Clinical Practice Guidelines

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 Comparison of Medical
Paradigms
 Practice derived from
personal observation
 Reasoning based on
pathophysiology
 Guidelines based on
expert opinion
Guidelines-EBM 2005
 Practice explicitly
derived from the best
external clinical
evidence available
 Reasoning based on
clinical studies
 Guidelines based on
evaluation of medical
literature
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 Decision making
EBM • By Anecdote
• By press cutting
• By expert opinion (eminence based medicine)
Clinical expertise • By cost minimization
Be

The best care

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The best results

ea

The most cost-effective price

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Clinical Practice Guidelines

Evidence B i ased Medicine

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 Examples of Patient Values Affecting Clinical Decisions

Value Definition Example

Quality of life Patient prefers quality of life to a Decision to forego
prolongation of life aggressive
chemotherapy for
advanced cancer
Fear of specific Patient weight certain Fear of breast cancer
complication complications and outcomes over heart disease
differently than others influences woman’s
choice about HRT
Cost Personal or family risk of Decision to use generic
financial burden influences medication 3 times per
therapy day instead of a more
expensive medication
once a day
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 Examples of Clinician Values Affecting Clinical Decisions

Value Definition Examples

Primum non First do no harm, Doctors doing The decision not to place
nocere harm is worse than other adverse PA Catheter until evidence
outcomes of benefit
Chagrin Over treating and test ordering The decision to prescribe
are less likely to result in antibiotics to an elderly
embarrassing missed patient with a viral
complications and diagnoses syndrome
Justice Costs and benefits should be Decision not to use inhaled
distributed equitability in society NO

Fear Fear of litigation The decision to perform a

Cesarean section

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 Definition

 Institute of Medicine

“Systematically developed statements to assist

practinioner and patient decisions about
appropriate health care for specific clinical
circumstances”

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 Purpose of Guidelines
 To make EB standards explicit and accessible
 To make decision making in the clinic and at the
bedside easier and more objective
 To provide yardstick for assessing professional
performance
 To delineate the division of labor
 To educate patients and professionals about current
best practice
 To improve the cost effectiveness of health services
 To serve as a tool for external control

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 Skill needed for guideline development

 Literature searching and retrieval

 Epidemiology
 Biostatistics
 Health services research
 Clinical experts
 Group process experts
 Writing and editing

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 Guideline Development Methodology

1. Validity
2. Reliability/reproducibility
3. Clinical applicability
4. Clinical flexibility
5. Clarity
6. Multidisciplinary process
7. Scheduled review
8. Documentation
9. Developers and Sponsors
Filed MJ and Lohr KN, 1992
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 When should CG be updated

 Changes in evidence on the existing benefits

and harms of interventions
 Changes in outcomes considered important
 Changes in available interventions
 Changes in resources available for health care

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 Guides for deciding whether a
guideline is valid
 Did it’s developers carry out a comprehensive,
reproducible literature review within the past
12 months?
 Is each of its recommendations both tagged by
the level of evidence upon which it is based
and linked to a specific citation?

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 Frequency of Publication Vs Scientific Merit

Frequency of Scientific Merit

Publication

Expert opinion
Case reports
Animal studies
Volunteer studies
Case control studies
Cohort studies
RCT

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 Level of evidence
I: Properly randomized controlled trials

II-1: Well designed Controlled trials without randomization

II-2: Cohort or case-control analytic studies

II-3: Multiple time series with or wo intervention, dramatic

results in an uncontrolled experiments
III: Opinions of respected authorities, descriptive
epidemiology, case report, report of expert committee

 Guide to Clinical Preventive Services (US Preventive

Services Task Force, 1996)
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 Strength of recommendation*
A There is good evidence to support performing the
: preventive service
B: There is fair evidence to support performing
preventive service
C There is poor evidence to support performing the
: preventive service, but recommendations may be
made on other grounds
D There is fair evidence to discontinue performing
: the preventive service
E: There is good evidence to discontinue performing
the preventive service

 Guide to Clinical Preventive Services (US Preventive Services Task

Force, 1989) Guidelines-EBM 2005 14
Level of evidence and grades of recommendations
Grade of Level of Therapy/prevention/ Prognosis Diagnosis
recomm. evidenc etiology/harm
e

1a SR of RCTs SR of inception SR of level 1

cohort diagnostic
studies

1b Individual RCT with Individual Independent

A narrow CI inception cohort blind
study with > 80% comparison of
follow up an appropriate
spectrum of
consecutive
patients
1c All or none All or none case Absolute SpPins
series and SnNouts

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Sackett, et al 2000
 Level of evidence and grades of
recommendations
Recommendation Level of Evidence

A I a, b, c

B II a, b, c
III a, b
C IV IV

D V V

Sackett, et al 2000
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 Is this guideline potentially useful?

Does this guideline offer an opportunity for significant

improvement in the quality of health care practice

• Is there a large variation in current practice

• Does the guideline contain new evidence that could have
an important impact on management

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Should this guideline be applied in your practice?

1. What barriers exist to its implementation?

Can the barrier be overcome

2. Can you enlist the collaboration of key colleagues?

3. Can you meet the educational, administrative, and economic

conditions that are likely to determine the success or failure
of implementing the strategy?

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