Problems with analyses and interpretation of data in "use of the KDQOL-36™ for assessment of health-related quality of life among dialysis patients in the United States".

A recent article in the journal reported analyses of KDQOL-36™ survey data collected from 240,343 adults (330,412 surveys) dialyzed at a large dialysis organization in the United States during 2014-2016. The authors concluded that the KDQOL-36™ Symptoms and Problems of Kidney Disease scale had the highest mean score of the KDQOL-36™ scales. We note that this inference was erroneous because the scales are not scored on the same numeric scale. In addition, the authors found that responses to a general health perceptions item ("In general, would you say your health is excellent, very good, good, fair, or poor") was not significantly associated with any of the 5 KDQOL-36 scale scores. In contrast, we find significant and noteworthy correlations in two other datasets. These analytic issues call into question the accuracy and validity of the conclusions of this paper.

An Evaluation of Algorithms for Identifying Metastatic Breast, Lung, or Colorectal Cancer in Administrative Claims Data.

BACKGROUND: Administrative health care claims data are used for epidemiologic, health services, and outcomes cancer research and thus play a significant role in policy. Cancer stage, which is often a major driver of cost and clinical outcomes, is not typically included in claims data. OBJECTIVES: Evaluate algorithms used in a dataset of cancer patients to identify patients with metastatic breast (BC), lung (LC), or colorectal (CRC) cancer using claims data. METHODS: Clinical data on BC, LC, or CRC patients (between January 1, 2007 and March 31, 2010) were linked to a health care claims database. Inclusion required health plan enrollment ≥3 months before initial cancer diagnosis date. Algorithms were used in the claims database to identify patients' disease status, which was compared with physician-reported metastases. Generic and tumor-specific algorithms were evaluated using ICD-9 codes, varying diagnosis time frames, and including/excluding other tumors. Positive and negative predictive values, sensitivity, and specificity were assessed. RESULTS: The linked databases included 14,480 patients; of whom, 32%, 17%, and 14.2% had metastatic BC, LC, and CRC, respectively, at diagnosis and met inclusion criteria. Nontumor-specific algorithms had lower specificity than tumor-specific algorithms. Tumor-specific algorithms' sensitivity and specificity were 53% and 99% for BC, 55% and 85% for LC, and 59% and 98% for CRC, respectively. CONCLUSIONS: Algorithms to distinguish metastatic BC, LC, and CRC from locally advanced disease should use tumor-specific primary cancer codes with 2 claims for the specific primary cancer >30-42 days apart to reduce misclassification. These performed best overall in specificity, positive predictive values, and overall accuracy to identify metastatic cancer in a health care claims database.

Identification of metastatic cancer in claims data.

PURPOSE: To develop algorithms to identify metastatic cancer in claims data, using tumor stage from an oncology electronic medical record (EMR) data warehouse as the gold standard. METHODS: Data from an outpatient oncology EMR database were linked to medical and pharmacy claims data. Patients diagnosed with breast, lung, colorectal, or prostate cancer with a stage recorded in the EMR between 2004 and 2010 and with medical claims available were eligible for the study. Separate algorithms were developed for each tumor type using variables from the claims, including diagnoses, procedures, drugs, and oncologist visits. Candidate variables were reviewed by two oncologists. For each tumor type, the selected variables were entered into a classification and regression tree model to determine the algorithm with the best combination of positive predictive value (PPV), sensitivity, and specificity. RESULTS: A total of 1385 breast cancer, 1036 lung, 727 colorectal, and 267 prostate cancer patients qualified for the analysis. The algorithms varied by tumor type but typically included International Classification of Diseases-Ninth Revision codes for secondary neoplasms and use of chemotherapy and other agents typically given for metastatic disease. The final models had PPV ranging from 0.75 to 0.86, specificity 0.75-0.97, and sensitivity 0.60-0.81. CONCLUSIONS: While most of these algorithms for metastatic cancer had good specificity and acceptable PPV, a tradeoff with sensitivity prevented any model from having good predictive ability on all measures. Results suggest that accurate ascertainment of metastatic status may require access to medical records or other confirmatory data sources.

