bluuebunny/crossref_metadata_2025 huggingface dataset:
HYPERREFLECTIVITY ON OPTICAL COHERENCE TOMOGRAPHY IN MACULAR TELANGIECTASIA TYPE 2
Authors: Tzaridis Simone , Hess Kristina , Heeren Tjebo F. C. , Bonelli Roberto , Holz Frank G. , Friedlander Martin
Published: January 2021

Purpose:

To define, characterize, and classify hyperreflectivity on optical coherence tomography and report its prevalence in macular telangiectasia Type 2.

Methods:

In a primary cross-sectional analysis, multimodal imaging data were retrospectively analyzed. The definition of hyperreflectivity and neovascularization on optical coherence tomography followed optical coherence tomography angiography–based criteria. Eyes were graded for the presence of hyperreflectivity and neovascularization and further categorized into three classes based on position and extent of hyperreflectivity. In a secondary analysis, eyes were reviewed for ≥24 months using optical coherence tomography imaging.

Results:

Three hundred and twenty-two eyes from 161 patients were analyzed in the cross-sectional analysis. Hyperreflectivity was found in 177 (55%) and neovascular membranes in 49 (15%) eyes. Hyperreflectivity correlated significantly with parameters indicative of disease progression. In the longitudinal analysis, 206 eyes from 103 patients were reviewed over a mean of 35.6 months. 17/86 eyes (20%) showed a de novo development of hyperreflectivity. 8/29 eyes (28%) with preexistent intraretinal hyperreflectivity developed outer retinal hyperreflectivity. A high proportion of eyes with outer retinal hyperreflectivity (17/52 [33%]) developed neovascular membranes.

Conclusion:

Hyperreflectivity represents a common finding in macular telangiectasia Type 2 but lacks a uniform definition. We propose a hyperreflectivity grading scale that may help to estimate disease progression and identify eyes at risk for developing neovascular membranes.
Ultrasound-guided transversus abdominis plane block vs trigger point injections for chronic abdominal wall pain: a randomized clinical trial
Authors: Moeschler Susan M. , Pollard E. Morgan , Pingree Matthew J. , Pittelkow Thomas P. , Bendel Mark A. , Mauck W. David , Watson James C. , Eldrige Jason S. , Loftus Conor G. , Hooten W. Michael
Published: January 2021

The primary aim of this randomized clinical trial is to investigate the effects of ultrasound-guided transversus abdominis plane (TAP) vs ultrasound-guided trigger point injections (TPIs) on numerical rating scale pain scores at month 3 follow-up in patients with a chronic abdominal wall pain. The primary outcome measure was the difference in mean numeric rating scale pain scores between the TAP and TPI groups at month 3 in an intent-to-treat (ITT) analysis. A total of 60 patients were randomized 1:1 to receive an ultrasound-guided TAP block (n = 30) or an ultrasound-guided TPI (n = 30). No significant group differences in baseline demographic or clinical characteristics were observed. The mean baseline pain score for the TAP and TPI groups was 5.5 and 4.7, respectively. In the ITT analysis at month 3, the between-group difference in pain scores was 1.7 (95% confidence interval, 0.3-3.0) favoring the TPI group. In a secondary per-protocol analysis, the between-group difference in pain scores was 1.8 (95% confidence interval, 0.4-3.2) favoring the TPI group. For the ITT and per-protocol analyses, the group differences in pain scores were consistent with a medium effect size. The main finding of this randomized clinical trial is that adults with chronic abdominal wall pain who received a TPI reported significantly lower pain scores at month 3 follow-up compared with patients who received a TAP block.
Photobiomodulation therapy is not better than placebo in patients with chronic nonspecific low back pain: a randomised placebo-controlled trial
Authors: Guimarães Layana de Souza , Costa Lucíola da Cunha Menezes , Araujo Amanda Costa , Nascimento Dafne Port , Medeiros Flávia Cordeiro , Avanzi Marina Athayde , Leal-Junior Ernesto Cesar Pinto , Costa Leonardo Oliveira Pena , Tomazoni Shaiane Silva
Published: January 2021

