bluuebunny/crossref_metadata_2025_split huggingface dataset:
Road towards promoting patient safety practices among hospital pharmacists
Authors: Al-Surimi Khaled , Alwabel Ali Mohammed , Bawazir Amen , Shaheen Naila A. 
Published: January 2021

Abstract
Patient safety is a fundamental aspect of a healthcare system. The aim of this study was to assess the perception and determinants of the patient safety culture of pharmacists in hospitals, in Riyadh, Saudi Arabia.
A survey was conducted with pharmacists in the pharmacies of governmental, /military and private hospitals in Riyadh, Saudi Arabia. The pharmacy survey on patient safety culture questionnaire developed by Agency for Healthcare Research and Qualtity, a hard copy was distriuted to the pharmacists. The positive response rate (RR) was calculated and compared across hospitals using a chi-square test. The predictors of patient safety grades were identified using the generalized estimating equation. The data was analyzed using SAS.
A total of 538 questionnaires were distributed, of which 411 responded (RR 76.4%). Of the participants, 229 (56%) were females. The majority 255 (62%) were in the 18 to 34 years age range, and 361 (88%) had a bachelor's degree. The majority of the sample 376 (92%) was a pharmacist. The Positive RR (PRR) ranged between (25.6%–74%). The highest PRR was observed in teamwork (74.4%), followed by ‘staff, training and skills’ (68%), and ‘organizational learning continuous improvement’ (66%). The lowest PRR was observed in ‘staffing, work pressure, and pace’ (25.5%). Comparing the PPR of the various healthcare sectors, the governmental hospitals scored the highest in all patient safety domains. Generalized Estimating Equation analysis showed that with increase in scores of all patient safety culture domains increased the likelihood of reporting a better patient safety grade, whereas respondents’ demographic characteristics had no effect except the working experience years 6 years and above had odds of poor reporting of the patient safety grade (odds ratio = 2.54, 95% confience interval (1.543, 4.194), (P = .0003).
The grades achieved in the various domains of patient safety culture by pharmacists in Riyadh are below the expected standard. The highest scores were achieved in teamwork, with the lowest scores in staffing, work pressure and pace. Overall, pharmacists in government hospital settings have a better perception of patient safety than their peers in other settings. These results provide the baseline evidence for developing future interventional studies aiming at improving patient safety culture in hospital pharmacy settings.
Effect of thrombolysis in a mobile stroke unit versus in hospital for patients with ischemic stroke
Authors: Chen Jieyun , Lin Xiaoying , Huang Risheng , Luo Minyuan , Cai Yali , Zou Wenxiao 
Published: January 2021

Abstract

Introduction:
Ischemic stroke caused by arterial occlusion is the cause of most strokes. The focus of treatment is rapid reperfusion through intravenous thrombolysis and intravascular thrombectomy. Two acute stroke management including prehospital thrombolysis and in hospital have been widely used clinically to treat ischemic stroke with satisfied efficacy. However, there is no systematic review comparing the effectiveness of these 2 therapies. The aim of this study is to compare the effect of prehospital thrombolysis versus in hospital for patients with ischemic stroke.

Methods and analysis:
The following electronic databases will be searched: Web of Science, PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), China Biology Medicine disc (CBM), Wanfang Database, and Chinese Scientific Journal Database.
The randomized controlled trials of prehospital thrombolysis versus in hospital for ischemic stroke will be searched in the databases from their inception to December 2020 by 2 researchers independently. Onset to therapy (OTT) duration and National Institute Health Stroke Scale (NIHSS) scores will be assessed as the primary outcomes; safety assessment including intracerebral hemorrhage (ICH) and mortality will be assessed as the secondary outcomes. The Review Manager 5.3 will be used for meta-analysis and the evidence level will be assessed by using the method for Grading of Recommendations Assessment, Development and evaluation Continuous outcomes will be presented as the weighted mean difference or standardized mean difference with 95% confidence interval (CI), whereas dichotomous data will be expressed as relative risk with 95% CI. If heterogeneity existed (P < .05), the random effect model was used. Otherwise, we will use the fixed effect model for calculation.

Ethics and dissemination:
Ethical approval is not required because no primary data are collected. This review will be published in a peer-reviewed journal.

