tbuckley/cabot-search huggingface dataset:
Technical standards for respiratory oscillometry: test loads for calibration and verification
Authors: Cindy Thamrin, Raffaele L. Dellacà, Graham L. Hall, David W. Kaczka, Geoffrey N. Maksym, Ellie Oostveen, Shannon J. Simpson, Gregory G. King
Journal: European Respiratory Journal (2020)

<b>User verification of device accuracy using test loads should encompass the expected range of <i>Z</i><sub>rs</sub> to be tested; this letter clarifies the definition of <i>Z</i><sub>rs</sub> ranges of the population being tested. Manufacturers should report accuracy of both <i>R</i><sub>rs</sub> and <i>X</i><sub>rs</sub>.</b>https://bit.ly/2ZrnOCD
The association between clinical trial (CT) participation, pharmaceutical costs, and savings performance in the Oncology Care Model (OCM).
Authors: Kerin B. Adelson, Maureen Canavan, Sophia Mun, Cary Philip Gross, Naralys Sinanis, Amy J. Davidoff
Journal: Journal of Clinical Oncology (2020)

2 Background: The OCM is a Centers for Medicare and Medicaid Services (CMS) alternative payment model, which seeks to curb costs while improving care for patients receiving systemic cancer therapy. CMS models the expected spending target for each 6-month episode using historical, geographic and clinical factors, including CTr participation. We evaluated the relationship between CTr participation, drug costs and performance in the OCM. Methods: We used claims for OCM episodes attributed to the Yale Cancer Center between July 2016 and July 2018. We stratified episodes by CTr participation and used t-tests and chi-square tests to compare total cost, drug costs (Part B, Part D and novel cancer therapies) and whether observed episode costs were above or below CMS targets. Analyses were conducted for the total sample and among the most common cancer types. Results: Among 9,387 OCM episodes (5,270 unique patients), 815 (8.7%) episodes involved a CTr. Among non-CTr patients, the mean Medicare cost per episode ($32,909) was modestly higher than the mean episode spending target ($31,746; p &lt; 0.001), while in the CTr group, the mean Medicare cost per episode ($36,590) was substantially lower than the mean episode spending target ($48,124 p &lt; 0.001). CTr episode costs were more likely to be under spending targets than non-CTr episodes (66% vs 56%, p &lt; 0.001) overall and in breast, lung, and myeloma cancers, although only statistically significant for lung cancer (76% CTr vs 48% non-CTr, p &lt; .001). Overall, non-CTr had significantly higher mean Part D drug costs per episode ($8,441 vs $3,893, p &lt; 0.001), which was also noted among patients with lung cancer, ovarian cancer and lymphoma. Non-CTr episodes were also associated with higher mean novel therapies cost ($5,736) compared with CTr patient episodes ($4,346, p = 0.013). When comparing the sum of all other expenditures, CTr episodes were significantly associated with higher non-pharmaceutical expenditures than non-CTr episodes ($20,940 vs. $13,323, p &lt; 0.001) overall. Conclusions: Episodes with CTr participation out-performed non-CTr episodes in achieving savings relative to CMS spending targets. Savings were driven by lower drug costs for the CTr episodes, particularly in the categories of Part D and novel cancer therapies. This suggests that CTr enrollment shifts costs for expensive pharmaceuticals away from CMS and toward the CTr study sponsor. Further research should explore whether this finding is generalizable to other cancer centers and payment models.
ED utilization trends for medical oncology patients at Thomas Jefferson University during COVID-19.
Authors: Zachary L. Quinn, Adam Binder, Valerie Pracilio Csik, Helen Evers-Hunt, Nathan Handley
Journal: Journal of Clinical Oncology (2020)

