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Communicating With Your Patients About the Risks of Therapies . Meenakshi Bewtra , MD MPH University of Pennsylvania Division of Gastroenterology Center for Clinical Epidemiology & Biostatistics. CCEB. Outline:. Risks of immunosuppressant therapy* Benefits of immunosuppressant therapy*

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communicating with your patients about the risks of therapies

Communicating With Your Patients About the Risks of Therapies

MeenakshiBewtra, MD MPH

University of Pennsylvania

Division of Gastroenterology

Center for Clinical Epidemiology & Biostatistics

CCEB

outline
Outline:
  • Risks of immunosuppressant therapy*
  • Benefits of immunosuppressant therapy*
  • Putting it all together: for the physician
  • Putting it all together: for the patient
  • Conclusion
  • Immunosuppressant therapy: thiopurine analogs, biologics, calcineurininhibitors, methotrexate
outline1
Outline:
  • Risks of immunosuppressant therapy
  • Benefits of immunosuppressant therapy
  • Putting it all together: for the physician
  • Putting it all together: for the patient
  • Conclusion
risks in immunosuppressant therapy
Risks in Immunosuppressant Therapy*
  • Serious/Opportunistic Infections
  • Lymphoma
  • Hepatosplenic T-Cell Lymphoma (HSTCL)
  • Progressive Multifocal Leukoencepholapthy (PML)

*All following risks estimates are approximations based

upon (my) calculations of available data

disclaimer
Disclaimer

All risks estimates are approximations based upon calculations of available data

risks in immunosuppressant therapy1
Risks in Immunosuppressant Therapy
  • Serious/Opportunistic Infections
    • 3% / year risk monotherapy
    • 5% / year with combination therapy
  • Lymphoma
  • Hepatosplenic T-Cell Lymphoma (HSTCL)
  • Progressive Multifocal Leukoencepholapthy (PML)
risks in immunosuppressant therapy2
Risks in Immunosuppressant Therapy
  • Serious/Opportunistic Infections
    • 3% / year risk monotherapy
    • 5% / year with combination therapy
  • Lymphoma
    • 4x increased risk (monotherapy)
    • 8x increased risk (combination)
  • Hepatosplenic T-Cell Lymphoma (HSTCL)
  • Progressive Multifocal Leukoencepholapthy (PML)
risks in immunosuppressant therapy3
Risks in Immunosuppressant Therapy
  • Serious/Opportunistic Infections
    • 3% / year risk monotherapy
    • 5% / year with combination therapy
  • Lymphoma
    • 4x increased risk (monotherapy)
    • 8x increased risk (combination)
  • Hepatosplenic T-Cell Lymphoma (HSTCL)
    • 160x increased risk
  • Progressive Multifocal Leukoencepholapthy (PML)
risks in immunosuppressant therapy4
Risks in Immunosuppressant Therapy
  • Serious/Opportunistic Infections
    • 3% / year risk monotherapy
    • 5% / year with combination therapy
  • Lymphoma
    • 4x increased risk (monotherapy)
    • 8x increased risk (combination)
  • Hepatosplenic T-Cell Lymphoma (HSTCL)
    • 160x increased risk
  • Progressive Multifocal Leukoencepholapthy (PML)
    • 1 out of every 7000 treated; infinitely increased risk
risks in immunosuppressant therapy5
Risks in Immunosuppressant Therapy
  • Serious/Opportunistic Infections
    • 30/1000 annual risk (monotherapy)
    • 50/ 1000 annual risk (combination therapy)
  • Lymphoma
    • 0.8/1000 annual incidence (monotherapy)
    • 1.6/1000 annual incidence (combination)
  • Hepatosplenic T-Cell Lymphoma (HSTCL)
    • 0.0034 /1000 annual incidence
  • Progressive Multifocal Leukoencepholapthy (PML)
    • 0.14/1000 (not necessarily annual incidence)
outline2
Outline:
  • Risks of immunosuppressant therapy
  • Benefits of immunosuppressant therapy
  • Putting it all together: for the physician
  • Putting it all together: for the patient
  • Conclusion
risk of medication cessation
Risk of medication cessation:
  • Azathioprine

Trenton X et al. ClinGastroenterolHepatol 2009;7:80-5

risk of medication cessation1
Risk of medication cessation:
  • Infliximab

Intra-abdominal surgeries CD-related hospitalizations

Rutgeerts P et al. Gastroenterology 2004;126(2):402

risk of medication cessation2
Risk of medication cessation:
  • Cessation of anti-TNF therapy when on combination therapy

