bluuebunny/crossref_metadata_2025_split huggingface dataset:
Does nutritional status affect treatment tolarability, response and survival in metastatic colorectal cancer patients? Results of a prospective multicenter study
Authors: Karabulut Senem , Dogan Izzet , Usul Afsar Cigdem , Karabulut Mehmet , Karaman Sule , Ferhatoglu Ferhat , Tastekin Didem 
Published: September 2020

Background The efficacy and tolerability of modern cytotoxic chemotherapy regimens used in malnourished metastatic colorectal cancer (mCRC) patients is uncertain. The aim of this study was to investigate the effect of malnutrition on efficacy and tolerability of cytotoxic chemotherapy and overall survival in mCRC patients. Methods In this multicenter study, demographic, oncologic and nutritional data were collected prospectively from mCRC patients. Nutritional status of the patients were evaluated on the basis of NRI (Nutritional Risk Assessment), BMI (Body Mass Index) and WL (Weight Loss) before the first chemotherapy, after the first and second chemotherapy during 2 cycles of chemotherapy every 15 days. To determine the inter-treatment weight loss toxicity assessment was included to theese parameters after each chemotherapy. NRI calculation was performed as [1.51xserum albumin level (g/L)+41.7xcurrent weight/basic weight]. NRIs were examined in 3 categories as ‘no malnutrition’ (NRI >97.5), ‘moderate malnutrition’ (97.5 ≥NRI ≥83.5) or ‘severe malnutrition’ (NRI <83.5). Response to treatment and drug-induced toxicities were assessed based on Criteria in Solid Tumors (RECIST) 1.1 and National Cancer Institute CTCAE version 4.0 respectively. Results One-hundred and thirty-seven mCRC patients were prospectively included. Median age was 48 (range 18-83). Primary location was colon in 66% of patients and 84% of their primary source was left colon. Malnutrition was detected in 39% of the cases. Response rate to treatment was twenty four percent. While there was no significant relationship between chemotherapy response and moderate/severe malnutrition (p = 0.24), moderate/severe malnutrition was associated with multipl site of metastases, WHO PS (World Health Organization Performance Status) of 1, over the median value of CEA/CA 19-9 (carcinoembryonic antigen/carbohydate antigen 19-9) levels (p = 0.003, p = 0.03, p < 0.001, and p = 0.02; respectively). Hypoalbuminemia and moderate/severe malnutrition were associated with all types of toxicity (p < 0.001 and p < 0.001). Moderate/severe malnutrition was associated with thrombocytopenia, and diarrhea following chemotherapy predominately, (p = 0.02 and p = 0.04; respectively). In moderate/severe malnutrition group median overall survival was prominently shorter than those with no malnutrition [6.6 moths (95%CI, 5.6-7.6) vs 11.9 moths (95% CI, 11.1-12.7) respectively, p < 0.001]. Conclusions Our study showed that moderate/severe malnutrition in mCRC patients was associated with decreased overall survival and increased chemotherapy toxicity.
A Longitudinal Analysis of Inflammation and Depression in Patients With Metastatic Lung Cancer: Associations With Survival
Authors: McFarland Daniel C. , Miller Andrew H. , Nelson Christian 
Published: September 2020

Background: Depression and inflammation are concomitantly elevated in patients with lung cancer and may have collective survival implications. However, the longitudinal relationship between depression and inflammation in patients with metastatic lung cancer is not fully appreciated. We hypothesized that longitudinal changes in inflammation and depression would be concordant; that longitudinally elevated inflammation would lead to greater depression over time; and that depression with inflammation would be more persistent than depression without inflammation. Methods: Patients with metastatic lung cancer (n = 68) were assessed for clinically significant depression (Hospital Anxiety and Depression Scale ≥ 8) and inflammation (C-Reactive Protein ≥ 1 mg/L) along with demographic variables. Survival estimations were made using Cox Proportional Hazard Model and Kaplan-Meier plot analyses. Results: At baseline (T1), 15% had depression and 35% had increased inflammation followed by 18% with depression and 38% with increased inflammation 4.7 months later (T2). The odds ratio of depression in the presence of clinically significant inflammation was 4.8 at T1 and 5.3 at T2. Between time points, inflammation difference correlated with depression difference (r = −.26, p = .03). Significant depression at both time points was associated with a 4 fold risk of inferior survival while significant inflammation at any time point was associated with >3 fold risk of inferior survival. Conclusions: Depression and inflammation track together over time and have variable implications on survival. Persistent depression is particularly detrimental but incidental inflammation is more sensitive to predicting poor survival. These findings have implications for treating depression early in the lung cancer trajectory.
Outcome of AngioJet mechanical thrombus aspiration in the treatment of acute lower extremities deep venous thrombosis
Authors: Xu Yingjiang , Wang Xuemin , Shang Dan , Liu Jianyong , Chen Wei , Han Xinqiang 
Published: September 2020

