CURRENT NATIONAL PREVENTIVE HEALTH CARE GUIDELINES Juanita Halls, M.D. Professor of Medicine General Internal Medicine University of Wisconsin - UW Health June 2004

Objectives Review of latest evidence-based guidelines for preventive health care of adult patients: Cervical cancer screening Breast cancer screening Colon cancer screening Cholesterol screening No financial relationships to disclose

THIRD USPSTF: STRENGTH OF RECOMMENDATIONS THIRD USPSTF: STRENGTH OF RECOMMENDATIONS AStrongly recommends -Good evidence, improves important health outcomes, benefits substantially outweigh harms. BRecommends -Fair evidence, improves health outcomes, benefits outweigh harms DRecommends against routine use -Fair evidence, service is ineffective or that harms outweigh benefits

THIRD USPSTF: STRENGTH OF RECOMMENDATIONS (continued) CMakes no recommendations for or against -Fair evidence, can improve health outcomes but balance of benefits and harms is too close to call IInsufficient evidence to recommend for or against -Lack of evidence on clinical outcomes -Poor quality of existing studies -Good quality studies with conflicting results (possibility of clinically important benefits)

New Cervical Cancer (Pap smear) Recommendations ACS (2002): Start 3 years after onset of sexual activity or age 21 every 1 yr (2 yr if liq-based cytology) til age 30 then every 2-3 if normal risk after 3 consecutive neg paps

New Cervical Cancer (Pap smear) Recommendations USPSTF (2003): A – Pap smear at least every 3 years for women who have been sexually active and have a cervix

New Cervical Cancer (Pap smear) Recommendations USPSTF (2003): Good evidence that screening with Pap smears reduces incidence of and mortality from cervical cancer Indirect evidence suggests most of the benefit can be obtained by beginning screening within 3 years of onset of sexual activity or age 21 (whichever comes first) and screening at least every 3 years

Rationale for change in starting age for Pap: Adolescents: low risk for cervical cancer and many low grade lesions that regress No new data on interval But progression from HPV infection to cervical cancer is a long interval Most of benefit can be obtained by beginning screening within 3 yrs of onset of sexual activity or age 21 and screening at least every 3 years

Recommendations for pap smears in older women: USPSTF (2003): D – (not recommended) Over age 65 if adequate recent normal pap smears and not in high risk group ACS (2002): May stop age 70 if 3 negative paps and no abnormal paps prior 10 years and not high risk

Recommendations for pap smears in older women: Rationale: High number of procedures to detect very few high-grade lesions in previously screened women Harm may exceed benefit in women >65

Pap smear recommendations in women with hysterectomy for benign reasons ACS (2002): pap after hysterectomy for benign disease not indicated Am Coll OB/GYN: Recommends pap only if history of invasive cervical cancer or DES exposure USPSTF (2003): D (not recommended) – Women with total hysterectomy for benign diseases

Rationale: Two studies* on patients with hysterectomy Over 10,000 women No high-grade lesions found *Am J Ob Gyn 1995, NEJM 1996

Breast cancer screening recommendations USPSTF (2002): B - Recommends mammography, with or without clinical breast exam, every 1-2 years for women 40 and older: ACS (2003): Recommends mammography every year in women over 40

Mammogram screening trials - all women (RR of breast cancer mortality) 1992

Mammogram screening trials - women less than 50 (RR of breast cancer mortality) 1992

Mammogram screening trials - women less than 50 (RR of breast cancer mortality) 2001 Update

Issues with Breast cancer screening Evidence weaker and benefits smaller in younger women (40-49) Balance of benefits and harms improves with age from 40 to 70 Precise age to start screening is uncertain and should take into account patient preferences Age to discontinue screening uncertain Comorbid conditions should be considered

Other Breast Cancer Screening Recommendations Self Breast Exam: –USPSTF (2002): I - Insufficient evidence for or against self breast exam –ACS: monthly for >20 yrs Rationale: Two large controlled studies of self breast exam: Done in China and Soviet Union No benefit

Other Breast Cancer Screening Recommendations Clinical Breast Exam (CBE): USPSTF (2002): B - for ages 40 and older with mammogram I - Insufficient evidence (I) for or against clinical breast exam (CBE) alone ACS (1980): every 3 years for age yearly for age 40 and over

