tbuckley/cabot-search huggingface dataset:
Effects of a Workplace Wellness Program on Employee Health, Health Beliefs, and Medical Use
Authors: Julian Reif, David Chan, Damon Jones, Laura Payne, David Molitor
Journal: JAMA Internal Medicine (2020)

Many employers use workplace wellness programs to improve employee health and reduce medical costs, but randomized evaluations of their efficacy are rare.To evaluate the effect of a comprehensive workplace wellness program on employee health, health beliefs, and medical use after 12 and 24 months.This randomized clinical trial of 4834 employees of the University of Illinois at Urbana-Champaign was conducted from August 9, 2016, to April 26, 2018. Members of the treatment group (n = 3300) received incentives to participate in the workplace wellness program. Members of the control group (n = 1534) did not participate in the wellness program. Statistical analysis was performed on April 9, 2020.The 2-year workplace wellness program included financial incentives and paid time off for annual on-site biometric screenings, annual health risk assessments, and ongoing wellness activities (eg, physical activity, smoking cessation, and disease management).Measures taken at 12 and 24 months included clinician-collected biometrics (16 outcomes), administrative claims related to medical diagnoses (diabetes, hypertension, and hyperlipidemia) and medical use (office visits, inpatient visits, and emergency department visits), and self-reported health behaviors and health beliefs (14 outcomes).Among the 4834 participants (2770 women; mean [SD] age, 43.9 [11.3] years), no significant effects of the program on biometrics, medical diagnoses, or medical use were seen after 12 or 24 months. A significantly higher proportion of employees in the treatment group than in the control group reported having a primary care physician after 24 months (1106 of 1200 [92.2%] vs 477 of 554 [86.1%]; adjusted P = .002). The intervention significantly improved a set of employee health beliefs on average: participant beliefs about their chance of having a body mass index greater than 30, high cholesterol, high blood pressure, and impaired glucose level jointly decreased by 0.07 SDs (95% CI, -0.12 to -0.01 SDs; P = .02); however, effects on individual belief measures were not significant.This randomized clinical trial showed that a comprehensive workplace wellness program had no significant effects on measured physical health outcomes, rates of medical diagnoses, or the use of health care services after 24 months, but it increased the proportion of employees reporting that they have a primary care physician and improved employee beliefs about their own health.American Economic Association Randomized Controlled Trial Registry number: AEARCTR-0001368.
Patients' perceptions of nutrition care provided by general practitioners: focus on Type 2 diabetes
Authors: 陈丽英
Journal: BMJ (2013)

背景
在澳大利亚，慢性疾病通常是由全科医生来管理的。基于生活方式对慢性疾病预后的重要影响，全科医师会对患者进行营养学方面的指导以帮助他们改进自身的饮食习惯。那些对自身健康持积极态度的患者更容易听从医学专业人士的建议而改变他们的生活方式。患者对待全科医生的营养干预指导是否也有这种现象不得而知。2型糖尿病患者的管理可作为相关案例，用以调查患者对于澳大利亚全科医生提供的营养干预管理的认识。


目的
旨在调查2型糖尿病患者对他们从全科医生那里获得的关于糖尿病营养管理指导的认识。


方法
939例2型糖尿病患者完成了一份包含54个项目的在线调查，这些调查项目反映了人口统计信息、健康相关属性、营养管理预期的理想状态以及对既往营养干预指导的反馈。


结果
84%的被调查者认为由全科医生提供的理想的2型糖尿病管理应包含营养干预指导的内容，然而，仅有43%的被调查者曾从全科医生那里获得过相关指导。超过91%的被调查者对全科医生提供营养保健指导的做法表示满意，但仅有34%的被调查者认为此种营养宣教最终有效改进了他们的饮食行为习惯。


结论
尽管患者对全科医生提供的营养干预指导整体满意度较高，但患者并没有从全科医生那里获得符合预期的足够充分的营养指导，另外，患者高度关注营养指导的有效性。
茄病镰刀菌致角膜炎一例
Authors: 潘韶霞, 杨进, 郑文, 王胜江, 吴开庆, 唐文静, 王新蕾
Journal: BMJ (2009)