PROSPERO registration number:
CRD42020200708
Prospective, double-blind, randomized, placebo-controlled phase III study evaluating efficacy and safety of octagam 10% in patients with dermatomyositis (“ProDERM Study”)
Authors: Aggarwal Rohit , Charles-Schoeman Christina , Schessl Joachim , Dimachkie Mazen M. , Beckmann Irene , Levine Todd 
Published: January 2021

Abstract

Introduction:
Dermatomyositis (DM) is an inflammatory myopathy characterized by distinct skin manifestations and muscle weakness. Intravenous immunoglobulin (IVIg) has been used off-label as adjuvant therapy in DM, but is not indicated for DM, due to lack of proven efficacy in a large randomized controlled trial. The objective of the ProDERM (Progress in DERMatomyositis) study was to evaluate the efficacy, safety and long-term tolerability of IVIg (Octagam 10%) in patients with DM in a randomized, placebo-controlled, double-blind, Phase III study.

Methods:
Adult patients with active DM who were continuing standard therapy at a stable dose were eligible for this study. Patients were randomized 1:1 to receive either 2 g/kg of IVIg or placebo, administered every 4 weeks until week 16 (First Period). Patients were switched to the alternate treatment if they showed clinical deterioration in the First Period. After response assessment at week 16, all patients on placebo and those without deterioration on IVIg entered the open-label Extension Period, receiving 2 g/kg IVIg every 4 weeks for 24 weeks.

Results:
The primary efficacy endpoint was the proportion of responders in the IVIg vs placebo arm at week 16, where response was defined per 2016 ACR/EULAR Myositis Response Criteria of at least minimal improvement [Total Improvement Score (TIS) ≥20] and without deterioration at 2 consecutive visits up to week 16. TIS consists of composite response criteria, combining weighted improvement in 6 core set measures (CSMs), Global Disease Activity (Physician and Patient), manual muscle testing-8 (MMT-8), Health Assessment Questionnaire, extra-muscular disease activity, and muscle enzymes. Secondary endpoints included the mean change in individual CSMs, time to improvement in TIS, time to confirmed deterioration in the First Period, and the overall proportion of patients with deteriorations. Adverse events, including infusion reactions and thromboembolic events, were recorded.

Conclusions:
The ProDERM study was the first to assess the long-term efficacy and safety of IVIg (Octagam 10%) in a placebo-controlled, blinded, randomized trial in DM. The study aimed to inform on the use of IVIg in the treatment of DM, and results are expected in Q3 2020.

ClinicalTrials.gov Identifier:
NCT02728752.
CO2 artificial pneumothorax on coagulation and fibrinolysis during thoracoscopic esophagectomy
Authors: Ren Yunqin , Yan Hong , Ge Hengjiang , Peng Ji , Zheng Han , Zhang Peng 
Published: January 2021

Abstract

Background:
CO2 artificial pneumothorax creates a sufficient operative field for thoracoscopic esophagectomy. However, it has potential complications and continuous CO2 insufflation may impede coagulation and fibrinolysis. We sought to compare the effects of CO2 artificial pneumothorax on perioperative coagulation and fibrinolysis during thoracoscopic esophagectomy.

Methods:
We investigated patients who underwent thoracoscopic esophagectomy with (group P, n = 24) or without CO2 artificial pneumothorax (group N, n = 24). The following parameters of coagulation–fibrinolysis function: intraoperative bleeding volume; serum levels of tissue plasminogen activator (t-PA), plasminogen activator inhibitor (PAI-1), thromboelastogram (TEG), D-Dimer; and arterial blood gas levels were compared with two groups.

Results:
Group P showed higher levels of PaCO2, reaction time (R) value and kinetics (K) value, but significantly lower pH value, alpha (α) angle and Maximum Amplitude (MA) value at 60 minutes after the initiation of CO2 artificial pneumothorax than group N ((P < .05, all). The t-PA level after CO2 insufflation for 60 minutes was significantly higher in group P than in group N (P < .05), but preoperative levels were gradually restored on cessation of CO2 insufflation for 30 min (P > .05). There was no significant difference in D-dimer.

