Ten-Year Risk of False Positive Screening Mammograms and Clinical Breast Examinations
Joann G. Elmore, M.D., M.P.H., Mary B. Barton, M.D., M.P.P., Victoria M. Moceri, Ph.C., Sarah Polk, B.A., Philip J. Arena, M.D., and Suzanne W. Fletcher, M.D.
Background The cumulative risk of a false positive result ofa breast-cancer screening test is unknown.
Methods We performed a 10-year retrospective cohort study ofbreast-cancer screening and diagnostic evaluations among 2400women who were 40 to 69 years old at study entry. Mammogramsor clinical breast examinations that were interpreted as indeterminate,aroused a suspicion of cancer, or prompted recommendations foradditional workup in women in whom breast cancer was not diagnosedwithin the next year were considered to be false positive tests.
Results A total of 9762 screening mammograms and 10,905 screeningclinical breast examinations were performed, for a median of4 mammograms and 5 clinical breast examinations per woman overthe 10-year period. Of the women who were screened, 23.8 percenthad at least one false positive mammogram, 13.4 percent hadat least one false positive breast examination, and 31.7 percenthad at least one false positive result for either test. Theestimated cumulative risk of a false positive result was 49.1percent (95 percent confidence interval, 40.3 to 64.1 percent)after 10 mammograms and 22.3 percent (95 percent confidenceinterval, 19.2 to 27.5 percent) after 10 clinical breast examinations.The false positive tests led to 870 outpatient appointments,539 diagnostic mammograms, 186 ultrasound examinations, 188biopsies, and 1 hospitalization. We estimate that among womenwho do not have breast cancer, 18.6 percent (95 percent confidenceinterval, 9.8 to 41.2 percent) will undergo a biopsy after 10mammograms, and 6.2 percent (95 percent confidence interval,3.7 to 11.2 percent) after 10 clinical breast examinations.For every $100 spent for screening, an additional $33 was spentto evaluate the false positive results.
Conclusions Over 10 years, one third of the women screened hadabnormal test results requiring additional evaluation, eventhough no breast cancer was present. Techniques are needed todecrease false positive results while maintaining high sensitivity.Physicians should educate women about the risk of a false positiveresult of a screening test for breast cancer.
Mammography and clinical breast examination are the two principalmeans of screening for breast cancer.1 The effectiveness ofbreast-cancer screening has been well documented in eight randomized,controlled trials,2 but there has been less attention to itsaccuracy in community settings and to the consequences of afalse positive result. A national review of community mammographyfacilities in the United States found that 1 of every 10 screeningmammograms gave a false positive result.3 Equivalent informationfor clinical breast examination is not available.
If a woman undergoes annual screening beginning at the age of40, she will have had 60 opportunities for a false positiveresult by the age of 70, with 30 mammograms and 30 clinicalbreast examinations. The cumulative lifetime risk of her havinga result from a screening test that requires further workup,even though no breast cancer is present, is not known. An estimateof 25 percent has been given for the cumulative risk of a falsepositive result after 10 mammograms and 10 clinical breast examinations.4It is important to determine the cumulative risk of false positivetests, because women are advised to have breast-cancer screeningevery one to two years over several decades of their lifetimes,and false positive results can provoke anxiety, increase costs,and cause morbidity.5,6,7,8,9,10,11,12,13
Using the computerized clinical records of a health maintenanceorganization (HMO) for a group of women over a 10-year period,we determined the cumulative risk of a false positive resultof breast-cancer screening, the number and type of subsequentdiagnostic workups resulting from the false positive results,and the costs of the false positive results. The HMO we studiedhas long encouraged women who are 40 or older to undergo routinebreast-cancer screening. By studying the medical records, weascertained the 10-year cumulative rates of false positive resultsfor both mammography and clinical breast examination. We thendetermined the number of diagnostic examinations generated bythe false positive results and estimated their costs.
