tbuckley/cabot-search huggingface dataset:
MSK eConsent: Digitalizing the informed consent process to improve participant engagement and understanding.
Authors: Michael T. Buckley, Joseph M. Lengfellner, Matthew J. Koch, Benjamin Search, Carol Hoidra, Mary Lin, Sangeeta Kundu, Roy Cambria, Molly O'Shea, Jesse Galle, Jennifer Wang, Ann Rodavitch, Karima Yataghene, Jaclyn Pember, Stephanie Lucia Terzulli, Collette Houston, Eric Cottington, Paul Sabbatini
Journal: Journal of Clinical Oncology (2020)

2066 Background: eConsent was developed to digitize the research participant consenting experience with an educational engagement model. The eConsent platform tiers consent document content in an easy-to-navigate format, using videos, images, and access to supplementary information. We hypothesize that enhancing the consenting experience improves participant engagement and comprehension. Methods: Here we present two projects: 1) qualitative assessment of patient engagement in the eConsent process using a standardized 5-question survey sent to all patients who used it during 9 months in 2019, and 2) a report of our preliminary findings from exempt protocol, Assessing Participant Engagement and Protocol Education in the Consent Process (X19-055) that quantitatively compares paper and electronic consenting and a) assesses patient agency and b) tests comprehension of key consent elements in 2 protocols: Storage and Research Use of Human Biospecimens (06-107) and Genomic Profiling in Cancer Patients (12-245). Results: 1) 940 patients completed the qualitative experience survey (27% response). Most respondents (777; 83%) indicated that electronic consenting was very easy (371) or easy (406) to use. Only 25 (3%) said electronic consenting was somewhat difficult to use, 3 indicated it was difficult (0.3%), and 64 were neutral. Most (896; 95%) recommended electronic consenting to other MSK patients. Those who reported a 1 unit increase in technology discomfort, only reported a .48 unit increase in eConsent discomfort ( P&lt; .001). 2)Quantitative 10-question electronic tests were sent to each patient’s portal account within 72h after consenting via paper or eConsent to protocols 06-107 and 12-245. To date, for 06-107: 18 paper consenters completed the test with a score of 76% vs 23 eConsent users who scored 80%. For 12-245: 43 paper consenters scored 69% vs 13 eConsent users scoring 80%. Scores are a surrogate marker for patient comprehension and show that 12-245 protocol participants’ average testing scores are higher when participants are consented with eConsent vs paper (P &lt; .01). 06-107 protocol participants’ average test scores are trending toward eConsent improving patient understanding ( P= .11). We will follow this trend as our sample size increases to a total of 500 participants. Patient agency questions received favorable responses from most patients (100%-84%). Conclusions: eConsent enhances participant engagement and understanding and does not impose a digital burden on participants.
Serum 25-hydroxyvitamin D levels in elderly patients with hip and vertebral compression fracture
Authors: Shaohui Shi, Wei Pan, Guoping Wu, Dongjian Lu, Maoting Li, Sanli Cao
Journal: BMJ (2020)

Objective
To investigate the serum 25-hydroxyvitamin D [25(OH) D] levels in elderly patients with hip and vertebral compression fractures (VCF).


Method
Ninety patients (58 males and 32 females) aged over 60 years with hip fracture and 120 patients (88 males and 32 females) aged over 60 years with VCF admitted in the Aviation General Hospital from January 2017 to June 2019 were enrolled. Serum 25(OH)D levels were measured.


Results
Serum level of 25 (OH) D in hip fracture patients was (9.0±6.8) μg/L, the 25 (OH) D level was lower than the normal value(<19.0 μg/L)in 79 patients and<3 μg/L in 24 patients. The level of 25(OH)D in VCF patients was (16.7±10.6) μg/L, the 25 (OH) D level was<19.0 μg/L in 78 patients (65.0%) and <3 μg/L in 10 patients (8.3%). The low level of 25(OH)D was negatively correlated with age in two groups (r=-0.367, P=0.01; r=-0.313, P=0.04). The mean level of 25 (OH) D in the hip fracture group was lower than that in the VCF group (t=5.960,P<0.01), and the low 25(OH)D rate in the former group was significantly higher than that in the latter group (χ2=14.14, P<0.01; χ2=12.74, P<0.01). The 25(OH)D value of female VCF patients was (14.5±8.8) μg/L, which was significantly lower than that of male patients (22.5±12.9) μg/L (t=3.882,P<0.01).Among hip fracture patients, the 25(OH)D level in patients with fracture history was (8.3±6.9) μg/L, which was significantly lower than that of patients without fracture history (10.8±6.9) μg/L, and the difference was statistically significamt (t=2.123, P=0.04). The serum osteocalcin level was (20.5±19.8) μg/L in patients with fracture history, which was significantly higher than that in patients without fracture history [(10.6±5.4) μg/L, t=3.245, P<0.01].


