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Purpose of study Cigna's oncology case management programs identified the opportunity for case managers to integrate distress screening as recommended by the National Comprehensive Cancer Network (NCCN) in oncology populations. Our purpose in conducting this study was to quantify oncology case management program improvements as a result of using the NCCN Distress Screening Tool to guide telephonic case management. The program improvements we measured comprised more efficient identification of biopsychosocial problems and appropriate resource referrals. Primary practice setting Case managers in a large commercial health plan piloted integration of distress screening into telephonic case management among U.S. oncology customers experiencing a new diagnosis or care transition from September 2016 to April 2017. Methodology and sample A retrospective, matched case-control study was conducted among Cigna customers eligible for oncology case management. The pilot group of 317 received distress screening early in the oncology case management assessment. Outcomes included distress severity ranging from 0 to 10 (where 0 = no distress, 1-3 = mild, 4-7 = moderate, and 8-10 = severe), identification and number of biopsychosocial health problems, and percentage of direct resource referrals by case managers to supportive services. Results More than half (54%) of the screened customers reported mild or greater distress, and there was a strong correlation between degree of distress and average numbers of biopsychosocial health problems or direct resource referrals. Screened customers were 16% more likely to be referred to internal and external resources than customers not screened with the tool (66% vs. 50%, χp Implications for case management practice This study advances evidence-based oncology case management practice during care transitions by providing quantitative evidence for the utility of integrating the NCCN Distress Screening Tool into telephonic oncology case management. Using the tool (thermometer and problem list) to guide telephonic oncology case management and care coordination facilitated more tailored referrals to individuals with cancer enrolled in a large commercial health plan. On the basis of our findings, we integrated distress screening to address unmet biopsychosocial needs in patients with cancer.

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: The observed 12% increased rate of creation of AV fistulas and $199 (6%) decrease in PMPM cost between the intervention and control groups corresponded to a savings of more than $18 million in 2015 U.S. dollars (USD). On the basis of observation of substantial improvements in outcomes and cost savings, health plan administrators could better serve those at highest risk of progression by implementing focused case management. Our findings support the value of care coordination between nephrologists, providers, and health plan case managers in improving outcomes and reducing total medical costs among beneficiaries at risk for CKD progression from Stage 4 to Stage 5.

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.

Among Cigna’s claimant population with at least one year of continuous medical or pharmacy eligibility over 2014–2015 (N = 2.7 million), our objective was to accurately identify high-cost claimants and identify clinical and demographic cost drivers among individuals with commercial health plan benefits. High-cost claimants were defined as those with annual costs over $100,000. We collected 800+ potential risk factors and utilized multivariable weighted logistic regression on an oversampled model dataset to estimate odds ratios for clinical and demographic factors available in claims data. We used decision tree methodology to assist in variable selection/reduction. High-cost claimants (n = 17,702) comprised only 0.6% of the 2015–2016 population, but accounted for over 20% of 2015–2016 total costs. Our optimized maximum likelihood estimation model identified cost drivers including: actuarial prospective episode-related group (ERG) risk score, prior-year medical claim costs, prior-year pharmacy claim costs, gaps in care/noncompliance score, hemophilia, short stature, and end-stage renal disease. Our findings show that weighted logistic regression modeling with oversampling techniques can be used to identify high-cost claimants in the upcoming year more accurately than traditional maximum likelihood estimation. Managed care decision makers should use prospective claims data analyses to target and implement intervention programs, with the goal of managing care among those at risk for incurring catastrophic costs.

Amanda Mann,1 Tara W Esse,2 Omar Serna,2 Liana D Castel,3,4 Susan M Abughosh5 1Cigna-HealthSpring, Houston, TX, USA; 2CareAllies, Houston, TX, USA; 3Cigna Health and Life Insurance Company, Raleigh, NC, USA; 4Lundy-Fetterman School of Business, Campbell University, Buies Creek, NC, USA; 5Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, TX, USA 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

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.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.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.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.

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.

To develop a social health measurement framework, to test items in diverse populations and to develop item response theory (IRT) item banks.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).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.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.