Methods
Setting
This retrospective cohort study was conducted at 11 staff-modelhealth centers of Harvard Pilgrim Health Care, a large HMO inNew England. The health centers serve nearly 300,000 adultsin and around Boston. Although the majority of members belongto the HMO through an employer or a spouse's employer, approximately5 percent are enrolled through the state Medicaid program forlow-income persons. This study was approved by the Human StudiesCommittee of Harvard Pilgrim Health Care and the institutionalreview board of the University of Washington School of Medicine.
Breast-cancer screening for the members of Harvard Pilgrim HealthCare is encouraged by internal guidelines and a computerizedreminder system that prompts health care providers to performclinical breast examinations and order mammograms for screening.Beginning in 1984 and throughout the study period, the HMO recommendedthat all women from 40 to 49 years of age be screened with mammographyevery two years and that women 50 years of age or older be screenedannually. Most of the women were referred to sites outside theHMO for mammography, including local community and academicradiology centers. All of the radiologists who read the mammogramswere board certified and worked in groups that contracted withthe HMO.
Study Population
All 14,382 women who were members of the HMO and who were between40 and 69 years of age on July 1, 1983, were potentially eligiblefor the study. Women were excluded for the following reasons:a lapse in enrollment in the HMO between July 1, 1983, and June30, 1995 (8816 women); health coverage from a source other thanHarvard Pilgrim Health Care or from a noncomputerized HMO centerduring the study period (1093 women); and a history of breastcancer or a prophylactic mastectomy or breast implants beforeJuly 1, 1983, (146 women) or a prophylactic mastectomy or breastimplants during the study period (8 women). From the cohortof 4319 remaining eligible subjects, a random sample was chosen,consisting of 1200 women 40 to 49 years of age, 600 women 50to 59 years of age, and 600 women 60 to 69 years of age, fora total sample of 2400 women.
Review of Medical Records
Harvard Pilgrim Health Care keeps computerized records of patients'visits for ambulatory care services.14,15 Data on demographiccharacteristics, risk factors for breast cancer, screening clinicalbreast examinations, screening mammography, diagnostic testingperformed as a result of breast-cancer screening, and breastcancers diagnosed were abstracted from these records onto standardizedforms. If information was missing or clarification was needed,the original test reports were reviewed. Household income wasestimated by matching each patient's address on December 1,1995, with census-tract data.16
For development and training purposes, the data on the first581 patients were extracted independently by a research assistantand one of the authors. To ensure quality, the data on a randomlyselected sample of 5 percent of the next 1443 patients wereextracted by a second person who was unaware of the first researchassistant's results. Inconsistencies between the reviewers werefound for 175 (0.9 percent) of the 19,407 variables reviewedamong the 1443 patients. Forty of these inconsistencies (0.2percent) were considered clinically important because they concernedthe specific reasons for ordering the test. In view of thislow rate of discrepancy, a 5 percent sample of the remaining376 charts was reviewed by two different persons, who were notblinded to each other's results. In this final review, 1 inconsistencywas noted among 4093 variables (0.02 percent). All inconsistencieswere resolved by consensus.
Information was recorded for each appointment at which screeningoccurred. The diagnostic impressions for both mammography andclinical breast examination were classified as normal; abnormaland probably benign; abnormal, indeterminate; or abnormal andarousing a suspicion of cancer. Recommendations for additionaltesting were recorded, including diagnostic mammography withinthe next 12 months or second-opinion review of the screeningfilms, ultrasound examination, physical examination (by theprimary care provider or a surgeon), and biopsy (including fine-needleaspiration, open, and core biopsies). Information was recordedon all diagnostic procedures and follow-up visits resultingfrom positive breast-cancer screening tests.
The computerized medical records, the HMO's tumor registry,and, if needed, the original paper copy of the test resultswere searched to identify incident cases of breast cancer. Inaddition, the study participants' records for two years aftercompletion of the study (from July 1, 1993, to June 30, 1995)were searched to be certain that all breast-cancer cases wereidentified.