Photobiomodulation therapy (PBMT) has been used in several musculoskeletal disorders to reduce pain, inflammation, and promoting tissue regeneration. The current evidence about the effects of PBMT on low back pain (LBP) is still conflicting. We aimed to evaluate the effects of PBMT against placebo on pain intensity and disability in patients with chronic nonspecific LBP. This was a prospectively registered, randomised placebo-controlled trial, with blinded patients, therapists, and assessors. The study was conducted on an outpatient physical therapy clinic in Brazil, between April 2017 and May 2019. A total of 148 patients with chronic nonspecific LBP were randomised to either active PBMT (n = 74) or placebo (n = 74). Patients from both groups received 12 treatment sessions, 3 times a week, for 4 weeks. Patients from both groups also received an educational booklet based on “The Back Book.” Clinical outcomes were measured at baseline and at follow-up appointments at 4 weeks, 3, 6, and 12 months after randomisation. The primary outcomes were pain intensity and disability measured at 4 weeks. We estimated the treatment effects using linear mixed models following the principles of intention-to-treat. There was no clinical important between-group differences in terms of pain intensity (mean difference = 0.01 point; 95% confidence interval = −0.94 to 0.96) and disability (mean difference = −0.63 points; 95% confidence interval = −2.23 to 0.97) at 4 weeks. Patients did not report any adverse events. Photobiomodulation therapy was not better than placebo to reduce pain and disability in patients with chronic nonspecific LBP.
Brief preoperative mind–body therapies for total joint arthroplasty patients: a randomized controlled trial
Authors: Hanley Adam W. , Gililland Jeremy , Erickson Jill , Pelt Christopher , Peters Christopher , Rojas Jamie , Garland Eric L.
Published: January 2021

Although knee and hip replacements are intended to relieve pain and improve function, up to 44% of knee replacement patients and 27% of hip replacement patients report persistent postoperative joint pain. Improving surgical pain management is essential. We conducted a single-site, 3-arm, parallel-group randomized clinical trial conducted at an orthopedic clinic, among patients undergoing total joint arthroplasty (TJA) of the hip or knee. Mindfulness meditation (MM), hypnotic suggestion (HS), and cognitive-behavioral pain psychoeducation (cognitive-behavioral pain psychoeducation) were each delivered in a single, 15-minute group session as part of a 2-hour, preoperative education program. Preoperative outcomes—pain intensity, pain unpleasantness, pain medication desire, and anxiety—were measured with numeric rating scales. Postoperative physical functioning at 6-week follow-up was assessed with the Patient-Reported Outcomes Measurement Information System Physical Function computer adaptive test. Total joint arthroplasty patients were randomized to preoperative MM, HS, or cognitive-behavioral pain psychoeducation (n = 285). Mindfulness meditation and HS led to significantly less preoperative pain intensity, pain unpleasantness, and anxiety. Mindfulness meditation also decreased preoperative pain medication desire relative to cognitive-behavioral pain psychoeducation and increased postoperative physical functioning at 6-week follow-up relative to HS and cognitive-behavioral pain psychoeducation. Moderation analysis revealed the surgery type did not differentially impact the 3 interventions. Thus, a single session of a simple, scripted MM intervention may be able to immediately decrease TJA patients' preoperative clinical symptomology and improve postoperative physical function. As such, embedding brief MM interventions in surgical care pathways has the potential to improve surgical outcomes for the millions of patients receiving TJA each year.
Functional Training in Portuguese Firefighters
Authors: Lajoso-Silva Nuno , Bezerra Pedro , Silva Bruno , Carral José Maria Cancela
Published: January 2021

Objective:

To investigate the influence of specific functional training (FT) with and without personal protective equipment (PPE) and self-contained breathing apparatus (SCBA), on firefighters (FFs) physical fitness condition.

Methods:

Sixty FFs run a 24 weeks intervention, divided into three groups (EG1 training with PPE+SCBA; EG2 training with regular equipment, and Control Group). FFs anthropometric and physical fitness (PF) were assessed pre- and post-intervention.

Results:

Significant differences were found between the training groups and control group. Both training groups interventions were effective in improving PF and lean mass. However, EG1 presented a higher percentage of improvement.

