transforming guidelines into electronic tools
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Transforming GuidelinesInto Electronic Tools
Richard N. Shiffman, MD, MCIS
Yale Center for Medical Informatics
New Haven, Connecticut, USA
Overview
• Cultural contrasts• Computer-based Decision Support• Ways developers can help implementers• Implementers have some tools that may help
developers
• URL and email are on my last slide!
ulturesRick Shiffman
Suave and
debonair
Cultural difference: food
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We Read Different Journals
We Meet in Different Places(at the same time!)
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August 20–24, 2007
Language differences
• Guideline prose– Woolly, fudgy– Both inadvertent and deliberate
• C#, JAVA, ASBRU, GLIF, … – Precise– Ambiguity causes crashes
SAME GOAL:DIMINISHING INAPPROPRIATE PRACTICE
VARIATIONPROMOTING KNOWLEDGE-BASED CARE
78.7
64.7
63.9
53.9
53.5
45.4
39
22.8
0 20 40 60 80 100
Hypertension
Colorectal CancerAsthmaDiabetesPneumoniaHip Fx
CHF
Senile Cataract
% Receiving Recommended Care
(McGlynn. NEJM 2003)
Strategies
• Authors: Sculpting recommendations to match evidence
• Implementers: Operationalizing recommendations in a system that influences behavior
High Probability of Effectiveness
• Patient-specific reminder at time of consultation– Grimshaw JM and Russell IT. Effect of
clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993
Computer-Based Decision SupportSystematic Reviews
Mary Johnston McMaster JAMA 1994
Derek Hunt McMaster JAMA 1998
Amit Garg Univ. Western Ontario
JAMA 2005
Ken Kawamoto Duke BMJ 2005
Basit Chaudhry
UCLA Ann Intern Med 2006
Findings
• Computer-based decision support regularly—but not always—improves the process of care
• Outcomes—though infrequently measured—sometimes improve
CDSS Definition
• A system that compares patient characteristics with a knowledge base and then guides a health provider by offering patient-specific and situation-specific advice
CP FriedmanJC Wyatt
Functions of CDSS
Alerting Out-of-range lab values
Reminding Schedule preventive service
Critiquing Rejecting an electronic order
Interpreting EKG
Predicting Mortality from severity score
Diagnosing Differential based on symptoms
Assisting Tailoring dosages based on renal function
Suggesting Ventilator adjustments
Randolph AG. JAMA 1999
DocumentationTemplates Interpreter
DocumentationTemplates Calculator
Interpreter
RelevantData Summary
Interpreter
Alerts / Reminders
OrderCreation
Facilitator
InfoButton
ThoughtfulAssistant
(Electronic) Implementers Need More Help from
Developers
Language
Obstacles to Implementation
Define Recommendation Strength
• Different recommendations would be given for the same patient using …encoded representations of vaccine- and breast mass workup guidelines formulated by different members of the (same) laboratory.
Translation of Guideline Knowledge for Decision Support
Patel VL.JAMIA 1998
Why is attention to implementability important?
• “We found that it was possible—if not inevitable—that two encoders would encode the same guideline in two different ways. Sources of variation included differences in the order in which data elements are collected, differences in the level of detail represented, differences in the use of atomic sentences or composite sentences in criteria, differences in the specification of data elements, and omissions due to human error…
is not contraindicated Single dose of PCV-7 for high risk children of any age
may benefit from RSV prophylaxis for infants 32 weeks’ gestation or less
may be beneficial Meningococcal polysaccharide vaccine for travelers
will benefit from RSV monoclonal antibody for children 24 months of age or less with hemodynamically significant congenital heart disease
may be helpful Testing for asymptomatic seroconversion after varicella exposure and receipt of VZIG
most experts recommend RSV prophylaxis for infants 32 to 35 weeks’ gestation with risk factors
some experts recommend Pertussis vaccine for children who have had natural pertussis
some experts suggest Duration of face-to-face contact that qualifies for significant varicella exposure
some experts prefer Serologic testing for anti-HBsAg antibody after primary vaccine series in perinatally exposed infants
some experts consider Safety of influenza vaccine during early pregnancy
experts differ in opinion HBIG for the incompletely immunized child exposed to a discarded needle in the community
the manufacturer recommends
Avoidance of salicylates after varicella vaccine
Statement of fact is NOT a recommendation
• Adjuvant hormone therapy for locally advanced breast cancer results in improved survival in the long term.
