Effectiveness of mailed letters to improve medication adherence among Medicare Advantage Plan participants with chronic conditions.

BACKGROUND: Medication adherence is associated with improved health outcomes in multiple chronic diseases. Information is needed on the effectiveness of specific adherence interventions. This study's objectives were to quantify effects of a targeted mailing intervention on adherence among older adults at risk for nonadherence, and to examine associations of individual and plan characteristics with adherence. MATERIALS AND METHODS: Among adults enrolled in a Medicare Advantage Plan with prescription drug coverage from May 2014 to June 2015, those identified as eligible for the mailing intervention had a late refill for oral antidiabetic medication, statin, angiotensin-converting enzyme inhibitor, or angiotensin receptor blocker medication and were previously unreachable by telephone. Pharmacy claims data were analyzed with the outcome of 6-month proportion of days covered (PDC) before and after the mailing. The t-test and chi-square analyses were used to evaluate univariate associations. Multivariable linear and logistic regression models were conducted to assess relative covariate effects. A sub-analysis of those with at least one medication fill post-mailing was also performed. RESULTS: A total of 460 non-adherent individuals aged 70±10.5 years, with 50.2% female and 66.7% white individuals, were included. Of those who were mailed a letter, 24.1% became adherent to the specified maintenance medication. Those who received >30-day supplies were more than twice as likely to become adherent after the mailed letter than those who received 30-day supplies or less (P<0.05). Baseline higher PDC was also associated with greater adherence post-mailing (P<0.01). A total of 284 (61.7%) individuals filled their medication at least once after the mailed letter; of those, 39.1% became adherent (mean [SD] change in PDC =0.15 [±0.28]). CONCLUSION: Our findings suggest that a single mailed letter improved medication adherence by 24.1% in adults with chronic conditions. As a health plan seeking to improve its customers' well-being and outcomes, Cigna continues to utilize targeted mail interventions to improve medication adherence.

Economic and Clinical Outcomes Resulting From the Stage 4 Chronic Kidney Disease Case Management Quality Improvement Initiative.

PURPOSE OF STUDY: Chronic kidney disease (CKD) is a costly and burdensome public health concern. The goal of this study was to evaluate the impact on outcomes and utilization of a pilot program to identify and engage beneficiaries with CKD at risk for progression from Stage 4 to Stage 5. PRIMARY PRACTICE SETTINGS: A quality improvement initiative was conducted to assess the impact of case management on costs and outcomes among 7,720 Cigna commercial medical beneficiaries with Stage 4 CKD enrolled in the United States between January 2012 and October 2012. METHODOLOGY AND SAMPLE: Claims data were analyzed to compare 3,861 beneficiaries randomized to receive condition-focused case management with 3,859 controls, with follow-up through July 2013. After using an algorithm to identify beneficiaries at highest risk of progression, a case management team implemented, among those assigned to the intervention, an evidence-based assessment tool, provided education and follow-up, engaged nephrologists and other providers, and conducted weekly rounds. Primary outcome measures were hospital admissions, emergency department visits, nephrologist visits, dialysis, arteriovenous (AV) fistula creation, and total medical costs. Analysis of variance techniques were used to test group differences. RESULTS: As compared with controls, intervention beneficiaries were 12% more likely to have fistula creation (p = .004). Intervention beneficiaries were observed to have savings of $199 per member per month (PMPM), F = 23.05, p = .04. This difference equated to 6% lower total medical costs in the intervention group. Savings observed were derived half from improved in-network utilization and half from reduced hospital costs. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: .

Lumbar fusion surgery for degenerative conditions is associated with significant resource and narcotic use 2 years postoperatively in the commercially insured: a medical and pharmacy claims study.