Objectives The objective of this study was to evaluate the efficacy and safety in patients with acute lower extremity deep venous thrombosis who underwent pharmacomechanical thrombectomy (PMT, AngioJet mechanical thrombus aspiration). Methods In this retrospective, 424 consecutive patients with acute lower extremity deep venous thrombosis from three institutions were enrolled in the study from January 2015 to December 2018. Of these, patients were divided into two groups, AngioJet group ( n = 186) and catheter-directed thrombolysis (CDT) group ( n = 238). Evaluation indexes including limb circumference difference, length of stay (LOS), urokinase dosage, periprocedural complications, follow-up imaging findings and villalta scores were analyzed from the medical records. Results A total of 424 patients diagnosed with acute lower extremity deep venous thrombosis were collected in this study. These patients were categorized into AngioJet group and CDT group. Significant differences were observed between the two groups with respect to the thigh circumference difference (5.32 ± 1.85 cm vs. 4.69 ± 2.15 cm; p = 0.04), calf circumference difference (2.79 ± 1.54 cm vs. 2.35 ± 1.25 cm; p = 0.01), thigh detumescence rate (72.19 ± 19.55% vs. 65.35 ± 17.26%; p = 0.00) and calf detumescence rate (62.79 ± 18.56% vs. 55.75 ± 17.27%; p = 0.00). The mean dose of urokinase in AngioJet group was 95.16 ± 45.89 million IU significantly less than that in the CDT group 293.76 ± 42.71 million IU ( p = 0.00). The overall bleeding complication rate was 9.91% (19 patients in AngioJet group and 23 patients in CDT group), which included three major (0.71%, 3/424) and 39 minor (9.2%,39/424) events. In the AngioJet group, serum creatinine (sCr) concentration and urine erythrocyte from the hemolysis caused by the mechanical process were higher than baseline data at admission ( p = 0.00, p = 0.00). The postoperative red blood cell and hemoglobin in two groups were lower than baseline data ( p = 0.00, p = 0.00). Compared with CDT, AngioJet thrombectomy has significantly lower estimated incidence of PTS in the follow-up. Conclusion AngioJet thrombectomy has stronger clearance ability for acute lower extremity deep venous thrombosis leading to significant reduction in the consumption of hospital resources, total dose of thrombolytic agents, and infusion time, thereby preventing adverse bleeding events, but patients with renal insufficiency should be careful. Ideal short-term and medium-term efficacy and safety are certain.
Summarising salient information on historical controls: A structured assessment of validity and comparability across studies
Authors: Hatswell Anthony , Freemantle Nick , Baio Gianluca , Lesaffre Emmanuel , van Rosmalen Joost 
Published: September 2020

