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Explaining Contraceptive Risk to Patients. Sponsored by Association of Reproductive Health Professionals Planned Parenthood ® Federation of America. A component of You Decide: Making Informed Health Decisions about Hormonal Contraception

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explaining contraceptive risk to patients

Explaining Contraceptive Risk to Patients

Sponsored by

Association of Reproductive Health Professionals

Planned Parenthood® Federation of America

A component of You Decide: Making Informed Health Decisions about Hormonal Contraception

Supported by an independent educational grant from Ortho Women’s Health and Urology

expert medical advisory committee
Expert Medical Advisory Committee

David Grimes, MD (co-chair) Vice President Biomedical AffairsFamily Health International Durham, NC

Joel Shuster, PharmD, BCPPProfessor of Clinical PharmacyTemple University School of PharmacyClinical Pharmacy ConsultantEpiscopal Hospital Temple University School of Pharmacy Philadelphia, PA

Eshauna Smith, MPA Program ManagerPro-Choice Public Education Project (PEP) New York, NY

Scott Spear, MD Director of Clinical ServicesUniversity Health Services Associate Professor of Pediatrics (CHS) University of Wisconsin-MadisonMadison, WI

James Trussell, BPhil, PhD DirectorOffice of Population ResearchPrinceton University Princeton, NJ

Sandy Worthington, MSN, RNC, CNMProgram DirectorPlanned Parenthood Federation of America Philadelphia, PA

James R. Allen, MD, MPH Medical AdvisorAmerican Social Health Association Washington, DC

Vanessa Cullins, MD, MPH, MBA (co-chair) Vice President for Medical AffairsPlanned Parenthood Federation of America New York, NY

Linda Dominguez, RN-C, NPAssistant Medical DirectorPlanned Parenthood of New Mexico Albuquerque, NM

Julie Downs, PhD Research FacultyCarnegie Mellon University Department of Social and Decision SciencesPittsburgh, PA

Martin Fishbein, PhDProfessor, Annenberg Public Policy Center University of Pennsylvania Philadelphia, PA

Kamini Geer, MD Fellow, Family PlanningMontefiore Medical Center Department of Social and Family MedicineBronx, NY

learning objectives
Learning Objectives
  • Define relative risk, attributable risk and absolute risk
  • List three different means of presenting risk and describe the advantages of each
  • Identify at least three patient characteristics to consider when counseling about risks and benefits
  • Describe at least one patient education tool that can be used to effectively communicate the risks and benefits of hormonal contraceptives
case study alyssa smith
Case Study: Alyssa Smith
  • 25 year old nonsmoker, 3 children
  • Satisfied user of DMPA for 3 years
  • Past contraceptive history
    • Patch caused nausea
    • Difficulty remembering to take oral contraceptives (OCs)
    • Not interested in IUD
    • Not interested in vaginal insertion methods
case study alyssa smith cont d
Primary care clinic stopped prescribing DMPA

Ms. Smith left without a plan for an effective contraceptive method

Early medication abortion

Physician said, “It’s bad for bones” but provided no specifics

Pregnancy within 3 months

Case Study, Alyssa Smith (cont’d)
case study cont
Case Study (cont.)
  • Specific risks were explained and placed in context by another provider
  • Ms. Smith was comfortable with risks and benefits of DMPA
  • She decided to resume DMPA
risk misperception the provider
Risk Misperception & the Provider

Chaker AM. Wall Street Journal November 22, 2005.

risk misperception the patient
Risk Misperception & the Patient

“…incorrect perceptions of excess risk of contraceptive products may lead women to use them less than effectively or not at all.”

Gardner J, Miller L. J Womens Health 2005

misperception affects health decisions oc discontinuation
Misperception Affects Health Decisions: OC Discontinuation
  • In 1995, the British Committee on Safety of Medicines warned of possible increased risk of VTE among users of 3rd generation OCs
  • Many women stopped taking OCs
  • Prescribing patterns changed
  • Pregnancy and abortion numbers increased
  • Deemed a “non-epidemic”

Chasen-Taber L, Stampfer M. N Engl J Med 2001; Drife L. Drug Saf 2002; Furedi A, Paintin D. Lancet 1998;

Spitzer WO. Hum Reprod 1997. .

unintended pregnancy rates by age 2001
Unintended Pregnancy Rates by Age, 2001

100

90

80

70

60

Percentage ofpregnancies unintended

50

40

30

20

10

0

15-19

20-24

25-29

30-34

35-39

>40

Age

Finer LB, Henshaw SK. Perspect Sexual Reprod Health 2006.

definition of risk
Definition of Risk

“The possibility of suffering harm or loss.”