A Systematic Literature Review of Health-related Quality of Life Measures for Women with Hypoactive Sexual Desire Disorder and Female Sexual Interest/Arousal Disorder.

INTRODUCTION: Hypoactive Sexual Desire Disorder (HSDD) / Female Sexual Interest/Arousal Disorder (FSIAD) impacts health-related quality of life (HRQoL) of women and their partners, yet existing measures fail to adequately capture relevant concepts (ie, what is essential to measure including symptoms/impacts) important to women with HSDD/FSIAD. OBJECTIVES: To identify HRQoL tools used to assess women with HSDD/FSIAD, and to evaluate their psychometric properties (ie, reliability, validity, and responsiveness). METHODS: We conducted searches in PubMed, Embase and PsychINFO from June 5, 1989 to September 30, 2020 for studies in women with HSDD/FSIAD and psychometric analyses (English only). Principles of the Preferred Reporting Items for Systematic reviews and Meta-Analyses, the COnsensus-based Standards for the selection of health Measurement INstruments Risk of Bias Checklist and other psychometric criteria were applied. Based on this search, 56 papers were evaluated including 15 randomized-controlled trials, 11 observational/single arm/open label studies, and 30 psychometric studies. RESULTS: Of the 18 measures identified, the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) were included in most studies (> 50%). General HRQoL instruments were not used in any of the clinical trials; the SF-12, SF-36 and EQ-5D-5L were reported in two observational studies. No instruments achieved positive quality ratings across all psychometric criteria. The FSFI, FSDS-R, Sexual Event Diary (SED) and the Sexual Desire Relationship Distress Scale (SDRDS), were the only measures to receive a positive rating for content validity. CONCLUSION: Reliable and valid HRQoL measures that include sexual desire and distress are needed to provide a more systematic and comprehensive assessment of HRQoL and treatment benefits in women with HSDD/FSIAD. While inferences about HRQoL are limited due to the lack of uniformity in concepts assessed and limited psychometric evaluation of these measures in women with HSDD/FSIAD, opportunities exist for the development of reliable and validated tools that comprehensively measure the most relevant and important concepts in women with HSDD/FSIAD. Lim-Watson MZ, Hays RD, Kingsberg S, et al. A systematic literature review of health-related quality of life measures for women with Hypoactive Sexual Desire Disorder and Female Sexual Interest/Arousal Disorder. Sex Med Rev 2022;10:23-41.

Disruptions in Rheumatology Care and the Rise of Telehealth in Response to the COVID-19 Pandemic in a Community Practice-Based Network.

OBJECTIVE: The effect of the COVID-19 pandemic on community-based rheumatology care and the use of telehealth is unclear. We undertook this study to investigate the impact of the pandemic on rheumatology care delivery in a large community practice-based network. METHODS: Using a community practice-based rheumatologist network, we examined trends in in-person versus telehealth visits versus canceled visits in 3 time periods: pre-COVID-19, COVID-19 transition (6 weeks beginning March 23, 2020), and post-COVID-19 transition (May-August). In the transition period, we compared patients who received in-person care versus telehealth visits versus those who cancelled all visits. We used multivariable logistic regression to identify factors associated with canceled or telehealth visits. RESULTS: Pre-COVID-19, there were 7,075 visits/week among 60,002 unique rheumatology patients cared for by ~300 providers practicing in 92 offices. This number decreased substantially (24.6% reduction) during the COVID-19 transition period for in-person visits but rebounded to pre-COVID-19 levels during the post-COVID-19 transition. There were almost no telehealth visits pre-COVID-19, but telehealth increased substantially during the COVID-19 transition (41.4% of all follow-up visits) and slightly decreased during the post-COVID-19 transition (27.7% of visits). Older age, female sex, Black or Hispanic race/ethnicity, lower socioeconomic status, and rural residence were associated with a greater likelihood of canceling visits. Most factors were also associated with a lower likelihood of having telehealth versus in-office visits. Patients living further from the rheumatologists' office were more likely to use telehealth. CONCLUSION: COVID-19 led to large disruptions in rheumatology care; these disruptions were only partially offset by increases in telehealth use and disproportionately affected racial/ethnic minorities and patients with lower socioeconomic status. During the COVID-19 era, telehealth continues to be an important part of rheumatology practice, but disparities in access to care exist for some vulnerable groups.