BACKGROUND: Chronic back pain is one of the costliest and most complex medical conditions to manage, involving physiological, psychological, mechanical, social, and environmental factors. An increasing trend of lumbar fusion (LF) surgery for chronic back pain continues despite conflicting evidence for pain relief or improved long-term outcomes. Our goal was to assess medical and pharmacy utilization (including continued use of pain medication) over a 2-year period among patients receiving LF to relieve back pain for degenerative conditions without instability. METHODS: We conducted a 2-year longitudinal cohort study of 1,422 commercially insured patients who received LF from January through September 2009, and who had continuous benefit eligibility through 2011. We assessed resource use among patients with ICD-9-CM diagnostic codes consistent with a degenerative condition, identified from Cigna's national claim database (CPT codes 22612, 22630 and/or 22558). Patients with fracture, tumor, infection, spondylolisthesis, inflammatory arthritis, or deformity diagnostic codes were excluded. RESULTS: Over the 2 years following LF, 992 patients (70%) incurred $9.0 million in additional medical claims payments which averaged $9,383 per patient. These payments included pain management interventions and long term therapy services in 30% of patients. A subset of 850 patients (60%) also had pharmacy benefits and 829 (97.5%) received multiple pain-related classes of medication over the same period. The majority of patients continued on chronic narcotic use (62.5%), and 95% of patients on narcotics preoperatively continued narcotic utilization at two years. This pharmacy benefit subset incurred an additional $2.2 million for pain-related medications at an average cost of $2,600 per patient. Total average payment for patients with combined medical and pharmacy benefits was $12,283. CONCLUSIONS: LF for patients with a degenerative lumbar diagnosis incurred significant resources postoperatively, and was followed by long-term pain and psychotropic medication utilization.

Cost drivers for breast, lung, and colorectal cancer care in a commercially insured population over a 6-month episode: an economic analysis from a health plan perspective.

AIMS: In the absence of clinical data, accurate identification of cost drivers is needed for economic comparison in an alternate payment model. From a health plan perspective using claims data in a commercial population, the objective was to identify and quantify the effects of cost drivers in economic models of breast, lung, and colorectal cancer costs over a 6-month episode following initial chemotherapy. RESEARCH DESIGN AND METHODS: This study analyzed claims data from 9,748 Cigna beneficiaries with diagnosis of breast, lung, and colorectal cancer following initial chemotherapy from January 1, 2014 to December 31, 2015. We used multivariable regression models to quantify the impact of key factors on cost during the initial 6-month cancer care episode. RESULTS: Metastasis, facility provider affiliation, episode risk group (ERG) risk score, and radiation were cost drivers for all three types of cancer (breast, lung, and colorectal). In addition, younger age (p < .0001) and human epidermal growth factor receptor-2 oncogene overexpression (HER2+)-directed therapy (p < .0001) were associated with higher costs in breast cancer. Younger age (p < .0001) and female gender (p < .0001) were also associated with higher costs in colorectal cancer. Metastasis was also associated with 50% more hospital admissions and increased hospital length of stay (p < .001) in all three cancers over the 6-month episode duration. Chemotherapy and supportive drug therapies accounted for the highest proportion (48%) of total medical costs among beneficiaries observed. CONCLUSIONS: Value-based reimbursement models in oncology should appropriately account for key cost drivers. Although claims-based methodologies may be further augmented with clinical data, this study recommends adjusting for the factors identified in these models to predict costs in breast, lung, and colorectal cancers.

Validity and reliability of the Patient-Reported Arthralgia Inventory: validation of a newly-developed survey instrument to measure arthralgia.

