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Explaining Contraceptive Risk to Patients Sponsored by Association of Reproductive Health Professionals Planned Parenthood ® Federation of America A component.

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Presentation on theme: "Explaining Contraceptive Risk to Patients Sponsored by Association of Reproductive Health Professionals Planned Parenthood ® Federation of America A component."— Presentation transcript:

1 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 Womens Health and Urology

2 Expert Medical Advisory Committee James R. Allen, MD, MPH Medical Advisor American Social Health Association Washington, DC Vanessa Cullins, MD, MPH, MBA (co-chair) Vice President for Medical Affairs Planned Parenthood Federation of America New York, NY Linda Dominguez, RN-C, NP Assistant Medical Director Planned Parenthood of New Mexico Albuquerque, NM Julie Downs, PhD Research Faculty Carnegie Mellon University Department of Social and Decision Sciences Pittsburgh, PA Martin Fishbein, PhD Professor, Annenberg Public Policy Center University of Pennsylvania Philadelphia, PA Kamini Geer, MD Fellow, Family Planning Montefiore Medical Center Department of Social and Family Medicine Bronx, NY David Grimes, MD (co-chair) Vice President Biomedical Affairs Family Health International Durham, NC Joel Shuster, PharmD, BCPP Professor of Clinical Pharmacy Temple University School of Pharmacy Clinical Pharmacy Consultant Episcopal Hospital Temple University School of Pharmacy Philadelphia, PA Eshauna Smith, MPA Program Manager Pro-Choice Public Education Project (PEP) New York, NY Scott Spear, MD Director of Clinical Services University Health Services Associate Professor of Pediatrics (CHS) University of Wisconsin-Madison Madison, WI James Trussell, BPhil, PhD Director Office of Population Research Princeton University Princeton, NJ Sandy Worthington, MSN, RNC, CNM Program Director Planned Parenthood Federation of America Philadelphia, PA

3 Learning Objectives 1.Define relative risk, attributable risk and absolute risk 2.List three different means of presenting risk and describe the advantages of each 3.Identify at least three patient characteristics to consider when counseling about risks and benefits 4.Describe at least one patient education tool that can be used to effectively communicate the risks and benefits of hormonal contraceptives

4 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

5 Case Study, Alyssa Smith (contd) Primary care clinic stopped prescribing DMPA Physician said, Its bad for bones but provided no specifics Ms. Smith left without a plan for an effective contraceptive method Pregnancy within 3 months Early medication abortion

6 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

7 Risk Misperception & the Provider Chaker AM. Wall Street Journal November 22, 2005.

8 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

9 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 3 rd 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

10 Unintended Pregnancy Rates by Age, 2001 Age Percentage of pregnancies unintended >40 Finer LB, Henshaw SK. Perspect Sexual Reprod Health 2006.

11 Definition of Risk The possibility of suffering harm or loss. The American Heritage Dictionary of the English Language

12 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.

13 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.

14 Commonly Used Risk Calculations

15 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 Misselbrook D, Armstrong D. Fam Practice 2002.

16 Example of Absolute Risk > Of 100,000 women on 3 rd generation OCs, 30 will develop venous thromboembolism (VTE) per year Mills A. Hum Reprod Absolute risk 30 per 100,000 woman-years

17 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

18 Example of Absolute Risk Reduction > Of 100,000 women on 2 nd generation OCs, 15 will develop VTE per year Mills A. Hum Reprod Absolute risk 15 per 100,000 woman-years Absolute risk reduction = 15 per 100,000 woman-years

19 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.

20 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 Hennekens CH, Buring JE. Epidemiology in Medicine 1987.

21 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.

22 Example of Relative Risk Mills A. Hum Reprod Absolute risk 3 rd Generation OCs 30 per 100,000 woman-years Absolute risk 2 nd Generation OCs 15 per 100,000 woman-years Relative risk = 30 / 15 = 2

23 Interpreting Relative Risk Hennekens CH, Buring JE. Epidemiology in Medicine Relative risk = 1 No increase in risk in exposed group compared with unexposed group Relative risk > 1 Increased risk in exposed group Relative risk < 1 Decreased risk in exposed group

24 Example of Relative Risk: Induction of Labor & Cesarean Delivery = 2 Risk of cesarean delivery with elective induction of labor 20% Risk of cesarean delivery with spontaneous onset of labor 10% Relative risk with induction: 20% 10% Grimes DA, Schulz KF. Lancet 2002.

