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Our objective was to assess the economic impact of a new cytokine therapy that was being compared to standard therapy as supportive care in patients receiving autologous bone marrow transplantation for treatment of lymphoma. We performed an economic study accompanying a multicenter, randomized, controlled clinical trial in academic medical centers. One hundred and fifteen patients consented to participate in a parallel economic study of a randomized controlled trial of sequential IL-3 followed by GM-CSF vs GM-CSF alone after autologous bone marrow transplantation. We measured costs and quality-adjusted survival over a 13-month follow-up period. For the 13-month study period, the total cost estimates were $79892 (95% CI $69343 to $90544) for patients receiving GM-CSF alone and $89651 (95% CI $79769 to $102114) for patients receiving IL-3/GM-CSF. The difference was not statistically significant. During the 13-month study period, the total number of quality-adjusted life-months in the GM-CSF arm was 6.67 (95% CI 5.75 to 7.56) months, while the total number of quality-adjusted life-months in the IL-3 arm was 6.26 (95% CI 5.34 to 7.15) months. The difference in quality-adjusted life-months between the two treatment arms was not statistically significant. We conclude that economic analysis of a phase III clinical trial of IL-3/GM-CSF compared with GM-CSF alone showed no significant effect of IL-3 on the costs of care for patients undergoing bone marrow transplantation for a period of up to 13 months after the procedure. This study demonstrates the feasibility of prospective economic evaluation within phase III trials of new cancer therapies. Data from this type of economic protocol could be used to help physicians, patients and managed care organizations understand the effect of new treatments from both a clinical and an economic perspective. [ABSTRACT FROM AUTHOR]

An abstract of a national survey of doctors in the U.S. about the screening behavior of gynecologists, family doctors and internal medicine doctors for cervical cancer, published in the November 03, 2009 issue of the journal "Annals of Internal Medicine."

Objectives: This study examines patient and provider barriers to screening for colorectal cancer among low-income uninsured African-Americans aged 50 years or older in an urban safety-net primary care clinic, with the goal of informing a future intervention., Methods: Four focus groups were conducted among 40 patients from, or living in the immediate neighborhood of, a primary care clinic for uninsured residents of Washington, DC. An additional focus group was conducted among primary care providers from the same clinic. Using semistructured open-ended questions, moderators elicited perceptions of barriers and promoters of colorectal cancer screening and suggestions to improve adherence to screening guidelines. The focus groups were audio-taped and transcribed verbatim. The transcripts were independently coded by two reviewers using established qualitative methodology., Results: Patient and provider comments from the five focus groups fell into one of eight content areas: primary care characteristics (36% of comments), procedural issues related to screening (16% of comments), knowledge (14% of comments), cost/insurance coverage (13%), ordering of priorities (12%), attitudes (5%), information sources (2%), and perceptions of discrimination (2%). Involving various members of the primary care team in colorectal cancer screening processes, and using reminders with feedback, were identified as promising avenues for future interventions in the safety-net setting. Patients and providers cited the lack of referral sources for colonoscopy for follow-up of abnormal fecal occult blood tests (FOBT), and lack of treatment sources as major barriers to the initiation of colorectal cancer screening in uninsured populations., Conclusions: Organizational level interventions, such as a team approach to colorectal cancer screening, are important areas identified for future colorectal cancer screening interventions in the safety-net primary care setting. Larger policy efforts to provide coverage for screening, diagnosis, and treatment among the uninsured are critical to implementing adequate colorectal cancer screening for this population., (Copyright 2004 The Institute for Cancer Prevention and Elsevier Inc.)