Definitions of Screening Tests and False Positive Results
Mammography or clinical breast examinations performed on asymptomaticwomen without previously noted abnormalities were classifiedas screening tests. Mammography or clinical breast examinationsperformed because of abnormalities previously noted by cliniciansor patients were classified as diagnostic tests.
A false positive result was defined in a manner consistent withcurrent recommendations regarding mammography audits17,18,19and reported by other investigators.3,20,21,22 A test was classifiedas positive if the results were indeterminate or aroused a suspicionof cancer, or if there was a recommendation for nonroutine follow-up,including physical examination, diagnostic mammography withinthe next 12 months, ultrasound examination, or biopsy. A positivetest was classified as true positive if breast cancer (invasiveor ductal carcinoma in situ) was diagnosed in the patient onthe basis of pathological findings within one year of the test,and as false positive otherwise. False positive results wereindependent of each other.
Analysis and Assessment of Costs
The data were double-entered and verified for computer analysis.Initial comparisons were made with use of the chi-square testfor categorical data and Student's t-test or analysis of variancefor continuous data. Tests for trend were made with use of theMantelHaenszel chi-square statistic with one degree offreedom. These analyses were performed with SAS software.23
Estimates of the cumulative risk of having a false positivetest are based on a Bayesian version of a product or an estimateof the KaplanMeier type, in which screening events (mammographyor clinical breast examinations) are used instead of time (seeAppendix 1).
A current procedural and technical code24 was assigned to allworkups resulting from the breast-cancer screening. The nationalMedicare fee schedule25 and the average HMO payment were usedto estimate the average payment. Inpatient care was assigneda payment specific to the diagnosis-related group (see Appendix2).
Results
Characteristics of the Patients
Most of the 2400 women were white (75 percent); 11 percent wereblack, 3 percent were of other races, and 11 percent were ofunknown race. The median household income was $47,940 (range,$13,230 to $161,710). Eighteen percent of the women had a familyhistory of breast cancer recorded, and 28 percent used estrogen-replacementtherapy at some time during the study period.
Frequency of Breast-Cancer Screening
On average, the women underwent screening mammography and ascreening clinical breast examination every two years. A smallnumber of women (88 [3.7 percent]) had no documented breast-cancerscreening, either by clinical examination or by mammography,during the 10 years of the study.
Over the 10-year period, 9762 screening mammograms were obtainedfor 2227 women; 173 women (7.2 percent) underwent no screeningmammography. For those who had at least one mammogram, the mediannumber of mammograms obtained was four (range, one to nine).The mammograms were read by 93 radiologists at 28 radiologyfacilities, consisting of 17 community, 7 HMO, and 4 academicsites. Four radiologists each read more than 1000 mammograms,one radiologist read 624 mammograms, and the others each readfewer than 500 mammograms.
Also during these 10 years, 10,905 screening clinical breastexaminations were performed on 2245 women; 155 women (6.5 percent)had no screening breast examination. For those who had at least1 breast examination, the median number of examinations performedwas 5 (range, 1 to 16). The breast examinations were performedby 381 health care providers; 9290 were performed by internists,1385 by registered nurses, nurse practitioners, or physician'sassistants, 160 by obstetrician-gynecologists, 50 by surgeons,and 20 by providers with unknown credentials.
Detection of Cancer
Between July 1, 1983, and June 30, 1994, breast cancer was diagnosedin 88 women. The mean age of the women was 59 years (range,42 to 76). Local disease was present in 67 women, and regionaldisease in 21. Ductal carcinoma in situ was diagnosed in 15of the 88 women. In 58 women, the breast cancer was diagnosedas a result of an abnormality first noted on a screening mammogram(50 cancers were diagnosed within 12 months after mammographyand 8 after more than 12 months). In 7 women, the cancer wasdiagnosed as a result of a clinical breast examination (4 cancerswere diagnosed within 12 months after the breast examinationand 3 after more than 12 months). In the remaining 23 women,the cancers were diagnosed after the women themselves notedan abnormality and sought medical evaluation.