25 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.

26 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 Graph of relative risk of Relative risk (log scale) Increased risk Decreased risk Grimes DA, Schulz KF. Lancet

27 Example of Relative Risk, #2: Infection after Cesarean Delivery = 0.5 Rate with prophylactic antibiotics6% Rate without prophylactic antibiotics:12% Relative risk: 6% 12% Grimes DA, Schulz KF. Lancet

28 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 Graph of relative risk of Relative risk (log scale) Increased risk Decreased risk Grimes DA, Schulz KF. Lancet 2002.

29 Comparing Relative Risk Zone of increased risk Zone of reduced risk 2 and 0.5 are equal in strength but opposite in direction, one harmful and one protective Graph of relative risks of 2 and Relative Risk (log scale) Grimes DA, Schulz KF. Lancet 2002.

30 Comparative Risk of Venous Thromboembolism Incidence of VTE per 100,000 woman-years Shulman LP, Goldzieher JW. J Reprod Med Chang J, et al. In: Surveillance Summaries Pregnancy High-dose OC Low-dose OC General population

31 Risk & Health Decisions Decisions about risk are not technical, but value decisions. Baker B. In: Risk Communication and Health 1999.

32 Causes of Risk Misperception about Hormonal Contraceptives > Lack of understanding of statistics > Psychological factors > Media influence > Factors that affect risk perception and interpretation

33 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.

34 Degree of OC Discontinuation Related to Media Event Percentage Months after event Jones EF, et al. Fam Plann Perspect Grimes DA. In: Oral Contraceptives and Breast Cancer 1989.

35 Temporal Relationship Between Product Launch & Reported Adverse Events Hartnell NR, Wilson JP. Pharmacotherapy Weber JCP. In: Iatrogenic Diseases Number of Reports Year/Month

36 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

37 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.

38 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 Luna B, Sweeney JA. Ann NY Acad Sci 2004.

39 Factors Related to Risk Presentation > Framing effects (positive or negative) > Uncertainty > Trust Edwards A, et al. BMJ Bennett P. Dept Health UK 1997.

40 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 Bennett P. In: Risk Communication and Public Health

41 Estimated & Actual Mortality Rates Bennett P. In: Risk Communication and Public Health Estimated number of deaths per year Actual number of deaths per year Botulism Tornado Smallpox Vaccination Flood Electrocution Asthma TB Pregnancy Homicide Motor Vehicle Accidents All Accidents All Disease All Cancer Heart Disease Stroke Stomach Cancer Diabetes

42 Understanding Risk: Relative Effectiveness of Contraceptives Steiner MJ, et al. Obstet Gynecol 2003.

43 WHO Decision Aid on Contraceptive Effectiveness World Health Organization 2006.

44 Tools: Categories Table Effectiveness GroupTypical Success Rate Protection Against STDs/AIDS Sterilization (male & female) More effective (for all users) no Implantsno Hormone shotno Intrauterine device (hormonal)no Intrauterine device (copper)no Birth control pills (combined pill & mini) Effectiveno Barrier methods Less effective yes Spermicidelimited Natural methodsno Adapted from Steiner MJ, et al. Obstet Gynecol 2003.

45 Comprehension of Contraceptive Effectiveness by Teaching Method Pre/post percent improvement in correct score by teaching method 0%40% Pill vs. condom Hormone shot vs. pill Numbers (FDA) Numbers & categories (WHO) Categories Steiner MJ, et al. Obstet Gynecol 2003.

46 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.

47 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.

48 Cardiovascular Events Events (per million woman-years) (Women years old) Farley TMM, et al. Contraception 1998.

49 Cardiovascular Mortality Deaths (per million woman-years) (Women years old) Farley TMM, et al. Contraception 1998.

50 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.

51 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.

52 Cardiovascular Adverse Events: Screening for Risk Factors Deaths (per million woman-years) (Women years old) Farley TMM, et al. Contraception 1998.

53 Communicating Risk: The How Tos What to askPatient needs & concerns What to considerRelevant factors What to useTools What to doGuidance

54 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?

55 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

56 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.