Conclusion:

This 24-week FT intervention improved participants’ muscle strength, endurance, and power, and it led to increases in lean body mass. Regularly FT with PPE+SCBA helps FFs maintain a healthy general physical condition and develop optimum fitness levels related to firefighting specific tasks, specially torso muscular endurance.
2B or not 2B? A diagnosis of von Willebrand disease a lifetime of 86 years in the making
Authors: Chapman Kent , Prasad Ritam , Mohammed Soma , Favaloro Emmanuel J.
Published: January 2021

Type 2B von Willebrand disease (2B VWD) is a rare, autosomal dominant bleeding disorder characterized by a hyperadhesive form of von Willebrand factor (VWF). 2B VWD expresses phenotypically as an enhanced ristocetin-induced platelet aggregation and usually also a discordance in VWF activity versus protein level, with loss of high molecular weight VWF and (mild) thrombocytopenia. While all cases of 2B VWD supposedly share these characteristics, there is significant heterogeneity in laboratory findings within this group of patients, which are largely dictated by the underlying genetic defect. We present a case of such a patient, expressing a clearly atypical VWF phenotype, but as still associated with enhanced ristocetin-induced platelet aggregation, thrombocytopenia, and a previously undescribed VWF variant (c.4130C>G; p.Ala1377Gly). The patient was misdiagnosed over his lifetime as idiotypic thrombocytopenia – a (mis)diagnosis that took a lifetime of 86 years to redress.
Marked von Willebrand factor and factor VIII elevations in severe acute respiratory syndrome coronavirus-2-positive, but not severe acute respiratory syndrome coronavirus-2-negative, pneumonia: a case–control study
Authors: De Cristofaro Raimondo , Liuzzo Giovanna , Sacco Monica , Lancellotti Stefano , Pedicino Daniela , Andreotti Felicita
Published: January 2021

Patients with novel coronavirus pneumonia show increased thrombotic risk. Although hemostatic alterations have been described in novel coronavirus pneumonia patients, case–control studies of von Willebrand factor (VWF), factor VIII (FVIII), and a disintegrin-like and metalloprotease with thrombospondin type I motif, member 13 (ADAMTS13) are lacking. VWF, ADAMTS13, FVIII, d-dimer, C-reactive protein, and routine blood cells and chemistry were measured in 10 novel coronavirus pneumonia patients and 10 non-novel coronavirus pneumonia controls. Hemostatic factors were measured less than 48 h of hospital admission in patients without invasive ventilation. d-Dimer, C-reactive protein, and fibrinogen concentrations, high in both groups, did not differ significantly in novel coronavirus pneumonia vs. non-novel coronavirus pneumonia patients. Median VWF-antigen (324 vs. 153 IU/dl, P < 0.0001), VWF-Rco (342 vs. 133 IU/dl, P < 0.001), and FVIII-activity levels (203 vs. 123 IU/dl, P < 0.0001) were significantly higher in novel coronavirus pneumonia cases vs. controls ADAMTS13-activity was normal in both groups. Coronavirus pneumonia cases vs. non-novel coronavirus pneumonia controls showed marked VWF/FVIII elevation, suggesting specific virus-induced endothelial activation causing VWF/FVIII hypersecretion, which may represent a therapeutic target in novel coronavirus pneumonia.
Viscoelastic hemostasis assays in septic, critically ill coronavirus disease 2019 patients: a practical guide for clinicians
Authors: Gergi Mansour , Goodwin Andrew , Freeman Kalev , Colovos Christos , Volod Oksana
Published: January 2021

Coronavirus disease 2019 (COVID-19)-associated coagulopathy is unusual, poorly defined and is linked with significant hypercoagulability and microthrombotic and macrothrombotic complications leading to worse outcomes and higher mortality. Conventional coagulation assays do not always actively reflect these derangements and might fail to detect this coagulopathy. Viscoelastic hemostatic assays (VHA) provide a possible tool that adds to conventional coagulation assays in identifying this hypercoagulable state. VHA has been mostly used in surgery and trauma but it's still not well defined in sepsis patients with lack of large randomized trials. Few studies described VHA findings in patients with COVID-19 showing significant hypercoagulability and fibrinolysis shutdown. Clinicians taking care of these patients might have little experience interpreting VHA results. By reviewing the available literature on the use of VHA in sepsis, and the current knowledge on COVID-19-associated coagulopathy we provide clinicians with a practical guide on VHA utilization in patients with COVID-19.
A novel mutation (Ser951LeufsTer8) in F5 gene leads to hereditary coagulation factor V deficiency
Authors: Su Kankan , Wang Lin , Wang Mingshan , Wang Hong
Published: January 2021

