An assessment of the association between patient characteristics and timely lung cancer treatment.

PURPOSE: Prior data have demonstrated relationships between patient characteristics, the use of surgery to treat lung cancer, and the timeliness of treatment. Our study examines whether these relationships were observable in 2019 in patients with Medicare Advantage health plans being treated for lung cancer. METHODS: Claims data pertaining to patients with Medicare Advantage health plans who had received radiation therapy (RT) or surgery to treat lung cancer within 90 days of diagnostic imaging were extracted. Other databases were used to determine patients' demographics, comorbidities, the urbanicity of their ZIP code, the median income of their ZIP code, and whether their treatment was ordered by a physician at a hospital. Multivariable logistic and Cox Proportional Hazards models were used to assess the association between patient characteristics, receipt of surgery, and time to non-systemic treatment (surgery or RT), respectively. RESULTS: A total of 2,682 patients were included in the analysis. In an adjusted analysis, patients were significantly less likely to receive surgery if their first ordering physician was based in a hospital, if they were older, if they had a history of congestive heart failure (CHF), if they had a history of chronic obstructive pulmonary disease, or if they had stage III lung cancer. Likewise, having stage III cancer was associated with significantly shorter time to treatment. CONCLUSIONS: Within a Medicare Advantage population, patient demographics were found to be significantly associated with the decision to pursue surgery, but factors other than stage were not significantly associated with time to non-systemic treatment.

Sickle Cell Disease in an Older Adult Population: A Retrospective Review of Health Care Resource Utilization.

Sickle cell disease (SCD) has a history of health inequity, as patients with SCD are primarily Black and often marginalized from the health care system. Although recent health care and treatment advancements have prolonged life expectancy, it may be insufficient to support the complex needs of the growing population of older adults with SCD. This retrospective study used a cohort (N = 812) of Medicare Advantage beneficiaries 45 years and older (ages: 45-54, 55-64, 65-74, 75-89) with SCD to identify associations of SCD-related complications and comorbidities with emergency department (ED) visits, potentially avoidable ED visits, all-cause hospitalization, and potentially avoidable hospitalizations, 2018-2020. The 75-89 age group had lower odds of an ED visit (OR 0.56; 95% CI 0.32-1.00), 65-74 age group had lower odds of an ED visit (OR 0.49; 95% CI 0.31-0.78) and hospitalization (OR 0.50; 95% CI 0.31-0.79), compared with the 45-54 age group. Acute chest syndrome was associated with increased odds of an ED visit (OR 2.02; 95% CI 1.10-3.71), avoidable ED visit (OR 1.87; 95% CI 1.14-3.06), and hospitalization (OR 3.61; 95% CI 2.06-6.31). Pain was associated with increased odds of an ED visit (OR 2.64; 95% CI 1.85-3.76), an avoidable ED visit (OR 3.08; 95% CI 1.90-4.98), hospitalization (OR 1.51; 95% CI 1.02-2.24), and avoidable hospitalization (OR 6.42; 95% CI 1.74-23.74). Older adults with SCD have been living with SCD for decades, often while managing pain crises and complications associated increased incidence of an ED visit and hospitalization. The characteristics and needs of this population must continue to be examined to increase preventative care and reduce costly emergent health care resource utilization.

The association between community social vulnerability and prescription opioid availability with individual opioid overdose.