New Colorectal Cancer Screening Recommendations USPSTF: (2002) A - strongly recommends screening men and women 50 years of age or older for colorectal cancer Insufficient evidence to say which method is best: FOBT Flexible sigmoidoscopy +/- FOBT Colonoscopy DCBE

New Colorectal Cancer Screening Recommendations ACS (2001): After age 50 (start earlier if risk factors): Options include: FOBT yearly Flex sig every 5 years Flex sig every 5 yr and FOBT yrly (preferred) Colonoscopy every 10 years DCBE every 5 years

New Colorectal Cancer Screening Recommendations Am Gastroenterological Assoc (2003) - Same as ACS but no preferred strategy Am College Gastroenterology (2000): After age 50: -Colonoscopy every 10 years (preferred) -Yearly FOBT and Flex sig q 5yr (alternative)

Colorectal Cancer Screening Rationale: All options appear to be cost-effective (< $30,000 per LYS) No single option is clearly more Cost Effective Choice of strategy based on: Patient preference Medical contraindications Patient adherence Available resources for testing and f/u

Colorectal Cancer Screening Issues: FOBT Sensitivity = approximately 40 % for CRC (lower for polyps) Specificity = up to 97 % Advantages of FOBT: Easy, completed at home Inexpensive Anyone can order Disadvantages: High false positive rate leads to additional costly tests False negatives can give false reassurance Acceptability and compliance

Colorectal Cancer Screening Issues: Flexible sigmoidoscopy Sensitivity- 90% for area of colon reached % for all of colon Specificity -99% Advantages: Less prep needed, no sedation, shorter procedure Less trained providers can perform (e.g General internists, Family Medicine, NPs, PAs) Disadvantages: Less depth if patient gets cramping Often do not biopsy or remove polyps Decision of who needs follow-up colonoscopy (25% of patients have polyps (50% are adenomas and 20% of these are high grade) Acceptability and compliance

Colorectal Cancer Screening Issues: Colonoscopy Sensitivity – 90% Specificity – 99% Advantages: Gold standard High sensitivity and specificity Used to work up other positive screening tests (FOBT, flexible sigmoidoscopy, barium enema) Capable of detecting and removing premalignant polyps and biopsy of suspicious lesions Disadvantages: Cost and availability Small risk of perforation and death Acceptance and compliance

High risk patients – Do Colonoscopy Am Gastroenterologist Assn high risk groups: Hx of adenomatous polyp or colorectal cancer Inflammatory Bowel Disease Family hx of  two 1° relatives with colorectal cancer or adenomatous polyps or one 1° affected relative if <60 yr old - Start at 40yr or 10yr younger than affected relative Familial adenomatous polyposis Hereditary nonpolyposis colorectal cancer (HNPCC) Gastroenterology 2003;124:

Virtual colonography (CT) Pickhardt, et al (NEJM 2003;349:23) Screening (asx) population, 3 D images and contrast Sensitivity for adenomas >10 mm =.92 Specificity for adenomas >10 mm =.96 Cotton, et al (JAMA 2004;291:1713): Clinically indicated referrals, 2 D images Sensitivity for any polyps > 10 mm =.55 Specificity for any polyps > 10 mm = 1.0

Cholesterol guidelines USPSTF (2001) Screening includes: Total cholesterol (A recommendation) HDL-cholesterol (B recommendation) A -Men 35 and older, women 45 and older B - Men , women if other cardiac risk factors C - Men , women and no risk factors I -Trigyceride screening

NCEP III (2001) (National Cholesterol Education Program) Cholesterol guidelines NCEP III (2001) (National Cholesterol Education Program) All individuals over 20: Fasting Lipoprotein profile (TC, LDL, HDL, TG) If not fasting: -get Total and HDL -but if Total > 200 or HDL < 40 then get fasting profile

Issues - Screening younger patients Lower absolute risk of CHD events Lack of RCT of effect of early screening and treatment of lipid disorders on late CHD and mortality (need 30 year follow-up studies) Statins - $1,400/year,Costs of visits and labs Cost per life year saved: - high risk middle-aged men - $17-35,000 - low risk young male/female $1-10 million

Conclusions – cholesterol screening Clear benefits for men and women with CHD and high risk middle-aged men Benefits likely for high risk post menopausal women and elderly Cost per life year saved: high risk middle-aged men - $17-35,000 low risk y/o male - $125,000 low risk y/o female - $175,000