False Positive Results
False positive results occurred in 6.5 percent of the mammogramsand 3.7 percent of the clinical breast examinations (Table 1).Among the women who were screened, 23.8 percent had at leastone false positive mammogram and 13.4 percent had at least onefalse positive breast examination during the 10 years. A falsepositive test due to either type of screening was noted in 31.7percent of the women. In the majority of these women, therewas only one false positive result; 89 women had two or morefalse positive mammograms, 72 had two or more false positivebreast examinations, and 96 had false positive results on botha mammogram and a breast examination.
Table 1. False Positive Breast-Cancer Screening Tests over a 10-Year Period.
The percentage of screening mammograms that were false positiveincreased from 4.2 percent in the first three years (1983 to1986) to 6.1 percent (1986 to 1990) and 7.6 percent (1990 to1993) (P for trend = 0.001); however, the false positive ratevaried substantially according to year. The percentage of screeningclinical breast examinations with false positive results decreasedslightly over the same three periods, from 4.5 percent to 3.4percent to 3.5 percent (P = 0.08).
The false positive rates were higher for younger women thanfor older women (Table 2). The percentage of mammograms thatwere false positive decreased from 7.8 percent for women 40to 49 years of age to 4.4 percent for women 70 to 79 years ofage (P = 0.001). The false positive rate for clinical breastexamination was highest for women 40 to 49 years of age (6.0percent) and decreased to 2.2 percent for women 70 to 79 yearsof age (P = 0.001).
Table 2. Rate of False Positive Breast-Cancer Screening Tests According to the Age of the Woman at the Time of Screening.
Cumulative Risk of a False Positive Result
The risk of a woman's ever having a false positive result increasedas she underwent more screening. The estimated cumulative riskof having at least one false positive result after 10 screeningswas 49.1 percent (95 percent confidence interval, 40.3 to 64.1percent) for mammograms and 22.3 percent (95 percent confidenceinterval, 19.2 to 27.5 percent) for clinical breast examinations(Figure 1 and Figure 2).
Figure 1. A Woman's Estimated Risk of Having at Least One False Positive Screening Mammogram, According to the Total Number of Screening Mammograms Performed.
The numbers in parentheses are the numbers of women with at least that many mammograms. The I bars indicate 95 percent confidence intervals.
Figure 2. A Woman's Estimated Risk of Having at Least One False Positive Screening Clinical Breast Examination, According to the Total Number of Clinical Breast Examinations Performed.
The numbers in parentheses are the numbers of women with at least that many examinations. The I bars indicate 95 percent confidence intervals.
The cumulative risk of a false positive result was higher forwomen 40 to 49 years of age at the time of the test than forthose 50 to 79 years of age, for both mammography and clinicalbreast examination. For example, for women 40 to 49 years ofage the cumulative risk after 5 screening mammograms was 30.3percent (95 percent confidence interval, 23.9 to 39.4 percent)as compared with 23.8 percent (95 percent confidence interval,21.6 to 26.4 percent) among women who were 50 or older, andafter 10 screening mammograms it was 56.2 percent (95 percentconfidence interval, 39.5 to 75.8 percent) as compared with47.3 percent (95 percent confidence interval, 37.8 to 63.0 percent).For these two groups of women, the cumulative risk of a falsepositive clinical breast examination after 5 examinations was20.8 percent (95 percent confidence interval, 16.7 to 25.4 percent)in the women 40 to 49 years old, as compared with 11.1 percent(95 percent confidence interval, 9.4 to 13.2 percent) in theolder women, and after 10 examinations it was 34.1 percent (95percent confidence interval, 22.8 to 59.0 percent) as comparedwith 18.7 percent (95 percent confidence interval, 14.8 to 26.1percent).