2008年6月,本中心微生物实验室由一患者左眼分泌物培养标本中,分离出1株茄病镰刀菌. 患者男,64岁.因左眼畏光流泪,视力下降7 d入院.无外伤史.采用标准对数视力表测视力,右眼1.2,左眼0.02,眼压正常,左眼混合性充血(+++),左角膜直径4 mm,灰白色混浊,边缘不规则,界较清楚,混浊区略高于角膜,不易拭去混浊物,前房无积脓,瞳孔2 mm,光反射消失。
Access to new therapies: FDA accelerated approvals and the corresponding Canadian regulatory and funding decisions.
Authors: Howard John Lim, Melissa Hunt, Julia A. Beaver, Paul Gustav Kluetz, Christopher Gravel, Andrew Raven, Dean Regier, Cheryl Ho
Journal: Journal of Clinical Oncology (2020)

e19066 Background: Accelerated approval (AA) by the FDA enables earlier access to promising new therapies while evidence generation is ongoing. Health Canada (HC) has a similar process with a Notice of Compliance conditional (NOCc) before full approval (NOC). Canada implemented health technology assessment (HTA) for determination of funding through the pan Canadian Oncology Drug Review (pCODR) in 2011. This study evaluated timelines and decisions from AA approval to HC NOC/c to HTA approval and formulary listing. Methods: FDA AA malignant hematology and oncology approvals from Jan 1 2000-Dec 31 2019 were reviewed. HC decisions were reviewed to determine submission/approval status and dates of NOC/c. pCODR decisions were reviewed to determine submission/approval status and dates of decision. First date of provincial formulary listing was collected. Results: In the 20 year time frame, there were 97 AA by the FDA. Current FDA status: 48 full approval, 44 pending verification and 5 withdrawn. Of the 92 AA that remain approved, HC status: 44 received NOC, 24 NOCc, 24 were not submitted for review, 2 currently under review. Of the 5 AA that were withdrawn; 3 were submitted to HC and received NOC/c and all were subsequently withdrawn. From 2011, 31 of 45 HC approved indications were reviewed at pCODR: 17 received a positive recommendation conditional on cost-effectiveness, 9 not recommended, 3 withdrawn by company, 2 pending final decision. Of the 10 not recommended/withdrawn, 6 were subsequently re-submitted and approved. Time from AA to NOC/c was 9.4 m, time from NOC/c to pCODR decision 15.0 m and time from pCODR decision to first formulary listing 18.4 m. Conclusions: Despite significant timeline differences between AA and HC NOC/c all indications that received AA submitted to Canada were granted regulatory approval. Since 2011, 74% of HC approved therapies submitted to pCODR were recommended and added to formularies. Collaboration between FDA and HC, independent regulatory agencies, through innovative programs such as FDA Project Orbis, may improve time from AA to NOC/c. Stringent criteria for HTA recommendation results in lower approval rates however, provision of additional data at re-submission may enable subsequent approval and adoption of treatment.
Inflammatory and clinical risk factors for chemotherapy-induced peripheral neuropathy (CIPN): A nationwide longitudinal study in 143 cancer patients during chemotherapy.
Authors: Ian Kleckner, Todd Jusko, Eva Culakova, Amber Kleckner, Matthew Asare, Julia Ellen Inglis, Kah Poh Loh, Luke Joseph Peppone, Jeffrey L. Berenberg, Alison Katherine Conlin, Deborah J. Ossip, Karen Michelle Mustian
Journal: Journal of Clinical Oncology (2020)

