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Objective: The present study established the psychometric properties of the Functional Assessment of Cancer Therapy-Neutropenia (FACT-N), a self-report instrument to assess neutropenia-specific concerns and health-related quality of life (HRQL), in a sample of adults 65 years of age and older.Materials and Methods: Participants were undergoing chemotherapy for lung, breast, or ovarian cancer or non-Hodgkin's lymphoma (n = 852) and were randomly assigned to receive pegfilgrastim beginning with cycle 1 (primary prophylaxis) or pegfilgrastim subsequent to cycle 1 at their clinicians' discretion (usual care). Participants completed a self-report assessment on day 1 of each cycle (up to six cycles) and at the expected nadir of the white blood cell count of each cycle. Using factor analysis, three subscales were identified in the 19-item FACT-N subscale: Malaise, Worry, and Flu-like symptoms.Results and Discussions: The FACT-N and each of the subscales were sensitive to the presence of neutropenia although did not correlate with the absolute neutrophil count (ANC). While ANC is a marker of the impact of chemotherapy on the myeloid precursors of the bone marrow and is correlated with risk of febrile neutropenia, however the constellation of symptoms and patient experience vary throughout the period of neutropenia as the ANC first declines and then recovers. The 19-item neutropenia subscale can be used alone; however, evidence supporting reliability and validity was most robust for aggregate scores from the FACT-N and the Trial Outcome Index-Neutropenia (TOI-N).Conclusion: Understanding the impact of neutropenia on HRQL through the availability of a validated self-report measure will, ideally, lead to interventions to reduce the burden associated with cancer and its treatments. [ABSTRACT FROM AUTHOR]

For the past six years, the Chicago-area faith-based Reach Out Consortium has mobilized low-income uninsured and underinsured African American women and Latinas to seek screening for breast and cervical cancer. The funding history for this program illustrates how funds for a small community-based program were leveraged into a broader program, and that grew to serve low-income women across the state. Further, as the program reached more and more uninsured women, community activism led to a further state investment in services for the uninsured. Program sustainability and expansion depended on a combination of public and private competitive grants and grassroots advocacy. [ABSTRACT FROM AUTHOR]

Objective: Health-related quality of life (HRQOL) impairment may be a central component of chronic prostatitis for men afflicted with this condition. Our objective was to examine HRQOL, and factors associated with HRQOL, using both general and condition-specific instruments.Design: Chronic Prostatitis Cohort (CPC) study.Setting: Six clinical research centers across the United States and Canada.Participants: Two hundred seventy-eight men with chronic prostatitis.Measurements and Main Results: The Short Form 12 (SF-12) Mental Component Summary (MCS) and Physical Component Summary (PCS), and the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) were measures used. CPC subjects' MCS scores (44.0 +/- 9.8) were lower than those observed in the most severe subgroups of patients with congestive heart failure and diabetes mellitus, and PCS scores (46.4+/-9.5) were worse than those among the general U.S. male population. Decreasing scores were seen in both domains with worsening symptom severity (P < .01). History of psychiatric disease and younger age were strongly associated with worse MCS scores, whereas history of rheumatologic disease was associated with worse PCS scores. Predictors of more severe NIH-CPSI scores included lower educational level and lower income; history of rheumatic disease was associated with higher scores.Conclusions: Men with chronic prostatitis experience impairment in the mental and physical domains of general HRQOL, as well as condition-specific HRQOL. To optimize the care of men with this condition, clinicians should consider administering HRQOL instruments to their patients to better understand the impact of the condition on patients' lives. [ABSTRACT FROM AUTHOR]