Conclusion
Elderly patients with new hip fractures have more severely low vitamin D level than patients with new VCF, and patients with previous fracture history have lower vitamin D levels than patients without fracture history.


Key words: 
Osteoporotic fractures; 25-Hydroxyvitamin D 2; Aged; Middle aged
Inner fistula by abdomino-back arteriovenous anastomosis in patients with hemodialysis
Authors: Sheng-gui Zhang, Hai Bai, Jie Sun, Bin Chen
Journal: BMJ (2010)

Inner fistula by abdomino-back anastomosis of cephalic vein to radial artery was erformed in 86 patients with hemodialysis (test group) and end-to side arteriovenous anastomosis was performed in 85 cases (control group).There were no significant differences in postoperative anastomotic blood flow and vascular complications between two groups (P ＞ 0.05);however the average time consuming for operation in test group was shorter than that in control group (36 min vs.75 min,P ＜ 0.01).The minimally invasive abdomino-back anastomosis is a desired arteriovenous fistula method for hemodialysis patients.

Key words: 
Arteriovenous anastomosis;  Arteriovenous fistula
AMI远离区室壁节段运动估测冠状动脉累及程度探讨
Authors: 邹凤军, 杜雪平, 杨明, 王青, 丁五麟, 张小杭, 马莉, 王泳
Journal: BMJ (2004)

应用超声心动图检测急性心肌梗死患者梗死远离区室壁节段运动,并与冠状动脉造影结果比较,以评价冠状动脉累及程度.结果超声心动图与冠状动脉造影检出单支病变的诊断符合率为83.8%,检出多支病变的诊断符合率为76.9%。
Patterns of the risk for subsequent primary cancer among survivors of adult-onset cancers in the United States.
Authors: Hyuna Sung, Noorie Hyun, K Robin Yabroff, Ahmedin Jemal
Journal: Journal of Clinical Oncology (2020)

12060 Background: The number of cancer survivors who develop new cancers is projected to grow in the US. Few studies, however, have provided a comprehensive overview of the contemporary pattern in the risk of subsequent primary cancer (SPC) among survivors of adult-onset cancers. Herein, we evaluate overall and type-specific risks of SPCs among adult-onset cancer survivors by first primary cancer types and sex. Methods: We assessed the excess risk of SPCs among 1,442,374 persons aged 20-84 years who were diagnosed with first primary cancers from 1992-2010 and survived ≥5 years in the 12 Surveillance, Epidemiology, and End Results registries. We expressed the risks using excess absolute risk (EAR) per 10,000 person-years and standardized incidence ratio (SIR) by first primary cancer types and sex, compared to those expected in the general population. We also estimated percent contributions of each specific type of SPCs to the total EAR for all first primary cancers combined by sex. Results: The overall risk of SPCs was higher than expected for 24 of the 34 first primary types among male survivors and for 28 of the 35 first primary types among female survivors. The greatest SIR and EAR were estimated after laryngeal cancer in both men (SIR = 1.74, 95%CI = 1.67-1.82; EAR = 159.3, 95%CI = 143.6-175.5) and women (SIR = 2.48, 95% CI = 2.26-2.73; EAR = 202.7; 95%CI = 171.8-236). There were 290 type-specific associations with significantly higher risk of SPC, 36% of which being reciprocal, predominantly among smoking-associated, HPV-associated, and hematologic cancers. The SIRs in men ranged from 1.05 (95%CI = 1.00-1.10; EAR = 1.69) for lung/bronchus cancer after colorectal cancer to 73.9 (95%CI = 58.3-92.3; EAR = 23.3) for anal cancer after Kaposi sarcoma; and in women the SIRs ranged from 1.08 (95%CI = 1.02-1.15; EAR = 0.36) for pancreatic cancer after breast cancer to 19.9 (95%CI = 15.0-26.0; EAR = 39.5) for oral cavity/pharyngeal cancer after laryngeal cancer. For all first primary cancers combined, lung/bronchus cancer comprised the greatest proportion of the total EAR of SPCs, 34.6% in men and 29.1% in women, followed by urinary bladder (11.8%) and oral cavity/pharynx (7.5%) in men and by corpus uterus (12.9%) and colorectum (7.6%) in women. Conclusions: Despite the substantial heterogeneity in the risk of SPCs across the first primary types, only a few cancers comprised a considerable proportion of the total excess risk among survivors. Better understanding of contributing factors to these patterns will inform survivorship care plans and care delivery.
A phase II open-label multicenter study to assess the efficacy and safety of AFM13 in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma or transformed mycosis fungoides: The REDIRECT study design and rationale.
Authors: Cassandra Choe-Juliak, Karenza M. Alexis, Sylvia Schwarz, Linta Garcia, Ahmed Sawas
Journal: Journal of Clinical Oncology (2020)

