Biosimilar Use Among 38 ASCO PracticeNET Practices, 2019-2021.

PURPOSE: Biosimilars offer increased patient choice and potential cost-savings, compared with originator biologics. We studied 3 years of prescribed biologics among US physician practices to determine the relationship of practice type and payment source to oncology biosimilar use. METHODS: We acquired biologic utilization data from 38 practices participating in PracticeNET. We focused on six biologics (bevacizumab, epoetin alfa, filgrastim, pegfilgrastim, rituximab, and trastuzumab) for the period from 2019 to 2021. We complemented our quantitative analysis with a survey of PracticeNET participants (prescribers and practice leaders) to reveal potential motivators and barriers to biosimilar use. We implemented logistic regression to evaluate the biosimilar use for each biologic, with covariates including time, practice type, and payment source, and accounted for clusters of practices. RESULTS: Use of biosimilars increased over the 3-year period, reaching between 51% and 80% of administered doses by the fourth quarter of 2021, depending on the biologic. Biosimilar use varied by practice, with independent physician practices having higher use of biosimilars for epoetin alfa, filgrastim, rituximab, and trastuzumab. Compared with commercial health plans, Medicaid plans had lower biosimilar use for four biologics; traditional Medicare had lower use for five biologics. The average cost per dose decreased between 24% and 41%, dependent on the biologic. CONCLUSION: Biosimilars have, through increased use, lowered the average cost per dose of the studied biologics. Biosimilar use differed by originator biologic, practice type, and payment source. There remains further opportunity for increases in biosimilar use among certain practices and payers.

A rapid review of evidence relating to service use, experiences, and support needs of adults from minority ethnic communities along the eyecare pathway in the United Kingdom.

Background: There is growing awareness of the health inequalities experienced by minority ethnic communities, who make up an increasing proportion of the United Kingdom (UK) population and have been found to be at increased risk of visual impairment (V.I.). V.I. impacts on a wide range of life domains including employment, social functioning and activities of daily living. Considering existing health inequalities, the increased risk of V.I. and its wide-ranging impact, it is important to understand the experiences of adults from minority ethnic communities living with V.I. in the UK. Methods: A rapid evidence review of academic and gray literature published since 2005 and in English was performed. A search of AMED, CINAHL Plus and MEDLINE via EBSCOhost identified 969 articles. Articles were included in the review if they reported findings relating to the UK-context, to adults from minority ethnic communities living with V.I., and to experiences of V.I. and the eyecare pathway. Results: A total of 11 academic articles and 4 charity reports presented findings relating to perceptions of V.I. and eye disease (n = 3), access to services and service use (n = 5), impact of interventions (n = 7), the wider impact of V.I. (n = 2), and registration status (n = 1). Much of the literature focused on primary eyecare resulting in a comprehensive list of barriers and recommendations to increase eye tests. Less research addressed experiences and use of services further along the eyecare pathway although use of services may be low. Overall, the research on the experiences of adults with V.I. from minority ethnic communities in the UK remains anecdotal, outdated or unavailable. There are substantial gaps in the evidence relating to the wider impact of V.I., the impact of perceptions of V.I., and the use of services beyond primary eyecare. Conclusions: This review summarizes our current knowledge of the experiences of adults from minority ethnic communities living with V.I. in the UK and highlights substantial gaps in the evidence. The findings provide practical implications for practitioners and researchers committed to addressing health inequalities in the field of eyecare in the UK.

An overview of psychological and social factors in Charles Bonnet syndrome.

Charles Bonnet syndrome (CBS) is a condition where cognitively normal individuals with sight impairment experience simple and/or complex visual hallucinations. The exact pathogenesis of CBS is unknown; however, deafferentation is often recognised as a causal mechanism. Studies have provided insight into the multifaceted impact of CBS on wellbeing. Onset of CBS may cause distress among those believing visual hallucinations are indicative of a neurological condition. Hallucinatory content is often congruent with the emotional response. For example, hallucinations of a macabre nature typically result in a fearful response. Visual hallucinations may be highly disruptive, causing everyday tasks to become challenging. Clinical management relies on forewarning and pre-emptive questioning. Yet, knowledge and awareness of CBS is typically low. In this review, we provide a summary of the social and psychological implications of CBS and explore recent developments aimed at raising awareness and improving patient management.