12099 Background: CIPN is a common dose-limiting side effect of taxane and platinum chemotherapy. It is difficult for clinicians to predict who will experience CIPN before initiating chemotherapy, partly because the etiology of CIPN is poorly understood. Specifically, although inflammation putatively plays a role in CIPN, there is limited evidence of the role of inflammation in CIPN in humans. Here, we identified the strongest predictors of CIPN using variables measured before taxane or platinum chemotherapy, including serum inflammation. Methods: 143 sedentary patients with cancer (81% breast, 7% colon, 5% lung; 7% other; mean age 56 years) receiving taxane or platinum chemotherapy rated the severity of (a) numbness and tingling, and (b) hot/coldness in hands/feet on 0-10 point scales before and after their first 6 weeks of chemotherapy. Linear regression models were fit to predict CIPN symptom severity at 6 weeks using variables related to inflammation (serum IL-1β, IL-6, IL-8, IL-10, IFN-γ, sTNFR1; 69 patients who gave blood), clinical factors (cancer stage, baseline neuropathy, fatigue, anxiety, depression, using diabetes medications), behavior (daily pedometer steps), and demographics (age, race) measured before chemotherapy. The final model was identified by the smallest AIC goodness of fit. Results: The strongest pre-chemotherapy predictors of numbness and tingling after 6 weeks of taxane and/or platinum chemotherapy were worse patient-reported fatigue/anxiety/depression (explaining 25% of variance), platinum chemotherapy (7%), and older age (5%). The strongest predictors of hot/coldness in hands/feet included worse baseline neuropathy (13%), platinum chemotherapy (8%), and fatigue/anxiety/depression (6%). In the 69 patients with serum data, a more pro-inflammatory state was a risk factor for CIPN as higher levels of pro-inflammatory IL-1β (7%) predicted numbness/tingling, and lower levels of anti-inflammatory IL-10 (7%) predicted hot/coldness in hands/feet. Conclusions: The strongest pre-chemotherapy predictors of CIPN included worse fatigue/anxiety/depression and platinum chemotherapy in this sedentary population of cancer patients (mostly breast). A pro-inflammatory state before chemotherapy may also increase risk for CIPN, suggesting that inflammation may underlie the etiology of CIPN in humans. Clinicians should consider assessing these factors to inform the patient’s risk for CIPN. Funding: NCI UG1CA189961, NCI K07 K07CA221931, T32CA102618. Clinical trial information: NCT00924651 .
Measurable residual disease (MRD) assessed by mass spectrometry (MS) in peripheral blood versus next generation sequencing (NGS) in bone marrow in multiple myeloma treated on phase II trial of KRd+ASCT.
Authors: Benjamin Avi Derman, Andrew T Stefka, Amanda McIver, Ken Jiang, Tadeusz Kubicki, Jagoda Jasielec, Andrzej J. Jakubowiak
Journal: Journal of Clinical Oncology (2020)

8513 Background: MRD-negativity in multiple myeloma (MM) assessed by NGS in bone marrow (BM) aspirate is associated with longer progression free survival (PFS) and overall survival. MS can detect monoclonal protein at a heightened sensitivity in peripheral blood (PB). We sought to assess the concordance of MS in PB and NGS in BM, comparing outcomes by MRD status. Methods: MRD was tested on paired PB and BM samples from transplant (ASCT)-eligible pts with newly diagnosed secretory MM who received treatment on a phase II clinical trial (NCT01816971) with KRd for 4 cycles, ASCT, KRd for 14 cycles, and lenalidomide maintenance (LM). Both NGS and MS were evaluable in 36 pts after a total of 18 cycles of KRd (C18) and in 24 pts after 1 year of LM. MS signatures were identified in pretreatment PB samples. C18 and after 1 year of LM PB samples were evaluated using both MALDI-TOF and liquid-chromatography-MS (LCMS) by the Binding Site Group. Paired MRD by NGS was performed by ClonoSEQ. 20/60 samples reached the limit of detection for 10 −6 and 40/60 for 10 −5 . Results: There was substantial concordance between NGS and MALDI-TOF among the 60 samples ( κ= 0.667, 83% agreement) and fair concordance between NGS and LCMS ( κ= 0.348, 63% agreement). However, all 22 discordant samples (8 with NGS depth 10 −6 , 14 with NGS depth 10 −5 ) were NGS − /LCMS + . 4/16 (25%) of these pts converted to NGS + , and 3/16 (19%) clinically progressed. There was stronger concordance between LCMS and NGS 10 −6 ( κ= 0.615) than with NGS 10 −5 ( κ= 0.375). At a median follow-up of 56 months, C18 LCMS − (n = 9) was associated with superior PFS vs all LCMS + (n = 27; p = 0.03) and independently vs NGS — /LCMS + (n = 14; p = 0.04). There were 10 events (including 4 deaths) in the C18 LCMS + group vs 0 in the LCMS − group. Conclusions: MRD assessment by LCMS in PB appears to reach and possibly exceed the sensitivity of MRD by NGS in BM at a depth of 10 −5 -10 −6 . LCMS positivity predicted conversion from NGS — to NGS + in 25% of discordant cases, and LCMS negativity was a better predictor of superior PFS than MRD negativity by NGS. These observations need confirmation in larger prospective studies.
Estimating molecular variability of patient-derived xenografts of esophageal cancer.
Authors: Tatiana P. Protasova, Natalya N. Timoshkina, Evgeniy N. Kolesnikov, Mikhail A. Averkin, Umar Muhmadovich Gaziev, Sergei Kit, Aleksandr E. Anisimov, Anna S. Goncharova, Denis S. Kutilin, A. V. Volkova, M. V. Mindar, Sergey Yu. Tkachev, Ekaterina V. Zaikina, D. V. Khodakova, Ekaterina A. Lukbanova, Aleksey Yu. Maksimov, Liubov Yu Vladimirova, Oleg I. Kit
Journal: Journal of Clinical Oncology (2020)

