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Health Maintenance

Health Maintenance. Presented by John Zweifler, M.D., M.P.H. . Who and What do we screen?. Significance of condition. Severity Frequency Detectable during asymptomatic period. Effective intervention available. Targeting Health Maintenance Activities*.

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Health Maintenance

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  1. Health Maintenance Presented by John Zweifler, M.D., M.P.H.

  2. Who and What do we screen? • Significance of condition. • Severity • Frequency • Detectable during asymptomatic period. • Effective intervention available.

  3. Targeting Health Maintenance Activities* • Deaths/year attributable to various conditions. • Cigarette smoking - 400,000 • Diet and exercise - 300,000 • Excess alcohol - 100,000 • Breast cancer - 40,000 • Cervical cancer - 4,000 • Colo-rectal cancer - 56,000 • Prostate - 30,000 • Lung -155,000 • *Ganiats T Prevenion Strategies in Family Practice. AAFP. 2003

  4. Assessing screening interventions • Quality of screening test. • Sensitivity, specificity • Accuracy • Acceptability of screening. • Cost • Convenience • Availability • Potential adverse effects of screening and treatment.

  5. Condition Present Positive Test a Negative Test c Sensitivity=a/(a+c) Positive Predictive Value=a/(a+b) Condition Absent Positive Test b Negative Test d Specificity=d/(b+d) Legend: a=true positive b=false positive c=false negative d=true negative Sensitivity and Specificity

  6. Cancer Prevalence = 1% Cancer Cancer Present Absent Positive 900 9,900 Test Negative 100 89,100 Test Positive Predictive Value= 8.3% Cancer Prevalence = 0.1% Cancer Cancer Present Absent Positive 90 9,990 Test Negative 10 89,910 Test Positive Predictive Value = 0.9% Testing ConditionsSize of Population = 100,000Sensitivity of Test = 90%Specificity of Test = 90%

  7. Cost Effective Analysis • Considerations in cost effective analysis: • Perspective - Patient, payor, society • Cost of intervention. • Cost of necessary additional tests or monitoring. • Cost of complications. • Opportunity cost - allocation of resources.

  8. Cost effective analysis*Cost per year of life saved • Mandating automatic seat-belts: $0-$25,000. • Influenza vaccination: $500. • Nicotine gum/smoking cessation: $6,000-$13,000. • Statin drugs for men 35-55 years with CHD and chol >250mg/dl: $0-$9,000. • Statin drugs for women 35-45, no CHD, cholesterol >300: $1,000,000. • *Deyo R. JABFP JAN. - FEB. 2000. Vol. 13 #No. 1 47-54

  9. Cost Effectiveness of Various Screenings • Annual screening for cervical cancer, women 21 years or older - $50,000 per life year gained. • Hypertension screening for asymptomatic men 20 years and older - $48,000. • Hypertension screening for asymptomatic women 20 years and older - $87,000.

  10. Types of Prevention • Primary prevention: prevent or arrest the disease process in its earliest stages by promoting healthy lifestyles or immunizing against infectious disease. • Secondary prevention: detecting and treating asymptomatic risk factors or early asymptomatic disease. • Tertiary prevention: screening for complications of known disease.

  11. United States Preventive Service Task Force (USPSTF) Guide to Clinical Preventive Services • www.preventiveservices.ahrq.gov • Released the first report in 1989. • Now supported by the Agency for Health Care Research and Quality, and the United States Public Health Service. • Relies on evidence based approaches. • Task force members represent health-care related federal organizations and primary care and preventive medicine specialties.

  12. Hierarchy of Research Design* • I. At least one properly randomized control trial. • II-1. Well designed control trials without randomization. • II-2. Well designed cohort or case-control analytic studies. • II-3. Multiple timed series with or without the intervention or dramatic results in uncontrolled experiments. • III. Opinions of respected authorities, descriptive studies and case reports, or reports of expert committees. • *USPSTF. 2001.

