tbuckley/cabot-search huggingface dataset:
Context and Approach in Reporting Evaluations of Electronic Health Record–Based Implementation Projects
Authors: R. Brian Haynes, Guilherme del Fiol, Matthew Michelson, Alfonso Iorio
Journal: Annals of Internal Medicine (2020)

Electronic health records (EHRs) are ubiquitous yet still evolving, resulting in a moving target for determining the effects of context (features of the work environment, such as organization, payment systems, user training, and roles) on EHR implementation projects. Electronic health records have become instrumental in effecting quality improvement innovations and providing data to evaluate them. However, reports of studies typically fail to provide adequate descriptions of contextual details to permit readers to apply the findings. As for any evaluation, the quality of reporting is essential to learning from, and disseminating, the results. Extensive guidelines exist for reporting of virtually all types of applied health research, but they are not tailored to capture some contextual factors that may affect the outcomes of EHR implementations, such as attitudes toward implementation, format and amount of training, post go-live support, amount of local customization, and time diverted from direct interaction with patients to computers. Nevertheless, evaluators of EHR-based innovations can choose reporting guidelines that match the general purpose of their evaluation and the stage of their investigation (planning, protocol, execution, and analysis) and should report relevant contextual details (including, if pertinent, any pressures to help justify the huge investments and many years required for some implementations). Reporting guidelines are based on the scientific principles and practices that underlie sound research and should be consulted from the earliest stages of planning evaluations and onward, serving as guides for how evaluations should be conducted as well as reported.
Cerebral magnetic resonance features in patients with spontaneous intracranial hypotension and subsequent cerebral venous thrombosis
Authors: Yong Bi, Jieqin Gong, Jia Li, Guoqian Chen, Dongqing Liang, Weian Chen, Benyan Luo
Journal: BMJ (2014)

To explore the clinical and cerebral magnetic resonance imgaing (MRI) characteristics of spontaneous intracranial hypotension (SIH) and subsequent cerebral venous thrombosis (CVT) for early diagnosis and treatment.Retrospective analysis was conducted for 4 clinical cases of SIH and subsequent CVT from 2007 to 2012.Their clinical features, neuroimaging and treatment strategies were analyzed.All of them had neuroimaging features of SIH and CVT.Frequent manifestations included subdural effusion, diffuse pachymeningeal gadolinium enhancement and downward cerebral displacement.Superior sagittal sinus thrombosis (n=2) and cerebral cortical veinous thrombosis (n=2) were found.Cerebral MRI and magnetic resonance venography (MRV) scans were helpful for the diagnoses of SIH and CVT.All of them recovered with anticoagulation redressed and intracranial hypotension therapy.SIH may be associated with an increased risk of CVT.We should consider cerebral MRI if the character of headache changes or if there an onset of new signs.


Key words: 
Intracranial pression; Venous thrombosis
Effect of video-based patient education on pancreatic cancer knowledge and behavior.
Authors: Wendy Turell, Tariqa Ackbarali, Eileen Mary O'Reilly, Matthew Alsante, Kathryn Pucci, Elizabeth A Del Nido
Journal: Journal of Clinical Oncology (2020)

11005 Background: Treatment outcomes for pancreatic cancer are optimized when patients/caregivers are engaged, informed and supported participants in their care. However, challenges exist regarding care engagement, disease and treatment related education, and the attainment of adequate psychosocial support. To address these needs, we created video-based patient education activities with the National Pancreas Foundation to empower patients/care with information and resources on pancreatic cancer facts, diagnosis, medical management, and strategies to minimize side effects and maximize quality of life. Methods: One 1-hour patient education activity was broadcast live and online, followed by on-demand release, in 2018-2019 at CancerCoachLive.com and via Facebook Video for 12 months. Features included panel discussions, slides, live polling and Q&amp;A, and video vignettes of real patient experiences. Knowledge-focused test questions were administered at 3 time points (pre-activity, immediate post-activity, and 2-mos [follow-up] post). Behavioral and communication-focused questions were also asked at follow-up. Data from these questions, live poll responses, and learner-submitted questions pre-event and during live Q&amp;A were analyzed to determine engagement, lessons learned and continuing patient needs. Results: In total, 6,276 patients took part in the activity. Patient questions prior to and during the activity focused on basic knowledge about pancreas gland function, tumor development, disease escalation, and medical management. In-session polling results revealed that prognosis and life expectancy were the top concerns for participants. Two months post-education evaluation showed: 33% reported improved communication with their healthcare providers (HCPs) regarding pancreatic cancer; 46% reported improved feelings of being more “in-control” of health care decisions; 25% reported improved care behaviors for their health. Reports of improved HCP communication were specific to: side effect management, clinical trials availability, treatment option knowledge, and confidence related to engaging in discussions. Knowledge improvements were observed for 3 of 4 questions related to facts about the pancreas, pancreatic cancer, and treatment.Conclusions: Patient/caregiver education on pancreatic cancer yields gains in knowledge and behavior, improves patient/caregiver engagement, improves treatment decision-making, and maximizes quality of life.
Long-term outcomes of locally advanced and borderline resectable esthesioneuroblastoma and sinonasal tumor with neuroendocrine differentiation treated with neoadjuvant chemotherapy.
Authors: Amit Kumar, Vanita Noronha, Vijay Maruti Patil, Amit Joshi, Nandini Sharrel Menon, Kumar Prabhash
Journal: Journal of Clinical Oncology (2020)