Objective: to assess the effectiveness of patient-targeted interventions in increasing mammography use when performed outside (outreach) or inside the primary care medical setting (inreach)., Methods: We performed a meta-analysis of controlled interventions to increase mammography use in patients in the United States published between 1980 and February 2001. Interventions were classified by setting (inreach or outreach), mechanism of action (behavioral, cognitive, sociologic, or a combination), type of control group (active or usual care), number of strategies, and mode of delivery (static or interactive). Summary estimates were calculated with DerSimonian and Laird random effects models for each group of interventions., Results: We included 66 studies with 98 separate interventions. Inreach and outreach interventions were equally effective in increasing mammography use. Compared to active controls, behavioral interventions with multiple strategies increased mammography use by 14.0% (95% CI, 8.7-19.2) in inreach and 18.7% (95% CI, 4.9-32.4) in outreach settings. Theory-based educational strategies delivered interactively increased mammography use by 10.7% (95% CI, 6.8-14.7) and 19.9% (95% CI, 10.6-29.1) in inreach and outreach settings, respectively. Interventions that combined behavioral and theory-based educational strategies with usual care controls increased mammography use by 14.0% (95% CI, 7.9-20.2) in inreach and 27.3% (95% CI, 14.7-40.0) in outreach settings. Finally, sociologic interventions increased mammography use by 10.7% (95% CI, 3.4-18.0) and 9.1% (95% CI, 1.7-13.3) in inreach and outreach settings, respectively., Conclusions: Inreach and outreach interventions to increase mammography use were similarly effective within intervention categories based on mechanism of action, mode of delivery, and type of control group. Ultimate decisions about intervention strategies will depend on the characteristics of the target population, practical considerations, and relative cost-effectiveness.

Objective: To utilize health services research techniques in developing an episode of care using an administrative data set. This method is demonstrated for an episodic clinical condition, migraine., Data Sources: Medicaid administrative data set of 3,372 patients with a diagnosis of migraine (ICD-9-CM 346.0, 346.1) in the state of Pennsylvania between May 1990 and March 1992., Study Design: The duration of a migraine episode was measured by assessing the magnitude of resource utilization and the proportion of patients with charges in the period after the index migraine as compared to the period before the index migraine. A confidence interval (CI) was developed around each measure using bootstrap techniques., Data Collection Methods: All charge data were extracted daily for a 113-day observation period surrounding each index migraine in order to observe the duration of impact of a migraine diagnosis on resource utilization., Principal Findings: The lower limits of both the 95% and 99% CIs for the difference in charges are greater than 0 for three weeks. The lower limits of both CIs for the difference in the proportion of patients with charges are above 0 for six weeks., Conclusions: Our analysis demonstrates that a health services research framework can be used to define an episode of care for a chronic disease category such as migraine. This method can be used to evaluate episodes of care for clinical studies of limited or episodic conditions and to complement clinical expertise in developing time horizons for clinical trials.

Objective: The purpose of this study was to determine the effectiveness of interventions designed to improve follow-up after an abnormal Pap smear., Methods: We performed a qualitative meta-analysis of interventions designed to improve follow-up after an abnormal Pap smear and included studies that met the following criteria: randomized or concurrently controlled study design, defined outcomes, and data available for abstraction. Interventions were classified as behavioral, cognitive, sociologic, or combined strategies (e.g., behavioral and cognitive). Abnormal Pap smears were defined as any test result requiring additional follow-up. Effectiveness was measured by the rate of compliance with recommended follow-up., Results: Twenty-two interventions in 10 studies met the inclusion criteria. Cognitive interventions utilizing interactive telephone counseling were the most effective, improving compliance by 24 to 31%. Behavioral interventions, such as patient reminders, were also effective, increasing follow-up by up to 18%. Not all of these results achieved statistical significance. The single sociologic intervention we identified used video-taped peer discussions to provide a message about abnormal Pap smears and appropriate follow-up. This intervention was not associated with increased follow-up after an abnormal test. The effectiveness of interventions using multiple types of strategies to improve follow-up was inconsistent., Conclusions: Cognitive strategies led to the greatest improvement in compliance with follow-up of abnormal Pap smear screening tests. Extension of similar interventions to follow-up of abnormal breast and colon cancer screening, development of physician- and system-targeted interventions, and evaluation of the cost-effectiveness of these strategies are important priorities for future research., (Copyright 2000 American Health Foundation and Academic Press.)

