Articles

LETTERS TO THE EDITORS

Verification of a Decision Analytic Model Assumption Using Real-world Practice Data: Implications for the Cost Effectiveness of Cyclo-oxygenase 2 Inhibitors (COX-2s)

The Centers for Disease Control and Prevention project that within the next 10 years cancer will replace cardiovascular disease as the number one cause of death in the United States. Currently, malignant neoplasms are the leading cause of death in individuals under the age of 75, and they are responsible for more deaths in those aged 45-64 years than the next 3 leading causes (heart disease, accidents, and stroke) combined.

 Although cardiovascular mortality has declined by almost 60% since 1950, no appreciable decreases in cancer mortality have been achieved over the same time period. 

A Multi-Faceted Approach to Reducing Cancer Mortality Is Needed

The bulk of resources devoted to cancer research is expended on either basic science efforts to better understand why cancer occurs or on the development of effective treatments for a specific neoplasm once it arises. Indeed, when considering the cancer research enterprise (often referred to as the "War Against Cancer"), attention is too often focused on the latest "cure" for cancer or on the most recent basic science breakthrough regarding tumor genesis. These sophisticated and expensive research efforts, while extremely worthwhile, are only part of the multi-pronged approach required to decrease cancer-related mortality. Despite the extensive focus on molecular genetics and cancer therapeutics, one can argue that the return on investment on the billions of dollars spent thus far has not been very robust. 

Prevention and early detection of premalignant states of more readily treatable cancerous lesions are a crucial component in a comprehensive strategy to effectively battle cancer. Cancer prevention can likely be achieved for many common cancers with lifestyle choices (eg, smoking cessation, improved diet, and more regular exercise). As the widely publicized obesity epidemic indicates, changing lifestyle for the better is extremely difficult and is unlikely to be achieved in the near future. Cancer chemoprevention, an area of intense investigation but with few proven interventions, may someday play a pivotal role in diminishing cancer risk and mortality. But until we can reliably prevent cancer, more attention should be paid to increasing adherence to those cancer-screening interventions that have been convincingly demonstrated to produce meaningful clinical benefits. It is evident that an aggressive strategy to enhance early detection of malignant or premalignant lesions has real potential to bring about meaningful reductions in the burden of cancer. 

Despite rigorous evidence demonstrating life-saving potential, national surveys reveal that there is systematic underutilization of screening interventions.

 Moreover, even for those willing to participate in screening, there is a wide variance in acceptance rates among proven screening tests. For example, rates of colorectal cancer screening among American women lag compared to breast and cervical cancer screening rates, despite a proven decrease in mortality from colon cancer screening.

Improving Adherence With Cancer Screening: The Role of Managed Care Organizations 

In a recent meta-analysis conducted by Stone, et al, the authors review interventions directed at improving breast, cervical, and colon cancer screening services, and found that organizational change (ie, establishing a separate clinic devoted to screening and prevention activities, using planned care visits for prevention, and designating nursing or clerical staff to arrange a physician visit or to identify patients in need of prevention services) consistently increased utilization of cancer screening services when compared with physiciandirected and patient-directed interventions.

 In addition, the authors demonstrated that coupling education about a "less effective" intervention while a patient underwent treatment for a more accepted therapy produced positive effects. In this issue of the Journal, the articles by Goldzweig et al and Klabunde et al add to this research by evaluating organizational components that enhanced screening for breast, cervical, and colorectal cancers.

 Like Stone et al, these authors also found that interventions directed at the level of the patient (eg, financial incentives, reminders, and education) had modest success. These latest studies suggest that health systems have substantial opportunities to independently enhance adherence with these potentially life-saving interventions. If, as Stone suggests, the acceptance of a less effective yet proven intervention can be improved by coupling it with education around a better accepted intervention, we may have a golden opportunity to advance patient education and increase screening rates. 

For example, a woman may diligently undergo breast cancer screening after her mother is diagnosed with breast cancer. Her mother's cancer diagnosis represents a teachable moment, which has been described as a naturally occurring life or health event thought to motivate individuals to spontaneously adopt risk-reducing health behaviors.

 The teachable moment has been extensively evaluated in smoking cessation interventions. A systematic review by McBride on smoking cessation proposed office visits, notification of abnormal test results, hospitalization, and disease diagnosis as opportune times to provide patient education and perhaps fundamentally shift patient thinking and behavior. The authors demonstrated relatively high cessation rates after these types of teachable moments versus an untimed formal intervention. 

Many reasons can explain why an individual may not elect to undergo cancer screening. For example, doctors may not routinely recommend screening; patients may have an inadequate understanding of the health benefits screening provides; or patients might wrestle with the psychological dread of the specific procedures. These factors have been identified as potential barriers to adherence with cancer screening. Educational efforts alone, such as informational brochures, phone calls, or videos, when distributed in a non-cancer screening setting, only modestly improve cancer screening.

 In light of the modest success in non-cancer clinical settings, we believe that providing education during a screening teachable moment will likely increase the acceptance rates of underused screening tests. The effects can be significant since most Americans receive at least 1 cancer screening intervention, and many get repeated tests for this one type of cancer but neglect to be screened for other types of cancers. For women, well-accepted cancer screening tests, such as screening mammography or Pap smear, represent potential teachable moments for providing general cancer education designed to improve overall knowledge of cancer screening and to address specific psychosocial concerns. 

Cancer develops along a continuum. Screening interventions designed to decrease cancer-related morbidity and mortality target different time points in the evolution of the cancerous lesion. At one end of this continuum is prevention, but this preferred extreme is most difficult to achieve. At the other end is treatment - which occurs after neoplasm has already developed and is often diagnosed at a stage of disease less amenable to effective therapy. In the middle of the continuum is screening - screening for treatable malignant (or better yet, premalignant) disease. Despite strong evidence showing significant mortality reductions due to cancer screening, acceptance of these procedures is suboptimal. But as our experience with breast, cervical, and prostate cancer screening has shown, screening programs can gain widespread public acceptance. In the case of breast cancer, annual screening on a national level reaches over 80%; rates of colorectal cancer screening among women are approximately half that. As noted, many women undergo multiple repeated testing for one disease and completely neglect screening tests for other treatable cancers. Since most would agree that the first test for a particular disease (assesses prevalence) will often provide more benefit than the second test for the same disease (assesses incidence), greater emphasis on at minimum, initial testing for multiple conditions is likely to maximize the benefits of screening. It is our view (and a question that should be answered empirically) that the use of a commonly accepted event, such as mammography, can be a teachable moment having great potential to elevate screening rates of other less widely accepted, but proven interventions, such as colon cancer screening. 