Background: Individualized breast cancer risk assessment can identify women at increased risk who are candidates for interventions with proven benefit, including chemoprevention, enhanced surveillance, genetic testing and risk-reducing surgery. Systematic risk assessment and prescription of individualized, risk-adapted cancer control recommendations provides a novel method for addressing cancer disparities in underserved minority women. Widespread dissemination of these approaches requires implementation in the primary care setting. Purpose: to determine potential benefits and harms of a policy for routinely providing personalized breast cancer risk assessment for underserved minority women from the perspectives of patients and primary care providers (PCPs), and to explore ethical implications of breast cancer risk communication in this patient population. Methods: African American and Hispanic women age 25-69 years without a history of breast cancer, presenting for a routine scheduled appointment with their primary provider at a Federally Qualified Health Center were invited to participate in a study on women's views about breast cancer risk. Breast cancer risk factor data was collected from all participants and individualized risk assessments were performed using three models (NCI BCRAT, Claus model and a pedigree assessment tool). PCPs discussed the results of the assessment with their patients and provided computer-generated, risk-adapted recommendations for screening and prevention that are based on national guidelines. Using a mixed methods approach, we collected quantitative survey data from participants at baseline (prior to receipt of risk information), immediately following the encounter with their PCP and two weeks later. We also used qualitative approaches in a subgroup of participants from each of three risk strata (general population risk, moderately-increased and high risk) including audio-recorded observational data from physician-patient interactions and in-depth interviews with patients and physicians in order to evaluate how women process risk information and make decisions regarding how to act on that information. Data collected broadly focused on the following topics: * Interpretation and initial reaction to the personalized risk information provided by the PCP * What it means to be "at (baseline, moderate, high) risk" * Views on value of/potential benefits and harms of personalized risk information * Level of trust in the information * Preferences regarding recommended surveillance strategies and risk reduction strategies (for moderate and high risk groups) * Preferences regarding shared decision making * Future plans/action steps based on personalized risk information * Perceptions of the manner that personalized risk information was presented to them by their PCP Results: We are planning to enroll 480 participants for the quantitative survey portion and 48 participants for in-depth qualitative data collection, including audio-recorded patient-physician interactions and in-depth patient interviews, along with 8 in-depth provider interviews. Data collection is ongoing and results will be presented. [ABSTRACT FROM AUTHOR]

Purpose: The prominence of health related quality of life end points in international clinical research underscores the importance of well validated and translated measures to enable cross-cultural comparison. The National Institutes of Health (NIH)-Chronic Prostatitis Symptom Index (CPSI) assesses symptoms and health related quality of life in men with chronic nonbacterial, NIH type III prostatitis. To expand its use to Spanish speaking patients we performed a translation and linguistic validation., Materials and Methods: The 9-item NIH-CPSI was translated into Spanish according to a standard methodology of 2 forward translations, 1 reconciled version, back translation of the reconciled version and 3 independent reviews by bilingual experts. The purpose of this methodology was to create a single universal Spanish version that would be acceptable to native Spanish speakers inside and outside of the United States. After the translation process the Spanish version was pre-tested in Argentina, Mexico, Spain and the United States. Patient responses were analyzed to identify necessary modifications. The internal consistency of the CPSI was evaluated using Cronbach's alpha. Pearson's product moment correlations were used to evaluate construct validity., Results: Data were collected from chronic prostatitis patients, including 15 in Argentina, 15 in Mexico, 4 in the United States and 3 in Spain. The translation had high reliability overall and in all subscales (Cronbach's coefficient alpha = 0.81 to 0.94), and the subscales correlated well with each other (r = 0.76 to 0.97). However, patients expressed difficulty in distinguishing the response categories "a menudo" ("often") from "normalmente" ("usually") in question 3. We revised "a menudo" to "muchas veces" ("much of the time") and "normalmente" to "casi siempre" ("almost always") to improve the distinctiveness of response categories., Conclusions: The Spanish NIH-CPSI has high reliability as well as face and construct validity in Spanish speaking men from various countries. The Spanish NIH-CPSI permits cross-cultural comparisons of men with chronic nonbacterial prostatitis.

Objective: Health-related quality of life (HRQOL) impairment may be a central component of chronic prostatitis for men afflicted with this condition. Our objective was to examine HRQOL, and factors associated with HRQOL, using both general and condition-specific instruments., Design: Chronic Prostatitis Cohort (CPC) study., Setting: Six clinical research centers across the United States and Canada., Participants: Two hundred seventy-eight men with chronic prostatitis., Measurements and Main Results: The Short Form 12 (SF-12) Mental Component Summary (MCS) and Physical Component Summary (PCS), and the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) were measures used. CPC subjects' MCS scores (44.0 +/- 9.8) were lower than those observed in the most severe subgroups of patients with congestive heart failure and diabetes mellitus, and PCS scores (46.4+/-9.5) were worse than those among the general U.S. male population. Decreasing scores were seen in both domains with worsening symptom severity (P < .01). History of psychiatric disease and younger age were strongly associated with worse MCS scores, whereas history of rheumatologic disease was associated with worse PCS scores. Predictors of more severe NIH-CPSI scores included lower educational level and lower income; history of rheumatic disease was associated with higher scores., Conclusions: Men with chronic prostatitis experience impairment in the mental and physical domains of general HRQOL, as well as condition-specific HRQOL. To optimize the care of men with this condition, clinicians should consider administering HRQOL instruments to their patients to better understand the impact of the condition on patients' lives.