TPS3148 Background: AFM13 is a tetravalent, bispecific (anti-CD30/anti-CD16A) recombinant antibody being developed for the treatment of CD30-positive T-cell malignancies and Hodgkin lymphoma. AFM13 selectively kills CD30-positive tumor cells by engaging and activating natural killer cells and macrophages. AFM13 was well tolerated at doses of 0.01 to 7 mg/kg and showed clinical activity in patients with relapsed/refractory (R/R) Hodgkin lymphoma in a Phase 1 study. In an ongoing biomarker Phase 1b/2a study in patients with R/R CD30-positive lymphomas with cutaneous involvement, 4 of 8 patients responded (at different doses) including one CR. Based on these findings, this Phase 2 study (REDIRECT) has been initiated. Methods: This is a Phase 2, open-label, multicenter global study investigating the efficacy and safety of AFM13 in patients with R/R CD30-positive peripheral T cell lymphoma (PTCL) or transformed mycosis fungoides (TMF). AFM13 is administered at 200 mg weekly via an intravenous infusion until disease progression, unacceptable toxicity, investigator discretion or withdrawal of consent. Cohorts A and B include PTCL patients with ≥10%, and ≥1% to &lt;10% CD30 expression by IHC, respectively. Cohort C includes patients with TMF who express ≥1% CD30. Eligible PTCL patients must have received at least 1 prior line of systemic therapy and, if diagnosed with systemic anaplastic large cell lymphoma, must have failed or be intolerant to brentuximab vedotin. Eligible patients with TMF must have received at least 1 prior line of systemic therapy and have exhausted systemic therapies with regular approval for their disease. This global trial started enrollment in Oct 2019. The primary endpoint is objective response rate as confirmed by an Independent Review Committee for all cohorts. The study will also assess investigator-measured efficacy parameters, safety, PK, immunogenicity and QOL. Disease assessment will be done at screening and every 8 weeks for the first 3 assessments, then every 12 weeks thereafter, regardless of any treatment/cycle delays that may occur. ClinicalTrials.gov identifier: NCT04101331. References: Reusch U et al. mAbs. 2014;6(3):728-739. Rothe A et al. Blood. 2015;125(26):4024-4031. Clinical trial information: NCT04101331 .
Pembrolizumab with trastuzumab and chemotherapy (PTC) in HER2-positive metastatic esophagogastric cancer (mEG): Plasma and tumor-based biomarker analysis.
Authors: Steven Brad Maron, Walid Khaled Chatila, Brittanie M Millang, Shalom Sabwa, Joanne F. Chou, Lilan Ling, Rebecca Nagy, Marc Simmons, Richard K. G. Do, Viktoriya Paroder, Hans Gerdes, Pari M. Shah, Geoffrey Yuyat Ku, David H. Ilson, Marinela Capanu, Jaclyn Frances Hechtman, Taha Merghoub, David B. Solit, Nikolaus Schultz, Yelena Yuriy Janjigian
Journal: Journal of Clinical Oncology (2020)