The American Heritage Dictionary of the English Language

risk calculations
Risk Calculations
  • Allow researchers to hypothesize about causality
  • Allow consumers and clinicians to weigh the pros and cons of treatment interventions
  • Allow epidemiologists to calculate the degree to which a disease or event is attributable to a particular hazard

Hennekens CH, Buring JE. Epidemiology in Medicine 1987.

associations vs causality
Associations vs. Causality
  • An association does not always mean exposure caused outcome
  • It could be due to random chance or bias

Grimes DA, Schulz KF. Lancet 2002.

absolute risk
Absolute Risk
  • Absolute risk is
    • The percentage of people in a group who experience a discrete event
    • The number of people with event/the total # of people at risk

NY Academy of Medicine. www.emeb.org 2005.

Misselbrook D, Armstrong D. Fam Practice 2002.

example of absolute risk
Absolute risk

30 per 100,000 woman-years

Example of Absolute Risk
  • Of 100,000 women on 3rd generation OCs, 30 will develop venous thromboembolism (VTE) per year

Mills A. Hum Reprod 1997.

absolute risk reduction
Absolute Risk Reduction
  • Absolute risk reduction is:
    • The difference in risk of the outcome between those exposed and those not exposed
    • Risk in exposed – risk in unexposed
  • Reflects the reduction in risk associated with an intervention

NY Academy of Medicine. www.emeb.org 2005.

example of absolute risk reduction
Absolute risk

Absolute risk reduction

15 per 100,000 woman-years

30 - 15 =15 per 100,000 woman-years

Example of Absolute Risk Reduction
  • Of 100,000 women on 2nd generation OCs, 15 will develop VTE per year

Mills A. Hum Reprod 1997.

attributable risk
Attributable Risk
  • Similar to absolute risk reduction
  • Attributable risk is:
    • The difference in risk of the outcome between those exposed and those not exposed
    • Risk in exposed – rate in unexposed
  • Reflects degree of risk associated with exposure

BMJ Collections 2006.

relative risk
Relative Risk
  • Frequency in exposed group divided by frequency in unexposed group
  • Reflects likelihood of developing the outcome based on exposure
  • Used to identify an association between exposure and outcome
  • Similar to odds ratio

Grimes DA, Schulz KF. Lancet 2002.

Hennekens CH, Buring JE. Epidemiology in Medicine 1987.

odds ratio
Odds Ratio
  • Used to identify an association between exposure and outcome in a case-control study
  • Similar to relative risk

Hennekens CH, Buring JE. Epidemiology in Medicine 1987.

example of relative risk
Absolute risk

Absolute risk

3rd Generation OCs

30 per 100,000 woman-years

2nd Generation OCs

15 per 100,000 woman-years

Example of Relative Risk

Relative risk = 30 / 15 = 2

Mills A. Hum Reprod 1997.

interpreting relative risk
Relative risk = 1

Relative risk > 1

Relative risk < 1

No increase in risk in exposed group compared with unexposed group

Increased risk in exposed group

Decreased risk in exposed group

Interpreting Relative Risk

Hennekens CH, Buring JE. Epidemiology in Medicine 1987.

example of relative risk induction of labor cesarean delivery
Example of Relative Risk: Induction of Labor & Cesarean Delivery

= 2

Grimes DA, Schulz KF. Lancet 2002.

example of relative risk cont
Example of Relative Risk (cont.)
  • Interpretation: the risk of cesarean delivery with elective induction of labor is 2 times that associated with spontaneous labor, or, stated alternatively, twice as high

Grimes DA, Schulz KF. Lancet 2002.

example of relative risk cont26
Graph of relative risk of 2

10

Relative risk (log scale)

1

0.1

Example of Relative Risk (cont.)
  • Interpretation: the risk of cesarean delivery with elective induction of labor is 2 times that associated with spontaneous labor, or, stated alternatively, twice as high

Increased risk

Decreased risk

Grimes DA, Schulz KF. Lancet 2002..

example of relative risk 2 infection after cesarean delivery
Example of Relative Risk, #2: Infection after Cesarean Delivery

= 0.5

Grimes DA, Schulz KF. Lancet 2002..