Purpose: While chemotherapy-related toxicities affect cancer patients' activities of daily living and result in large expenditures of medical care for treatment, few studies have assessed the out-of-pocket and indirect costs incurred by patients who experience toxicity. The objective of this study was to evaluate the feasibility of obtaining detailed and comprehensive cost information from patients who experienced neutropenia, thrombocytopenia, or neurotoxicity during treatment., Methods: Ovarian cancer patients who experienced chemotherapy-associated hematologic or neurologic toxicities were asked to record detailed information about hospitalization, laboratories, physician visits, phone calls, home visits, medication, medical devices, lost productivity, and caregivers. Resource estimates were converted into cost units, with direct medical cost estimates based on hospital cost-accounting data and indirect costs (i.e., productivity loss) on modified labor force, employment, and earnings data., Results: Direct medical costs were highest for neutropenia (mean of $7,546/episode), intermediate for thrombocytopenia (mean of $3,268/episode), and lowest for neurotoxicity (mean of $688/episode). Indirect costs relating to patient and caregiver work loss and payments for caregiver support were substantial, accounting for $4,220, $3,834, and $4,282 for patients who developed neurotoxicity, neutropenia, and thrombocytopenia, respectively. The total costs of chemotherapy-related neurotoxicity, neutropenia, and thrombocytopenia were $4,908, $11,830, and $7,550., Conclusion: Our study has shown that, with the assistance of patients who are experiencing toxicity, estimation of the total costs of cancer-related toxicities is feasible. Indirect costs, while not included in prior estimates of the costs of toxicity studies, accounted for 34% to 86% of the total costs of cancer supportive care.

Purpose: Chronic Prostatitis, or Chronic Pelvic Pain Syndrome [CPPS], is a common disorder characterized by pelvic pain and varying degrees of inflammation in expressed prostatic secretions (EPS). In search of markers to more clearly define CPPS, we compared proinflammatory cytokines interleukin-1beta (IL-1beta) and tumor necrosis factor-alpha (TNF-alpha) levels in EPS from men with CPPS, to healthy men and men with Benign Prostatic Hyperplasia (BPH)., Methods: 78 men: controls (n = 16), BPH (n = 14), CPPS IIIA [>/=10 white blood cells per high power field (WBC/hpf) in EPS] (n = 18), CPPS IIIB [<10 WBC/hpf in EPS] (n = 20), and asymptomatic inflammatory prostatitis (AIP) (n = 10) were evaluated for EPS WBC, and IL-1beta and TNF-alpha by ELISA., Results: IL-1beta and TNF-alpha levels in EPS were usually detectable in men with CPPS IIIA (89% and 45%, respectively) or AIP (90%; 100%), but less often in controls (31%; 17%), BPH (57%; 15%), and CPPS IIIB (35%; 15%) respectively. IL-1beta and TNF-alpha levels were higher in CPPS IIIA versus CPPS IIIB, and in AIP versus controls or BPH (p's <0.001). Cut-points for IL-1beta and TNF-alpha discriminated AIP from controls (predictive values = 94% and 83%, respectively) and CPPS IIIA from CPPS IIIB (predictive values 84% and 100%). Overall, there was a correlation between IL-1beta and TNF-alpha (p <0.003), but no correlation between WBC and IL-1beta (p <0.1) or TNF-alpha (p <0.50)., Conclusions: Cytokines are frequently present and elevated in the EPS from men with CPPS IIIA and AIP and provide a novel means for identification, characterization and potential management of men with CPPS that differs from traditional methods based on WBC.

Purpose: Chronic abacterial prostatitis is a syndrome characterized by pelvic pain and voiding symptoms, which is poorly defined, poorly understood, poorly treated and bothersome. Research and clinical efforts to help men with this syndrome have been hampered by the absence of a widely accepted, reliable and valid instrument to measure symptoms and quality of life impact. We developed a psychometrically valid index of symptoms and quality of life impact for men with chronic prostatitis., Materials and Methods: We conducted a structured literature review of previous work to provide a foundation for the new instrument. We then conducted a series of focus groups comprising chronic prostatitis patients at 4 centers in North America, in which we identified the most important symptoms and effects of the condition. The results were used to create an initial draft of 55 questions that were used for formal cognitive testing on chronic prostatitis patients at the same centers. After expert panel review formal validation testing of a revised 21-item draft was performed in a diverse group of chronic prostatitis patients and 2 control groups of benign prostatic hyperplasia patients and healthy men. Based on this validation study, the index was finalized., Results: Analysis yielded an index of 9 items that address 3 different aspects of the chronic prostatitis experience. The primary component was pain, which we captured in 4 items focused on location, severity and frequency. Urinary function, another important component of symptoms, was captured in 2 items (1 irritative and 1 obstructive). Quality of life impact was captured with 3 items about the effect of symptoms on daily activities. The 9 items had high test-retest reliability (r = 0.83 to 0.93) and internal consistency (alpha = 0.86 to 0.91). All but the urinary items discriminated well between men with and without chronic prostatitis., Conclusions: The National Institutes of Health chronic prostatitis symptom index provides a valid outcome measure for men with chronic prostatitis. The index is psychometrically robust, easily self-administered and highly discriminative. It was formally developed and psychometrically validated, and may be useful in clinical practice as well as research protocols.

