Post on 03-Jan-2016
description
Making Guidelines WORK
Richard N. Shiffman, MD, MCISYale School of Medicine
NYAM Teach 2011
Disclosure
• Funding from AHRQ and NLM
• Will describe several applications developed in our laboratory available gratis for non-commercial use
Today
• Making Guidelines WORK– Improving the delivery of knowledge to the point
of care– Computer-based clinical decision support
3
• Making Guidelines THAT Work– Improving the product– Clarity, transparency, and implementability– GLIA and BRIDGE-Wiz
Guidelines have problems…• Cluzeau (Int J Qual Healthcare 1999), Shaneyfelt (JAMA 1999)
majority of guidelines failed quality criteria
• Grilli: 431 specialty society guidelines (Lancet 2000)– 82% did not apply explicit criteria to grade evidence
– 87% did not report whether a literature search was performed
– 67% did not describe type of professionals involved in development
• Shaneyfelt (JAMA 2009): persisting biases; lack of specificity, flexibility, regular updating
• Alonso-Coello: in 42 reviews of 626 guidelines over past 20 years, mean quality scores for rigor of development, stakeholder involvement, editorial independence, and applicability are “moderate” or “low” (GIN 2009)
CPGs are 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
Guidance on the use of glitazones for the treatment of type 2 diabetes
• For people with type 2 diabetes, the use of a glitazone as second-line therapy added to either metformin or a sulphonylurea--as an alternative to treatment with a combination of metformin and a sulphonylurea-- is not recommended except for those who are unable to take metformin and a sulphonylurea in combination because of intolerance or a contraindication to one of the drugs. In this instance, the glitazone should replace in the combination the drug that is poorly tolerated or contraindicated.
Authors Should Be Explicit About
• WHEN {under what circumstances} • WHO {in the Intended Audience}• Ought to {with what level of obligation}• DO WHAT• {To WHOM} {which members of the target population}
• HOW• WHY
IF
THEN
Denominator
Numerator
Guidance on the use of glitazones for the treatment of type 2 diabetes
• If a patient is unable to take the combination of metformin and sulfonylurea (because of intolerance or contraindication), the clinician should prescribe a glitazone to replace the drug that is not tolerated.
Guidance on the use of glitazones for the treatment of type 2 diabetes
• If a patient is unable to take the combination of metformin and sulfonylurea (because of intolerance or contraindication), the clinician should prescribe a glitazone to replace the drug that is not tolerated.
UNDER WHAT CIRCUMSTANCES?
WHO?
OUGHT? To do WHAT?
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?)…
Lomotan E, et al. Qual & Safety in Health Care 2010
How “Should” We Write Guideline Recommendations:
Interpretation of Deontic Terminology
• Goal: To describe the level of obligation conveyed by deontic terms commonly used in practice guidelines
• Can level of obligation be standardized?
Measuring Obligation
0 50 100
Level of Obligation
Musts (19/1250 – 1.5%)• Narcotic use must be carefully titrated and supervised.• Clinicians working in juvenile justice settings must be vigilant for
personal safety and security issues and aware of actions that may compromise their safety and/or the safety and containment of the incarcerated youth
• Nurses working with individuals with asthma must have the appropriate knowledge and skills to identify the level of asthma control, provide basic asthma education, conduct appropriate referrals to physician and community resources
• Treatment of duodenal adenomas depends on adenoma size and the presence of severe dysplasia. Small tubular adenomas with mild dysplasia can be kept under surveillance, but adenomas with severe dysplasia must be removed
15
The Dreaded “Consider”
• The Expert Panel concludes that initiating daily long-term control therapy should be considered for reducing impairment in infants and young children who consistently require symptomatic treatment more than 2 days per week for a period of more than 4 weeks (Evidence D).
• Referral may be considered if a child 0–4 years of age requires step 2 care or a child 5–11 years of age requires step 3 care.
Measurement
• If you can’t measure it, you can’t manage it.
• If you don’t measure it, you can’t improve it.