• Clinicians should prescribe adjuvant hormone therapy for locally advanced breast cancer (when/unless?)…
“Ambiguity”: Resolution by classification
• Ambiguous statements are interpretable in more than one discrete way– “I’ll meet you at the bank.”– “MS”: morphine sulfate, magnesium sulfate; multiple
sclerosis– “LAD”: left axis deviation, lymphadenopathy
• Vague- lack a crisp threshold in a single dimension– “Fever,” “tall”
• Underspecified - lack specificity in multiple dimensions– “sufficiently ill to warrant immediate antimicrobial therapy”
Deliberate vaguenessand underspecification
• Insufficient evidence• Inability to reach consensus• Legal concerns (standard of care)• Economic reasons• Ethical/religious issues (e.g., concept of
“burden,” “futility of care”)
• What if authors were transparent aboutthe reason for AVUL?
Authors Should Be Explicit About
• WHEN {under what circumstances}
• WHO should
• Do WHAT
• To WHOM
• HOW
• WHY
AUTHORS SHOULD USE STRONG VERBS
• Active voice– Passive masks the actor
• Appropriate choice of deontic operators– The clinician must, must not; the Committee strongly
recommends– The clinician should, should not; the Committee
recommends– The clinician may; the Committee suggests
• The dreaded “consider”
GLIA (GuideLine Implementability Appraisal)
• Helps to identify obstacles to implementation• Provides feedback to guideline authors to anticipate and
address these obstacles before a draft guideline is finalized• Assists implementers to select guidelines and to focus
attention on anticipated obstacles
• GLIA is available from http://gem.med.yale.edu/glia
How does GLIA complement AGREE?
• Limited to issues related to implementation• Emphasis on individual recommendation
(rather than the guideline as a whole)• Concordance
– Of 23 AGREE items (and 31 GLIA items)• 5 have equivalent questions in GLIA• 3 have similar questions in GLIA
GuideLine Implementability Appraisal(GLIA)
• Decidability - precisely under what circumstances to do something
• Executability - exactly what to do under the circumstances defined)
• Effect on process of care - the degree to which a recommendation impacts upon the usual workflow of a care setting)
• Presentation and formatting - the degree to which the recommendation is easily recognizable and succinct
• Measurable outcomes - the degree to which the guideline identifies markers or endpoints to track the effects of implementation of this recommendation
GLIA Constructs (2)
• Apparent validity - the degree to which a recommendation reflects the intent of the developer and the strength of evidence
• Novelty/innovation - the degree to which a recommendation proposes behaviors considered unconventional by clinicians or patients
• Flexibility - the degree to which a recommendation permits interpretation and allows for alternatives in its execution
• Computability - the ease with which a recommendation can be operationalized in an electronic information system
Guideline Authors are committed to appraising the quality of scientific
evidence• As they should!• But they regularly fall short in helping users
understand how to use the information• Implementers are rarely interested in
evidence quality per se• Implementers need authors’ assessment of
strength of recommendation
Tripod of Concepts
Benefits vs. HarmsAssessment
Confidence (we’ve got benefits
& harms right:Evidence Quality)
Importance of AdherenceRecommendation Strength
American Academy of PediatricsGrading Recommendation Strength
Evidence Quality
Preponderance of Benefit or
Harm
Balance of Benefit and
Harm
A. Well designed RCTs or diagnostic studies on relevant population
B. RCTs or diagnostic studies with minor limitations;overwhelmingly consistent evidence from observational studies
C. Observational studies (case-control and cohort design)
D. Expert opinion, case reports, reasoning from first principles
X. Exceptional situations where validating studies cannot be performed and there is a clear preponderance of benefit or harm
Strong
Strong
Rec
RecOption
Option No Rec
Clinicians and Strong Recommendations
• Benefits of the recommended approach clearly exceed the harms
• Quality of the evidence is excellent • Clinicians should follow such guidance unless a
clear and compelling rationale for acting in a contrary manner is present
• Optimal source for P4P
Clinicians and Recommendations
• Benefits exceed the harms
• Quality of the evidence on which this recommendation is based is not as strong
• Clinicians generally should follow such guidance but also should be alert to new information and sensitive to patient preferences.