Managed care organizations and clinicians accept the clinical and economic benefits of early cancer detection and prevention and encourage their use. Since most Americans undergo one health screening intervention, health systems should give strong consideration to using these "teachable moments" to educate and motivate their patients to increase participation in underused yet potentially life-saving interventions.

From the Departments of Radiology (RCC) and Internal Medicine (AMF), the University of Michigan, Ann Arbor, MI. 

Address correspondence to: Ruth C. Carlos, MD, MS, Department of Radiology, Radiology B2B311B UH #0030, Ann Arbor, MI 48109. E-mail: 

1. National Center for Health Statistics.

 Health, United States 2003, with chartbook on trends in the health of Americans. Hyattsville, Md; 2003.

From the Centers for Disease Control and Prevention: Colorectal cancer test use among persons aged 

3. Nelson DE, Bolen J, Marcus S, Wells HE, Meissner H. 

Cancer screening estimates for US metropolitan areas. 

4. Selby JV, Friedman GD, Quesenberry CP Jr, Weiss NS. 

A case-control study of screening sigmoidoscopy and mortality from colorectal cancer. 

5. Stone EG, Morton SC, Hulscher ME, et al. 

Interventions that increase use of adult immunization and cancer screening services: a meta-analysis. 

6. Goldzweig CL, Washington DL, Lanto AB, Parkerton PH, Yano EM. 

Primary care practice and facility quality orientation: influence on breast and cervical cancer screening rates. 

7. Klabunde CN, Riley GF, Mandelson MT, Frame PS, Brown ML.

Health plan policies and programs for colorectal cancer screening: a national profile. 

8. McBride CM, Scholes D, Grothaus LC, Curry SJ, Ludman E, Albright J. 

Evaluation of a minimal self-help smoking cessation intervention following cervical cancer screening. 

Videotape-based decision aid for colon cancer screening: a randomized, controlled trial. 

EDITORIAL

Improving Cancer Screening Adherence: Using the "Teachable Moment" as a Delivery Setting for Educational Interventions

 To use a national population-based automatedclaims database to study the testing rate, prevalence, and prescribingpatterns for chronic hepatitis C.

 A retrospective descriptive study that analyzesmedical and pharmacy automated claims from affiliated healthplans in 4 regions of the United States.

 Data were collected from 11 UnitedHealth Groupâ€“affiliated health plans (3.9 million members) from January 1, 1997,to December 31, 1999. Medical claims were used to identify personstested for hepatitis C virus (HCV). Persons with chronic HCVwere identified through medical and pharmacy claims. Patterns ofdrug use and treatment were analyzed, including prescribingphysician specialty and proportion of patients receiving baselineand follow-up testing.

 Of 27 871 members tested for HCV (0.7%), 1869(6.7%) were diagnosed as having chronic HCV. Tested patientswere more likely to be female (odds ratio [OR], 1.1) and older (&#8805;25years; OR, 4.1). Of 3259 patients with HCV, most were male (OR,1.8) and older (&#8805;25 years; OR, 32.0). Of these patients, 33.6% (n =670) of men and 25.2% (n = 319) of women received treatment.Combination therapy users were more likely to undergo baseline(OR, 4.8) and follow-up (OR, 6.2) testing compared with interferonalfa monotherapy users.

 Of the total population, 0.7% were tested forHCV, of whom 6.7% were diagnosed as having chronic HCV.Although women were more likely to undergo testing, prevalenceand therapy rates for chronic HCV were higher in men. Mostpatients did not receive recommended baseline and follow-up testing,and the approximate 30% therapy rate suggested that manypatients with HCV remain untreated.

During the past 2 decades, hepatitis C virus (HCV)has been recognized as a silent epidemic and anemerging public health threat.

 Estimates bythe Centers for Disease Control and Prevention suggestthat approximately 4 million persons in the UnitedStates are infected with HCV.

 Many have not beendiagnosed, because fewer than 20% are symptomatic

 Chronic HCV infectionis the leading cause of liver transplantation in theUnited States and Europe.

 Hepatitis C virus also mayaccount for a 2-fold increase in the incidence of hepatocellularcarcinoma between 1975 and 1998.

 The totalsocietal cost estimates may be as high as $600 millionper year in the United States.

Most of the prevalence data on hepatitis C in theUnited States are derived from the National Health andNutrition Examination Study (NHANES) study, whichwas a survey of noninstitutionalized civilians carriedout between 1988 and 1994. The prevalence of anti-HCV was 1.8%, indicating that there were 3.9 millionpersons infected with HCV, of whom 2.7 million hadchronic infection.

 Prevalence rates vary according tothe population studied. A San Francisco VeteransAdministration medical center study

 of more than1000 patients indicated an anti-HCV prevalence of 18%,while another study

 of homeless veterans suggested anHCV prevalence of 42%. The global prevalence of anti-HCV is estimated at 2.9%, with lower prevalence ratesnoted in Western Europe, Australia, and SoutheastAsia.

 set a goal of decreasingthe prevalence of this virus from 18.3 per 100 000 personsin 1987 to 13.7 per 100 000 persons in 2000.

 specifies the additional goal ofreducing new cases of HCV from 2.4 per 100 000 personsin 1996 to 1 per 100 000 persons in 2010.

Managed care organizations (MCOs) are key sites forsurveillance of the prevalence and treatment of HCV forseveral reasons. First, healthcare delivery has increasinglyshifted from the public sector to private healthcaresystems through MCOs. Second, the age group most frequentlydiagnosed as having HCV, ages 30 to 49 years, islikely to be employed and covered by employer-insuredhealthcare. Approximately 93% of privately insured personsreceiving coverage from their employer are enrolledin managed care.

 Third, a national MCO setting provides population-based automated data to determine theprevalence and treatment pattern of HCV in the generalmedical community. Previous studies have focused onselect regional practices, rather than a broader comparisonacross several geographic areas.

 In addition, mostof the published literature on the treatment of HCV summarizesclinical trials that may not reflect treatment patternsin the general medical community.

The objectives of this retrospective population-basedadministrative claims study were to determine theprevalence of chronic HCV infection in a national MCOby age, sex, geographic region, and insurance type; toquantify the rate of testing for HCV in a national MCOby these same factors; and to characterize the prescribingof medications for HCV, including patterns of druguse and treatment.

Employer-insured and Medicaid-covered populationsof 11 geographically diverse health plans affiliated withUnitedHealth Group were included in this study. These11 plans, with 3.9 million persons enrolled fromJanuary 1, 1997 to December 31, 1999, were located inthe following geographic regions: Midwest (6 plans, 2.1million enrollees), Southeast (3 plans, 1.1 millionenrollees), Northeast (1 plan, 450 000 enrollees), andWest (1 plan, 326 000 enrollees). The plans were mostlyindependent practice association models, contractingwith large networks of physicians typically reimbursedon a discounted fee-for-service basis.