BACKGROUND: This study aims to assess the association of community social vulnerability and community prescription opioid availability with individual non-fatal or fatal opioid overdose. METHODS: We identified patients 12 years of age or older from the Oregon All Payer Claims database (APCD) linked to other public health datasets. Community-level characteristics were captured in an exposure period (EP) (1/1/2018-12/31/2018) and included: census tract-level social vulnerability domains (socio-economic status, household composition, racial and ethnic minority status, and housing type and transportation), census tract-level prescriptions and community-level opioid use disorder (OUD) diagnoses per 100 capita binned into quartiles or quintiles. We employed Cox models to estimate the risk of fatal and non-fatal opioid overdoses events in the 12 months following the EP. MAIN FINDINGS: We identified 1,548,252 individuals. Patients were mostly female (54%), White (61%), commercially insured (54%), and lived in metropolitan areas (81%). Of the total sample, 2485 (0.2%) experienced a non-fatal opioid overdose and 297 died of opioid overdose. There was higher hazard for non-fatal overdose in communities with greater OUD per 100 capita. We also found higher non-fatal and fatal hazards for opioid overdose among patients in communities with higher housing type and transportation-related vulnerability compared to the lowest quintile. Conversely, patients were at less risk of opioid overdose when living in communities with greater prevalence of the young or the elderly, the disabled, single parent families or low English proficiency. CONCLUSION: These findings underscore the importance of the environmental context when considering public health policies to reduce opioid harms.

Lung Cancer Treatment Trends During the Coronavirus Disease 2019 (COVID-19) Pandemic: A Claims and Order Data Analysis (2019-2021).

Introduction: Lung cancer is treated using systemic therapy, radiation therapy (RT), and surgery. This study evaluates how utilization of these modalities and cancer stage at initial treatment shifted from 2019 to 2021. Methods: Claims for lung cancer treatment were extracted from the database of a national health care organization offering Medicare Advantage health plans and paired with enrollment data to determine utilization rates. Seasonally adjusted rates were trended, with monotonicity evaluated using Mann-Kendall tests. Using contemporaneous prior authorization order data, the association between year and the patient's cancer stage at the time of the initial RT or surgery order was evaluated through univariable and multivariable analyses. Results: The study considered 140.9 million beneficiary-months of data. There were negative and significantly monotonic trends in utilization of RT (p = 0.033) and systematic therapy (p = 0.003) for initial treatment between January 2020 and December 2021. Analysis of RT and surgery order data revealed that the patients were significantly (p < 0.001) more likely to have advanced (stage III or IV) cancer at the time of their surgery order in 2020 and 2021 than in 2019. After adjusting for urbanicity, age, and local income, a significant relationship between year of the initial order and presence of advanced cancer at the time of ordering was found for surgery orders placed in 2020 (p < 0.001) and 2021 (p < 0.01), but not for RT orders. Conclusions: There was a per-capita reduction in lung cancer treatment in 2020 and 2021, and patients receiving initial orders for surgery after the onset of the pandemic had more advanced cancer.

An assessment of the association between patient race and prior authorization program determinations in the context of radiation therapy.

BACKGROUND: When a physician determines that a patient needs radiation therapy (RT), they submit an RT order to a prior authorization program which assesses guideline-concordance. A rule-based clinical decision support system (CDSS) evaluates whether the order is appropriate or potentially non-indicated. If potentially non-indicated, a board-certified oncologist discusses the order with the ordering physician. After discussion, the order is authorized, modified, withdrawn, or recommended for denial. Although patient race is not captured during ordering, bias prior to and during ordering, or during the discussion, may influence outcomes. This study evaluated if associations existed between race and order determinations by the CDSS and by the overall prior authorization program. METHODS: RT orders placed in 2019, pertaining to patients with Medicare Advantage health plans from one national organization, were analyzed. The association between race and prior authorization outcomes was examined for RT orders for all cancers, and then separately for breast, lung, and prostate cancers. Analyses controlled for the patient's age, urbanicity, and the median income in the patient's ZIP code. Adjusted analyses were conducted on unmatched and racially-matched samples. RESULTS: Of the 10,145 patients included in the sample, 8,061 (79.5%) were White and 2,084 (20.5%) were Black. Race was not found to have a significant association with CDSS or prior authorization outcomes in any of the analyses. CONCLUSIONS: CDSS and prior authorization outcomes suggested similar rates of clinical appropriateness of orders for patients, regardless of race. IMPLICATIONS: Prior authorization utilizing rule-based CDSS was capable of enforcing guidelines without introducing racial bias.

Rate of Whole-Breast Hypofractionated Radiation Therapy Before Versus After Virtual Tumor Board Implementation.