Background While placebo-controlled randomised controlled trials remain the standard way to evaluate drugs for efficacy, historical data are used extensively across the development cycle. This ranges from supplementing contemporary data to increase the power of trials to cross-trial comparisons in estimating comparative efficacy. In many cases, these approaches are performed without in-depth review of the context of data, which may lead to bias and incorrect conclusions. Methods We discuss the original ‘Pocock’ criteria for the use of historical data and how the use of historical data has evolved over time. Based on these factors and personal experience, we created a series of questions that may be asked of historical data, prior to their use. Based on the answers to these questions, various statistical approaches are recommended. The strategy is illustrated with a case study in colorectal cancer. Results A number of areas need to be considered with historical data, which we split into three categories: outcome measurement, study/patient characteristics (including setting and inclusion/exclusion criteria), and disease process/intervention effects. Each of these areas may introduce issues if not appropriately handled, while some may preclude the use of historical data entirely. We present a tool (in the form of a table) for highlighting any such issues. Application of the tool to a colorectal cancer data set demonstrates under what conditions historical data could be used and what the limitations of such an analysis would be. Conclusion Historical data can be a powerful tool to augment or compare with contemporary trial data, though caution is required. We present some of the issues that may be considered when involving historical data and what (if any) statistical approaches may account for differences between studies. We recommend that, where historical data are to be used in analyses, potential differences between studies are addressed explicitly.
Peer review of third trimester abdominal circumference measurements
Authors: Dyer Ellen , Chudleigh Trish 
Published: September 2020

Background Third trimester growth scans represent a significant proportion of the workload in obstetric ultrasound departments. The objective of these serial growth scans is to improve the antenatal detection of babies with fetal growth restriction. The aim of this paper is to describe a method of peer review for third trimester abdominal circumference measurements which is realistic within busy obstetric ultrasound departments in the UK. Method Twenty-two, third trimester, measured abdominal circumference images were randomly selected. Images were assessed subjectively by 12 sonographers using the image Criteria Achieved Score. For quantitative assessment, termed the Inter-operator Variability Score, three of the abdominal circumference (AC) images were blindly remeasured. Following this, a questionnaire was used to ascertain which image criteria sonographers considered most important and to reach an agreement on correct caliper placement. Results The least frequently met image criteria with the lowest Criteria Achieved Score related to an oblique abdominal circumference section. These included fetal kidney present (Criteria Achieved Score 24.6%), multiple oblique ribs (Criteria Achieved Score 39.4%) and oblique spine (Criteria Achieved Score 37.5%). Caliper placement was also identified as inconsistent. Discussion This study demonstrates that the perfect AC section is not always possible and sonographers use their professional judgement to determine whether an image is acceptable. Seventy-three percent of the images reviewed were of an acceptable standard. There can be inconsistencies in sonographer opinion regarding what is an acceptable third trimester abdominal circumference image. These differences need to be addressed to maximise the effectiveness of the third trimester ultrasound examination. Conclusion Peer review can be used to monitor scan quality and identify areas of inconsistency.
Hemodialysis patients with low serum parathyroid hormone levels have a poorer prognosis than those with secondary hyperparathyroidism
Authors: Yu Yue , Diao Zongli , Wang Ying , Zhou Peiyi , Ding Rui , Liu Wenhu 
Published: September 2020

Background: Low serum parathyroid hormone (PTH) level and secondary hyperparathyroidism (SHPT) are very common in hemodialysis patients. However, the outcomes of patients with low PTH level or SHPT have not been carefully compared. Therefore, in the present study, we compared the outcomes of hemodialysis patients with low PTH level or SHPT. Methods: This was a multi-center, prospective, cohort study of 647 patients. The patients were recruited between 1 September 2016 and 1 January 2017 and followed until 31 December 2018. The participants were allocated to a low PTH group [serum intact PTH (iPTH) concentration < 60 pg/ml] and an SHPT group (iPTH ⩾ 600 pg/ml) according to their mean iPTH concentration across the entire observation period, and the outcomes were compared between these groups. The primary outcome was a composite outcome, which comprised all-cause mortality, non-fatal acute myocardial infarction, non-fatal acute stroke, and acute heart failure. Results: A total of 197 hemodialysis patients were allocated to the two groups: 87 with low PTH level and 110 with SHPT; 450 patients with time-averaged iPTH concentrations of 60–600 pg/ml were excluded. Kaplan–Meier analysis of the composite endpoint revealed a significant difference between participants with low PTH level and those with SHPT ( p = 0.002). Cox multiple regression showed that participants with low PTH level had a higher incidence of the composite endpoint than those with SHPT (relative risk: 1.337, 95% confidence interval: 1.059–1.688). Conclusion: Hemodialysis patients with low PTH level had a higher incidence of mortality and non-fatal cardiovascular events than those with SHPT, irrespective of whether the participants were age-matched.
Mindful Mentors: Is a Longitudinal Mind–Body Skills Training Pilot Program Feasible for Pediatric Cardiology Staff?
Authors: Freedenberg Vicki A , Jiang JiJi , Cheatham Carla A , Sibinga Erica MS , Powell Cynthia A , Martin Gerard R , Steinhorn David M , Kemper Kathi J 
Published: September 2020