e13649 Background: The survival of patients with esophageal squamous cell carcinoma depends not only on clinical signs (TNM, tumor site), but also on the molecular genetic subtype of the tumor. Identification of the molecular genetic subtype and the presence/absence of clinically significant mutations is an important step towards finding new effective drugs and choosing the most appropriate therapeutic strategies. A patient-derived xenograft (PDX) model is a valuable resource to solving the problem, provided that the model accurately reproduces the basic clinical and molecular genetic characteristics of a human tumor. Our purpose was to create a PDX model of a human tumor and to study 7 polymorphisms of the xenograft tissue and tissues of a donor tumor. Methods: PDX models of esophageal cancer were produced by transplanting a tumor fragment from a patient with esophageal squamous cell carcinoma to the BALB/c Nude athymic mice (n = 10 for one PDX generation). 5 PDX were generated. 7 polymorphisms (NFE2L2 (c.85G &gt; A), NOTCH1 (c.1379C &gt; T), NOTCH1 (c.1451G &gt; T), ZNF750 (c.414C &gt; A), ZNF750 (c.1621G &gt; A), SMARCA4 (c.2272C &gt; T), KMT2D (c.15508C &gt; T)) were determined by the HRM analysis in tissues of each PDX generation and in the donor tumor. Results: All examined samples demonstrated the absence of ZNF750 (c.1621G &gt; A) and NOTCH1 (c.1379C &gt; T) polymorphisms and the presence of ZNF750 (c.414C &gt; A), SMARCA4 (c.2272C &gt; T) and KMT2D (c.15508C &gt; T) polymorphisms. Polymorphisms in the NFE2L2 (c.85G &gt; A) gene and in the NOTCH1 (c.1451G &gt; T) gene were found in the F3, F4 and F5 PDX generations, but were absent in the donor tumor and the F1 and F2 generations. Conclusions: Molecular and genetic characteristics of the donor tumor change through several PDX generations. Early PDX generations are recommended for the studies as they better reproduce molecular and genetic characteristics of the original tumors.
选择降血压药物的原则
Authors: 华琦
Journal: BMJ (2007)

有效控制血压对防治动脉粥样硬化性心脑血管疾病至关重要.但是中国人群的高血压防治情况很不乐观.临床医务工作者应针对每一个患者进行全面评价,采用个体化的治疗方案,切实有效地控制血压,提高对靶器官的保护,并将药物的副作用降到最小。
Living life post cancer treatment (LLPCT): An assessment of a 12-week multidimensional wellness intervention to improve quality of life and physical activity in cancer survivors.
Authors: Christopher C. Marino, Colleen Dwyer, Janette T. Poppenberg, Jill Brufsky, Shuyan Zhai, G J. Van Londen
Journal: Journal of Clinical Oncology (2020)