PURPOSE: The virtual tumor board (VTB) is a multidisciplinary group of specialist physicians who remotely educate the treating physician on the development of an evidence-based cancer treatment plan that will enhance patient outcomes according to the available literature. The use of hypofractionated (HF) radiation therapy (RT) is a preferred approach according to National Comprehensive Cancer Network guidelines and is encouraged by the VTB, when appropriate. MATERIALS AND METHODS: An observational, cohort study using prior authorization and claims data were conducted to show how the relative use of HF and conventional fractionated (CF) RT changed after the implementation of the VTB. Orders and claims for qualifying patients from 1 year before launch (August 2016) to 1 year after launch (August 2018) of the VTB were extracted. Claims were examined to observe which patients received CF (28-35 fractions) versus HF (15-21 fractions) RT. χ2 tests were used to assess the association between time period and the ordering and use of HF RT. Logistic regressions were used to test the association, after adjusting for the patient's age, urbanicity, local average income, and the RT modality used. RESULTS: After implementation, we observed a significantly higher percentage of orders for HF RT (60.3% [n = 1,254 of 2,079] v 53.2% [n = 1,010 of 1,899]; P < .001) and claims for HF RT (71.5% [n = 1,143 of 1,598] v 59.0% [n = 941 of 1,595]; P < .001). Relative to before implementation, the adjusted odds of an order for HF RT was 1.35 (CI, 1.19 to 1.54), and the adjusted odds of a claim for HF RT was 1.76 (CI, 1.52 to 2.04). CONCLUSION: After the VTB was implemented, there was a significant increase in HF RT orders and claims.

NCCN Policy Summit: Defining, Measuring, and Applying Quality in an Evolving Health Policy Landscape and the Implications for Cancer Care.

Quality measurement is a critical component of advancing a health system that pays for performance over volume. Although there has been significant attention paid to quality measurement within health systems in recent years, significant challenges to meaningful measurement of quality care outcomes remain. Defining cost can be challenging, but is arguably not as elusive as quality, which lacks standard measurement methods and units. To identify industry standards and recommendations for the future, NCCN recently hosted the NCCN Oncology Policy Summit: Defining, Measuring, and Applying Quality in an Evolving Health Policy Landscape and the Implications for Cancer Care. Key stakeholders including physicians, payers, policymakers, patient advocates, and technology partners reviewed current quality measurement programs to identify success and challenges, including the Oncology Care Model. Speakers and panelists identified gaps in quality measurement and provided insights and suggestions for further advancing quality measurement in oncology. This article provides insights and recommendations; however, the goal of this program was to highlight key issues and not to obtain consensus.

Claims identification of patients with severe cancer-related symptoms.

OBJECTIVES: The goal of this study was to establish a claims-based mechanism for identifying patients with metastatic non-small cell lung cancer (mNSCLC) and high levels of patient-reported cancer-related symptoms who could benefit from engagement with health care programs. STUDY DESIGN: A cross-sectional survey of patients with mNSCLC was conducted from July 2017 to May 2018. Surveys were mailed to patients who were within 3 months of cancer treatment and enrolled in a Medicare Advantage health plan. METHODS: Pain, fatigue, and sleep disturbance were measured using the Patient-Reported Outcomes Measurement Information System. Depression was assessed using the Patient Health Questionnaire-2. Medical claims were linked to survey results to identify comorbidities and assess preindex health care resource utilization. Cluster analysis was used to differentiate patients based on patient-reported pain interference, pain intensity, depression, and sleep disturbance. Logistic regression was used to identify claims-based measures associated with more severe symptoms. RESULTS: For 698 respondents, 2 distinct symptom clusters were identified: a less severe (38.4%) cluster and a more severe (61.6%) cluster. Patients in the more severe cluster were younger, were more frequently dually eligible for Medicare and Medicaid, and more frequently had prescription fills for opioids. Claims-based factors associated with the more severe cluster included 2 or more 30-day fills for opioids in the prior 6 months, age younger than 75 years, depression diagnosis or antidepressants, bone metastases, and pain-related outpatient visits. CONCLUSIONS: The claims-based factors associated with the severe symptom cluster can enable identification of patients with mNSCLC who could benefit from clinical outreach programs to enhance the care and support provided to these patients.