The impact of methodological approach on cost findings in comparison of epoetin alfa with darbepoetin alfa.

BACKGROUND: Two erythropoiesis-stimulating agents (ESAs), epoetin alfa and darbepoetin alfa, are approved for the treatment of chemotherapy-induced anemia in patients with cancer. Randomized controlled trials indicate that the drugs are similarly efficacious, but that the duration of clinical benefit (DCB) ranges from 2 to 7 days for epoetin alfa and from 7 to 21 days for darbepoetin alfa, depending on dose. Given equivalent efficacy, payers are increasingly interested in understanding the cost differences for these 2 drugs. OBJECTIVE: To examine the impact of different methodological approaches on the cost comparison between epoetin alfa and darbepoetin alfa users, with cancer from a payer perspective. METHODS: Episodes of care (episode) were constructed for cancer patients treated with ESAs, using MarketScan claims data. Episodes started with the first ESA claim and ended on the last ESA claim or the claim before a 42-day or longer gap in ESA therapy. Each episode was augmented with an estimated DCB based on the last dose in the episode. Cost was reimbursed amount observed in the claims database. Adjusted weekly cost was estimated using generalized linear models to control for difference in clinical and demographic differences across epoetin alfa and darbepoetin alfa episodes. RESULTS: Episodes were created in 324 darbepoetin alfa and 342 epoetin alfa users. Darbepoetin alfa users tended to be younger, had more comorbidities, and had advanced cancer (all p < 0.001). After accounting for DCB, the average weekly cost of darbepoetin alfa was significantly lower than that of epoetin alfa ($619 vs $940; p < 0.001). After multivariate adjustment, darbepoetin alfa had lower costs than epoetin alfa in the base case and all alternative approaches. CONCLUSIONS: To reduce the risk of potential bias, DCB and different patient characteristics should be taken into account when using retrospective claims data to conduct cost comparisons between agents that have significant differences in dosing schedule.

The importance of clinical variables in comparative analyses using propensity-score matching: the case of ESA costs for the treatment of chemotherapy-induced anaemia.

BACKGROUND: The erythropoiesis-stimulating agents (ESAs) epoetin alfa (EA) and darbepoetin alfa (DA) have comparable efficacy in treating chemotherapy-induced anaemia (CIA). Therapy choice depends on many factors, including cost. Previous estimates of ESA cost differences have been derived from claims data. These data lack clinical variables, such as baseline haemoglobin (Hb) level, which are likely to influence choice of ESA, dosing and costs. We estimated cost differences between DA and EA in patients with cancer receiving chemotherapy, using a propensity-score matched analysis of baseline patient characteristics with and without Hb values to assess the effect of this clinical variable on ESA cost estimates. METHODS: Data were extracted from electronic medical records in two US databases between January 2004 and December 2006. The study sample included 6743 patients receiving chemotherapy, with one or more visits during the study period, who received an ESA during a chemotherapy episode. Episodes of chemotherapy care were constructed using a 90-day gap in administration to identify the start and end. Patients receiving both DA and EA during their initial chemotherapy episode or with missing data were excluded, representing 42% of patients with CIA receiving an ESA. Drug costs were calculated from the cumulative dose multiplied by 106% of the average sales price (ASP) for DA or EA. Two propensity-score matches were conducted: first using variables available in administrative billing claims systems, then adding the baseline Hb test result. Regression-adjusted cost differences were estimated with and without baseline Hb, using generalized linear models. RESULTS: Using baseline Hb levels resulted in a better match of the baseline characteristics for the EA and DA treatment groups than the original sample or the matched sample without Hb variables. Mean ESA costs (year 2007 values) for the original sample were $US4171 for EA and $US3811 for DA (mean difference $US360; p < 0.001, standard error [SE] $US99). With propensity-score matching without Hb variables, mean estimated costs were $US3836 for EA and $US3599 for DA (mean difference $US237; p = 0.053, SE $US123). With propensity-score match including Hb variables, mean costs were $US3965 for EA and $US3536 for DA (mean difference $US429; p = 0.001, SE $US125). Cost differences in sensitivity analyses ranged between $US102 (p = 0.201) and $US261 (p = 0.003). CONCLUSIONS: Addition of baseline Hb level as a variable in propensity score and ESA cost models affects ESA treatment cost estimates in patients with cancer receiving chemotherapy. Cost comparisons based on observational data should use analytical methods that account for differences in clinical variables between treatment groups.

