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Learning Objectives After participating, you should be able to:

Learning Objectives After participating, you should be able to:. Pre- WHI : Before 2002… hormone therapy (HT) formulations. $2 billion+ in worldwide annual sales Taken by ≈ 38% of postmenopausal women in US for symptomatic treatment and protection against bone loss and cardiovascular disease.

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Learning Objectives After participating, you should be able to:

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  1. Learning ObjectivesAfter participating, you should be able to:

  2. Pre-WHI: Before 2002…hormone therapy (HT) formulations • $2 billion+ in worldwide annual sales • Taken by ≈ 38% of postmenopausal women in US for symptomatic treatment and protection against bone loss and cardiovascular disease Source: Griffith, V. Financial Times. July 9, 2002

  3. Source: The Women’s Health Initiative Study Group. Controlled Clinical Trials.1998; 19(1);61-109

  4. Initial WHI Findings • 10,000 women taking conjugated equine estrogen/medroxyprogesterone acetate (CEE + MPA) over 1 year compared with placebo might be expected to experience: • 6 more coronary heart disease events • 8 more invasive breast cancers • 7 more strokes • 18 more venous thromboembolisms (VTE) • 8 more pulmonary embolisms (PE) • 6 fewer colorectal cancers • 5 fewer hip fractures • 47 fewer total fractures The Writing Group for the Women’s Health Initiative. Risks and benefits of estrogen plus progestin in healthy postmenopausalwomen: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002;288:321–33.

  5. Women Who Quit Hormone Therapy After WHI Percentage of women who attempted to stop Number of correct answers on quiz Ettinger B et al. Obstetrics & Gynecology. 2003;102(6):1225.

  6. Give Me Back My Hormones! 26% of women who quit HR returned because of: Source: Grady D et al. Obstetrics & Gynecology. 2003;102(6):1233

  7. The Backlash Begins How NIH Misread Hormone Study in 2002 By TARA PARKER-POPEJuly 9, 2007; Page B1

  8. Evaluate with Caution “ . . . These studies (WHI and Heart and Estrogen/Progestin Replacement Study [HERS]) included an insufficient number of younger, symptomatic, newly postmenopausal women to determine whether similar patterns of events apply to these women.” • Source: March 2007 position statement of The North American Menopause Society. Menopause. 2007;14(2):168-182.

  9. WHI Today “. . . More tempered critical reappraisals of the cumulating randomized, controlled trial data in relation to the totality of data have emerged. This apparent “flip-flopping” is partly due to the fact that assessment of risks and benefits is a dynamic process with very few unambiguous certitudes.” Source: HodisHN, Mack WJ. Postmenopausal hormone therapy in clinical perspective. Menopause. 2007;14(5):944-957

  10. Menopause: The Reality • Clinical diagnosis • Permanent cessation of menses following the loss of ovarian activity • Lack of menses for 12 months • Mean age in US is 51 (45-55 years) • Women will spend one-third to one-half of their lives postmenopausally Source: Katz VL, Lentz GM, Lobo RA, Gershenson DM. Comprehensive Gynecology. 5th ed. Philadelphia, PA: Mosby; 2007

  11. Quality of Life Issues and Overall Functioning in Menopause • Vasomotor (hot flushes and night sweats) • Low libido/painful intercourse • Weight gain • Memory problems, difficulty concentrating • Mood swings • Insomnia, fatigue • Dizziness, rapid irregular heartbeat • Atrophic vaginitis, bladder irritability • Headaches RapkinAJ. Am J Obstet Gynecol. 2007;196(2):97-106.

  12. More Women in USEntering Menopause 2007 2015 22.2 Million* 19.9 Million Increase of 11.6% *Projected estimate. US Census Bureau. Statistical Abstract of the United States. 2000:15.US Census Bureau. National population projections. Available at: http://www.census.gov/population/www/projections/natsum-T3.html.

  13. Women Will Come to Physicians with Symptoms • 15%-30% of middle-aged women consult a health care professional annually for menopausal problems • 50%-86% seek advice one or more times over a 9-year period • Most (91%) begin the discussion around menopausal symptoms Source: Guthrie JR et al. Climacteric. 2003;6(2):112-117

  14. Women’s Sources of Information about Menopause :63% :16% :15% :8% :7% :6% Singh B et al., AlternTher Health Med. 2007;13(3):24-29

  15. Why Is It So Hard To Talk About Menopause And HT? • Limited understanding of HT’s effects on menopausal symptoms • Uncertainty about risks and benefits of HT • Fear and concerns about adverse effects Confusion, concerns, and uncertainty increase indecision and ambivalence Source: Frymier R. Why are we here? Menopause Learning Experience Architectural Planning (LEAP) Group. October 7, 2007. Dallas, TX

