tbuckley/cabot-search huggingface dataset:
Effect of informational charts on patient understanding of nontherapeutic research procedures in phase I trials.
Authors: Gavin Paul Campbell, Eli Rowe Abernethy, John W. Cook, Minisha Lohani, Colleen Margaret Lewis, Jeffrey M. Switchenko, Margie D Dixon, Donald Harvey, Rebecca D. Pentz
Journal: Journal of Clinical Oncology (2020)

e24193 Background: It is difficult for patients to distinguish non-therapeutic from therapeutic procedures in research. In phase I trials, day 1 pretreatment biological samples are used for research and care; posttreatment samples are for research purposes only. Preliminary data suggested patients did not understand this difference. Our study tested to see if a simple information chart would improve understanding of the nontherapeutic research procedure. Methods: A sequential two arm study was conducted. Controls (C) were asked whether samples taken at different times on day 1 of the trial were to be used for their care, for research only, or for both. The experimental (E) group provided patients with a study-specific information chart labeling the purpose of required samples and patients were then asked the same questions. Results: 100 patients (50 each C and E) were interviewed after consenting to a trial. Patients were mostly white (63%), male (53%), with an annual income &gt; $60,000 (51%); 49% had a college degree. In both arms, understanding that pretreatment samples were for patient care and research was moderate (50% C; 62% E). Understanding that posttreatment samples were for research was significantly higher in the experimental arm (16% C; 44% E p = 0.002). Conclusions: Questions regarding the purpose of biological samples taken pre-administration of study drug were less susceptible to therapeutic misconception due to the “both” option being true. Since the provision of an informational chart significantly improved understanding of the purpose of the posttreatment sample, we suggest that providing such a chart may help alleviate this type of therapeutic misconception. [Table: see text]
Application of OSTE in teaching competence assessment for general practice preceptors in community training bases
Authors: Jie Gu, Xiaoqing Gu, Meijuan Yuan, Haiying Chen, Xingqian Xie, Shanzhu Zhu, Jian Zou, Jian Gong, Yao Liu, Juan Shou
Journal: BMJ (2019)

Objective
To apply objective structured teaching evaluation (OSTE) in teaching competence assessment for general practice preceptors in community training bases.


Methods
The teaching competency was assessed with OSTE for 28 general practice preceptors in Fengxian District of Shanghai in December 2017. The application of OSTE was evaluated with questionnaire among preceptors, examiners and standardized students(SS).


Results
Among 28 preceptors there were 23 females (82.1%), with an average age of (37.3±4.2) years. The average teaching duration was (2.8±2.1) years. In the five OSTE station, the highest total score was (88.1±2.7) points in the first station self-presentation, while the lowest was (70.8±14.5) points of the second part physical examination feedback of the third station ambulatory care teaching. The total score in the fifth station (doctor-patient communication teaching) of participants with<15 years of community practice was higher than those ≥15 years of community practice [(80.1±8.5) vs.(71.6±7.1), t=2.092, P=0.007]. Exceptbeing able to adapt to this form of evaluation, the proportions of choosing very good were all more than 50% in other 4 aspects. The overall willingness of recommending OSTE as the main method to evaluate the teaching competence of GP trainers was higher in examiners and SS than that inpreceptors (Z=2.836, P=0.005).


Conclusion
The innovative approach of OSTE has been widely recognized, but the professional capability, the cognition of general practice, the teaching competence and the willingness to use OSTE need to be strengthened for general practice receptors in community bases.


Key words: 
General practice; Objective structured teaching evaluation; Basic practice trainer; Teaching competence
Association Between Opioid Prescriptions and Non–US-Born Status in the US
Authors: Fernando A. Wilson, Kavita Mosalpuria, Jim P. Stimpson
Journal: JAMA Network Open (2020)