Will savings from biosimilars offset increased costs related to dose escalation? A comparison of infliximab and golimumab for rheumatoid arthritis.

INTRODUCTION: Biosimilar infliximab has the potential for appreciable cost savings compared to its reference biologic, but dose escalation is common and increases costs. We compared frequency of dose escalation and associated Medicare-approved amount so as to determine the break-even point at which infliximab dose escalation would offset the cost savings of using a biosimilar, referent to alternatively using golimumab. METHODS: We studied Medicare enrollees with rheumatoid arthritis (RA) initiating infliximab or golimumab. Frequency of dose escalation was summarized descriptively over 18 months, as were Medicare-approved amounts for reimbursement. Analyses were repeated conditioning on high adherence (i.e., non-discontinuation, > 10-week gap). Multivariable-adjusted logistic regression and mixed models evaluated factors associated with infliximab dose escalation. RESULTS: A total of 5174 infliximab and 2843 golimumab initiators were observed. Dose escalation was rare for golimumab (5%) but common for infliximab (49%), and was even more common (72%) for infliximab among patients who persisted on treatment. Regardless of dose escalation, the adjusted least square mean dollar amounts were appreciably higher for golimumab ($28,146) than for infliximab ($21,216) and greater among persistent patients (cost difference $9269, favoring infliximab). Only when patients escalated infliximab to ≥ 8 mg/kg every 6 weeks was golimumab IV at break-even or less expensive. After controlling for multiple factors, physician ownership of the infusion center was associated with greater likelihood of infliximab dose escalation (odds ratio = 1.25, 95% CI 1.09-1.44). CONCLUSION: Despite frequent dose escalation with infliximab that often increase its dose by threefold or more, the savings from the current price of its biosimilar substantially offsets the costs of an alternative infused TNFi biologic for which no biosimilar is available.

Budget impact analysis of darbepoetin alfa every 3 weeks versus epoetin alfa every week for the treatment of chemotherapy-induced anaemia from a US payer's perspective.

OBJECTIVE: This analysis was conducted to compare the direct medical costs of treatment with darbepoetin alfa every 3 weeks (Q3W) and epoetin alfa every week (QW) in patients with chemotherapy-induced anaemia (CIA) from the payer's perspective. METHODS: An analysis was conducted from a US health plan perspective to compare the annual budget impact for CIA with darbepoetin alfa Q3W and epoetin alfa QW over a 16-week treatment period. Dosing regimens were obtained from registration clinical trials. RESULTS: Mean doses, including dose adjustments, were 375.6 microg Q3W for darbepoetin alfa and 43,187 U QW for epoetin alfa. Costs of medical resources included drug acquisition and administration costs. The base case analysis resulted in a per-patient budget impact of $8,544 and $8,667 for darbepoetin alfa and epoetin alfa, respectively. Per member per month cost was $0.90 for darbepoetin alfa and $0.91 for epoetin alfa, based on an estimate of 2,735 CIA patients in a health plan population of 2.17 million. The analysis was most sensitive to drug dose, treatment period and drug price. CONCLUSIONS: Results suggest that per-patient direct medical costs of CIA treatment, when initiated at labelled starting doses, are comparable for darbepoetin alfa Q3W and epoetin alfa QW.

