bluuebunny/crossref_metadata_2025_split huggingface dataset:
Racial and Ethnic Differences in Biomarkers, Health Status, and Cardiac Remodeling in Patients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan
Authors: Ibrahim Nasrien E. , Piña Ileana L. , Camacho Alexander , Bapat Devavrat , Felker G. Michael , Maisel Alan S. , Butler Javed , Prescott Margaret F. , Abbas Cheryl A. , Solomon Scott D. , Januzzi James L. ,   on behalf of the Prospective Study of Biomarkers, Symptom Improvement and Ventricular Remodeling During Entresto Therapy for Heart Failure (PROVE-HF) Study Investigators
Published: October 2020

Background:
Among patients with heart failure and reduced ejection fraction (left ventricular (LV) ejection fraction ≤40%), sacubitril/valsartan (S/V) treatment is associated with improved health status and reverse cardiac remodeling. Data regarding racial and ethnic differences in response to S/V are lacking.

Methods:
This was an analysis from the PROVE-HF study (Prospective Study of Biomarkers, Symptom Improvement and Ventricular Remodeling During Entresto Therapy for Heart Failure). Longitudinal changes in NT-proBNP (N-terminal pro-B-type natriuretic peptide), cardiac reverse remodeling, and health status scores were compared between groups using multivariate latent growth curve modeling.

Results:

Among the 782 patients included in this study, 22.7% were non-Hispanic Black (from here referred to as Black), 14.9% were Hispanic, and 62.4% were non-Hispanic White (from here referred to as White). At baseline, compared with White patients, Black and Hispanic patients had lower NT-proBNP (
g
=0.34) and differences between groups in baseline values for LV end-diastolic volume index and LV end-systolic volume index were negligible (
g
<0.10). Following S/V initiation, NT-proBNP decreased in all 3 groups (
P
<0.0001) associated with improvements in LV ejection fraction, LV end-diastolic volume index, and LV end-systolic volume index. Although total improvement in LV measures was similar between groups, Black patients averaged larger gains in the first half of the trial while White patients averaged larger gains in the second half. Improvements in Kansas City Cardiomyopathy Questionnaire-23 Total Symptom scores were seen in all 3 groups. Treatment with S/V was well-tolerated.

Conclusions:
Among Black, Hispanic, and White patients with heart failure and reduced ejection fraction, treatment with S/V was associated with similar reduction in NT-proBNP, improvement in health status, and reverse remodeling. More data regarding racial and ethnic responses to heart failure and reduced ejection fraction treatment are needed.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT02887183.
Treatment of Masked Hypertension with a Chinese Herbal Formula
Authors: Zhang Dong-Yan , Cheng Yi-Bang , Guo Qian-Hui , Shan Xiao-Li , Wei Fang-Fei , Lu Feng , Sheng Chang-Sheng , Huang Qi-Fang , Yang Chuan-Hua , Li Yan , Wang Ji-Guang 
Published: October 2020

Background:
Masked hypertension is associated with adverse cardiovascular outcomes. Nonetheless, no randomized controlled trials exist in the treatment of masked hypertension. The aim of this randomized, placebo-controlled trial was to investigate the efficacy and safety of blood pressure (BP)–lowering treatment with a Chinese herbal formula, gastrodia-uncaria granules, in patients with masked hypertension.

Methods:
Patients with an office BP of <140/90 mm Hg and daytime ambulatory BP of 135 to 150 mm Hg systolic or 85 to 95 mm Hg diastolic were randomly assigned 1:1 to the treatment of gastrodia-uncaria granules or placebo 5 to 10 g twice daily for 4 weeks. The primary efficacy variable was the change in daytime ambulatory BP.

Results:

At baseline, office and daytime BP of the 251 participants (mean age, 50.4 years; 53.4% men; mean body mass index 24.5 kg/m
2
; and 2.8%, 1.6%, and 30.7% with cardiovascular disease, diabetes, and smoking, respectively) averaged 129/82 and 135/89 mm Hg, respectively. In the intention-to-treat analysis, daytime systolic/diastolic BP was reduced by 5.44/3.39 and 2.91/1.60 mm Hg in the gastrodia-uncaria granules and placebo groups, respectively. The between-group difference in BP reductions was significant for the daytime (2.52/1.79 mm Hg;
P
≤0.025) and 24-hour BP (2.33/1.49 mm Hg;
P
≤0.012), but not for the clinic and nighttime BPs (
P
≥0.162). The per-protocol analysis in 229 patients produced similar results. Only 1 adverse event (sleepiness during the day) was reported, and no serious adverse event occurred.