Conclusion:
CO2 artificial pneumothorax during thoracoscopic esophagectomy had a substantial impact on coagulation and fibrinolysis, inducing significant derangements in pH and PaCO2.

Trial registration:
The study was registered at the Chinese clinical trial registry (ChiCTR1800019004)
Efficacy of thermotherapy for herpes zoster and postherpetic neuralgia
Authors: Li Zhuang , She Yalin , Luo Zhenke , Liu Zijun , Pei Wenya , Zeng Jingchun , Lin Guohuo 
Published: January 2021

Abstract

Background:
Herpes zoster (HZ), is a painful skin rash disease with cutaneous symptoms and acute zoster-associated pain (ZAP). Postherpetic neuralgia (PHN), as the most frequent sequela of HZ, can persist a long time. Both HZ and PHN may significantly impact the quality of life and made great economical afford to affected patients. Its optimal treatment on HZ and PHN is still an urgent problem. In China, thermotherapy, including moxibustion and fire needle, is widely used because they can quickly promote the recovery of shingles and reduce the occurrence of PHN. Thermotherapy can also reduce pain intensity, relieve anxiety, and improve quality of life of PHN. Based on the current literatures, the effect and safety of thermotherapy will be systematically evaluated to provide appropriate complementary therapies for HZ and PHN.

Methods:
Studies search for eligible randomized controlled trials (RCTs) that use thermotherapy including fire needle and moxibustion for HZ or PHN from the following databases: PubMed, EMBASE, Web of Science, the Cochrane Library, China National Knowledge Infrastructure (CNKI), China Biology Medicine Database (CBM), Technology Periodical database (VIP), and Wanfang database. Language restrictions for retrieving literature are English and Chinese. Their data extraction will be done by 2 researchers. Mean difference (MD) or relative risk (RR) with fixed or random effect model in terms of 95% confidence interval (CI) will be adopted for the data synthesis. To evaluate the risk of bias, the Cochrane's risk of bias assessment tool will be utilized. The sensitivity or subgroup analysis will also be conducted when meeting high heterogeneity (I
2 > 50%).

Results:
This meta-analysis will provide an authentic synthesis of the thermotherapy's effect on HZ and PHN, including incidence of postherpetic neuralgia and adverse events.

Discussion:
The findings of the review offer updated evidence and identify whether thermotherapy can be an effective treatment for HZ and PHN for clinicians.

Registration number:
INPLASY2020110009.
Vitamin D status was associated with sepsis in critically ill children
Authors: Yu Weijie , Ying Qinlai , Zhu Wen , Huang Lisu , Hou Qiuying 
Published: January 2021

Abstract

Background:
Sepsis leads to the high mortality in critically ill infants and children. It is still controversial whether vitamin D deficiency was associated with the incidence of sepsis. Thus we designed the systematic review and meta-analysis.

Methods:
The Ovid Medline, Embase, PubMed, and Cochrane library were systematically searched until April 5, 2020. The 25 hydroxyvitamin D (25-OHD) level was recorded and set 20 ng/mL as cut-off in cohort study to divide the lower and higher 25-OHD group. The odds ratio (OR) and 95% confidence intervals (CIs) were calculated for comparing the impact of vitamin D deficiency on the incidence of sepsis in critically ill children.

Results:
A total of 27 studies were included with 17 case-control studies and 10 cohort studies. In those case-control studies, the maternal 25-OHD level and neonatal 25-OHD level in sepsis group was significant lower than non-sepsis group (P < .001). The percentage of severe vitamin D deficiency was significant higher in sepsis group comparing to non-sepsis group (odds ratio [OR] = 2.66, 95% CI = 1.13–6.25, P < .001). In those cohort studies, the incidence of sepsis in lower 25-OHD group was 30.4% comparing with 18.2% in higher 25-OHD level group. However, no statistical significant difference in terms of mechanical ventilation rate and 30-day mortality.

