CURRENT NATIONAL CURRENT NATIONAL PREVENTIVE HEALTH PREVENTIVE HEALTH

CARE GUIDELINESCARE GUIDELINES

Juanita Halls, M.D.Juanita Halls, M.D.

Professor of MedicineProfessor of Medicine

General Internal MedicineGeneral Internal Medicine

University of Wisconsin - UW HealthUniversity of Wisconsin - UW Health

June 2004June 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 THIRD USPSTF: STRENGTH OF RECOMMENDATIONSRECOMMENDATIONS

A Strongly recommends -Good evidence, improves important health outcomes,

benefits substantially outweigh harms.

B Recommends-Fair evidence, improves health outcomes,

benefits outweigh harms

D Recommends against routine use-Fair evidence, service is ineffective or that harms outweigh benefits

THIRD USPSTF: STRENGTH OF THIRD USPSTF: STRENGTH OF RECOMMENDATIONSRECOMMENDATIONS (continued) (continued)

C Makes no recommendations for or against -Fair evidence, can improve health outcomes but balance of benefits and harms is too close to call

I Insufficient 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)New Cervical Cancer (Pap smear)RecommendationsRecommendations

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 Breast cancer screening recommendationsrecommendations

USPSTF (2002):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 Issues with Breast cancer screeningscreening

•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 uncertainComorbid conditions should be considered

Other Breast Cancer Screening Other Breast Cancer Screening RecommendationsRecommendations

Self Breast ExamSelf Breast Exam::

– USPSTF (2002):USPSTF (2002): I - I - Insufficient evidence Insufficient evidence for or against self for or against self breast exambreast exam

– ACS:ACS: monthly for >20 yrsmonthly 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 20-40 • yearly for age 40 and over

New Colorectal Cancer ScreeningRecommendations

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 ScreeningRecommendations

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 ScreeningRecommendations

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: Colorectal Cancer Screening Issues: FOBTFOBT

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: Colorectal Cancer Screening Issues: Flexible sigmoidoscopyFlexible sigmoidoscopy

Sensitivity - 90% for area of colon reached - 50-70% 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 ColonoscopyAm 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: 544-560

Virtual colonography (CT)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 20 - 35, women 20 - 45 if other cardiac risk factors

C - Men 20 - 35, women 20 - 45 and no risk factors

I - Trigyceride screening

Cholesterol guidelines NCEP III (2001)NCEP III (2001)

(National Cholesterol Education Program)(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

www.nhlbi.nih.gov/guidelines

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 55-84 y/o male - $125,000• low risk 55-84 y/o female - $175,000