The current study aims to explore the phenotype and genotype of a novel mutation (Ser951LeufsTer8) of F5 gene combined with polymorphism (R485K) in a family of hereditary coagulation factor V deficiency. The factor V activity and antigen were tested with clotting assay and ELISA. The F5 gene was amplified by PCR with direct sequencing and TA-clone-sequenced. The protein structure and harmfulness of the mutation were studied by Swiss-PdbViewer and bioinformatics software. The prothrombin time and activated partial thromboplastin time of proband were significantly prolonged, factor V activity and factor V antigen both were reduced to less than 20%. Sequencing analysis detected proband with Ser951LeufsTer8 and R485K (Arg513Lys), four family members with novel mutation and their factor V activity and factor V antigen were all decreased about 50%. The Ser951LeufsTer8 is associated with decrease in the factor V level of the family, and it is the first mutation report in the position (Ser951LeufsTer8) with factor V deficiency.
Acquired factor V inhibitor in the setting of coronavirus disease 2019 infection
Authors: Bennett Joseph , Cunningham Mark T. , Howard Christin , Hoffmann Marc , Plapp Fred V.
Published: January 2021

Factor V inhibitors are a rare cause of life-threatening bleeding. We present a case of an acquired factor V inhibitor likely caused by coronavirus disease 2019 infection. Bleeding was manifested by severe anemia requiring frequent red-cell transfusion, left psoas muscle hematoma, and left retroperitoneal cavity hematoma. Factor V activity was less than 1% and the factor V inhibitor titer was 31.6 Bethesda units. Severe acute respiratory syndrome coronavirus 2 RNA testing of the nasopharynx was positive 2 weeks before presentation and continued to be positive for 30 days. The patient failed treatment with intravenous immunoglobulin and dexamethasone. Three cycles of plasmapheresis with fresh frozen plasma replacement resulted in correction of the bleeding and laboratory coagulopathy. This is the first reported case of a factor V inhibitor in a coronavirus disease 2019 patient and suggests that plasmapheresis may be a successful treatment strategy.
Bisphosphonates and risk of lung cancer
Authors: Li Minghao , Zhong Muyan , Guan Chengnong
Published: January 2021

The association between the use of bisphosphonates (BPs) and the risk of lung cancer has been concerned recently. There is no explicit study indicating that whether the use of BPs would affect the risk of lung cancer. So, we conducted a meta-analysis to figure out the relationship between BPs and lung cancer.

We searched the databases of PubMed and Embase. The random effects were used to calculate the pooled odds ratios (ORs) and 95% confidence interval (CIs) for the risk of lung cancer in BPs users compared with non-users. The stability of our results was evaluated by the sensitivity analysis. The publication bias was assessed in our study. The data in our study comes from the public database, therefore ethical approval is not necessary. Also, our study did not involve patient consent.

Four studies met our inclusion criteria. All the included studies are cohort studies. Our analysis indicated that there was no significant association between the use of BPs and the risk of lung cancer (OR 1.02, 95%CI 0.85- 1.24, I
2 71%). In our secondary analysis, the use of alendronate may increase the risk of lung cancer. The pooled OR of 3 studies is (OR 1.10, 95%CI 0.84–1.45, I
2 77%), but when we performed a sensitivity analysis, 1 of the OR is (OR 1.23, 95%CI 1.02–1.49, I
2 4.1%).

This is the most detailed meta-analysis on this topic. And there was no significant association between the use of BPs and lung cancer. However, exposure to alendronate may increase the risk of lung cancer. More studies are needed to confirm our findings.
Postoperative acute kidney injury and early and long-term mortality in acute aortic dissection patients
Authors: Meng Wenbin , Li Rui , E Lihua , Zha Nashunbayaer
Published: January 2021

Objective:

To evaluate the impact of postoperative acute kidney injury (AKI) on early and long-term mortality in patients with acute aortic dissection by conducting a meta-analysis.

