Israel Deaconess. Medical Center. Glyn Elwyn, BA MD MSc. PhD. Professor & Physician- researcher, Dartmouth. Institute for Health. Policy & Clinical Practice.
Harmonizing Clinical Practice Guidelines and Shared Decision Making Alper BS, Oettgen P, Elwyn G, Agoritsas T, Kunnamo I, Qaseem A, Vandvik PO, Price A; Healthcare Guidance for Patients Society ISDM, July 2017
Healthcare Guidance for Patients Society
Brian Alper, MD, MSPH, FAAFP Founder, DynaMed VP of Innovations & EBM Development, EBSCO Health
Amy Price, PhD Public Trialist, Research at ThinkWell; CEO, Empower2Go
Glyn Elwyn, BA MD MSc PhD Professor & Physicianresearcher, Dartmouth Institute for Health Policy & Clinical Practice
Amir Qaseem, MD, PhD, MHA, FACP VP, Clinical Policy & Center for Evidence Reviews, American College of Physicians
Thomas Agoritsas, MD, PhD Senior Clinical Associate, Divisions of General Internal Medicine & Clinical Epidemiology, University Hospitals of Geneva
Ilkka Kunnamo, MD, PhD Editor-in-Chief, EBM Guidelines at EBMeDS at Duodecim Medical Publications
Peter Oettgen, MD, FACC, FAHA EIC, DynaMed; Director, Preventive Cardiology, Beth Israel Deaconess Medical Center
Per Olav Vandvik MD, PhD Career Grant Researcher at Helse Sør-Øst RHF
Disclosure Slide • Drs. Alper and Oettgen are full-time employees of EBSCO which produces DynaMed Plus which systematically develops recommendations. • Dr. Kunnamo is an employee of Duodecim which produces EBM Guidelines which systematically develops recommendations. • Dr. Qaseem is full-time employee of American College of Physicians which systematically develops recommendations. He is also a Recommendations Editor for DynaMed Plus. • Dr. Vandvik is head of the MAGIC research and innovation program (www.magicproject.org) which provides tools to create, publish and dynamically update trustworthy recommendations (www.magicapp.org). • Dr Price is a research fellow with the BMJ and an advisor with the BMJ Patient Partnership Panel. Her contributions include consultation and review of guideline development as it is considered in terms of methodology, public research involvement and end user engagement. • Dr Elwyn is a tenured professor and physician-researcher at The Dartmouth Institute for Health Policy & Clinical Practice, USA. He leads an interdisciplinary team that studies shared decision making. He is also Editor-in-Chief for EBSCO Health Option Grid. • Dr. Agoritsas is a Senior Clinical Associate at the Divisions of General Internal Medicine & Clinical Epidemiology, University Hospitals of Geneva and Assistant Professor at the Department of Health Research Methods, Evidence, and Impact, McMaster University.
Clinical practice guidelines (CPGs) provide recommendations. The language of recommendations often uses GRADE. Strong recommendation We recommend doing it. Weak recommendation We suggest doing it. This CPG with GRADE approach is • Simple to phrase • Clear in distinguishing strength of recommendation • Explicit if following evidence-to-decision framework
Clinical practice guidelines (CPGs) helps clinicians answer the question What should we do?. We = the clinicians What should we do? = What course of action is correct? What degree of obligation? One “goal” is to decrease practice variation: Reduce overuse, underuse, and misuse
6.1.1 Strong recommendation A strong recommendation is one for which guideline panel is confident that the desirable effects of an intervention outweigh its undesirable effects (strong recommendation for an intervention). A strong recommendation implies that most or all individuals will be best served by the recommended course of action.
6.1.2 Weak recommendation A weak recommendation is one for which the desirable effects probably outweigh the undesirable effects (weak recommendation for an intervention) but appreciable uncertainty exists. A weak recommendation implies that not all individuals will be best served by the recommended course of action. There is a need to consider more carefully than usual the individual patient’s circumstances, preferences, and values. When there are weak recommendations caregivers need to allocate more time to shared decision making, making sure that they clearly and comprehensively explain the potential benefits and harms to a patient.
The CPG view?
Is there certainty that benefits outweigh harms for most or all people? If YES: Strong Recommendation - We recommend doing … If NO: Weak Recommendation - We suggest doing …
The CPG view?
Is there certainty that benefits outweigh harms for most or all people? If YES: Strong Recommendation - We recommend doing … If NO: Weak Recommendation - We suggest doing … Could be due to uncertainty that benefits outweigh harms for a “representative estimate” of patient’s values (this relates to certainty of evidence) Could be due to uncertainty that benefits outweigh harms across the range of “actual values” and “informed preferences” across a population of patients (this relates to sensitivity to values and preferences)
The CPG view? Certainty that benefits outweigh harms for “representative” patient values? YES Certainty that YES benefits outweigh harms for nearly all with NO informed preferences?
NO Strong Recommendation
Weak Recommendation
We recommend doing …
We suggest doing …
Weak Recommendation
Weak Recommendation
We suggest doing …
We suggest doing …
Shared decision making (SDM) is an approach in which clinicians and patients communicate together using the best available evidence when faced with the task of making decisions. Patients are supported to deliberate about the possible attributes and consequences of options, to arrive at informed preferences in making a determination about the best course of action which respects patient autonomy, as well as ethical and legal norms. --Wikipedia
• Shared decision making (SDM) • • • •
uses best available evidence communicates best evidence to patients considers patient’s values for attributes and consequences arrives at informed preferences rather than authoritative recommendations • respects patient autonomy
Shared decision making (SDM) helps the patient answer the question What should I do?. I = the patient What should I do? = What course of action will best meet my goals?
