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Care Process Model ap r i l 2012 MANAGEMENT OF Abnormal Uterine Bleeding This care process model (CPM) was developed by Intermountain Healthcare’s Gynecology Development Team under the guidance of the Women and Newborns Clinical Program. It recommends an evidence-based approach for assessing and treating ovulatory or anovulatory abnormal uterine bleeding in women of reproductive age. Why Focus ON ABNORMAL UTERINE BLEEDING? Abnormal uterine bleeding (AUB) — irregular menstrual bleeding or unusually heavy or prolonged bleeding — warrants our attention for several reasons. • It’s common. In the general population, abnormal uterine bleeding is estimated to affect 11% to 13% of reproductive-age women at any given time; this prevalence increases with age, reaching 24% in those 36 to 40 years of age.1 AUB is on par with urinary tract infections and vaginitis as one of the most common health concerns prompting a medical visit. Gynecologists, pediatricians, family physicians, internists and other providers caring for female patients will all encounter and manage this condition. • It’s costly. Estimated annual direct and indirect economic costs of AUB are $1 billion and $12 billion, respectively, not accounting for intangible costs and productivity loss.2 • It’s complex. AUB has numerous possible causes, and management can involve many decisions about diagnosis and treatment. Changing terminology in the medical literature, narrow recommendations focused on particular age groups or symptoms, and guidelines specific to select AUB causes have done little to clarify or simplify clinical practice.1,3 • A systematic, practical, and broad-based approach may improve treatment and outcomes. The process outlined in this CPM — one that helps physicians investigate the type and cause of AUB and use resources wisely to address it — may ensure that treatment matches the condition and that surgical approaches are ventured appropriately. what’s iNside algorithm: management of AUB. . . . . . . . . . 2 Notes on the algorithm . . . . . . . . . . . . Initial work-up. . . . . . . . . . . . . . . . . . . . Identifying patients at lower-risk for pathology . . . . . . . . . . Medical management . . . . . . . . . . . . . . Surgical management . . . . . . . . . . . . . . 3 3 3 3 3 Patient education. . . . . . . . . . . . 4 References . . . . . . . . . . . . . . . . . . 4 Goals of this cpm The overarching goal of this model is to promote clinical best practice and clinical consistency in the management of abnormal uterine bleeding. Specific goals include: • Optimize use of resources applied to the assessment and treatment of AUB • Eliminate ablations performed without prior biopsy ABnormal uterine bleeding a p r i l 2 012 A lg o r i t h m : m a n ag e m e n t o f A b n o r m a l u t e r i n e b l e e d i n g Patient presents with abnormal uterine bleeding Perform initial workup see (a) LOW-RISK patient? see (b) yes MEDICAL MANAGEMENT see (c) Success? see (c) yes watchful waiting no no 1.BIOPSY endometrial tissue 2.Obtain iMAGes: transvaginal/abdominal ultrasound, saline infusion sonography (SIS), hysteroscopy, or MRI Negative biopsy: Identify next steps based on all imaging & pathology findings POSITIVE biopsy : •Atypical hyperplasia •Endometrial cancer Hysterectomy with possible oncology consult • Simple hyperplasia • Nonsecretory (proliferative ) endometrium • Polyps ≤ 1 cm (will often regress spontaneously) • Myomata or suspected adenomyosis AND –– uterus <12 week size, or –– fibroids <8 cm and not submucosal • Polyps > 1 cm • Significant pelvic pain or pressure • Myomata or suspected adenomyosis AND –– uterus >12 week size, or –– fibroids >8 cm and not submucosal MEDICAL MANAGEMENT (may have been tried previously) see (c) surgical MANAGEMENT Success? see (c) yes watchful waiting 2 no • Polypectomy/D&C with or without hysteroscopy • Endometrial ablation • Myomectomy • Hysteroscopic resection • Uterine arterial embolization (UAE) • Hysterectomy See (d) for comments ©2012 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED . ABnormal uterine bleeding a p r i l 2 012 Notes on the algorithm4,5,6 (d) Surgical management (a) Initial work-up: Key activities and goals for initial visit(s) •• Medical history: timing & quantity of bleeding, menstrual