e18507 Background: Sinonasal tumors are a rare subgroup of head and neck cancers. Locally advanced esthesioneuroblastoma and sinonasal neuroendocrine tumors (SNEC) are treated with a multidisciplinary approach with combination of surgery followed by adjuvant radiation or chemo radiation; but have unsatisfactory outcomes. Hence we devised the approach of administering neoadjuvant chemotherapy (platinum and etoposide) followed by surgery and adjuvant chemoradiation. This approach had the advantage of improved response rates, orbital preservation and improvement in short term outcomes. The present analysis was done to estimate the 5 year outcomes and late adverse events of locally advanced sinonasal tumors treated with induction chemotherapy followed by local therapy. Methods: Twenty five patients with locally advanced esthesioneuroblastoma or SNEC treated between August 2010 to August 2014 with induction chemotherapy followed by local therapy were selected. The 5 year outcomes and late adverse events (CTCAE version 4.02) were noted. Progression free survival (PFS) and overall survival (OS) were estimated using the Kaplan Meier method. COX regression analysis was used to identify factors impacting PFS and OS. Results: The median follow up was 5.15 years. The 5 year PFS in esthesioneuroblastoma cohort and in SNEC cohort was 63.5% (95%CI 28.9-84.7) and 34.6% (95%CI 10.1-61.1) respectively (p = 0.1). The only factor impacting PFS on multivariate analysis was response to neoadjuvant chemotherapy (p = 0.033). The 5 year OS in esthesioneuroblastoma cohort and in SNEC cohort were 91.7% (95%CI 53.9-98.9) and 46.2% (95%CI 19.2-69.6) respectively (p = 0.024). Any grade late adverse event was seen in 20 patients (80%). Metabolic late adverse events were seen in 19 patients (76%). Conclusions: Neoadjuvant chemotherapy in advanced sinonasal cancers is associated with improvement in 5 year outcomes. However late side effects especially metabolic are seen in these patients and should be evaluated during follow up. Keywords: Sinonasal; Adverse event; Esthesioneuroblastoma; SNEC; Induction; Neoadjuvant [Table: see text]
Effect of automated TIL quantification in early-stage melanoma on accuracy of standard T staging using AJCC guidelines.
Authors: Michael Moore, Isabel D Friesner, Emanuelle M. Rizk, Megan Trager, Julide T. Celebi, Jeani Rich, Ijeuru Chikeka, Tahsin Kurc, Jing Wang, Bethany Rohr, Eric Robinson, Larisa J. Geskin, Basil Horst, Kevin Gardner, George Niedt, Jane Messina, Tammy Ferringer, Joel H. Saltz, Rami Vanguri, Yvonne M. Saenger
Journal: Journal of Clinical Oncology (2020)