Background Stress and burnout among medical professionals are common and costly, placing professionals, organizations, and patients at risk. Objectives To determine feasibility and acceptability of a longitudinal mind–body skills training initiative to help staff decrease stress and burnout, improve well-being, and empower them to utilize basic mindfulness methods with coworkers, patients, and families. Methods Prospective cohort, mixed methods approach. Nurses, doctors, technicians, social workers, child life specialists were eligible to participate. The 12-month curriculum consisted of 16 hours of intensive education/practice over 2 days, with training in mindfulness skills, self-compassion, nonviolent communication, overcoming barriers to practice, and mindful listening/speaking, followed by monthly 1 hour booster/debriefing sessions. Results A total of 37 staff participated (RN = 18, MD = 5, Technician = 6, Social Worker = 3, Child life = 3, others = 2) in the initial training, and 24 (65%) completed the 3- and 12-month follow-up surveys. Compared with pretraining scores, there were significant improvements 3 to 12 months after the initial training in stress ( P < .0001), distress ( P ≤ .04), anxiety ( P = .01), self-efficacy in providing non-drug therapies ( P < .0001), mindfulness ( P = .002), burnout ( P < .0001), and confidence in providing compassionate care ( P < .0001). In addition, 25 (67%) participants initiated projects incorporating what they learned into staff/patient wellness activities. Conclusion This longitudinal pilot program was feasible and was associated with improvements in measures of psychological well-being over the 12-month intervention. The innovative approach of training participants to teach basic techniques to coworkers and other staff can increase the impact of this program beyond any individual participant. Future research will investigate the aspects of implementation and potential effects on patient care and experience.
Do Intraoperative Neurophysiological Changes During Decompressive Surgery for Cervical Myeloradiculopathy Affect Functional Outcome? A Prospective Study
Authors: Akbari Keyur Kantilal , Badikillaya Vigneshwara , Venkatesan Muralidharan , Hegde Sajan K. 
Published: September 2020

Study Design: Prospective cohort. Objective: To investigate whether intraoperative neuromonitoring (IONM) positive changes affect functional outcome after surgical intervention for myeloradiculopathy secondary to cervical compressive pathology (cervical compressive myelopathy). Methods: Twenty-eight patients who underwent cervical spine surgery with IONM for compressive myeloradiculopathy were enrolled. During surgery motor-evoked potential (MEP) and somatosensory evoked potential (SSEP) at baseline and before and after decompression were documented. A decrease in latency >10% or an increase in amplitude >50% was regarded as a “positive changes.” Patients were divided into subgroups based on IONM changes: group A (those with positive changes) and group B (those with no change or deterioration). Nurick grade and modified Japanese Orthopaedic Association (mJOA) score were evaluated before and after surgery. Results: Nine patients (32.1%) showed improvement in MEP. The mean preoperative Nurick grade and mJOA score of group A and B were (2.55 ± 0.83 and 11.11 ± 1.65) and (2.47 ± 0.7 and 11.32 ± 1.24), respectively. The mean postoperative Nurick grade of groups A and B at 6 months was 1.55 ± 0.74 and 1.63 ± 0.46, respectively, and this difference was not significant. The mean postoperative mJOA score of groups A and B at 6 months was 14.3 ± 1.03 and 12.9 ± 0.98, respectively, and this difference was statistically significant ( P = .011). Spearman correlation coefficient showed significant positive correlation between the IONM change and the mJOA score at 6 months postoperatively ( r = 0.47; P = .01). Conclusion: Our study shows that impact of positive changes in MEP during IONM reflect in functional improvement at 6 months postoperatively in cervical compressive myelopathy patients.
Physical Examination of the Spine Using Telemedicine: A Systematic Review
Authors: Piche Joshua , Butt Bilal B. , Ahmady Arya , Patel Rakesh , Aleem Ilyas 
Published: September 2020