  13. Pelvics and Rectals!?

  14. Colorectal Screening Sigmoidoscopy • Selby, NEJM, 1992 - Case control study showed 70% reduction in distal CRC in those exposed to sigmoidoscopy. • Selby, Atkins & Sakamoto JFP, 1994 - Studies suggest sigmoidoscopic screening q 10 years may be effective. • Atkins, NEJM, 1992 - Adenomatous polyps <1 cm no benefit to colonoscopic follow up.

  15. Colorectal Cancer and Polyps • ~30-50% of Americans 50-75 y.o. have polyps. • 90% of polyps <one centimeter. • If polyp found in sigmoidoscopy -> biopsy • If adenomatous -> colonoscopy: • Risk of colorectal cancer S/P excision of small polyp (<1 cm.) same as general population.

  16. Colorectal Screening Colonoscopy • Q3 year colonoscopic surveillance results in 88-90% reduction in colorectal cancer (Family Practice News. 8-1-94) • Cost - 3 billion/year

  17. Colorectal Screening Hemoccults Allison, NEJM, 1996 - sens. spec. +PPV Hemoccult 32 98 23 Hemoccult Sens 71 87 9 Hemeselect 67 95 20 Mandel, NEJM, 1993 - 1/3 reduction in colorectal cancer (CRC) with hemoccults and rehydration.

  18. Colon cancer Fecal occult blood testing • Newer tests (hemoccult Sensa, and Heme Select) are more sensitive. • Newer tests less specific, resulting in high false positive rates. : -.

  19. Colonoscopy vs. Barium Enema • BE safer, less costly. • Colonoscopy diagnostic & curative. • BE - 44% sensitive, 75% specific (Family Practice News. Aug. 1,1994).

  20. Colorectal Screening RecommendationsUSPSTF 2002 • Strongly recommends screen men and women 50 years of age or older: A • Screening modalities; • FOBT, sigmoidoscopy, or FOBT + sigmoidoscopy • Colonoscopy • Double contrast barium enema • Cost effective- <$30,000/year of life saved regardless which screening test used • Interval and upper limits not specified

  21. Prostate Cancer • 50% of men >80 y.o. found to have prostate cancer at autopsy. • Incidence increased from 90,000 in 1987 -> 317,000 in 1996. • 2nd most common cause of death from cancer in men. • 21st in years of life lost.

  22. Prostate Cancer* • Cost of screening and f/u of local disease in men 50-70 y.o. - $12-28 billion/year. • Complications of treatment (impotence, incontinence, scarring). • Screening results in marginal increase in life expectancy, decrease in quality of life, and high cost. *Krahn M, et al., Screening for Prostate Cancer. JAMA Sept. 14,1994

  23. Prostate Cancer Survival • Rate of prostatectomy increased 600% from 1984-1990. • Age adjusted mortality rates - no change. • 10 year survival with stage A cancer - 85% • 95% of men with prostate cancer die from other causes. • 10 times more likely to die from cardiovascular disease.

  24. Prostate Specific Antigen (PSA) • Approved by FDA, 1996 - 10% positive. • Large overlap between BPH & prostate cancer. • PSA 55-75% sensitive, 70% specific. • Follow-up with ultrasound, biopsy.

  25. Prostate Cancer ScreeningUSPSTF 2002 • Insufficient evidence to recommend for or against routine screening with PSA or digital rectal exam: I • PSA can detect early stage prostate cancer. • Inconclusive evidence that early detection improves health outcomes. • Screening associated with important harms including false positives, biopsies, and complications of treatment. • Uncertain if benefits exceed risk

  26. Osteoporosis • 1.3 million osteoporosis-related fractures in U.S. each year • 15% of women have hip fractures • Strongly associated with low bone mineral density(BMD) • Risk factors - female, age, anglo, low body weight, & bilat. oophorectomy

  27. Value of Screening • Women >65 years old with low BMD are eight times more likely to have hip fracture • No studies correlating perimenopausal BMD with long-term fracture risk • Other risk factors-age, health,activity,vision • ?impact on recommendations re calcium, hormone replacement therapy, or exercise