BACKGROUND: There is a need for a survey instrument to measure arthralgia (joint pain) that has been psychometrically validated in the context of existing reference instruments. We developed the 16-item Patient-Reported Arthralgia Inventory (PRAI) to measure arthralgia severity in 16 joints, in the context of a longitudinal cohort study to assess aromatase inhibitor-associated arthralgia in breast cancer survivors and arthralgia in postmenopausal women without breast cancer. We sought to evaluate the reliability and validity of the PRAI instrument in these populations, as well as to examine the relationship of patient-reported morning stiffness and arthralgia. METHODS: We administered the PRAI on paper in 294 women (94 initiating aromatase inhibitor therapy and 200 postmenopausal women without breast cancer) at weeks 0, 2, 4, 6, 8, 12, 16, and 52, as well as once in 36 women who had taken but were no longer taking aromatase inhibitor therapy. RESULTS: Cronbach's alpha was 0.9 for internal consistency of the PRAI. Intraclass correlation coefficients of test-retest reliability were in the range of 0.87-0.96 over repeated PRAI administrations; arthralgia severity was higher in the non-cancer group at baseline than at subsequent assessments. Women with joint comorbidities tended to have higher PRAI scores than those without (estimated difference in mean scores: -0.3, 95% confidence interval [CI] -0.5, -0.2; P<0.001). The PRAI was highly correlated with the Functional Assessment of Cancer Therapy-Endocrine Subscale item "I have pain in my joints" (reference instrument; Spearman r range: 0.76-0.82). Greater arthralgia severity on the PRAI was also related to decreased physical function (r=-0.47, 95% CI -0.55, -0.37; P<0.001), higher pain interference (r=0.65, 95% CI 0.57-0.72; P<0.001), less active performance status (estimated difference in location (-0.6, 95% CI -0.9, -0.4; P<0.001), and increased morning stiffness duration (r=0.62, 95% CI 0.54-0.69; P<0.0001). CONCLUSION: We conclude that the psychometric properties of the PRAI are satisfactory for measuring arthralgia severity.

Determinants of health after hospital discharge: rationale and design of the Vanderbilt Inpatient Cohort Study (VICS).

BACKGROUND: The period following hospital discharge is a vulnerable time for patients when errors and poorly coordinated care are common. Suboptimal care transitions for patients admitted with cardiovascular conditions can contribute to readmission and other adverse health outcomes. Little research has examined the role of health literacy and other social determinants of health in predicting post-discharge outcomes. METHODS: The Vanderbilt Inpatient Cohort Study (VICS), funded by the National Institutes of Health, is a prospective longitudinal study of 3,000 patients hospitalized with acute coronary syndromes or acute decompensated heart failure. Enrollment began in October 2011 and is planned through October 2015. During hospitalization, a set of validated demographic, cognitive, psychological, social, behavioral, and functional measures are administered, and health status and comorbidities are assessed. Patients are interviewed by phone during the first week after discharge to assess the quality of hospital discharge, communication, and initial medication management. At approximately 30 and 90 days post-discharge, interviewers collect additional data on medication adherence, social support, functional status, quality of life, and health care utilization. Mortality will be determined with up to 3.5 years follow-up. Statistical models will examine hypothesized relationships of health literacy and other social determinants on medication management, functional status, quality of life, utilization, and mortality. In this paper, we describe recruitment, eligibility, follow-up, data collection, and analysis plans for VICS, as well as characteristics of the accruing patient cohort. DISCUSSION: This research will enhance understanding of how health literacy and other patient factors affect the quality of care transitions and outcomes after hospitalization. Findings will help inform the design of interventions to improve care transitions and post-discharge outcomes.

Time course of arthralgia among women initiating aromatase inhibitor therapy and a postmenopausal comparison group in a prospective cohort.

BACKGROUND: More than 80,000 postmenopausal breast cancer patients in the United States each year are estimated to begin a 5-year course of aromatase inhibitors (AIs) to prevent recurrence. AI-related arthralgia (joint pain and/or stiffness) may contribute to nonadherence, but longitudinal data are needed on arthralgia risk factors, trajectories, and background in postmenopause. This study sought to describe 1-year arthralgia trajectories and baseline covariates among patients with AI and a postmenopausal comparison group. METHODS: Patients initiating AIs (n = 91) were surveyed at the time of AI initiation and at 6 repeated assessments over 1 year. A comparison group of postmenopausal women without breast cancer (n = 177) completed concomitantly timed surveys. Numeric rating scales (0-10) were used to measure pain in 8 joint pair groups (bilateral fingers, wrists, elbows, shoulders, hips, knees, ankles, and toes). Poisson regression models were used to analyze arthralgia trajectories and risk factors. RESULTS: By week 6, the AI-initiating group had more severe arthralgia than did the comparison group (ratio of means = 1.8, 95% confidence interval = 1.24-2.7, P = .002), adjusting for baseline characteristics. Arthralgia then worsened further over 1 year in the AI group. Menopausal symptom severity and existing joint-related comorbidity at baseline among women initiating AI were associated with more severe arthralgia over time. CONCLUSIONS: Patients initiating AI should be told about the timing of arthralgia over the first year of therapy, and advised that it does not appear to resolve over the course of a year. Menopausal symptoms and joint-related comorbidity at AI initiation can help identify patients at risk for developing AI-related arthralgia.