238 Background: For patients receiving cancer care, utilization of acute care resources can be frequent and, in many instances, is avoidable. At Thomas Jefferson University (TJU), up to 50% of emergency department (ED) visits for medical oncology patients on active treatment (receiving intravenous or oral chemotherapy within 30 days) may be preventable based on OP-35 criteria. The COVID-19 pandemic drastically altered healthcare delivery, prompting providers and patients to re-evaluate the safety and necessity of acute care. We aimed to evaluate the effect of the COVID-19 pandemic on ED utilization for medical oncology patients at TJU. Methods: We reviewed the total number of visits to the TJU ED for all patients and for medical oncology patients from January 1, to May 31, 2020. We defined the months of January and February as “Pre-COVID” and the months of April and May as “COVID”. We excluded data from March in our analysis. For medical oncology patients, we tallied both the number of patients with an ED visit and total ED visits for each month. We stratified patients by whether or not they were on active treatment. We reviewed the outcome of each ED visit and categorized results as admission (inpatient admission or observation) or discharge. We classified each ED visit as avoidable or unavoidable using OP-35 criteria. Results: In the Pre-COVID months there were 489 total visits by 432 oncology patients; 41% (179) of these patients were on active treatment. During COVID months there were 313 visits by 284 oncology patients; 48% (137) were on active treatment at the time of visit. During COVID, total ED visits decreased by 37%. Visits by medical oncology patients decreased by 35%. For medical oncology patients on active treatment, we observed a 21% reduction in ED visits. In the Pre-COVID months, 38% of oncology patient visits were considerable potentially avoidable and 41% of visits ended with a discharge to home. In comparison, during COVID, 31% of visits were considered potentially avoidable and 35% of visits ended with a discharge to home. Conclusions: We observed a decrease in ED utilization by oncology patients that mirrored decrease in total ED utilization following the COVID-19 outbreak. The decrease was less prominent for patients on active treatment. The percent of visits that were potentially avoidable and the percentage of patients discharged to home from the ED decreased slightly during the COVID period. Further analysis is ongoing to understand factors driving reduction in ED utilization observed immediately following the COVID-19 outbreak.
Abstract 16784: Under-Enrollment of Real-World Heart Failure With Preserved Ejection Fraction Patients in Major HFpEF Clinical Trials
Authors: Joban Vaishnav, Lisa R Yanek, Virginia S Hahn, Eunice Yang, Rishi Trivedi, David A Kass, Kavita Sharma
Journal: Circulation (2020)

Introduction: Inclusion criteria for enrollment in HFpEF clinical trials vary considerably and often exclude patients with co-morbidities such as obesity. We tested the hypotheses that: 1) a large number of patients with clinical and hemodynamic evidence of HFpEF are excluded from major HFpEF clinical trials; and 2) there is no difference in clinical outcomes between patients excluded versus those who met enrollment criteria by evaluating reasons for exclusion from HFpEF clinical trials and comparing clinical outcomes in a real-world HFpEF cohort. Methods: Patients referred to the Johns Hopkins HFpEF Clinic with clinical and hemodynamic evidence of HFpEF (pulmonary capillary wedge pressure [PCWP] ≥ 12 mmHg on a loop diuretic or PCWP ≥ 15 mmHg) were assessed for inclusion into 4 major HFpEF trials (TOPCAT, I-PRESERVE, PARAGON-HF, and RELAX). Cumulative hazard of HF hospitalization or death at 2 years from index clinic visit was compared between patients included and excluded by each trial. Results: Of 132 HFpEF patients, the median PCWP was 19 mmHg (IQR: 15-22 mmHg). Forty-four (33%) of patients met enrollment criteria for TOPCAT, 39 (29%) for I-PRESERVE, 21 (16%) for PARAGON-HF, and 50 (38%) for RELAX. The top 5 criteria that would have excluded patients included low natriuretic peptide level, obesity, elevated blood pressure, young age, and low hemoglobin (Figure 1A) . There was no difference in HF burden (hospitalizations, diuretic dosing, or NYHA class), or in clinical outcomes including HF hospitalization or death between patients who did or did not meet inclusion criteria for each clinical trial (Figure 1B ). Conclusion: We demonstrate that in a real-world cohort of hemodynamically-proven HFpEF few patients would have met criteria for enrollment in major HFpEF clinical trials, yet HF burden and outcomes were no different. Given the lack of proven therapies in HFpEF, consideration should be given to unifying and broadening enrollment criteria in HFpEF clinical trials.
Experience, Perceptions, and Recommendations Concerning COVID-19–Related Clinical Research Adjustments
Authors: David E. Gerber, Thomas Y. Sheffield, M. Shaalan Beg, Erin L. Williams, Valerie L. Clark, Yang Xie, M.E. Blair Holbein, Celette Sugg Skinner, Simon J. Craddock Lee
Journal: Journal of the National Comprehensive Cancer Network (2021)