Glaucoma Home Monitoring Using a Tablet-Based Visual Field Test (Eyecatcher): An Assessment of Accuracy and Adherence Over 6 Months.

PURPOSE: To assess accuracy and adherence of visual field (VF) home monitoring in a pilot sample of patients with glaucoma. DESIGN: Prospective longitudinal feasibility and reliability study. METHODS: Twenty adults (median 71 years) with an established diagnosis of glaucoma were issued a tablet perimeter (Eyecatcher) and were asked to perform 1 VF home assessment per eye, per month, for 6 months (12 tests total). Before and after home monitoring, 2 VF assessments were performed in clinic using standard automated perimetry (4 tests total, per eye). RESULTS: All 20 participants could perform monthly home monitoring, though 1 participant stopped after 4 months (adherence: 98% of tests). There was good concordance between VFs measured at home and in the clinic (r = 0.94, P < .001). In 21 of 236 tests (9%), mean deviation deviated by more than ±3 dB from the median. Many of these anomalous tests could be identified by applying machine learning techniques to recordings from the tablets' front-facing camera (area under the receiver operating characteristic curve = 0.78). Adding home-monitoring data to 2 standard automated perimetry tests made 6 months apart reduced measurement error (between-test measurement variability) in 97% of eyes, with mean absolute error more than halving in 90% of eyes. Median test duration was 4.5 minutes (quartiles: 3.9-5.2 minutes). Substantial variations in ambient illumination had no observable effect on VF measurements (r = 0.07, P = .320). CONCLUSIONS: Home monitoring of VFs is viable for some patients and may provide clinically useful data.

Validation of a Falls Risk Screening Tool Derived From InterRAI Acute Care Assessment.

OBJECTIVES: This study aimed to develop and validate a falls risk screening tool derived from interRAI Acute Care (AC) Assessment. METHODS: For derivation and validation, two prospective cohorts were recruited from AC hospitals in Australia. The derivation cohort comprised 1418 patients from 11 hospitals. In the validation cohort, 393 patients were recruited from four hospitals. The interRAI AC tool was used to collect comprehensive geriatric assessment data at admission. In-hospital falls were documented from medical records. A falls risk score was calculated using logistic regression. Predictive ability was compared with St. Thomas Risk Assessment Tool In Falling elderlY (STRATIFY), using area under curve (AUC). The validation cohort provided external validity. RESULTS: Complete data in the derivation cohort were available for 1288 patients (91%), with 75 (5.8%) having an in-hospital fall. The derived interRAI AC falls risk score (range = 0-6) had significantly better predictive ability (AUC = 0.70, 95% confidence interval [CI] = 0.63-0.76) compared with St. Thomas Risk Assessment Tool In Falling elderlY (AUC = 0.64, 95% CI = 0.58-0.70) (P = 0.033). At a cut point of three, 54 of 75 falls were correctly predicted by the falls risk score derived from interRAI AC (sensitivity = 0.72 [95% CI = 0.60-0.82] and specificity = 0.60 [95% CI = 0.57-0.62]). The falls risk score performed similarly in the validation cohort. CONCLUSIONS: The falls risk tool developed from interRAI AC is a valid measure to screen for in-hospital falls. Reduction in assessment burden without loss of fidelity can be achieved through integrating the risk screener within the interRAI hospital system, which automatically triggers protocols for falls prevention based on identified risk.

The State of Cancer Care in America: Impact of State Policy on Access to High-Quality Cancer Care.