UnitedHealth Group maintains longitudinally linkedcomputerized claims research databases.

 The dataused in this study include enrollment files with demographics,outpatient pharmacy claims, and physicianand facility claims. The prescription claims databasecontains information on prescription drugs dispensed tohealth plan members in the ambulatory care settingfrom retail pharmacies. Employer-insured members paida higher copayment for brand drugs compared withgeneric equivalents. Medications not on the PreferredDrug List were available to enrollees for a higher copayment.Physician claims include services provided byphysicians and other health care providers on an outpatientbasis (including laboratory tests), whereas hospitaland other facility claims include emergency care andinpatient services provided to health plan members.

Analyses were conducted in the aggregate and bygeographic region. Patient confidentiality was preservedbecause the files used for the study analyses did notcontain patient-specific identifiers. An independentinstitutional review board approved this study.

During the 3-year study, outpatient physician andfacility claims were used to identify members whounderwent testing for HCV, using HCV antibody andHCV RNA tests. Hepatitis C testing was defined as atleast 1 outpatient claim with a 

 procedure code for 1 or more ofthe following: (1) hepatitis C antibody test (86803); (2)hepatitis panel (80059) that includes hepatitis A, B, andC antibody tests; (3) hepatitis C confirmatory test(86804); or (4) HCV RNA test (87520, 87521, or 87522)used to confirm active infection and monitor diseaseprogression during drug therapy. Laboratory tests frominpatient facility claims were not included in the studybecause they could not reliably identify tests for HCV,as they are bundled under hospital billing codes. Therate of HCV testing by age, sex, geographic region, andinsurance type (employer-insured vs Medicaid) was calculated,using each health plan's enrollee population asa denominator.

InternationalClassification of Diseases, Ninth Revision (ICD-9)

A combination of physician, facility, and pharmacyclaims files was screened during the study to identifyhealth plan members with chronic HCV, defined as havingat least 1 primary or secondary 

 diagnosiscode for chronic HCV (070.44 or 070.54) or at least 1prescription for interferon in combination with ribavirin.The prevalence rate of chronic hepatitis C by age group,sex, geographic region, and insurance type was calculatedusing enrollee population as a denominator.

The automated outpatient pharmacy claims ofpatients with chronic HCV were screened to determinethe proportion of patients receiving interferon monotherapy,combination interferon alfa-2b and ribavirintherapy, or no treatment. The following types of interferonwere included: interferon alfa-2a, interferon alfa-2b, interferon alfacon-1, and interferon alfa-n3.Interferons commonly used for the treatment of conditionsother than hepatitis C, such as multiple sclerosis,were excluded from this study (eg, interferon beta-1a,interferon beta-1b, and interferon gamma-1b). The percentagesof patients with interferon claims alone(monotherapy users), combination therapy claimsalone (combination therapy), or both interferon andcombination therapy claims (both) were calculated.The specialty type of the prescribing physician was alsodetermined based on the pharmacy claims.

Further analyses of drug treatment patterns, includingduration of treatment and baseline and follow-uptesting, were completed on a subset of patients meetingcertain criteria. First, patients had to be "new users" ofthese medications. A patient was considered a new userif he or she had no prescriptions for interferon or combinationtherapy during the 3 months before the firstprescription (index date). For some patients, a break intherapy of at least 3 months' duration may signify thestart of a new course of therapy. Second, new users hadto be continuously enrolled in the health plan, with nogap in enrollment greater than 32 days from at least 3months before the index date through 6 months afterthe index date (a minimum of 9 months' continuousenrollment). These additional criteria allowed forappropriate standardized comparisons across treatmentgroups because patients had to be enrolled at least 9months and were new users (of these medications).Duration of therapy was determined by calculating thenumber of months between the patient's first and lastprescriptions and then adding the days' supply amountof the final prescription.

Pharmacy claims were analyzed to determinewhether recommended guidelines for monitoring theresponse to drug therapy were followed. We determinedif a patient received a baseline HCV RNA (CPT codes,87520, 87521, or 87522) or alanine aminotransferase(CPT codes, 84460, 80058, or 80012-80019) test beforeinitiating treatment with interferon alone or combinationtherapy. In addition, we identified whether apatient received follow-up testing within the first 6months following treatment initiation.

Data were analyzed using the Statistical AnalysisSystem program (SAS Institute Inc, Cary, NC). Rates ofchronic HCV and testing for HCV were calculated.Logistic regression analyses were conducted to evaluatethe effects of sex, age, geographic region, and insurancetype on the prevalence of chronic HCV and testing forthe disease. For the subset of patients receiving drugtherapy for chronic HCV, differences in the rates ofbaseline and follow-up testing also were examined.

Of 3.9 million members, 27 871 (0.7%) were tested forHCV (

). More than half of those tested (53.3%)were female (n = 14 849). Women had a higher overalltesting rate (74.8%) than men (66.6%), 1.08; 95% confidenceinterval [CI], 1.05-1.10) (

). Testing ratesincreased with age from 119 per 100 000 for childrenyounger than 18 years of age, to 1461 per 100 000 forthe group aged 55 to 64 years. As expected, patients 25years or older were more likely than younger patients toundergo testing for HCV(OR, 4.1; 95% CI, 4.0-4.3).The Northeast region hadthe highest testing rate(1582/100 000), and theWest had the lowest(497/100 000). Comparedwith the Midwest region,patients in the Northeastwere significantly morelikely to undergo testing(OR, 2.5; 95% CI, 2.4-2.6).Medicaid beneficiaries hada higher rate of testing(917/100 000) comparedwith employer-insuredmembers (696/100 000)(OR, 1.6; 95% CI, 1.5-1.7).Of the patients who underwenttesting for HCV, 6.7%(n = 1869) had a claimsdiagnosis for chronic HCV.Whereas the testing ratewas higher for women,patients who were testedand diagnosed with chronic HCV were more likely to bemale (61.7% of those tested and diagnosed).

Across the 11 health plans, 3259 members (0.08% ofthe total population) were identified as having chronicHCV based on the diagnosis codes in claims data(Table). Of these, 38.8% (n = 1265) were female. Asshown in 

, the rate of chronic HCV was 64 per100 000 for women and 102 for 100 000 for men. Menwere significantly more likely to have a diagnosis codefor chronic HCV compared with women (OR, 1.76; 95%CI, 1.64-1.89). The group aged 45 to 54 years had thehighest observed prevalence rate of chronic HCV infection(277 per 100 000), followed by the group aged 35 to44 years (190/100 000). Persons younger than 25 yearshad the lowest disease prevalence (13/100 000). Thosediagnosed with chronic HCV tended to be 25 years orolder (OR, 32.0; 95% CI, 26.3-39.0). Compared with theMidwest, the Northeast region had the highest rate ofchronic HCV based on claims diagnosis codes(127/100 000) (OR, 1.6; 95% CI, 1.4-1.7). Overall,Medicaid beneficiaries had a higher rate of chronic HCVthan employer-insured members (OR, 4.3; 95% CI, 3.8-4.9), based on claims data.