Measuring social health in the patient-reported outcomes measurement information system (PROMIS): item bank development and testing.

PURPOSE: To develop a social health measurement framework, to test items in diverse populations and to develop item response theory (IRT) item banks. METHODS: A literature review guided framework development of Social Function and Social Relationships sub-domains. Items were revised based on patient feedback, and Social Function items were field-tested. Analyses included exploratory factor analysis (EFA), confirmatory factor analysis (CFA), two-parameter IRT modeling and evaluation of differential item functioning (DIF). RESULTS: The analytic sample included 956 general population respondents who answered 56 Ability to Participate and 56 Satisfaction with Participation items. EFA and CFA identified three Ability to Participate sub-domains. However, because of positive and negative wording, and content redundancy, many items did not fit the IRT model, so item banks do not yet exist. EFA, CFA and IRT identified two preliminary Satisfaction item banks. One item exhibited trivial age DIF. CONCLUSION: After extensive item preparation and review, EFA-, CFA- and IRT-guided item banks help provide increased measurement precision and flexibility. Two Satisfaction short forms are available for use in research and clinical practice. This initial validation study resulted in revised item pools that are currently undergoing testing in new clinical samples and populations.

Spine and pain clinics serving North Carolina patients with back and neck pain: what do they do, and are they multidisciplinary?

STUDY DESIGN: Cross-sectional survey. OBJECTIVE: Our primary objective was to describe spine and pain clinics serving North Carolina residents with respect to organizational characteristics. Our secondary objective was to assess the multidisciplinary nature of the clinics surveyed. SUMMARY OF BACKGROUND DATA: Pain clinics have become common in the United States, and patients with chronic back pain have increasingly been seeking services at these clinics. Little is known about the organizational characteristics of spine and pain clinics. METHODS: We identified and surveyed spine and pain clinics serving North Carolina residents with chronic back and neck pain. Practice managers at 46 clinics completed a 20-minute questionnaire about the characteristics of their clinic, including providers on staff and services offered. Descriptive and exploratory analyses were conducted to summarize the data. Several variables were constructed to assess the multidisciplinary nature of the clinics. RESULTS: The response rate was 75%. There was marked heterogeneity among the clinics surveyed. Fifty-nine percent of practices were free-standing (n = 27) and 61% were physician-owned (n = 28). Twenty-five clinics (54%) had an anesthesiologist. Other common physician providers were physiatrists and surgeons. Less than one third of sites had mental health providers (n = 12; 26%); only 26% employed physical therapists. Seventy-six percent of sites offered epidural injections, 74% long-term narcotic prescriptions, and 67% antidepressants. The majority of clinics (30 of 33) prescribing narcotics provided monitoring of therapy using periodic urine toxicology testing. Forty-eight percent of sites (n = 22) offered exercise instruction. Few clinics were multidisciplinary in nature. Only 3 (7%) met the criteria of having a medical physician, registered nurse, physical therapist, and mental health specialist. CONCLUSION: Clinics varied widely in their organizational characteristics, including providers and scope of services available. Few clinics were multidisciplinary in nature. This information should be used to determine how pain clinics can better serve patients and improve outcomes.

The rising prevalence of chronic low back pain.