Health policy in America has shifted rapidly over the last decade, and states are increasingly exercising greater authority over health policy decision-making. This localization and regionalization of healthcare policy poses significant challenges for patients with cancer, providers, advocates, and policymakers. To identify the challenges and opportunities that lay ahead of stakeholders, NCCN hosted the 2019 Policy Summit: The State of Cancer Care in America on June 27, 2019, in Washington, DC. The summit featured multidisciplinary panel discussions to explore the implications for access to quality cancer care within a shifting health policy landscape from a patient, provider, and lawmaker perspective. This article encapsulates the discussion from this NCCN Policy Summit.

Cancer Treatment as an Accelerated Aging Process: Assessment, Biomarkers, and Interventions.

An accumulating body of evidence supports the hypothesis that cancer and/or cancer treatment is associated with accelerated aging. The majority of these data come from the pediatric literature; however, a smaller yet growing body of literature points toward similar findings in the geriatric population. This is a key survivorship issue the growing number of older adults with cancer face, along with the short- and long-term impact of cancer therapy on the aging process. This article will review clinical and biologic markers of aging in older adults with cancer, use cardiovascular disease as a model of accelerated aging, and discuss potential interventions to decrease the risk.

Midlife Cardiorespiratory Fitness, Incident Cancer, and Survival After Cancer in Men: The Cooper Center Longitudinal Study.

IMPORTANCE: Cardiorespiratory fitness (CRF) as assessed by formalized incremental exercise testing is an independent predictor of numerous chronic diseases, but its association with incident cancer or survival following a diagnosis of cancer has received little attention. OBJECTIVE: To assess the association between midlife CRF and incident cancer and survival following a cancer diagnosis. DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, observational cohort study conducted at a preventive medicine clinic. The study included 13 949 community-dwelling men who had a baseline fitness examination. All men completed a comprehensive medical examination, a cardiovascular risk factor assessment, and incremental treadmill exercise test to evaluate CRF. We used age- and sex-specific distribution of treadmill duration from the overall Cooper Center Longitudinal Study population to define fitness groups as those with low (lowest 20%), moderate (middle 40%), and high (upper 40%) CRF groups. The adjusted multivariable model included age, examination year, body mass index, smoking, total cholesterol level, systolic blood pressure, diabetes mellitus, and fasting glucose level. Cardiorespiratory fitness levels were assessed between 1971 and 2009, and incident lung, prostate, and colorectal cancer using Medicare Parts A and B claims data from 1999 to 2009; the analysis was conducted in 2014. MAIN OUTCOMES AND MEASURES: The main outcomes were (1) incident prostate, lung, and colorectal cancer and (2) all-cause mortality and cause-specific mortality among men who developed cancer at Medicare age (≥65 years). RESULTS: Compared with men with low CRF, the adjusted hazard ratios (HRs) for incident lung, colorectal, and prostate cancers among men with high CRF were 0.45 (95% CI, 0.29-0.68), 0.56 (95% CI, 0.36-0.87), and 1.22 (95% CI, 1.02-1.46), respectively. Among those diagnosed as having cancer at Medicare age, high CRF in midlife was associated with an adjusted 32% (HR, 0.68; 95% CI, 0.47-0.98) risk reduction in all cancer-related deaths and a 68% reduction in cardiovascular disease mortality following a cancer diagnosis (HR, 0.32; 95% CI, 0.16-0.64) compared with men with low CRF in midlife. CONCLUSIONS AND RELEVANCE: There is an inverse association between midlife CRF and incident lung and colorectal cancer but not prostate cancer. High midlife CRF is associated with lower risk of cause-specific mortality in those diagnosed as having cancer at Medicare age.

The primacy of vital signs--acute care nurses' and midwives' use of physical assessment skills: a cross sectional study.

