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BACKGROUND: Despite the expanding role of machine learning (ML) in health care and patient expectations for clinicians to understand ML-based tools, few for-credit curricula exist specifically for neurosurgical trainees to learn basic principles and implications of ML for medical research and clinical practice. We implemented a novel, remotely delivered curriculum designed to develop literacy in ML for neurosurgical trainees. METHODS: A 4-week pilot medical elective was designed specifically for trainees to build literacy in basic ML concepts. Qualitative feedback from interested and enrolled students was collected to assess students' and trainees' reactions, learning, and future application of course content. RESULTS: Despite 15 interested learners, only 3 medical students and 1 neurosurgical resident completed the course. Enrollment included students and trainees from 3 different institutions. All learners who completed the course found the lectures relevant to their future practice as clinicians and researchers and reported improved confidence in applying and understanding published literature applying ML techniques in health care. Barriers to ample enrollment and retention (e.g., balancing clinical responsibilities) were identified. CONCLUSIONS: This pilot elective demonstrated the interest, value, and feasibility of a remote elective to establish ML literacy; however, feedback to increase accessibility and flexibility of the course encouraged our team to implement changes. Future elective iterations will have a semiannual, 2-week format, splitting lectures more clearly between theory (the method and its value) and application (coding instructions) and will make lectures open-source prerequisites to allow tailoring of student learning to their planned application of these methods in their practice and research.
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Educación de Pregrado en Medicina , Estudiantes de Medicina , Humanos , Curriculum , Atención a la Salud , Educación de Pregrado en Medicina/métodos , RetroalimentaciónRESUMEN
OBJECTIVE: Most surgical journals are published in English, representing a challenge for researchers from non-Anglophone countries. We describe the implementation, workflow, outcomes, and lessons learned from the WORLD NEUROSURGERY Global Champions Program (GCP), a novel journal-specific English language editing program for articles rejected because of poor English grammar or usage. METHODS: The GCP was advertised via the journal website and social media. Applicants were selected to be a reviewer for the GCP if they demonstrated English proficiency on writing samples supplied in their application. The demographics of GCP members and characteristics and outcomes of articles edited by the GCP during its first year were reviewed. Surveys of GCP members and authors who used the service were conducted. RESULTS: Twenty-one individuals became part of the GCP, representing 8 countries and 16 languages apart from English. A total of 380 manuscripts were peer reviewed by the editor-in-chief, who determined these manuscripts to have potentially worthwhile content but needed to be rejected due to poor language. The authors of these manuscripts were informed of the existence of this language assistance program. Forty-nine articles (12.9%) were edited by the GCP in 41.6 ± 22.8 days. Of 40 articles resubmitted to WORLD NEUROSURGERY, 24 (60.0%) were accepted. GCP members and authors understood the purpose and workflow of the program and recognized improvements in article quality and the probability of acceptance through their participation. CONCLUSIONS: The WORLD NEUROSURGERY Global Champions Program mitigated a critical barrier to publication in an English language journal for authors from non-Anglophone countries. This program promotes research equity by providing a free, largely medical student and trainee operated, English language editing service. This model or a similar service can be replicated by other journals.
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OBJECTIVE: The US-based Spinal Laminectomy versus Instrumented Pedicle Screw (SLIP) trial reported improvement in disability following laminectomy with fusion versus laminectomy alone for patients with lumbar spondylolisthesis. Despite using similar methods, a concurrent Swedish trial investigating the same question did not reach the same conclusion. The authors performed a simulation-based analysis to elucidate potential causes of these divergent results. METHODS: The mean and standard deviation of the preoperative and 2-year postoperative Oswestry Disability Index (ODI) scores for each study group (laminectomy with fusion and laminectomy alone) were collected from the spondylolisthesis stratum of the Swedish trial and used to create a MATLAB simulator using linear transformations to predict postoperative ODI distributions. Applying this simulator to both varied and published preoperative ODI distributions from the SLIP trial, the authors simulated the results of the US-based trial using treatment effects from the Swedish study and compared simulated US results to those published in the SLIP trial. RESULTS: Simulated US results showed that as preoperative disability increased, the difference in postoperative ODI scores grew between treatment groups and increasingly favored laminectomy alone (p < 0.0001). In 100 simulations of a similarly sized US trial, the average mean change in ODI scores postoperatively was significantly higher than was published for laminectomy alone in the SLIP trial (-21.3 vs -17.9), whereas it was significantly lower than published for fusion (-16.9 vs -26.3). CONCLUSIONS: The expected benefit of surgical treatments for spondylolisthesis varied according to preoperative disability. Adapting Swedish-estimated treatment effects to the US context mildly overapproximated the improvement in postoperative disability scores for laminectomy, but more severely underapproximated the improvement reported for laminectomy and fusion in the SLIP trial. The observed heterogeneity between these studies is influenced more by patient response to fusion than response to laminectomy. This analysis paves the way for future studies on the impact of preoperative treatment group heterogeneity, differences in surgical methods, and empirical design on reported clinical benefits. Although bayesian reanalysis of published randomized controlled trial data is susceptible to biases that typically limit post hoc analyses, the authors' method offers a simple and cost-effective approach to improve the understanding of published clinical trial results and their implications for future studies.