10076 Background: Patients diagnosed with early stage melanoma are at risk of recurrence and death. Adjuvant therapy decreases risk but incurs toxicity and expense. While tumor-infiltrating lymphocytes (TILs) improve prognosis, studies have shown conflicting results due, at least in part, to inter-observer variability. Thus, TILs are not included in standard American Joint Committee on Cancer (AJCC) staging. Here, we quantitatively analyze TILs in hematoxylin and eosin (H&amp;E) melanoma images using two machine learning algorithms. Methods: H&amp;E images were evaluated by two methods for patients with resectable stage I-III melanoma from Columbia (N = 81) and validated using samples from Geisinger and Moffitt (N = 128). For both methods, H&amp;E images were manually annotated using open source software, QuPath, to specify tumor regions. For Method A, images were divided into patches and, for each patch, a probability was generated to detect lymphocytes. Patches above a set threshold were considered to be “TIL positive”. Ratio of TIL positive patches to total patches was assessed for every image. For Method B, a classifier was manually trained in QuPath and then applied on each image to determine the ratio of the areas of all immune cells to all tumor cells as previously published. Cutoff values to define high and low risk groups were established based on a test set and then validated in an independent cohort. Results: Both methods distinguished patients with visceral recurrence from those without for the Columbia training set (Method A p = .0015, Method B p = .043). Using Method A, Kaplan-Meier curve at the selected cutoff also correlated significantly with disease specific survival (DSS) for Columbia (p = .022) and was validated in the Geisinger/Moffitt (p = .046) cohort. Cox analysis using Method A showed that TIL status predicted DSS in the validation set (p = .047) and added significantly to depth and ulceration (HR = 3.43, CI: 1.047-11.257, p = .042). Conclusions: Both open source machine learning algorithms find significantly higher TILs in patients who do not develop metastasis. Notably, Method A may add to standard predictors, such as depth and ulceration. These results demonstrate the promise of computational algorithms to enhance visual grading, and suggest that digital TIL evaluation may add to current AJCC staging. [Table: see text]
Interim results from the OPTIMAL trial: A phase II clinical trial of combination nivolumab, ipilimumab, and taxane in patients with untreated metastatic non-small cell lung cancer (NSCLC).
Authors: Jeffrey Melson Clarke, Xiaofei F. Wang, Lin Gu, Marvaretta Miesha Stevenson, Tom Stinchcombe, Sundhar Ramalingam, Scott Joseph Antonia, Afreen Shariff, Jennifer Garst, Jeffrey Crawford, Neal E. Ready
Journal: Journal of Clinical Oncology (2020)

e21683 Background: Combination chemo-immunotherapy is a well-established frontline therapeutic option for treatment naïve NSCLC. Dual immune checkpoint blockade (ICB) with nivolumab (nivo) and ipilimumab (ipi) has demonstrated improved clinical outcomes compared with chemotherapy alone in this setting. Combination dual ICB with low-dose chemotherapy may have advantages of preventing early disease progression and potentiating immunogenic response to treatment. Methods: We are conducting a single arm phase II clinical trial of nivo 360 mg IV Q3 weeks, ipi 1 mg/kg IV Q6 weeks, and weekly paclitaxel 80 mg/m2 IV on d1 and d8 of a 21 day cycle in ECOG 0-1 patients (pts) with treatment naïve NSCLC. Paclitaxel is stopped after a total of 4-6 cycles. The primary endpoint of the trial is progression free survival (PFS) with secondary endpoints of safety and objective response rate (ORR) by independent radiologic review. Interim results are presented from the first 23 evaluable pts, of a planned sample size of 49. Results: 23 pts were enrolled and evaluable with a mean age 63.8 years, 56.5% ECOG 0, 87% current/previous smoking history, and 70% adenocarcinoma. PDL1 score for &lt; 1%, 1-49%, ³ 50% was seen in 9 (39.1%), 4 (17.4%), and 10 (43.5%) pts, respectively. Median time of follow up was 6.5 months (range 1.4–15.0). Partial response was observed in 14 pts, stable disease was seen in 8 pts, and 1 pt progressed during cycle 1, resulting in an ORR of 61%. Grade 3 or higher toxicity at least possibly attributed to study treatment was seen in 47.8% of 23 AE evaluable patients, of which included 4 cases of secondary adrenal insufficiency. Other toxicity rates were as expected for the respective agents. Conclusions: This is the first trial to evaluate weekly paclitaxel with nivo plus ipi in pts with untreated NSCLC. This regimen has demonstrated highly encouraging clinical activity with a manageable toxicity profile. The study is ongoing and updated results will be presented at the annual meeting. Clinical trial information: NCT03573947.
Comprehensive profiling of androgen receptor-positive (AR+) triple-negative breast cancer (TNBC) patients (pts) treated with standard neoadjuvant therapy (NAT) +/- enzalutamide.
Authors: Bora Lim, Sahil Seth, Lei Huo, Rachel M. Layman, Vicente Valero, Alastair Mark Thompson, Jason B White, Jennifer Keating Litton, Senthil Damodaran, Rosalind P Candelaria, Banu Arun, Gaiane M Rauch, Rashmi Krishna Murthy, Qingqing Ding, William Fraser Symmans, Li Zhao, Jianjun Zhang, Debu Tripathy, Stacy L. Moulder, Naoto T. Ueno
Journal: Journal of Clinical Oncology (2020)