Patient-reported outcomes: instrument development and selection issues.

At its most elemental, patient-reported outcomes (PRO) assessment involves asking the patients questions and evaluating their answers. Instrument developers need to be clear about what they want to know, from whom they want to know it and why, whether what they learned is credible, and whether they can interpret what they learned in the context of the research objectives. Because credible instrument development is neither inexpensive nor technically trivial, researchers must first determine that no available measure meets their research objectives. We suggest that the tasks of either reviewing current instruments or developing new ones originate from the same basic premise: PRO assessment requires a well-articulated conceptual framework. Once defined in the context of the research objectives, the conceptual framework needs to be adapted to the population of interest. We discuss how qualitative methods enrich the conceptual framework and facilitate the technical measurement tasks of item development, testing, and reduction. We recognize that PRO assessment stands at a technological crossroads with the increasingly frequent application of "modern" psychometric methods and discuss how innovations such as item banks and computer-adaptive testing will influence PRO instrument development. Although items are the essential building blocks for instruments, scales are the primary unit of analysis for PRO assessment, and we discuss methods for scoring and combining them. Finally, PRO assessment is meaningless if the key figure chooses not to cooperate. We consider how respondent burden influences the quality of PRO assessment.

Costs associated with erythropoiesis-stimulating agent administration to hemodialysis patients.

BACKGROUND: Treatment of anemia in hemodialysis patients usually requires the use of expensive erythropoietic proteins. Cost analyses usually focus on drug acquisition costs. Other costs associated with anemia therapy include resources for anemia monitoring as well as preparation and administration of an erythropoiesis-stimulating agent. METHODS: The nonacquisition costs associated with subcutaneous administration of epoetin alfa were determined in a Canadian hemodialysis unit. A time-and-motion technique was used to determine the nursing time for preparation and administration. Fixed anemia costs were inventory control, monitoring, blood sampling, and laboratory analysis. Variable costs were those which varied with dosing frequency. The costs are expressed in Canadian dollars (2005). RESULTS: The mean time associated with preparation and administration was 3.2 min/injection. The annual nonacquisition per patient cost was CAD 2,290.04. Fixed costs were CAD 1,946.01, while the variable costs were CAD 344.03/year. Sensitivity analysis showed a decrease in cost to CAD 1,611.34, if iron monitoring were decreased from monthly to 3 monthly, and to CAD 2,090.66, if patients were converted to less frequent dosing using darbepoetin alfa. CONCLUSIONS: The nonacquisition costs associated with anemia therapy in hemodialysis patients are considerable. Less frequent monitoring of iron therapy and less frequent dosing could decrease costs by CAD 678.40 and CAD 199.38/patient/year, respectively.

Efficacy of darbepoetin alfa in alleviating fatigue and the effect of fatigue on quality of life in anemic patients with lymphoproliferative malignancies.

Anemia-related fatigue in cancer patients reduces health-related quality of life (HRQOL). These analyses evaluate the effect of hemoglobin level on fatigue and examine the relationship between improved fatigue and HRQOL. Data were collected during a multicenter, randomized trial involving 344 anemic patients with lymphoproliferative malignancies receiving chemotherapy and darbepoetin alfa or placebo. At baseline, interim study visits, and end of treatment, patients completed an HRQOL questionnaire. Improved hemoglobin levels were significantly associated (P < 0.001) with improved fatigue. Mean change in the Functional Assessment of Cancer Therapy (FACT) Fatigue score was 5.9 points greater when hemoglobin improved > 2 g/dl than when it declined. Patients experiencing a clinically meaningful improvement in fatigue reported significantly (P < 0.001) greater improvements in all other scales, except the FACT Social subscale. Managing anemia-related fatigue appears to have a positive impact on HRQOL, enhancing cancer patients' activity levels, mood, and perceived overall health.

Resource utilisation and time commitment associated with correction of anaemia in cancer patients using epoetin alfa.