Overdose from opioids causes nearly 50 000 deaths in the US each year. Adverse consequences from opioid use are particularly pronounced among low-income and publicly insured individuals. However, little is known about patterns of opioid prescribing among non-US-born individuals in the US.To examine the association of opioid prescriptions with non-US-born status, particularly among patients clinically diagnosed with pain.This cross-sectional analysis assessed opioid prescriptions among US-born and non-US-born adults using the 2016-2017 Medical Expenditure Panel Survey. Data were analyzed from January 1, 2016, to December 31, 2017.Practitioner-verified binary variable for any opioid prescription, number of prescriptions received, and a count variable for number of days of prescribed medicine. Multivariable logistic and negative binomial regression adjusted for sex, age, race/ethnicity, marital status, educational level, poverty, insurance status, clinical diagnoses for acute or chronic pain, census region, and survey year.Among all 48 162 respondents (mean [SD] age, 47.0 [18.1] years; 25 831 [53.6%] female), 14.2% of US-born and 7.0% of non-US-born individuals received at least 1 opioid prescription within a 12-month period. For those diagnosed with chronic pain, 25.5% of US-born individuals and 15.6% of non-US-born individuals received at least 1 opioid prescription within a 12-month period. In multivariable logistic regression, non-US-born individuals had 35% lower odds of receiving an opioid prescription than US-born individuals (adjusted odds ratio, 0.65; 95% CI, 0.56-0.74). In negative binomial regression adjusting for confounding factors, non-US-born individuals with chronic pain who were prescribed opioids received significantly fewer days' supply (50.0; 95% CI, 40.0-59.9) than US-born individuals (77.2; 95% CI, 72.7-81.6). Differences between US-born and non-US-born individuals were not statistically significant for patients with acute pain (16.7% [95% CI, 14.9%-18.4%] of US-born individuals received opioids vs 12.5% [95% CI, 9.3%-15.6%] of non-US-born individuals). Non-US-born individuals with less than 5 years of residency in the US were significantly less likely to receive a prescription for opioids than were those with longer residency after adjustment for type of pain and other confounding factors (adjusted odds ratio, 0.51; 95% CI, 0.30-0.88).The findings suggest that non-US-born individuals, particularly those with shorter US residency, are less likely to be prescribed opioids than US-born individuals.
开展社区妇幼保健咨询社会需求的调查分析
Authors: 刘学伟, 赵学英, 管燕, 高国花, 张辉
Journal: BMJ (2005)

采用发放问卷的方式调查520名妇女对社区妇幼保健咨询的社会需求,回收有效问卷512份.结果显示,446例(87.1%)调查对象认为应该在社区卫生服务机构开展妇幼保健咨询;不同年龄段妇女对咨询内容的需求各不同;大多数妇女希望获得准确性高、专业性强、解答充分的社区妇幼保健咨询。
Thyroid dysfunction in lung cancer patients treated with immune checkpoint inhibitors (ICI): Role of race, gender, and concurrent chemotherapy in a multiethnic urban cohort.
Authors: Angelica D'Aiello, Rasim A. Gucalp, Vafa Tabatabaie, Haiying Cheng, Noah A. Bloomgarden, Balazs Halmos
Journal: Journal of Clinical Oncology (2020)

e21622 Background: Immune-related adverse events (irAE) associated with ICI have been reported, but remain poorly understood. We sought to characterize patterns of thyroid dysfunction—one of the most common irAE—in a large cohort of ethnically-diverse lung cancer patients treated with ICI. Methods: A retrospective chart review of lung cancer patients receiving an anti-PD1 or PD-L1 agent from January 2016 to July 2019 was performed. Subjects included had normal baseline thyroid function. Thyrotoxicosis and hypothyroidism was defined as thyroid-stimulating hormone level less than 0.4 and greater than 4.6, respectively. Time to event analysis with inverted Kaplan Meier curves and log-rank tests were used to compare thyroid dysfunction among race, gender, and treatment subgroups. Results: We identified 256 subjects: 206 had normal baseline thyroid function and 76 went on to develop thyroid dysfunction. Rates of thyroid dysfunction by one year occurred at similar frequencies among all races. Thyrotoxicosis occurred at significantly higher rates in Black (25, 31.7%) than in White (8, 12.9%) and Hispanic (7, 16.7%) subjects. In contrast, hypothyroidism occurred more often in White (13, 21.0%) and Hispanic (18, 42.9%) than in Black (12, 15.2%) subjects. Gender and concurrent chemotherapy showed no significant association with thyroid dysfunction. Of subjects with thyrotoxicosis (N = 42), hypothyroidism followed in 33.3% (N = 14) with 1 subject receiving methimazole and 13 levothyroxine. In those subjects, median time to thyrotoxicosis and hypothyroidism was 4.0 and 7.2 weeks, respectively. Conclusions: Despite the higher prevalence of non-ICI-related thyroid disease among females and the anticipated immunosuppressive effect of chemotherapy, neither gender nor chemotherapy correlated with thyroid dysfunction; however, race did. Black subjects exhibited significantly higher rates of thyrotoxicosis. Our findings are consistent with prior research showing that thyrotoxicosis, including Graves’ disease, occurs more often in Blacks. While the pathogenesis of ICI-related thyroid dysfunction is unclear, the early onset of thyrotoxicosis demonstrated by our study calls for careful monitoring, especially for particular races. [Table: see text]
Metastasis free survival in older men with nonmetastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: An FDA-pooled analysis.
Authors: Harpreet Singh, Lijun Zhang, Anup Amatya, Yutao Gong, Daniel L. Suzman, Chana Weinstock, Elaine Chang, Mitchell Steven Anscher, Dow-Chung Chi, James Xu, Jamie Renee Brewer, Sundeep Agrawal, Michael Holman Brave, Mehrnoosh Hadadi, Marc Robert Theoret, Paul Gustav Kluetz, Amna Ibrahim, Richard Pazdur, Julia A. Beaver
Journal: Journal of Clinical Oncology (2020)