  28. Screening Tests • Plain films • C.T. • Absorptiometry-measures BMD • Dual energy x-ray (DXA) • Femoral neck measure best predictor of hip fx • Experimental - Ultrasound and biochemical

  29. Interventions • Calcium, exercise, safety measures • Hormone replacement therapy • Selective estrogen receptor modulators • Biphosphanates

  30. Osteoporosis Treatment • Meta analysis of Alendronate showed reductions in vertebral and forearm fractures • Fracture Intervention Trial showed benefit of Alendronate in hip (50%) and total fx (30% less) in women with low BMD only. • Raloxifene study showed fewer vertebral fx. • USPSTF estimates need to screen 731 women over 64 years old, or 1,856 women 60-64 to prevent one hip fracture.

  31. Raloxifene To Prevent Osteoporosis • Estrogen-like effect on bones and lipid metabolism (decreases total LDL cholesterol without changing HDL). • No estrogen-like effects on breast or uterine tissue. • No post-menopausal bleeding or increase in breast CA. • Patients may experience hot flashes • Decreases risk of osteoporosis, has not been proven to decrease fracture risk.

  32. USPSTF Osteoporosis Guidelines-2002 • Screen women aged 65 and older B • Begin at age 60 for women at increased risk for osteoporotic fractures B • Benefits/harms of screening and treatment too close to recommend for other age groups.C • Risk for osteoporosis and fracture increases with age and other factors • BMD measures accurately predict fracture risk • Treating asymptomatic women with osteoporosis reduces fracture risk.

  33. Hormone Replacement • Can reduce risk of fractures by 25-50% • Need to continue indefinitely • More likely to continue if have low BMD • Decision re HRT hinges on factors besides BMD

  34. Proceed With CautionEstrogen Replacement Therapy • Risk of coronary heart disease exceeds risk of breast cancer (230,000 deaths from CHD, 34,000 from breast cancer in women older than 55 years). • Observational studies suggested 40-50% reduction in fatal coronary heart disease in post menopausal estrogen users. (Grady, et al., Ann Intern Med, 1992;117:1016-1037). • Observational studies do not establish causal relationship.

  35. Prevention of Coronary Heart Disease in Post-menopausal Women* • Randomized trial of estrogen plus progesterone. -No differences in cardiovascular outcomes, cancer, or total mortality despite lower LDL and higher HDL in HRT group. -More thromboembolic events and gallbladder disease in HRT group. -Trend toward more coronary heart disease in first year, and less in later years. *Hulley, et al., JAMA, 1998;280:6055 & 613.

  36. Hormone Replacement Therapy* • Large RCT’s including women’s Health Initiative and the Heart and Estrogen/Progestin Replacement Study (HERS) have evaluated HRT. • HRT beneficial in relieving vasomotor symptoms. • HRT has beneficial effects on colon cancer and hip fractures. • Benefits more than offset by increased risk of coronary events, stroke, pulmonary embolism, and breast cancer. • Further analysis of WHI indicates HRT has no significant effects on general health, vitality, mental health, depressive symptoms, or sexual satisfaction. (Hays et al. NEJM 2003; 348: 1839-54.) • *Grady D NEJM 348; 19. May 8, 2003. 1835-1837.

  37. Breast Cancer • 192,000 cases of breast CA & 40,000 deaths in 2001 • Breast CA deaths decreased 8-9% in women 36-59 y/o & 3-5% in women 60-79 from 1989-92 • African-American women > 2 times more likely to die of breast CA • More than 40% of years of life lost are from women diagnosed < 50 y/o

  38. Mammography & Breast Cancer • Seven randomized controlled trials in women ages 40-74 • The six trials involving women >50 years old demonstrate decrease in mortality from breast cancer of 20-30% • No difference if screened every 12 months or every 18-33 months

