JNCI Monographs - recent issues

Introduction

Minasian, L., O'Mara, A. — 2007-10-18

Translating the Science of Patient-Reported Outcomes Assessment Into Clinical Practice

Osoba, D. — 2007-10-18

Patient-reported outcomes (PROs) are based on direct reporting by patients without the intervention of an observer. They include the self-assessment of functional status, symptoms, and other concerns such as needs and satisfaction with care. Health-related quality of life (HRQOL) assessment is a form of PRO and often includes both functional status and symptoms. The science underlying the assessment of HRQOL in clinical practice requires an understanding of the relationships between symptoms, functional status, and HRQOL, as well as instrument selection, and analysis and interpretation of the data. A modification of the Wilson and Cleary model is proposed to show the likelihood of bidirectional relationships between symptoms, functions, and HRQOL. Instrument selection should be based on the measurement properties of the instruments and patient populations in which they will be used. Analyses of data that allow a calculation of the proportion of patients who benefit from an intervention are preferred to analyses that show only the mean change in scores from baseline. HRQOL assessment in clinical practice has been shown to lead to a better understanding of patients' concerns with improvement in counseling and referral for required services. Potentially, HRQOL assessment should also be used to monitor the progress of a patient's disease and benefit from treatment.

Outcomes Research in Cancer Symptom Management Trials: The Radiation Therapy Oncology Group (RTOG) Conceptual Model

Bruner, D. W. — 2007-10-18

The Radiation Therapy Oncology Group (RTOG) Health Services Research and Outcomes (HSRO) Committee aims to guide the study of the interactions among clinical, humanistic, and economic variables that optimize patient outcomes on clinical trials. To guide this work, the RTOG Outcomes Model was developed. Within this framework, measurement focuses primarily on patient-reported outcomes (PROs). In the examples presented, these outcomes have served to better quantify the benefit of one therapy over alternative therapies, as in the example of multimodality therapy for lung cancer, and to add evidence to clinical outcomes when clinical outcomes alone have not been strong enough to change clinical practice, as in the example of palliative radiotherapy for painful bone metastasis. The unique contribution to the RTOG of the HSRO Committee is the selection and use of PRO measures that give "voice" to the patient in clinical trials as well as provide data to better manage symptoms.

Symptom Burden: Multiple Symptoms and Their Impact as Patient-Reported Outcomes

Cleeland, C. S. — 2007-10-18

Cancer and its treatment produce multiple symptoms that significantly distress patients and impair function. Symptoms caused by treatment may delay treatment or lead to premature treatment termination, and residual treatment-related symptoms often complicate posttreatment rehabilitation. When treatment is no longer possible, symptom control becomes the focus of cancer care. Patient ratings of symptom severity and impact are important patient-reported outcomes (PROs) in cancer clinical trials and comprise a subset of a larger domain of PROs generally referred to as health-related quality of life (HRQOL). Symptoms rarely occur in isolation; rather, there is now ample evidence that symptoms frequently occur in clusters. The impact of these multiple symptoms upon the patient can be described as "symptom burden," a concept that encompasses both the severity of the symptoms and the patient's perception of the impact of the symptoms. The distress caused by symptoms is a subject of much investigation, and several validated measures of the severity and impact of multiple symptoms are now available. Symptom measures are generally brief, thereby reducing respondent burden, and can be administered repeatedly during a trial to give a relatively fine-grained picture of the patient's status across time. In many instances, information on trial-related changes in symptom burden, or comparison of symptom burden between arms in a clinical trial, may provide sufficient self-report data for clinical trial consumers (patients, clinicians, and regulators) to make treatment choices or to evaluate new therapies, without measuring other HRQOL domains.

Differences in What Quality-of-Life Instruments Measure

Ferrans, C. E. — 2007-10-18

To address the question of what value is added by assessing quality of life (QOL) in symptom management trials in cancer, we used the model of Wilson and Cleary to identify what is measured by the most commonly used QOL instruments. Examples of clinical trials are presented demonstrating the contributions of these broad-based QOL instruments in terms of symptoms, functioning, general health perceptions, and overall QOL. The examples show that QOL instruments can provide valuable information about side effects and impact on other aspects of life, which would not be captured by a more narrowly focused measure of the target symptom. A better understanding is needed of the differences in what QOL instruments measure, since conclusions regarding the effectiveness of treatment may differ depending on which one is used to assess outcomes. Head-to-head comparisons of instruments within the same studies would increase precision for selecting QOL instruments for symptom management trials.

Challenges to Use of Health-Related Quality of Life for Food and Drug Administration Approval of Anticancer Products

2007-10-18

The U.S. Food and Drug Administration (FDA) approves labeling claims of drug efficacy based on substantial evidence of clinical benefit demonstrated in adequate and well-controlled investigations. Patient-reported outcomes (PROs) may support marketing claims of clinical benefit, either alone or with other study endpoints. Health-related quality of life (HRQL) is a PRO that comprehensively measures patients' reported health status. We present an overview of why HRQL-based efficacy claims have not to date been accepted by the FDA for inclusion in anticancer product labels. Persistent challenges to allowance of such claims include shortcomings in randomization and blinding of clinical trials, missing data, statistical multiplicity, and unclear intrinsic meaning of selected HRQL findings.

Do General Dimensions of Quality of Life Add Clinical Value to Symptom Data?

Moinpour, C. M., Donaldson, G. W., Redman, M. W. — 2007-10-18

Since global health-related quality of life (GHRQL) reflects broad impacts of treatment, its assessment in an advanced-stage disease trial should add valuable clinical information beyond that of a targeted symptom. Using latent trajectory modeling that allowed for individual trends as well as overall relationships, we reanalyzed three repeated assessments of the present pain intensity from the McGill Pain Questionnaire and the European Organization for Research and Treatment of Cancer Quality of life Questionnaire- Core 30 (QLQ-C30) GHRQL score from a hormone-refractory prostate cancer trial. Within- and between-treatment differences not detected in the original S9916 report of pain palliation and GHRQL suggested substantial individual variation in GHRQL level and change after controlling for within-assessment pain. The treatment had a differential effect on the relationship between GHRQL and pain; we observed an approximately threefold stronger association of reported pain with GHRQL in the docetaxel plus estramustine (D + E) arm compared with the mitoxantrone plus prednisone (M + P) arm (P = .02). In addition, the treatment had an effect, on average, on the rate of change in GHRQL, after controlling for pain level. GHRQL for patients on the M + P arm tended to improve over the assessment period while GHRQL tended to deteriorate for patients on the D + E arm (P = .02). Important, interpretable effects and systematic individual variation in GHRQL remain after controlling statistically for the effects of pain, the targeted symptom, in this trial. In addition, identifying the rate at which a person's GHRQL changes or responds to treatment provides clinically relevant information.