Of 3259 patients with chronic HCV, 989 (30.3%)received treatment during the 3-year study. Approximately33.6% (n = 670) of men and 25.2% (n = 319) ofwomen underwent drug therapy for HCV. Most treatedpatients (67.7%) were men. The highest rate of treatedpatients was in the Northeast region (35/100 000) andthe lowest in the West (13/100 000). Of those whoreceived treatment, 22.3% were prescribed interferonmonotherapy, 58.0% were prescribed combination therapy,and 19.6% both therapies. Approximately 62.5% ofprescriptions for these medications were written by gastroenterologists,15.3% by primary care physicians, and12.7% by other specialists, including oncologists (5.2%),infectious disease specialists (3.6%), and hematologists(1.3%). A further 9.4% of prescriptions were obtained atfacilities such as hospitals, emergency departments, andurgent care centers.

Of the 989 patients with chronic HCV who underwenttreatment, 704 (71.2%) met the new user criteria(no treatment in the 3 months before the index date)and had continuous enrollment of at least 9 months.Subsequent analyses were conducted on this subset ofpatients, including duration of drug therapy and baselineand follow-up testing.

Of the 704 new users, 57.0% (n = 401) were combinationtherapy users, 22.9% (n = 161) were interferonmonotherapy users, and 20.2% (n = 142) received both.Of the 142 users of both, 78.9% (n = 112) were initiallyprescribed interferon monotherapy, and 21.1% (n = 30)initially received combination therapy. This suggeststhat many patients who received combination therapywere likely to have failed interferon monotherapy first.

As expected, duration of treatment was shorter forpatients who received combination therapy only (median,5 months; range, <1 to 24 months) than for those whoreceived interferon monotherapy (median, 7 months;range, <1 to 32 months). Patients filling prescriptions forboth interferon and combination therapy had the longestduration of treatment (median, 14 months; range, 2-37months), with 53.5% (76/142) taking more than 1 year tocomplete the course of treatment for both therapies.

Of combination therapy users, 64.8% (260/401) completedthe standard 6-month therapy regimen within 6months, while 75.8% (122/161) of interferon monotherapyusers completed the standard 12-month therapy regimenwithin 12 months. These criteria are based on therecommended course of therapy. The proportion of treatedpatients who discontinued therapy within the first3 months was 28.2% (113/401) for combination therapyusers and 19.9% (32/161) for interferon monotherapyusers. Although it is likely that these patientsdiscontinued therapy because of nonresponse, we cannotbe certain of this based on the claims data alone.

Of the 704 persons who received treatment forchronic HCV, 454 (64.5%) had a claim for baseline RNAor alanine aminotransferase testing before beginningdrug therapy. 

 shows the percentage of patientsundergoing baseline testing by type of drug treatment(interferon monotherapy, combination therapy, orboth). Of 161 interferon-only users, 44.1% (n = 71)received baseline testing, compared with 78.3%(314/401) of combination therapy—only users. Only6.2% (10/161) of interferon-only users received an RNAtest and an alanine aminotransferase test, comparedwith 34.7% (139/401) of combination therapy users.The likelihood of receiving a baseline test was associatedwith the type of drug a patient was prescribed. Combinationtherapy users were significantly more likelythan interferon monotherapy users to receive a baselinetest (OR, 4.8; 95% CI, 3.2-7.2). Approximately 87% of allbaseline testing occurred between the ages of 35 and 54years, with the group aged 45 to 54 years having thehighest rate of baseline testing (44/100 000), followedby the group aged 35 to 44 years (27/100 000). Patients25 years or older also were more likely to get a baselinetest than younger patients (OR, 13.3; 95% CI, 2.7-65.0).No differences were found with respect to sex, geographicregion, or insurance type.

Overall, 32.5% (229/704) of patients receivedan RNA test within the first 6 months of treatment.For combination therapy—only users, thispercentage was higher at 41.6% (167/401),compared with 10.6% (17/161) for interferononlyusers. Combination therapy users alsowere significantly more likely to receive followuptesting compared with interferon monotherapyusers (OR, 6.2; 95% CI, 3.6-10.7). Nodifferences were found with respect to age, sex,geographic region, or insurance type.

Despite a significant decline in the incidenceof HCV infection during the pastdecade, morbidity and mortality amongpatients with chronic HCV will continue torise during the next 10 to 20 years, resulting ina substantial societal health and economic burden.

The cost of treating chronic liver disease from HCV willfall, in large part, on MCOs.

 Although research suggeststhat standard interferon and ribavirin combinationtherapies are cost effective,

 we found thatapproximately 70% of patients infected with HCV didnot receive antiviral therapy. This may have significantimplications for the economic burden during the next10 to 20 years. Many of these patients are likely to haveasymptomatic disease, which may also explain theirlow referral rate for treatment. Assuming a 20% referralfor treatment, a previous analysis of HCV screening inaverage-risk, asymptomatic patients was found not tobe cost effective.

 An increased referral pattern fortreatment and a higher disease progression mayimprove the cost-effectiveness ratio of screening.However, the approximate 30% treatment rate in ourstudy may still not be enough to show a cost benefit forscreening. In our study, men had a greater overallincidence of chronic HCV infection and were morelikely to receive drug therapy. Women, however, had ahigher rate of diagnostic testing. This suggests the needto promote awareness of risk factors to increasescreening for high-risk men in MCOs. In general, treatmentis cost effective, and although screening shouldbe reserved for patients at high risk, there is a need toincrease rates of referral for treatment.

The rate of treatment monitoring varied by the typeof drug therapy at baseline and during follow-up. Abouttwo thirds of patients treated for HCV had a claim forbaseline RNA or alanine aminotransferase testing, witha higher rate of testing for combination therapy (78.3%)than for interferon monotherapy (44.1%). The recommendationfor HCV RNA monitoring within 6 monthsof initiating therapy was followed only one third of thetime, again with a higher rate for combination therapy(41.6%) than for interferon monotherapy (10.6%).These findings suggest that increases in the rate of baselinetesting are needed and an even greater need existsto improve the rate of follow-up testing. This was especiallyevident for interferon monotherapy, althoughhigher rates of monitoring for the newer combinationtherapy suggest a trend toward increased rates of testing.