BACKGROUND: National or state-level estimates on trends in the prevalence of chronic low back pain (LBP) are lacking. The objective of this study was to determine whether the prevalence of chronic LBP and the demographic, health-related, and health care-seeking characteristics of individuals with the condition have changed over the last 14 years. METHODS: A cross-sectional, telephone survey of a representative sample of North Carolina households was conducted in 1992 and repeated in 2006. A total of 4437 households were contacted in 1992 and 5357 households in 2006 to identify noninstitutionalized adults 21 years or older with chronic (>3 months), impairing LBP or neck pain that limits daily activities. These individuals were interviewed in more detail about their health and health care seeking. RESULTS: The prevalence of chronic, impairing LBP rose significantly over the 14-year interval, from 3.9% (95% confidence interval [CI], 3.4%-4.4%) in 1992 to 10.2% (95% CI, 9.3%-11.0%) in 2006. Increases were seen for all adult age strata, in men and women, and in white and black races. Symptom severity and general health were similar for both years. The proportion of individuals who sought care from a health care provider in the past year increased from 73.1% (95% CI, 65.2%-79.8%) to 84.0% (95% CI, 80.8%-86.8%), while the mean number of visits to all health care providers were similar (19.5 [1992] vs 19.4 [2006]). CONCLUSIONS: The prevalence of chronic, impairing LBP has risen significantly in North Carolina, with continuing high levels of disability and health care use. A substantial portion of the rise in LBP care costs over the past 2 decades may be related to this rising prevalence.

Exercise prescription for chronic back or neck pain: who prescribes it? who gets it? What is prescribed?

OBJECTIVE: To describe exercise prescription in routine clinical practice for individuals with chronic back or neck pain because, although current practice guidelines promote exercise for chronic back and neck pain, little is known about exercise prescription in routine care. METHODS: We conducted a computer-assisted telephone survey of a representative sample of individuals (n = 684) with chronic back or neck pain who saw a physician, chiropractor, and/or physical therapist (PT) in the past 12 months. Individuals were asked about whether they were prescribed exercise, the amount of supervision received, and the type, duration, and frequency of the prescribed exercise. Descriptive and multivariable regression analyses were conducted. RESULTS: Of the 684 subjects, 48% were prescribed exercise. Of those prescribed exercise, 46% received the prescription from a PT, 29% from a physician, 21% from a chiropractor, and 4% from other. In multivariable analyses, seeing a PT or a chiropractor were the strongest predictors of exercise prescription. The likelihood of exercise prescription was increased in women, those with higher education, and those receiving worker's compensation. PTs were more likely to provide supervision and prescribe strengthening exercises compared with physicians and chiropractors, and were more likely to prescribe stretching exercises compared with physicians. CONCLUSION: Our findings suggest that exercise is being underutilized as a treatment for chronic back and neck pain and, to some extent, that the amount of supervision and types of exercises prescribed do not follow current practice guidelines. Exercise prescription provided by PTs appears to be most in line with current guidelines.

Content validity in the PROMIS social-health domain: a qualitative analysis of focus-group data.

PURPOSE: Our aim was to assess the content validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) social health item banks by comparing a prespecified conceptual model with concepts that focus-group participants identified as important social-health-related outcomes. These data will inform the process of improving health-related quality-of-life measures. METHODS: Twenty-five patients with a range of social limitations due to chronic health conditions were recruited at two sites; four focus groups were conducted. Raters independently classified participants' statements using a hierarchical, nested schema that included health-related outcomes, role performance, role satisfaction, family/friends, work, and leisure. RESULTS: Key themes that emerged were fulfilling both family and work responsibilities and the distinction between activities done out of responsibility versus enjoyment. Although focus-group participants identified volunteerism and pet ownership as important social-health-related concepts, these were not in our original conceptual model. The concept of satisfaction was often found to overlap with the concept of performance. CONCLUSION: Our conceptual model appears comprehensive but is being further refined to more appropriately (a) distinguish between responsibilities versus discretionary activities, and (b) situate the outcome of satisfaction as it relates to impairment in social and other domains of health.