Conceptual Issues in Symptom Clusters Research and Their Implications for Quality-of-Life Assessment in Patients With Cancer

Miaskowski, C., Aouizerat, B. E., Dodd, M., Cooper, B. — 2007-10-18

The majority of the research on the various aspects of symptom management has focused on individual symptoms. However, patients with cancer often experience multiple symptoms simultaneously as a result of their disease and treatment. In 2001, symptom management researchers began to study the impact of symptom clusters on patient outcomes. Over the past 6 years, a number of conceptual reviews as well as several research studies have been published on symptom clusters in oncology patients. This paper summarizes the conceptual basis for symptom cluster research, describes two conceptual approaches to symptom cluster research, and discusses the implications of symptom clusters for quality-of-life research. The paper concludes with an enumeration of the critical considerations that need to be addressed if this area of scientific inquiry is to move forward.

Health-Related Quality of Life Measurement in Symptom Management Trials

Ganz, P. A., Goodwin, P. J. — 2007-10-18

There is increasing support for the incorporation of patient-reported outcomes (PROs) into clinical trials in cancer. While the need for inclusion of measures of target symptoms in symptom management trials is clear, arguments can also be made for measurement of a broader range of symptoms, for evaluation of symptom burden, and for evaluation of health-related quality of life (HRQOL) in these trials. What is key to their inclusion is a priori selection of instruments, provision of a theoretic basis for inclusion of instruments, and a clearly described plan of analysis. The federal Food and Drug Administration (FDA) has provided guidance regarding the use of PROs (symptom and HRQOL measures) to support treatment benefit claims in product labeling. Moving forward, research is needed to address methodological issues raised by the FDA and to increase understanding of relationships among symptoms, symptom clusters, HRQOL, and other outcome measures.

Should Health-Related Quality of Life Be Measured in Cancer Symptom Management Clinical Trials? Lessons Learned Using the Functional Assessment of Cancer Therapy

Cella, D., Wagner, L., Cashy, J., Hensing, T. A., Yount, S., Lilenbaum, R. C. — 2007-10-18

There are several advantages to including comprehensive health-related quality of life (HRQL) in symptom trials in oncology. The most obvious is to test the hypothesis that HRQL will be improved in addition to the symptom benefit. We should not "require," however, that a successful symptom intervention also improve other dimensions of HRQL. On the other hand, we should expect that it will not make other dimensions worse through side effects or exacerbation of disease, even if it improves the symptom. HRQL assessment in the trial helps evaluate the competing risks of any therapy. Furthermore, assessment of HRQL is now accomplished with very brief assessment (usually 30 questions or less), and the knowledge gained is valuable. With HRQL, one can compare cancer patients with those with other conditions and can determine the contribution of symptoms and side effects to the more broadly defined HRQL. Examples using the Functional Assessment of Cancer Therapy measurement system will demonstrate how HRQL assessment has contributed to our understanding of common cancer symptoms and their place in the conceptualization of HRQL. The prevalence of clinically significant symptoms is greatest in poor performance status (PS) patients compared with patients with good PS. Symptom improvement trials specifically designed for these patients should be encouraged, particularly with interventions that can provide symptomatic relief and improve multidimensional HRQL.

Executive Summary

2006-10-10

Chapter 1: Modeling the Impact of Adjuvant Therapy and Screening Mammography on U.S. Breast Cancer Mortality Between 1975 and 2000: Introduction to the Problem

Feuer, E. J. — 2006-10-10

Chapter 2: Dissemination of Adjuvant Multiagent Chemotherapy and Tamoxifen for Breast Cancer in the United States Using Estrogen Receptor Information: 1975-1999

Mariotto, A. B., Feuer, E. J., Harlan, L. C., Abrams, J. — 2006-10-10

Background: Clinical trials have shown tamoxifen to be effective only in women with estrogen receptor (ER)–positive tumors. In a previous model, trends in the utilization of adjuvant therapy were modeled only as a function of age and stage of the disease and not ER status. In this paper, we integrate this previous estimate on the use of adjuvant systemic therapy for breast cancer in the United States with information on ER status from the Patterns of Care (POC) data to estimate the dissemination of adjuvant therapy for women with different ER-status tumors. We also summarize efficacy of adjuvant systemic therapy reported in the overviews of early breast cancer clinical trials. These two inputs, dissemination and efficacy, are key pieces for models that investigate the effect of breast cancer adjuvant therapy on the decline of U.S. breast cancer mortality. Methods: The adjustments to the previous models are calculated using the POC data on 7116 women with breast cancer diagnosed from 1987 to 1991 and in 1995 who were randomly selected from the Surveillance, and Epidemiology, and End Results (SEER) program registries. The POC data provide more accurate information on treatment and clinical variables (e.g., ER status) than the SEER data because medical records are reabstracted and further verified with treating physicians. Results: Use of multiagent chemotherapy is higher for younger women (<50 years) and for women whose tumors were shown to be ER negative or borderline. The use of tamoxifen is higher among older women and women with ER-positive tumors. After 1980 the combined use of multiagent chemotherapy and tamoxifen for women diagnosed with breast cancer at ages 69 or younger increased more for women whose tumors were ER status positive or unknown than ER status negative. Older women (>69 years) seem to receive almost exclusively tamoxifen irrespective of ER status, except for a small percentage of those with more advanced stages (II- and II+/IIIA) who also receive multiagent chemotherapy. Discussion: The estimated dissemination trends by ER status, based on modeling the POC data, reveal that treatment strategies with demonstrated efficacy in clinical trials have been adopted into practice. The dissemination and efficacy are the two factors necessary to input into models to determine the population impact of these therapies on U.S. breast cancer mortality. The largest decline in mortality would be expected for younger women (<60 years) with ER-positive tumors or whose tumors are of unknown status because of the largest efficacy and dissemination of adjuvant therapy in this group.

Chapter 3: Competing Risks to Breast Cancer Mortality

Rosenberg, M. A. — 2006-10-10

Background: Simulation models analyzing the impact of treatment interventions and screening on the level of breast cancer mortality require an input of mortality from causes other than breast cancer, or competing risks. Methods: This chapter presents an actuarial method of creating cohort life tables using published data that removes breast cancer as a cause of death. Results: Mortality from causes other than breast cancer as a percentage of all-cause mortality is smallest for women in their forties and fifties, as small as 85% of the all-cause rate, although the level and percentage of the impact varies by birth cohort. Conclusion: This method produces life tables by birth cohort and by age that are easily included as a common input by the various CISNET modeling groups to predict mortality from other causes. Attention to removing breast cancer mortality from all-cause mortality is worthwhile, because breast cancer mortality can be as high as 15% at some ages.