Exercise is a common treatment for individuals with chronic low back or neck pain and is used to improve physical function and decrease symptoms (e.g., pain, stiffness). Exercise has also been used to minimize disability by decreasing individuals’ fears about pain during movement and by reshaping their attitudes and beliefs about their pain. The latter goal is common in cognitive behavioral and functional restoration programs that typically use a quota-based, non-pain contingent approach to exercise.1 In the past decade, a number of randomized trials, systematic reviews, and clinical practice guidelines have supported the use of exercise for the treatment of chronic low back pain (LBP) 2–14 and chronic neck pain.15–19 While there is still much to learn about the types and intensity of exercises that are most effective, recent meta-analyses by Hayden and colleagues suggest individually tailored, supervised exercise programs that include stretching and strengthening are associated with the best outcomes for individuals with chronic LBP.5, 6 Hayden et al. also found that exercise in combination with other conservative treatments and “high dose” exercise, defined as an exercise intervention with a total time of 20 hours or more, improved pain and function more than exercise alone or “low dose” exercise.6 The findings for chronic neck pain are similar, though somewhat less definitive, with data suggesting that certain types of exercise are most effective and supervised exercise is more effective than non-supervised exercise. According to evidence statements on the treatment of chronic neck pain published by the Bone and Joint Decade 2000–2010 Task Force on Neck Pain, supervised and home exercise plus advice is marginally more effective than advice alone for chronic whiplash associated disorders; a neck exercise program alone or in combination with spinal manipulation is more effective than spinal manipulation alone, TENS, or usual care for chronic “non-specific” neck pain; and both endurance (repetitive, submaximal resistance exercises) and strengthening exercises (repetitive, maximal resistance exercises) are effective treatments for chronic “non-specific” neck pain.19 Data also suggest that aerobic exercise and stretching alone are less effective than endurance and strengthening exercises,20, 21 and that stretching exercises for the neck are as effective as manual therapy.22 Evidence on the additive effect of other conservative treatments in combination with exercise for the treatment of chronic neck pain is less clear. There are some data to suggest that multimodal approaches that include exercise may be more effective than single treatment approaches.23, 24 While the past decade has led to gains in our understanding of the efficacy of exercise for chronic low back and neck pain, less is known about exercise prescription in routine clinical practice. Who is prescribing it? Who is getting it? What is being prescribed? Such information would be useful in assessing the translation of research findings to clinical practice and in identifying areas to target for increased promotion of exercise as an effective treatment. We analyzed data from a population-based survey of healthcare provider and treatment use by individuals with chronic low back or neck pain to gain a better understanding of the use of exercise in the treatment of these conditions. Our specific objectives were: 1) to determine the extent to which exercise is prescribed by physicians, physical therapists (PTs), and chiropractors for the treatment of chronic low back and neck pain; 2) to identify demographic, insurance, work, and health-related characteristics associated with exercise prescription; 3) to describe the amount of supervision provided and types of exercises prescribed for each provider type; and 4) to determine the extent to which other conservative treatments are used in combination with exercise.

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. 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. 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. 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.

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. 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. 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. 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.

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. Cancer 2008. © 2007 American Cancer Society.

Among a group of therapies collectively known as energy psychology (EP), emotional freedom techniques (EFT) is the most widely practiced. Clinical EFT is an evidence-based practice combining elements of cognitive and exposure therapies with the manual stimulation of acupuncture points (acupoints). Lacking is a recent quantitative meta-analysis that enhances understanding of the variability and clinical significance of outcomes after clinical EFT treatment in reducing depression.All studies (2005-2015) evaluating EFT for sufferers of depression were identified by electronic search; these included both outcome studies and randomized controlled trials (RCTs). Our focus was depressive symptoms as measured by a variety of psychometric questionnaires and scales. We used meta-analysis to calculate effect sizes at three time points including posttest, follow-ups less than 90 days, and follow-ups more than 90 days.In total, 20 studies were qualified for inclusion, 12 RCTs and 8 outcome studies. The number of participants treated with EFT included N = 461 in outcome studies and N = 398 in RCTs. Clinical EFT showed a large effect size in the treatment of depression in RCTs. At posttest, Cohen׳s d for RCTs was 1.85 and for outcome studies was 0.70. Effect sizes for follow-ups less than 90 days were 1.21, and for ≥ 90 days were 1.11. EFT were more efficacious than diaphragmatic breathing (DB) and supportive interview (SI) in posttest measurements (P = .06 versus DB, P.001 versus SI), and sleep hygiene education (SHE) at follow-up (P = .036). No significant treatment effect difference between EFT and eye movement desensitization and reprocessing (EMDR) was found. EFT were superior to treatment as usual (TAU), and efficacious in treatment time frames ranging from 1 to 10 sessions. The mean of symptom reductions across all studies was -41%.The results show that Clinical EFT were highly effective in reducing depressive symptoms in a variety of populations and settings. EFT were equal or superior to TAU and other active treatment controls. The posttest effect size for EFT (d = 1.31) was larger than that measured in meta-analyses of antidepressant drug trials and psychotherapy studies. EFT produced large treatment effects whether delivered in group or individual format, and participants maintained their gains over time. This meta-analysis extends the existing literature through facilitation of a better understanding of the variability and clinical significance of depression improvement subsequent to EFT treatment.

