Use Of Active Treatment Research Articles

The utility of a genetic progression risk test for Barrett esophagus.

This study sought to characterize the utility of a gene methylation-based biomarker test that has been validated to predict progression towards esophageal adenocarcinoma. Barrett esophagus (BE) is a precursor condition for esophageal adenocarcinoma (EAC) with somewhat variable approaches among gastroenterologists toward managing neoplastic progression risk. Capsulomics has developed a validated multigene DNA methylation-based biomarker assay performed on BE biopsies designed to address this variability by classifying BE patients into progression risk groups. In the current study, a survey was administered to practicing gastroenterologists in order to assess the potential impact of this assay on clinical practice. In this context, 89% (95% Cl: 85.4-92.6%) of surveyed physicians felt strongly that the multigene Barrett Esophagus test helped resolve uncertainties and optimize care of patients with BE by impacting their decisions on surveillance intervals and use of active treatments, such as ablation. The assay significantly impacted surveillance intervals for both high-risk (22.0 no assay vs 12.3 months with assay; P = 1.7E-8) and low-risk (7.9 no assay vs 11.4 months with assay, P = 8.8E-4) stratified case results. Finally, the assay also significantly impacted decisions to pursue active ablation treatments in both high-risk (5% recommending ablation without assay vs 42% with assay; P = 3.7E-11) and low-risk (42% recommending ablation without assay vs 29% with assay; P = .049) stratified case results. Results demonstrated a strong effect of the assay on clinical decision making, even in conjunction with established clinical guidelines.

Factors Related to Neuropathic Pain following Lower Extremity Amputation.

Lower extremity amputations are common, and postoperative neuropathic pain (phantom limb pain or symptomatic neuroma) is frequently reported. The use of active treatment of the nerve end has been shown to reduce pain but requires additional resources and should therefore be performed primarily in high-risk patients. The aim of this study was to identify the factors associated with the development of neuropathic pain following above-the-knee amputation, knee disarticulation, or below-the-knee amputation. Retrospectively, 1565 patients with an average follow-up of 4.3 years who underwent a primary above-the-knee amputation, knee disarticulation, or below-the-knee amputation were identified. Amputation levels for above-the-knee amputations and knee disarticulations were combined as proximal amputation level, with below-the-knee amputations being performed in 61 percent of patients. The primary outcome was neuropathic pain (i.e., phantom limb pain or symptomatic neuroma) based on medical chart review. Multivariable logistic regression was performed to identify independent factors associated with neuropathic pain. Postoperative neuropathic pain was present in 584 patients (37 percent), with phantom limb pain occurring in 34 percent of patients and symptomatic neuromas occurring in 3.8 percent of patients. Proximal amputation level, normal creatinine levels, and a history of psychiatric disease were associated with neuropathic pain. Diabetes, hypothyroidism, and older age were associated with lower odds of developing neuropathic pain. Neuropathic pain following lower extremity amputation is common. Factors influencing nerve regeneration, either increasing (proximal amputations and younger age) or decreasing (diabetes, hypothyroidism, and chronic kidney disease) it, play a role in the development of postamputation neuropathic pain. Risk, III.

Rurality, Stage-Stratified Use of Treatment Modalities, and Survival of Non-small Cell Lung Cancer

To eliminate them, non-small cell lung cancer (NSCLC) care and outcome disparities need to be better understood. How does rurality interact with NSCLC care and outcome disparities? We examined guideline-concordant use of active treatment for NSCLC across five institutions in one community-based health care system spanning 44%of the Delta Regional Authority catchment area from 2011 to 2017. Institution- and patient-level rurality were based on Rural-Urban Commuting Area codes. Chi-squared, F-tests, and logistic regressions were used to analyze differences across institutions and rurality; survival was examined using log-rank tests and Cox regression. Of 6,259 patients, 47%resided in rural areas; two of five institutions were rurally located and provided care for 20%of patients. Compared with rural residents at rural institutions, urban and rural residents attending urban institutions were more likely to receive stage-preferred treatment: OR 1.68 (95%CI, 1.44-1.96), and 1.33 (1.11-1.61), respectively, after adjusting for insurance, age, and clinical stage. Urban and rural residents attending urban institutions had a lower hazard of death compared with rural residents attending rural institutions: hazard ratio (HR) 0.69 (0.64-0.75) and 0.61 (0.55-0.67), respectively. Among recipients of stage-preferred treatment, care at urban institutions remained less hazardous: HR 0.7 (0.63-0.79). When further stratified by stage, care for late-stage patients at urban institutions remained less hazardous: HR 0.8 (0.71-0.91). Rurality-associated treatment and survival disparities were present at the patient and institution levels, but the institution-level disparity was greater. Rural residents receiving care at urban institutions had similar outcomes to urban residents receiving care at urban hospitals. To overcome rurality-associated NSCLC survival disparity, interventions should preferentially target the institution level, including expanding access to higher-quality guideline-concordant care.