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BACKGROUND: The use of directional deep brain stimulation (dDBS) electrodes for the treatment of movement disorders such as Parkinson disease (PD) has become relatively widespread. However, the efficacy of dDBS relative to its omnidirectional deep brain stimulation (oDBS) counterpart is not well characterized. This systematic review aims to synthesize the literature comparing clinical and therapeutic outcomes of dDBS relative to oDBS in patients with PD. METHODS: A systematic literature search for studies with comparative clinical outcome data between dDBS and oDBS was performed across the PubMed, Ovid MEDLINE, and Web of Science databases. Data including therapeutic window (TW) and surrogate measures and the Unified Parkinson's Disease Rating Scale score were collected and summarized across multiple time periods. RESULTS: Ten studies met the eligibility criteria. Three of these studies evaluated motor performance in the form of Unified Parkinson's Disease Rating Scale III, with none finding differences between dDBS and oDBS. Two studies assessed quality-of-life measures with neither finding differences between dDBS and oDBS. TW or a surrogate measure was assessed in 6 studies; 5 studies found an increase or strong trend toward increase in dDBS relative to oDBS. CONCLUSIONS: The current evidence, although limited by bias, does suggest that dDBS in the treatment of PD yields improvements in motor symptoms and quality of life that are comparable to oDBS; TW and surrogate measures are consistently improved in patients with PD under a directional configuration relative to omnidirectional.
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Estimulación Encefálica Profunda , Enfermedad de Parkinson , Humanos , Enfermedad de Parkinson/terapia , Calidad de Vida , Resultado del Tratamiento , ElectrodosRESUMEN
OBJECTIVE: There is a paucity of evidence describing the price information that is publicly available to patients wishing to undergo neurosurgical procedures. We sought to investigate the public availability and usefulness of price estimates for non-emergent, elective neurosurgical interventions. METHODS: Google was used to search for price information related to 15 procedures in 8 major U.S. health care markets. We recorded price information that was published for each procedure and took note of whether itemized prices, potential discounts, and cross-provider price comparisons were available. RESULTS: Online searches yielded 2356 websites, of which 228 (9.7%) offered geographically relevant price information for neurosurgical procedures. Although accounting for only 16.4% of total search results, price transparency websites provided most treatment price estimates (74.1% of all estimates), followed by clinical sites (19.3%), and other related sites (5.3%). The number of websites providing price information varied significantly by city and procedure. websites rarely divulged data sources, specified how prices were estimated, indicated how frequently price estimates were updated, offered itemized breakdowns of prices, or indicated whether price estimates encompassed the full spectrum of possible health care charges. CONCLUSIONS: Under 10% of websites queried yield geographically relevant price information for non-emergent neurosurgical imaging and operative procedures. Even when this information is publicly available, its usefulness to patients may be limited by various factors, including obscure data sources and methods, as well as sparse information on discounts and bundled price estimates. Inconsistent availability and clarity of price information likely impede patients' ability to discern expected costs of treatment and engage in cost-conscious, value-based neurosurgical decision-making.