Diagnostic Evaluations Performed
The relevant diagnostic evaluations performed within one yearof the false positive result are shown in Table 3. False positivemammograms led to more outpatient visits, diagnostic imagingexaminations, and biopsies than false positive clinical breastexaminations. In one patient, cellulitis requiring hospitalizationfor surgical débridement and intravenous antibiotic therapydeveloped after a biopsy prompted by a false positive mammogram.In addition to the workups shown in Table 3, we found documentationof 260 telephone calls to patients, 32 letters to patients,and 64 second opinions obtained from radiologists after falsepositive mammograms. These additional events were less commonafter false positive clinical breast examinations, which resultedin 23 telephone calls, 5 letters, and 9 second opinions fromradiologists.
Table 3. Diagnostic Workups Performed within One Year after the 631 False Positive Mammograms and the 402 False Positive Clinical Breast Examinations.
One hundred fourteen women (5.1 percent) had at least one documentedinvasive procedure (open, core, or fine-needle aspiration biopsy)within one year as a result of a false positive mammogram, afteran average of four screening mammograms. False positive clinicalbreast examinations led to biopsy in 45 women (2.0 percent),after an average of five examinations.
A woman's estimated cumulative risk of having at least one biopsy(open, core, or fine-needle aspiration biopsy) as a result ofa false positive test also increased with repeated screenings.The risk was 6.2 percent (95 percent confidence interval, 5.1to 7.3 percent) after 5 screening mammograms and 18.6 percent(95 percent confidence interval, 9.8 to 41.2 percent) after10 screening mammograms. For clinical breast examinations, therisk was 2.4 percent (95 percent confidence interval, 1.8 to3.2 percent) after 5 examinations and 6.2 percent (95 percentconfidence interval, 3.7 to 11.2 percent) after 10 examinations.
Cost of Diagnostic Evaluations
The payment allowances for the initial screenings (mammographyand clinical breast examinations) were $993,870 according toHMO payment-allowance estimates and $1,042,311 according toMedicare estimates. The payment allowances for the diagnosticworkups undertaken as a result of the false positive tests shownin Table 3 were $329,649 according to HMO estimates and $309,755according to Medicare payment allowances. The payment allowancesfor workups after false positive mammograms were three timesas high as those for workups after false positive clinical breastexaminations.
Discussion
On average, the women in this community-based cohort underwentbreast-cancer screening every two years. Over a 10-year period,the result in one third of these women required additional evaluationwhen no breast cancer was present. The risk of a false positivetest increased with the number of breast-cancer screening tests,so that by the time a woman had undergone 10 tests, the estimatedcumulative risk of at least one false positive mammogram wasabout 50 percent and the estimated cumulative risk of at leastone false positive breast examination was about 25 percent.
The HMO setting provided complete follow-up for each woman,and the computerized medical records allowed simplified dataextraction for a large, community-based cohort. Results in managed-carepopulations do not necessarily apply to other populations; however,our findings are likely to be applicable to other communities,since 93 different radiologists read the mammograms and 381different health care providers performed the clinical breastexaminations.
The cumulative risk of false positive results that we estimatedfrom community-based data is twice the risk estimated by Eddyin 1989.4 In addition, our estimates of the cumulative riskof false positive results for screening mammography may be low,because the overall percentage of abnormal screening mammogramsin our study was 6.5 percent, whereas the national rate is nearlytwice as high.3
Our definition of a false positive result is consistent withcurrent recommendations regarding mammography audits.17,18,19We classified as positive results all instances in which screeningmammograms were interpreted as indeterminate or as arousinga suspicion of cancer or in which additional workup was recommended.This definition, which has been used by others,3,20,21,22,26may be considered too broad. However, we found that even withthis definition of false positive results, some follow-up diagnosticprocedures were not counted. For example, five women who didnot have cancer had breast biopsies prompted by screening mammogramsthat were interpreted by the radiologist as "abnormalbenign"but with no specific recommendations made. These cases werenot included in our definition of a false positive test. Someauthors have calculated false positive rates by counting aspositive only impressions that led to breast biopsy.27 Whenthis definition was applied to our data, the estimated cumulativerisk of having at least one biopsy as a result of a false positivetest was 19 percent after 10 mammograms and 6 percent after10 clinical breast examinations.