Conclusions:
BP-lowering treatment with Chinese traditional medicine gastrodia-uncaria granules is efficacious for patients with masked hypertension.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT02156024.
Percutaneous Endoscopic Gastrostomy and Mortality After Stroke in England From 2007 to 2018
Authors: Sutcliffe Lou , Flynn Darren , Price Christopher I. 
Published: October 2020

Background and Purpose:
Swallowing difficulties are common poststroke. National clinical guidelines recommend feeding by percutaneous endoscopic gastrostomy (PEG) when oral nutrition cannot be maintained although survival benefit might be short term. It is unknown whether a decade of general care improvements have impacted upon PEG provision and outcomes. This retrospective cohort study examined PEG placement and mortality poststroke in England.

Methods:

National Health Service Hospital Episode Statistics and Office for National Statistics mortality data between April 2007 and March 2018 were linked to identify all admissions in England with stroke-related
International Classification of Diseases
codes (I61, I63, and I64)±PEG insertion and deaths at 3, 6, and 12 months. Linear and logistic regression examined trends over time and mortality.

Results:

Patients (923 236) with stroke underwent 17 532 PEG procedures (mean rate 1.9%), with an average reduction of −27 procedures/year ([95% CI, −56 to 1.4];
P
=0.06) despite an average increase of 1804 stroke admissions/year. Mortality decreased among cases without a PEG procedure: −190 deaths/year ([95% CI, −276 to −104];
P
<0.001) at 3 months, −167 deaths/year ([95% CI, −235 to −98];
P
<0.001) at 6 months and −103 deaths/year ([95% CI, −157 to −50];
P
<0.01) at 12 months; and also reduced following PEG insertion: −28 deaths/year ([95% CI, −35 to −20];
P
<0.001) at 3 months, −33 deaths/year ([95% CI, −46 to −20];
P
<0.01) at 6 months and −30 deaths/year ([95% CI, −48 to −13];
P
<0.01) at 12 months. With all years combined, PEG insertion was weakly associated with reduced mortality at 3 months (odds ratio, 0.94 [95% CI, 0.90–0.97]) but significantly higher mortality at 6 months (odds ratio, 1.69 [95% CI, 1.64–1.75]) and 12 months (odds ratio, 2.14 [95% CI, 2.08–2.20]).

Conclusions:
PEG procedures and subsequent deaths have decreased in the context of general mortality reductions after hospitalization for stroke, but survival at 6 and 12 months remains significantly worse for patients with PEG placement.
Laparoscopic Exploration of the Common Bile Duct: A Systematic Review of the Published Evidence Over the Last 10 Years
Authors: Marks Bertram , Al Samaraee Ahmad 
Published: October 2020

Introduction Endoscopic and open surgical interventions are widely implemented as the standard practice in common bile duct exploration. However, the laparoscopic approach has been also reported to have comparative/superior outcomes in this concept. This has created an ongoing debate about the ideal approach to adopt in practice. Methods A systematic review of the published evidence over the last decade that has looked into the outcomes of laparoscopic exploration of the common bile duct through transductal and transcystic approaches. Results Our systematic review included 36 relevant papers. The majority were based on nonrandomized protocols conducted in single centers with high expertise. The data analysis showed that laparoscopic common bile duct exploration through both approaches was successful in more than 84% of the patients, with an average length of hospital stay of 5.6 days. Conversion to open surgery was reported in 5%-8% of the patients, and the bile leak rates from the more recent studies was 0%-12%, with mortality figures of 0%-1.3%. The outcomes were statistically in favor of the transcystic route when compared to the transductal route from the viewpoints of bile leak rates, mean operative time, duration of hospital stay and morbidity. Conclusion In experienced hands, both laparoscopic approaches in common bile duct exploration are safe in patients who are clinically fit to have this intervention. It is associated with a statistically significant lower overall morbidity and shorter duration of hospital stay when compared to open surgery. Relevant up-to-date high-quality randomized trials are unavailable.
Engagement of Occupational Therapy Organizations with Public Policy: A Qualitative Analysis
Authors: Osman Alia , Webber Cecelia , Oliel Stefanie , Couture-Lavoie Karine , Lencucha Raphael , Shikako-Thomas Keiko 
Published: October 2020