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Neurocirugia , Atención a la Salud , Procedimientos Quirúrgicos Electivos , Humanos , Procedimientos Neuroquirúrgicos , EdiciónRESUMEN
OBJECTIVE: In a healthcare landscape in which costs increasingly matter, the authors sought to distinguish among the clinical and nonclinical drivers of patient length of stay (LOS) in the hospital following elective lumbar laminectomy-a common spinal surgery that may be reimbursed using bundled payments-and to understand their relationships with patient outcomes and costs. METHODS: Patients ≥ 18 years of age undergoing laminectomy surgery for degenerative lumbar spinal stenosis within the Cleveland Clinic health system between March 1, 2016, and February 1, 2019, were included in this analysis. Generalized linear modeling was used to assess the relationships between the day of surgery, patient discharge disposition, and hospital LOS, while adjusting for underlying patient health risks and other nonclinical factors, including the hospital surgery site and health insurance. RESULTS: A total of 1359 eligible patients were included in the authors' analysis. The mean LOS ranged between 2.01 and 2.47 days for Monday and Friday cases, respectively. The LOS was also notably longer for patients who were ultimately discharged to a skilled nursing facility (SNF) or rehabilitation center. A prolonged LOS occurring later in the week was not associated with greater underlying health risks, yet it nevertheless resulted in greater costs of care: the average total surgical costs for lumbar laminectomy were 20% greater for Friday cases than for Monday cases, and 24% greater for late-week cases than for early-week cases ultimately transferred to SNFs or rehabilitation centers. A Poisson generalized linear model fit the data best and showed that the comorbidity burden, surgery at a tertiary care center versus a community hospital, and the incidence of any postoperative complication were associated with significantly longer hospital stays. Discharge to home healthcare, SNFs, or rehabilitation centers, and late-week surgery were significant nonclinical predictors of LOS prolongation, even after adjusting for underlying patient health risks and insurance, with LOSs that were, for instance, 1.55 and 1.61 times longer for patients undergoing their procedure on Thursday and Friday compared to Monday, respectively. CONCLUSIONS: Late-week surgeries are associated with a prolonged LOS, particularly when discharge is to an SNF or rehabilitation center. These findings point to opportunities to lower costs and improve outcomes associated with elective surgical care. Interventions to optimize surgical scheduling and perioperative care coordination could help reduce prolonged LOSs, lower costs, and, ultimately, give service line management personnel greater flexibility over how to use existing resources as they remain ahead of healthcare reforms.
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As cancer drug prices rise, it remains unclear whether the cost of new interventions is related to their beneficial impact for patients at a societal-level. Using data for 2003-2015 from the IQVIA MIDAS® dataset, the relationship between cancer drug costs and drug clinical benefits was studied in four countries with different approaches to drug pricing. Summary measures of drug clinical effects on overall survival, quality of life, and safety were obtained from a review of health technology assessments. Mean total drug costs for a full course of treatment were estimated using standard posology for each medicine and in each country. Regression analysis was used to test whether, at a societal-level, the cost of recently licensed drugs is related to their beneficial impact for patients. Across all eligible medicines, average treatment costs were lowest in France and Australia and highest in the UK and US. Compared with Australia, France, and the UK, cancer medicines were on average between 1.2 and 1.9 times more expensive in the US, where the average total per patient cost for treatment was $68,255.17. Costs for new cancer medicines are high and, at best, only weakly associated with drug clinical benefits. The strength of this relationship nevertheless varied across countries. Some new cancer drugs-particularly in the US-may be neither affordable nor clinically beneficial over existing treatments. While all countries can benefit from strategies that more robustly align price with therapeutic benefit in cancer drugs, the US stands out in its opportunity to improve both affordability and value in cancer drug treatment.