Chapter 4: Changing Patterns in Breast Cancer Incidence Trends

Holford, T. R., Cronin, K. A., Mariotto, A. B., Feuer, E. J. — 2006-10-10

Incidence rates for breast cancer in U.S. women have steadily increased for decades, but the reasons are not well understood. A recent upturn in these trends suggests that one component may be the effect of more aggressive screening in the population. The age–period–cohort framework, in which the temporal components associated with year of diagnosis and generation are evaluated, can assist in interpreting the elements associated with these trends. A unique approach for exploring other ways of partitioning the contribution of the different temporal components is described and applied to breast cancer incidence data (ICDO 174.0–174.9) from the Surveillance, Epidemiology and End Results (SEER) registries. Single-year intervals for age and year of diagnosis were used to fit models that provide estimates of the trends associated with the individual temporal elements. A log-linear model for age, period, and cohort was fitted using Poisson regression, and estimates of the separate time trends were calculated. The trends with period increased after 1982, when more aggressive screening began, and the trend is steeper for women older than 40 years. Cohort trends have increased steadily, although recent cohorts appear to be somewhat flat for women aged 50 years or younger, whereas the trend for those older than 50 years have continued to increase. Estimates of cohort trends in rates are also provided by extrapolating what would have occurred had there been no period trend before or after 1982, thus providing an estimate of the magnitude of the upturn that occurred after the recent emphasis on screening.

Chapter 5: Additional Common Inputs for Analyzing Impact of Adjuvant Therapy and Mammography on U.S. Mortality

Cronin, K. A., Mariotto, A. B., Clarke, L. D., Feuer, E. J. — 2006-10-10

In estimating the impact of mammography and adjuvant treatment on U.S. breast cancer mortality rates, several parameters were common to all the Cancer Intervention and Surveillance Modeling Network (CISNET) models participating in the breast cancer base case. Models either used the parameters directly as input or calibrated their models to reproduce the common set of parameters. This chapter describes the common input parameters that are not specifically discussed elsewhere in the monograph.

Chapter 6: Modeling the Impact of Treatment and Screening on U.S. Breast Cancer Mortality: A Bayesian Approach

2006-10-10

Background: Breast cancer mortality (BCM) in the United States declined from 33.1 per 100 000 women in 1990 to 26.6 per 100 000 women in 2000, yielding a 19.6% relative decline in BCM since 1990. Our goal is to apportion this decline between screening and therapy and to be able to state with some certainty that these interventions affected this decline. Methods: We started with an age-appropriate population of 2 000 000 women in 1975 and monitored these women through 2000. On the basis of population data each year, we assigned screening and breast cancer to women. If a woman was diagnosed with breast cancer, we simulated a lifetime for her with death from breast cancer, and we modified this lifetime depending on the use of adjuvant therapy and whether the cancer was screen-detected. A woman's lifetime was taken as the minimum of her lifetime with death from breast cancer and her simulated natural lifetime. We used Bayesian simulation modeling, which allows for associating probability distributions with our estimates. Results: We calculated the probabilities that screening mammography and adjuvant therapy contributed to the observed decline in BCM to be 90% and 99%, respectively. The posterior mean reduction in BCM due to screening is 10.6% ± 5.7% and due to therapy is 19.5% ± 5.4%. The decrease in the hazard of BCM due to tamoxifen use for ER-positive tumors is 37% ± 14% and that due to adjuvant (nontaxane) chemotherapy is 15% ± 14%. Discussion: The spread in our posterior distributions reflect the uncertainty present in the data sources available to us. However, despite this uncertainty we conclude a high probability that both screening and improvements in therapy contributed to the reduction in BCM observed in the United States from 1990 to 2000.

Chapter 7: The Wisconsin Breast Cancer Epidemiology Simulation Model

2006-10-10

The Wisconsin Breast Cancer Epidemiology Simulation Model is a discrete-event, stochastic simulation model using a systems-science modeling approach to replicate breast cancer incidence and mortality in the U.S. population from 1975 to 2000. Four interacting processes are modeled over time: (1) natural history of breast cancer, (2) breast cancer detection, (3) breast cancer treatment, and (4) competing cause mortality. These components form a complex interacting system simulating the lives of 2.95 million women (approximately 1/50 the U.S. population) from 1950 to 2000 in 6-month cycles. After a "burn in" of 25 years to stabilize prevalent occult cancers, the model outputs age-specific incidence rates by stage and age-specific mortality rates from 1975 to 2000. The model simulates occult as well as detected disease at the individual level and can be used to address "What if?" questions about effectiveness of screening and treatment protocols, as well as to estimate benefits to women of specific ages and screening histories.

Chapter 8: The SPECTRUM Population Model of the Impact of Screening and Treatment on U.S. Breast Cancer Trends From 1975 to 2000: Principles and Practice of the Model Methods

Mandelblatt, J., Schechter, C. B., Lawrence, W., Yi, B., Cullen, J. — 2006-10-10

Objective: This stochastic simulation model was developed to estimate the impact of screening and treatment diffusion on U.S. breast cancer mortality between 1975 and 2000. Modeling Approach: We use an event-driven continuous-time state transition model. Women who are destined to develop breast cancer may be screen detected, present with symptoms, or die of other causes before cancer is diagnosed. At presentation, the cancer has a stage assigned on the basis of mode of detection. Cancers are assumed to be estrogen receptor (ER) positive or negative. Data on screening and treatment diffusion are based on national datasets; other parameters are based on a synthesis of the evidence available in the literature. Model Methods: The model is calibrated to predict incidence and stage distribution (in situ, local, regional, and distant). Other than screening or treatment, background events that affect mortality are not explicitly modeled but are captured in the deviation between model projections of mortality trends and actual trends. We assume that: 1) tumors progress more slowly in older age groups, 2) screen- and clinically detected disease have the same survival conditional on age and stage, 3) women do not die of breast cancer within the "lead time" period, 4) screening benefits are captured by shifts in stage at diagnosis, 4) tamoxifen benefits only ER-positive women, and 5) preclinical sojourn time and dwell times in each of the clinical stages are stochastically independent. Model Results: Dissemination of screening and therapeutic advances had a substantial impact on mortality trends. We estimate that, by the year 2000, diffusion of screening lowered mortality by 12.4% and treatment improvements and dissemination lowered mortality by 14.6%. Conclusions: Models such as this one can be useful to translate clinical trial findings to general populations. This model can also be used inform policy debates about how to best achieve targeted reductions in breast cancer morbidity and mortality.