  16. Number of Studiesand Confusing Findings How NIH Misread Hormone Study in 2002 By TARA PARKER-POPEJuly 9, 2007; Page B1

  17. Practice Recommendation Consider initiating discussions about menopause and hormone therapy beginningat age 40 Source: Institute for Clinical Systems Improvement. Health Care Guideline: Menopause and Hormone Therapy (HT): Collaborative Decision-Making and Management. October 2006. Website:http://www.icsi.org/menopause_and_hormone_therapy/menopause_and_hormone_replacement_therapy_ht___collaborative_decision_making_and_management_.html Strength of Evidence: Cross-sectional study, case series, case report, non-randomized trial with concurrent or historical controls, case-control study, study of sensitivity and specificity of a diagnostic test, population-based descriptive study, randomized, controlled trial, consensus statement, consensus report, narrative review

  18. North AmericanMenopause Society (NAMS) • ET and EPT recommended for: • Moderate-to-severe vasomotor symptoms • Moderate-to-severe symptoms of vulvar and vaginal atrophy • Offer vaginal, not systemic HT if vaginal symptoms only indication • Not recommended as single or primary indication for coronary protection in women of any age • Lower doses of oral estrogens may be safer in terms of VTE risk than higher doses • Not recommended for primary or secondary prevention of stroke • Avoid in women with elevated baseline of stroke • Source: March 2007 position statement of The North American Menopause Society

  19. NAMS: Depression,Dementia, Cognitive Decline • Evidence currently does not support use of ET/EPT for depression treatment (although NAMS recognizes studies showing benefits of ET for depression during perimenopause) • Initiating EPT after age 65 for primary prevention of dementia or cognitive decline may increase risk of dementia during ensuing 5 years • Evidence insufficient to support or refute efficacy or harm of ET/EPT for primary prevention of dementia when initiated during the menopause transition or early postmenopause • ET does not appear to convey a direct benefit or harm for treatment dementia due to Alzheimer’s disease • Source: March 2007 position statement of The North American Menopause Society

  20. NAMS: Osteoporosis • There is strong evidence of the efficacy of ET/EPT in reducing the risk of postmenopausal osteoporotic fracture • ET/EPT can be considered an option for women requiring drug therapy for osteoporosis risk reduction • Source: March 2007 position statement of The North American Menopause Society. Menopause. 2007;14(2):168-182.

  21. NAMS: Breast Cancer Risk • Estrogen alone for < 5 years has little impact on breast cancer risk • ET for > 15 years may increase risk of breast cancer (based on limited observational data) • Minimal data reports any change in breast cancer mortality with HT • EPT and, to a lesser extend, ET, increase breast cell proliferation, breast pain, and mammographic density • EPT may impede the diagnostic interpretation of mammograms • Recommendations for estrogen and progestogen use in peri-and postmenopausal women: March 2007 position statement of The North American Menopause Society. Menopause. 2007;14(2):168-182.

  22. NAMS: Progesterone • Only for endometrial protection from unopposed ET in women with intact uterus • Postmenopausal women without uterus should not be prescribed progestogen with systemic estrogen • Progestogen generally not indicated with low-dose, locally administered estrogen for vaginal atrophy • No evidence to recommend off-label use of long-cycle progestogen, vaginal administration of progesterone, the levonorgestrel-releasing IUD, or low-dose estrogen without progestogen as alternative to standard HT regimens • Recommendations for estrogen and progestogen use in peri-and postmenopausal women: March 2007 position statement of The North American Menopause Society. Menopause. 2007;14(2):168-182.

  23. American Collegeof OB/Gyns(ACOG) • Counsel women that although (WHI) findings indicate estrogen/progestogen is associated with increased risk of breast cancer, the absolute risk for any individual woman remains low • Women taking estrogen only need to consider other risk factors, including heart disease, VTE, and stroke • Breast cancer survivors should consider alternatives to HT for treating menopausal symptoms • Source: ACOG Task Force on HT. Obstet Gynecol. 2004;104(suppl 4):106s-17s

  24. United States PreventiveServices Task Force (USPSTF) • Recommends against: • The use of EPT for the prevention of chronic conditions in postmenopausal women • Routine use of unopposed estrogen for prevention of chronic conditions in postmenopausal women who have had a hysterectomy Source: Hormone therapy for the prevention of chronic conditions in postmenopausal women: recommendations from the U.S. Preventive Services Task Force. Ann Intern Med 2005 May 17;142(10):855-60