Study Objectives: To determine whether physician experience and specialty influence the approach to care of AIDS patients with pneumonia, we surveyed physicians about their management of possible Pneumocystis carinii pneumonia (PCP) infection., Design, Setting, Participants: A postal survey was sent to a random sample of 1,500 internists and family physicians in the United States drawn from the American Medical Association master file who were identified by a pharmaceutical marketing company as having written prescriptions for AIDS-related agents in the previous year., Measurements and Results: The survey had a 53% response rate. Physicians more experienced in AIDS care were more likely to advocate diagnostic bronchoscopy over initiation of empiric anti-PCP therapy for HIV-infected patients with undiagnosed pulmonary infiltrates (odds ratio [OR], 1.4 for a patient with mild severity of illness [p = 0.02]; OR, 1.7 for a severely ill patient [p < 0.001]). Physician specialty and fee-for-service reimbursement were independently associated with higher rates of bronchoscopy, with internists favoring bronchoscopy more frequently than family physicians. High-experience providers and internists also predicted better clinical outcomes for the hypothetical patients., Conclusions: Our findings extend the observations about HIV experience and PCP prophylaxis to the setting of diagnosis and treatment. Physicians with higher levels of experience with AIDS, internists, and physicians reimbursed as fee-for-service providers are more likely to support diagnostic confirmation of PCP than empiric treatment approaches.

Physicians are frequently pressured to make therapeutic decisions within a cost-effective framework to demonstrate value to managed care. Because cancer is a chronic disease, health care costs are known to be expensive and physicians must use their resources as efficiently as possible. Historically, economic analyses in oncology have emphasized survival as their clinical end point. Today, both government groups and professional organizations are moving toward making quality of life the clinical end point in determining the economics of chemotherapy. This report evaluates the cost and efficacy of amifostine (Ethyol; Alza Pharmaceuticals, Palo Alto, CA/US Bioscience, West Conshohocken, PA) use in the treatment of advanced ovarian cancer using two pharmacoeconomic analyses. A cost-utility analysis performed in the United States indicated that inclusion of amifostine therapy had both a favorable clinical and cost-utility profile compared with other medical therapies. A second cost-benefit analysis, conducted in Canada, suggested that use of amifostine in patients with advanced ovarian cancer would be cost saving. Amifostine is a novel agent that protects against both chemotherapy- and radiotherapy-induced toxicities, such as nephrotoxicity, neutropenia, thrombocytopenia, peripheral neuropathy, mucositis, and xerostomia. These toxicities are disturbing to both patients and physicians alike. The results of these studies support the use of amifostine as a valuable resource both economically and clinically.

Background: We conducted a pilot study to evaluate issues related to chemotherapy-induced toxicities by eliciting assessments of toxicity from women with advanced stage ovarian cancer and gynecologic oncologists., Patients and Methods: Fifteen ovarian cancer patients and ten gynecologic oncologists completed the survey exercises. All patients surveyed had received at least six courses of a cisplatin-containing chemotherapy regimen., Results: For both patients and physicians, there was good face validity to the utility exercise as assessments of health states with cisplatin were (1) consistently associated with less favorable assessments than the health state with no toxicity and (2) neurotoxicity was viewed less favorably than either ototoxicity or nephrotoxicity. While the 15 patients as a group viewed health states with toxicity more favorably than physicians (P < 0.05 for each toxicity), patient assessments varied, depending on individual experiences with cisplatin. Physician assessments of toxicity were most similar to those obtained from patients who had not experienced cisplatin toxicity and were less favorable than those elicited from patients who had experienced any toxicity., Conclusions: In deciding upon therapeutic strategies, women with advanced stage ovarian cancer and treating physicians markedly differ in their assessment of the impact of specific toxicities on quality of life., (Copyright 1998 Academic Press.)