Background. Public policy is an important feature of occupational therapy practice. Occupational therapy organizations have a mandate to engage in policy processes to improve the conditions for clients, including the nature of care received. Purpose. Describe the approaches that Canadian occupational therapy organizations use to engage with and impact public policy. Methods. This study used interpretive description methodology. Participants were recruited from Canadian occupational therapy professional organizations. Participants shared their experiences and perspectives on policy engagement through semi-structured interviews. Data was analyzed inductively. Findings. Engagement with policy involved reaching out (building relationships, educating practitioners about policy and occupational therapy contributions, and developing statements), and reaching in (consulting with occupational therapists and generating data informing policy). Implications. Occupational therapy organizations can share and coordinate approaches to impact public policy and advocate for both clients and the profession. Future research can expand this analysis in other contexts to generate a deeper understanding of engagement.
Identification of Parkinson’s disease-related pathways and potential risk factors
Authors: Shen Jun , Chen Xiao-Chang , Li Wang-Jun , Han Qiu , Chen Chun , Lu Jing-Min , Zheng Jin-Yu , Xue Shou-Ru 
Published: October 2020

Objective To identify Parkinson’s disease (PD)-associated deregulated pathways and genes, to further elucidate the pathogenesis of PD. Methods Dataset GSE100054 was downloaded from the Gene Expression Omnibus, and differentially expressed genes (DEGs) in PD samples were identified. Functional enrichment analyses were conducted for the DEGs. The top 10 hub genes in the protein–protein interaction (PPI) network were screened out and used to construct a support vector machine (SVM) model. The expression of the top 10 genes was then validated in another dataset, GSE46129, and a clinical patient cohort. Results A total of 333 DEGs were identified. The DEGs were clustered into two gene sets that were significantly enriched in 12 pathways, of which 8 were significantly deregulated in PD, including cytokine–cytokine receptor interaction, gap junction, and actin cytoskeleton regulation. The signature of the top 10 hub genes in the PPI network was used to construct the SVM model, which had high performance for predicting PD. Of the 10 genes, GP1BA, GP6, ITGB5, and P2RY12 were independent risk factors of PD. Conclusion Genes such as GP1BA, GP6, P2RY12, and ITGB5 play critical roles in PD pathology through pathways including cytokine−cytokine receptor interaction, gap junctions, and actin cytoskeleton regulation.
Impact of waiting times on tumour growth and pathologic upstaging in patients with non-small cell lung cancer having lung resection
Authors: Bhat Insha , Okiror Lawrence , Nair Arjun , Billè Andrea 
Published: October 2020

Objective: There are limited data on tumour growth or pathologic upstaging in patients with early-stage lung cancer awaiting lung resection. We aimed to evaluate whether waiting times on the current lung cancer treatment pathway were associated with significant tumour growth or pathologic upstaging. Methods: This is a retrospective observational study of a consecutive series of patients with early-stage, non-small cell lung cancer who underwent resection for lung cancer. The difference between tumour size at diagnostic and preoperative computed tomography (CT) scans was calculated. Significant tumour growth was defined as a diameter increase of ⩾5 mm or ⩾20%. The time intervals between baseline and repeat CT (CT-int) and between baseline CT and date of surgery (Surg-int), as well as other potential clinical and pathologic prognostic factors, were compared between upstaged and nonupstaged patients. Results: There were 121 patients identified. Fifty-four patients (44.6%) had tumour growth ⩾5 mm and 27 patients (22%) had tumour growth ⩾20%. Median CT-int and Surg-int were 2.4 and 2.6 months, respectively. Forty-four patients (36%) were upstaged at surgery due to new lymph node involvement (n = 19), pleural invasion (n = 12), satellite nodules (n = 4), or increase in tumour diameter (n = 9). There was a marginal, but statistically insignificant, difference in median CT intervals in patients who had tumour growth <20% vs ⩾20% at 2.4 vs 2.6 months ( p = 0.06). Conclusion: Current cancer pathway waiting times are not associated with significant tumour growth or pathologic upstaging in this cohort.
Validation of the Colon Life nomogram in patients with refractory metastatic colorectal cancer enrolled in the RECOURSE trial
Authors: Pietrantonio Filippo , Fucà Giovanni , Manca Paolo , Pagani Filippo , Raimondi Alessandra , Prisciandaro Michele , Randon Giovanni , Corti Francesca , de Braud Filippo , Cremolini Chiara , Miceli Rosalba 
Published: October 2020