Geographical variations in the use of cancer treatments are associated with survival of lung cancer patients

IntroductionLung cancer outcomes in England are inferior to comparable countries. Patient or disease characteristics, healthcare-seeking behaviour, diagnostic pathways, and oncology service provision may contribute. We aimed to quantify associations between...

Inpatient Treatment Patterns and Health Care Expenditures for Hepatocellular Carcinoma among the Population with Urban Basic Health Insurance in China

ObjectiveTo identify inpatient treatment patterns and health care expenditures for hepatocellular carcinoma (HCC) among the population with urban basic health insurance (BHI) in China. MethodsHospitalizations for patients 18 years or older with discharge diagnosis of HCC from 2008 to 2011 and enrolled in the Chinese BHI plan were identified from the Chinese Health Insurance Research Association database. Treatment approaches and hospital expenditures were assessed for the full sample, and according to city level and hospital tier. Analyses were extrapolated to the national urban BHI population. ResultsA total of 3679 HCC hospitalizations were identified in the period 2008 to 2011, representing 615,359 hospitalizations among the urban BHI population. More than two-thirds of the patients received active treatment during hospitalization (68%, N = 418,394), most commonly with traditional Chinese medicine (51%) and/or transarterial intervention therapy (21%). Cases from larger level 1 cities and larger tier 3 hospitals reported greater use of active treatments (81% and 83%, respectively) than did those from smaller level 3 cities (46%) or tier 1 hospitals (56%). Hospital expenditures were higher in level 1 cities (mean [95% confidence interval] Chinese currency renminbi [¥] 17,119 [¥16,292–¥17,946]; US $2,506 [$2,385–$2,628]) than in level 3 cities (mean [95% confidence interval] ¥7,870 [¥5,775–¥9,964]; $1,152 [$846–$1,459]). ConclusionsMost patients with HCC received active treatment during hospitalization in China. There were substantial disparities, however, in the use of HCC treatments across different economic regions, and nearly a third received only palliative care. With the recent launch of health care reform, this study provides valuable insights into current resource use and costs for HCC in China to help prioritize areas of improvement.

Implementation of PSA-based active surveillance in prostate cancer.

Prostate cancer screening had led to the diagnosis of a large proportion of localized and low-risk disease. Many of these cancer cases are believed to be indolent and would not be clinically perceived in the absence of screening. In addition to that, the wide use of active treatment has exposed these patients to treatment-related quality-of-life impact. In this setting active surveillance as a way of deferring active treatment and reserving such treatment to cases of disease progression only has gained interest. PSA has been widely used to identify patients eligible for active surveillance and also for disease monitoring. The goal of this review was to describe the place of PSA in the monitoring of patients under active surveillance based on the existing studies and to discuss the importance of PSA in light of other existing or emerging tools to monitor prostate cancer in active surveillance.

Building useful evidence: changing the clinical research paradigm to account for comparative effectiveness research

Comparative effectiveness research (CER) calls for substantial changes in the way clinical research is conducted, interpreted and practically applied in the USA, in order to produce useful clinical evidence. Departing from classic efficacy and effectiveness research, the evolving CER paradigm requires structural and substantive innovations that address three basic questions: what works? for whom? and in whose hands? Addressing these questions will require fundamental changes in the approach to clinical research that include: the use of active treatments (or comparators) versus placebos in the comparisons of treatments, innovative or 'alternative' research methods, the specification and a priori design of studies to account for important subgroups, accounting for the nested nature of healthcare delivery in design and analysis of CER, the simultaneous study of multiple treatments or treatment modalities, the study of multiple outcomes (benefits and harms) for each treatment compared, and the reassessment of the value of different study designs in the hierarchy of collective 'evidence'. In order to aid individual providers and patients in making informed, personalized treatment decisions, guided by the best evidence possible, CER studies must generalize to a broad range of subgroups reflecting the spectrum of patients, providers and health systems that populate real-world practice settings. Without expansion in the scope, conduct and subsequent interpretation of clinical research reflected in the issues outlined above, CER will fall short of its potential for informing evidence-based practice and personalized medicine. The current paradigm for conducting, interpreting and applying clinical research does not meet the needs of optimal generalizability and application to individual physician-patient efforts to identify the most effective treatment, and therefore does not support the basic requirements of CER. The proposed changes should neither require decades nor exorbitant budgets to achieve. Using two examples, prostate cancer, and comparisons of single medications, we illustrated how the proposed changes in clinical research, matching strategy to each application, might be addressed.

