Clinical Practice Guidelines

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Clinical (Practice) Guidelines

• Sudigdo Sastroasmoro
• sudigdo_s_at_yahoo.com

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Clinical guidelines What are they?
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Taxonomy of healthcare standards

• Clinical (practice) guidelines
• Protocols
• Standard operating procedures
• Algorithms
• Clinical pathways
• Standing orders

Must be Evidence-based Periodically
revisedb
Ashton, 2002
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EBM

• Bringing research evidence into practice
• EBM concerns with practical application of theory
  (clinical epidemiology)
• We are not daydreaming with theoretical basis of
  medicine, but primarily concern with the
  practical implementation of advances in medical
  science and technology

CEBM, 1994
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Medical practice in modern eraWhat are the
facts?

• 25,000 journals
• 6,000,000 articles per yr
• 17,000 biomedical books/yr
• 1,500 procedures

• Problems in daily practice
• 3,000 diseases
• 80 symptoms and signs
• consumerism, IT
• demographic changes, etc

• Strategies
• Read all available evidence and apply to your
  patients (impossible)
• Find out the clinical problem from our daily
  practice and systematically
• search, appraise, and apply the evidence

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• Clinical guideline is one way
• to implement
• research evidence into practice

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What are CGs?

• Clinical (practice) guidelines are defined as
  systematically developed statements to assist
  practitioner and patient decisions about
  appropriate health care for specific clinical
  circumstances. They tend (but not always) to be
  used after a diagnosis has been reached.

NICE, 2003
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What are CGs?

• Guidelines are evidence-based (based on current
  research), and unlike other types of formats that
  provide a step-wise approach to care and
  treatment, the guidelines provide information
  regarding the most effective managements.
• Physicians use this information along with their
  experience and knowledge of the patient to
  determine the appropriate plan of care.

NICE, 2003
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When a guideline is needed?

• Highly varied clinical practice
• Difference opinions among professionals
• especially if they have the following
  characteristics
• High volume
• High risk
• High cost

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Relevance Types of Evidence

• POE Patient-oriented evidence
• mortality, morbidity, quality of life
• DOE Disease-oriented evidence
• pathophysiology, pharmacology, etiology

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POEM

• Patient-Oriented
• Evidence
• that Matters
• matters to us, the clinicians, because if valid,
  will require us to change our practice

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Comparing DOEs and POEMs
Drug A ? mortality
Antiarrhythmic Therapy
Drug A ? PVC On ECG
DOE POEM contradicts

Drug X ? mortality
POEM agrees With DOE
Antihypertens. Therapy
Drug X ? BP
PSA screening detects prostate Ca. early
? whether PSA screening ? mortality
Prostate screening
DOE exists, but POEM unknown
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Good Guidelines should

• be effective - lead to health gains expected from
  them
• be efficient - and hence cost effective
• be evidence based

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Aim of Guidelines

• to rid ineffective methods
• to rid waste of resources

Improvement of quality of care
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Who should make up the guidelines?

• Everyone
• Professional organizations
• Universities
• Hospitals
• Individuals
• NGOs, Insurance companies
• Government

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Who should make up the guidelines?

• Depends on the subject and who develops the
  guidelines. Usually
• Experts in respective area (Multidisciplinary)
• Relevant consultants
• A Health Authority/Medical Pharmaceutical Adviser
  Pharmacist
• Epidemiologist/Health Economist
• A Specialist in Guideline methodology
• Laymen

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The process guidelines development

• Select relevant subject
• List specific questions
• Search and synthesise published reports
• Assess the quality of each study
• Perform economic analysis
• Determine the grade of recommendations
• Resolve unanswered questions
• Determine schedule for revision

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The process guidelines development

• Select relevant subject
• Management of complex febrile convulsions

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The process guidelines development

• 2. List specific questions to be answered
• In a child with complex febrile convulsion do
• long-term anticonvulsants compared with no
  treatment
• prevent subsequent seizures?