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Neoplasias , Calidad de Vida , Australia , Costos de los Medicamentos , Francia , Humanos , Neoplasias/tratamiento farmacológico , Reino UnidoRESUMEN
With the establishment of state-based health insurance marketplaces, how U.S. health insurers are responding to market pressures and influencing premiums have represented important questions. We made novel use of the Standard and Poor's (S&P) Financial, a Wall Street financial dataset platform, to analyze trends in market capitalization and total direct written premiums (DWPs) from 2001 to 2016 of the top 5, 10, and 25 health insurance companies. Our results indicate that the market concentration of publicly traded companies has remained relatively stable over the past decade. The top 5, 10, and 25 health insurance companies were 43.5%, 57.5%, and 78.6% of the total market share in 2001 and 39.4%, 52.9%, and 72.8% in 2016, respectively. DWPs have grown nearly four-fold from $177 billion to $631 billion at a compounded annual rate of 8.8%, consistent with overall healthcare sector growth. Aggregating state-specific data, the overall U.S. health insurance market has become slightly less consolidated over recent years, as measured using the population-weighted Herfindahl-Hirschman index, a measure for market concentration, falling from 3,817 to 2,174 during this time period. As health insurance costs place a growing burden on American families, additional efforts are needed to study the impact on choice, quality, access, cost, and value to patients and providers from evolving health insurance markets.
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BACKGROUND: This study provides nationally representative estimates of the direct incremental economic burden of mood disorders in the United States between 2007-2017, and examines trends in spending on mood disorders by healthcare setting over time. METHODS: The Medical Expenditure Panel Survey (MEPS) was used to analyze nationally-representative data related to healthcare expenditures between 2007-2017. A two-part regression model was used to estimate healthcare expenditures for patients with mood disorders compared to those without, adjusting for several sociodemographic and health-related factors. RESULTS: Total annual healthcare costs for patients with mood disorders were over twice as high as for those without, even after adjusting for potential confounders. A mood disorder diagnosis independently accounted for $6,591.60 in additional annual healthcare spending over this period. While healthcare spending on mood disorders increased significantly in the outpatient setting (14%), home health setting (84%), and on prescription medications (17%), it decreased in the inpatient setting and remained stable for emergency care. LIMITATIONS: Study limitations include an inability to determine specific components of cost in each setting, analyze costs for distinct depressive and bipolar disorders by four- or five-digit diagnosis code, and the potential for recall bias during data collection. CONCLUSIONS: Spending on outpatient care, prescription medications, and home health care for mood disorder patients grew significantly between 2007 and 2017, but decreased for inpatient care and remained stable in the emergency care setting. Future research should examine drivers of spending in these settings and explore ways to improve patient outcomes and stabilize growing healthcare expenditures.
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Costos de la Atención en Salud , Trastornos del Humor , Atención Ambulatoria , Atención a la Salud , Gastos en Salud , Humanos , Trastornos del Humor/epidemiología , Estados UnidosRESUMEN
BACKGROUND: The degree to which elevated mortality associated with weekend or night-time hospital admissions reflects poorer quality of care ('off-hours effect') is a contentious issue. We examined if off-hours admissions for primary percutaneous coronary intervention (PPCI) were associated with higher adjusted mortality and estimated the extent to which potential differences in door-to-balloon (DTB) times-a key indicator of care quality for ST elevation myocardial infarction (STEMI) patients-could explain this association. METHODS: Nationwide registry-based prospective observational study using Myocardial Ischemia National Audit Project data in England. We examined how off-hours admissions and DTB times were associated with our primary outcome measure, 30-day mortality, using hierarchical logistic regression models that adjusted for STEMI patient risk factors. In-hospital mortality was assessed as a secondary outcome. RESULTS: From 76 648 records of patients undergoing PPCI between January 2007 and December 2012, we included 42 677 admissions in our analysis. Fifty-six per cent of admissions for PPCI occurred during off-hours. PPCI admissions during off-hours were associated with a higher likelihood of adjusted 30-day mortality (OR 1.13; 95% CI 1.01 to 1.25). The median DTB time was longer for off-hours admissions (45 min; IQR 30-68) than regular hours (38 min; IQR 27-58; p<0.001). After adjusting for DTB time, the difference in adjusted 30-day mortality between regular and off-hours admissions for PPCI was attenuated and no longer statistically significant (OR 1.08; CI 0.97 to 1.20). CONCLUSION: Higher adjusted mortality associated with off-hours admissions for PPCI could be partly explained by differences in DTB times. Further investigations to understand the off-hours effect should focus on conditions likely to be sensitive to the rapid availability of services, where timeliness of care is a significant determinant of outcomes.