BACKGROUND: Registered nurses and midwives play an essential role in detecting patients at risk of deterioration through ongoing assessment and action in response to changing health status. Yet, evidence suggests that clinical deterioration frequently goes unnoticed in hospitalised patients. While much attention has been paid to early warning and rapid response systems, little research has examined factors related to physical assessment skills. OBJECTIVES: To determine a minimum data set of core skills used during nursing assessment of hospitalised patients and identify nurse and workplace predictors of the use of physical assessment to detect patient deterioration. DESIGN: The study used a single-centre, cross-sectional survey design. SETTING AND PARTICIPANTS: The study included 434 registered nurses and midwives (Grades 5-7) involved in clinical care of patients on acute care wards, including medicine, surgery, oncology, mental health and maternity service areas, at a 929-bed tertiary referral teaching hospital in Southeast Queensland, Australia. METHODS: We conducted a hospital-wide survey of registered nurses and midwives using the 133-item Physical Assessment Skills Inventory and the 58-item Barriers to Registered Nurses' Use of Physical Assessment Scale. Median frequency for each physical assessment skill was calculated to determine core skills. To explore predictors of core skill utilisation, backward stepwise general linear modelling was conducted. Means and regression coefficients are reported with 95% confidence intervals. A p value <.05 was considered significant for all analyses. RESULTS: Core skills used by most nurses every time they worked included assessment of temperature, oxygen saturation, blood pressure, breathing effort, skin, wound and mental status. Reliance on others and technology (F=35.77, p<.001), lack of confidence (F=5.52, p=.02), work area (F=3.79, p=.002), and clinical role (F=44.24, p<.001) were significant predictors of the extent of physical assessment skill use. CONCLUSIONS: The increasing acuity of the acute care patient plausibly warrants more than vital signs assessment; however, our study confirms nurses' physical assessment core skill set is mainly comprised of vital signs. The focus on these endpoints of deterioration as dictated by early warning and rapid response systems may divert attention from and devalue comprehensive nursing assessment that could detect subtle changes in health status earlier in the patient's hospitalisation.

Poverty and pediatric palliative care: what can we do?

It has been recognized that families of children with life-limiting health conditions struggle with significant financial demands, yet may not have awareness of resources available to them. Additionally, health care providers may not be aware of the socioeconomic needs of families they care for. This article describes a mixed-methods study examining the content validity and utility for health care providers of a poverty screening tool and companion resource guide for the pediatric palliative care population. The study found high relevance and validity of the tool. Significant barriers to implementing the screening tool in clinical practice were described by participants, including: concerns regarding time required, roles and responsibilities, and discomfort in asking about income. Implications for practice and suggestions for improving the tool are discussed. Screening and attention to the social determinants of health lie within the scope of practice of all health care providers. Social workers can play a leadership role in this work.

Searchers vs surveyors in estimating the monetary value of a QALY: resolving a nasty dilemma for NICE.

Recently, for many health economics researchers, empirical estimation of the monetary valuation of a quality-adjusted life year (QALY) has become an important endeavour. Different philosophical and practical approaches to this have emerged. On the one hand, there is a view that, with health-care budgets set centrally, decision-making bodies within the system can iterate, from observation of a series of previous decisions, towards the value of a QALY, thus searching for such a value. Alternatively, and more consistent with the approach taken in other public sectors, individual members of the public are surveyed with the aim of directly eliciting a preference-based - also known as a willingness-to-pay-based (WTP-based) - value of a QALY. While the former is based on supply-side factors and the latter on demand, both in fact suffer from informational deficiencies. Sole reliance on either would necessitate an acceptance or accommodation of chronic inefficiencies in health-care resource allocation. On the basis of this observation, this paper makes the case that in order to approach optimal decision making in health-care provision, a framework incorporating and thus, to a degree, reconciling these two approaches is to be preferred.

Evidence-based risk assessment and recommendations for physical activity clearance: cancer.

Physical activity is becoming increasingly acknowledged as an integral component of in the multidisciplinary management of cancer patients. Intensive inquiry in this area is likely to increase further over the next decade; however, cancer-specific, evidence-based risk assessment and recommendations for physical activity are not available. A systematic literature review was performed of all studies conducting an exercise training intervention and (or) any form of objective exercise test among adults diagnosed with cancer. Studies were assessed according to evaluation criteria developed by a panel of experts. A total of 118 studies involving 5529 patients were deemed eligible. Overall, the results suggest that exercise training and maximal and submaximal exercise testing are relatively safe procedures with a total nonlife-threatening adverse event rate of <2%. There was only 1 exercise training-related death. However, the quality of exercise testing methodology and data reporting is less than optimal. Thus, whether the low incidence of events reflects the true safety of exercise training and exercise testing in cancer patients or less than optimal methodology and (or) data reporting remains to be determined. Evidence-based absolute and relative contraindications to physical activity and exercise training and testing are provided as well as probing decision-trees to optimize the adoption and safety of physical activity in persons diagnosed with cancer.