12052 Background: Cancer survivors face unique health challenges with implications on health-related quality of life (HRQoL) and physical, social, and emotional wellbeing. With advancements in cancer treatment and aging populations, the prevalence of cancer survivors is expected to grow prompting the need for improved survivorship care delivery and comprehensive rehabilitative services. Living Life Post Cancer Treatment (LLPCT) is a community-based 12-week program that provides multidimensional support to patients of any cancer diagnosis transitioning from active treatment to post-treatment life. This single-arm intervention study aims to assess the program’s impact on HRQoL and physical activity in cancer survivors. Methods: A total of 125 participants within 2 years of treatment completion were enrolled in a 12-week program comprised of 9 sessions of engaging workshops, personalized exercise training, and nutrition and psychosocial counseling with an interprofessional team of oncology providers, social workers, exercise trainers, and dietitians. The program consisted of 8 consecutive weekly sessions followed by a 1-month follow-up session at week 12. Ninety-six (77%) participants completed the eighth or ninth session of the program and were included in the analysis. A series of questionnaires were administered at baseline and weeks 8 and 12. Primary outcomes assessed were HRQoL using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire and physical activity using average daily steps by pedometer and 2-minute step test performance. Results: Among the 96 participants (mean age 60.4 ± 11.7) who completed the program, the majority were female, white, and married. Post-intervention median FACT-G scores significantly increased from baseline at weeks 8 (+8.8, p = 0.002) and 12 (+7.3, p &lt; 0.001). Average daily steps by pedometer increased by 1063 (p = 0.003) and 1233 (p = 0.015) and 2-minute step test performance increased by 18 (p &lt; 0.001) and 21 (p &lt; 0.001) steps at weeks 8 and 12, respectively. Participants reported high levels of satisfaction and improved self-efficacy to incorporate lifestyle modifications. Conclusions: These findings suggest that this 12-week intervention improves HRQoL and step-based physical activity levels in cancer survivors and could serve as a multidimensional model for post-treatment support. Further research is needed to determine if these benefits are sustained long-term.
Efficacy of imiquimod in the management of lentigo maligna.
Authors: Brigitte Dréno, Monica Dinulescu, Jean-Michel NGuyen, Hevé Maillard, Florence Le Duff, Laurent Machet, Marie Beylot-Barry, Delphine Legoupil, Ewa Wierzbicka-Hainaut, Christophe Bedane, Marie Thérèse Leccia, Sébastien Debarbieux, Nicolas Meyer, Sandrine Monestier, Guido Bens, Marc G. Denis, Celine Bossard, Beatrice Vergier, Amir Khammari
Journal: Journal of Clinical Oncology (2020)

10074 Background: Lentigo maligna (LM), a melanocytic proliferation occurring on photoexposed skin, might progress to LM melanoma. Surgery is recommended as first-line treatment. However, the main challenge is the size of the excision inducing often-aesthetic injuries on the face and thus often refused by patients. The excision margins of 5 to 10 mm remain without international consensus. Several studies have shown that imiquimod induced LM regression, acting by enhancing IFN-γ production and effector function of T cells. The main goal of this study is to investigate the effect of imiquimod versus placebo in neoadjuvant setting to decrease the excision size as from the first surgical procedure. Methods: We performed a prospective, randomized, open, multicenter, phase III clinical study (NCT01720407). The health authority and ethics committee approvals were obtained and all subjects signed an informed consent. The primary endpoint was to demonstrate that in neoadjuvant situation, imiquimod could reduce the surgical excision size of LM with a healthy tissue margin of 5 mm. The main inclusion criteria were: Patients &gt; 18 years fit for surgery. LM of the head histologically confirmed and not previously treated. Surface lesion ≥ to 1cm² and ≤ to 20cm². The two treatment arms were imiquimod or placebo followed by LM excision. Imiquimod or placebo were applied once daily, 5 days/week for 4 weeks followed by 5 mm margin surgery performed four weeks after the last treatment application. For sample size, 268 patients were expected to demonstrate a difference of 15% between the two arms in a bilateral situation with an alpha risk of 5% and a beta risk of 20%. Results: The trial involved 273 patients, 238 (105 men (44%) and 133 women (56%), mean age of 71 ± 10.2 years, were analyzed in modified ITT. Statistical analysis was performed on 122 patients in the imiquimod arm and 116 patients in the placebo arm. For the primary endpoint, the first extralesionnal excision has been achieved for 112 (91.8%) patients in the imiquimod arm and for 98 (84.5%) placebo patients group. There was no significant difference (p value = 0.1067) between the two arms. However, regarding the surface of LM, imiquimod allowed a highly significant reduction (4.2 cm² ± 4.6 to 2.3 cm² ± 3.3) compared to LM treated by placebo (4.0 cm² ± 3.5 to 4.0 cm² ±3.3; p &lt; 0.0001). Conclusions: This randomized prospective study shows that imiquimod reduces the LM area (-50%) after one month of treatment. Reducing the surface of LM with imiquimod is not associated with a higher risk of intralesional excision (marge 5mm), with a significant esthetic result (less excised surface). Clinical trial information: NCT01720407.
症状体征的重要性
Authors: 曾昭耆
Journal: BMJ (2008)

