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COMBINATION HORMONAL CONTRACEPTION:

COMBINATION HORMONAL CONTRACEPTION:. Translation of Clinical Trial Findings of Efficacy and Safety into “Real World” Effectiveness and Safety. Paula J. Adams Hillard, M.D. University of Cincinnati Professor, Department of Obstetrics and Gynecology and Department of Pediatrics.

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COMBINATION HORMONAL CONTRACEPTION:

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  1. COMBINATION HORMONAL CONTRACEPTION: Translation of Clinical Trial Findings of Efficacy and Safety into “Real World” Effectiveness and Safety Paula J. Adams Hillard, M.D. University of Cincinnati Professor, Department of Obstetrics and Gynecology and Department of Pediatrics

  2. Hatcher, R., J. Trussell, et al. (2004). Contraceptive Technology.18th ed. New York, NY, Ardent Media, Inc.

  3. Inherent method efficacy User characteristics Consistency and correctness of method use Fecundity Frequency of Intercourse Age Parity Influence of the Investigator Design of the Study Participation criteria Methods for documenting pregnancy outcomes Use of additional methods (EC, initial dual methods) Study duration Factors That Influence Efficacy Results in Practice & in Research ARHP Slide Set 2000

  4. Terminology • Compliance • Paternalistic--Clinician centered • “Cheerful obedience”--Westhof • Fails to acknowledge the therapeutic alliance between clinician and patient • Adherence (a part of “illness management”) • Re: Contraception • “Successful Use”--Woman centered • Meeting her own family planning goals

  5. CONTRACEPTIVE COMPLIANCE --Correct use --Consistent use --Continuing use

  6. Compliance with Contraceptives and Other Treatments • “Contraceptive compliance can be placed in the context of compliance with other medications. • The potential consequence of failing to comply with contraception is pregnancy. • The literature on compliance suggests that there is no consequence of failed compliance that is severe or onerous enough to assure complete compliance.” Cramer, J.A.Obstet Gynecol, Vol. 88; 1989

  7. ADHERENCE

  8. Overview Consequences of Inconsistent Use of Effective Contraceptives in U.S. • Inconsistent/ improper OC usage or discontinuation of OCs results in ~1 million unintended pregnancies/year in the U.S. . Rosenberg MJ, et al. Reprod Med. 1995;40:355-360.

  9. “The accurate measurement of compliance is not easy; easy measurements of compliance are not accurate." Sackett,D in Compliance in Health Care. R. B. Haynes, D. W. Taylor and D. L. Sackett. Johns Hopkins University Press; 1979

  10. MEASURING PILL-TAKING • Direct Methods • Directly observed therapy • Measurement of blood levels • Measurement of biological marker in blood • Indirect Methods • Self-reports • Pill counts • Rates of prescription refills • Assessment of clinical response • Electronic medication monitor • Measurement of physiologic markers • Patient diaries • When patient is a child, asking caregiver Osterberg, L. and T. Blaschke (2005). "Adherence to Medication." N Engl J Med353(5): 487-497.

  11. Pill-Taking Behaviors by Age Oakley D et al. Fam Plann Perspect. 1991;23:150-154.

  12. Cycle 2 Cycle 3 Cycle 1 Reported Pill Use vs Actual Pill Use % of Women (Ages 18 and older)    Active Pills Missed Potter L et al. Family Planning Perspectives. 1996. 2(4):154-158.

  13. Patterns of OC Pill-taking in Adults • 50% of young women report imperfect pill use during a pill cycle • Potter L et al. Fam Plann Perspect 1996;28(4)154-8 • Oakley D et al. Fam Plann Perspect 1997;29(6)277-9, 287 • Approximately 25% of OCP users miss 2 or more pills during a pill cycle • Oakley D et al. Fam Plann Perspect 1997;29(6)277-9, 287

  14. OC Continuation Rates Continuation Rate (per 100 Women Enrolled) Study Month Adapted from Rosenberg MJ et al. Am J Obstet Gynecol. 1998;179:577-582