OBJECTIVE: This study set out to identify the resource use and time commitment associated with treatment of anaemia with erythropoietic therapy, for both haematology/oncology clinics and patients. METHODS: The study was carried out at three haematology/oncology clinics in the US, and included 124 cancer patients with anaemia. Stages in the administration of epoetin alfa were identified (preparation, injection and documentation). At each site a trained researcher observed medical staff and recorded the time taken for each stage, in minutes, using a stopwatch. The supplies used for each stage were also recorded. Travel times, waiting times and demographics for patients and caregivers attending the clinic were obtained from self-report questionnaires during the clinic visit. In total, 177 injections of epoetin alfa were administered. MAIN OUTCOME MEASURE: Total mean time clinic staff and patients spent on treatment visits. RESULTS: The total mean time expended by clinic staff for each injection, including preparation, administration, documentation and phlebotomy, was 25.5 minutes (range 18.6-31.2 at individual centres). The total mean time requirement for patients (time spent travelling to and from the clinic, time spent waiting for the epoetin alfa injection) was 83 minutes. CONCLUSION: Treatments that may reduce the time burden of anaemia management should be considered.

Using Certification to Promote Uptake of Real-World Evidence by Payers.

Most randomized controlled trials are unable to generate information about a product's real-world effectiveness. Therefore, payers use real-world evidence (RWE) generated in observational studies to make decisions regarding formulary inclusion and coverage. While some payers generate their own RWE, most cautiously rely on RWE produced by manufacturers who have a strong financial interest in obtaining coverage for their products. We propose a process by which an independent body would certify observational studies as generating valid and unbiased estimates of the effectiveness of the intervention under consideration. This proposed process includes (a) establishing transparent criteria for assessment, (b) implementing a process for receipt and review of observational study protocols from interested parties, (c) reviewing the submitted protocol and requesting any necessary revisions, (d) reviewing the study results, (e) assigning a certification status to the submitted evidence, and (f) communicating the certification status to all who seek to use this evidence for decision making. Accrediting organizations such as the National Center for Quality Assurance and the Joint Commission have comparable goals of providing assurance about quality to those who look to their accreditation results. Although we recognize potential barriers, including a slowing of evidence generation and costs, we anticipate that processes can be streamlined, such as when familiar methods or familiar datasets are used. The financial backing for such activities remains uncertain, as does identification of organizations that might serve this certification function. We suggest that the rigor and transparency that will be required with such a process, and the unassailable evidence that it will produce, will be valuable to decision makers.

The impact of anaemia and its treatment on employee disability and medical costs.

OBJECTIVE: Anaemia is a common haematological complication of cancer and cytotoxic treatment. The incremental economic burden associated with medical care and short-term disability of anaemia in patients with malignancy and receiving chemotherapy has not been well documented. This study evaluates the effect of anaemia on the costs associated with cancer treated with chemotherapy. METHODS: Patients receiving chemotherapy within 6 months of their initial cancer diagnosis were identified in a commercial claims database for 1999-2000. Data for these individuals were linked to their employers' short-term disability records via unique encrypted personal identification numbers provided by employers. Patients with anaemia were identified by a diagnosis of anaemia or treatment with transfusion or erythropoietin alfa (EPO). Healthcare expenditure and short-term disability leave were observed for up to 6 months following initial cancer diagnosis and were summarised into monthly averages. Exponential conditional mean models and zero-inflated negative binomial models were used to analyse mean monthly healthcare expenditures and short-term disability days. RESULTS: Twenty-five percent of the 619 newly diagnosed cancer patients treated with chemotherapy had anaemia. The presence of anaemia and longer length of transfusion therapy were associated with increased expenditures, while longer length of EPO treatment was associated with lower expenditures. The incremental costs due to anaemia among patients receiving chemotherapy were US$5,538 (year 2001 values) per month in the first 6 months following cancer diagnosis, 10.8% of which were costs related to short-term disability leave. CONCLUSION: Anaemia in patients undergoing chemotherapy presents a substantial burden to employers and payers. The findings also suggest that patients with anaemia treated with erythropoietin alfa can achieve expenditure levels similar to those patients without anaemia.