It is difficult to gauge how different our results wouldbe if our study included the current standard of carewith the combination of pegylated interferon and ribavirintherapy. The pegylated interferons were notavailable outside the clinical trial setting during ourstudy. There may have been an increased referral fortreatment due to the incremental benefits in terms ofsustained virologic response for the pegylated interferonand ribavirin therapy. If our study had been moved forwardby 18 months, the proportion of patients receivinginterferon monotherapy would have been expected todecline. Furthermore, we would have expected a higherproportion of patients to receive baseline HCV RNAtesting before initiation of combination therapy, as thisis an important predictor of response.

Several interesting patterns emerged regarding HCVsurveillance and treatment. With respect to geographiccomparisons, the health plan with the greatest testingrate also had the highest rate of HCV (Northeast),defined by claims for diagnosis or drug therapy. Thisunderscores the importance of testing to identify HCVand the need to provide subsequent treatment. In general,we found a greater prevalence of HCV in theMedicaid-covered population than among employerinsuredenrollees. Possible reasons may include a higherrate of injection drug use among the unemployed andpoor, as well as comorbid associations such as humanimmunodeficiency virus and alcohol use, which mayworsen liver injury and prompt earlier testing in thispopulation. However, many cases of HCV infection aredetected incidentally during routine health screening,when minor abnormalities of liver enzyme test resultsmay prompt further investigations.

There are few studies of healthcare delivery topatients with HCV, and most of the interest appears tolie with optimizing current treatment regimens andresponse outcomes.

 A multidisciplinary approach isrequired to ensure adequate healthcare delivery andadherence to therapy. This requires the combinedefforts of healthcare providers such as the treatingphysician and assistants, psychiatrists, social workers,nurses, pharmacists, and other support care staff. Ourstudy indicated that many of the prescriptions werewritten by nongastroenterologists, and better educationamong primary care physicians regarding risk factorsmay lead to more appropriate HCV testing practices andsubsequent referral for treatment. However, there is discordanceregarding appropriateness of therapy for HCVinfection even among hepatologists.

 There is anonuniform practice of HCV testing and educationamong drug treatment programs. A significant proportionof these programs did not test for HCV, and residentialdrug-free programs were more likely to providebetter education and testing for HCV compared withoutpatient-based services.

 This may relate to differencesin available resources and more favorable patient-staffratios. There is a need to enhance healthcaredelivery systems to create a better link with screeningand referral patterns in the community setting.

Because our study is large and US population—based,covering different geographic locations, it summarizesinformation on HCV surveillance through testing andtreatment using an extensive automated claims database.Denominators are available through enrollmentfiles, allowing calculation of rates of testing and prevalenceof HCV infection using claims data. In addition,we are able to link patient characteristics and healthservices use across sites of care to provide a longitudinalperspective and use patterns of therapies. Mostimportant, we can estimate treatment patterns of HCVin the general medical community, in contrast to clinicaltrials conducted with a subset of the patient populationin tertiary and specialty centers. Analyzing testingpatterns, we also can compare actual clinical practicewith recommended guidelines.

As with any study based on administrative claimsdata, there are certain inherent limitations. We mayhave underestimated testing and prevalence becauseeach was claims-based and required the submission of abill for payment. Because providers were paid only aftersubmission of a bill, it is likely that this information iscomplete. Claims for nonparticipating providers also areincluded in the automated database. However, if a testwas conducted or a drug prescribed outside the managedcare system and not submitted, this informationwould not be available. For patients who may have beentested or received a diagnosis of HCV before enrollmentin this setting, such information also would not be partof the claims files. Therefore, although the rates of testingand treatment may be underestimated, comparativerates across subgroups should be accurate (such ascomparisons by sex or age group). Our method of classifyingpatients as having chronic HCV may overestimatethe number of patients with chronic disease(defined as having HCV RNA or polymerase chain reactiontesting) because we do not have access to the testresults for positive confirmation. Therefore, we alsostudied rates of treatment with HCV therapies. Due tocosts, we did not review medical records to validateclaims for HCV testing, diagnosis, or treatment. Finally,for those patients who discontinued treatment, thisstudy did not attempt to identify the reasons for discontinuationfrom submitted claims because these reasonsmay be multifactorial or not apparent.

In summary, this study allowed us to analyze someof the epidemiologic and treatment-related issues inchronic HCV infection from a larger, national frame ofreference outside the scope of the randomized clinicaltrial setting. The study also demonstrates the value ofstudying chronic HCV surveillance and treatment usingpopulation-based claims data in a national, employer-insuredmanaged care setting. Based on nearly 4 millionmembers in 11 geographically diverse health plans,the overall rate of HCV testing was 0.7%, of which 6.7%of patients were diagnosed based on claims for chronicHCV. Whereas the incidence and use of drug therapywere greater for men, women were more likely to betested for HCV. The low overall therapy rate of approximately30% suggests the need for development of drugtherapies with fewer adverse effects that may be suitablefor a larger number of patients infected with HCVand a greater awareness of appropriate therapies.

In addition, a greater understanding of recommendationsfor baseline and follow-up testing during thecourse of drug therapy is needed. This may beachieved by the implementation of guidelines for prevention,HCV testing, and treatment, along with theeducation of healthcare providers, as well as qualityassurance measures to ensure that recommendedpractices are followed. Simple algorithms and regularupdates through education meetings for primary careproviders may improve initial testing rates and ensurebetter counseling for infected patients. Collaborativetreatment and support networks among practices alsomay enhance testing rates and encourage attendanceat clinics. The provision of improved healthcare deliverysystems needs to be extended to special populationsthat do not have access to services or areineligible for current therapies. Healthcare providersinvolved in the care of these patients or other high-riskpopulations also need to be encouraged to regularlyattend educational programs regarding HCVinfection. Lessons learned from this population-basedstudy provide greater insight into community practiceas it relates to HCV infection and may help identifyimportant areas for further public health research andeducation.

We thank Paula Rheault for programming expertise andBharati Manda, MS, for statistical expertise.

From the UnitedHealth Group, Center for Health Care Policy and Evaluation, Minneapolis, Minn (DS, SDS), and the Duke Clinical Research Institute and Division of Gastroenterology, Duke University Medical Center, Durham, NC (KP, JGM).

No financial support was provided for this study, directly or through a third party.

The results of this study were presented in part at the 52nd Annual Meeting of the American Association for the Study of Liver Disease, November 9-11, 2001, Dallas, Tex.

Address correspondence to: Deborah Shatin, PhD, UnitedHealth Group, Center for Health Care Policy and Evaluation, 12125 Technology Drive, MN002-0260, Minneapolis, MN 55344. E-mail 

 Hepatitis C: and miles to go before we sleep. 