example of relative risk 2 cont
Graph of relative risk of 0.5

10

Increased risk

Relative risk (log scale)

1

Decreased risk

0.1

Example of Relative Risk, #2 (cont.)
  • Interpretation: Use of prophylactic antibiotics (the exposure of interest) is associated with a 50% reduction in risk of infection, or, stated alternatively, one-half the risk

Grimes DA, Schulz KF. Lancet 2002.

comparing relative risk
Comparing Relative Risk

Graph of relative risks of 2 and 0.5

10

Zone of increased risk

2

Relative Risk (log scale)

1

Zone of reduced risk

0.5

0.1

2 and 0.5 are equal in strength but opposite in direction, one harmful and one protective

Grimes DA, Schulz KF. Lancet 2002.

comparative risk of venous thromboembolism
60

Pregnancy

High-dose OC

Low-dose OC

40

General population

20

0

Comparative Risk of Venous Thromboembolism

Incidence of VTE per 100,000woman-years

Shulman LP, Goldzieher JW. J Reprod Med 2003.Chang J, et al. In: Surveillance Summaries 2003.

risk health decisions
Risk & Health Decisions

Decisions about risk are not technical,but value decisions.

Baker B. In: Risk Communication and Health 1999.

causes of risk misperception about hormonal contraceptives
Causes of Risk Misperception about Hormonal Contraceptives
  • Lack of understanding of statistics
  • Psychological factors
  • Media influence
  • Factors that affect risk perception and interpretation
media influence
Media Influence
  • Positive: widespread dispersion of reproductive health information
  • Negative: misperception of contraceptive risks
    • Incomplete information; “sound bites”
    • Business of selling news; “if it bleeds, it leads”
    • Risks not put in context
    • TV ads conclude with adverse events

Grimes DA. In: Oral Contraceptives and Breast Cancer 1989.

degree of oc discontinuation related to media event
Degree of OC Discontinuation Related to Media Event

Percentage

Months after event

Jones EF, et al. Fam Plann Perspect 1980.Grimes DA. In: Oral Contraceptives and Breast Cancer 1989.

temporal relationship between product launch reported adverse events
Temporal Relationship Between Product Launch & Reported Adverse Events

400

200

0

82 - 83

2

3

4

5

6

7

8

9

91 - 92

11

12

13

14

15

16

17

99 - 00

Number of Reports

Year/Month

Hartnell NR, Wilson JP. Pharmacotherapy 2004.Weber JCP. In: Iatrogenic Diseases 1986.

factors that affect perception interpretation of risk
Factors that Affect Perception & Interpretation of Risk
  • Factors related to the individual
  • Factors related to risk presentation
  • Factors related to the characteristics of the risk
factors related to the individual
Factors Related to the Individual
  • Culture
  • Literacy level and education
  • Developmental stage
  • Human tendencies
    • Underestimate effectiveness and overestimate risk of hormonal contraception
    • Optimism-pessimism bias

Noone J. Clin Excell Nurse Pract 2000; Hubertus AAMV. Br J Obstet Gynecol 2001; Grimes DA, Snively GR. Obstet Gynecol 1999; Steinberg L. Ann NY Acad Sci 2004; Mann L, et al. J Adolesc 1989; Steinberg L. Trends Cogn Sci 2005; Edwards JE, et al. Br J Fam Plann 2000; Bowling A, Ebrahim S. Qual Health Care 2001.

developmental stage
Developmental Stage
  • By age 15, reasoning is fully developed in hypothetical situations
  • Early adolescence: puberty causes increase in reward sensitivity
  • Later adolescence: self-regulation systems develop

Steinberg L. Ann NY Acad Sci 2004.Luna B, Sweeney JA. Ann NY Acad Sci 2004.

factors related to risk presentation
Factors Related to Risk Presentation
  • Framing effects (positive or negative)
  • Uncertainty
  • Trust

Edwards A, et al. BMJ 2002.Bennett P. Dept Health UK 1997.

factors related to the characteristics of the risk
Factors Related to the Characteristics of the Risk
  • People worry more about risks that
    • The individual cannot control
    • Are involuntary
    • Are associated with particular dread
    • Are novel or unfamiliar
    • Result from man-made sources
    • Are more easily recalled

Harvard Center for Risk Statistics 2003.