Background: Zoledronic acid reduces skeletal-related events associated with prostate cancer and has long-term efficacy in pain outcomes. Findings of treatment group differences in pain early in treatment are less reliable. We used a recently recommended analytic approach to examine the effect of zoledronic acid on pain. Materials and methods: In a trial of zoledronic acid (n = 214) versus placebo (n = 208), we used the Brief Pain Inventory to assess pain at baseline, 3 weeks, 6 weeks and every 6 weeks thereafter for a total of 60 weeks. We used a modified longitudinal rank test to determine whether clinically meaningful changes in pain were related to treatment group. Results: Seventy-six of 214 patients (35.5%) receiving zoledronic acid and 62 of 208 patients (29.8%) receiving placebo completed the 60-week visit (P = 0.22). In all 11 pain assessments, patients receiving zoledronic acid reported more favorable, clinically meaningful changes in pain scores. Overall, patients receiving zoledronic acid had a 33% chance of a favorable response, compared with 25% for patients receiving placebo (P = 0.04; 95% CI 0.5% to 15.6%). Conclusions: Zoledronic acid was more likely than placebo to be associated with clinically meaningful reductions in pain. Thus, zoledronic acid may help to avert the pain experienced by patients with progressing metastatic disease secondary to prostate cancer.

Background We examined the clinical relevance of skeletal-related events (SREs) for health state preferences, pain and health-related quality of life in patients with advanced prostate cancer and a history of bone metastases. Patients and methods Data were from a clinical trial of zoledronic acid versus placebo in the treatment of SREs associated with advanced prostate cancer metastatic to bone. Patients (n = 248) were included if they experienced an SRE during the study. Outcome measures were assessed at fixed intervals. We used mixed-effects models to estimate changes in outcomes after each patient's first SRE. Results There were clinically meaningful and statistically significant declines in physical well-being after: radiation and pathologic fractures; functional well-being after radiation; and emotional well-being after radiation and pathologic fractures. There also were meaningful and significant declines in preference and utility scores after radiation and fracture. Pain intensity declined after radiation, but not after other SREs; no other pain measure changed substantively. Conclusions SREs have important and significant effects on measures of health-related quality of life in men with prostate cancer. Treatments that prevent SREs may not demonstrate corresponding effects on outcomes if the effects of SREs occur between scheduled outcome assessments. Implications for trial design are discussed.

Purpose: To describe and compare the perceptions of cancer patients and their physicians regarding phase I clinical trials. Methods: Eligible patients had been offered phase I trial participation and had decided to participate but had not yet begun treatment. Each patient’s physician also served as a study subject. Patients and physicians completed questionnaires with domains including perceptions of potential benefit and harm from treatment (experimental and standard), relative value of quality and length of life, and perceived content of patient-physician consultations. Results: Three hundred twenty-eight patients and 48 physicians completed surveys. Patients had high expectations regarding treatment outcomes (eg, median 60% benefit from experimental therapy), with those choosing to participate in a phase I trial being more optimistic than those declining phase I participation. Patients predicted a higher likelihood of both benefit and adverse reactions from treatment (experimental and standard) than their physicians (P < .0001 for all comparisons). Although 95% of patients reported that quality of life was at least as important as length of life, only 28% reported that changes in quality of life with treatment were discussed with their physicians. In contrast, 73% of physicians reported that this topic was discussed (P < .0001). Conclusion: Cancer patients offered phase I trial participation have expectations for treatment benefit that exceed those of their physicians. The discordant perceptions of patients and physicians may possibly be explained by patient optimism and confidence; however, the discrepancies in reports of consultation content, particularly given patients’ stated values regarding quality of life, raise the possibility that communication in this context is suboptimal.