Peter Drucker
MonitorTest
Gather Data Interpret Act
Dispose
Action-Types
Conclude Prescribe
Educate/counsel
Document
Procedure
Consult/refer
Advocate
PreparePrevent
Inquire Examine
Action-Type Pattern: Prescribe
• Drug information
• Safety alerts (allergy, drug-drug, drug-disease, drug-lab)
• Formulary check
• Dosage calculation
• Pharmacy transmission
• Patient education
• Corollary orders
A Transparent Process for Generating Recommendations
A transparent development process makes clear…
• How authors weighed• evidence • pathophysiologic reasoning (first principles)• expert experience• patients’ and society’s values
• Allows users to judge reasonableness of recommendations
Requires untangling and specifying 2 related (but distinct) concepts
• Quality of evidence
• Recommendation strength
{Elegant and erudite work of GRADE Collaboration}
<---developers’ focus
<-what implementers need to know to design systems that influence care
• level of expected adherence• level of enforcement / incentive
Evidence Quality
• An indication of the authors’ confidence in their appraisal of benefits and harms
• Based on an analysis of the validity, consistency, and directness of the evidence supporting a recommendation
Recommendation Strength
• Implementers need to understand experts’ assessment of strength of recommendation
• Communicates authors’ assessment of the importance of adherence
• Levels based on aggregate evidence quality and balance of anticipated benefits and harms– Strong recommendation (“MUST”)– Recommendation (“SHOULD”)– Option (“MAY”)
Grading 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
GuideLine Implementability
Appraisal
• Goals– To identify intrinsic obstacles to implementation, i.e., those
that are within the purview of guideline developers– To provide feedback to guideline authors to anticipate and
address these obstacles before a draft guideline is finalized– To assist implementers in guideline selection and to target
attention toward anticipated obstacles• GLIA (and eGLIA) available from http://gem.med.yale.edu/glia
BMC Medical Informatics and Decision Making 2005
GLIA v2.0 Dimensions
• Decidability - precisely under what conditions (e.g., age, gender, clinical findings, lab results) to do something
• Executability - exactly what to do under the circumstances defined)
• Validity - the degree to which a recommendation reflects the intent of the developer and the strength of evidence
• Flexibility - the degree to which a recommendation permits interpretation and allows for alternatives in its execution
• Effect on process of care - the degree to which a recommendation impacts upon the usual workflow in a typical care setting
GLIA v 2.0 Dimensions (cont’d)
• Measurability – the degree to which the guideline identifies markers or endpoints to track the effects of implementation of this recommendation
• Novelty/innovation - the degree to which a recommendation proposes behaviors considered unconventional by clinicians or patients
• Computability - the ease with which a recommendation can be operationalized in an electronic information system
Bridge the Gap
Between Authors and Implementers
With BRIDGE-Wiz
(Building Recommendations In a Developer’s Guideline Editor)
BRIDGE-Wiz• Displays a sequence of screens representing chunks of
information about a recommendation• The authors systematically and sequentially determine:
– action(s) to be recommended– condition(s) under which the action is to be performed– benefits, risks, harms, and costs of the proposed action– the quality of the evidence supporting the action.
• The program’s output is an IF…THEN rule and supporting recommendation profile
30
Bridge-Wiz Demo
31
BRIDGE-WizBuilding Recommendations in a Developer’s Guideline Editor
• Formalizes a process for writing implementable recommendations• Focuses discussion• Incorporates prompts based on COGS to improve guideline quality• Controlled natural language
– Offers verb choices based on action-type– Traps and disallows use of “consider”– Discourages “statement of fact” masquerading as recommendation– Limits boolean connectors to all ANDs or ORs in a statement
• Incorporates decidability and executability checks• Requires systematic appraisal of evidence quality and benefit-harms
– Suggests appropriate obligation term (deontic modal)• Output includes a high-level “rule” and an evidence profile
Making Guidelines Work
33
Interventions to Influence Practice
• Education (conferences, courses)
• Audit & feedback
• Financial incentives/disincentives
• Patient-mediated interventions
• Computer based decision support
34
Grol, Grimshaw Lancet 2003
Clinical Decision Support: Definition
• Use of the computer to bring relevant knowledge to bear on the health care and well-being of a patient (Greenes).
• Systems that link health observations with health knowledge to influence health choices by clinicians for improved health care (Hayward)
35
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
•Computer-based decision support regularly—but not always—improves the process of care
•Outcomes—though infrequently measured—sometimes improve
Identifying Features Critical to Success
• Significant improvement in practice in 68% of 70 trials• Predictors of improved practice:
– Automatic provision of DS as part of workflow– Providing DS at time and site of decision making– Providing recommendations, not just assessments– Providing periodic performance feedback– Sharing recommendations with patients– Requesting reasons for not following recommendations
Kawamoto K. BMJ 2005
Allergy Alert
38
Palette of CDS Interventions
Alert
Infobutton
Algorithm
Calculator
ReminderDocumentationtemplate
Flowsheet
OrderFacilitator
Selected Guideline
• Asthma – EPR3 Diagnosis and Management of Asthma from
the NHLBI (2007)– Demonstrates challenges involved in implementation
of recommendations for chronic management of complex disease
40
Prompts for documentation
Real-time calculation and display
Information Access
Prompts forAssessments
Display of RelevantPast Information
Alert
Order Set
46
Customizable Handout
Medication Authorization
Summary
• Making Guidelines WORK– Computer-based clinical decision support– Improving the delivery of knowledge to the point
of care
47
• Making Guidelines THAT Work– Must address:
– Clarity, transparency, and implementability– GLIA and BRIDGE-Wiz
Thank You!
ycmi.med.yale.edu/GLIDES
richard.shiffman@yale.edu