The incidence of both breast and cervical cancer increases with age, and older socioeconomically disadvantaged and minority women are most likely to develop or die of these diseases. Early detection has the potential to decrease the disproportionate burden of disease in these vulnerable groups at a reasonable cost to society. Yet despite impressive overall gains in use of mammography and Pap smears, older women, especially older minority women, remain underrepresented in screening programs. Physician recommendation is one of the most powerful predictors of screening across all age, socioeconomic, and ethnic groups. The overwhelming majority of older women, make one or more physician visits each year, each of which represents an opportunity to screen for breast and cervical cancer. Although older women will accept screening if it is offered by their providers, physicians are less likely to offer it to them than to their younger, white patients. Conflicting professional recommendations for screening older women, leaving older women out of clinical trials of screening efficacy, competing causes of mortality with increasing age, and possible negative attitudes held by physicians and patients all contribute to the underscreening of older women. Cancer control challenges for the next century include defining groups of women most likely to benefit from screening (based on age, disease risk, competing mortality, and quality of life), improving regular use of early detection, educating providers, and conducting research on age-mediated differences in breast or cervical cancer biology that could affect screening recommendations.

Background: Barriers to cancer care have been documented in nearly all settings and populations; such barriers represent potentially avoidable morbidity or mortality. A conceptual framework was used to describe patient, provider, and system barriers to cancer services., Methods: A review of the English language literature on cancer care from 1980-1998 was conducted; key research was summarized for each domain in the conceptual model., Results: Key patient barriers are related to old age, minority race, and low socioeconomic class; the common pathways by which these sociodemographic factors appear to mediate cancer outcomes include social class and race-related or class-related attitudes. Providers are often ill-prepared to communicate the complexities of cancer care to their diverse patient populations; constraints of the medical care system also can impede the delivery of care. To the authors' knowledge the impact of the rapid growth in managed care organizations (MCOs) on access to care has yet to be evaluated fully. Although MCOs historically have provided high levels of cancer screening in healthy populations, to the authors' knowledge there are fewer data regarding outcomes for elderly and poor populations and for treatment services., Conclusions: Additional research is needed to develop and test interventions to overcome barriers to care and evaluate the impact of the growth of managed care on access to cancer care for diverse populations., (Copyright 1999 American Cancer Society.)

The objective of this study was to determine the effectiveness of interventions targeted at providers to enhance the use of mammography. We performed a meta-analysis and included United States studies that used a randomized or nonrandomized concurrent control design, had defined outcomes, and presented data that could be abstracted for reanalysis. Interventions were classified as behavioral, cognitive, or sociological and further categorized by the type of control group (active versus usual care). Data were combined using DerSimonian and Laird random effects models to yield summary effect sizes. Thirty-five studies met the inclusion criteria. All types of interventions targeted at providers were effective in increasing mammography rates. Behavioral interventions increased screening by 13.2% [95% confidence interval (CI), 7.8-18.4] as compared with usual care and by 6.8% (95% CI, 4.8-8.7) as compared with active controls. Cognitive intervention strategies improved mammography rates by 18.6% (95% CI, 12.8-24.4). Sociological interventions also had a similar magnitude of effect on screening rates (13.1% increase; 95% CI, 6.8-19.3). Interventions targeting both patients and providers were not significantly better at increasing screening than those targeting providers alone, and multiple approaches (e.g., behavioral and cognitive) were generally not more effective than a single approach. All interventions targeted at physicians were effective in increasing screening rates. Decisions to use a particular approach will depend on resources, expertise, feasibility, and cost effectiveness.