Clinicians and Options
• Evidence quality is suspect or well-designed, well-conducted studies have demonstrated little clear advantage to one approach versus another
• Options offer flexibility in decision making about appropriate practice, although they may set boundaries on alternatives
• Patient preference should have a substantial role in influencing clinical decision making
• Hard to hold clinicians accountable (P4P)
Electronic Implementers and Recommendation Strength
• Strong recommendation– Cannot close form until issue is addressed
• Recommendation– Recommended action is default; some
effort required to override
• Option– Radio buttons, checkboxes for choices
within limited range
(Electronic) Implementers have some tools that can help
developers
GEM
EXTRACTOR
eGLIA
Action-types
Implementation Section
Logical Analysis with Highlighters
•UTI Recommendation 3
If an infant or young child 2 months to 2 years of age with unexplained fever is assessed as being sufficiently ill to warrant immediate antimicrobial therapy, a urine specimen should be obtained by SPA or bladder catheterization; the diagnosis of UTI cannot be established by a culture of urine collected in a bag. (Strength of evidence: good) Urine obtained by SPA or urethral catheterization is unlikely to be contaminated...
XML: From a small number of discrete colors to an unlimited palette
XML
• Multi-platform, Web-based, open standard
• “Tags” enclose and describe text
<inclusion.criterion>hematuria</
inclusion.criterion>
• Human-readable, yet can be processed by
machine
• Markup can be performed by non-
programmers
• “Hot”—considerable energies invested in X-
tech
• Knowledge model for guideline documents
• GEM adopted as a standard by ASTM in 2002; GEM II updated and re-standardized in 2006
• Models heterogeneous information contained in guidelines
– Multi-level hierarchy (>100 elements) indicates relationships
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GEM
GEM II-Top Level
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Conditional
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GEM Cutter
MORO
Reuse OftenMarkup Once,
GQAQ Report Card
Markup OnceReuse Often
• Markup with GEM Cutter Editor
• Guideline quality appraisal with GEM-Q
• Feedback to developers with Extractor
Feedback to authors
Decision Variable Values Decidable?
Age <6m, 6m-2yr,>2yr
Attend day care Y, N
Recently treated with abx Y, N
Severe illness Y, N
Followup can be assured Y, N
Action Executable?
Amoxicillin 45 mg/kg/d in 2 divided doses
Observation is appropriate
Action-Types in405 Recommendations
Monitor
Test
Gather Interpret Perform Dispose
Action
Conclude Prescribe
Educate
Document
Procedure
Consult
Advocate
Prepare
Essaihi A. Proc AMIA 2004
Action Distribution
Refer 5%
Dispose 4%Conclude 3%Monitor 3%Document PrepareAdvocate
No Rec
Example: Application of Action-Types
• Action-type: Prescribe– Drug information– Safety alerts (allergy, drug-drug, drug-
disease, drug-lab)– Formulary check– Dosage calculation– Pharmacy transmission– Patient education– Corollary orders
Key Messages• Developers and implementers (esp electronic) represent
different cultures• Electronic DSS work• Electronic implementers need help from developers
– Watch your language!– Anticipate problems in implementation: GLIA– Define recommendation strength
• Implementers have some tools that may help developers– GEM: a standardized document representation– EXTRACTOR– Action-typing to define recurring patterns
Thank You!
http://gem.med.yale.edu
richard.shiffman@yale.edu
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