Study Design: This is a systematic review. Objective: To systematically review (1) the reliability of the physical examination of the spine using telehealth as it pertains to spinal pathology and (2) patient satisfaction with the virtual spine physical examination. Methods: We searched EMBASE, PubMed, Medline Ovid, and SCOPUS databases from inception until April 2020. Eligible studies included those that reported on performing a virtual spine physical examination. Two reviewers independently assessed all potential studies for eligibility and extracted data. The primary outcome of interest was the reliability of the virtual spine physical exam. Secondary outcomes of interest were patient satisfaction with the virtual encounter. Results: A total of 2321 studies were initially screened. After inclusion criteria were applied, 3 studies (88 patients) were included that compared virtual with in-person spine physical examinations. These studies showed acceptable reliability for portions of the low back virtual exam. Patient satisfaction surveys were conducted in 2 of the studies and showed general satisfaction (>80% would recommend). Conclusions: These results suggest that the virtual spine examination may be comparable to the in-person physical examination for low back pain, though there is a significant void in the literature regarding the reliability of the physical examination as it pertains to specific surgical pathology of the spine. Because patients are overall satisfied with virtual spine assessments, validating a virtual physical examination of the spine is an important area that requires further research.
Impact of COVID-19 on Life Experiences of Essential Workers Attending a Dental Testing Facility
Authors: Fontana M. , McCauley L. , Fitzgerald M. , Eckert G.J. , Yanca E. , Eber R. 
Published: September 2020

COVID-19 poses a threat to health and well-being. Objectives: 1) To compare the impact of COVID-19 on the life experiences of essential workers attending a COVID-19 antibody testing clinic at a dental school. 2) To compare responses of dental, non–dental health care, and non–health care essential workers. 3) To assess acceptability/satisfaction of testing done in a dental setting. Method: A total of 984 participants completed a self-administered online questionnaire. Results: Over 90% were healthy (i.e., not in a high-risk health-related group for COVID-19), did not have COVID-19 symptoms within 30 d, and always/frequently engaged in preventive measures. Fifty-eight percent thought that they had a 0% to 25% chance of having immunity/antibodies to COVID-19. Non–dental health care workers thought that their chance was significantly higher (P < 0.05) than others. Over 70% were sometimes, frequently, or always worried about their friends and loved ones getting COVID-19 and of resulting financial problems. Dental workers were significantly less afraid than non–dental health care and non–health care providers. For all groups, more than half of the respondents stated that the pandemic had a negative (somewhat worse or worse) impact on daily life (59%), interactions with others (65%), stress levels (66%), and enjoyment of life (56%). There were significant differences among all 3 groups regarding the percentage of individuals with a negative impact on job security (dental, 47%; non–dental health care, 34%; non–health care, 31%). However, more than half of the respondents stated that the pandemic had a positive impact (same, somewhat better, or much better) on caring about one another, self-care, and exercise. Knowing the results of an antibody test would decrease the level of stress and anxiety in 67% of respondents. Over 80% found a COVID-19 test received in a dental setting acceptable, were “definitely” satisfied, and would “definitely” recommend it to a friend, family, or coworker. Conclusions: These findings support that dental workers are as vulnerable as other essential workers to threats and psychological impacts of COVID-19. They also support the acceptability and satisfaction of testing for a pandemic done in a dental setting. Knowledge Transfer Statement: The results of this study highlight the impact that pandemics such as COVID-19 can have on life experiences of essential workers, including dentists. It also highlights a role that dentistry can play within the broader health care system, during and beyond the current pandemic, to help with surveillance efforts of community health. Testing may also help alleviate stress and anxiety associated with these pandemics.