Conclusion:
We demonstrated that critically ill infants and children with sepsis could have a lower 25-OHD level and severe vitamin D deficiency comparing to those without sepsis. Future studies should focus on the association of vitamin D supplement and the occurrence of sepsis in critically ill children.
PD-L1 – inhibitors in neuroendocrine neoplasia
Authors: Özdirik Burcin , Jann Henning , Bischoff Philip , Fehrenbach Uli , Tacke Frank , Roderburg Christoph , Wiedenmann Bertram 
Published: January 2021

Abstract
Immune check-point inhibitors (ICIs) have changed our view on how to treat cancer. Despite their approval in treatment of many different cancers, efficacy of immune check-point inhibitors (ICI) in neuroendocrine neoplasia is limited and poorly understood. Established treatment options of neuroendocrine tumors (NET) and neuroendocrine carcinomas (NECs) are based on surgery, tumor-targeted medical treatments, Peptide Receptor Radionuclide Therapy (PRRT), and locoregional therapies. However, in many patients these treatments lose efficacy over time, and novel therapies are urgently needed. We report on 8 patients diagnosed with neuroendocrine neoplasms (NEN) that were treated with ICI (pembrolizumab, avelumab, nivolumab plus ipilimumab) as salvage therapy. In this cohort, we observed tumor response with partial remission in 3 patients and stable disease in 1 patient. Four patients showed progressive disease. Of note, responses were observed both in PD-L1 positive and PD-L1 negative patients. Here, we discuss clinical courses of these patients in the context of available literature to highlight limitations and drawbacks currently preventing the use of ICI in routine management of patients with NEN.
Efficacy of treatment for acneiform eruptions related to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) for non-small cell lung cancer (NSCLC)
Authors: He Canfeng , Lin Ruiting , Zhang Jing , Sun Lingling , Lin Jietao , Lin Lizhu 
Published: January 2021

Abstract

Background:
Acneiform eruptions from epidermal growth factor receptor tyrosine kinase inhibitors is a frequent adverse event in non-small cell lung cancer patients but the efficacy of its treatment including antibiotics, corticosteroid, sunscreen is still poorly understood.

Methods:
Eight electronic databases (PubMed, EMBASE, ClinicalTrials.gov, etc) will be searched from inception to April 2020. Risk of bias of randomized controlled trials will be assessed in terms of the Risk of Bias 2 (RoB 2) tool. Eligible randomized controlled trials will be enrolled for a Bayesian network meta-analysis using R software.

Results:
This study is still ongoing and the results will be submitted and published in a peer-reviewed scientific journal.

Conclusion:
We hope the results of this study will provide reliable evidence for the management of acneiform due to epidermal growth factor receptor tyrosine kinase inhibitors for non-small cell lung cancer.

Ethics and dissemination:
Ethical approval is not applicable for this study is based on published trials.

Protocol registration number:
CRD42020206724
Impact of aerobic exercise on cognitive function in patients with schizophrenia during daily nursing
Authors: Chen Chunmian , Yang Yafang , Ye Xinwu , Jin Yulian , Cai Ziyao , Zheng Jie 
Published: January 2021

Abstract

Objectives:
To assess the effect of aerobic exercise (AE) on cognition function in people with schizophrenia (SZ) during daily nursing.

Methods
The literature search will be conducted via PubMed, Embase, Cochrane Library, and Web of Science. Weighted mean difference (WMD) or standardized mean difference (SMD) and 95% confidence intervals (CIs) will be adopted to calculate the association between AE and cognitive function in patients with SZ. Publication bias will be performed by Begg test. When there is publication bias, “cut-and-fill method” will be adopted to adjust publication bias. Sensitivity analysis will be used to test the stability of the result. When the heterogeneity is large (I
2 ≥ 50%), meta regression will be used to explore the source of inter-study heterogeneity. When the heterogeneity is large (I
2 ≥ 50%) and the results are statistically significant (P < .05), age, sex, duration of disease, duration of intervention, amount of exercise per week, improvement of cardiopulmonary health, and other factors will be sub-analyzed.

Conclusion
This meta-analysis will evaluate the impact of aerobic exercise on cognitive function in patients with SZ during daily nursing on the basis of existing evidence.

OSF registration number
10.17605/OSF.IO/C8ABX
Effect of traditional Chinese medicine (TCM) on survival, quality of life, and immune function in patients with ovarian carcinoma
Authors: Ge Shuxia , Xing Qianqian , Zhang Anqi , Wang Yucui 
Published: January 2021

Abstract

Background:
Traditional Chinese medicine (TCM) has been widely applied as promising adjunctive drugs for ovarian carcinoma (OC) in China and other Asian countries. However, its exact clinical efficacy and safety is still not well investigated. In this study, we aimed to summarize the efficacy of TCM on survival, quality of life (QoL), and immune function in patients with OC through the meta-analysis.