Background: During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. Methods: We developed and distributed an anonymous survey assessing COVID-19–related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. Results: A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had &gt;5 years’ professional experience in clinical research, and 56% had personal experience with a COVID-19–related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with &gt;5 years’ professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth ( P =.04) and therapy shipment ( P =.02). Conclusions: Clinical research professionals perceive that COVID-19–related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience—both specific to COVID-19–related changes and more generally—are more likely to recommend that these adjustments continue in the future.
Effects of a geriatric assessment (GA) intervention on symptomatic toxicity burden reported by older adults with advanced cancer during treatment.
Authors: Eva Culakova, Supriya Gupta Mohile, Huiwen Xu, Amita Patil, Sandy Plumb, Mostafa Mohamed, Zhi Pan, Sixu Meng, Nikesha Gilmore, Megan Wells, Rebecca Ritterman, Allison Magnuson, Erika E. Ramsdale, Luke Joseph Peppone, Kah Poh Loh, Marie Anne Flannery
Journal: Journal of Clinical Oncology (2020)

138 Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. We found that providing a GA summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients with advanced cancer receiving high risk treatment (presented at ASCO2020). Herein, we report on the effects of the GA intervention on symptomatic toxicities measured by Patient-Reported Outcomes Common Terminology Criteria for Adverse Events [PRO-CTCAE]. Methods: In the national cluster randomized clinical trial eligible patients (n=718) had age&gt;70, advanced solid tumors or lymphoma, 1+ GA impairment, and were initiating a new treatment regimen with high risk of toxicity. Severity grade of 24 PRO-CTCAE items was collected on a 0-4 scale at enrollment, 4-6 weeks, 3, and 6 months. Of 24 items, 11 (e.g. fatigue, dyspnea) were classified as core (Reeve 2014). Baseline adjusted method (Basch 2016) was used to determine symptomatic toxicities: if the severity of any item increased after baseline to grade 2 or higher, the patient was classified as experiencing grade ≥2 event (similarly for grade ≥ 3 events). The effects of GA intervention on symptomatic toxicities were assessed using generalized linear mixed model (GLMM) with random effect for the practice cluster. Results: Mean age was 77 years (range 70-96); 43% female, 87% white; 34% had gastrointestinal and 25% had lung cancer; 27% received prior chemotherapy. 710 patients provided PRO-CTCAE data (366 usual care, 344 intervention), 85.6% reported grade ≥2 and 49.4% grade ≥3 events at baseline. After baseline, compared to usual care, patients in the GA intervention arm reported fewer grade ≥2 overall symptomatic toxicities (76.5% vs. 84.7%) and fewer core symptomatic toxicities (grade ≥2: 71.8% vs. 82.0%; grade ≥3: 46.2% vs. 53.6%). Specifically, less dyspnea and less fatigue was reported in GA-arm (Table). Conclusions: GA intervention resulted in fewer symptomatic toxicities as evaluated by PRO-CTCAE. Clinical trial information: NCT02054741 . [Table: see text]
Exploration of the use and impact of patient-reported experience measures (PREMs) in oncology settings: A systematic review.
Authors: Olivia Cook, Yunyun Daiyan, Ladan Yeganeh, Amy Georgina Davies, Alastair Kwok, Kate Webber, Eva Segelov
Journal: Journal of Clinical Oncology (2020)