12038 Background: The FDA has approved three androgen receptor (AR) inhibitors for nonmetastatic castration-resistant prostate cancer (nmCRPC) based on improvements in metastasis-free survival (MFS). MFS is an earlier endpoint, defined as the time from randomization to either imaging-detectable distant disease or death. This pooled analysis examines MFS, time to initiation of cytotoxic chemotherapy (TTCyto), and safety outcomes in men over 80 treated with AR inhibitors. Methods: Data was pooled from three randomized controlled studies (n=4117) of AR inhibitors for nmCRPC. The treatment effect of AR inhibitors on MFS and TTCyto across age groups was evaluated using Kaplan-Meier estimates and a Cox proportional hazards regression model. Hazard Ratios for MFS and TTCyto were adjusted for baseline ECOG, total Gleason score, PSA doubling time, and prior bone-targeting therapy. Results: For patients age 80 years or older (n=675) who were treated with AR inhibitors, the hazard ratio was 0.38 (95% CI 0.29, 0.49) with an estimated median MFS of 40 months (95% CI 36, 41) versus 22 months (95% CI 18, 29) for those treated with placebo (n=348). For patients &lt;80 (n=2019) treated with AR inhibitors, the HR was 0.31 (95% CI 0.27, 0.36) with an estimated median MFS of 41 months (95% CI 36, NR) versus 16 months (95% CI 15, 18) for those treated with placebo (n=1075). Patients over 80 also derived similar improvements in time to initiation of cytotoxic chemotherapy (HR 0.43 95% CI 0.23, 0.82), compared to their younger counterparts (HR 0.41 95% CI 0.33, 0.50). See Table for selected safety outcomes. Conclusions: In an exploratory subgroup analysis, older men (≥80) with nmCRPC derived similar benefit in MFS and time to initiation of cytotoxic chemotherapy with AR inhibitors compared with younger patients. Men age 80 and above experienced higher rates of Grade 3-4 adverse events, serious adverse events, falls, and fractures. This trend towards increased toxicity was observed regardless of treatment arm. Analysis of patient reported outcomes is ongoing. [Table: see text]
Predictive value of changes in plasma vascular endothelial growth factor at eight weeks after lenvatinib administration in patients with unresectable hepatocellular carcinoma.
Authors: Kaoru Tsuchiya, Masayuki Kurosaki, Shun Kaneko, Yutaka Yasui, Sakura Kirino, Shuhei Sekiguchi, Kento Inada, Koji Yamashita, Yuka Hayakawa, Mayu Higuchi, Kenta Takaura, Chiaki Maeyashiki, Nobuharu Tamaki, Hiroyuki Nakanishi, Jun Itakura, Namiki Izumi
Journal: Journal of Clinical Oncology (2020)