The Association Between Use of Hypofractionation and Treatment Completion Among Recipients of Radiation Therapy Post-Mastectomy.

PURPOSE: Although there is some evidence to support the use of hypofractionated (HF) radiation therapy (RT) postmastectomy, it is not currently the standard of care. RT noncompletion and delayed completion have been shown to lead to inferior outcomes. This study assesses the association between the choice of an HF versus conventionally fractionated regimen and completion. METHODS AND MATERIALS: RT orders placed in 2016 and 2017 for patients with a national health plan, along with the associated claims, were extracted. Each order was assigned a target date for timely completion, as well as a date 30 days after the target, which was used to assess delayed completion. Univariate analyses and logistic regressions were conducted to test for an association between regimen and completion. A Poisson regression was used to examine the association between regimen and length of treatment delay among patients completing RT. RESULTS: Of the 743 orders meeting inclusion criteria, 56 (7.5%) were for HF. Unadjusted analyses found that the timely and delayed completion rates were significantly (P < .001) higher for patients receiving HF. The adjusted odds ratios (HF order versus CF order) were 3.96 (95% confidence interval, 2.23-7.01) for timely completion and 2.64 (95% confidence interval, 1.43-5.15) for completion within 30 days of the target. Among completers, an order for HF was significantly (P < .001) associated with less delay. CONCLUSIONS: When an HF regimen was ordered, patients were more likely to complete therapy without a delay, to complete therapy overall, and, if experiencing a delay, to experience a shorter delay.

Serum Histidine is Lower in Fatigued Women with Multiple Sclerosis.

BACKGROUND: Disabling persistent perceived fatigue occurs in 50% of people with multiple sclerosis (MS), but mechanisms are poorly understood. Low histidine could contribute to fatigue since it is the neurotransmitter histamine precursor and low serum levels are reported in other diseases where fatigue is common (e.g., breast cancer, kidney disease, diabetes). Serum histidine is also inversely correlated with proinflammatory cytokines (e.g., TNF, IFN-y), which have been linked to MS fatigue. PURPOSE: To determine if serum histidine is low in fatigued women with MS, and if histidine is related to differences in proinflammatory cytokines. METHODS: Participants were classified as having elevated (n = 19) or normal (n = 18) perceived fatigue based on a median sample split using Profile of Mood States fatigue scale scores, with the elevated fatigue group having scores >7. Histidine and gene-expression of TNF, IFN-y, and leptin were assayed from a serum sample. RESULTS: After adjustment for depression, serum histidine was significantly lower in women with MS with elevated fatigue, compared to normal fatigue (64.57 vs. 70.48 nmol/ml, p = .048, g = 0.75). There were no differences between groups in cytokine expression (all p > .24). Gene expression of TNF correlated with histidine only in people with normal fatigue (r = .51, p = .034), while no other cytokines related to histidine levels. CONCLUSIONS: These results provide evidence that serum histidine is lower in fatigued women with MS, but the study did not find a relationship between histidine and TNF, IFN-y, or leptin gene expression.

Effects of lipoic acid on walking performance, gait, and balance in secondary progressive multiple sclerosis.