Bennett P. In: Risk Communication and Public Health

estimated actual mortality rates
106

AllAccidents

Motor VehicleAccidents

105

All Disease

All Cancer

Heart Disease

104

Homicide

Stroke

Stomach Cancer

Pregnancy

Diabetes

Flood

TB

Estimated number of deaths per year

103

Tornado

Asthma

Botulism

Electrocution

102

Smallpox Vaccination

10

1

1

106

103

105

102

104

10

Actual number of deaths per year

Estimated & Actual Mortality Rates

Bennett P. In: Risk Communication and Public Health 1999.

understanding risk relative effectiveness of contraceptives
Understanding Risk: Relative Effectiveness of Contraceptives

Steiner MJ, et al. Obstet Gynecol 2003.

tools categories table
Tools: Categories Table

Adapted from Steiner MJ, et al. Obstet Gynecol 2003.

comprehension of contraceptive effectiveness by teaching method
Numbers (FDA)

Numbers & categories (WHO)

Categories

Comprehension of Contraceptive Effectiveness by Teaching Method

Pre/post percent improvement in correct score by teaching method

Hormoneshotvs. pill

Pill vs.condom

0%

40%

Steiner MJ, et al. Obstet Gynecol 2003.

communicating contraceptive effectiveness cont
Communicating Contraceptive Effectiveness (cont.)
  • Given only effectiveness category information, women overestimated pregnancy risk
  • When later shown percentage tables, majority reported rate accurately
  • Authors recommended category tools with general range of risk shown within each category

Steiner MJ, et al. Obstet Gynecol 2003.

understanding risk cardiovascular adverse events
Understanding Risk: Cardiovascular Adverse Events
  • Cardiovascular events: most common major adverse events associated with combined OC use
    • Venous thromboembolism (VTE)
    • Stroke
    • Myocardial infarction (MI)

Farley TMM, et al. Contraception 1998.

cardiovascular events
Cardiovascular Events

Events (per million woman-years)

(Women 30-34 years old)

Farley TMM, et al. Contraception 1998.

cardiovascular mortality
Cardiovascular Mortality

Deaths (per million woman-years)

(Women 30-34 years old)

Farley TMM, et al. Contraception 1998.

cardiovascular adverse events in context
Cardiovascular Adverse Events in Context
  • Context is important
    • Incidence is low in reproductive age women, with or without OC use
    • Smoking and OC use have a synergistic effect on cardiovascular event incidence and mortality at all ages

Farley TMM, et al. Contraception 1998.

cardiovascular adverse events weighing the risks benefits
Cardiovascular Adverse Events: Weighing the Risks & Benefits
  • For most women, non-contraceptive benefits of combined hormonal contraceptives outweigh the risks

Burkman R, et al. Am J Obstet Gynecol 2004.

cardiovascular adverse events screening for risk factors
Cardiovascular Adverse Events:Screening for Risk Factors

Deaths (per million woman-years)

(Women 30-34 years old)

Farley TMM, et al. Contraception 1998.

patient needs concerns what to ask
Patient Needs & Concerns: What to Ask
  • How important is it to avoid pregnancy right now?
  • How important is privacy regarding contraception?
  • Do you have concerns about a particular contraceptive?
  • What side effects are you willing to accept?
  • Are you comfortable with methods that require insertion in the vagina?
factors relevant to risk communication
Factors Relevant to Risk Communication
  • Level of trust
  • Framing effects
  • Cultural, literacy, and developmental effects
  • Not strictly an intellectual issue
  • Risk comparisons can be misleading
tools numerical data
Tools: Numerical Data
  • Try different ways to explain numerical data

SAY “3 of every 10 women develop nausea”

ALSO SAY “You have a 30% chance of nausea”

Gigerenzer G, Edwards A. BMJ 2003.

tools numerical data cont
Tools: Numerical Data (cont.)
  • Avoid shifting denominators in proportions

SAY “Headache developed in 3 of every 1000 women”

NOT “Headache developed in 1 of every 333 women”

Grimes DA, Snively GR. Obstet Gynecol 1999.

Gigerenzer G, Edwards A. BMJ 2003.

tools numerical data cont58
Tools: Numerical Data (cont.)
  • Use absolute risk

SAY “Of every 1 million OC users, 4 develop heart attack each year compared with 2 nonusers.”