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. Cancer 2003;98:166–75. © 2003 American Cancer Society. DOI 10.1002/cncr.11483

e18340 Background: Advances in oncology have led to rising costs which are unsustainable, necessitating value-based arrangements that maximize quality and overall outcomes. Our objective was to identify clinical and patient factors that predict higher costs and utilization among breast, lung, and colorectal cancer in a commercial population. Methods: We conducted a longitudinal analysis of claims in a sample of 9,748 commercially insured patients with breast, lung, and colorectal cancer, to measure costs and utilization based on presence of metastases, proxies for clinical biomarkers, patient demographics, and treatments. Results: Episode Risk Group (ERG) risk score, metastasis, and facility provider affiliation were cost drivers for all three types of cancer (breast, lung, and colorectal). Hypertension and younger age were cost drivers for breast cancer. In addition, HER2 positive status (β = 68,946, SE = 2,104, p < .0001) was significant in breast cancer, and VEGF in both lung (β = 56,975, SE = 10,138, p < .0001) and colorectal (β = 24,400, SE = 5,671, p < .0001) cancers. Metastasis also was associated with greater hospital admissions and hospital length of stay in all three cancers. Chemotherapy and supportive drug therapies accounted for the highest proportions of total medical costs among beneficiaries observed. Conclusions: Value-based reimbursement models in oncology should appropriately risk adjust by accounting for key cost drivers. Although claims-based methodologies may be further augmented with clinical data, we recommend adjusting for the factors we identified in models to predict costs and outcomes in breast, lung, and colorectal cancers.

Our goal was to calculate resource use associated with administration of zoledronic acid, compared with pamidronate, as palliative care for patients with metastatic bone lesions. We conducted a time-and-motion study of therapy administration at each of three outpatient chemotherapy infusion sites participating in clinical trials of zoledronic acid and pamidronate. We developed a data-collection instrument to record all staff effort and patient resource use in drug administration. The main outcome measures were (a) direct costs of therapy administration per patient and (b) opportunity benefits expressed as the availability of resources gained per year. The average visit time for patients receiving the study dose of zoledronic acid, 4 mg, was 1 h, 6 min, compared to 2 h, 52 min for patients receiving a 90-mg dose of pamidronate. Infusion time accounted for much of the difference. In the base-case analysis, total direct costs per patient were $728 for zoledronic acid and $776 for pamidronate. The opportunity benefit for infusion of zoledronic acid vs pamidronate in the base case was 1.8 chairs per day, or 426 chairs per 240-workday year. Results were sensitive to changes in infusion facility size, days of operation, and average number of patients treated. Shorter infusion time associated with the administration of zoledronic acid, compared with pamidronate, yields substantial time savings for patients, as well as opportunity benefits for outpatient oncology facilities.

Pamidronate was an important advance in the palliative treatment of patients with cancer. However, pamidronate must be infused over at least 2 hours in most patients. Zoledronic acid represents the next-generation bisphosphonate with a potential for improved efficacy in the palliative care setting. One important advantage of zoledronic acid is that it can be administered over a 15-minute infusion. To measure the overall efficiency of zoledronic acid as compared with pamidronate in the outpatient setting, a USA microcosting model was adapted to Canadian inputs. Time and motion data were collected from six patients being treated with zoledronic acid or pamidronate in three USA outpatient cancer clinics. Resource use and time impact on outpatient clinical staff were reanalyzed using Canadian cost estimates. This included the evaluation of fixed, variable, and labour costs obtained from Canadian sources. The manufacturer provided drug costs. The base case analysis assumed a 5300-ft2 out-patient chemotherapy clinic with eight infusion chairs designated for bisphosphonate administration in the province of Ontario. Mean treatment times in the original USA data collected were 2 hours, 52 minutes for pamidro-nate, and 1 hour, 6 minutes for zoledronic acid (a difference of 1 hour, 46 minutes). In the Canadian version of the microcosting model, the overall treatment cost was Can$673 for pamidronate and Can$682 for zoledronic acid (2001 Canadian dollars). Findings suggest that the shorter zoledronic acid infusion time would allow an additional 27 bisphosphonate patients to be treated per day. Alternatively, approximately one additional hour of chair time could be made available with each zoledonic acid infusion. Sensitivity analyses revealed that (a) the base case results were consistent when geographic region was varied, and (b) the shorter the infusion time for zoledronic acid relative to pamidronate, the lesser the cost difference and more patients could be treated daily. In conclusion, zoledronic acid may enhance the overall efficiency of outpatient chemotherapy clinics by reducing patient waiting time for bisphosphonate administration. These benefits would be obtained at an incremental cost of Can$9 per infusion.