BACKGROUND: Gait and balance impairment is common in secondary progressive multiple sclerosis (SPMS). Lipoic acid (LA), an over-the-counter antioxidant, is effective in MS animal models and may improve walking speed, but effects on mobility are unreported. OBJECTIVE: Examine the effects of 1200 mg daily oral dose of LA versus placebo (PLA) on gait and balance in a 2-year, randomized, double-blind pilot study. METHODS: 134 participants were screened for eligibility before assignment to LA (n = 28) or PLA (n = 26). Included here were, 21 participants with SPMS who took LA (N = 11) or PLA (N = 10) capsules for 2 years (enrolled May 2, 2011 - August 14, 2015) and completed all tasks without the use of an assistive device. Participants completed the Timed Up and Go (TUG) and quiet standing tasks every 6 months while wearing inertial sensors (APDM Opals) to quantify mobility. RESULTS: LA had a medium effect on time to complete TUG at 2 years (g = 0.51; 95% CI = -0.35, 1.38). In a subset of 18 participants with less disability (EDSS < 6, no use of ambulatory device), turning time was significantly shorter with LA (p = 0.048, Δ= 0.48 s). No differences in balance metrics were found between groups. CONCLUSIONS: LA had an effect on walking performance in people with SPMS, particularly in those with lower baseline disability. TRIAL REGISTRATION: Lipoic Acid for Secondary Progressive Multiple Sclerosis https://clinicaltrials.gov/ct2/show/NCT01188811?term=spain+lipoic+acid&rank=1 NCT0118881.

Perceived fatigue and energy are independent unipolar states: Supporting evidence.

Persistent fatigue is a common problem (∼20-45% of U.S. population), with higher prevalence and severity in people with medical conditions such as cancer, depression, fibromyalgia, heart failure, sleep apnea and multiple sclerosis. There are few FDA-approved treatments for fatigue and great disagreement on how to measure fatigue, with over 250 instruments used in research. Many instruments define fatigue as "a lack of energy", thus viewing energy and fatigue states as opposites on a single bipolar continuum. In this paper, we hypothesize that energy and fatigue are distinct perceptual states, should be measured using separate unipolar scales, have different mechanisms, and deficits should be treated using tailored therapies. Energy and fatigue independence has been found in both exploratory and confirmatory factor analysis studies. Experiments in various fields, including behavioral pharmacology and exercise science, often find changes in energy and not fatigue, or vice versa. If the hypothesis that energy and fatigue are independent is correct, there are likely different mechanisms that drive energy and fatigue changes. Energy could be increased by elevated dopamine and norepinephrine transmission and binding. Fatigue could be increased by elevated brain serotonin and inflammatory cytokines and reduced histamine binding. The hypothesis could be tested by an experiment that attempts to produce simultaneously high ratings of energy and fatigue (such as with two drugs using a randomized, double-blind, placebo-controlled design), which would offer strong evidence against the common viewpoint of a bipolar continuum. If the hypothesis is correct, prior literature using bipolar instruments will be limited, and research on the prevalence, mechanisms, and treatment of low energy and elevated fatigue as separate conditions will be needed. In the immediate future, measuring both energy and fatigue using unipolar measurement tools may improve our understanding of these states and improve therapeutic outcomes.

Adenosine A2A receptor gene polymorphisms (ADORA2A) are associated with maximal concentric contraction pain.

Objectives: To test associations of adenosine A2A receptor gene (ADORA2A) polymorphisms with maximal concentric contraction pain, caffeine-induced perceptual changes, and responses to mild eccentric injury. Design: Targeted candidate gene association study. Methods: ADORA2A (rs5751876) was genotyped in 26 adults. Pain of a maximal elbow flexor contraction was assessed. Participants performed 18 eccentric actions of the elbow flexors. Arm volume was measured before and 24- and 48-h post-injury. At 24- and 48-h post-injury, caffeine or placebo capsules were given using a randomized cross-over design and effort and pain were assessed. Results: Maximal concentric contraction pain was higher for the CC compared to the CT/TT group (effect size d = 0.89) and lower for the TT compared to the CT/CC group (d = 0.62). There were moderate sized differences between CC and TT/CT groups for post-injury exertion and arm volume 24-h post injury. Conclusions: ADORA2A polymorphisms are moderately associated with muscle pain during maximal contractions in uninjured muscle.

Alternative Payment Models in Medical Oncology: Assessing Quality-of-Care Outcomes Under Partial Capitation.