The objective of this study was to determine the effects of patient-based mammography screening strategies. We performed a meta-analysis and included United States studies that met the following criteria: (a) randomized or concurrent control design; (b) defined outcomes; and (c) data available for reanalysis. Interventions were classified as behavioral, cognitive, or sociological and further categorized by the type of control group (active versus usual care), number of interventions, and mode of intervention (interactive versus static). Data were combined using DerSimonian and Laird random effects models to yield summary effect sizes. A total of 63 interventions in 43 studies met the inclusion criteria. Behavioral interventions increased screening by 13.2% [95% confidence interval (CI), 4.7-21.2] compared with usual care, and by 13.0% (95% CI, 8.7-17.4) when using multiple strategies and 5.6% (95% CI, 0.6-10.6) when using a single intervention compared to active controls. Cognitive interventions using generic education strategies had little impact on screening, but those that used theory-based education (e.g., health belief model) increased rates by 23.6% (95% CI, 16.4-30.1) compared with usual care. Sociological interventions also increased screening rates. Interventions using a theoretical framework were the most effective in increasing screening rates. The ability of these interventions to increase screening among subgroups and improve rates of ongoing screening, as well as the costs of these strategies, is unknown and is an important area for future research.

Objective: To utilize health services research techniques in developing an episode of care using an administrative data set. This method is demonstrated for an episodic clinical condition, migraine., Data Sources: Medicaid administrative data set of 3,372 patients with a diagnosis of migraine (ICD-9-CM 346.0, 346.1) in the state of Pennsylvania between May 1990 and March 1992., Study Design: The duration of a migraine episode was measured by assessing the magnitude of resource utilization and the proportion of patients with charges in the period after the index migraine as compared to the period before the index migraine. A confidence interval (CI) was developed around each measure using bootstrap techniques., Data Collection Methods: All charge data were extracted daily for a 113-day observation period surrounding each index migraine in order to observe the duration of impact of a migraine diagnosis on resource utilization., Principal Findings: The lower limits of both the 95% and 99% CIs for the difference in charges are greater than 0 for three weeks. The lower limits of both CIs for the difference in the proportion of patients with charges are above 0 for six weeks., Conclusions: Our analysis demonstrates that a health services research framework can be used to define an episode of care for a chronic disease category such as migraine. This method can be used to evaluate episodes of care for clinical studies of limited or episodic conditions and to complement clinical expertise in developing time horizons for clinical trials.

Anecdotal evidence suggests that patients who have life-threatening conditions often choose to undergo high-cost, high-risk treatments for them. This kind of risk-seeking behavior seems irrational because most patients are risk-averse. The Health Stock Risk Adjustment (HSRA) model seeks to explain this phenomenon. The model is based on the concept of relative health stock--the ratio of patients' expected quality-adjusted life years (QALYs) after a diagnosis to their expected QALYs before the diagnosis. The model predicts risk-averse patients will behave in a risk-seeking manner as their relative health stocks deteriorate. The HSRA model can help physicians better understand why some seriously ill patients seek high-risk treatments while others elect to forgo treatment. State legislatures and insurers are attempting to appropriately design insurance benefits for patients with life-threatening conditions. The HSRA model can help predict which patients will most likely take advantage of these benefits.

Quality of life is used increasingly as a primary and secondary endpoint of clinical investigations of new therapies. Quality of life information may be especially useful for the assessment of cancer treatments, where increases in survival may be accompanied by detrimental side effects. The recognition of the importance of quality of life has led to the recent proliferation of cancer specific quality of life instruments. As more is understood about the heterogeneity of patient populations, however, we must assess how culturally defined factors may impact patient quality of life and its assessment. Quality of life instruments are diverse, ranging from those focusing on objective measures of functionality to those assessing subjective measures of patient preferences for their current health state. These instruments have been developed for use in the general population and for disease-specific populations. Assessment of the appropriateness of potential quality of life instruments in specific clinical settings, in addition to understanding the cultural diversity of the clinical population being studied, will guide the researcher in the choice of an appropriate quality of life instrument for cancer clinical trials.