Hepatitis C: SilentEpidemic, Mute Public Health Response, 105th Congress, 2nd Sess, HouseReport 105-820.

2. Committee on Government Reform and Oversight. 

 Washington, DC: US Government Printing Office; October 1998.

 Hepatitis C: the clinical spectrum of disease. 

CLINICAL

Population-Based Hepatitis C Surveillance and Treatment in a National Managed Care Organization

There is growing evidence of a negative effect of the current American preoccupation with malpractice on efforts to reduce error, enhance safety, and improve other domains of quality. The use by some insurers of systems assessment and risk analysis programs, linked to rewards for performanceâ€”which, taken together, we term 

â€”offers an opportunity to enhance our focus on systems and to bring patient safety and malpractice risk reduction into close congruence with other quality improvement efforts. Given the increasing burden of malpractice, as well as the emerging concerns about patient safety, managed care organizations and their providers need to work together with malpractice insurers and quality improvement experts to refocus their efforts on creating systems improvement; driving measurement, analysis, and feedback; and developing incentives for performance that will align quality and risk management efforts and drive breakthroughs in quality, including patient safety. 

Crossing the QualityChasm: A New Health System for the 21st Century

Two recent Institute of Medicine reports haveincreased our knowledge of the key issues relatedto patient safety and of the factors that lead toless than optimal quality of care in our healthcare system.

,classified patient safety as 1 of 6 desirable attributes ofour healthcare system (the other domains of qualitywere efficiency, patient-centeredness, timeliness, efficiency,and equity). Current efforts to include patientsafety in quality improvement efforts have been overshadowedby the specter of malpractice litigation andhampered by a conceptual difference in approaches toquality related to patient safety vs other desirable attributessuch as effectiveness or patient-centeredness.

Improvement and accountability in domains otherthan safety have been driven by the forces of professionalismand regulation and by a combination of theseforces that underlies certification and accreditation programs.

 In the past 2 decades, market-based interventions,including reporting and rewarding performance,have been introduced with varied degrees of success.

By contrast, before publication of the Institute ofMedicine reports, patient safety was assumed by thepublic to be mitigated through the threat of malpractice,the efforts of providers to avoid malpractice, and theremoval of “badâ€ physicians. Recent efforts by theInstitute for Healthcare Improvement, the NationalPatient Safety Foundation, The Leapfrog Group, andothers have begun to bring quality improvementapproaches, professionalism, and marketplace mechanismsinto play in an effort to drive improvements inpatient safety.

 However, little attention has been paidto how to integrate these efforts to enhance patient safetywith other efforts in quality improvement or with thepersistent issue of avoiding malpractice litigation.

To Err Is Human: Building a Safer HealthSystem

In contrast to the public's view, there is little evidencethat malpractice, specifically litigation related to malpractice,acts as an impetus to improve patient safety or todeter unsafe practices or that it even compensates victimsin a fair and equitable manner.

 Moreover, malpracticelitigation is based on the need to prove negligence andto place blame on an individual (or entity) and is antitheticalto the systems and quality improvement focusof patient safety suggested by the Institute of Medicinereport 

 Given our recurrent malpractice insurance crisis,it is likely that, without some shift in emphasis, moretime, resources, and concern will be placed on efforts toavoid malpractice litigation in the future.

Despite this overshadowing presence of litigation, afew malpractice insurers are increasing their emphasison a set of programs that use a proactive, empiric, systems-focused approach to determining the causes oferrors and their relationship to patient harm and subsequentlitigation. These insurers use this information tocreate tools to assess and improve systems as a means toreduce the likelihood of future errors, patient harm, andlitigation.

 and believe this emphasismirrors in many ways the shift of clinical medicine duringthe past 4 decades from an almost exclusive focus oncaring for acute events, such as heart attacks, to a complementary emphasis on the proactive identification andmanagement of risk factors (hypertension, diabetes mellitus,and hypercholesterolemia) as means of preventingheart attacks.

Example of a Systems-Oriented, Risk ManagementApproach to Malpractice

The set of programs used by COPIC InsuranceCompany, Denver, Colo, is offered as an illustration ofthe firms that use proactive risk analysis and systemsassessment to reduce malpractice occurrences. COPIC(originally an acronym for Colorado Physicians InsuranceCompany) is a physician-sponsored malpracticeinsurer that insures about 75% of the eligible physicianspracticing in Colorado.

 Although the COPIC program isamong the most highly developed, we would note thatthere are other insurers, such as Medical Mutual, HuntValley, Md,

 and the malpractice subsidiary (CRICO) ofPartners Healthcare, Boston, Mass,

 that place a majoremphasis on proactive risk management. Key elements ofthe COPIC program are described.

Focus on Incident Reporting and Using Data toFoster Prevention

. Physicians and organizationsinsured by COPIC are encouraged to report, via telephone,any incident that they believe might result in amalpractice claim. Although nearly all malpracticeinsurers invite reporting of incidents, COPIC providesencouragement through active outreach and repeatedreminders to providers to report even minor adverseevents. When an incident is reported, it is coded intothe COPIC database. Risk managers and claim adjustersreview the report in the context of information providedby the database of prior incidents. The physician ororganization and insurance company work together tounderstand and address the likely cause and course ofevents resulting from the incident.

The incident database is structured through the useof a coding system developed by COPIC that categorizesreported incidents using multiple characteristics,including the setting, providers involved, and type ofoccurrence. COPIC then uses the data to analyze andunderstand “near missesâ€ and which incidents are mostlikely to lead to malpractice claims and payouts. Thesedata are also used to help structure the systems analysisand feedback, as noted in the next subsection.

To Err IsHuman: Building a Safer Health System

. Amajor point of the Institute of Medicine report 

 and of muchof the literature on safety in general, is that errors andadverse events are more often due to system designflaws than to individual culpability.

 systems produce the results they are designed toproduce, including errors that arise. Several ways ofanalyzing systems problems related to patient safetyconcerns have been proposed, including root-causeanalysis and applying the concepts of continuous qualityimprovement.

 A subsidiary of COPIC (PracticeQuality LLC) employs nurses with specialized trainingin the assessment of risks to patient safety that may bepresent in practice settings. The nurses use a standardsurvey protocol to evaluate office systems and practicesin each insured physician's office and hospital at leastonce every 2 years. The overall protocol and assessmentinstrument were developed using information fromincidents, claims filed, and a payout database developedby COPIC. 

 provides a synopsis of the areasassessed. Results of the practice risk assessment areshared with the office practice leadership at the end ofthe survey, along with a variety of suggestions andoptions for improving areas identified as being at risk. Inaddition, the program links the providers to “tool kits”and other educational programs that are designed tohelp in correcting problems identified by the audit, aswell as providing clinicians with examples of best practicesthat can enhance safety and other domains ofquality. This focus on systems assessment and improvementprovides an important linkage between patientsafety and other domains of quality, which we will subsequentlyexplore in more detail.