  25. United States PreventiveServices Task Force (USPSTF) • Clinicians should use a shared decision-making approach to preventing chronic diseases in perimenopausal and postmenopausal women • The USPSTF did notconsider the use of hormone therapy for managing menopausal symptoms. • Women and their clinicians should discuss the balance of risks and benefits before deciding to initiate or continue hormone therapy for menopausal symptoms. Source: Hormone therapy for the prevention of chronic conditions in postmenopausal women: recommendations from the U.S. Preventive Services Task Force. Ann Intern Med 2005 May 17;142(10):855-60

  26. To Treat or Not To Treat?How are symptoms affecting a woman’s life?

  27. Event EPT Relative Risk EPT Absolute Risk(per 10,000 women) ET Relative Risk ET Absolute Risk(per 10,000 women) CHD 1.29 7 more 0.91 5 less Stroke 1.41 8 more 1.39 12 more VTE 2.11 18 more 1.33 7 more Breast cancer 1.26 8 more 0.77 7 less Putting WHI Risks Into Perspective Writing Group for the Women's Health Initiative Investigators. JAMA. 2002;288:321-333. Women’s Health Initiative Steering Committee. JAMA. 2004;291:1701-1712.

  28. Practice Recommendation The exact risks associated with HT, as well as possible side effects, may not be fully defined, but they cannot be dismissed and must alwaysbe considered and discussedas part of the collaborative decision-making process. Source: Institute for Clinical Systems Improvement. Health Care Guideline: Menopause and Hormone Therapy (HT): Collaborative Decision-Making and Management. October 2006. Web site: http://www.icsi.org/menopause_and_hormone_therapy/menopause_and_hormone_replacement_therapy_ht___collaborative_decision_making_and_management_.html. Supporting evidence: Randomized, controlled trial, cohort study, non-randomized trial with concurrent or historical controls, case-control study, study of sensitivity and specificity of a diagnostic test, population-based descriptive study, meta-analysis, systematic review, decision analysis, cost-effectiveness analysis, consensus statement or report, narrative review

  29. Practice Recommendation Careful consideration and in-depth discussion are required whenever the initiation or continuation of HT is considered; help each woman clarify her individual values and priorities so that she may decide how important each of the potential benefits and risks of HT is to her unique situation. Source: Institute for Clinical Systems Improvement. Health Care Guideline: Menopause and Hormone Therapy (HT): Collaborative Decision-Making and Management. October 2006. Web site: http://www.icsi.org/menopause_and_hormone_therapy/menopause_and_hormone_replacement_therapy_ht___collaborative_decision_making_and_management_.html. Supporting evidence: Not provided

  30. Practice Recommendation Prescription drugs, including clonidine, antidepressants, and anticonvulsants, may have benefit for some menopausal women (on the basis of LOE 2 studies) and may be tried in individual patients who have no specific contraindications Source: American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of menopause Web site: http://www.aace.com/pub/guidelines/ Strength of Evidence: B: Evidence from at least one large well-designed clinical trial, cohort or case-controlled analytic study, or meta-analysis

  31. Commonly Used CAM Therapies for Menopause • Black cohosh • Red clover leaf • Soy isoflavones • Kava • Dong quai root • Ginseng • Behavioral interventions Source: NIH State of the Science Conference Statement on Management of Menopause-Related Symptoms, Volume 22, Number 1, March 21–23, 2005

  32. Practice Recommendation First-line therapies for women with vaginal atrophy include non-hormonal vaginal lubricants and moisturizers. For symptomatic vaginal atrophy that does not respond to non-hormonal vaginal lubricants and moisturizers, prescription therapy may be required. Source: The role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women: 2007 position statement of The North American Menopause Society. Web site: www.menopause.org Strength of Evidence: Randomized, controlled trials, meta-analyses, and review articles.

  33. Practice Recommendation Women should be counseled that data regarding the estrogenic effects of soy are inconclusive. Therefore, women with a personal or strong family history of hormone-dependent cancers (breast, uterine, or ovarian), thromboembolic events, or cardiovascular events should not use soy-based therapies (grade D). Source: American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of menopause Web site: http://www.aace.com/pub/guidelines/ Strength of Evidence: D: Not rated. No conclusive level 1, 2, or 3 publication demonstrating the benefit > risk; conclusive level 1, 2, or 3 publication demonstrating risk > benefit

  34. Bioidentical Hormones: Communicating with the Patient • Source: March 2007 position statement of The North American Menopause Society. Menopause. 2007;14(2):168-182

  35. Lifestyle Changes • Adapted from North American Menopause Society. Menopause. 2004;11(1):11-33

  36. Challenges to Communicating about Menopause What Women Need for Menopause Conversation Time Understand Problems Good Info Discuss Symptoms Help make decisions Doesn’t Interrupt Normalize Menopause Time Confusing Messages Complicated Issues around Symptoms& Treatment Confusing Media Messages Inconclusive data Complicated Issues around Tx Options Time Constraints Information Lacking about Treatment Sources:Singh B, Liu XD, Der-Martirosian C, et al. Am J Obstet Gynecol. 2005;193(3 Pt 1):693-700.Singh B et al., AlternTher Health Med. 2007;13(3):24-29