Historically, new therapeutic strategies for cancer have been evaluated on the basis of safety and clinical efficacy. However, the current national emphasis on efficiency of resource allocation has led to the inclusion of economic assessments in oncology studies. Economic assessments measure patients' health status and resource consumption associated with a therapeutic strategy, and combine these in a cost-effectiveness analysis. Study design can include prospective analysis of clinical trials, retrospective analysis of a clinical trial or administrative databases, or a decision analytic model. Economic analysis is being used increasingly in oncology and will continue to provide meaningful data to assist clinicians in determining the optimal treatment strategies for cancer patients and to help inform health policy decision-makers about the importance of specific cancer therapeutic strategies.

Recent changes in the health care environment have led to the assessment of the costs and benefits of cancer treatment as criteria for the evaluation of new cancer therapies. The methodological framework for these assessments is provided by the field of clinical economics, a discipline that combines the techniques from clinical medicine, economics, epidemiology, and biostatistics. This article reviews the concepts of clinical economics and issues related to economic analysis of new therapies. This type of information is increasingly important to patients, clinicians, and health policy decision makers to help assure patients' access to effective cancer therapies.

Using analogous models of acute dermal vasculitis and alveolitis in rats, we have examined the role of oxygen-derived metabolities in the tissue damage associated with neutrophil influx into sites of immune complex deposition. In the lung, as previously reported, catalase and deferoxamine are highly protective, while superoxide dismutase (SOD) has a transient protective effect. The xanthine oxidase inhibitors, allopurinol, and lodoxamide, are also protective. In the skin, neither catalase (which has been covalently linked to the antibody) nor deferoxamine is protective, suggesting that H2O2 and iron are not absolutely required for the development of dermal vasculitis. In the skin, SOD, as well as the inhibitors of xanthine oxidase, have protective effects. These data suggest that the neutrophil-mediated pathways of immune complex injury in the dermal and pulmonary microvascular compartments are fundamentally different. As a measurement of neutrophil accumulation, measurements of myeloperoxidase in tissue extracts have been employed. In both the lung and skin, the protective effects of SOD and the xanthine oxidase inhibitors are paralleled by reductions in neutrophil influx into sites of injury. In contrast, catalase and deferoxamine have no effect on neutrophil accumulation. These data suggest that vascular beds in rat skin and lung are fundamentally different with respect to mechanisms of acute immune complex mediated injury. The data also provide evidence that O2- contributes significantly to the accumulation of neutrophils.

We have examined the role of intrapulmonary TNF in a rat model of acute immune complex-triggered alveolitis. Intratracheal instillation of IgG anti-bovine serum albumin (anti-BSA) followed by intravenous infusion of BSA results in acute alveolitis. Over the 4-h course of evolving lung injury, a 10-fold increase in TNF activity occurred in bronchoalveolar lavage (BAL) fluid. Immunohistochemical analysis of lung sections and BAL cells revealed that alveolar macrophages are the chief source of TNF. Antibodies that specifically neutralize rat TNF activity were raised in rabbits immunized with recombinant mouse TNF alpha. When administered into the lungs with anti-BSA, anti-TNF resulted in a marked reduction (up to 61%) in lung injury. Intratracheal instillation of exogenous TNF alone, or in combination with anti-BSA, resulted in an increase in lung injury compared to controls. Morphometric analysis and measurements of myeloperoxidase activities in whole lung extracts from rats treated with anti-TNF revealed a marked reduction in neutrophils compared to positive controls. The anti-TNF antibody preparation did not inhibit in vitro complement activation or diminish neutrophil chemotactic activity present in activated rat serum. These data indicate that intrapulmonary TNF activity is required for the full development of acute immune complex-triggered alveolitis, that alveolar macrophages are the primary source of this cytokine, and that TNF participates in the pathogenesis of immune complex alveolitis through a mechanism involving neutrophil recruitment.