Chapter 9: The MISCAN-Fadia Continuous Tumor Growth Model for Breast Cancer

2006-10-10

The MISCAN-Fadia model was used to analyze the impact of screening and adjuvant treatment on U.S. breast cancer mortality between 1975 and 2000. MISCAN-Fadia uses the concept of "fatal diameter" to model survival and screening benefit and is based on continuous tumor growth. It consists of four major components: population, natural history, screening, and treatment. Population parameters were quantified using U.S. population data. Most natural history and screening parameters were fitted to the Swedish Two County screening trial data; some were based on Surveillance, Epidemiology, and End Results data. Adjuvant treatment parameters were quantified using data from the Early Breast Cancer Trialists' Collaborative Group's meta-analysis. The simulated trend in incidence matches the observed trend reasonably well; the simulated mortality is equal to the observed in 1975 but becomes increasingly too high in 2000. We estimate that screening leads to a 15% and adjuvant treatment to a 21% mortality reduction in the year 2000.

Chapter 10: The University of Rochester Model of Breast Cancer Detection and Survival

Hanin, L. G., Miller, A., Zorin, A. V., Yakovlev, A. Y. — 2006-10-10

This paper presents a biologically motivated model of breast cancer development and detection allowing for arbitrary screening schedules and the effects of clinical covariates recorded at the time of diagnosis on posttreatment survival. Biologically meaningful parameters of the model are estimated by the method of maximum likelihood from the data on age and tumor size at detection that resulted from two randomized trials known as the Canadian National Breast Screening Studies. When properly calibrated, the model provides a good description of the U.S. national trends in breast cancer incidence and mortality. The model was validated by predicting some quantitative characteristics obtained from the Surveillance, Epidemiology, and End Results data. In particular, the model provides an excellent prediction of the size-specific age-adjusted incidence of invasive breast cancer as a function of calendar time for 1975–1999. Predictive properties of the model are also illustrated with an application to the dynamics of age-specific incidence and stage-specific age-adjusted incidence over 1975–1999.

Chapter 11: A Stochastic Model for Predicting the Mortality of Breast Cancer

Lee, S., Zelen, M. — 2006-10-10

Consider a cohort of women, identified by year of birth, some of whom will eventually be diagnosed with breast cancer. A stochastic model is developed for predicting the U.S. breast cancer mortality that depends on advances in therapy and dissemination of mammographic screening. The predicted mortality can be compared with the same cohort having usual care with no screening program and absence of modern therapy, or a cohort in which only a proportion participate in a screening program and have modern therapy. The model envisions that a woman may be in four health states: i.e., 1) no disease or breast cancer that cannot be diagnosed (S₀), 2) preclinical state (S_p), 3) clinical state (S_c), and 4) disease-specific death (S_d). The preclinical disease refers to breast cancer that is asymptomatic but that may be diagnosed with a special exam. The clinical state refers to symptomatic disease diagnosed under usual care. One of the basic assumptions of the model is that the disease is progressive; i.e., the transitions for the first three states are S₀->S_p->S_c. The other basic assumption is that any reduction in mortality associated with earlier diagnosis is due to a stage shift in diagnosis; i.e., early diagnosis results in a larger proportion of earlier stage patients. The model is used to predict changes in female breast cancer mortality in the U.S. women for 1975–2000. The model is general and may predict mortality for other chronic diseases that satisfy the two basic assumptions.

Chapter 12: A Stochastic Simulation Model of U.S. Breast Cancer Mortality Trends From 1975 to 2000

Plevritis, S. K., Sigal, B. M., Salzman, P., Rosenberg, J., Glynn, P. — 2006-10-10

Background: We present a simulation model that predicts U.S. breast cancer mortality trends from 1975 to 2000 and quantifies the impact of screening mammography and adjuvant therapy on these trends. This model was developed within the Cancer Intervention and Surveillance Network (CISNET) consortium. Method: A Monte Carlo simulation is developed to generate the life history of individual breast cancer patients by using CISNET base case inputs that describe the secular trend in breast cancer risk, dissemination patterns for screening mammography and adjuvant treatment, and death from causes other than breast cancer. The model generates the patient's age, tumor size and stage at detection, mode of detection, age at death, and cause of death (breast cancer versus other) based in part on assumptions on the natural history of breast cancer. Outcomes from multiple birth cohorts are summarized in terms of breast cancer mortality rates by calendar year. Result: Predicted breast cancer mortality rates follow the general shape of U.S. breast cancer mortality rates from 1975 to 1995 but level off after 1995 as opposed to following an observed decline. Sensitivity analysis revealed that the impact adjuvant treatment may be underestimated given the lack of data on temporal variation in treatment efficacy. Conclusion: We developed a simulation model that uses CISNET base case inputs and closely, but not exactly, reproduces U.S. breast cancer mortality rates. Screening mammography and adjuvant therapy are shown to have both contributed to a decline in U.S. breast cancer mortality.

Chapter 13: A Comparative Review of CISNET Breast Models Used To Analyze U.S. Breast Cancer Incidence and Mortality Trends

Clarke, L. D., Plevritis, S. K., Boer, R., Cronin, K. A., Feuer, E. J. — 2006-10-10

The CISNET Breast Cancer program is a National Cancer Institute–sponsored collaboration composed of seven research groups that have modeled the impact of screening and adjuvant treatment on trends in breast cancer incidence and mortality over the period 1975–2000 (base case). This collaboration created a unique opportunity to make direct comparison of results from different models of population-based cancer screening produced in response to the same question. Comparing results in all but the most cursory way necessitates comparison of the models themselves. Previous chapters have discussed the models individual in detail. This chapter will aid the reader in understanding key areas of difference between the models. A focused analysis of differences and similarities between the models is presented with special attention paid to areas deemed most likely to contribute substantially to the results of the target analysis.

Chapter 14: Impact of Mammography on U.S. Breast Cancer Mortality, 1975-2000: Are Intermediate Outcome Measures Informative?

Habbema, J. D. F., Tan, S. Y. G. L., Cronin, K. A. — 2006-10-10

Seven models have estimated the contribution of screening to the decrease in U.S. breast cancer mortality between 1975 and 2000. We will investigate whether the model estimates of the mortality reduction due to screening are associated with intermediate outcome measures (IOMs). Detection rates at screening, 1- and 2-year sensitivity, program sensitivity, and incidence of advanced tumors are used as IOMs. Moreover, the model parameters preclinical duration and sensitivity are analyzed. The correlation of IOMs with mortality is assessed for actual U.S. screening and for an intensive screening scenario, with annual screening at ages 40–79 years with 100% participation. Also, 12 alternative screening scenarios are run for one of the models, and within-model correlation between IOMs and mortality reduction is described. Resulting correlations between IOMs and mortality reduction are mostly weak. For 2-year sensitivity and the incidence of advanced tumors, correlations are high in the intensive screening scenario. Within-model correlations are strong for incidence of advanced tumors and program sensitivity. Intermediate outcome measures have limited potential in predicting the impact of mammographic screening on mortality. Incidence of advanced tumors and program sensitivity are measures that merit further consideration as surrogates for mortality reduction.