4559 Background: Pembrolizumab can be safely combined with trastuzumab and chemotherapy and has promising activity with median OS 27 months and 91% objective response rate in HER2-positive mEG cancer irrespective of PD-L1 status (NCT02954536; Janjigian ESMO 2019). Tumor biopsies and blood samples were collected in this phase II trial to identify molecular and immune predictors of response and resistance to PTC. Methods: Pre-treatment and post-progression biopsies were analyzed using WES and IHC (HER2, PD-L1). Peripheral blood was collected pre-treatment, every 9 weeks on-treatment and at progression for plasma ctDNA (Guardant 360, Guardant Health, Redwood, CA). Tumor-matched DNA alterations were identified by correlating ctDNA and solid tumor WES results. Landmark PFS analysis was used to compare ctDNA clearance status at 9 weeks post-treatment. Results: Baseline ctDNA was analysed from 31 of 37 patients of whom 84% (26/31) had tumor-matched ctDNA detected at baseline. Patients who cleared ctDNA at 9 weeks (n = 17/23) achieved a longer median PFS than those who did not - mPFS 12.3 months (95% CI 7.44-NA vs 3.9 months (95% CI 2.01-NA) (log-rank p = 0.02). On serial blood monitoring of 16 patients with eventual radiographic progression, ctDNA re-appearance preceded CT detection in 8 (50%) patients. WES was completed in 31 patients with pre-treatment, and 12 patients post-progression, including matched samples from 10 patients. Loss of HER2 over-expression/amplification was noted in 44% (7/16) of post-progression samples by IHC/FISH (2 IHC 0/1, 5 FISH-). In paired post-progression samples on WES, we observed loss of ERBB2 in 2 patients, and new amplifications of CCND1/3, FGF3/4/19, CDK6/12, KRAS, MYC, and MET, as well as mutations in KRAS, PIK3CD and PIK3RA. Plasma analysis at progression demonstrated copy number increases and/or new amplifications in MET, CKD6, PIK3CA, KRAS, FGFR2, EGFR and CCDN1 as well as KRAS, RB1, PTEN, NF1, NOTCH1, BRAF, and FGFR1 mutations. Conclusions: The majority of patients with previously untreated HER2 positive mEG have detectable plasma ctDNA at baseline. The re-appearance of ctDNA during therapy may serve as an early predictor of progression and help identify genetic drivers of acquired resistance. Loss of ERBB2 over-expression/amplification and activating MAPK alterations occur at PTC progression. Evaluation of tumor immune environment by multiplex IHC and additional ctDNA analysis is underway.
Non-pneumonitis immune-mediated adverse events (imAEs) with durvalumab in patients with unresectable stage III NSCLC (PACIFIC).
Authors: Jarushka Naidoo, Johan F. Vansteenkiste, Corinne Faivre-Finn, Mustafa Özgüroğlu, Shuji Murakami, Rina Hui, Xavier Quantin, Helen Broadhurst, Michael Newton, Phillip A. Dennis, Scott Joseph Antonia
Journal: Journal of Clinical Oncology (2020)