Racial differences in pain during 1 year among women with metastatic breast cancer: a hazards analysis of interval-censored data.

BACKGROUND: Longitudinal tumor-specific studies of cancer pain across the disease trajectory provide insight into the course of pain. Information on pain predictors refines our understanding of patients with greatest distress and need. METHODS: The authors studied 1124 women with metastatic breast cancer and bone metastases, all of whom received standard treatment in an international clinical trial conducted from October 1998 to January 2001. The Brief Pain Inventory (BPI) was administered repeatedly during the course of 1 year. Hazard models were fitted to identify baseline and time-dependent covariates as predictors of pain worsening within cumulative 80-day intervals during the year. RESULTS: Increased severe pain hazards were associated with non-Caucasian race (hazard ratio [HR] = 2.52; 95% CI, 1.69-3.76), restricted performance status (HR = 1.73; 95% CI, 1.13-2.64), and radiation therapy in a previous interval (HR = 2.86; 95% CI, 1.61-5.09). Estimated cumulative rates for not yet reaching a BPI score of 7 or above ranged from 0.79 (0.72-0.85) in the first interval to 0.64 (0.55-0.74) in the last interval for non-Caucasian women, whereas these rates ranged from 0.91 (0.89-0.93) to 0.84 (0.81-0.87) for Caucasian women. CONCLUSIONS: By using a time-to-event hazards analysis for cancer symptom data, the authors demonstrated that non-Caucasian race predicted poorer pain control among women with metastatic breast cancer. Disparity findings from cross-sectional studies were confirmed. Pain management strategies should take race into account as a risk factor for worsening pain outcomes, and further investigation should seek to uncover and resolve the reasons for this obvious disparity.

Hazards for pain severity and pain interference with daily living, with exploration of brief pain inventory cutpoints, among women with metastatic breast cancer.

Few longitudinal studies have assessed risk factors for pain outcomes in tumor-specific populations. Such studies are needed to improve clinical practice guidelines for cancer pain management over the course of treatment. Among patients with metastatic breast cancer, we assessed the impact of baseline clinical and demographic risk factors on patients reaching different pain severity and interference scores. We analyzed data originally collected in a clinical trial of two bisphosphonate therapies. Pain was measured by the Brief Pain Inventory (BPI) severity and interference with daily living 0-10 subscales. We fit univariate (per-cutpoint) and multivariate (cutpoints 3, 4, 5, 6, and 7 on the BPI) proportional hazards models to identify predictors of pain outcomes over 51 weeks among 1,124 women with metastatic breast cancer. Predictors included race, age, education, geographic region, performance status, chemotherapy versus hormonal therapy only, time from first bone metastasis to randomization, and previous skeletal-related event (SRE, e.g., fractures, spinal cord compression). Non-Caucasian women had greater hazards for reaching higher cutpoints (5 and above) on the severity scale than Caucasian women (hazard ratio [HR] for cutpoint 5 interaction term=1.76; 95% confidence interval [CI]=1.37-2.26). For the interference scale, these hazards were greater for those patients with restricted (versus active) baseline Eastern Cooperative Oncology Group (ECOG) performance status (HR for cutpoint 5 interaction term=2.51; 95% CI=2.01-3.13). In the multivariate severity model, other factors associated with higher pain severity were restricted baseline ECOG performance status, previous SRE, and not being employed full-time at baseline (HRs=1.70, 1.23, and 1.33, respectively). Our findings that non-Caucasian race and restricted performance status were associated with greater pain hazards over time confirm previous cross-sectional findings that these characteristics are pain risk factors. Because we found that the most influential demographic and clinical baseline factors had predictive value for worsening outcomes as early as cutpoint 5, we recommend that pain management strategies use cutpoints informed by risk factors for worsening outcomes as cues for earlier intervention, thus delaying or preventing worst pain among women with metastatic disease who are at greatest risk.