Chapter 15: Impact of Adjuvant Therapy and Mammography on U.S. Mortality From 1975 to 2000: Comparison of Mortality Results From the CISNET Breast Cancer Base Case Analysis

Cronin, K. A., Feuer, E. J., Clarke, L. D., Plevritis, S. K. — 2006-10-10

The CISNET breast cancer program is a consortium of seven research groups modeling the impact of various cancer interventions on the national trends of breast cancer incidence and mortality. Each of the modeling groups participated in a CISNET breast cancer base case analysis with the objective of assessing the impact of mammography and adjuvant therapy on breast cancer mortality between 1975 and 2000. The comparative modeling approach used to address this question allowed for a unique view into the process of modeling. Results shown here expand on those recently reported in the New England Journal of Medicine (Berry et al., N Engl J Med 2005;353:1784–92) by presenting mortality impact in several different ways to facilitate comparisons between models. Comparisons of each group's results in the context of modeling assumptions made during the process gave insight into how specific model assumptions may have affected the results. The median estimate for the percent decline in breast cancer mortality due to mammography was 15% (range of 8%–23%), and the median estimate for the percent decline in mortality due to adjuvant treatment was 19% (range of 12%–21%). A detailed discussion of the differences in modeling approaches and how those differences may have influenced the mortality results concludes the chapter.

Chapter 16: Modeling Cancer Natural History, Epidemiology, and Control: Reflections on the CISNET Breast Group Experience

Habbema, J. D. F., Schechter, C. B., Cronin, K. A., Clarke, L. D., Feuer, E. J. — 2006-10-10

Introduction

Vogt, T. M., Wagner, E. H. — 2005-11-14

Building a Research Consortium of Large Health Systems: The Cancer Research Network

2005-11-14

Critical questions about cancer prevention, care, and outcomes increasingly require research involving large patient populations and their care delivery organizations. The Cancer Research Network (CRN) includes 11 integrated health systems funded by the National Cancer Institute (NCI) to conduct collaborative cancer research. This article describes the challenges of constructing a productive consortium of large health systems, and explores the CRN's responses. The CRN was initially funded through an NCI cooperative agreement in 1999 and has since received a second 4-year grant. Leadership and policy development are provided through a steering committee, subcommittees, and an external advisory committee. The CRN includes integral and affiliated research projects supported by a Scientific and Data Resources Core. Three characteristics of the CRN intensified the general challenges of consortium research: 1) its members are large health systems with legitimate concerns about confidentiality of data about enrollees, providers, and the organization; 2) CRN research projects often generate highly sensitive data about quality of care; and therefore 3) each participating organization wants a strong voice in CRN direction. CRN experience to date confirms that a consortium of health systems with internal research capacity can address a range of important cancer research questions that would be difficult to study in other venues. The advantages and challenges of consortium research are explored, with suggestions for the development, execution, and management of multisystem population laboratories.

Building a Virtual Cancer Research Organization

2005-11-14

Background: The Cancer Research Network (CRN) comprises the National Cancer Institute and 11 nonprofit research centers affiliated with integrated health care delivery systems. The CRN, a public/private partnership, fosters multisite collaborative research on cancer prevention, screening, treatment, survival, and palliation in diverse populations. Methods: The CRN's success hinges on producing innovative cancer research that likely would not have been developed by scientists working individually, and then translating those findings into clinical practice within multiple population laboratories. The CRN is a collaborative virtual research organization characterized by user-defined sharing among scientists and health care providers of data files as well as direct access to researchers, computers, software, data, research participants, and other resources. The CRN's research management Web site fosters a high-functioning virtual scientific community by publishing standardized data definitions, file specifications, and computer programs to support merging and analyzing data from multiple health care systems. Results: Seven major types of standardized data files developed to date include demographics, health plan eligibility, tumor registry, inpatient and ambulatory utilization, medication dispensing, laboratory tests, and imaging procedures; more will follow. Data standardization avoids rework, increases multisite data integrity, increases data security, generates shorter times from initial proposal concept to submission, and stimulates more frequent collaborations among scientists across multiple institutions. Conclusions: The CRN research management Web site and associated standardized data files and procedures represent a quasi-public resource, and the CRN stands ready to collaborate with researchers from outside institutions in developing and conducting innovative public domain research.

Measuring and Improving Performance in Multicenter Research Consortia

Greene, S. M., Hart, G., Wagner, E. H. — 2005-11-14

Background: Some evidence suggests that the quality of the organization and management of research consortia influences productivity and staff satisfaction. Collaborators in a research consortium generally focus on developing and implementing studies and thus rarely assess the process of collaboration. We present an approach to evaluating and improving a research consortium, using the HMO Cancer Research Network (CRN) as an example. Methods: Five domains are evaluated: extent of collaboration and quality of communication; performance of projects and infrastructure; data quality; scientific productivity; and impact on member organizations. The primary assessment tool is a survey of CRN scientists and project staff, undertaken annually. Results: Each year, the evaluation has identified critical aspects of this collaboration that could be improved. Several tangible changes have been implemented to improve productivity of the consortium. The most important result of the CRN Evaluation is the ability to have open dialogue about ways to improve its overall performance. Conclusion: Optimizing the process of collaboration will contribute to achievement of the scientific goals. The experience of the CRN provides a useful framework and process for evaluating the structure of consortium-based research.

Characteristics of Women Refusing Follow-up for Tests or Symptoms Suggestive of Breast Cancer

2005-11-14

Background: Delay in diagnosis of breast cancer can occur at several points on the diagnostic pathway. We examined characteristics of women with breast cancer who before diagnosis actively refused recommended follow-up of tests or symptoms suggestive of breast cancer. Methods: We identified women aged 50 years or older diagnosed with late-stage (metastatic disease or tumors ≥ 3cm at diagnosis) and a matched sample of women with early-stage (tumors < 3 cm) breast cancer from 1995 to 1999. Using medical records, we investigated clinical characteristics, use of health care, and documentation of care refusal during the 3 years before diagnosis. We used logistic regression models to compare refusers to nonrefusers. Results: Of the 2694 women studied, 7.2% refused provider follow-up advice during the 3 years. These women were more likely to have late-stage breast cancer at diagnosis than were nonrefusers (odds ratio [OR] = 1.9, 95% confidence interval [CI] = 1.4 to 2.6). They were more likely to be aged 75 years or older (OR = 1.9, 95% CI = 1.4 to 2.7 compared with age 50–64) or to have six or more children (OR = 2.3, 95% CI = 1.3 to 4.2 compared to women with one to two children). Clinical factors associated with refusal included low use of mammography, high use of clinical breast exam, and missed appointments. A minority of women who refused had a reason documented in the medical record; the most frequent reasons were avoidance–denial–fatalism, fear of diagnostic tests, and fear of surgery or disfigurement. Conclusions: Our results suggest that certain demographic and clinical characteristics are associated with women's refusal of diagnostic testing for breast cancer. Further study is needed on refusers' characteristics and on how such refusals affect outcomes. Efforts aimed at identifying and counseling women with abnormal results who refuse follow-up are warranted.