We advocate a broad definition of false positive tests, becausein formulating policy for the delivery of health care, it isimportant to determine the type and cost of all follow-up procedures,not just breast biopsies. In addition, it is increasingly clearthat being told of an abnormal mammogram can cause increasedanxiety in women for extended periods, regardless of whethera biopsy is performed.5,6,7,8,9,10,11,12,13 In the United States,Lerman et al.10 found that three months after they had falsepositive results on mammography, 47 percent of women who hadhighly suspicious readings reported that they had substantialanxiety related to the mammogram, 41 percent reported that theyhad worries about breast cancer, 26 percent reported that theworry affected their daily mood, and 17 percent reported thatit affected their daily function.10 In Norway, 18 months afterscreening mammography, 29 percent of women with false positiveresults reported anxiety about breast cancer, as compared with13 percent of women with negative results.7 Two studies in Britainalso found that women with false positive mammograms had moreanxiety than those with normal mammograms.5,6
The standard definition of false positive tests in breast-cancerscreening uses a one-year cutoff date,17,18,19,20,27 so thatwomen without a diagnosis of breast cancer in the 12 monthsafter a positive test are counted as having had false positivetests. However, a patient's actual clinical course does notalways fit into the one-year period. In our study, eight breastcancers were diagnosed after a series of evaluations that tooklonger than one year after a positive mammogram. This situationcan arise when a radiologist recommends follow-up mammography,which is then repeated for several six-month periods beforethe diagnosis is made. Similarly, three breast cancers werediagnosed more than 12 months after positive clinical breastexaminations. If the cutoff date were changed to two years,the false positive rates we reported would change very little;the number of false positive mammograms would decrease from631 to 624, and the number of false positive clinical breastexaminations would decrease from 402 to 397.
Abnormal mammographic readings are more common in the UnitedStates than in other countries (for example, in the United Statesapproximately 11 percent of mammograms are read as abnormal,as compared with 2 to 5 percent in Sweden), whereas the sensitivityis about the same.2,3 The possibility that radiologists in theUnited States are interpreting too many mammograms as abnormalshould be investigated. Little is known about the accuracy ofclinical breast examinations in a community setting, despitethe fact that these examinations are recommended for all womenover the age of 40.28
The cost of working up patients with false positive resultsin this study was approximately one third the cost of performingthe screening. The costs of evaluating women with false positivemammograms in the Stockholm randomized clinical trial were aboutone fourth of the costs of the initial screening.26
If our rates are representative, the number of breast-cancerscreenings in the United States in which abnormalities are notedthat require additional testing in women who do not have cancermay be substantial. For example, if 32 million American womenwho are 40 to 79 years old received breast-cancer screeningannually for 10 years, 16 million women would have at leastone false positive mammogram and 7 million would have at leastone false positive clinical breast examination.
This study was a retrospective review, and therefore some missingdata were inevitable. However, because we required all patientsto be enrolled for at least two years beyond the study periodand we searched for data from multiple sources, we are confidentwe did not misclassify the breast-cancer status of patientswith abnormal test results. The sensitivity of breast-cancerscreening cannot be calculated from these data, because eligibilityfor the study was confined to women enrolled continuously inthe HMO for 12 years. Women who died during the study period(some of whom may have died of advanced breast cancer) weretherefore ineligible. Exclusion of these women may have ledto an artificial lowering of the stage of the breast cancersnoted. It is theoretically possible that women might have quitthe health plan because they had false positive breast-cancerscreening results; these women would also not have been eligiblefor the study.
Although much is known about breast-cancer screening from randomizedclinical trials and academic settings, little information isavailable about the effect of repeated breast-cancer screeningon women in a community setting. This study indicates that weneed to develop ways to reduce the false positive rates of breast-cancerscreening and their associated psychological and economic costs.One possibility for reducing the psychological sequelae is touse on-site radiologists to obtain immediate workups insteadof requiring women to return for follow-up. In the meantime,women should be educated about their chances of having an abnormalitynoted on breast-cancer screening tests, and health care providersshould be trained to deal with positive results when they occur.