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Infarto del Miocardio , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Inglaterra , Femenino , Mortalidad Hospitalaria , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , Factores de Tiempo , Resultado del TratamientoRESUMEN
Orthopaedic surgeons often require highly specialized medical devices, implants, and equipment, which are usually offered by several vendors/companies. This study assesses long-term market trends for orthopaedic medical device companies and examines various implications for healthcare cost. Using S&P Capital IQ, a Wall Street database, financial data were gathered on orthopaedic device companies, ranked by worldwide sales, from 1999 to 2015. Annual sales were aggregated to calculate market share and compounded annual growth rates (CAGRs). Overall, the global orthopaedic device market grew at 12.0% CAGR from 1999 to 2008, before slowing to 2.8% from 2009 to 2015. Between 1999 and 2015, the top 5 companies increased total market share from 52.8 to 62.2%. The orthopaedic device market is not only consolidating under a few dominant players, but also growing at a decreasing rate, both of which signal a maturing industry. These trends are likely to shape patient care and healthcare costs in orthopaedic surgery in years to come.
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Comercio/tendencias , Industrias/tendencias , Equipo Ortopédico/tendencias , Comercio/economía , Humanos , Industrias/economía , OrtopediaRESUMEN
BACKGROUND: Around 200 million adults in China have hypertension, but few are treated or achieve adequate control of their blood pressure. Available and affordable medications are important for successfully controlling hypertension, but little is known about current patterns of access to, and use of, antihypertensive medications in Chinese primary health care. METHODS: We used data from a nationwide cross-sectional survey (the China Patient-Centered Evaluative Assessment of Cardiac Events Million Persons Project primary health care survey), which was undertaken between November, 2016 and May, 2017, to assess the availability, cost, and prescription patterns of 62 antihypertensive medications at primary health-care sites across 31 Chinese provinces. We surveyed 203 community health centres, 401 community health stations, 284 township health centres, and 2474 village clinics to assess variation in availability, cost, and prescription by economic region and type of site. We also assessed the use of high-value medications, defined as guideline-recommended and low-cost. We also examined the association of medication cost with availability and prescription patterns. FINDINGS: Our study sample included 3362 primary health-care sites and around 1 million people (613â638 people at 2758 rural sites and 478â393 people at 604 urban sites). Of the 3362 sites, 8·1% (95% CI 7·2-9·1) stocked no antihypertensive medications and 33·8% (32·2-35·4) stocked all four classes that were routinely used. Village clinics and sites in the western region of China had the lowest availability. Only 32·7% (32·2-33·3) of all sites stocked high-value medications, and few high-value medications were prescribed (11·2% [10·9-11·6] of all prescription records). High-cost medications were more likely to be prescribed than low-cost alternatives. INTERPRETATION: China has marked deficiencies in the availability, cost, and prescription of antihypertensive medications. High-value medications are not preferentially used. Future efforts to reduce the burden of hypertension, particularly through the work of primary health-care providers, will need to improve access to, and use of, antihypertensive medications, paying particular attention to those with high value. FUNDING: CAMS Innovation Fund for Medical Science, the Entrusted Project from the China National Development and Reform Commission, and the Major Public Health Service Project from the Ministry of Finance of China and National Health and Family Planning Commission of China.