Effects of skeletal morbidities on longitudinal patient-reported outcomes and survival in patients with metastatic prostate cancer.

GOALS OF WORK: Patients with prostate cancer metastasized to bone frequently experience skeletal morbidities as a result of their disease. We sought to quantify the longitudinal effects on patient-reported outcomes of skeletal-related events (SREs) and to ascertain the declines in health-related quality of life (HRQOL) and pain experienced by patients who experienced SREs. MATERIALS AND METHODS: Data are from a clinical trial for the treatment of SREs associated with advanced prostate cancer metastatic to bone. Outcome measures included the Functional Assessment of Cancer Therapy-General (FACT-G) and the Brief Pain Inventory. Among patients who survived 6 months after randomization, patients with no SREs in the initial 6 months after randomization were matched via propensity scores with those experiencing one or more SREs. Similarly, patients with one SRE were matched with a subset of patients with two or more SREs. MAIN RESULTS: Patients with SREs in the initial period had significantly worse survival and HRQOL than those with no SREs. Significant differences were found between the pain differences, FACT-G total scores, and FACT-G physical, emotional, and functional subscales. Comparisons of patients with single vs multiple SREs showed similar patterns. CONCLUSIONS: The presence of SREs is significantly associated with worse survival and poorer HRQOL in this patient population. Increasing SRE intensity shows a pattern of increasingly decreased survival and poorer HRQOL.

Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials.

BACKGROUND: There is concern that patients with poor numeracy may have difficulty understanding the information necessary to make informed treatment decisions. The authors sought to characterize a special form of numeracy among patients with advanced cancer who were offered participation in Phase I oncology clinical trials. METHODS: Surveys were administered to 328 cancer patients who were considering Phase I trials. Their frequency-type numeracy was assessed using a multiple-choice question involving a hypothetical scenario in which a physician stated that an experimental treatment would control cancer in "40% of cases like yours." In univariate and multivariable analyses, patient characteristics that were associated with better numeracy were identified. RESULTS: The correct frequency-type interpretation was selected by 72% of respondents. Fourteen percent of respondents incorrectly selected a belief-type answer, "The doctor is 40% confident that the treatment will control my cancer." In a multivariable model, patients who answered incorrectly tended to have less formal education and less experience with experimental therapies. CONCLUSIONS: Because the misunderstandings some patients demonstrated may influence their treatment decision making adversely, it is critical to identify such patients and to give them special consideration when communicating information about potential risks and benefits of treatment.

An exploration of relative health stock in advanced cancer patients.

OBJECTIVE: The authors sought to empirically test whether relative health stock, a measure of patients' sense of loss in their health due to illness, influences the treatment decisions of patients facing life-threatening conditions. Specifically, they estimated the effect of relative health stock on advanced cancer patients' decisions to participate in phase I clinical trials. METHOD: A multicenter study was conducted to survey 328 advanced cancer patients who were offered the opportunity to participate in phase I trials. The authors asked patients to estimate the probabilities of therapeutic benefits and toxicity, their relative health stock, risk preference, and the importance of quality of life. RESULTS: Controlling for health-related quality of life, an increase in relative health stock by 10 percentage points reduced the odds of choosing to participate in a phase I trial by 16% (odds ratio = 0.84, 95% confidence interval = 0.72, 0.97). CONCLUSION: Relative health stock affects advanced cancer patients' treatment decisions.

Health-related quality of life among patients with breast cancer receiving zoledronic acid or pamidronate disodium for metastatic bone lesions.