  37. Criteria for Informed Decision Making Source: Braddock CH et al. J Gen Intern Med. 1997;12(6):339-345

  38. Informed Decision Making:Where Are We Today? • Less than 10% of patient/physician consultations meet basic criteria for involving patients • Risk presentation determines patient reaction Sources: 1. Braddock CH et al. J Gen Intern Med. 1997;12(6):339-345 2. Marvel MK et al. JAMA. 1999;281(3):283-287 3. Kjellgren KI et al. Int J Cardiol.1998;64(2):161-169 4. Hoffmann M et al. Maturitas. 2005;50(1):8-18

  39. Risk Discussions Around HT • Physicians use different strategies for risk discussion even when discussing the exact same issue (menopause) • Physicians do not compare HT to other treatment strategies • The decision to use HT is reached before the risk discussion is completed or even begun • Physicians introduce the use of HT in positive terms early in consultation • None used written or visual aids to help women understand risk Source: Hoffmann M et al., Maturitas. 2005;50(1):8-18.

  40. Model of Complete Clinical Care Opening Communication Tasks Biomedical Tasks Closing Keller, V., & Carroll, J. (1994). A new model of physician-patient communication. Patient Education and Counseling, 23, 131-140. Source: Core skills for enhancing clinician-patient communication. Institute for Healthcare Communication, 2006

  41. Engage: Make the Connection • Obtain the patient’s story • Be curious • Use open-ended inquiry • “Tell me about your symptoms. . . “ • “Howare your symptoms affecting your daily life?” • “Whatdo you think is going on?” • “Whatdo you hope to accomplish today?” • Avoid “why” questions Keller, V., & Carroll, J. (1994). A new model of physician-patient communication. Patient Education and Counseling, 23, 131-140.

  42. Empathy: The Goal “Empathy is the process through which an effective therapeutic relationship is established.” Goal is to: • Understand the person at a deeper level • Understand their emotions, thoughts and values • Help the person feel seen, heard and understood Source: SquierRW. Soc Sci Med, 1990, 30 (3), 325-339; Miller WR. Psychol Addict Behav, 2000; 14(1), 6-18;Keller V, Carroll J. Patient Education and Counseling, 1994; 23, 131-140

  43. Remember: Empathy is the most important predictor of a clinician’s success when counseling a patient about behavior change. Source: SquierRW. Soc Sci Med, 1990, 30 (3), 325-339; Miller WR. Psychol Addict Behav, 2000; 14(1), 6-18;Keller V, Carroll J. Patient Education and Counseling, 1994; 23, 131-140

  44. Empathy Beginswith Reflective Listening • Listening with anticipation to what the patient says • Reading nonverbal clues • Reflecting verbally on what you hear • Providing nonverbal support Keller V, Carroll J. Patient Education and Counseling, 1994; 23, 131-140

  45. Education • Goal is to provide patients with: • Greater knowledge and understanding • Increased capacity and skills • Reduced anxiety • Increased ability and confidence to participate in decisions Source: SquierRW. Soc Sci Med, 1990, 30 (3), 325-339; Miller WR. Psychol Addict Behav, 2000; 14(1), 6-18;Keller V, Carroll J. Patient Education and Counseling, 1994; 23, 131-140

  46. Education: 3-Step Process Assess what she already knows Convey info in easy-to-understand terms Check for understanding Source: SquierRW. Soc Sci Med, 1990, 30 (3), 325-339; Miller WR. Psychol Addict Behav, 2000; 14(1), 6-18;Keller V, Carroll J. Patient Education and Counseling, 1994; 23, 131-140

  47. Informed Decision Making and the Educational Process The educational process targets 3 components of informed decision making: Keller V, Carroll J. Patient Education and Counseling, 1994; 23, 131-140

  48. Education: Risks • Women want accurate, truthful and individualized risk information • Key issues in communicating risk are choice, consent and trust • Patients best understand risk when it is presented in a variety of complementary formats (verbal, numerical , contextual, graphic) • Audiotape and booklet decision aid about HT can reduce a woman’s uncertainty, improve her comprehension and create realistic expectations Source: Walter FM et al. Patient EducCouns. 2004;53(2):121-128.

  49. Enlistment Process of inviting the patient to collaborate in the treatment decision and next steps. • Elicit the patient’s preferences and values re: options • Explore the pros and cons of each • Agree on the best option based on her preferences and values • Arrange follow-up visit Source: Keller V, Carroll J. Patient Education and Counseling, 1994; 23, 131-140.

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