Reductions in anaemia and fatigue are associated with improvements in productivity in cancer patients receiving chemotherapy.

OBJECTIVE: Cancer-related anaemia is associated with fatigue that adversely affects patients' everyday functioning and wellbeing. We explore the impact of fatigue on patient productivity and caregiver burden. METHODS: The analyses are based on data from a randomised, open-label, active-controlled, dose-finding trial of darbepoetin alfa among solid-tumour cancer patients with anaemia, who are receiving chemotherapy. Fatigue is assessed with the Functional Assessment of Cancer Therapy (FACT)-Fatigue subscale score. Productivity and caregiver outcomes include time (hours) missed from usual activities, amount of assistance (hours) needed from others, overall ability to perform desired activities and ability to perform family responsibilities. These outcomes are assessed at baseline and the end of the 12-week treatment period. ANOVA and linear regression models are used to evaluate associations. RESULTS: Patients (n=300) were aged 61 years on average, with a mean (SD) baseline haemoglobin of 9.9 (0.9) g/dL. FACT-Fatigue subscale score improvements were significantly (p=0.003) associated with haemoglobin improvements. Over a 2-week period, after controlling for age, sex and disease progression, one-point improvements in FACT-Fatigue subscale scores corresponded to a 1-hour (95% CI 0.5, 1.5) gain in productive time, 0.7-hour (95% CI 0.4, 1.0) reduction in caregiver time and 1.6% (95% CI 1.4, 1.7) improvement in overall activity. CONCLUSIONS: Reducing fatigue is associated with gains in productive time, reductions in caregiver burden and enhanced ability to perform activities. These outcomes may have broader implications for patients' wellbeing and for the societal impact of cancer-related fatigue and anaemia.

Psychological outcomes associated with anemia-related fatigue in cancer patients.

This article examines the relationships between chemotherapy-induced anemia, fatigue, and psychological distress among anemic cancer patients with solid tumors. Patients participating in two randomized clinical trials evaluating the efficacy of darbepoetin alfa (Aranesp) completed a questionnaire at baseline, at the beginning of each chemotherapy cycle, and at the end of the 12-week treatment period. The questionnaire included four psychological distress outcomes: Brief Symptom Inventory (BSI) Depression and Anxiety, Functional Assessment of Cancer Therapy (FACT)-Emotional Well-Being, numeric rating scale of Overall Health, and the FACT-Fatigue subscale. Patients with a hemoglobin response of at least a 2 g/dL increase were more likely to experience meaningful improvements (at least 3 points) in FACT-Fatigue scores than nonresponders (55.0% vs 39.8%; P = .0004). Patients with meaningful improvements in FACT-Fatigue scores reported significantly greater improvements in each of the psychological outcomes relative to those without improved fatigue (P <.0001). For BSI Depression and Anxiety, the differences in mean change scores between patients with and without improved fatigue were 8.2 and 7.7, respectively. Improving the hemoglobin levels of patients undergoing chemotherapy and suffering from anemia-related fatigue has the potential to produce significant positive effects on patients' fatigue, depressive symptoms, anxiety, feelings of helplessness, and overall health.

Osteoporosis medication adherence: physician perceptions vs. patients' utilization.

Few data are available on physician perceptions of osteoporosis medication adherence. This study compared physician-estimated medication adherence with adherence calculated from their patients' pharmacy claims. Women aged ≥45 years, with an osteoporosis-related pharmacy claim between January 1, 2005 and August 31, 2008, and continuous coverage for ≥12 months before and after first (index) claim, were identified from a commercial health plan population. Prescribing physicians treating ≥5 of these patients were invited to complete a survey on their perception of medication adherence and factors affecting adherence in their patients. Pharmacy claims-based medication possession ratio (MPR) was calculated for the 12-month post-index period for each patient. Physicians who overestimated the percentage of adherent (MPR ≥0.8) patients by ≥10 points were considered "optimistic". Logistic regression assessed physician characteristics associated with optimistic perception of adherence. A total of 376 (17.2%) physicians responded to the survey; 62.0% were male, 58.2% were aged 45 to 60 years, 55.3% had ≥20 years of practice, and 35.4% practiced in an academic setting. Participating physicians prescribed osteoporosis medications for 2748 patients with claims data (mean [SD] age of 62.0 [10.6] years). On average, physicians estimated 67.2% of their patients to be adherent; however, only 40% of patients were actually adherent based on pharmacy data. Optimistic physicians (73.4%) estimated 71.9% of patients to be adherent while only 32.2% of their patients were adherent based on claims data. Physicians in academic settings were more likely to be optimistic than community-based physicians (odds ratio 1.69, 95% CI: 1.01, 2.85). Overestimation of medication adherence may impede physicians' ability to provide high quality care for their osteoporosis patients.