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.

Chronic spinal pain is a common and costly problem in the United States.1,2 In a 2002 prevalence study, low back pain lasting at least a whole day in the past 3 months was reported by over 26% of US respondents, and neck pain was reported by over 13%.2 Perhaps, because the condition affects the physical, mental, emotional, social, and financial well-being of those afflicted,3,4 individuals often seek care from numerous physicians as well as other traditional and alternative health care providers. It is also common for individuals to undergo numerous treatments over months or years.5 In the past few decades, pain clinics became common—in the mid-80s, it was estimated that there were more than 1200 pain clinics in existence in the United States.5 People with chronic spinal pain have increasingly been seeking services at these clinics. Pain clinics have been described in various ways. According to Bonica,6 who has been credited with the development of modern multidisciplinary pain clinics,7 one key feature of a pain clinic is its ability to provide comprehensive assessment of an individual with a persisting and oftentimes intractable pain problem. Multidisciplinary function arose from Bonica's method of referring patients to other types of specialists, then reconvening to discuss the patient and reach consensus on the best course of action. Carron8 and Johnson9 have classified pain clinics as single modality clinics—such as those that offer nerve blocks—that are typically run by one provider type (i.e., anesthesiologist); syndrome-oriented clinics, such as back pain or headache clinics; and comprehensive clinics that are multidisciplinary and treat a variety of chronic pain problems. This classification is neither necessarily exhaustive nor mutually exclusive and as Johnson et al note,9 many clinics do not fall into these categories. The definition of multidisciplinary pain clinics also varies. According to the International Association for the Study of Pain (IASP), a multidisciplinary pain clinic should be staffed with a variety of physician and nonphysician providers who specialize in the diagnosis and treatment of chronic pain.10 At a minimum, 3 physician specialties should be represented including a psychiatrist, or 2 physician specialties and a clinical psychologist.10 Shealy and Cady's minimum criteria for multidisciplinary pain management are a physician (Medical Physician or Physician of Osteopathy), registered nurse, psychologist/psychotherapist or someone with a Master's degree in social work, and a physical therapist.11 Although many pain clinics specialize in the treatment of chronic back and neck pain, to date there has been little study in the United States of what constitutes a spine/pain clinic, who provides care at these clinics, and what types of care are provided. There is evidence that multidisciplinary biopsychosocial rehabilitation improves outcomes in chronic back pain, when compared with inpatient or outpatient nondisciplinary and/or “unimodal” treatments.12-14 Whether and to what extent current spine and pain clinics are “multidisciplinary” has not been evaluated to date. The primary objective of our study was to describe spine and pain clinics serving North Carolina (NC) residents with chronic back and/or neck pain. Specifically, we were interested in types of providers and services offered, and organizational characteristics of the clinics. Our secondary objective was to assess the multidisciplinary nature of the clinics surveyed. The substantial costs of back pain15 mandate examination of current treatment patterns16; gaining a better understanding of the nature of spine and pain clinics will help to inform future clinical and health services research on the treatment of chronic spinal 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.

Liana D Castel,1 Kenneth A Wallston,2 Benjamin R Saville,3 JoAnn R Alvarez,3 Bradley D Shields,4 Irene D Feurer,3 David Cella5 1Meharry-Vanderbilt Alliance, Nashville, TN, USA; 2Psychology in Nursing, Vanderbilt University School of Nursing, Nashville, TN, USA; 3Surgery and Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA; 4Medical Sciences, University of Arkansas School of Medicine, Little Rock, AR, USA; 5Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA 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

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.

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.

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. Cancer 2004. © 2004 American Cancer Society.

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.