Late-Stage Breast Cancer Among Women With Recent Negative Screening Mammography: Do Clinical Encounters Offer Opportunity for Earlier Detection?

2005-11-14

Background: Opportunities to prevent late-stage breast cancer within the course of usual care are needed. We evaluate whether clinical encounters offer such opportunities. Methods: Within seven health care plans, we identified 1298 women aged more than 50 years with early (<3 cm), late-stage (≥3 cm), or metastatic invasive breast cancer diagnosed during 1995–1999, whose first screening mammogram 13–36 months prior to the diagnosis (index) was negative. We audited all care occurring in the health plans up to 36 months prior to the cancer diagnoses. Ordinal logistic regression compared the frequency of events by disease category. We hypothesized that during the 13–36 months prior to diagnosis, women with late-stage or metastatic breast cancer would have more symptoms and be more likely to have breast-related clinical visits but have less breast screening (clinical breast examination [CBE] or mammography) than women with early-stage disease, thereby indicating clinical opportunities for earlier detection. Results: We found no differences in demographic characteristics across breast cancer stage among the 1298 women. Both before and after the negative index mammogram but during the 13–36 months prior to diagnosis, few women had breast symptoms (5% before index, 8% after), but many sought breast care (86% before index, 90% after) and screening CBE (62% before index, 43% after). Only the occurrence of screening CBE (odds ratio [OR] = 0.73, 95% confidence interval [CI] = 0.56 to 0.95) or screening mammograms (OR = 0.74, 95% CI = 0.57 to 0.97) after the negative index mammogram reduced odds of more severe disease at diagnosis. Conclusion: Although the mortality benefit of CBE, or one compared to two year mammography has not been established, we found that women with late-stage breast cancers undetected by screening mammography did not experience opportunities for earlier detection except through CBE or additional screening mammography.

Breast and Cervical Cancer Screening: Clinicians' Views on Health Plan Guidelines and Implementation Efforts

2005-11-14

Background: Optimizing breast and cervical cancer screening rates within health plans requires clinician support for screening guidelines, an awareness of whether there are tools available and functioning to aid screening implementation, and a perception of collegial and leadership support for quality screening services. This study investigated clinicians' perceptions of guidelines, reminders for screening, and plan and practice commitment in order to assess where opportunities exist to improve the screening process. Methods: A stratified sample of 761 primary care clinicians from three comprehensive health plans were surveyed to assess awareness of and agreement with guideline elements, perception of guidelines' usefulness, awareness of plan strategies to promote guideline adherence, perception of support for high-quality screening services, and ratings of plan efforts to maximize members' access. Results: Clinician awareness of and agreement with guideline elements was high (98% breast, 94% cervical). Across guideline elements, agreement was lower for mammography than cervical screening, notably for upper age limit recommendations (58% breast, 79% cervical). Knowledge of systems that cue patients and clinicians that screening is due varied by cancer test, and clinician report and plan report data about the existence of systems were, at times, not congruent. Views about consistent operation of systems differed by test (mammograms, 74%–92%; Pap, 66%–84%). Clinicians rated local colleagues and local and plan medical leadership as very committed to high-quality screening, albeit with somewhat lower ratings for cervical testing. Although the majority rated overall plan efforts to maximize screening as very good or excellent, perceived consistency of systems to cue a woman that she is due for testing and perception of collegial support were independently and significantly related to ratings of plan efforts. Conclusions: Improvements in knowledge of systems that support guideline implementation varied, and action to ensure accurate perception of reminders, as well as consistent implementation of systems, may be important for improving screening rates and outcomes. Plan efforts and clinician efforts at the practice level are closely linked and need to be aligned to maximize screening rates. This requires plan and practice–level analyses of structures and processes that could be improved.

Women's Decision-Making Roles Regarding Contralateral Prophylactic Mastectomy

2005-11-14

Background: Contralateral prophylactic mastectomy (CPM) is the removal of a nonaffected breast in a woman with unilateral breast cancer and is effective in reducing the risk of recurrences. Little is known about women's decision-making roles regarding CPM. Methods: Women aged 18–80 years with CPM performed at one of six health maintenance organizations between 1979 and 1999 were surveyed. We determined women's reported decision-making roles at the time of CPM, analyzed their trends over time, and explored the association between decision-making roles and psychosocial outcomes following CPM. Results: We received 562 responses (response rate = 73%); 431 completed items needed for this analysis. Most respondents were white, younger than 55 years at CPM, married, and had CPM within 10 years of completing the survey. Forty-five percent made the decision to undergo CPM alone, 37% considered their doctor's opinion, 15% shared the decision with their doctor and only 3% reported their doctor primarily made the decision. Women reporting active roles were more likely to be younger (P<.0008), college educated (P<.0001) and have CPM more recently (P = .002). Compared with those sharing the decision with their doctors, women with active roles were twice as likely to be satisfied 6 months following CPM (odds ratio [OR] = 2.2, 95% confidence interval [CI] = 1.1 to 4.2) and report current concern about breast cancer (OR = 1.9, 95% CI = 1.0 to 3.4). Conclusions: Most women reported active or shared roles in decision making regarding CPM, particularly younger women, those with college education, and those with recent CPM. Women with active roles were more often satisfied in the short term but were also more likely to report current concern about breast cancer. Whether higher concern is related to insufficient input from clinicians should be explored. Prospective data are needed.

Complications Following Bilateral Prophylactic Mastectomy

2005-11-14

Background: Bilateral prophylactic mastectomy significantly decreases breast cancer risk, but complications of the procedure have only been described in single-site studies. We describe the frequency and type of complications in women who underwent bilateral prophylactic mastectomy in a multisite community-based cohort. Methods: Women aged 18–80 years undergoing bilateral prophylactic mastectomy without a personal history of breast cancer at one of six health plans were eligible. We identified women from automated data sources, then reviewed hospital data, ambulatory notes, and other chart elements to confirm eligibility and obtain all charted information about complications and surgeries performed after prophylactic mastectomy, including reconstructive procedures. Reconstructions were characterized by type (implant vs. tissue graft). Complications were noted for a 1-year period after any surgical procedure. Results: We identified 269 women with prophylactic mastectomy who were followed for a mean of 7.4 years. Their mean age was 44.9 years. Nearly 80% undertook reconstruction, most with prosthetic implants. One or more complications occurred in 64%. The most common complications were pain (35% of women), infection (17%), and seroma (17%). Women with no reconstruction had fewer complications (mean of .93) than women who had implant (2.0) or tissue graft (2.4) reconstruction procedures (differences from no reconstruction: 1.07 [95% confidence interval = 0.36 to 1.77] and 1.50 [95% confidence interval = 0.44 to 2.56] respectively). Delay of reconstruction after mastectomy was associated with a borderline-significant higher risk of complications (80.6%) compared to simultaneous reconstruction (64.0%, P = .055). Conclusion: We found that almost two-thirds of women undergoing bilateral prophylactic mastectomy had at least one complication following surgery. Further work should be done to minimize and to understand the effect of complications of bilateral prophylactic mastectomy.