The social value of a QALY: raising the bar or barring the raise?

BACKGROUND: Since the inception of the National Institute for Health and Clinical Excellence (NICE) in England, there have been questions about the empirical basis for the cost-per-QALY threshold used by NICE and whether QALYs gained by different beneficiaries of health care should be weighted equally. The Social Value of a QALY (SVQ) project, reported in this paper, was commissioned to address these two questions. The results of SVQ were released during a time of considerable debate about the NICE threshold, and authors with differing perspectives have drawn on the SVQ results to support their cases. As these discussions continue, and given the selective use of results by those involved, it is important, therefore, not only to present a summary overview of SVQ, but also for those who conducted the research to contribute to the debate as to its implications for NICE. DISCUSSION: The issue of the threshold was addressed in two ways: first, by combining, via a set of models, the current UK Value of a Prevented Fatality (used in transport policy) with data on fatality age, life expectancy and age-related quality of life; and, second, via a survey designed to test the feasibility of combining respondents' answers to willingness to pay and health state utility questions to arrive at values of a QALY. Modelling resulted in values of £10,000-£70,000 per QALY. Via survey research, most methods of aggregating the data resulted in values of a QALY of £18,000-£40,000, although others resulted in implausibly high values. An additional survey, addressing the issue of weighting QALYs, used two methods, one indicating that QALYs should not be weighted and the other that greater weight could be given to QALYs gained by some groups. SUMMARY: Although we conducted only a feasibility study and a modelling exercise, neither present compelling evidence for moving the NICE threshold up or down. Some preliminary evidence would indicate it could be moved up for some types of QALY and down for others. While many members of the public appear to be open to the possibility of using somewhat different QALY weights for different groups of beneficiaries, we do not yet have any secure evidence base for introducing such a system.

Weighting and valuing quality-adjusted life-years using stated preference methods: preliminary results from the Social Value of a QALY Project.

OBJECTIVES: To identify characteristics of beneficiaries of health care over which relative weights should be derived and to estimate relative weights to be attached to health gains according to characteristics of recipients of these gains (relativities study); and to assess the feasibility of estimating a willingness-to-pay (WTP)-based value of a quality-adjusted life-year (QALY) (valuation study). DESIGN: Two interview-based surveys were administered - one (for the relativities study) to a nationally representative sample of the population in England and the other (for the valuation study) to a smaller convenience sample. SETTING: The two surveys were administered by the National Centre for Social Research (NatCen) in respondents' homes. PARTICIPANTS: 587 members of the public were interviewed for the relativities study and 409 for the valuation study. METHODS: In the relativities study, in-depth qualitative work and considerations of policy relevance resulted in the identification of age and severity of illness as relevant characteristics. Scenarios reflecting these, along with additional components reflecting gains in QALYs, were presented to respondents in a series of pairwise choices using two types of question: discrete choice and matching. These questions were part of a longer questionnaire (including attitudinal and sociodemographic questions), which was administered face to face using a computer-assisted personal interview. In the valuation study, respondents were asked about their WTP to avoid/prevent different durations of headache or stomach illness and to value these states on a scale (death = 0; full health = 1) using standard gamble (SG) questions. RESULTS: Discrete choice results showed that age and severity variables did not have a strong impact on respondents' choices over and above the health (QALY) gains presented. In contrast, matching showed age and severity impacts to be strong: depending on method of aggregation, gains to some groups were weighted three to four times more highly than gains to others. Results from the WTP and SG questions were combined in different ways to arrive at values of a QALY. These vary from values which are in the vicinity of the current National Institute for Health and Clinical Excellence (NICE) threshold to extremely high values. CONCLUSIONS: With respect to relative weights, more research is required to explore methodological differences with respect to age and severity weighting. On valuation, there are particular issues concerning the extent to which 'noise' and 'error' in people's responses might generate extreme and unreliable figures. Methods of aggregation and measures of central tendency were issues in both weighting and valuation procedures and require further exploration.