Supported by a Research Development Grant from the Yale ClaudePepper Aging Center (to Dr. Elmore), the American Cancer Society(to Dr. Elmore), a Robert Wood Johnson Generalist Faculty ScholarAward (to Dr. Elmore), and the Harvard Pilgrim Health Care Foundation(to Drs. Barton and Fletcher).
We are indebted to Ms. Rhoda Demiany-Pahl for assistance indata abstraction; to H. Gilbert Welch, M.D., John Grabowski,Pamela Okura, Thomas S. Inui, M.D., and Eric Larson, M.D., fortheir suggestions; to Heidi Lowrey and Margaret Oppenheimerfor assistance in the preparation of the manuscript; and toAlan Gelfand, Ph.D., and Fei Wang, who developed the Bayesianmodeling and conducted the analysis.
Source Information
From the Departments of Medicine (J.G.E.) and Epidemiology (J.G.E., V.M.M.), University of Washington School of Medicine, Seattle; and the Departments of Ambulatory Care and Prevention (M.B.B., S.P., S.W.F.) and Diagnostic Radiology (P.J.A.), Harvard Pilgrim Health Care and Harvard Medical School, Boston. Presented in part at the national meeting of the Society of General Internal Medicine, Washington, D.C., May 13, 1997.
Address reprint requests to Dr. Elmore at the Division of General Internal Medicine, University of Washington School of Medicine, 1959 N.E. Pacific, Rm. BB527E, Box 356429, Seattle, WA 98195-6429.
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Appendix
Appendix 1. The Bayesian Model Used to Estimate the CumulativeRisk of a False Positive Result
The cumulative risk of a false positive result is estimatedby using a Bayesian version of an estimator of the product orKaplanMeier type in which the number of screening events(mammography or clinical breast examinations) is used insteadof time. For the i th subject in the study, we define Wi asthe "time," measured by the number of screenings, until thefirst false positive result. That is, Wi = j if her first j-1tests were negative and a false positive result occurred atthe j th screening. If the i th subject had a total of ki screeningsduring the study, with none of them false positive, we denotethis by Wi >ki. Then
We define the cumulative risk of a false positive test as asequence of probabilities. In particular, we let pj denote theprobability of at lease one false positive test within the firstj screenings. Then
where K is the largest number of screenings observed for anysubject in the study, rl is the observed number of women withat least l screenings and no false positive result for the firstl -1 of them, and sl is the number of women with at least lscreenings and no false positive results of these screenings.A priori, we assume that the unknown ql values for both mammographyand clinical breast examination arise independently from a beta(0.6,9.4) distribution. This distribution reflects the prior knowledgethat about 6 percent of tests are false positive, but allowsa high degree of imprecision (standard deviation, 7 percent).The resulting estimator (posterior mean) of ql is
The estimates of pj can be plotted against j to display theestimated cumulative risk graphically. By using simulation,95 percent equal-tail-interval estimates may be assigned toeach pj, providing confidence bands for the cumulative-riskcurve.
Appendix 2. The 1997 Medicare Payment Allowance and the 1995HMO Average Payment Used to Estimate Costs
The values used to estimate the total costs of breast-cancerscreening and the evaluations performed after false positiveresults are shown below. Current procedural and technical codes(CPT) and, if applicable, ambulatory-surgical-center (ASC) paymentlevels were assigned for each procedure. The relative-valueunits for each CPT code were multiplied by $36. No costs wereassessed for the documented telephone calls and letters notedafter the false positive tests.
False Positive Rate of Screening Mammography
Olivotto I. A., Kan L., Coldman A. J., Paci E., Giorgi D., del Turco M. R., Roux S., Markle L., Diamond A., Sickles E. A., Fishbein M., Gross T. L., Kopans D. B., Feig S. A., Elmore J. G., Barton M. B., Arena P. J., Sox H. C.
Extract |
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N Engl J Med 1998;
339:560-564, Aug 20, 1998.
Correspondence
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