BACKGROUND: Alternative payment models (APMs) in healthcare are emerging that reward quality of care over quantity of services. Most bundled payment programs that are described in published studies are related to episodes for a surgical inpatient hospital stay. With outpatient services, monthly capitated payments are an alternative to bundled payments for specialty services. OBJECTIVE: To assess the association of a capitated contractual arrangement between a primary care physician group and an oncology clinic group with the quality of care received. METHODS: We evaluated the effect of an oncology group's transition from a fee-for-service (FFS) arrangement to a partial-capitated-payment model with a primary care group. We compared outcomes for patients who received treatment after implementation of the new arrangement (ie, postcontract capitated group) with outcomes of patients receiving treatment before the change (ie, precontract capitated group). In addition, we conducted a parallel analysis of patients from a population that was not affected by the contract to assess temporal effects (ie, postcontract FFS group vs precontract FFS group). All patients were enrolled in Medicare Advantage plans of a single health plan (ie, Humana), and outcomes were measured using claims data provided by that company. Patients in the 2 precontract groups received treatment between July 1, 2010, and June 30, 2011; patients in the 2 postcontract groups received treatment between January 1, 2013, and December 31, 2013. Age- and sex-adjusted all-cause hospitalization, complications from cancer treatment, and ambulance transfers during 6 months of follow-up were evaluated. RESULTS: In the population subject to the partial-capitated-payment model, the postcontract group (N = 305) was younger than the precontract group (N = 165). In a subset of patients in the 2 capitated groups who had Deyo-Charlson Comorbidity Index (CCI) RxRisk scores, the postcontract capitated group had significantly higher CCI scores. Adjusted odds ratios for the postcontract capitated group versus the precontract capitated group showed no difference in the likelihood that any of the outcomes would occur. However, the mean number of chemotherapy-related complications and ambulance transports were greater postcontract. In the parallel analysis of the population not affected by the new payment arrangement, no differences were found between the pre- and postcontract groups. This suggests that temporal changes potentially affecting patients in the capitated and FFS populations would not have influenced postcontract outcomes. CONCLUSIONS: After the implementation of partial-capitated payments for medical oncology services in the oncology practice, the likelihood of a patient experiencing at least 1 event of a specific adverse outcome did not change; however, the average number of some adverse events did increase, which may in part be explained by a higher level of underlying morbidity in the postcontract group. The overall findings of this study suggest that quality of care was not compromised in this APM.

Relationship between perceived fatigue and performance fatigability in people with multiple sclerosis: A systematic review and meta-analysis.

BACKGROUND: Perceived fatigue (i.e., subjective perception of reduced capacity) is one of the most common and disabling symptoms for people with multiple sclerosis (MS). Perceived fatigue may also be related to performance fatigability (i.e., decline in physical performance over time), although study findings have been inconsistent. OBJECTIVE: To locate all studies reporting the relationship between perceived fatigue and fatigability in people with MS, determine the population correlation, and examine moderating variables of the correlation size. METHODS: In accordance with PRISMA guidelines, systematic searches were completed in Medline, PsychInfo, Google Scholar, and the Cochrane Library for peer-reviewed articles published between March 1983 and August 2016. Included articles measured perceived fatigue and performance fatigability in people with MS and provided a correlation between measures. Moderator variables expected to influence the relationship were also coded. Searches located 19 studies of 848 people with MS and a random-effects model was used to pool correlations. RESULTS: The mean correlation between fatigue and fatigability was positive, "medium" in magnitude, and statistically significant, r=0.31 (95% CI=0.21, 0.42), p<0.001. Despite moderate between-study heterogeneity (I2=46%) no statistically significant moderators were found, perhaps due to the small number of studies per moderator category. CONCLUSION: There is a significant relationship between perceived fatigue and fatigability in MS, such that people reporting elevated fatigue also are highly fatigable. The size of the relationship is not large enough to suggest fatigue and fatigability are the same construct, and both should continue to be assessed independently.

Presentation at computed tomography (CT) scan of the thorax and first year diagnostic and treatment utilization among patients diagnosed with lung cancer.

