence

Grading of Recommendations

• Limitations in adopting conventional grading of recommendations• Value of expert opinion – shared knowledge from practice

Consultation and Peer Review

• Access to experts• Consultation beyond geographical boundaries• Applicability and implementation issues

3. Challenges in developing E-B Guidelines for health protection

3. Challenges in developing E-B Guidelines for health protection

Formulating recommendationsFormulating recommendations

GradingGrading

Strength of recommendation (1)

A – high level of evidenceBCD GPP – Good Practice Point

Strength of recommendation (1)

A – high level of evidenceBCD GPP – Good Practice Point

Pool of EvidenceHierarchy of evidence

Pool of EvidenceHierarchy of evidence

3. Challenges in grading recommendationsIntrinsic to the nature of Health Protection (1 of 2)

3. Challenges in grading recommendationsIntrinsic to the nature of Health Protection (1 of 2)

RCTRCT

Systematic ReviewsSystematic Reviews

CohortCohort

Case controlCase control

Case ReportCase Report

Case seriesCase series

(1) Grades of Recommendation from SIGN 50. Jan 2008

Grey LiteratureGrey Literature

Legislation

Codes of Practice

Legislation

Codes of Practice

E-B Guidelines onHealth ProtectionHPN / HPS

3. Challenges in grading recommendations

Intrinsic to the nature of HP (2 of 2)

3. Challenges in grading recommendations

Intrinsic to the nature of HP (2 of 2)

no

no

some

D

GPP

no

no

some

D

GPP

E-B Guidelines for Health Protection

E-B Guidelines for Health Protection

??

4. Key Considerations4. Key Considerations

• Good understanding of what’s needed to produce good quality guidelines:

• Provide clear statements and standards for the delivery of care/service• Clarify roles and responsibilities• Support the implementation of evidence-based practice• Promotes high quality, effective care / service

• Propose a validated method to systematically produce guidelines… and test it… test it… test it… • acknowledge limitations – investment / prioritisation• try resolve the scientific challenges amongst the wider community

• A path to solution – Collaboration (NICE/SIGN… RKI/ECDC… HPA)

• Good understanding of what’s needed to produce good quality guidelines:

• Provide clear statements and standards for the delivery of care/service• Clarify roles and responsibilities• Support the implementation of evidence-based practice• Promotes high quality, effective care / service

• Propose a validated method to systematically produce guidelines… and test it… test it… test it… • acknowledge limitations – investment / prioritisation• try resolve the scientific challenges amongst the wider community

• A path to solution – Collaboration (NICE/SIGN… RKI/ECDC… HPA)

““In order to move forward, we need two legs: In order to move forward, we need two legs: action and reflection”action and reflection”

Gaudi

ThanksAlex Sánchez-VivarAlex Sánchez-Vivar

alex.sanchez-vivar@nhs.netalex.sanchez-vivar@nhs.net

What are evidence based guidelines?

Mechanisms to improve the quality of health care and decrease costs and utilisation

Recommendations devised to influence decisions about health interventions

Tools to outline procedures which operate the implementation of evidence-based practice

Decision tools to close gaps between current and optimal practiceDecision tools to close gaps between current and optimal practice

Good Practice GUIDELINES

Derived from: Institute of Medicine Committee to Advise the Public Health Service on Clinical Practice Guidelines. Clinical Practice Guidelines: Directions for a new

program. Washington DC: National Academy Press, 1990.

Good Practice GUIDELINES

Derived from: Institute of Medicine Committee to Advise the Public Health Service on Clinical Practice Guidelines. Clinical Practice Guidelines: Directions for a new

program. Washington DC: National Academy Press, 1990.

“Systematically developed statements to assist practitioners (and public) to make decisions about appropriate public health interventions

for specific circumstances”

“Systematically developed statements to assist practitioners (and public) to make decisions about appropriate public health interventions

for specific circumstances”