Screening Clinical Breast Examination: How Often Does It Miss Lethal Breast Cancer?

2005-11-14

Background: Although most American women regularly receive screening clinical breast examination (CBE), little is known about CBE accuracy in community practice. We sought to estimate the rate of cancer detection (sensitivity) of screening CBE performed by community-based clinicians on women who ultimately died of breast cancer, as well as to identify factors associated with accurate detection. Subjects and Methods: We evaluated CBE accuracy among asymptomatic female health plan enrollees in five states (WA, OR, CA, MA, and MN) who received a CBE within 1 year of breast cancer diagnosis and who died of breast cancer within 15 years of diagnosis (N = 485). Sensitivity was estimated as the proportion whose exam was abnormal. Bivariate and logistic regression analyses identified patient characteristics associated with cancer detection. Results: An abnormality was noted on screening CBE in one of five women who ultimately succumbed to breast cancer (sensitivity = 21.6%; 95% confidence interval [CI] = 18.1% to 25.6%). The odds of a true-positive screening CBE (sensitivity) were decreased among women using estrogen (odds ratio [OR] = 0.23; 95% CI = 0.07 to 0.80), receiving a Pap smear during the same visit as CBE (OR = 0.45; 95% CI = 0.27 to 0.72), and with increasing chronic disease comorbidity (P_trend = .08). Conclusion: Screening CBE as performed in the community may be insufficiently sensitive to detect most lethal breast cancers. Low sensitivity of screening CBE in community practice may be partly attributable to its performance alongside time-consuming clinical tasks such as Pap smear screening or chronic illness care.

Race and Ethnicity: Comparing Medical Records to Self-Reports

2005-11-14

Understanding and eliminating health disparities requires accurate data on race/ethnicity. To assess the quality of race/ethnicity data, we compared medical record classifications to self-report of a study of prophylactic mastectomy. A total of 788 women had race/ethnicity from both sources; 69.9% were 55 years of age or older, 38.3% were at least college graduates, and 67.8% were married or living with someone. There were 817 race/thnicity classifications for the 788 women, of which 758 (92.3%) were identical in the medical record and self-report. Sensitivity and positive predictive value were high (86.7%–97.2%) for whites, Asians, and blacks and moderate (64.0% and 68.1%) for Latinas. However, only one of 18 Native Americans was correctly identified in her medical record. Our results indicate that even if the overall accuracy of medical record classifications for race/ethnicity is high, such a finding may obscure substantial inaccuracies in the recording for racial/ethnic minorities, especially Latinas and Native Americans.

Relationship Between Tobacco Control Policies and the Delivery of Smoking Cessation Services in Nonprofit HMOs

2005-11-14

Background: This project examined tobacco policies and delivery of cessation services in nonprofit HMOs that collectively provide comprehensive medical care to more than 8 million members. Methods: Three annual surveys with health plan managers showed that all of these health plans had written tobacco control guidelines that became more comprehensive over the span of this study. We also surveyed a random sample of 4207 current smokers who had attended a primary care visit in the past year (399–528 at each of nine health plans). Results: Of these smokers, 71% reported advice to quit, 56% were asked about their willingness to quit, 49% were provided some assistance in quitting (mostly self-help material or information about classes or counseling), and 9% were offered some kind of follow-up. Smokers receiving assistance in quitting reported higher satisfaction with their care. Conclusions: In general, health plans with the most comprehensive policies also showed higher rates of implementing tobacco treatment programs in primary care. Compared with tobacco control efforts of a decade or more ago, considerable progress has been made. However, there is still room for improvement in the proportion of smokers who receive the most effective forms of assistance in quitting.

Creating Standard Cost Measures Across Integrated Health Care Delivery Systems

2005-11-14

Background: Economic analyses are increasingly important in medical research. Accuracy often requires that they include large, diverse populations, which requires data from multiple sources. The difficulty is in making the data comparable across different settings. This article focuses on how to create comparable measures of health care resource use and cost using data from seven health plans and delivery systems participating in the Cancer Research Network's HMOs Investigating Tobacco study. Methods: We used a data inventory to identify variation in data capture across sites and used data dictionaries to develop algorithms for assigning standardized cost to the three major components of health care use: outpatient, inpatient, and pharmacy. Results: The plans included in this study varied from fully integrated, closed-panel models to plans and delivery systems that include network or independent physician association components. Information derived from the data inventory and data dictionary instruments demonstrated a substantial variation in both the content and capture of data across all sites and across all components of usage. The methods we employed for cost allocation varied by usage component and were based on our ability to leverage the data points available to best reflect actual resource use. Conclusions: The importance of this article is the method of ascertaining, cataloging, and addressing the within- and between-plan differences in health care resource use. Second, the decisions we made to address the differences between health plans provide other researchers a starting point when creating a cost algorithm for multisite retrospective research.

Disparities and Survival Among Breast Cancer Patients

2005-11-14

Background: Although rates of survival for women with breast cancer have improved, the survival disparity between African American and white women in the United States has increased. Purpose: To determine whether this survival disparity persists in an insured population with access to medical care. Methods: In this retrospective cohort study, we extracted data from the tumor registries of six nonprofit, integrated health care delivery systems affiliated with the Cancer Research Network and assessed the survival of African American (n = 2276) and white (n = 18 879) female enrollees who were diagnosed with invasive breast cancer from January 1, 1993, through December 31, 1998. Cox proportional hazards regression was used to estimate the death rate among African American women relative to that of white women after adjustment for potential explanatory factors including stage at diagnosis, tumor characteristics, and treatment. Results: Five-year survival was lower for African American women (73.8%) than for white women (81.6%). African American women were less likely to have tumor characteristics with good prognosis. Controlling for age at diagnosis, stage, grade, tumor size, and estrogen and progesterone receptor status, the adjusted hazard rate ratio for African American women was 1.34 (95% confidence interval = 1.22 to 1.46). Similar risks were found among women ages 20–49 and 50 and older. Controlling for treatment slightly lowered the hazard rate ratio to 1.31 (95% confidence interval = 1.20 to 1.43). Conclusions: Among women with invasive breast cancer, being insured and having access to medical care does not eliminate the survival disparity for African American women.