11 Background: Aromatase inhibitors (AIs) are standard of care for adjuvant endocrine therapy (AET) to prevent recurrence of early stage breast cancer in postmenopausal women. Previous AET adherence research has focused on the 25-96% adherence observed with, but more information is needed about AI adherence, especially regarding the role of arthralgia (joint pain or stiffness) in AET changes. Our objective was to understand AET changes within a year of AI initiation. Methods: We examined AET switching (either to another AI or to tamoxifen), overall changes in AET (including switching and temporary or permanent discontinuation), and physician- and patient-reported arthralgia, using data abstracted from medical records and self-administered surveys among 93 patients initiating AI. We conducted Chi-square and Wilcoxon univariate analyses. Results: Anastrazole was initially prescribed to 64 patients (69%), letrozole to 28 patients (30%), and exemestane to 1 patient. A year after AI initiation, 64 patients (69%) had no change in AET. Among the 29 patients (31%) who had an AET change, 14 switched to at least one other AI, 11 switched to tamoxifen, 9 temporarily discontinued AET, and 7 entirely discontinued AET (categories not mutually exclusive). Average time to first AET switch was 182.7 days. Average number of AET switches was 1.4. Arthralgia was the most common reason for AET changes, noted in the records of 19 patients (66% of those who changed AET). Patients who changed AET reported more severe arthralgia (median pain from 0-10 among 8 joint groups =1.4, interquartile range [IQR]=0.3-2.6) at week 12 than those who did not (median=0.3, IQR=0-1.1), p=0.03. A higher proportion (46%) of the 28 patients who initiated with letrozole changed AET due to arthralgia, compared with 20% of the 64 patients who initiated with anastrazole (p=0.01). Conclusions: A substantial proportion of women initiating AI change AET over one year. Arthralgia appears to play a key role in AET changes, particularly for letrozole as compared with anastrazole. More longitudinal patient-reported arthralgia data are needed to guide clinical decision making about AI initiation and AET changes.

4680 Background: Zoledronic acid (ZA) has been shown to significantly decrease skeletal-related events (SREs) in patients with prostate cancer by 11% relative to placebo. Trends were seen in pain improvement with ZA vs placebo, but there were no reliable treatment group differences. The objective of this study was to reexamine the pain outcomes using an alternative analytic framework that focuses on the frequency of clinically meaningful changes in pain scores. Methods: Patients were randomized to ZA 4mg (n=214) or placebo (n=208). The Brief Pain Inventory Composite Score (BPI) was used to assess pain at baseline, 3 weeks, 6 weeks, and every 6 weeks for a total of 60 weeks. We determined whether clinically meaningful pain changes from baseline (+/- 2 BPI points) were related to treatment assignment using a modified non-parametric rank test. Results: The rapid progression of the prostate cancer led to high rates of dropout as only 76 of 214 (35.5%) patients randomized to ZA and 62 of 208 (29.8%) patients r...

We read with concern the conclusion of Joyce et al. that the Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) had little effect on perinatal health care use among foreign-born Latinas.1 We are particularly concerned about whether the data can be interpreted clearly enough to support this conclusion. Also, regardless of the findings, we wonder about the relevance of this study to our understanding of welfare reform's impact. First, the authors sought to discern the effects of PRWORA on foreign-born Latinas' perinatal health care use. Yet the broad category “foreign-born Latinas” does not accurately reflect the population affected by PRWORA—noncitizen Latinas who were admitted to the United States after August 1996 and who sought Medicaid coverage for nonemergency care during their first 5 years in the country. The sample most likely did not include all members of the population of interest, and it definitely included people not in the population of interest, making it difficult to determine PRWORA's effect on the appropriate group. Second, the authors' conclusion might have been justified if it had been based on a larger number of locations. Yet Joyce et al. studied only 3 locations, and California and New York City had effectively nullified the impact of PRWORA. We appreciate the difficulty of obtaining high-quality data, but we feel strongly that researchers should evaluate whether the quality of their data is such that it would be better to withhold premature conclusions. An alternative approach would have been to measure PRWORA's effects on long-term resource reallocation, especially more than 2 years beyond the act's implementation. Finally, we are concerned that PRWORA's effects on perinatal health outcomes might be misinterpreted as representative of effects on other health outcomes. As Joyce et al. acknowledge, hospitals generally facilitate Medicaid applications in obstetric cases. Also, it seems reasonable to expect that pregnant women would be more likely than others to receive aid that would offset losses in public assistance. We wonder how the findings might have differed had the authors conducted their comparison using, say, noncitizen Latino men with coronary disease. Whether this was the authors' intention or not, the article could be interpreted by some as supporting the idea that PRWORA has not harmed health care. Such an interpretation would be ill advised, given the grossly defined sample, the selection of locations that (except for one) did not implement the eligibility provisions of PRWORA, and the selection of a condition that is less vulnerable than others to changes in federal funding. With these considerations in mind, it is unclear what one could conclude from this research.