Methods:
Relevant clinical trials of TCM for the treatment OC patients will be searched in Cochrane Library, Web of Science, Google Scholar, PubMed, Medline, Embase, China Scientific Journal Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang Database from their inception to November 2020. Two researchers will perform data extraction and risk of bias assessment independently. The clinical outcomes, including overall survival (OS), QoL, immune function, tumor markers, and adverse events, were systematically evaluated by using Review Manager 5.3 and Stata 14.0 statistical software.

Results:
The results of this study will provide high-quality evidence for the effect of TCM on survival, QoL and immune function in patients with OC.

Conclusion:
The conclusions of this meta-analysis will be published in a peer-reviewed journal, and draw an objective conclusion of the efficacy of TCM on survival, QoL, and immune function in patients with OC.

Trial registration number:
INPLASY2020110104.
The global state of research in pain management of osteoarthritis (2000–2019)
Authors: Chen Taoyu , Zhu Jiaying , Zhao Yu , Li Haoqian , Li Pengcui , Fan Jianjun , Wei Xiaochun 
Published: January 2021

Abstract
There has been a highly active area in the pain management of osteoarthritis (OA) over the past 2 decades. The study aims to unmask the global status and trends in this field.
Publications on pain management of OA from 2000 to 2019 were retrieved from the Web of Science (WOS) database. The data were analyzed using bibliometric statistical methodology. The software VOS viewer was used for bibliographic coupling, co-authorship, co-citation, co-occurrence analysis and to investigate the publication trends in pain management of OA.
A total of 8207 researches in amount were included. The relative research interests and number of publications indicated a rising trend. The USA made the greatest contribution to this field, with the most publications, total citations and the highest H-index, while Sweden had the highest average citation per publication. The most contributive organization was Boston University. The journal OA and Cartilage published the most relative articles. Researches could be grouped into 5 clusters based on co-occurrence network map: Health and Epidemiology; Sport Medicine; Clinical Study; Mechanism Research and Medical Technology and Science. Medical Technology and Science was predicted as the next research topic in this field.
The number of publications about pain management of OA would be increasing based on current global trends. The USA made the largest contribution to this field. The development of Medical Technology and Science may be the next popular topics in the pain management of OA research.
Efficacy and safety of metformin in the treatment of gestational diabetes
Authors: Mao Weirong , Zhang Shengzhi , Wang Lanying , Shen Shaohua 
Published: January 2021

Abstract

Background:
The incidence of gestational diabetes is increasing, which not only cause adverse pregnancy outcomes, but also increases the risk of diabetes for pregnant women and their children. Insulin is the gold standard for the treatment of gestational diabetes, but there are some disadvantages, such as poor patient compliance. Metformin has been used in the treatment of gestational diabetes, but the evaluation of its efficacy and safety is lack of reliable evidence-based medicine evidence. The purpose of this study was to systematically investigate the efficacy and safety of metformin in the treatment of diabetic gestational diabetes.

Methods:
Computer searches China National Knowledge Infrastructure, Wanfang, Vipu Information Chinese Journal Service Platform and China Biomedical Database, PubMed, Embase, Web of Science, the Cochrane Library from the establishment of the database to November 2020, randomized controlled clinical trials of metformin in the treatment of gestational diabetes mellitus were conducted in English and Chinese. Two researchers independently carried out data extraction and literature quality evaluation on the quality of the included study, and the included literature was analyzed by Meta using RevMan5.3 software.

Results:
In this study, the efficacy and safety of metformin in the treatment of diabetic gestational diabetes were investigated by evaluating the outcome indicators of pregnant women and newborn babies respectively.

Conclusion:
This study will provide reliable evidence for the clinical application of metformin in the treatment of diabetic gestational diabetes.

Ethics and dissemination:
The private information from individuals will not be published. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences.

OSF Registration number:
DOI 10.17605/ OSF.IO / 7RB95