Louis E et al. Gastroenterology 2012;142(1):63-70

corticosteroids are bad
Corticosteroids: are bad
  • Fluid retention
  • CHF
  • Metabolic abnormalities
  • Hypertension
  • Muscle weakness
  • Loss of muscle mass
  • Osteoporosis
  • Compression fractures (spine)
  • Aspectic necrosis (femoral/humeral head)
  • Pathologic fractures
  • Tendon rupture
  • Hyperglycemia
  • cataracts
  • Gastric ulcers
  • Pancreatitis
  • Impaired wound healing
  • Bruising
  • Pseudotumorcerebri
  • Emotional disturbances
  • Menstrual irregularities
  • Cushingoid features
  • Growth suppression (children)
  • Secondary adrenocortical /pituitary unresponsiveness
  • Diabetes mellitus
  • Glaucoma
  • Weight gain
corticosteroids infection risk
Corticosteroids: Infection risk
  • Serious infections: TREAT registry
    • Adj OR 2.2 (1.5-3.3), p=0.001
  • Opportunistic infection: Mayo Clinic
    • OR 3.3 (1.8-6.1), p<0.001
  • Post-operative infections: elective IBD surgery
    • Any infection (29%): OR 3.7 (1.2-11.0)
    • Major infection (20%): OR 5.5 (1.1-27.3)
      • Higher risk with higher dosages used

Aberra et al. Gastro 2003;125:320

Lichtenstein et al Clin Gastro Hep 2006;4:621

Toruner et al. Gastro 2008;134:929-36

corticosteroids risk of mortality
Corticosteroids: risk of mortality
  • Lichtenstein: TREAT
    • Corticosteroid use: OR 2.1 (1.1–3.8) p=.016
  • Lewis: GPRD

Lichtenstein et al. Clin Gastro Hep 2006;4:621–630

Lewis et al. Am J Gastro 2008;103:1428–1435

untreated active ibd r isk of mortality
Untreated/Active IBD: risk of mortality

Lewis et al. Am J Gastro 2008;103:1428–1435

outline3
Outline:
  • Risks of immunosuppressant therapy
  • Benefits of immunosuppressant therapy
  • Putting it all together: for YOU
  • Putting it all together: for the patient
  • Conclusion
how do these risks stack up
How do these risks stack up?*

Adapted from: Lewis JD et al, Am J Gastro 2008 Lichtenstein G et al. CGH 2006

Kandiel A et al. Gut 2005 Siegel C. et al. CGH 2006 Herrinton L et al Pharm Drug Safe 2012

Trenton X et al. CGH 2009 Rutgeerts P et al. Gastro 2004 Singh S et al, IBD 2012

Toruner M et al, Gastro 2008 Grijalva CG et al, JAMA 2011 Bloomgren G et al NEJM 2012

why is changing the way we practice so hard
Why is changing the way we practice so hard?
  • How one perceives risk:
    • Epidemiologist: risk is a measured property of a group of people
    • Physician/patient: risk is a specific property of ME
  • Perception becomes reality:
    • Reject statistical reasoning in favor of anecdotal reasoning
    • Accept common risks we “know” in favor of uncommon risks we “fear”
outline4
Outline:
  • Risks of immunosuppressant therapy
  • Benefits of immunosuppressant therapy
  • Putting it all together: for the physician
  • Putting it all together: for your patient
  • Conclusion
discussing risk with patients
Discussing risk with patients
  • Numeracy: basic math skills for health-related activities
    • Over 50% of Americans lack minimum basic skills to apply to arithmetic operations of numbers in print materials
  • Patients have problems with risk presentation, framing, proportions/probabilities, denominator neglect

Burkell J et al, J Med LibrAssoc 2004

Aptar AJ et al, J Gen Intern Med 2008

Renya VF et al, Individ Differ 2008

Fagerlin A et al, Med Decis Making 2007

discussing risk with patients1
Discussing risk with patients
  • Risk presentation:
    • Avoid vague labels such as “low,” “very low,” “often” or “very common” which lead to inconsistent interpretations
  • Framing
    • Relative risks can make small (rare) risks appear large (infinite)
      • Absolute risks anchor all risks
    • Use similar frame (“gain frame” or “loss frame”)

Burkell J et al, J Med LibrAssoc 2004

Aptar AJ et al, J Gen Intern Med 2008

Fagerlin A et al, Med Decis Making 2007

discussing risk with patients2
Discussing risk with patients
  • Avoid “artificial” constructs such as proportions, ratios, probabilities, odds
    • Require conditional math skills
    • Use frequencies/count data
  • Denominator neglect: people are very sensitive to numerators
      • Ex: 1,286 in 10,000 viewed riskier than 24 in 100
    • Present all risks with similar denominator

Burkell J et al, J Med LibrAssoc2004 Reyna VF et al Learn Individ Diff 2008

Akl EA et al Cochrane Database Syst Rev 2011 Brase GL J BehavDecis Making 2002

Fagerlin A et al Am J Health Beahv 2007 Garcia-Retamero Am J Pub Health 2009

Ancker JS et al, J Am Med Inform Assoc 2006 Yamagishi K. ApplCognPsychol 1997

outline5
Outline:
  • Risks of immunosuppressant therapy
  • Benefits of immunosuppressant therapy
  • Putting it all together: for YOU
  • Putting it all together: for the patient
  • Conclusion
conclusions
Conclusions:
  • There are documented risks with immunosuppressant therapy
    • The absolute risks are low
    • Did not discuss: higher-risk populations (elderly, young men)
  • The absolute risks of active/untreated disease and/or corticosteroid therapy are high
  • Be aware of numeracy issues when discussing with patients
    • Avoid vague descriptions of risk, use absolute counts with similar denominators, and consider incorporating visual aids
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