20-39: Q3 yrs > 40: annually

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1 The Evolving Well Woman Visit Michael Policar, MD, MPH UCSF School of Medicine Why Is This Important To Clinicians? EBM provides an opportunity to impact quality Provide patients with services that work Avoid the provision of services that don t work Reduce the morbidity, mortality, and economic cost resulting from unnecessary tests Reduce demand pressures on clinics, offices Integrate preventive health messages between clinicians and health educators Why Is This Important to Consumers? Avoid the hazards of false positive test results Avoid time lost for visits and services of limited or no benefit Save on out-of-pocket costs Understand that screening tests are only a small part of prevention Traditional Periodic Health Screening Pre-1920 s: check-up visit did not exist 1922: American Medical Association Advised annual exam of healthy persons 1922 to mid-1990s Check-ups done annually or more often Routine panel of tests often done for each patient regardless of age, risk factors, or underlying medical conditions Screening intervals often arbitrary Inconsistent patterns of adoption of new tests

2 Where Does The Evidence Come From? US Preventive Services Taskforce Agency for Healthcare Research and Quality Rigorous evidence-based review process Multidisciplinary, non-industry expert panel Screening recommendations by disease and by four age groups + pregnancy Supports opportunistic prevention model Web site: Strength of Recommendation A Strongly recommends routine provision B Recommends routine provision C No recommendation for or against D Recommends against routine provision I Insufficient evidence to recommend for or against routine provision USPSTF: Age Band Anticipatory Guidance (counseling) Substance abuse; tobacco; avoid alcohol while driving Diet, exercise: limit fat and cholesterol; adequate Ca Injury prevention: seat belts, helmets, smoke detector Sexual behavior: contraception, STDs Dental health Immunizations TDaP booster; Rubella vaccine (childbearing age) Influenza vaccine (annually) Chemoprophylaxis Multivitamin with folate (women planning pregnancy) USPSTF: Age Band Physical exam, lab, and imaging tests Height and weight Physical Blood pressure exam Pap smear (at least every 3 years) Clinical breast exam (starting at 40 yo) Mammography (starting at 40 yo) Lipid screening (starting at 45) Bowel cancer screening ( starting at 50 yo) Rubella serology or history (childbearing age)

3 USPSTF: Age Band High risk sexual behavior RPR, GC, Ct, HIV Hepatitis A, B vaccine Injection drug use RPR, HIV; hep A,B vaccine Low income, TB contacts PPD Native Americans Hepatitis A vaccine, PPD, pneumococcal vaccine Travelers to dev countries Hepatitis A,B vaccine Blood product recipients HIV, hepatitis B vaccine Health care workers Hepatitis A,B vaccine; PPD; influenza vaccine Family h/o skin cancer Avoid sun; protective clothing Preventing Cancer, CVD, and Diabetes: A Common Agenda of the ACS, ADA, AHA 2004 Implied disappointing results of opportunistic prevention No recommendation for screening intervals Time has come for new models of periodic health maintenance visits and schedules ACOG Primary and Preventive Care Interventions Beyond USPSTF PHS visit should be done annually Physical examination Height, weight, BMI, BP, neck, breasts, abdomen, pelvic >40 yo: oral cavity, axillae; ; skin if high risk Lab TSH (Q5 yrs) > 50 yo; ; 19-49: if increased risk FPG (Q 3 45 years old Lipid profile (Q5 45 years old HIV serology (check state laws) Mammography starting at 40 years old Bone density, Q2 65 yo; > 50 increased risk Cancer Deaths in Women, 2006 Female deaths % Dths Screening Test Lung 27% None Breast 15% Yes Bowel, Rectum 10% Yes Lymphoma/Leuk 7 % None Pancreas 6 % None Ovary 6 % None (low risk woman) Uterus 3 % None Cervix (3,710) 1 % Yes Screening tests available to prevent 26% of cancer deaths

4 Self Breast Exam Clinical Breast Exam Breast Cancer Screening Previous Guideline Monthly Annually Mammogram : Q2 yrs > 50: yearly USPSTF 2002 Insufficient evidence Insufficient evidence >40: 1-2* yrs * In women > 50, biennial equal to annual screening ACS 2003 Optional 20-39: Q3 yrs > 40: annually > 40: annually Colorectal Cancer Screening USPSTF (2002) screening options 50 years old Annual FOBT: 3 samples in well prepared pt» Rectal exam + single FOBT test is not recommended Flexible sigmoidoscopy ( + FOBT)» Every 5 years; + annual FOBT improves accuracy Colonoscopy: every 10 years Double contrast Barium enema: every 5-10 yr Start at 40 yo, screen more frequently if risk factors USPSTF (2007): [D] against routine use of NSAIDs to prevent colorectal cancer in average risk individuals I feel a great disturbance in the force Obi-wan Kenobi Star Wars, Episode IV, 1979 Cervical Cancer Screening Previous Guideline ACS 2002 Initiate Paps* 18 or SD SD + 3yrs or 21 yrs old Hysterectomy (benign disease) Q3-5 yrs not recommended Upper age limit None 70 yo* * 3 nl, no abnl x10 yrs Pap interval < 30 yrs old annually annual (glass) Q2 yr (LBC) USPSTF 2003 SD + 3yrs or 21 yrs old not recommended 65 yo, if previously nl at least every 3 years > 30 yrs old annually Q2-3 years at least every 3 years ACOG 2003 SD + 3yrs or 21 yrs old not recommended no comment annually Q2-3 years