Racial and Age Differences in Colon Examination Surveillance Following a Diagnosis of Colorectal Cancer

2005-11-14

Purpose: The purpose of this analysis is to describe factors associated with colorectal surveillance following diagnosis and treatment of nonmetastatic colorectal cancer. Methods: Subjects were identified as part of the HMO Cancer Research Network's study of colorectal cancer survivors. To be eligible for the main study, patients had to be part of the staff model components of health maintenance organizations in southeastern Michigan and Minnesota. Using computerized databases, individuals were identified who were 40 years or older with incident nonmetastatic colorectal cancer diagnosed between January 1, 1990, and December 31, 2000. Using data current through 2002, we analyzed the cohort using chi-square test statistics, life tables, and Cox proportional hazards models to understand variations in posttreatment surveillance practices. Subjects were followed up from date of diagnosis to date of recurrence, death, disenrollment from the health plan, or loss to follow-up, which ever came first. We assessed factors associated with colorectal surveillance at 1, 3, and 5 years after treatment. We also included an analysis comparing those who received an exam and those who didn't regardless of exam timing. Results: A total of 908 patients were eligible for the main study. Of these, we excluded subjects who were not white or African American (n = 27), resulting in an analytic sample of 881 (97% of the eligible cohort). Twenty-five percent of subjects were African American, 43% were female, and 48% were aged 70 years or older. The proportion who received an exam at 1 year was 18%, at 3 years was 60%, and at 5 years was 67%. Chi-square tests showed that African Americans were statistically significantly less likely than whites to receive an exam at all three time points. The Cox proportional hazards model for examinations regardless of timing and adjusted for confounders showed that African Americans were still less likely than whites to receive an exam (hazard ratio = 0.62; 95% confidence interval [CI] = 0.51 to 0.75). The same trend in undersurveillance was also observed for those 80 years of age or older at diagnosis, with an adjusted hazard ratio of 0.39 (95% CI = 0.26 to 0.57). Conclusion: Our data indicate that colorectal cancer survivors who are African American or aged 80 years or more at diagnosis are less likely to receive posttreatment colorectal surveillance. Whether these differences are due to system or patient level barriers needs further study.

Participation of Asian-American Women in Cancer Treatment Research: A Pilot Study

Nguyen, T. T., Somkin, C. P., Ma, Y., Fung, L.-C., Nguyen, T. — 2005-11-14

Few Asian-American women participate in cancer treatment trials. In a pilot study to assess barriers to participation, we mailed surveys to 132 oncologists and interviewed 19 Asian-American women with cancer from Northern California. Forty-four oncologists responded. They reported as barriers language problems, lack of culturally relevant cancer information, and complex protocols. Most stated that they informed Asian-American women about treatment trials. Only four women interviewed knew about trials. Other patient-identified barriers were fear of side effects, language problems, competing needs, and fear of experimentation. Family decision making was a barrier for both oncologists and patients. Compared to non-Asian oncologists, more Asian oncologists have referred Asian-American women to industry trials and identified barriers similar to patients' reports. Our findings indicate that Asian-American women need to be informed about cancer treatment trials, linguistic barriers should be addressed, and future research should evaluate cultural barriers such as family decision making.

Changes in Women's Use of Hormones After the Women's Health Initiative Estrogen and Progestin Trial by Race, Education, and Income

2005-11-14

Background: We examined the impact of race, education, and household income on changes in rates of discontinuation and initiation of hormone therapy before and after release of the Women's Health Initiative estrogen plus progestin trial results. Methods: We conducted an observational cohort study of 221 378 women aged 40–80 years enrolled in five health maintenance organizations to estimate the prevalence and rates of discontinuation and initiation of estrogen plus progestin and estrogen only between September 1, 1999, to June 31, 2002 (baseline), and December 31, 2002 (follow-up). We identified the census block group for each participant by geocoding her 2003 residential address. We categorized women into racial, education, and income groups based on the distribution of these characteristics in her community from year 2000 census data and the distributions of these characteristics within her HMO. Results: There were significant differences in estrogen plus progestin and estrogen only prevalence by race, education level, and household income, and in estrogen plus progestin initiation by race and education level, but not by household income at follow-up. However, there were no differences by community race, education, or household income in change in the prevalence of either hormone therapy use at follow-up or in the rates of hormone therapy discontinuation or initiation from baseline to follow-up. Conclusions: Given the wide spread media attention to the Women's Health Initiative estrogen plus progestin trial results, our findings suggest comparable dissemination of this information across diverse socioeconomic groups.

Health System Responses to the Women's Health Initiative Findings on Estrogen and Progestin: Organizational Response

2005-11-14

Recent randomized trials have indicated that the risks of hormone therapy for menopausal women may outweigh the benefits. The purpose of this study was to describe how health plans responded to the findings of the Women's Health Initiative (WHI) estrogen plus progestin trial. We surveyed five health plans affiliated with the HMO Research Network and the Cancer Research Network to document the response of each plan to the WHI in terms of patient and provider education and guidelines. Every health plan issued responses within 3 months of WHI's termination in a variety of formats. Recommendations were relatively consistent across the organizations. Given the documented changes in hormone therapy use in these five health plans in the post-WHI era, we conclude that attempts on the part of each organization to educate patients and providers about the implications of the WHI may have contributed to the observed changes in hormone therapy use.

An Automated Data Algorithm To Distinguish Screening and Diagnostic Colorectal Cancer Endoscopy Exams

Haque, R., Chiu, V., Mehta, K. R., Geiger, A. M. — 2005-11-14

Despite questions about accuracy, automated data are used increasingly for research and quality measurement. The goal of this study was to develop an automated data algorithm designed to distinguish screening and diagnostic endoscopy (sigmoidoscopy and colonoscopy) exams. We assessed the algorithm's ability to correctly classify the exams using paper medical records as the "gold standard." The algorithm used diagnostic codes to identify the indication of the endoscopies. The algorithm's ability to classify the indication varied by endoscopy exam. The sensitivities for identifying diagnostic sigmoidoscopy and colonoscopy were 48.1% and 23.8%, respectively. The algorithm missed most of the diagnostic endoscopies. Conversely, the sensitivities for identifying screening sigmoidoscopy and colonoscopy were high (87.9% and 84.4%, respectively) but were associated with low specificities. Our findings suggest that studies relying solely on automated data overestimate screening rates if indication is not considered. The automated algorithm presented here needs further improvements to better differentiate screening from diagnostic exams.