• Shared decision making (SDM) helps the patient • Recognize there is a choice • Express their values (desires, goals) • Understand relevant evidence for patient-important consequences • Determine well-informed preferences
Language of Shared decision making (SDM)
Preferences Choice Options Discussion Shared Values
One “goal” is to increase practice variation: Vary the practice to fit the patient
The SDM view?
For any decision where “informed preferences” will vary for a considerable minority of people, the optimal approach is not a “recommendation” but rather offering the options to patients, helping patients understand the consequences in relation to their values, and determining informed preferences Is there certainty that benefits outweigh harms for nearly all with informed preferences? If YES: Explain the course of action (discuss if patient desires) If NO: Offer to support deliberation about options (share certainty of evidence)
The SDM view?
Certainty that benefits outweigh harms for “representative” patient values? YES Certainty YES that benefits outweigh harms for NO nearly all with informed preferences?
NO
Explain the course of action (discuss if patient desires)
Explain the course of action (discuss if patient desires)
Offer to support deliberation about options (share certainty of evidence)
Offer to support deliberation about options (share certainty of evidence)
The CPG view?
The SDM view?
METHODS • WHO: Healthcare Guidance for Patients Society (Healthcare GPS) includes experts in evidence-based medicine (EBM), CPGs and SDM. • HOW: We considered the Grading of Recommendations Assessment, Development and Evaluation (GRADE) and International Patient Decision Aids Standards Collaboration (IPDAS) standards • WHAT: We are developing (via a consensus-based approach) a model for recommendation phrasing. The consensus is not complete.
THEMES • An EBM-CPG-SDM model should allow clinicians and patients a practical way to discuss net benefits and harms of interventions that change with the patient’s values. • Offer options with an SDM approach for preference-sensitive decisions with net benefit for some patients (and net harm for some patients with different values).
• This is not a Strong recommendation for the intervention, even with high certainty of evidence. • But it is not a Weak recommendation for offering the intervention, especially with high certainty of evidence. • The nuance of action (the action of doing the intervention, the action of offering the intervention) can get confusing in brief phrasing of recommendations.
• Strong or Weak recommendations to perform the action (do the intervention) would still be made for preference-insensitive conditions.
EXAMPLES for Antibiotic use • Population: Patients with meningococcal meningitis • Certainty that benefits outweigh harms for “typical” patient?: YES • Certainty for nearly all with informed preferences?: YES • CPG view = We recommend antibiotics for patients with meningococcal meningitis (Strong recommendation) • SDM view = Explain the course of action (discuss if patient desires) • Harmonized view for CPG = We recommend antibiotics (Strong recommendation) • Phrasing to patient/family: We will start antibiotics to treat your meningococcal meningitis.
EXAMPLES for Antibiotic use • Population: Patients on mechanical ventilation with elevated WBC • Certainty that benefits outweigh harms for “typical” patient?: NO (uncertainty in risk of infection) • Certainty for nearly all with informed preferences?: YES (uncertainty is not coming from uncertainty in patient’s values) • CPG view = We suggest empiric antibiotics for patients with respiratory illness requiring mechanical ventilation, non-infectious cause, and elevated inflammatory markers (Weak recommendation) • SDM view = Explain the course of action (discuss if patient desires) • Harmonized view for CPG = We suggest antibiotics (Weak recommendation) • Phrasing to patient/family: We will add antibiotics to cover a possible infection while your family member is on the ventilator.
EXAMPLES for Antibiotic use • • • •
Population: Children with community-acquired pneumonia Certainty that benefits outweigh harms for “typical” patient?: NO Certainty for nearly all with informed preferences?: NO CPG view = We suggest antibiotics for children with community-acquired pneumonia (Weak recommendation) • SDM view = Offer to support deliberation about options • Harmonized view for CPG = We suggest offering the options of antibiotics and no antibiotics (Options suggested). Provide support for shared decision making. • Phrasing to patient/family: Antibiotics and not using antibiotics are both options for treating your child with pneumonia. Would you like to better understand the benefits and harms to decide what is right for you and your child?
EXAMPLES for Antibiotic use • • • •
Population: Women with uncomplicated urinary tract infection Certainty that benefits outweigh harms for “typical” patient?: YES Certainty for nearly all with informed preferences?: NO CPG view = We suggest antibiotics for women with uncomplicated urinary tract infection (Weak recommendation) • SDM view = Offer to support deliberation about options • Harmonized view for CPG = We suggest offering the options of antibiotics and no antibiotics (Options suggested). Provide support for shared decision making. • Phrasing to patient/family: Antibiotics and not using antibiotics are both options for treating your urinary tract infection. Most women choose to use antibiotics. Would you like to know more?
Challenges with this model • ? Expectation for labeled recommendation • Keep “Weak recommendation” • Use “Options suggested” as a different label to clarify the recommended action for the clinician is to offer options
• ? Decisions with common preferences (but not universal) • Full deliberation may not be optimal time use for most patients and clinicians • How to determine such decisions (eg topical antibiotics for uncomplicated impetigo) • How to convey such recommendations in CPGs (where there is still a significant potential for shared decision making)
A Harmonized CPG-SDM view? For CPG phrasing: What should we (clinicians) do? Certainty that benefits outweigh harms for “representative” patient values? YES Certainty that benefits outweigh harms for nearly all with informed preferences?
YES
NO
NO
Strong Recommendation
Weak Recommendation
We recommend X.
We suggest X.
Options Suggested We suggest offering the options with acknowledgement of common preferences. Provide support for shared decision making.
Options Suggested We suggest offering the options. Provide support for shared decision making.
A Healthcare Guidance for Patients System view?