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Antihipertensivos/economía , Costos de los Medicamentos/estadística & datos numéricos , Atención Primaria de Salud/estadística & datos numéricos , Adulto , Anciano , Antihipertensivos/provisión & distribución , Antihipertensivos/uso terapéutico , China/epidemiología , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina/estadística & datos numéricosRESUMEN
IMPORTANCE: There is a dearth of evidence examining the impact of newly licensed cancer medicines on therapy. This information could otherwise support clinical practice, and promote value-based decision-making in the cancer drug market. OBJECTIVE: To evaluate the comparative therapeutic value of all new cancer medicines approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) between 2003 and 2013. DESIGN, SETTING, AND PARTICIPANTS: We used a narrative synthesis approach to systematically synthesize and analyze English, French, and Australian health technology assessments (HTAs) of all new cancer medicines licensed in the United States and Europe between 2003 and 2013. INTERVENTIONS: Sixty-two new molecular entities with a primary oncology indication. MAIN OUTCOMES AND MEASURES: Overall survival (OS), quality of life (QoL), and safety. RESULTS: Of the 62 new active cancer molecules approved by the FDA and EMA between 2003 and 2013, 53 were appraised by English, French, or Australian HTA agencies through May 2015. Of these 53 drugs, 23 (43%) increased OS by 3 months or longer, 6 (11%) by less than 3 months, and 8 (15%) by an unknown magnitude; there was no evidence to suggest that the remaining 16 (30%) increased OS over best alternative treatments. Where overall survival gains could be quantified, all new cancer drugs were associated with a mean (SE) total increase in OS of 3.43 (0.63) months over the treatments that were available in 2003. Drug-related improvements in OS were, however, widely distributed across therapeutic targets-ranging between 0 (thyroid, ascites) and 8.48 months (breast cancers)-and were sometimes based on modeled data, indirect or nonactive comparisons, or nonvalidated evidence. Although 22 (42%) of 53 new medicines were associated with an increase in QoL, 24 (45%) were also associated with reduced patient safety. Of the 53 new cancer drugs, 42 (79%) were associated with at least some improvement in OS, QoL, or safety. CONCLUSIONS AND RELEVANCE: Although innovation in the oncology drug market has contributed to improvements in therapy, the magnitude and dimension of clinical benefits vary widely, and there may be reasons to doubt that claims of efficacy reflect real-world effectiveness exactly. These findings raise important questions for clinical decision-making and value-based policy.
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Antineoplásicos/administración & dosificación , Aprobación de Drogas/organización & administración , Neoplasias/tratamiento farmacológico , Evaluación de la Tecnología Biomédica/organización & administración , Antineoplásicos/efectos adversos , Australia , Inglaterra , Francia , Humanos , Neoplasias/mortalidad , Calidad de Vida , Análisis de Supervivencia , Estados Unidos , United States Food and Drug AdministrationRESUMEN
OBJECTIVE: With the increasing prevalence of diabetes, annual screening for diabetic retinopathy (DR) by expert human grading of retinal images is challenging. Automated DR image assessment systems (ARIAS) may provide clinically effective and cost-effective detection of retinopathy. We aimed to determine whether ARIAS can be safely introduced into DR screening pathways to replace human graders. DESIGN: Observational measurement comparison study of human graders following a national screening program for DR versus ARIAS. PARTICIPANTS: Retinal images from 20 258 consecutive patients attending routine annual diabetic eye screening between June 1, 2012, and November 4, 2013. METHODS: Retinal images were manually graded following a standard national protocol for DR screening and were processed by 3 ARIAS: iGradingM, Retmarker, and EyeArt. Discrepancies between manual grades and ARIAS results were sent to a reading center for arbitration. MAIN OUTCOME MEASURES: Screening performance (sensitivity, false-positive rate) and diagnostic accuracy (95% confidence intervals of screening-performance measures) were determined. Economic analysis estimated the cost per appropriate screening outcome. RESULTS: Sensitivity point estimates (95% confidence intervals) of the ARIAS were as follows: EyeArt 94.7% (94.2%-95.2%) for any retinopathy, 93.8% (92.9%-94.6%) for referable retinopathy (human graded as either ungradable, maculopathy, preproliferative, or proliferative), 99.6% (97.0%-99.9%) for proliferative retinopathy; Retmarker 73.0% (72.0 %-74.0%) for any retinopathy, 85.0% (83.6%-86.2%) for referable retinopathy, 97.9% (94.9%-99.1%) for proliferative retinopathy. iGradingM classified all images as either having disease or being ungradable. EyeArt and Retmarker saved costs compared with manual grading both as a replacement for initial human grading and as a filter prior to primary human grading, although the latter approach was less cost-effective. CONCLUSIONS: Retmarker and EyeArt systems achieved acceptable sensitivity for referable retinopathy when compared with that of human graders and had sufficient specificity to make them cost-effective alternatives to manual grading alone. ARIAS have the potential to reduce costs in developed-world health care economies and to aid delivery of DR screening in developing or remote health care settings.