BACKGROUND: As Medicare expands the use of computed tomography (CT) for diagnosing lung cancer, there is increased opportunity to diagnose lung cancer in asymptomatic patients. This descriptive study characterizes the disease-specific diagnostic and treatment services that patients with a positive diagnosis following CT received, stratified by presentation at CT. METHODS: Patients who were diagnosed with lung cancer following CT in 2013, had no history of lung cancer, survived at least 1 year, were aged 55-80 years, and had Medicare Advantage insurance were included. Patients were grouped based upon presentation at CT: morbidities unrelated to lung cancer, classic lung cancer symptoms, and cancer syndromes. Patients with none of these factors were categorized into a no diagnoses/symptoms group. The type and intensity of services used in the year following the CT was reported for each group. RESULTS: 1,261 patients were included. Early treatment services were most common in the group with morbidities unrelated to lung cancer (13.7%) and least common in the cancer syndromes group (6.6%). Advanced treatment services were used by 47.3% of the cancer syndromes group versus 23.5% of the no diagnoses/symptoms group. CONCLUSIONS: The intensity of disease-specific diagnostic and treatment services varied by presentation at CT. Patients with no symptoms or morbidities at the time of CT less frequently received advanced interventions. Learning about the utilization patterns of others with a similar presentation at CT may help patients with positive lung cancer diagnoses engage in shared decision making and in norming their experiences against those of other similarly-situated patients.

Effect of Acute Exercise on Fatigue in People with ME/CFS/SEID: A Meta-analysis.

PURPOSE: A prominent symptom of myalgic encephalomyelitis, chronic fatigue syndrome, or systemic exertion intolerance disease (ME/CFS/SEID) is persistent fatigue that is worsened by physical exertion. Here the population effect of a single bout of exercise on fatigue symptoms in people with ME/CFS/SEID was estimated and effect moderators were identified. METHODS: Google Scholar was systematically searched for peer-reviewed articles published between February 1991 and May 2015. Studies were included where people diagnosed with ME/CFS/SEID and matched control participants completed a single bout of exercise and fatigue self-reports were obtained before and after exercise. Fatigue means, standard deviations, and sample sizes were extracted to calculate effect sizes and the 95% confidence interval. Effects were pooled using a random-effects model and corrected for small sample bias to generate mean Δ. Multilevel regression modeling adjusted for nesting of effects within studies. Moderators identified a priori were diagnostic criteria, fibromyalgia comorbidity, exercise factors (intensity, duration, and type), and measurement factors. RESULTS: Seven studies examining 159 people with ME/CFS/SEID met inclusion criteria, and 47 fatigue effects were derived. The mean fatigue effect was Δ = 0.73 (95% confidence interval = 0.24-1.23). Fatigue increases were larger for people with ME/CFS/SEID when fatigue was measured 4 h or more after exercise ended rather than during or immediately after exercise ceased. CONCLUSIONS: This preliminary evidence indicates that acute exercise increases fatigue in people with ME/CFS/SEID more than that in control groups, but effects were heterogeneous between studies. Future studies with no-exercise control groups of people with ME/CFS/SEID are needed to obtain a more precise estimate of the effect of exercise on fatigue in this population.

Patterns of Care in Patients with Metastatic Renal Cell Carcinoma Among a U.S. Payer Population with Commercial or Medicare Advantage Membership.