NOT “OC use doubles the risk of heart attack”

Gigerenzer G, Edwards A. BMJ 2003; Farley TMM, et al. Contraception 1998;

Sloman SA, et al. Organizational Behavior and Human Decision Processes 2003.

tools descriptive terms
Tools: Descriptive Terms

Risk level

High <1 in 100

Moderate 1 to 10 in 1,000

Low 1 to 10 in 10,000

Very low 1 to 10 in 100,000

Minimal 1 to 10 in 1 million

Calman KC. BMJ 1996.Berry DC, et al. Drug Saf 2003.

tools risk comparisons
Tools: Risk Comparisons

Skydiving 100

Driving 20

Pregnancy 11.5

Riding a bicycle 0.8

Airplane crash 0.4

Using OC* 0.06

Annual Risk of Death (per 100,000)

*Nonsmoker, under age 35

Trussell J, Jordan B. Contraception in press.

Chang J, et al. MMWR 2003.

Harvard Center for Risk Analysis 2006.Bennett P. In: Risk Communication and Public Health 1999.

tools diagrams
Tools: Diagrams
  • Categories table
  • Numbers and categories table
  • Flower diagram
  • Paling Perspective Scale
  • Paling Palette
tools categories table62
Tools: Categories Table

Adapted from Steiner MJ, et al. Obstet Gynecol 2003.

tools numbers categories table
Tools: Numbers & Categories Table

Adapted from Steiner MJ, et al. Obstet Gynecol 2003.

tools paling perspective scale
Tools: Paling Perspective Scale®

Risks from smallpox: for the 115M Americans over the age of 30 - previously vaccinated and DO NO live in a major metropolitan area

1 in 100M

1 in 10M

1 in 100K

1 in 10K

1 in 100

1 in 100B

1 in 10B

1 in 1T

1 in 1B

1 in 1K

1 in 1

1 in 10

1 in 1M

Estimates of Specific Risks

Look at the consequencesas well as the odds

RISK INCREASING

Risk of death from vaccination:1 in 2 million

Risk of Smallpox Infection: 1 in 100M people (or less)

Death from Smallpoxif not vaccinated post exposure: 1 in 1.7B (or less)

Death from Smallpoxif vaccinated post exposure: 1 in 100B (or less)

Fig. 2 Paling Perspective Scale® - for giving perspective to risks of low order of probability.

Paling J. BMJ 2003.

tools paling palette
Tools: Paling Palette®

Paling J. BMJ 2003.

guidance
Guidance
  • Remember to present absolute risk
  • Use different forms of numerical data to explain risk
  • Be aware of framing effects
  • Use risk comparisons with care
  • Have multiple, complementary tools available
decision aid for risk communication
Decision Aid for Risk Communication
  • Clarify situation
  • Provide information
    • “On the benefit side…”
    • “On the harm side…”
  • Clarify patient’s values
  • Screen for implementation problems

O’Connor A, et al. BMJ 2003.

case study michelle gavin
Case Study: Michelle Gavin
  • 19-year-old college student
  • Using patch for 6 months

“I want off the patch—it killed that girl in New York”

O’Connor A et al. BMJ 2003.

case study michelle gavin69
Case Study: Michelle Gavin
  • Clarify situation
  • Provide information
  • Clarify patient’s values
  • Screen for implementation problems

O’Connor A et al. BMJ 2003.

tips for effective communication
Know your purpose

z

Be an active listener

Eliminate internal & external distractions

Present information in several ways

Ensure understanding

Tips for Effective Communication

Center for Urban Transportation Studies UWM 2006.

communication what patients want
Communication: What Patients Want
  • Explain the reasoning behind your questions
  • Present the options (pro and con) and let her know what she can do
  • Treat woman as a partner

Pro Choice Public Education Project 2004.

tips for communicating about alarming media reports
Tips for Communicating About Alarming Media Reports
  • Gather reputable information: PPFA, ARHP, ACOG, CDC
  • Review relevant editorials in peer-reviewed journals
  • Help patients gain perspective
learning objectives73
Learning Objectives
  • Define relative risk, attributable risk and absolute risk
  • List three different means of presenting risk and describe the advantages of each
  • Identify at least three patient characteristics to consider when counseling about risks and benefits
  • Describe at least one patient education tool that can be used to effectively communicate the risks and benefits of hormonal contraceptives
summary
Summary
  • A misperception of risks about contraception may unnecessarily limit a women’s choices
  • Risk perception is affected by a number of factors
  • Clinicians should consider relevant factors and expert guidance about risk communication
  • Several tools are available to aid risk communication
a final thought
A Final Thought

Two times a very rare event is

still a very rare event.

David Grimes, MD 2006.

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