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Análisis Costo-Beneficio , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/economía , Interpretación de Imagen Asistida por Computador , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Árboles de Decisión , Economía Médica , Reacciones Falso Negativas , Femenino , Humanos , Interpretación de Imagen Asistida por Computador/métodos , Masculino , Tamizaje Masivo/métodos , Persona de Mediana Edad , Examen Físico/métodos , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Programas InformáticosRESUMEN
BACKGROUND: Diabetic retinopathy screening in England involves labour-intensive manual grading of retinal images. Automated retinal image analysis systems (ARIASs) may offer an alternative to manual grading. OBJECTIVES: To determine the screening performance and cost-effectiveness of ARIASs to replace level 1 human graders or pre-screen with ARIASs in the NHS diabetic eye screening programme (DESP). To examine technical issues associated with implementation. DESIGN: Observational retrospective measurement comparison study with a real-time evaluation of technical issues and a decision-analytic model to evaluate cost-effectiveness. SETTING: A NHS DESP. PARTICIPANTS: Consecutive diabetic patients who attended a routine annual NHS DESP visit. INTERVENTIONS: Retinal images were manually graded and processed by three ARIASs: iGradingM (version 1.1; originally Medalytix Group Ltd, Manchester, UK, but purchased by Digital Healthcare, Cambridge, UK, at the initiation of the study, purchased in turn by EMIS Health, Leeds, UK, after conclusion of the study), Retmarker (version 0.8.2, Retmarker Ltd, Coimbra, Portugal) and EyeArt (Eyenuk Inc., Woodland Hills, CA, USA). The final manual grade was used as the reference standard. Arbitration on a subset of discrepancies between manual grading and the use of an ARIAS by a reading centre masked to all grading was used to create a reference standard manual grade modified by arbitration. MAIN OUTCOME MEASURES: Screening performance (sensitivity, specificity, false-positive rate and likelihood ratios) and diagnostic accuracy [95% confidence intervals (CIs)] of ARIASs. A secondary analysis explored the influence of camera type and patients' ethnicity, age and sex on screening performance. Economic analysis estimated the cost per appropriate screening outcome identified. RESULTS: A total of 20,258 patients with 102,856 images were entered into the study. The sensitivity point estimates of the ARIASs were as follows: EyeArt 94.7% (95% CI 94.2% to 95.2%) for any retinopathy, 93.8% (95% CI 92.9% to 94.6%) for referable retinopathy and 99.6% (95% CI 97.0% to 99.9%) for proliferative retinopathy; and Retmarker 73.0% (95% CI 72.0% to 74.0%) for any retinopathy, 85.0% (95% CI 83.6% to 86.2%) for referable retinopathy and 97.9% (95% CI 94.9 to 99.1%) for proliferative retinopathy. iGradingM classified all images as either 'disease' or 'ungradable', limiting further iGradingM analysis. The sensitivity and false-positive rates for EyeArt were not affected by ethnicity, sex or camera type but sensitivity declined marginally with increasing patient age. The screening performance of Retmarker appeared to vary with patient's age, ethnicity and camera type. Both EyeArt and Retmarker were cost saving relative to manual grading either as a replacement for level 1 human grading or used prior to level 1 human grading, although the latter was less cost-effective. A threshold analysis testing the highest ARIAS cost per patient before which ARIASs became more expensive per appropriate outcome than human grading, when used to replace level 1 grader, was Retmarker £3.82 and EyeArt £2.71 per patient. LIMITATIONS: The non-randomised study design limited the health economic analysis but the same retinal images were processed by all ARIASs in this measurement comparison study. CONCLUSIONS: Retmarker and EyeArt achieved acceptable sensitivity for referable retinopathy and false-positive rates (compared with human graders as reference standard) and appear to be cost-effective alternatives to a purely manual grading approach. Future work is required to develop technical specifications to optimise deployment and address potential governance issues. FUNDING: The National Institute for Health Research (NIHR) Health Technology Assessment programme, a Fight for Sight Grant (Hirsch grant award) and the Department of Health's NIHR Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital and the University College London Institute of Ophthalmology.