Patterns of osteoporosis treatment change and treatment discontinuation among commercial and Medicare Advantage Prescription Drug members in a national health plan.

RATIONALE, AIMS AND OBJECTIVES: Multiple treatments are available for osteoporosis; however, little is known about treatment change patterns and associated factors. Osteoporosis treatment change patterns, discontinuation and factors associated with treatment change in members of a large national health plan were examined. METHODS: A retrospective cohort study was conducted in 7315 commercial and 34 146 Medicare Advantage Prescription Drug (MAPD) members newly initiated on an osteoporosis medication between 2006 and 2008. Osteoporosis treatment change, discontinuation and re-initiation patterns were assessed. Multivariate logistic regression was used to examine factors associated with treatment change. Commercial and MAPD members were assessed separately because of differences in demographics and insurance benefits. RESULTS: Approximately 12% of members had a change in index therapy within 12 months. Almost 60% of members discontinued the index medication at least once, based on a 90-day refill gap. Over 40% of members discontinued all osteoporosis medications by the end of 12 months post-index. Among MAPD and commercial members, women and those with risedronate, ibandronate or calcitonin at index, index therapy in 2008 and an osteoporosis diagnosis were more likely to have a treatment change while members with health plans other than health maintenance organizations and generic alendronate at index were less likely to have a treatment change. CONCLUSIONS: Osteoporosis treatment change occurred in approximately 12% of members, while a greater proportion of members discontinued treatment completely within 12 months. Member characteristics may be used to predict therapy change for evaluation and quality initiatives within a health plan.

Health care costs for patients with cancer at the end of life.

PURPOSE: With rising health care costs in the United States, clearly defined end-of-life (EOL) cancer costs are needed to help health administrators proactively manage this important care. Our objective was to examine EOL health care resource costs among oncology patients in a US commercial insurance population. METHODS: A retrospective claims database affiliated with OptumInsight was analyzed. Included patients had: a medical claim with cancer diagnosis between July 1, 2002, and December 31, 2009; death on or before December 31, 2009; continuous enrollment with medical/pharmacy benefits from diagnosis until death; ≥ 180 follow-up days; and active cancer in the last 6 months before death (MBD). Death was captured from facility discharge codes or Social Security Administration death files. Costs were determined by summing paid amounts on all services utilized within the last 6 MBD: cancer-related inpatient (IP) stays, cancer- related hospice care, and cancer-related outpatient (OP) services (ie, chemotherapy, erythropoiesis-stimulating agents, granulocyte colony-stimulating factors, radiation, cancer-related office or emergency room visits, cancer-related hospital OP procedures, and other services with cancer diagnosis). RESULTS: A total of 28,530 patients met inclusion criteria. Mean total cancer-related costs in the last 6 MBD were $74,212 (standard deviation, $112,740), comprising IP costs of $40,702 (55%), OP costs of $30,254 (41%), and hospice costs of $3,256 (4%). OP costs decreased from $6,021 in the sixth MBD to $2,238 in the last MBD, whereas IP care costs increased from $1,785 to $20,559. Hospice utilization increased from 0.7% in the sixth MBD to 35.6% in the last MBD. CONCLUSION: Oncology costs increase in the last 6 MBD largely because of increased IP costs, whereas OP costs decrease.