BACKGROUND: Research on individual differences in health-related quality of life (HRQOL) can identify intervention targets and important covariates in analyses of treatment outcomes. OBJECTIVES: The objectives of this study were to describe HRQOL trajectories for women with metastatic breast cancer in a randomized trial of bisphosphonates and to identify characteristics associated with variations in HRQOL. RESEARCH DESIGN: We conducted a prospective quality-of-life study within a randomized, controlled trial. SUBJECTS: We studied women with metastatic breast cancer receiving zoledronic acid or pamidronate disodium to reduce the incidence of skeletal-related events (SREs). MAIN OUTCOME MEASURES: HRQOL was measured at fixed time points during the trial. Individual growth-curve modeling was used to describe longitudinal trajectories and to identify predictors of trajectories. RESULTS: For most domains of HRQOL, the mean trajectory reflected a mild increase, which leveled off later in the trial. Older age and full-time employment were associated with higher baseline HRQOL. Longer time from cancer diagnosis to randomization, lower Eastern Cooperative Oncology Group (ECOG) status (score of 2 ["inactive"]), and a history of SREs were associated with lower baseline HRQOL. Significant differences across geographic regions were observed for all domains. Active ECOG status (score of 0-1) at baseline was predictive of greater increases in all domains of HRQOL except Social/Family Well-Being. Age, geographic region, and time from first bone metastases to randomization were associated with longitudinal changes in some domains. CONCLUSIONS: Women with metastatic breast cancer receiving bisphosphonates for prevention of SREs experienced an overall increase in HRQOL. Variations among women's experiences are explained partly by such characteristics as a history of SREs.

The correlation between patient characteristics and expectations of benefit from Phase I clinical trials.

BACKGROUND: Patients in Phase I clinical trials sometimes report high expectations regarding the benefit of treatment. The authors examined a range of patient characteristics to determine which factors were associated with greater expectations of benefit from Phase I trials. METHODS: Participants were adult patients with cancer who had been offered participation in Phase I studies and had decided to participate. Patients completed interviewer-administered surveys before initiation of treatment. Physicians assessed Eastern Cooperative Oncology Group performance status for each patient. Statistical analyses (Pearson product moment correlation and t tests) used multiple imputation to account for missing data. RESULTS: Overall, 593 patients who were offered participation in Phase I trials were contacted, and 328 patients agreed to participate in a study of decision making by cancer patients. Of these, 260 patients (79%) enrolled in a Phase I trial. Patients' expectations regarding the chance that their disease would be controlled with experimental therapy were unrelated to age, gender, living situation, education level, or functional status. Expectations were correlated positively with beliefs about the benefit of standard therapy and the maximum benefit patients may experience from experimental therapy. Greater expectations of benefit were associated with better health-related quality of life, stronger religious faith, optimism, relative health stock, monetary risk seeking, and poorer numeracy. CONCLUSIONS: Expectations expressed as beliefs in personal outcomes may be related more to quality of life and personality variables than to patients' knowledge or functional status. Whether such expectations are accurate reflections of knowledge has important implications for evaluating the informed consent process.

Toward estimating the impact of changes in immigrants' insurance eligibility on hospital expenditures for uncompensated care.

BACKGROUND: The Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996 gave states the option to withdraw Medicaid coverage of nonemergency care from most legal immigrants. Our goal was to assess the effect of PRWORA on hospital uncompensated care in the United States. METHODS: We collected the following state-level data for the period from 1994 through 1999: foreign-born, noncitizen population and health uninsurance rates (US Census Current Population Survey); percentage of teaching hospitals (American Hospital Association Annual Survey of Hospitals); and each state's decision whether to implement the PRWORA Medicaid bar for legal permanent residents or to continue offering nonemergency Medicaid coverage using state-only funds (Urban Institute). We modeled uncompensated care expenditures by state (also from the Annual Survey of Hospitals) in both univariate and multivariable regression analyses. RESULTS: When measured at the state level, there was no significant relationship between uncompensated care expenditures and states' percentage of noncitizen immigrants. Uninsurance rates were the only significant factor in predicting uncompensated hospital care expenditures by state. CONCLUSIONS: Reducing the number of uninsured patients would most surely reduce hospital expenditures for uncompensated care. However, data limitations hampered our efforts to obtain a monetary estimate of hospitals' financial losses due specifically to the immigrant eligibility changes in PRWORA. Quantifying the impact of these provisions on hospitals will require better data sources.