  15. INCONSISTENT PILL USE Inconsistent = Self-report of >= 2 missed pills in past 3 months NSFG 1995. Peterson et al. FP Persp.1998 30(1):19-23

  16. ADOLESCENT PREGNANCYAn International Perspective Per 1000 15-19 year olds UNICEF Innocenti Report Card #3, July 2001

  17. Patterns of OC Pill-taking in Adolescents • “Effective OCP use requires method commitment ( i.e., considering one’s birth control method to be OCP) as well as OCP use consistent with the method’s pharmacology and mechanism of action (i.e., method adherence).” • Many young women are at risk, especially during transitions into or out of periods of OCP use • Even among young women with stable patterns of OCP method choice, many have daily pill-taking patterns that are sufficiently inconsistent to increase pregnancy risk Woods, JL et al JAH 2006; 29(3):381-7

  18. Patterns of OC Pill-taking in Adolescents • Categorized by pattern of use • Stable/3 months • Starting • Stopping • Daily Diaries • Results: • Mean days of consecutive OCP 20-32.5/ 3 mos • Mean days of sequential missed OCP 17-31/ 3 mos • Episodes of 3 or > missed OCP 1.9-2.2 / 3 mos • 27% of coital events occurred during a period of 2 or more missed pills Woods, JL et al JAH 2006; 29(3):381-7

  19. OC Continuation in Adolescents • 18-57% of teenagers discontinued use of a contraceptive within a year • Furstenberg et al. Contraceptive continuation among adolescents attending family planning clinics. Fam Plann Perspect 1983;15;211-7 • 50% failed to return to clinic at 3 months--all of these had discontinued and 69% at risk for pregnancy • Balassone. Risk of contraceptive discontinuation among adolescents. J Adol Health Care.1989;10:527-33

  20. OC Continuation in Adolescents • Mean wait after coitarche before coming to clinic • 1.4 years • “inconsistent” (Discontinuing) users • Missed 3.4 pills/month • “Consistent” (Continuing) users • Missed 2.7 pills/month Balassone. Risk of contraceptive discontinuation among adolescents. J Adol Health Care.1989;10:527-33

  21. FACTORS INFLUENCING SUCCESSFUL USE OF HORMONAL CONTRACEPTIVES • Side Effects/Fear of Side Effects • Bleeding • Weight gain • Concerns about safety • Make you sick • Make you infertile • Cause cancer • Influences on use • Family members • Boyfriend

  22. OPTIONS AFTER DISCONTINUING OCs • Continued sexual activity • With alternative method of contraception • Effective method--hormonal • Less effective method • Without contraception • Celibacy/Abstinence

  23. OC Use in AdolescentsDecreased Dysmenorrhea and Compliance • Reduction of dysmenorrhea was the most statistically and clinically significant predictor of consistent OC use • Adolescents with severe dysmenorrhea who experienced positive side effects (decreased cramping or flow) were 8 times more likely to be consistent pill users (missed 3 pills per month) than others Robinson et al. Am J Obstet Gynecol. 1992;166:578-583.

  24. Barriers to Adherence Osterberg, L. and T. Blaschke (2005). "Adherence to Medication." N Engl J Med353(5): 487-497.

  25. LOGISTICAL FACTORSAffecting OC Continuation • $/ Insurance/ HMO Coverage • One month at a time • Formulary • Generics • Office/ Clinic Hours • Sunday start • Extended cycle requirements for additional pills

  26. OC Continuation:Access/Pill Packages Dispensed • Women receiving 13 cycles of OCs were more likely to be continuing to get pills one year later than those receiving 1 or 3 cycles 49% vs 46% vs 42% (p< .001) • Continuous use at 15 months: • 13 cycles 43% • 3 cycles 22% • 1 cycle 20% (p< .001) Foster, D. G., R. Parvataneni, et al. (2006). "Number of Oral Contraceptive Pill Packages Dispensed, Method Continuation, and Costs." Obstet Gynecol 108(5): 1107-1114.

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