517 Background: The luminal androgen receptor (LAR) subtype of TNBC has a low pathologic complete response (pCR) rate after NAT. We determined the pCR rate of the enzalutamide and paclitaxel (ZT) regimen for pts with anthracycline-insensitive AR + TNBC (NCT02689427), and related biomarkers. Methods: ARTEMIS (NCT02276443) is a non-randomized trial to determine if NAT can be used to personalized therapy. Pts received 4 cycles of doxorubicin-based NAT (AC). Pts with insensitive disease by imaging were offered clinical trials as the second phase of NAT based upon molecular profiling of pre-treatment biopsies. Immunohistochemistry (IHC) of AR + ≥10% was the threshold for selecting ZT (enzalutamide 160 or 120 mg PO qD + paclitaxel 80 mg/m 2 qW for 12 cycles). pCR was determined by surgery after NAT. Trial had two-stage Phase II design, and we report the completed first stage. We evaluated the concordance between Vanderbilt LAR subtype by molecular profiling (microarray and RNAseq) and IHC %AR + cells. Frequency of PI3K pathway alterations within the LAR subtype was assessed. Results: 267 pts had tumors profiled by IHC, 220 by microarray, 187 by RNAseq and 197 by whole exome sequencing. 96 pts had post-AC RNAseq. LAR scores from both RNAseq and microarray profiling (n = 139) were highly concordant (R = 0.89, P &lt; 0.001) and identified ~10% of TNBCs tested as LAR. The %AR + cells from IHC correlated with LAR subtype scores according to RNAseq (R = 0.6, P &lt; 0.001), with a cut-point of ≥30% AR + having the best concordance with LAR subtype. Unlike other subtypes, by serial profiling, LAR TNBCs did not change subtype signatures after exposure to AC. LAR TNBCs had low rates of pCR (23%) and high rates of PI3K pathway activating aberrations (85%); however PI3K aberrations did not correlate with pCR. Seventeen patients with AC-insensitive TNBC received ZT. Five of 15 patients (33.3%) had responses (pCR or RCB-I). Toxicities are Grade (Gr) 4 syncope (n = 1), Gr3 abnormal liver function (n = 2), Gr3 neutropenia (n = 4). IHC &amp; LAR subtype scores did not statistically associate with response to ZT (P = 0.8, P = 0.9). However, all responders to ZT had an upregulated androgen response pathway (ssGSEA Z &gt; 1) as measured by transcriptomic analysis in pre-treatment biopsies analysis (P = 0.05, ppv = 0.56, npv = 1). Conclusions: The LAR TNBC subtype has a low pCR rate to NAT. Among pts with AC-insensitive TNBC, baseline upregulated androgen response pathway and LAR subtype may benefit from the ZT regimen, potentially by PI3K targeting. Clinical trial information: NCT02689427 .
Phase III TRIDENT trial: Radiation and temozolomide +/- tumor treating fields in newly diagnosed glioblastoma.
Authors: Wenyin Shi, Lawrence Kleinberg, Suriya A. Jeyapalan, Samuel Aaron Goldlust, Seema Nagpal, David A. Reardon, Stephanie E Combs, David Roberge, Ryo Nishigawa, Martin Glas
Journal: Journal of Clinical Oncology (2020)

TPS2580 Background: Tumor treating fields (TTFields) is a non-invasive, regional antimitotic treatment approved as a standard of care for glioblastoma (GBM). In the EF-14 phase III trial, TTFields (200 kHz) plus temozolomide (TMZ) significantly increased the survival of patients with newly diagnosed GBM (ndGBM) without increase in systemic toxicity. TTFields-related AEs were mainly skin AEs. In preclinical models, TTFields increase the therapeutic effects of radiation therapy (RT). A pilot study showed that TTFields concomitant with RT and TMZ is well tolerated. The benefit of concomitant TTFields with RT and TMZ will be tested in this phase III TRIDENT randomized trial. Methods: TRIDENT is an international phase III randomized trial comparing standard RT with TMZ vs the triple combination of RT plus TMZ with concomitant TTFields. RT is delivered through the TTFields arrays. Patients in both arms will receive maintenance TTFields with TMZ. TTFields (200 KHz) will be delivered &gt;18 hours/day using Optune. Patients will continue TTFields treatment until second recurrence. Patients with pathologically confirmed newly ndGBM, ≥ 18 years, KPS ≥ 70, either sex, post-surgery or biopsy, who are amenable for RT/TMZ therapy will be enrolled. Patients will be stratified by extent of resection and MGMT promoter methylation status. The primary endpoint is overall survival (OS). Secondary end points include: progression free survival (PFS; RANO), 1- and 2-year survival rates, overall radiological response (ORR; RANO), progression-free survival (PFS2, PFS6, PFS12); severity and frequency of AEs (CTCAE V5.0); pathological changes in resected GBM tumors post treatment; quality of life (EORTC QLQ-C30); and correlation of OS to TTFields compliance. The hypothesis is that concomitant TTFields with radiation and TMZ will significantly improve OS as compared to radiation and TMZ alone. The sample size is 950, with 475 in each arm to detect a HR &lt;0.8 with a 5% type I error. Survival will be measured from the time of randomization until date of death. At the time of analysis, patients who are lost to follow-up or still on protocol follow-up will be censored at the last date known to be alive.
泮托拉唑治疗急性胰腺炎36例
Authors: 谈荣玖
Journal: BMJ (2004)