Quantitative assessment of cardiorespiratory fitness, skeletal muscle function, and body composition in adults with primary malignant glioma.

BACKGROUND: The study was undertaken to evaluate cardiorespiratory fitness, skeletal muscle function, and body composition of patients with newly diagnosed and untreated, postsurgical primary malignant glioma. METHODS: By using a cross-sectional design, patients with clinically stable (10 +/- 7 days postsurgery) high-grade glioma (HGG; n = 25) or low-grade glioma (LGG; n = 10) were studied. Participants performed a cardiopulmonary exercise test (CPET) with expired gas analysis to assess cardiorespiratory fitness (peak oxygen consumption, VO2peak). Other physiological outcomes included skeletal muscle cross-sectional area (CSA; magnetic resonance imaging), isokinetic muscle strength (isokinetic dynamometer), and body composition (air displacement plethysmography). Quality of life was assessed with the Functional Assessment of Cancer Therapy-Brain scale. RESULTS: CPET was a feasible and safe procedure to assess VO2peak, with no serious adverse events. VO2peak indexed to total body weight and lean body mass (LBM) for both groups was 13.0 mL x weight x min(-1) and 19 mL x LBM x min(-1), the equivalent to 59% and 38% below age- and sex-predicted normative values, respectively. Skeletal muscle strength and mid-thigh CSA were lower in HGG relative to LGG patients (83 vs 125 Nm, P = .025; 94 vs 119 cm2, P = .171, respectively). Skeletal muscle isokinetic strength, CSA, and body composition outcomes predicted VO2peak (r = -0.59 to 0.68, P < .05). CONCLUSIONS: Postsurgical glioma patients have markedly reduced cardiorespiratory fitness, isokinetic strength, and CSA. Prospective studies are now required to determine whether such abnormalities influence treatment toxicity and clinical outcome as well as to test the effect of appropriately selected interventions to prevent and/or mitigate dysfunction.

Assessment of physical functioning in recurrent glioma: preliminary comparison of performance status to functional capacity testing.

BACKGROUND: Performance status (PS) scoring systems are tools of immense clinical importance in the management of patients with malignant disease but these tools are subjective and do not provide an objective evaluation of physical functioning. We conducted a pilot study to explore the feasibility and clinical utility of functional capacity testing to assess physical functioning in recurrent primary malignant glioma patients. PATIENTS AND METHODS: Using a cross-sectional design, consecutive patients with recurrent glioma performed a six minute walk (6MW) test to assess functional capacity. Performance status was assessed using Karnofsky Performance Status (KPS) scoring system. QOL was assessed by the Functional Assessment of Cancer Therapy-Brain scale. Self-reported exercise behavior was assessed using the Godin Leisure Time Exercise Questionnaire (GLTEQ). RESULTS: A total of 171 patients were recruited and tested. Seventy percent were diagnosed with glioblastoma multiforme (WHO grade IV) and 85% were undergoing therapy. Median KPS was 90% (range, 70-100%). Median 6MW distance was 400 m (range, 102-630 m), equivalent to 56 +/- 13% (range, 14-87%) of that predicted for age and sex. KPS, self-reported exercise, and QOL increased across 6MW distance quartiles (P < 0.05) although there was considerable variation within each category. 6MW distance and KPS were significantly correlated with each other (r = 0.34, P < 0.01) and several QOL domains (range, r = -0.43 to 0.46, P < 0.05). CONCLUSIONS: 6MW distance is a clinically feasible tool that provides an objective measure of physical functioning in select patients with recurrent glioma. Further research is required to investigate the prognostic value of these tests in patients with advanced malignancy.