5 Post-Hysterectomy Pap Smears There is no reason to screen for (cervical) cancer in an organ which is no longer present Yet, 60% of women with a hysterectomy for benign disease are still receiving cuff Pap smears!! Common Questions About Pap Intervals Do virginal women need Pap smears? What if a person is immunecompromised? Are the intervals any different for women With multiple sexual partners? Using hormonal contraceptives, menopausal hormone therapy? Who are pregnant? Who are in a lesbian relationship? So Now You re Thinking O.K.I understand that women over 30 years old may need Pap smears only every couple of years But don t they need to come in one a year for a pelvic exam to screen for ovarian cancer? Ovarian Cancer Screening Options for screening (Bimanual) Pelvic examination Transvaginal pelvic ultrasound (TVS) Serum Tumor Marker: CA-125 None are recommended for low risk asymptomatic women Low sensitivity, specificity for early disease Low prevalence of disease High cost of evaluation

6 Ovarian Cancer Screening USPSTF (2004) Screening asymptomatic women with ultrasound, tumor markers, or exam is not recommended [D] Insufficient evidence to recommend for or against in asymptomatic women at increased risk [I] EBM vs. The Conventional Wisdom ACOG (Committee Opinion, 12/2002) Data suggest that currently available (ovarian cancer) screening tests do not appear to be beneficial for screening low risk, asymptomatic women. An annual gynecological examination with an annual pelvic examination is recommended for preventive health care. Routine STI Screening Cervical Chlamydia (in women) Annually in sexually active women thru 25 years old Cervical gonorrhea (in women) Annually in sexually active women thru 25 years old Only if practice-site prevalence is at least 1% HIV serology (CDC 2006) ; USPSTF (2007): [C] recomm dn Screen once 13-64; repeat < annually if known risk Only if practice site prevalence is at least 0.1% Pregnant women Syphilis, HIV, Chlamydia (under 26 years old) Hepatitis B antigen (newborn treatment) Are We Screening the Wrong Women for Ct? Many women in the target age range (25 and younger) are not being screened Yet, in many systems, screening rates for women over age 25 are equal to women 25 and younger So what?? Rates of chlamydia in women over age 25 are <1% and decline with age Chlamydia infects the columnar epithelium of the cervical ectropion; recedes with aging As prevalence decreases, positive predictive value declines, making incorrect diagnoses more likely

7 2.8% 2.6% 1.0% yo: 0.15% Targeted Screening: Risk Factors GC + Ct screening History of GC, chlamydia, or PID in the past 2 years More than 1 sexual partner in the past year New sexual partner within 90 days Sexual partner who has other partners Syphilis, HIV screening Sexual history, partner behaviors, local prevalence CDC,2005 Contact Testing for STI Exposure Test asymptomatic persons with high risk sexual exposure (new or multiple sexual partners) for Gonorrhea Chlamydia Syphilis HIV Maybe: HSV-2 serology No contact testing for HSV (culture), HPV (DNA) HBV, HBC (strategy for HBV is vaccination) High Risk HPV DNA Testing Clinically useful for Primary screening (HPV+Pap) if age 30 and over Triage of ASC-US Pap smears (reflex) 12-month follow-up of LSIL in adolescents Post-colposcopy and post-treatment treatment follow-up NO proven benefit for Triage of ASC-H, LSIL, HSIL, AGC Paps STD screening in the general population Evaluation of sex partners Evaluation of genital warts

8 Is the Screening Pelvic Exam Outdated? Screen for Preferred test GC, Ct Use NAAT with urine sample Cervical cancer Not within 3 years of sexual debut Pap every 2-3 yrs afterward None if total hyst for benign dz Ovarian cancer USPSTF rec. against bimanual exam Vulvar lesions Unnecessary if asymptomatic Vaginal infxn Unnecessary if asymptomatic Myomas Unnecessary if asymptomatic Lipid Screening Guidelines USPSTF 2001 Strongly recommend [A] routine screening every 5 yrs» Men 35 and older, women 45 and older Recommend [B] routine screening if CAD risk factors» Men years old, women years old Screen with total cholesterol and HDL-C [ B ] Insufficient evidence [ I ] regarding value of TG screen Adult Treatment Panel (ATP III), 2004 LP profile (TC, HDL, LDL, TG) Q5 yrs >20 years old LDL <100 mg/dl; HDL >40 mg/dl are optimal USPSTF: Diabetes Screening USPSTF Guidelines, 2003 Evidence is insufficient [ I ] to recommend for or against routinely screening adults for Type 2 diabetes or IGT Screening recommended for type 2 diabetes in adults with hypertension or hyperlipidemia [B] American Diabetes Association, 2007 Screen adults at 3-year intervals beginning at age 45 Consider screening at an earlier age (or more frequently) if overweight (BMI > 25) or risk other factors present FPG is the recommended screening test Diabetes Screening: Interpretation ADA 2007 Initial screen: fasting plasma glucose (FPG) Normal: plasma glucose < 100 mg/dl IFG*: mg/dl Diabetes: >126 (on two occasions) Diagnosis of diabetes (on two occasions) FPG > 126 mg/dl 2 hr PLGT* > 200 mg/dl Random PG > 200 mg/dl with DM symptoms * IFG: impaired fasting glucose ** PLGT: post-load glucose test