 The thirdmajor component of the COPIC proactive risk managementprogram involves the use of an incentive systemthat rewards physicians for adopting safe and effectivepractices. COPIC has created a system by which practicesare awarded points based on their adherence toCOPIC guidelines to improve performance, rangingfrom attendance at educational seminars to online educationalopportunities to implementing changes suggestedby COPIC's practice evaluations. Malpracticepremium rates are tied to baseline levels of performanceon the survey, adherence to suggested correctiveactions, and participation in risk reduction programs. Inaddition, if COPIC's total payouts for claims are lowerthan expected, the savings are shared retroactivelywith insured physicians and organizations in the formof premium credits. Therefore, individual and collectiveperformances are rewarded.

Those individuals and practices that are identified asconsistently poor performers are given repeat surveys,with opportunities for remediation. If the problemappears to lie with an individual practitioner ratherthan the practice systems, referrals are made to programs(separate from COPIC) that provide in-depthassessment of clinical performance, individually tailoredskills training, and, if needed, counseling servicesfor physicians who are identified as having personalhealth issues, chemical dependency, or other problemsthat adversely affect their clinical performance. If all ofthese attempts fail, a last resort is the nonrenewal ofCOPIC insurance. Although this is rarely used, it carriesgreat weight in Colorado, because the state requiresproof of insurance for physician licensure.

Linking Patient Safety andEffectiveness of Care at theConceptual and Practice Level

Focus on Risk Factors and Fostering Prevention

.The use of proactive risk management (incident analysisand prevention, systems assessment and feedback, andrewarding performance) is similar in many respects tothe focus in managed care related to enhancing quality inthe domain of effectiveness of care. Most managed careorganizations structure their clinical quality improvementefforts in effectiveness of care around measurementand interventions related to primary and secondary riskprevention. Some examples of this focus include programsrelated to primary immunizations in childhoodand adolescence, screening for cancer in adults, the useof BETA-blockers and controlling cholesterol in patients identifiedas being at high risk for cardiovascular events, andscreening and control of glycosylated hemoglobin inpatients with diabetes mellitus. There is a congruence ofthis approach with that of malpractice insurers likeCOPIC with their focus on measurement and analysis ofincidents to guide preventive efforts in safety.

. Interms of assessment of systems as a quality measurebeyond the domain of safety, investigators have developedand demonstrated the use of a model that identifies,using existing empiric evidence, systems that arelinked to higher quality processes and outcomes ofcare in prevention and chronic illness.

 The model,variously referred to as the “chronic careâ€ or “plannedcareâ€ model, has been translated into several instruments,including one developed by the NationalCommittee for Quality Assurance that measures thepresence, content, and use of office systems in physicianpractices (available from L.G.P.). Although theseinstruments are in the developmental stages, the basicdomains and some of the subelements of the overallmodel are shown in 

 (more information isavailable from L.G.P.). Note the high degree of overlapin content with the office system assessment used byCOPIC (Table 1) to assess the presence or absence ofsystems critical to patient safety. This overlap suggeststhe possibility that a single assessment toolmight provide information to practices related tomultiple desirable attributes, including patient safetyand effectiveness.

An additional factor present in the COPIC model isthe provision of incentives that reward the implementationof systems that are linked to improved safety.Purchasers and health plans, in some cases encouragedby a grant program “Rewarding Performance,â€ fundedby the Robert Wood Johnson Foundation, have introducedfinancial and other incentives based on clinicalperformance, including effectiveness and patient-centeredness.If these efforts at rewarding performancecould be coordinated with those of malpractice insurerslike COPIC in reducing premiums for malpractice insurancefor improvements in safety, the combined marketlevers might be sufficient to drive substantial improvementin multiple domains of quality.

The final common pathway of most quality improvementactivities is the direct participation of cliniciansand practices in systems and behavioral changes thatbring about improvement. However, safety risk managementprograms in most hospitals and group practicesare often a defensive response to malpracticeconcerns and are located and staffed by the hospital orphysician group legal office. These programs are oftennot effective in gaining the involvement of clinical leaderswith the knowledge, experience, and influence necessaryto foster the needed improvement in clinicalpractice systems and provider behaviors. Combiningefforts in risk management with those in qualityenhancement may create a critical mass of focus andpersonnel that could drive systems and behavioralchange. The literature supporting integration of patientsafety with other quality assessment and improvementefforts spans more than 2 decades but provides little evidenceof progress.

Policy Implications and Future Directions

Despite the barriers to wider dissemination of proactiverisk management–increasing our efforts in systemsimprovement, integrating patient safety with otherdomains of quality, and rewarding performance–webelieve that these efforts, taken together, are close tocreating a synergy that could positively affect healthcarequality and safety. Although none of the activitieswe note are easy to implement, there are examples ofcutting-edge organizations that have successfully implementedmost or all of these practices. We believe it istime to develop policies and interventions that wouldencourage widespread use of these practices. The alternativeof following the traditional path of paying claimsor relying on isolated, disjointed risk management programsis likely to be increasingly costly and dysfunctionalto all parties.

We thank Jean Johnson, PhD, and a group of senior staff ofCOPIC for their review of and suggestions concerning an earlierversion of the manuscript.

From the National Committee for Quality Assurance, Washington, DC. 

Address correspondence to: L. Gregory Pawlson, MD, MPH, National Committee for Quality Assurance, 2000 L Street NW, Suite 500, Washington, DC 20036. E-mail: 

To Err Is Human: Building a SaferHealth System.

1. Kohn LT, Corrigan JM, Donaldson MS, eds.

 Washington, DC: National Academy Press; 2000.

Crossing the Quality Chasm: A New Health System forthe 21st Century.

 Washington, DC: National Academy Press; 2001.

 Professionalism, regulation, and the market: impact onaccountability for quality of care. 

Provider Incentive Models forImproving Quality of Care.

5. National Health Care Purchasing Institute.

 Washington, DC: National Health Care PurchasingInstitute; March 2002.

The Growing Case for UsingPhysician Incentives to Improve Health Care Quality.

6. National Health Care Purchasing Institute.

 Washington, DC: NationalHealth Care Purchasing Institute; December 2001.

 National Patient Safety Foundation studies systems [news].

9. Milstein A, Galvin RS, Delbanco SF, Salber P, Buck CR Jr. 

Improving the safetyof health care: the leapfrog initiative. 