BACKGROUND: Several systemic therapies are now approved for first- and second-line treatment of metastatic renal cell carcinoma (mRCC). Although the National Comprehensive Cancer Network (NCCN) guidelines offer physicians evidence-based recommendations for therapy, there are few real-world studies to help inform the utilization of these agents in clinical practice. OBJECTIVES: To (a) describe the patterns of use associated with systemic therapies for mRCC among Humana members in the United States diagnosed with mRCC, (b) assess consistency with the NCCN guidelines for treatment, and (c) to describe the initial first-line therapy regimen by prescriber specialty and site of care. METHODS: This was a retrospective study using Humana's claims database of commercially insured patients and patients insured by the Medicare Advantage Prescription Drug plan. The study period was from January 1, 2007, to December 31, 2013. Patients with mRCC were identified by ICD-9-CM codes 189.0/189.1 and 196.xx to 199.xx; all patients were between 18 and 89 years of age, had received systemic therapy for their disease, and were followed up for 180 days. Outcome measures included choice of initial systemic therapy, starting and ending doses, first-line treatment persistence and compliance, and choice of second-line therapy. Persistence was measured using time to discontinuation of first-line therapy and proportion of days covered (PDC; the ratio of [total days of drug available minus days of supply of last prescription] to [last prescription date minus first prescription date]). Compliance was measured using the medication possession ratio (MPR; the ratio of [total days supply minus days supply of last prescription] to [last prescription date minus first prescription date]). RESULTS: A total of 649 patients met all inclusion criteria; 109 were insured by commercial plans and 540 were insured by Medicare. The mean ± SD age of patients was 68.6 ± 9.4 years, and 68.6% were male; Medicare patients were older than commercial patients (71.7 ± 7.4 vs. 56.6 ± 9.1 years, respectively; P < 0.001). The most common comorbidities among the patient population were hypertension, hyperlipidemia, diabetes, and heart disease. The majority of patients (68.6%) received an oral tyrosine kinase inhibitor (TKI) as their first line of therapy: 43.9% received sunitinib, 14.0% received sorafenib, 10.0% received pazopanib, and 0.6% received axitinib. Mean ± SD time to discontinuation of first-line TKI treatment was 169.1 ± 29.5 days with sunitinib, 160.3 ± 41.1 days with pazopanib, and 160.1 ± 41.4 days with sorafenib. Other first-line therapies included inhibitors of mammalian target of rapamycin (mTOR) (19.7%) and the antivascular endothelial growth factor agent bevacizumab (9.4%). Among patients receiving mTOR inhibitors, 14.8% were started on temsirolimus and 4.9% were started on everolimus. The median starting and ending doses were the same for each drug except for sunitinib. Mean ± SD times to discontinuation of temsirolimus, everolimus, and bevacizumab were 171.8 ± 26.2, 137.0 ± 62.2, and 150.8 ± 56.0 days, respectively. Persistence on first-line regimen as measured by PDC was high (PDC ≥ 80%) for 89% of oral therapies and 77% of injectable therapies; first-line compliance was high (MPR ≥ 80%) for 77% of oral therapies and 68% of injectables. Among patients who received second-line therapy, the most common regimen was everolimus (29.2%), followed by bevacizumab (19.8%), temsirolimus (15.6%), and sunitinib (13.6%). Specialty codes obtained from the database provider identified internal medicine specialists and oncologists as the most common prescribers of TKIs and mTOR inhibitors. CONCLUSIONS: Patterns of use were similar for each of the prescribed systemic treatments for mRCC, and the majority of patients were highly persistent and compliant with first-line therapies. Time to treatment discontinuation was slightly longer with oral agents compared with injectable drugs.

Do Case Rates Affect Physicians' Clinical Practice in Radiation Oncology?: An Observational Study.

Case rate payments combined with utilization monitoring may have the potential to improve the quality of care by reducing over and under-treatment. Thus, a national managed care organization introduced case rate payments at one multi-site radiation oncology provider while maintaining only fee-for-service payments at others. This study examined whether the introduction of the payment method had an effect on radiation fractions administered when compared to clinical guidelines. The number of fractions of radiation therapy delivered to patients with bone metastases, breast, lung, prostate, and skin cancer was assessed for concordance with clinical guidelines. The proportion of guideline-based care ascertained from the payer's claims database was compared before (2011) and after (2013) the payment method introduction using relative risks (RR). After the introduction of case rates, there were no significant changes in guideline-based care in breast, lung, and skin cancer; however, patients with bone metastases and prostate cancer were significantly more likely to have received guideline-based care (RR = 2.0 and 1.1, respectively, p<0.05). For the aggregate of all cancers, the under-treatment rate significantly declined (p = 0.008) from 4% to 0% after the introduction of case rate payments, while the over-treatment rate remained steady at 9%, with no significant change (p = 0.20). These findings suggest that the introduction of case rate payments did not adversely affect the rate of guideline-based care at the provider examined. Additional research is needed to isolate the effect of the payment model and assess implications in other populations.