4594 Background: Lenvatinib (LEN) has been used in patients with unresectable hepatocellular carcinoma (u-HCC) and there is no established predictive biomarker. Previously it was reported that a plasma vascular endothelial growth factor (VEGF) concentration decrease at 8 weeks after starting sorafenib might predict favorable overall survival (OS) in patients with u-HCC (Tsuchiya, et al. Cancer, 2013). We aimed to investigate the value of changes in plasma VEGF at 8 weeks after LEN administration in patients with u-HCC. Methods: Forty-six patients with u-HCC who received LEN between April 2018 and August 2019 at our institution were enrolled. Plasma concentrations of VEGF and serum α-fetoprotein (AFP) levels were measured at baseline, 4 and 8 weeks after administration of LEN. A VEGF decrease was defined as &gt; 5% decrease during 8 weeks after the beginning of LEN therapy. AFP response was defined as &gt; 20% decrease during 8 weeks according to the previous reports. Results: Median overall survival (OS) was not reached and progression-free survival (PFS) was 5.9 months. Median observation period and treatment duration were 10.1 and 6.3 months. The objective response rate and disease control rate by mRECIST criteria were 43.5% and 82.6%. Median PFS in patients who had a VEGF decrease at week 8 (n = 29) was significantly longer than those who did not have a VEGF decrease (n = 17; 7.1 months vs 5.0 months; p = 0.014). AFP response was not associated with PFS. There were no significant differences in baseline VEGF, AFP, ALBI score, and extrahepatic metastasis between the patients with and without a VEGF decrease. A VEGF decrease was significantly associated with radiological objective response (p = 0.001) and 18 of 20 patients who achieved CR (n = 3) or PR (n = 17) had a VEGF response in LEN therapy. Conclusions: A decrease of plasma VEGF level at 8 weeks in patients with u-HCC on LEN was significantly associated with PFS. Changes in plasma VEGF could become a new biomarker for molecular targeted therapies including VEGF inhibitors in patients with unresectable HCC.
Abstract P150: Dietary Patterns and Fractures in Postmenopausal Women: Results From the Women’s Health Initiative Observational Study
Authors: Bernhard Haring
Journal: Circulation (2016)

Objective: To determine whether adherence to dietary patterns assessed by the alternative Mediterranean diet score (aMED), the Healthy Eating Index (HEI) 2010, the Alternate Healthy Eating Index (AHEI) 2010 or the Dietary Approach to Stop Hypertension (DASH) diet score is associated with hip or total fractures in postmenopausal women. Methods: The Women’s Health Initiative Observational Study (WHI-OS) prospectively followed 90,014 postmenopausal women. Food frequency questionnaires were used to assess adherence to established healthy eating patterns at baseline. Incident total and hip fractures were queried annually. We excluded toe, finger, sternum and clavicle fractures as total fracture events since these fractures are less likely related to osteoporosis. Associations of first incident fractures with dietary patterns were estimated using covariate-adjusted Cox proportional hazards models. Results: During a median follow-up of 15.9 years, we documented 2,121 hip fractures and 28,718 self-reported total fractures. In multivariable analyses, adhering to aMED was associated with a lower risk for hip fractures (HR Q5 = 0.80, 95% CI, 0.66, 0.97; p trend = 0.02) but not for total fractures (HR Q5 = 1.01, 95% CI, 0.95, 1.07; p trend = 0.77). Greater adherence to HEI-2010 or DASH was inversely related to hip fracture risk (p trend = 0.02 and 0.03, respectively) but not to total fracture risk (p trend = 0.15 and 0.47, respectively). The AHEI-2010 was not associated with total or hip fractures. Conclusions: Higher aMED, HEI-2010 or DASH dietary scoring was associated with lower risk for hip fractures. These results support that following a healthy dietary pattern is one cornerstone to maintain bone health in postmenopausal women. Table. Hazard Ratios (95% CI) for hip fractures and total fractures by quintiles of dietary pattern in the Women’s Health Initiative Observational Study 1 *Model 1 adjusted for age, race/ethnicity and body mass index. ** Model 2 model adjusted for age, race/ethnicity, body mass index, smoking status, physical activity, self-reported health, diabetes status, history of fracture at age ≥ 55, physical function score, number of chronic medical conditions, number of psychoactive medications and use of HT, bisphosphonates, calcitonin and SERM. 1 AHEI-2010, Alternative Healthy Eating Index[[Unable to Display Character: &amp;#8211;]]2010; aMED, alternate Mediterranean Diet; DASH, Dietary Approaches to Stop Hypertension; HEI-2010, Healthy Eating Index[[Unable to Display Character: &amp;#8211;]]2010; MCI, Mild Cognitive Impairment; PD, Probable Dementia. Quintile 1 (Q1) represents the least healthy quintile, whereas quintile 5 (Q5) represents the healthiest quintile.
Advance on pulmonary arterial hypertension in connective tissue disease with traditional Chinese and modern western medicine
Authors: 宣磊, 董振华
Journal: BMJ (2009)