10. Leape LL, Kabcenell AI, Gandhi TK, Carver P, Nolan TW, Berwick DM.

Reducing adverse drug events: lessons from a breakthrough series collaborative. 

 No-fault compensation for medical injuries: theprospect for error prevention. 

 Medical malpractice, mistake prevention, and compensation.

 Medical malpractice: treating the causes instead of the symptoms.

14. Studdert DM, Thomas EJ, Burstin HR, Zbar BI, Orav EJ, Brennan TA.

 Negligentcare and malpractice claiming behavior in Utah and Colorado. 

 Creating outcomes-based systems for quality andmalpractice reform: methodology of accelerated compensation events (ACEs).

COMMENTARY

Malpractice Prevention, Patient Safety, and Quality of Care: A Critical Linkage

 To determine the sensitivity and positive predictive value (PPV) of computerized diagnostic data from health maintenance organizations (HMOs) in identifying incident breast cancer cases.

An HMO without a cancer registry developed an algorithm identifying incident breast cancer cases using computerized diagnostic codes. Two other HMO sites with Surveillance, Epidemiology, and End Results (SEER) registries duplicated this case-identification approach. Using the SEER registries as the criterion standard, we determined the sensitivity and PPV of the computerized data.

 Data were collected from HMO computerized databases between January 1, 1996, and December 31, 1999. Surveillance, Epidemiology, and End Results data were also used.

 The overall sensitivity of the HMO databases was between 0.92 (95% confidence interval [CI], 0.91-0.96) and 0.99 (95% CI, 0.98-0.99). Sensitivity was high (range, 0.94-0.98), for the first 3 (of 4) years, dropping slightly (range, 0.81-0.94) in the last year. The overall PPV ranged from 0.34 (95% CI, 0.32-0.35) to 0.44 (95% CI, 0.42-0.46). Positive predictive value rose sharply (range, 0.18-0.20) after the first year to 0.83 and 0.92 in the last year because prevalent cases were excluded. Review of a random sample of 50 cases identified in the computerized databases but not by SEER data indicated that, while SEER usually identified the cases, the registry did not associate every case with the health plan.

 Health maintenance organization computerized databases were highly sensitive for identifying incident breast cancer cases, but PPV was low in the initial year because the systems did not differentiate between prevalent and incident cases. Health maintenance organizations depending solely on SEER data for cancer case identification will miss a small percentage of cases.

Methods commonly used to identify cancer cases in a defined population for observational research include geographically based registries such as the Surveillance, Epidemiology, and End Results (SEER) registries, hospital records, and ambulatory care data. Health maintenance organizations (HMOs) could provide an important opportunity to identify cancer cases in defined populations for which computerized medical data exist. As such, they offer promise as an important resource for cancer research in etiology, prognosis, and treatment efficacy, as well as for studies of clinical care.

 However, there is limited information regarding the accuracy of these data systems in the published literature, and we could not find a comparison to SEER registries, which are generally accepted as the most valid system of cancer case identification. While SEER has been used as the criterion standard in studies

 of Medicare claims data, published studies

 of managed care claims algorithms have not used the SEER standard, but have compared the findings of their algorithms with the medical record. Demonstrating the ability to use computerized data will enable studies on breast cancer without the age restrictions of Medicare. 

While conducting a large, multisite study that identified incident breast cancer cases to determine the benefits of early screening and prophylactic mastectomy in high-risk women, we were interested in comparing breast cancer cases identified by HMO computerized diagnostic data with cases in HMOs identified by SEER registries. We therefore developed an algorithm for case identification that was duplicated by 2 HMO sites in regions with SEER registries. Using cancer registries as the criterion standard, we determined the sensitivity and positive predictive value (PPV) of the computerized data. We then looked for ways to increase the sensitivity and PPV. We also examined a sample of cases for which computerized databases disagreed with the registry data. 

The participating sites are part of the Cancer Research Network, which consists of 11 HMOs and their research programs, enrollee populations, and databases. The Cancer Research Network aims to increase the effectiveness of preventive, curative, and supportive interventions that span the natural history of major cancers among diverse populations and health systems. 

International Classification of Diseases, Ninth Revision (ICD-9-CM)

Three sites were involved in the breast cancer case-identification comparison. One site without a registry developed an algorithm for breast cancer case identification by searching for diagnosis codes indicating breast cancer. These included 

 codes 174.0 to 174.9 (malignant neoplasm of female breast: nipple and areola, central portion, upper inner quadrant, lower inner quadrant, upper outer quadrant, lower outer quadrant, axillary tail, other specified sites of female breast, and breast [female] unspecified) and 233.0 (carcinoma in situ of breast or genitourinary system and breast). The data were obtained from the HMO use database that included diagnoses for each patient encountered from ambulatory and hospital settings. 

This case-identification approach was then duplicated at 2 other HMOs with members residing within the catchment areas of their cancer registries. The list of women generated from the computerized identification scheme was compared with those cases identified from the SEER registries. 

Surveillance, Epidemiology, and End Results is a federal cancer surveillance program designed to collect information on diagnosis and treatment of all cancer patients within a geographic area. Registries contain information about incident cancer cases as reported by difference sources, including health plans, hospitals, pathology departments, and death certificates. Each SEER registry identifies cases in a slightly different way. The data collected provide a basis for estimating national cancer incidence and monitoring trends. Both HMO sites regularly receive a file from the SEER identifying all cancer cases for which their health plans are listed as offering the first course of treatment. 

The same process was used at both sites to identify women with a breast cancer diagnosis within the health plans' computerized databases between January 1, 1996, and December 31, 1999. Site 1 used the hospital information system for inpatient and short stays, and the appointment, registration, and patient accounting system for ambulatory visits. When women used services outside the health plan, diagnoses were captured from the claims system that contains billing diagnosis data from HCFA1500 (medical and surgical claims) and UB92 (institutional claims) forms. Outpatient 

April 2004

Verification of a Decision Analytic Model Assumption Using Real-world Practice Data: Implications for the Cost Effectiveness of Cyclo-oxygenase 2 Inhibitors (COX-2s)

Improving Cancer Screening Adherence: Using the "Teachable Moment" as a Delivery Setting for Educational Interventions

Population-Based Hepatitis C Surveillance and Treatment in a National Managed Care Organization

Malpractice Prevention, Patient Safety, and Quality of Care: A Critical Linkage

Comparing Breast Cancer Case Identification Using HMO Computerized Diagnostic Data and SEER Data

Health Plan Policies and Programs for Colorectal Cancer Screening: A National Profile

Primary Care Practice and Facility Quality Orientation: Influence on Breast and Cervical Cancer Screening Rates