1976年初,刚让我恢复临床工作不久,一天上午,一位首长匆匆忙忙地来到高干门诊,要我马上给他开些感冒药.在询问病情时,他偶然提起看东西有双影,我当即意识到这是复视,是神经疾病的重要症状之一,建议他看一下神经科。
Phase Ib study of brentuximab vedotin (BV) with low-dose total skin electron beam (LD-TSEB) for treatment of mycosis fungoides (MF) and Sezary syndrome (SS).
Authors: Shiyu Song, Beata Holkova, Nitai Mukhopadhyay, Daeryl Williamson, Molly Dickinson
Journal: Journal of Clinical Oncology (2020)

e20037 Background: MF is generally not curable, causing severe symptoms and eventually leading to patient (pt) death. LD-TSEB is currently used for diffuse skin lesions but with short duration of response. BV is effective and approved for MF but also limited by short duration of response. In this study we proposed to evaluate the feasibility of combining these 2 treatments by assessing the safety and response rate/duration in these pts. Methods: Pts with stage IB - IVA CD30+ MF or SS who were candidates for TSEB were recruited for a 2-cohort open-label phase 1b trial. Cohort A included pts with earlier stage disease; cohort B included pts with more advanced disease. BV was given at 1.8 mg/kg 3 wks before initiation of TSEB and then every 3 wks. Pts in Cohort A received 3 doses of BV; pts in Cohort B continued BV until disease progression or unacceptable toxicity, up to 2 years. Standard 12 Gy TSEB was administered in 6 fractions (2/wk) beginning 3 wks after the first dose of BV. The Modified Severity Weighted Assessment Tool (mSWAT) was used to determine skin involvement at baseline and during and after treatment. Skindex-16 was used to assess pt-reported symptoms and toxicities. Pts were seen weekly during TSEB, monthly after TSEB, and every 3 months after the last dose of BV for response evaluation and time to progression (TTP). Results: Five pts were enrolled and treated in this study. Two were enrolled to Cohort A, and 3 were enrolled to Cohort B. One pt in Cohort B expired before completing study treatment due to comorbidity unrelated to MF. The other pt data is listed in the table. None of the pts developed grade 4 or 5 toxicities; pt 1 developed recurrent neuropathy and stopped BV after 5 cycles. Conclusions: As BV became approved for the indication, accrual slowed, and the trial was stopped with very few pts. These pt cohorts are heavily treated before trial entry, making conclusions regarding response hard to generalize. However, the combination of BV and TSEB is well tolerated with no significant increase in skin toxicity. Response rate seems comparable to current standard of care, though with no improvement in duration of response over BV alone. Clinical trial information: NCT02822586 . [Table: see text]
特发性心房颤动临床治疗观察
Authors: 牛凡, 黄从新
Journal: BMJ (2005)

特发性心房颤动在心房颤动患者中占相当比例,尤其在60岁以上普通人群中的发生率为2%～4%.心房颤动快速心率反应可引起心动过速性心肌病,导致心脏结构和功能变化,使心房重构、扩大,从而使心房颤动得以持续,影响生活质量,危及患者生命.现将自1984年以来转复心房颤动的病例中特发性心房颤动病例进行回顾性总结。