57 Tools: Numerical Data (cont.) > Avoid shifting denominators in proportions Grimes DA, Snively GR. Obstet Gynecol Gigerenzer G, Edwards A. BMJ SAY Headache developed in 3 of every 1000 women NOT Headache developed in 1 of every 333 women

58 Tools: Numerical Data (cont.) > Use absolute risk Gigerenzer G, Edwards A. BMJ 2003; Farley TMM, et al. Contraception 1998; Sloman SA, et al. Organizational Behavior and Human Decision Processes 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

59 Tools: Descriptive Terms Risk level High<1 in 100 Moderate 1 to 10 in 1,000 Low1 to 10 in 10,000 Very low1 to 10 in 100,000 Minimal1 to 10 in 1 million Calman KC. BMJ Berry DC, et al. Drug Saf 2003.

60 Tools: Risk Comparisons Skydiving100 Driving 20 Pregnancy11.5 Riding a bicycle0.8 Airplane crash0.4 Using OC*0.06 *Nonsmoker, under age 35 Trussell J, Jordan B. Contraception in press. Chang J, et al. MMWR Harvard Center for Risk Analysis Bennett P. In: Risk Communication and Public Health Annual Risk of Death (per 100,000)

61 Tools: Diagrams > Categories table > Numbers and categories table > Flower diagram > Paling Perspective Scale > Paling Palette

62 Tools: Categories Table Effectiveness GroupTypical Success Rate Protection Against STDs/AIDS Sterilization (male & female) More effective (for all users) no Implantsno Hormone shotno Intrauterine device (hormonal)no Intrauterine device (copper)no Birth control pills (combined pill & mini) Effectiveno Barrier methods Less effective yes Spermicidelimited Natural methodsno Adapted from Steiner MJ, et al. Obstet Gynecol 2003.

63 Tools: Numbers & Categories Table Effectiveness GroupFamily Planning Method Typical-Use Rate of Pregnancy Lowest Expected Rate of Pregnancy More effective (for all users) Male and female sterilization0.2%-0.5%0.1%-0.5% Implants0.1% Hormone shot0.3% Intrauterine devices (copper and progesterone) 0.8%-2%0.6%-1.5% EffectiveBirth control pills5%0.1%-0.5% Less effective Male latex condoms14%3% Diaphragm20%6 Cervical cap20%-40%9%-26% Female condoms21%5% Spermicide26%6% Withdrawal19%4% Natural family planning20%1%-9% No method85% Adapted from Steiner MJ, et al. Obstet Gynecol 2003.

64 1 in 1T 1 in 10B 1 in 1B 1 in 100M 1 in 10M 1 in 100K 1 in 10K 1 in in 10 1 in 1 Tools: Paling Perspective Scale ® Paling J. BMJ Fig. 2 Paling Perspective Scale ® - for giving perspective to risks of low order of probability. Risks from smallpox: for the 115M Americans over the age of 30 - previously vaccinated and DO NO live in a major metropolitan area Look at the consequences as well as the odds Risk of death from vaccination: 1 in 2 million Risk of Smallpox Infection: 1 in 100M people (or less) Death from Smallpox if not vaccinated post exposure: 1 in 1.7B (or less) Death from Smallpox if vaccinated post exposure: 1 in 100B (or less) Estimates of Specific Risks RISK INCREASING 1 in 100B 1 in 1M 1 in 1K

65 Tools: Paling Palette ® Paling J. BMJ 2003.

66 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

67 Decision Aid for Risk Communication 1.Clarify situation 2.Provide information – On the benefit side… – On the harm side… 3.Clarify patients values 4.Screen for implementation problems OConnor A, et al. BMJ 2003.

68 Case Study: Michelle Gavin > 19-year-old college student > Using patch for 6 months OConnor A et al. BMJ I want off the patchit killed that girl in New York

69 Case Study: Michelle Gavin 1.Clarify situation 2.Provide information 3.Clarify patients values 4.Screen for implementation problems OConnor A et al. BMJ 2003.

70 Tips for Effective Communication Center for Urban Transportation Studies UWM Be an active listener Eliminate internal & external distractions Present information in several ways Ensure understanding z Know your purpose

71 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.

72 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

73 Learning Objectives 1.Define relative risk, attributable risk and absolute risk 2.List three different means of presenting risk and describe the advantages of each 3.Identify at least three patient characteristics to consider when counseling about risks and benefits 4.Describe at least one patient education tool that can be used to effectively communicate the risks and benefits of hormonal contraceptives

74 Summary > A misperception of risks about contraception may unnecessarily limit a womens 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

75 A Final Thought Two times a very rare event is still a very rare event. David Grimes, MD 2006.


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