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Retinopatía Diabética/diagnóstico , Procesamiento de Imagen Asistido por Computador/economía , Procesamiento de Imagen Asistido por Computador/métodos , Tamizaje Masivo/métodos , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Niño , Análisis Costo-Beneficio , Retinopatía Diabética/etnología , Retinopatía Diabética/patología , Inglaterra , Etnicidad , Reacciones Falso Positivas , Femenino , Humanos , Procesamiento de Imagen Asistido por Computador/instrumentación , Masculino , Tamizaje Masivo/normas , Persona de Mediana Edad , Estudios Retrospectivos , Sensibilidad y Especificidad , Programas Informáticos , Medicina Estatal , Evaluación de la Tecnología Biomédica , Adulto JovenRESUMEN
Drug listing recommendations from health technology assessment (HTA) agencies often fail to coincide with one another. We conducted a comparative analysis of listing recommendations in Australia (PBAC), the Netherlands (CVZ), Sweden (TLV) and the UK (NICE) over time, examined interagency agreement, and explored how process-related factors-including time delay between HTA evaluations, therapeutic indication and orphan drug status, measure of health economic value, and comparator-impacted decision-making in drug coverage. Agreement was poor to moderate across HTA agency listing recommendations, yet it increased as the delay between HTA agency appraisals decreased, when orphan drugs were assessed, and when medicines deemed to provide low value (immunosuppressants, antineoplastics) were removed from the sample. International differences in drug listing recommendations seem to occur in part due to inconsistencies in how the supporting evidence informs assessment, but also to differences in how domestic priorities shape the value-based decision-making process.
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Toma de Decisiones en la Organización , Evaluación de Procesos y Resultados en Atención de Salud/organización & administración , Evaluación de la Tecnología Biomédica/organización & administración , Australia , Costos de los Medicamentos , Europa (Continente) , Política de Salud/economía , Humanos , Cobertura del Seguro/organización & administración , Evaluación de Procesos y Resultados en Atención de Salud/métodos , Evaluación de la Tecnología Biomédica/métodosRESUMEN
Cancer drugs account for a growing share of health care expenditure, raising questions about how much value is gained from their use. We used a proprietary international data set to examine real-world cancer drug consumption and expenditure in the period 2004-14 in Australia, Canada, France, Germany, Italy, Japan, Sweden, the United Kingdom, and the United States and to explore the value obtained. Even after adjusting for population and epidemiological factors, we found that the United States spent more than the other countries on cancer drugs, yet it often had lower utilization. All nine countries-most notably France and Japan-witnessed an improvement in neoplasm-related years of potential life lost, which suggests that although the costs of drugs have risen, their therapeutic benefits have increased as well. Net economic value derived from cancer drug expenditures appears to have remained positive, with base-case analyses indicating that the United States obtained an estimated $32.6 billion in net positive return from cancer drug care in 2014. However, the United States lags behind other countries in health gains obtained per dollar spent on cancer drugs, which suggests an opportunity to improve value in the oncology drug market.
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Antineoplásicos/economía , Análisis Costo-Beneficio , Gastos en Salud/estadística & datos numéricos , Gastos en Salud/tendencias , Antineoplásicos/uso terapéutico , Bases de Datos Factuales , Salud Global , Humanos , Modelos Económicos , Estados UnidosRESUMEN
OBJECTIVES: Diabetic retinopathy screening in England involves labour intensive manual grading of digital retinal images. We present the plan for an observational retrospective study of whether automated systems could replace one or more steps of human grading. METHODS: Patients aged 12 or older who attended the Diabetes Eye Screening programme, Homerton University Hospital (London) between 1 June 2012 and 4 November 2013 had macular and disc-centred retinal images taken. All screening episodes were manually graded and will additionally be graded by three automated systems. Each system will process all screening episodes, and screening performance (sensitivity, false positive rate, likelihood ratios) and diagnostic accuracy (95% confidence intervals of screening performance measures) will be quantified. A sub-set of gradings will be validated by an approved Reading Centre. Additional analyses will explore the effect of altering thresholds for disease detection within each automated system on screening performance. RESULTS: 2,782/20,258 diabetes patients were referred to ophthalmologists for further examination. Prevalence of maculopathy (M1), pre-proliferative retinopathy (R2), and proliferative retinopathy (R3) were 7.9%, 3.1% and 1.2%, respectively; 4749 (23%) patients were diagnosed with background retinopathy (R1); 1.5% were considered ungradable by human graders. CONCLUSIONS: Retinopathy prevalence was similar to other English diabetic screening programmes, so findings should be generalizable. The study population size will allow the detection of differences in screening performance between the human and automated grading systems as small as 2%. The project will compare performance and economic costs of manual versus automated systems.