history including menarche and recent periods, associated symptoms, family history of bleeding disorders •• Physical exam: bimanual may reveal bulky uterus/ discrete fibroids •• Lab: pregnancy testing, pap smear, CBC, PT/PTT, possible cervical culture, TSH ( t4 if abnormal) •• Consider ultrasound depending on AUB severity, patient’s age, presence of fibroids •• Rule out other causes of AUB: ––Pregnancy ––Medications ––Infection ––Trauma ––Coagulopathy ––Extrinsic sources of bleeding ––Systemic disease: hepatic, renal, leukemia, endocrinopathies (hypothyroidism, hyperprolactinemia, Cushings, PCOS, adrenal tumors, etc.) (b) Identifying patients at lower risk for pathology Patients may be considered at LOWER risk for endometrial cancer if ALL of the following are true: •• Age <35 •• NO findings (history, physical, or lab) suggestive of uterine/cervical pathology •• NO risk factors such as obesity, hypertension, diabetes mellitus, PCOS, family history of breast or colon cancer, chronic anovulation, history of unopposed estrogen (c) Medical management Success with medical management: Control of bleeding for 3 consecutive cycles (NO persistent bleeding for more than 8 days; NO profuse bleeding (e.g., large clots, gushes, significant limitations on activity); NO persistent anemia (Hct <30%, Hgb <10)) Med category estrogen and/or progestin 1 tablet daily Tier 1, $ for all those listed at left ••43-53% in blood loss ••First choice if short-term contraception desired ••Estradiol >35 mcg more effective ••First choice if pregnancy is not desired inserted, replaced every 5 years medical benefit copay (usually ~20%), $$$$ ••86-97% in blood loss (97% achieved after 1 yr of use) ••First choice if LONG-term contraception desired ••Cost-effective in long-term ••Aygestin: 2.5-10 mg 1x/ day for 5-10 days ••Provera: 5-10 mg 1x/day for 5-10 days Tier 1, $ for both listed at left ••32-50% in blood loss ••Use is NOT superior to other medical treatments including NSAIDs ••Second choice due to lower efficacy and adverse effects ••Second choice, but preferred in smokers age >35 or with risk of thromboembolism •• 1.25 mg oral, may repeat every 4 hours for 24 hours, then 1.25 mg 1x/day for 7-10 days •• 25 mg IM/IV, may repeat in 6-12 hours as needed ••oral: Tier 2, $$ ••IV: medical benefit copay (usually ~20%), $$$ ~ ••First choice for acute severe bleeding episodes ••Administered orally for outpatient, IV for hospital admit 1300 mg 3x/day for 5 days of the menstrual cycle Requires dose decrease (renal dose) if SCr >1.4 Tier 2, $$$ ••40-50% in blood loss ••First choice if NO contraception desired ••Cautions: thrombosis, renal insufficiency Tier 1, $ for all listed at left ••Adjunctive therapy ••Inexpensive and convenient (only taken during menses) ••Cautions: PUD/GERD, renal insufficiency, RAD, bleeding disorders, HTN, HF estrogen-progestin OC Zovia (Demulen equiv.), Apri/Solia (Desogen), TriPrevifem (Ortho Tri-cyclen Lo), Previfem (Ortho-Cyclen) LNG-IUD progestin ••norethindrone acetate (Aygestin) ••medroxyprogesterone (Provera) estrogen Premarin NSAIDS use for dose Mirena antifibrinoltytics agents tier, est. use for ovulatory AUB cost* type, name tranexamic acid (Lysteda) diclofenac (Voltaren) 50 mg 3x/day ibuprofen (Motrin) 800 mg 3x/day naproxen sodium(Anaprox) 275 - 500 mg every 6-12 hrs anovulatory AUB * 2012 from SelectHealth; Tier defines patient copay for 30-day supply: Tier 1 = $5-10, Tier 2 = $25-30, Tier 3 = $50 or 20%. $ symbol gives total prescription cost (copay + insurance payment): $= <$25, $$= ~$25-$99, $$$= >$100, $$$$= >$250 . ©2012 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED . ~ ~ Surgical intervention to treat abnormal uterine bleeding should be done only after imaging and endometrial sampling; surgery may be warranted when other treatment modalities have failed or when significant uterine anatomic abnormalities are present. The list below presents general recommendations for surgical treatment of possible causes/complications of AUB: • Polyps: polypectomy/D&C with or without hysteroscopy; consider combining with endometrial ablation • Uterus <12 cm: global endometrial ablation • Uterus>12 cm OR failed ablation: hysterectomy • Myomata, submucosal (2 or fewer) and uterus <12 cm in length: hysteroscopic resection or hysterectomy • Myomata, intramural or serosal: myomectomy or hysterectomy With patients Withablation, ablation,ensure ensurethat that patient understand ablation that is NOT candidatesthat understand ablation sterilization or a formor ofacontraception — is NOT sterilization form of and that they must not that become contraception — and theypregnant must after ablation.pregnant (Consider recommending not become after ablation. sterilization with ablation.) Use the patient (Consider recommending sterilization with education fact sheet referenced on pagefact 4 ablation.) Use the patient education of this CPM. sheet referenced on page 4 of this CPM. Discussion Both endometrial ablation and hysterectomy provide satisfactory results for women with AUB that has not responded to medication. While almost one third of women having endometrial ablation will have reoperation within 5 years, hysterectomy is associated with more perioperative morbidity. Transcervical resection of submucosal myomata is a safe and effective treatment for women with a normal uterine size and not more than two submucosal fibroids (procedure does not affect fertility). New technologies to treat myomata include uterine artery embolization, MRIguided focused ultrasonography, laparocopic uterine artery occlusion, and cryomyolysis. Embolization appears to be effective for up to 5 years in reducing bulk symptoms and menorrhagia associated with myomata. However, the chance of reoperation for myoma-related symptoms within 5 years is 20% to 29%. The other modalities listed above are considered investigational and trial studies are ongoing. 3 ABnormal uterine bleeding a p r i l 2 012 patient EDUCATION Patient education is critical for obtaining informed consent for invasive procedures and for providing good care in general. To support this education, the following Fact Sheet handouts are available (in English and Spanish) on intermountain.net/clinicalprograms on the “GYN” topic page. • Clean Intermittent Catheterization (CIC) for Women After Surgery • Dilation and Curettage (D&C) • Endometrial ablation • Hysterectomy • Hysteroscopy • Sterilization REFERENCES 1. Primary care management of abnormal uterine bleeding (AUB). AHRQ Evidence-based Practice Center (EPC) Systematic Review Protocol. http://www.effectivehealthcare.ahrq.gov/index.cfm/ search-for-guides-reviews-and-reports/?productid=850&pageaction=displayproduct. Published November 21, 2011. Accessed March 20, 2012. RESOURCES Patient and provider tools relating to gynecologic care are available on the Clinical Programs website at: intermountain.net/clinicalprograms. Select the “GYN” topic page to access the following tools: • This CPM • Other gynecology-related CPMs: VBAC, Nonsurgical Management of Ectopic Pregnancy, Use of Synthetic Mesh in Pelvic Support Procedures, etc. • Forms and regulations from CMS on hysterectomy, sterilization and abortion • GYN Blood Utilization Guidelines • Patient education • Links to other resources and references 4 2. Liu Z, Doan QV, Blumenthal P, Dubois RW. A systematic review evaluating health-related quality of life, work impairment, and health-care costs and utilization in abnormal uterine bleeding. Value Health. 2007;10(3):183-194. 3. Ely JW, Kennedy CM, Clark EC, Bowdler NC. Abnormal uterine bleeding: a management algorithm. J Am Board Fam Med. 2006;19(6):590-602. 4. Goodman A. Initial approach to the premenopausal woman with abnormal uterine bleeding. UpToDate. http://www.uptodate.com/contents/initial-approach-to-the-premenopausal-womanwith-abnormal-uterine-bleeding?source=search_result&search=abnormal+uterine+bleeding&sel ectedTitle=1%7E150 . Updated September 24, 2010. Accessed March 21, 2012. 5. Kemp JD, Boardman A. Abnormal uterine bleeding [5-minute clinical suite]. Clin-eguide. http://clineguide.ovid.com/clinicalresource/re/bookFT?xpath=%2Fbookdb%2F01241372%2F6 th_Edition%2F3%2FOVIDBOOK%5B1%5D%2FTXTBKBD%5B1%5D%2FDIVISIONA%5B10%5D% 2FDIVISIONB%5B1%5D%2FCHAPTER%5B2%5D&title=-35324312&odasn=app&tocid=none&act ionIndex=1. Accessed March 21, 2012. 6. American College of Obstetricians and Gynecologists; ACOG Committee on Practice Bulletins— Gynecology. ACOG practice bulletin no. 14: management of anovulatory bleeding. Int J Gynaecol Obstet. 2001;72(3):263-271. ©2012 INTERMOUNTAIN HEALTHCARE. ALL RIGHTS RESERVED. Patient and Provider Publications 801.442.2963 CPM048 - 4/12