9 Diabetes Screening: Interpretation ADA hour post-load glucose test (PLGT) 75 gm oral glucose load Fasting PG test is not necessary Indications Evaluation of impaired fasting glucose T2DM screening in women with PCOS Interpretation Normal: <140 mg/dl IGT: mg/dl Diabetes: >200 mg/dl (on two separate occasions) Screening for Thyroid Disease USPSTF (2004): [ I ] recommendation ATA, AACE, Endocrine Society (JAMA, 2004;291:228) Insufficient evidence to support routine screening Screen women >60, personal or family history of thyroid disease, symptoms or physical findings of or T4, T1DM, autoimmune disease and atrial fibrillation Screen pregnant women only if above risk factors ACOG (2006) TSH every 5 years, starting at 50 years old (2002) There are insufficient data to warrant routine screening of asymptomatic pregnant women Osteoporosis Screening with BMD Testing [C] recommendation Risk Factors [B] recommendation No risk factors Risk Factors No risk factors Treat, no BMD >75 USPSTF 2002 NOF Health Screening and Contraception Stewart, et.al., JAMA 2001;285:2232 Most contraindications to contraceptive use are found on medical history, not physical exam Other than BP check, there are no unique exam requirements for hormonal contraceptive users Initial and PHS visits are desirable, but are not linked to safe contraceptive use No precedent for requiring health screening as pre- requisite for unlinked preventive or therapeutic interventions

10 2004 WHO Selected Practice Recommendations for Contraceptive Use Do not recommend as contributing substantially to safe and effective use of contraceptive method Breast or genital tract examination Cervical cancer screening STI assessment or lab test screening Hemoglobin determination Other routine lab tests Blood pressure measurement before initiation of COC, CIC, POPs, DMPA, and implants Obstacles to Adoption Industry Booming market in new screening technologies Most achieve marginal improvements Government Major objective is political expediency, not EBM Example: 1997 NCI panel on Mammography Health systems NCQA: measure what s measurable Cancer screening as good marketing Consumers Clinicians Women s Perceptions of Pap Screening Smith M, Ann Fam Med 2003; 1: 203 Focus groups with 812 Michigan women Believe that Paps are highly effective in prevention of cervical cancer set against a change in GL Women should be screened annually (or more often), starting with menses or sexual activity Believe that Paps check for a variety of conditions Believe that efforts to reduce Pap frequency are economically motivated by health plan Annual Pap smears are firmly entrenched Obstacles to Clinician Adoption Reasons to continue the screening status quo My patients believe in it The legal system demands it My professional organization expects it Vendors are pressuring me to utilize it Payers still pay for it It keeps my office practice going I believe in it; common sense says that it may help And there s little incentive to do less just that The evidence says it s the right thing to do

11 What Is Future of the Well Woman Exam? Change is likely to evolve slowly, but. Women with a primary care provider will have less incentive to visit OBG for check-up visits Breast exams, screening tests, and contraception or menopause care can (and will) be provided by PCP Some women will choose to be seen by OBG only as required for Pap smears (every 2-3 years) What Is Future of the Well Woman Exam? Women who do not have a PCP can be offered periodic health screening services That focus on primary prevention and behavioral risk reduction That provides the same (limited) screening interventions offered by a PCP Either through opportunistic screening or dedicated periodic health screening visits How Can My Practice Prepare? Meet with your colleagues and determine the screening policies for your practice Make sure that all staff are aware of your policy Inform your patients of changes that apply to them During transitional phase, leave decisions to the patient Consider informing patients thru a letter or newsletter Keep track of benefit changes made by your payers Few have changed screening benefits yet E/M codes for PHS visits Use Preventive Medicine codes Code for total face time rather than history/pe/mdm An Ounce of Prevention is Worth a Pound of Cure But Two Ounces Aren t Necessarily Better Than One

12 If you think that you re really healthy You just haven t had enough tests

ACS 2003 Monthly Optional [D] USPSTF Previous Guideline. Breast Self-Examination (BSE) Clinical Breast Exam (CBE) [I] > 40: yearly

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