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The process guidelines development

• Search and synthesise published reports
• Use appropriate keywords in relevant databases
  (MEDLINE, Cochrane, AAP, etc)

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The process guidelines development

• 4. Assess the quality of each study VIA

• VALIDITY In Methods section
• design, sample, sample size, eligibility criteria
  (inclusion, exclusion) sampling method,
  randomization method, intervention, measurements,
  methods of analysis, etc
• IMPORTANCE In Results section
• characteristics of subjects, drop out, effect
  size, analysis, P value, confidence intervals,
  etc
• APPLICABILITY In Discussion section our
  patients characteristics, local setting

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Assessment of evidence

• Appropriateness of inclusion/exclusion criteria
• Concealment of allocation
• Blinding of patients, investigators, both
• Objective or blind method of data collection
• Valid or blind method of data analysis
• Completeness and length of follow up
• Appropriateness of outcome measures
• Statistical power of results
• Publication bias - was a company of interest
  sponsoring the study
• Conflict of interest

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5. Perform economic analysis
The process guidelines development

• Systemic appraisals of
• effectiveness
• compliance
• safety
• health service resource use
• cost effectiveness

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6. Evaluate strength of recommendation
The process guidelines development

• Effectiveness
• Applicability of the evidence to the population
  of interest
• Guideline developers awareness of the practical
  issues
• Cost effectiveness

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Hierarchy of the Evidence
Rec A B C
Meta-analysis of RCT Large RCT Small
RCT Quasi-experimentals Observational
studies Case series / reports Anecdotes,
expert, consensus
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7. Resolve unanswered question(s), if any
The process guidelines development

• Not all questions can be answered with firm
  evidence
• Try hard to answer even if not conclusive

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8. Scheduled review
The process guidelines development

• Every time new important evidence is available
• More practical Scheduled every . year
  depending on the expected rate of new evidence

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Attributes of high-quality CGs  

• Valid
• Reproducible
• Clinically flexible
• Multidisciplinary process
• Documentation
• Reliability
• Clinically applicable
• Clear
• Scheduled review

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Ten key principles for NHS clinical guidelines

• The objective of CGs is to improve the quality of
  care
• Quality care is based on clinical effectiveness
• Quality of care includes cost effectiveness of
  health care
• CGs are relevant to the care provided by the NHS
• CGs are advisory
• CGs are based on research evidence, expert
  opinion and consensus
• CGs should respect of patients, the NHS and
  stakeholders
• Patients are involved in a clinical guideline
  development.
• CGs should consider clinicians, patients, public,
  Government and the health care industries
• CGs should be both ambitious and realistic

NICE, 2003
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Formats of CGs

• Full-text
• Abridged or summary
• Format for patients

NICE, 2003
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Example of CGs

• Amer Assoc Clin Endocrinologist (2003) Guideline
  for evaluation and treatment of male sexual
  dysfunction. 19 pages, 104 references
• AAP Clinical Practice Guideline (2000) Diagnosis
  and evaluation of the child with ADHD. 13 pages,
  60 references.
• California Workgroup (2002) Guideline for
  management of Alzheimers disease. 55 pages, 217
  references
• APA (2001) Guideline for management of patients
  with sinusitis. 24 pages, 79 references
• American College of Cardiology / American Heart
  Association (2002) Guideline update for the
  management of chronic stable angina. 136 pages,
  1053 references

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Appraising CGs

• Validity
• Importance
• Applicability

Please refer to the Worksheet provided
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Implementing clinical guidelines

• Guideline should not be implemented rigidly
• In implementing clinical guidelines into
  individual patients it should be borne in mind
  that
• Guidelines are advisory
• Guidelines are developed for the average
  patients
• Guidelines are developed for isolated disease or
  condition
• Individual response to diagnostic and therapeutic
  procedure varies widely
• Guidelines are valid at the time of its
  publication
• Modern medical practice encourages involving
  patients in clinical decision making
• The most appropriate person make a decision is
  the doctor in charge
• Should the physician decides not to comply with
  the guideline she or he must write clearly her or
  his reasons to do so

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Remember the cardinal rule

• If it is not written down
• it didnt happen

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Types of health care professionals
Evidence generators
Evidence Users
Evidence Finders
Evidence Ignorer