166 Background: In addition to patient-reported outcome measures, the use of patient-reported experience measures (PREMs) is also developing as a patient-centred method for evaluating health performance. PREMs are tools that measure patients’ experience of health care including accessibility, the physical environment of services, and their interactions with health service providers and clinicians. This systematic review aimed to explore the use and impact of PREMs in the clinical care of cancer patients and survivors. Methods: This systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. An a priori protocol was established and systematic searches of major databases (CINAHL, Medline, PsycINFO, Ovid Emcare and Scopus) were conducted between 2009 and 2019. Quantitative studies of adult or paediatric populations were eligible for inclusion. Articles reporting patient satisfaction only were excluded. Quality appraisal was conducted using the Johanna Briggs Institute Critical Appraisal Tools. A narrative synthesis of findings was conducted. Results: A total of 3246 articles were screened for eligibility with 45 studies included in the systematic review. The majority of included studies (n=37) were cross-sectional in design with a variety of PREMs used, most commonly the National Cancer Patient Experience Survey. Most studies were assessed as ‘moderate’ to ‘high’ for quality. Studies were categorised according to the use of the PREM with the majority (n=40) utilising a PREM to evaluate cancer services at the service or national level, and five using a PREM to evaluate a specific clinical intervention. Various gaps in care were identified across studies highlighting areas for improvement such as time to diagnosis and information provision. Few studies reported the barriers or enablers to PREM collection or discussed service improvement initiatives arising from them. Conclusions: Whilst PREM collection is becoming more common in oncology settings, the use and impact of this valuable data is not well reported. Patients willingly share their experiences of oncology care, yet planned or complete actions resulting from the data to improve care are seldom reported. The collection of PREMs should be met with a commitment to service improvement and longitudinal collection of PREMs is recommended to evaluate quality improvement initiatives.
The National Coverage Decision for MitraClip in Functional Mitral Regurgitation
Authors: Satya Shreenivas, William T. Abraham, Scott Lilly
Journal: JAMA Cardiology (2020)

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Benign Evolution of SARS-Cov2 Infections in Children With Inflammatory Bowel Disease: Results From Two International Databases
Authors: Erica J. Brenner, Bénédicte Pigneur, Gili Focht, Xian Zhang, Ryan C. Ungaro, Jean-Frederic Colombel, Dan Turner, Michael D. Kappelman, Frank M. Ruemmele
Journal: Clinical Gastroenterology and Hepatology (2020)
Response to: ‘Correspondence on ‘Long-term outcome of a randomised controlled trial comparing tacrolimus with mycophenolate mofetil as induction therapy for active lupus nephritis’’ by Xu
Authors: Chi Chiu Mok
Journal: Annals of the Rheumatic Diseases (2020)

I would like to thank Dr Xu1 for his interest in our lupus nephritis (LN) randomised controlled trial.2 Although 28% of the recruited patients were ever positive for the antiphospholipid (aPL) antibodies at study entry, only four (2.7%) of them had history of thromboembolism and two times positivity of the aPL antibodies that qualified the consensus criteria for the antiphospholipid antibody syndrome (APS).3 Four more patients developed the APS on follow-up, giving rise to an overall …
Prospectively assessing risk of acute care utilization for patients with an active cancer diagnosis.
Authors: Valerie Pracilio Csik, Adam Binder, Michael Li, Nathan Handley
Journal: Journal of Clinical Oncology (2020)

