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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

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Explaining Contraceptive Risk to Patients

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  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 Women’s Health and Urology

  2. 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

  3. 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

  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. 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)

  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 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. .

  10. 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.

  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. Absolute risk reduction (attributable risk) Relativerisk Absoluterisk 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. www.emeb.org 2005. Misselbrook D, Armstrong D. Fam Practice 2002.

  16. 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.

  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. www.emeb.org 2005.

  18. 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.

  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 2002. 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. 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.

  23. 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.

  24. Example of Relative Risk: Induction of Labor & Cesarean Delivery = 2 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. 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..

  27. Example of Relative Risk, #2: Infection after Cesarean Delivery = 0.5 Grimes DA, Schulz KF. Lancet 2002..

  28. 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.

  29. 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.

  30. 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.

  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 1980.Grimes DA. In: Oral Contraceptives and Breast Cancer 1989.

  35. 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.

  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 2004.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 2002.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 2003. Bennett P. In: Risk Communication and Public Health

  41. 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.

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

  45. 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.

  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 30-34 years old) Farley TMM, et al. Contraception 1998.

  49. Cardiovascular Mortality Deaths (per million woman-years) (Women 30-34 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.

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