Background: The RECOURSE trial (Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies) demonstrated an overall survival (OS) benefit of trifluridine/tipiracil (FTD/TPI) vs placebo in refractory metastatic colorectal cancer (mCRC). Given the limited benefit of later line treatments, we developed the Colon Life nomogram to assess the 12-week death probability in the refractory setting. Methods: This post hoc analysis of RECOURSE included patients with available data to calculate the nomogram score: Eastern Cooperative Oncology Group Performance Status, primary tumor resection, lactate dehydrogenase, and peritoneal metastases. The nomogram calibration was assessed by calibration plots and C-index. The nomogram prognostic and predictive ability was assessed by Cox model analyses and the nomogram score predictive value was explored according to the cutoff identified at maximum value of the Youden index in time-dependent receiver operating characteristic curve analysis. Results: Overall, 251 trial patients were evaluable: 90 in the placebo arm and 161 in the FTD/TPI arm. The calibration was optimal in the placebo arm (C-index 0.807) and suboptimal in the FTD/TPI arm (0.657). The cutoff of the nomogram score of 23 showed the best discriminative ability for 12-week OS (hazard ratio 3.46, 95% confidence interval 2.17–5.51 for scores 40 vs 15) and had maximum value of the Youden index (0.381). Median OS and 3-month PFS were 9.0 vs 7.5 months and 39.3% vs 5.2%, respectively, for FTD/TPI vs placebo in the low-risk group (score <23) and 4.8 vs 3.4 months and 22.3% vs 9.8% in the high-risk group (score ⩾23) (interaction NS). Conclusion: The Colon Life nomogram is an accurate tool for estimating life expectancy in refractory mCRC. The benefit of FTD/TPI was independent of the predicted risk of early death.
The use of everyday technology; a comparison of older persons with cognitive impairments’ self-reports and their proxies’ reports
Authors: Jakobsson Elin , Nygård Louise , Kottorp Anders , Olsson Cecilia Bråkenhielm , Malinowsky Camilla 
Published: October 2020

Introduction Older persons with cognitive impairment have often been disregarded in providing information on their own perceptions. This study explored the number of relevant everyday technologies and the ability to use everyday technologies as perceived by persons with cognitive impairment in comparison with their proxies’ estimates using the Short Everyday Technology Use Questionnaire. Method In this cross-sectional study, persons with cognitive impairment ( n = 21) and their proxies ( n = 21) were interviewed on separate occasions with the Short Everyday Technology Use Questionnaire, which measures the number of relevant everyday technologies and the ability to use everyday technologies. The data were analysed with t-tests, z-comparisons, and Fisher’s exact test. The level of significance was set at p < 0.05. Results At the group level, no significant differences were found between persons with cognitive impairments’ perceptions and their proxies’ estimates regarding the number of relevant everyday technologies or the ability to use everyday technologies. On the individual level, significant differences were found in the ability measures within four out of the 21 dyads. Conclusion The persons with cognitive impairment and their proxies verified each other’s responses, providing evidence that persons with cognitive impairment should be the primary source for information about their own everyday technology use.
Thromboembolic Events and Role of Point of Care Ultrasound in Hospitalized Covid-19 Patients Needing Intensive Care Unit Admission
Authors: Kapoor Sumit , Chand Sudham , Dieiev Vladyslav , Fazzari Melissa , Tanner Tristan , Lewandowski David C. , Nalla Anil , Abdulfattah Omar , Aboodi Michael S. , Shiloh Ariel L. , Gong Michelle N. 
Published: October 2020