9048 Background: The phase 3 PACIFIC trial established durvalumab (durva) after chemoradiotherapy (CRT) as SoC for pts with unresectable stage III NSCLC. We report exploratory analyses to characterize non-pneumonitis (np) imAEs that occurred with durva in PACIFIC. Methods: PACIFIC was a double blind trial of pts without disease progression after platinum-based concurrent CRT (≥2 cycles). Pts were randomized 2:1 to receive durva 10 mg/kg or placebo (pbo) IV q2w for ≤12 months, stratified by age, sex and smoking history. We characterized the time to onset, duration, and management/outcomes of np imAEs and their association with (1) baseline pt/disease factors and (2) AEs (excluding all-cause pneumonitis). Results: Of 709 treated pts, 19% and 11% experienced imAEs and np imAEs of any grade, respectively; proportionally more had np imAEs with durva (71/475; 15%) vs pbo (5/234; 2%). Thyroid disorders (54/475; 11%), rash/dermatitis (9/475; 2%), and diarrhea/colitis (5/475; 1%) were the most common np imAEs with durva; rash/dermatitis had the shortest time to onset (Table). Among durva treated pts with np imAEs, 11% had grade 3/4 np imAEs, 41% had np imAEs that resolved, and none had fatal np imAEs; interventions included endocrine replacement therapy (73%), systemic corticosteroids (34%), high dose corticosteroids (16%), and discontinuation (10%). There were no apparent differences in baseline factors between pts with or without np imAEs. Durva had a broadly manageable safety profile irrespective of the occurrence of np imAEs. However, a higher proportion of durva treated pts with vs without np imAEs experienced all-cause, grade 3/4 events (41% vs 29%); none were fatal (excl. pneumonitis). Conclusions: Np imAEs occurred infrequently in PACIFIC, but were more common with durva vs pbo; thyroid disorders and rash/dermatitis were the most common np imAEs. Of durva treated pts with np imAEs, 11% experienced np imAEs of grade 3/4. Overall, np imAEs were broadly manageable and did not lead to high rates of discontinuation, and no association with baseline factors was seen, suggesting this should not deter use of durva in eligible pts. Clinical trial information: NCT02125461. [Table: see text]
北京市牛街社区60岁以上居民脑卒中流行病学调查
Authors: 胡海鹰
Journal: BMJ (2005)

为了研究脑卒中在北京市60岁以上人群中的分布规律,探讨该病发生的危险因素,并为制定脑卒中的一、二、三级预防措施提供可靠依据,对北京市牛街社区60岁以上居民脑卒中进行了流行病学调查,并对其分布规律和危险因素进行了分析和探讨。
外科治疗尿道旁腺囊肿36例
Authors: 陆敬义, 刘永江, 刘芳
Journal: BMJ (2006)

尿道旁腺分布于女性尿道口后壁的两旁,一旦感染常成为反复尿路感染的隐灶.如果腺体排出口阻塞,则可形成尿道旁腺囊肿或脓肿.我们于1991年7月至2004年10月共收治36例,均经手术治疗取得良好效果。
Performance of a prognostic 31-gene expression profile test in patients with node-negative cutaneous melanoma.
Authors: Pedram Gerami, Kyle R. Covington, Olga Zolochevska, Ann P. Quick, Robert W. Cook, Jeffrey D. Wayne
Journal: Journal of Clinical Oncology (2020)

e22071 Background: The National Comprehensive Cancer Network guidelines recommend considering sentinel lymph node biopsy (SLNB) for cutaneous melanoma (CM) patients with a 5-10% risk of SLN positivity and offering it to those with &gt; 10% risk. However, SLNB limitations include identification of only 1/3 of patients who end up with distant metastasis and a regional metastasis false negative rate ranging from 5-21% indicating a need to detect the risk of metastasis in patients with a negative SLNB. The 31 gene expression profile (31GEP) test uses the molecular biology of the primary tumor to predict 5-year recurrence-free (RFS), distant metastasis-free (DMFS), melanoma-specific (MSS), and overall survival (OS). Therefore, the objective of this study is to determine whether the 31GEP can stratify risk for patients with SLN-negative results to help guide CM management. Methods: 607 primary CM tumors were collected from patients with SLN-negative status who were enrolled in multi-center IRB-approved studies. Tumors were staged according to the AJCC 8 th edition and analyzed by 31GEP testing to differentiate low-risk (Class 1A), intermediate-risk (Class 1B/2A), and high-risk (Class 2B) tumor biology. Clinical data were recorded and Kaplan-Meier (KM) and Cox regression analyses were performed to assess the relationship between 31GEP class and patient outcomes including RFS, DMFS, MSS, and OS. Results: KM analysis for 5yr RFS, DMFS, MSS, and OS stratified by 31GEP class are listed in Table. Multivariate Cox regression analysis demonstrated that the 31GEP Class 2B status was an independent predictor of RFS, DMFS, MSS, and OS with hazard ratios of 4.4 (95% CI, 2.7-7.2; p &lt; 0.001), 4.4 (95% CI, 2.3-8.5; p &lt; 0.001), 15.6 (95% CI, 3.4-71.2; p &lt; 0.001), and 5.4 (95% CI, 2.6-10.9; p &lt; 0.001), respectively. Conclusions: The results indicate that the 31GEP can stratify risk for a subset of patients with SLNB-negative results with the highest 5-year survival rates being associated with a Class 1A result. Moreover, GEP Class 2B is a significant independent predictor of metastatic risk in patients who are node negative. [Table: see text]
腹股沟绞窄疝并肠坏死I期手术治疗30例
Authors: 赵勇, 蔡方
Journal: BMJ (2005)