  39. Randomized Controlled Trials of Breast Screening for Women Age 40–49: Relative Risk (RR) of Mortality for Screened Subjects Versus Control Subjects # of subjects Trial Year Screened Controls RR HIP Study 1963–69 14,423 14,701 0.77 Malmo 1976–86 3,658 3,679 0.51 Kopparberg 1977–85 9,582 5,031 0.73 Ostergotland 1977–85 10,262 10,573 1.02 Edinburgh 1979–88 5,913 5,810 0.78 Stockholm 1981–85 14,375 7,103 1.04 Gothenburg 1982–88 10,600 12,800 0.73 NBSS-1 1980–87 25,214 25,216 1.36 HIP—Health Insurance Plan; NBSS—National Breast Screening Study. Modified from Smart R, 1995.

  40. Study Design Controversy • Non-compliance and Contamination • Study size & statistical significance • Follow-up period • Lead-time & length-time bias • Inclusion of women with breast Ca. • False positives

  41. Screening for Breast Cancer in Women 40-49 Years Old • Canadian national breast screening study designed to answer this question • No benefit shown -study has been criticized (Miles A. Can Med Assoc J 1992;147:1459-1476) • 3 trials - no benefit, 4 trials - nonsignificant benefit of 22% or more • Meta-analysis of 40-49 y.o.subgroup showed no reduction in breast cancer mortality (Elwood J, Online Curr. Clin. Trials 1993, Doc. #32)

  42. 40-49 y/o 10% shift from Stage II Ca. to Stage I No benefit first 9 years 16% decrease in breast CA mortality 10-14 years 50-69 y/o 40% shift from Stage II Ca. to Stage I No benefit first 5 years 27% decrease in breast CA mortality after 5 years Benefits of Screening Peer, et al. Age Specific Effectiveness … J Nat’l Cancer Inst. 994;86:436-41 Kerlikowske, Efficacy of Screening Mammography. Monogr. Nat’l Cancer Inst. 1997;22:79-86

  43. Cost Effectiveness of Mammography • Breast CA incidence 2-3 x greater in 50-69 y/o than 40-49 age group (Saltzmann et al. Ann Intern Med 1997;127:955-965) • Previous studies showing equal cost effectiveness did not account for 10 year lag in benefits (Lindfors JAMA 1995;274:881-4 Feig. Cancer 1995;76:97-106)

  44. 40-49 y/o (screen q 18 mo) Increase life exectancy 2.5 d. 4 deaths prevented/10,000 at 80 y/o $105,000 per year of life saved 50-69 y/o (screen q 2 years) Increase life expectancy 12 d. 37 deaths prevented/10,000 at 80 y/o $21.400 per year of life saved Cost Effectiveness of Mammography (cont.)

  45. Genetic Testing for Breast Cancer* • 5-6% of breast cancers associated with inherited genetic mutation. • BRCA1 and BRCA2 among hundreds of mutations associated with breast cancer. • Found in .1% of general population. • Account for less than 1/5 of familial risk of breast cancer. • Also linked with ovarian cancer. *Isaacs C, Fletcher SW, Peshkin BN, Up To Date, last updated December 4, 2002

  46. BRCA 1 and 2 and Cancer* • Ashkenazi Jews with high incidence of BRCA mutations studied. • 10% of breast cancer associated with BRCA 1 or 2. • Associated with 82% lifetime risk of breast cancer. • Associated with 20-40% lifetime risk of ovarian cancer. *King M. Science October 2003

  47. Treatment Options for Breast Cancer Genetic Pre-disposition *Increased Surveillance • Cancer Genetic Study Consortium recommends: • monthly BSE at age 21, • annual CBE beginning at age 25-35, • annual mammography beginning at age 25-35, • annual or semi-annual ovarian cancer screening with ultrasound and CA-125 beginning at ages 25 or 35. • Efficacy of early and increased surveillance not known. *Isaacs C, Fletcher SW, Peshkin BN, UpToDate, last updated April 28, 2003

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