结缔组织病(connective tissue disease,CTD)是一类免疫介导的炎症性疾病,临床上常呈系统性多脏器累及.肺动脉高压(pulmonary arterial hypertension,PAH)是CTD常见的系统损害之一,严重影响患者的生存质量,日益受到医学界的重视;现概述近年来CTD并发PAH的中西医研究进展。
DREAMM-2: Single-agent belantamab mafodotin (GSK2857916) in patients with relapsed/refractory multiple myeloma (RRMM) and renal impairment.
Authors: Hans Chulhee Lee, Adam D. Cohen, Ajai Chari, Malin Hultcrantz, Ajay K. Nooka, Natalie Scott Callander, Attaya Suvannasankha, Ashraf Badros, Edward N. Libby, Suzanne Trudel, Paul G. Richardson, Douglas Weston Sborov, Paula Rodríguez Otero, Sagar Lonial, Eric Zhi, Eric Lewis, Ira Gupta, Joanna Opalinska
Journal: Journal of Clinical Oncology (2020)

8519 Background: Renal impairment, a frequent complication and poor prognostic factor in RRMM, often leads to poor tolerability of standard regimens. We report outcomes in patients with renal impairment receiving single-agent belantamab mafodotin (2.5 or 3.4 mg/kg; B-cell maturation antigen targeting immunoconjugate not renally metabolized) from the DREAMM-2 post-hoc analysis (NCT03525678). Methods: Eligible patients with RRMM had no active renal conditions and adequate renal function (based on albumin/creatinine ratio [&lt;500 mg/g] and eGFR [mL/min/1.73 m 2 ]: normal [≥90], mild impairment [mild, ≥60≤90], moderate impairment [mod, ≥30≤60]). Results: Overall response rates (95% CI) in patients with mild/mod impairment (2.5 mg/kg: 32% [21.4–44.0]; 3.4 mg/kg: 36% [25.6–48.5]) were similar to those in the overall population ( Lancet Oncol.2020). The median duration of response (DoR) was not reached (NR) in 2.5 mg/kg mild/mod subgroup (95% CI estimate: 4.2 months–NR); median DoR was 7.5 months (4.9–NR) in 3.4 mg/kg mild/mod subgroup. Rates of keratopathy and albuminuria were similar regardless of renal function; rates of anemia, pyrexia, and thrombocytopenia were more frequent in patients with impaired renal function (Table). eGFR did not change or changed to normal in most patients. Conclusions: Following treatment with single-agent belantamab mafodotin, patients with mild/mod renal impairment achieved a similar efficacy and safety profile as patients with normal renal function. Funding: GlaxoSmithKline (205678). Drug linker technology licensed from Seattle Genetics; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa. Clinical trial information: NCT03525678 . [Table: see text]
Comparison of clinical characteristics of severe hyperlipidemic pancreatitis and severe acute gallstone pancreatitis
Authors: Lei Yang, Chao Zhang, Dachuan Liu, Jianguo Jia
Journal: BMJ (2017)

Objective
To compare the clinical characteristics and the outcomes of severe hyperlipidemic pancreatitis (SHLP) and severe acute gallstone pancreatitis (SAGP).


Methods
The clinical data of 22 patients with SHLP and 91 patients with SAGP admitted from January 2009 to December 2015 were retrospectively reviewed. The clinical manifestations, laboratory tests, organ dysfunction, medical treatment, complications and outcomes in 30 d after admission were analyzed and compared between two groups of patients.


Results
There were 16 males and 6 females with a mean age of (60.5±9.1) years in SHLP group; while 32 males and 59 females with a mean age of (54.3±5.4) years in SAGP group. The blood and urine amylase levels in SHLP group were significantly lower than those in SAGP group [(715±99) U/L vs. (1 551±107) U/L, t=4.65, P=0.00; (382±56) U/L vs. (773±66) U/L, t=4.52, P=0.00, respectively]. The incidence of circulation insufficiency, respiratory insufficiency, renal dysfunction, and long-term pulmonary infection in SHAP patients was significantly higher than that in SAGP patients [36%(8/22) vs.14%(13/91), χ2=5.22, P=0.01; 41%(9/22) vs.7%(6/91), χ2=9.46, P=0.01; 23%(51/22) vs.5%(5/91), χ2=4.20, P=0.03; 55%(12/22) vs. 32% (29/91), χ2=7.02, P=0.01]. Two cases died in the SHLP group and 9 cases died in SAGP group due to critical infection, cardiac events and bleeding.


Conclusion
Compared to SAGP patients, the blood and urine amylase levels are usually not remarkably high in SHLP patients, and the prevention and management of multi-organ failure and lung infection are more important for SHLP patients.


Key words: 
Pancreatitis; Hyperlipidemias; Gallstones; alpha-Amylases