Increased Cytogenetic Testing and Prognostic Assessment Do Not Translate Into Higher Active Treatment of Elderly MDS Patients in Germany

Abstract 510▪▪This icon denotes a clinically relevant abstract Background:MDS is a disease of predominantly elderly patients with a median age of >70 years. At present there is a lack of data on MDS patient management in Germany. The following analysis offers a comprehensive insight into diagnosis, prognosis and management of MDS in German clinical practice. First results in 2009 showed that age was a key decision driver for MDS management, particularly with regards to cytogenetic testing, IPSS evaluation and choices of active treatment. The aim of a 2010 update was to monitor changes in management of MDS patients, especially in patients >75 years of age. Methods:The patient sample was defined based on a structural analysis taking into account the distribution of treatment prevalence by institutional type as well as the regional population density. 886 centers involved in MDS management including university hospitals (UH), community hospitals (CH) and office-based hematologists (OBH) were contacted. 94 centers provided information on their respective patient numbers during the third quarter of 2010, with 1,611 patients corresponding to 12% of the estimated national prevalence. The distribution of patients by institution was 10% UH, 55% CH, and 35% OBH. In order to adequately represent UH and to avoid bias due to a too small sample size, the proportion of patients treated in UH was adjusted to 33% in our sample. The adjusted sample consisted of 46 centres (12 UH, 15 CH and 19 OBH) which documented 365 patients. Patient samples in 2010 and 2009 were comparable. Consistent with 2009, patients with a treatment decision (diagnosis, start, change or termination of therapy) in the third-fourth quarter were included in this analysis. Results:Compared to 2009, cytogenetic testing at first diagnosis substantially increased from 67% to 86% in 2010. The biggest change was observed in patients >75 years with an absolute increase of 31%, reaching 75% in 2010 (fig. 1). Despite this change, a significant difference still remains in the level of cytogenetic testing between patients ’75 and >75 years (92% vs. 75%, p<0,0001) and a higher use in UH compared to OBH (96% vs. 84%, p<0,0001). Overall, prognostic IPSS assessment at first diagnosis increased from 61% in 2009 to 71% in 2010, but only from 51% to 53% in patients >75 years. With 26%, WPSS use tripled in 2010 compared to 2009, whereby WPSS was almost always (in 99% of cases) used as an adjunct to and not as a substitute for IPSS. [Display omitted] In 2010, 22% of all MDS patients did not receive any therapy. Of those treated, 52% received supportive care only, 45% received active treatment (i.e. chemo-, immunomodulatory or epigenetic therapy), 2% SCT, and 1% other treatments. Overall, compared to 2009, the proportion of active treatment remained stable. In the IPSS high risk group, the proportion of active treatment went up from 64% to 96%, declined from 34% to 20% in low risk MDS, but remained stable in patients unclassified by IPSS. In 43% of these patients cytogenetic testing was performed. A significantly lower use of active treatment was still observed in patients >75 years (27% vs. 56%, p<0,0001, fig. 2). As in 2009, the most frequently and increasingly used active drug in 2010 was azacitidine. [Display omitted] When trying to identify factors driving active treatment, bivariate analysis showed a significant positive correlation with age ≤75 years, hospital as center type, and Karnofsky-index ≤80% (p<0,01). Multivariate analysis revealed age ≤75 years as the most important factor (p<0,001), followed by Karnofsky-index ≤80% (p=0,044). Discussion:There seemed to be an increasing awareness and utilization of both cytogenetic testing and IPSS assessment in 2010 vs. 2009. This translated into more frequent use of IPSS for clinical decision making, with a positive correlation between higher IPSS scores and start of active treatment, providing a potential benefit to high risk MDS patients. In patients >75 years, however, IPSS usage remained unchanged despite the increase in cytogenetic testing. It appears that treatment decisions for these patients are more strongly influenced by age and cytogenetics than by IPSS assessment. This leaves room for improvement since under-utilization of prognostic assessment may lead to undertreatment of older MDS patients. Disclosures:Gattermann:Celgene: Consultancy, Research Funding. Kuendgen:Celgene: Honoraria. Kellermann:Celgene: Consultancy, Research Funding. Zeffel:Celgene: Employment. Paessens:Celgene: Employment. Germing:Celgene: Consultancy, Research Funding.

Withdrawal and limitation of life support in paediatric intensive care.

To compare the modes of death and factors leading to withdrawal or limitation of life support in a paediatric intensive care unit (PICU) in a developing country. Retrospective analysis of all children (< 12 years) dying in the PICU from January 1995 to December 1995 and January 1997 to June 1998 (n = 148). The main mode of death was by limitation of treatment in 68 of 148 patients, failure of active treatment including cardiopulmonary resuscitation in 61, brain death in 12, and withdrawal of life support with removal of endotracheal tube in seven. There was no significant variation in the proportion of limitation of treatment, failure of active treatment, and brain death between the two periods; however, there was an increase in withdrawal of life support from 0% in 1995 to 8% in 1997-98. Justification for limitation was based predominantly on expectation of imminent death (71 of 75). Ethnic variability was noted among the 14 of 21 patients who refused withdrawal. Discussions for care restrictions were initiated almost exclusively by paediatricians (70 of 75). Diagnostic uncertainty (36% v 4.6%) and presentation as an acute illness were associated with the use of active treatment. Limitation of treatment is the most common mode of death in a developing country's PICU and active withdrawal is still not widely practised. Paediatricians in developing countries are becoming more proactive in managing death and dying but have to consider sociocultural and religious factors when making such decisions.