腹股沟绞窄疝并肠坏死的传统治疗观点为切除坏死肠管,Ⅱ期疝修补术,近年来有行Ⅰ期疝修补术成功的报道[1].我院自1990年2月至2004年2月行腹股沟绞窄疝并肠坏死Ⅰ期疝修补术30例,现报告如下。
Covid-19 related hospital admissions in the United States: needs and outcomes
Authors: George L Anesi, Scott D Halpern, M Kit Delgado
Journal: BMJ (2020)

Cohort studies and case series of patients with coronavirus disease 2019 (covid-19) have spread almost as quickly as the virus, 1-5 with inadequate methodological quality sometimes hampering thoughtful interpretation.For example, one New York cohort study initially reported a mortality of 88% for patients requiring mechanical ventilation before readers' responses led to a correction clarifying that the rate was 25% and would grow to an uncertain extent because 72% of patients were still in hospital. 4In contrast, the two linked cohort studies from the United States provide rigorous outcome ascertainment and adjustment for case mix. 6 7By delaying publication until most enrolled patients had confirmed outcomes and by using modern survival analysis methods these authors have greatly enhanced our understanding of the epidemiology of covid-19.
Correlation of hormonal receptor level and survival outcome in HER2-positive nonmetastatic breast cancer.
Authors: Mengdi Chen, Jiayi Wu, Li Zhu
Journal: Journal of Clinical Oncology (2020)

e12568 Background: In human epidermal growth factor 2 (HER2)-positive breast cancer, emerging evidences imply that clinical behavior and prognosis differ according to hormone receptor (HR) status. However, there is no conclusion about the relevance between estrogen receptor (ER) or progesterone receptor (PR) expression and clinical outcome of HER2-positive breast cancer. Our study is designed to determine the effect of different ER/PR levels on survival benefit of HER2-positive early breast cancer. Methods: 984 non-metastatic HER2-positive breast cancer patients between January 2009 and December 2016 were retrospectively reviewed and HR+/HER2+ patients were further classified into several subgroups based on ER expression level (Low/L: 1-9%; Median/M: 10-74%; High/H: 75-100%) and PR expression level (Low/L: 0-19%; High/H: 20%-100%). Clinical features and survival outcomes were evaluated. Results: A total of 461 HR+/HER2+ and 523 HR-/HER2+ breast cancer patients were included in our study and 69.8% of them received target therapy (HR+ 67.5%, HR- 71.9%). While HR+/HER2+ breast cancer showed better survival than HR-/HER2+ subtype in 5-year disease free survival (DFS, 92.6% vs 87.6%, p = 0.002), no significant difference was observed between 5-year DFS rates in ER+/PR+ and ER+/PR- subgroup (94.3% vs 89.7%, p = 0.150). However, a possible correlation was found between ER/PR levels and DFS both in HR+/HER2+ (p = 0.057) and all HER2+ (p &lt; 0.001) breast cancer. In HR+/HER2+ breast cancer, all subgroups showed DFS improvement trend versus M-ER/L-PR patients and hazard ratio of H-ER/H-PR subtype had a statistical difference (0.36, 95%CI 0.13-0.99, p = 0.047). In all HER2+ patients, hazard ratio of H-ER/H-PR compared with HR- subtype was 0.32 (95% CI, 0.13-0.80, p = 0.015). M-ER/L-PR presented similar DFS outcome with HR- subtype in our study. Conclusions: ER/PR expression may become a predictor of survival benefit in HER2-positive non-metastatic breast cancer and a higher ER/PR expression level might be associated with better DFS.