208 Background: Acute care utilization (ACU)--emergency department visits or hospitalizations--is common in patients with cancer. As many as 83% of all patients with cancer visit the emergency department annually; nearly three quarters of patients with advanced cancer are hospitalized in the year after diagnosis. Much of this ACU may be preventable. Identifying patients at risk for ACU using model-based approaches has shown potential for risk stratifying certain patient subgroups. However, a model applicable to any patient with an active cancer diagnosis is needed. We developed a real time clinical prediction model to assess risk for acute care utilization in patients with an active cancer diagnosis. Methods: We completed a retrospective cohort analysis of patients with an active cancer diagnosis (defined as at least one medical oncology encounter in a 12 month period) at one health system. Clinical factors with potential to impact disease progression and ACU were identified through a clinical review. Significant variables were defined by multivariate logistic regression. Risk of ACU was further characterized through the development of a point scoring system to define the upper decile of patients at highest risk. Results: We included 8,246 patient records in the analysis. Seven variables were determined to be statistically significant: An emergency department visit in the last 90 days, chronic obstructive pulmonary disease, congestive heart failure, chronic kidney disease, low hemoglobin, low albumin, and low absolute neutrophil count. The model produced an overall C-statistic of 0.726 Each significant variable was assigned a score of 0 or 1 (with the exception of ED visits, which were given one point for each visit, with three points maximum). Each patient received a total score, resulting from the summation of the individual variable scores. An evaluation of the distribution of points determined that 10% of the patients achieved a score of 2 or higher and contributed to 46% of ACU in the last 90 days. Patients receiving 0 points were defined as low risk (73% of patients contributing to 30% of ED/admissions). Patients receiving 1 point were deemed intermediate risk (17% of patients contributing to 24% of ED/admissions). Conclusions: Risk of acute care utilization for patients with an active cancer diagnosis can be prospectively assessed. This tool is currently integrated into our clinical practice and is updated every 14 days, or any time the chart is accessed. Assessment of efficacy is ongoing.
The Aftermath of AKI: Recurrent AKI, Acute Kidney Disease, and CKD Progression
Authors: Yumeng Wen, Chirag R. Parikh
Journal: Journal of the American Society of Nephrology (2020)

AKI and CKD are interconnected syndromes with significant long-term sequelae such as progressive CKD, cardiovascular events, and death.[1][1],[2][2] Diabetes is not only a major cause of CKD, but is also an independent risk factor for AKI. AKI in diabetic patients is associated with medications such
Development and validation of a serum microRNA biomarker panel for detecting gastric cancer in a high-risk population
Authors: Jimmy Bok Yan So, Ritika Kapoor, Feng Zhu, Calvin Koh, Lihan Zhou, Ruiyang Zou, Yew Chung Tang, Patrick C K Goo, Sun Young Rha, Hyun Cheol Chung, Joanne Yoong, Celestial T Yap, Jaideepraj Rao, Chung-King Chia, Stephen Tsao, Asim Shabbir, Jonathan Lee, Kong-Peng Lam, Mikael Hartman, Wei Peng Yong, Heng-Phon Too, Khay-Guan Yeoh
Journal: Gut (2020)

Objective An unmet need exists for a non-invasive biomarker assay to aid gastric cancer diagnosis. We aimed to develop a serum microRNA (miRNA) panel for identifying patients with all stages of gastric cancer from a high-risk population. Design We conducted a three-phase, multicentre study comprising 5248 subjects from Singapore and Korea. Biomarker discovery and verification phases were done through comprehensive serum miRNA profiling and multivariant analysis of 578 miRNA candidates in retrospective cohorts of 682 subjects. A clinical assay was developed and validated in a prospective cohort of 4566 symptomatic subjects who underwent endoscopy. Assay performance was confirmed with histological diagnosis and compared with Helicobacter pylori (HP) serology, serum pepsinogens (PGs), ‘ABC’ method, carcinoembryonic antigen (CEA) and cancer antigen 19–9 (CA19-9). Cost-effectiveness was analysed using a Markov decision model. Results We developed a clinical assay for detection of gastric cancer based on a 12-miRNA biomarker panel. The 12-miRNA panel had area under the curve (AUC)=0.93 (95% CI 0.90 to 0.95) and AUC=0.92 (95% CI 0.88 to 0.96) in the discovery and verification cohorts, respectively. In the prospective study, overall sensitivity was 87.0% (95% CI 79.4% to 92.5%) at specificity of 68.4% (95% CI 67.0% to 69.8%). AUC was 0.848 (95% CI 0.81 to 0.88), higher than HP serology (0.635), PG 1/2 ratio (0.641), PG index (0.576), ABC method (0.647), CEA (0.576) and CA19-9 (0.595). The number needed to screen is 489 annually. It is cost-effective for mass screening relative to current practice (incremental cost-effectiveness ratio=US$44 531/quality-of-life year). Conclusion We developed and validated a serum 12-miRNA biomarker assay, which may be a cost-effective risk assessment for gastric cancer. Trial registration number This study is registered with ClinicalTrials.gov (Registration number: NCT04329299 ).