Background: Covid-19 associated coagulopathy (CAC) is associated with prothrombotic state and thromboembolism. However, true incidence of thromboembolic events is difficult to determine in the ICU setting. The aim of our study was to investigate the cumulative incidence of thromboembolic events in Covid-19 patients needing intensive care unit (ICU) admission and assessing the utility of point of care ultrasound (POCUS) to screen for and diagnose lower extremity deep venous thrombosis (DVT). Methods: We conducted a prospective observational study between April 22nd and May 26th, 2020 where all adult patients with the diagnosis of Covid-19 pneumonia admitted to 8 ICUs of Montefiore Medical Center were included. POCUS exam was performed on all patients at day 1 of ICU admission and at day 7 and 14 after the first exam. Results: The primary outcome was to study the cumulative incidence of thromboembolic events in Covid-19 patients needing ICU admission. A total of 107 patients were included. All patients got POCUS exam on day 1 in the ICU, 62% got day 7 and 41% got day 14 exam. POCUS diagnosed 17 lower extremity DVTs on day 1, 3 new on day 7 and 1 new on day 14. Forty patients developed 52 thromboembolic events, with the rate of 37.3%. We found a high 45-day cumulative incidence of thromboembolic events of 37% and a high 45-day cumulative incidence of lower and upper extremity DVT of 21% and 10% respectively. Twelve (30%) patients had failure of therapeutic anticoagulation. Occurrence of a thromboembolic event was not associated with a higher risk of mortality (HR 1.08, p value = .81). Conclusions: Covid-19 patients in ICU have a high cumulative incidence of thromboembolic events, but not associated with higher mortality. POCUS is an excellent tool to help screen and diagnose DVT during a pandemic.
Impact of the COVID-19 pandemic on patients with systemic lupus erythematosus: Observations from an Indian inception cohort
Authors: Rathi Manish , Singh Parmeshar , Bi Hayath Peta , Shivanna Archana , Kavadichanda Chengappa , Tripathy Saumya Ranjan , Parthasarathy Janani , Tota Sneha , Maurya Supriya , Vijayalekshmi Vishnupriya , Bhavani D , Jain Avinash , Gupta Ranjan , Danda Debashish , Rajasekhar Liza , Negi Vir Singh , Shobha Vineeta , Das Bidyut , Aggarwal Amita 
Published: October 2020

Introduction The ongoing pandemic of COVID-19 has led to severe disruption of healthcare services worldwide. We conducted this study to assess the impact of COVID-19 pandemic on the management of Systemic Lupus Erythematosus (SLE) patients who were enrolled in the nation-wide inception cohort. Methods A questionnaire was administered to the SLE patients enrolled in the inception cohort. Questions related to the effect on disease activity, preventive measures adopted against COVID-19, the incidence of COVID-19, hardships faced in getting access to health care professionals and availability of medicines, adherence, fear of COVID-19 and the potential benefits of being part of the registry. Results A total of 1040 (90% females) patients completed the questionnaire. The mean age was 27.5 ± 19.1 years and the mean disease duration was 1.25 years. Twenty-Four (2.3%) patients had developed fever (>1 day) during this period, including one patient with additional symptoms of diarrhoea and anosmia, however, none of the patients developed COVID-19 infection. 262 patients (25.2%) reported financial difficulty during this period and patients reported an average excess expenditure of at least 2255.45 INR ($30) per month. 378 patients (36%) reported problems in getting their prescribed medicines due to lockdown. Of these, 167 (40%) patients needed to change their medication schedule due to this non-availability. Almost 54% of patients missed their scheduled follow up visits during the lockdown period and 37% of patients were unable to get their investigations done due to closure of laboratories and hospitals. 266 patients (25.5%) reported worsening of various symptoms of SLE during this period. Almost 61% patients felt confident that being associated with the inception cohort had helped them in managing their disease better during this period of lockdown as they received help in the form of timely and frequent telephonic consults, assistance in making the medicines available, and regular counselling resulting in abetment of their fears and anxieties. Conclusion The current COVID-19 pandemic has made a huge impact on our SLE patients. Patients faced difficulty in the availability of medicines, missed the doses of medicines, had financial constraints, and spent more money on health during the pandemic.
Implications of Subject Matter Expertise as a Requirement for Debriefing: A Randomized Control Trial
Authors: Díaz Desiree A. , Gonzalez Laura , Anderson Mindi , MacKenna Valorie , Hoyt Erica , Hill Peggy P. 
Published: October 2020

Introduction. Healthcare certification standards do not mention subject matter expertise. This research answers the question: Is there a difference in participant perception of simulation effectiveness between simulation facilitators and SME simulation facilitators during the debrief? Methods. Senior-level nursing students (N=120) were randomized into groups to complete one pediatric critical care simulation. Simulation-based education (SBE) was delivered across five weeks. Two experienced facilitators, one with pediatric expertise and one without, used the PEARLS method to debrief each simulation. Following each debrief, participants completed a demographic survey and a SET-M. Results were analyzed using SPSS Version 24. Results. Eighty-four students completed the survey and SET-M instrument. Independent samples t-tests showed no significant difference between facilitators based on the SET-M total scores (p=.516), or mean scores (p=.492). Debriefing-specific items also showed no difference (p=.983). Conclusion. Subject matter expertise did not change the perception of simulation effectiveness for undergraduate nursing students during a critical care scenario. While SMEs are valuable for scenario creation and coaching non-SME facilitators on key elements for guided reflection, they may not be required to facilitate the debrief. Further research in this area is needed.