2001年1月～2003年6月,我们应用泮托拉唑治疗急性胰腺炎36例,现报道如下. 1.临床资料:将住院的72例急性胰腺炎患者随机分为两组:治疗组36例(A组),男25例,女11例,年龄23～57岁(平均33岁);对照组36例(B组):男23例,女13例,年龄22～58岁(平均29岁).两组均有不同程度的上腹、左上腹部疼痛,恶心,呕吐等症状.A组患者血清淀粉酶600～4 200 U(苏氏单位),平均1 280 U.B组患者血清淀粉酶500～4 000 U,平均1 310 U.入院时均查血糖、肝功能、肾功能、血清电解质、血常规、B超或CT等,临床证实为急性胰腺炎.两组年龄、性别、血清淀粉酶、B超或CT检查结果差异无显著性。
Statistical machine learning model to predict Oncotype DX risk category in women over age 50.
Authors: Kate R. Pawloski, Mithat Gonen, Hannah Yong Wen, Audree B. Tadros, Kelly Abbate, Donna Thompson, Monica Morrow, Mahmoud El-Tamer
Journal: Journal of Clinical Oncology (2020)

524 Background: The 21-gene Oncotype DX Breast Recurrence Score multigene assay (RS) identifies women with ER positive, HER negative, axillary node-negative breast cancer (BC) for whom chemotherapy provides no invasive disease-free survival benefit compared to endocrine therapy alone. International adoption of RS testing is limited by cost and resource availability. We created a supervised statistical machine learning model using standard clinicopathologic data to predict RS risk category in women &gt; 50 years old. Methods: From 2012 to 2018, women with ER positive, HER2 negative, pathologically node-negative BC of all ages were retrospectively identified from a prospective institutional database. Standard clinicopathologic data and RS were collected. Per institutional protocol, RS are ordered for all early-stage, ER positive tumors &gt; 5 mm. Data were randomly split into training (n=3755) and validation sets (n=1609). A random forest model with 500 trees was developed on the training set, then evaluated on the validation set. Model predictors included age, tumor size, histologic subtype, hormone receptor status, lymphovascular invasion, and overall grade. The model was used to predict RS category (low risk: RS ≤ 25, high risk: RS &gt; 25) in women &gt; 50 years old. Results: 5364 unique tumors in 5189 women were identified. 3731 (70%) of tumors were identified in women &gt; 50 years; median age was 63 years (IQR 57-69). In women &gt; 50, median tumor size was 12 mm (IQR 9-17). Most tumors were invasive ductal (79%), low or intermediate grade (79%), and LVI was absent in 82% of tumors. Median ER staining by IHC was 95%; 28% of tumors had negative or weakly positive PR staining (1-20%). The model correctly classified 96.8% of patients as low risk (95% CI: 95.7-97.7). Negative predictive value for identifying low risk category was also high (92.3%, 90.7-93.6). Sensitivity for identifying high-risk women was 44.7% (37.4-52.1) and positive predictive value was 67.2% (58.2-75.3). A classification table on the validation set includes tumors with complete data available, including predictors and RS. Conclusions: Our model was highly specific (96.8%) for identifying women &gt; 50 with RS ≤ 25 who do not benefit from adjuvant chemotherapy. This model may be utilized in lieu of RS testing if cost and availability are prohibitive. True RS &gt; 25 was not as well predicted. The model will be refined following pathologic review of discordant cases to reduce false negatives. [Table: see text]