Methods:

An extensive literature search was performed in PubMed and Embase databases until February 15, 2020. Observational studies that reported the associations between postoperative AKI and early (in-hospital and within 30 days) or long-term mortality in patients with acute aortic dissection were included.

Results:

Seven studies comprising 1525 acute aortic dissection patients were identified. A random effect meta-analysis showed that postoperative AKI was significantly associated with higher risk of long-term mortality (risk ratio [RR] 2.32; 95% confidence interval [CI] 1.50–3.59). Subgroup analysis revealed that the pooled RR of long-term mortality was 1.42 (95% CI 0.90–2.22) for stage 1 AKI, 1.72 (95% CI 0.95–3.12) for stage 2 AKI, and 4.46 (95% CI 2.72–7.32) for stage 3 AKI, respectively. Furthermore, postoperative stage 3 AKI was associated with an increased risk of early mortality (RR 11.3; 95% CI 4.2–30.5).

Conclusions:

This meta-analysis provided clinical evidence that postoperative stage 3 AKI is associated with higher risk of early and long-term mortality, even after adjusting important confounding factors. However, the current findings should be interpreted with caution due to the retrospective nature and limited number of studies analyzed.
Comparing the different viewpoints on overseas transplantation demands between genders and roles
Authors: Chen Hong-Mei , Shih Fu-Jong , Hu Rey-Heng , Shih Fu-Jin , Sheu Shuh-Jen
Published: January 2021

This study examined the different demands for overseas liver transplantation between genders and roles from the perspective of overseas liver transplant recipients and primary caregivers.

An exploratory qualitative method was employed using a purposive sample of individuals who had received overseas liver transplantation. We recruited 28 recipients and 29 family members from a leading hospital in Taiwan. Face-to-face semi-structured interviews were conducted with each participant, and data were analyzed using qualitative content analysis.

Three demands were identified across gender and roles:

Different patterns and meanings related to gender and roles were discussed. Male recipients were less enthusiastic about receiving the overseas liver transplantation. Rather, they complained about losing the economic and decision-making power due to body deterioration after overseas liver transplantation. Their primary need was to increase their dignity and significant position in the family. Female recipients were apprehensive for overseas liver transplantation and required more psychological support and positive experiences from other transplant recipients. Most male primary caregivers required a nursing aide quickly. Most female primary caregivers would engage in the health care task but needed more medical personnel, assistance, and high emotional support from relatives.

This study revealed the common and urgent demands of overseas liver transplant recipients and primary caregivers. The unique demands of recipients and primary caregivers based on their gender and roles were rooted in the potential influences of traditional cultures and modern medicine in an ethnic-Chinese society.
Road towards promoting patient safety practices among hospital pharmacists
Authors: Al-Surimi Khaled , Alwabel Ali Mohammed , Bawazir Amen , Shaheen Naila A.
Published: January 2021

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

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

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

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

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

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

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

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

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

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

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

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
The effectiveness and safety of Sun tip-flexible ureterorenoscope for the management of kidney stones
Authors: Yuan Yuecai , Zhong Rui , Lai Haibiao , Huang Zhifeng , Zeng Ye , Wu Song , Zhong Liang
Published: January 2021

Introduction:

Kidney stone is one of the urinary system diseases with a high incidence. In this study, we will evaluate the effectiveness and safety of Sun tip-flexible ureterorenoscope treating patients with kidney stone.

Methods and analysis:

English and Chinese literature about Sun tip-flexible ureterorenoscope treatment for kidney stones published before October 31, 2020 will be systematic searched in PubMed, Embase, Web of Science, Cochrane Library, Open Grey, Clinicaltrials.gov, Chinese Clinical Trial Registry, WANFANG, VIP Chinese Science and Technology Journal Database, CNKI, Chinese biomedical document service system (SinoMed). Only randomized controlled trials (RCTs) of patients with kidney stones will be included. Literature screening, data extraction, and the assessment of risk of bias will be independently conducted by 2 reviewers, and the 3rd reviewer will be consulted if any different opinions existed. Systematic review and meta-analysis will be produced by RevMan 5.3 and Stata 14.0. This protocol reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols (PRISMA-P) statement, and we will report the systematic review by following the PRISMA statement.

Results:

The current study is a protocol for systematic review and meta-analysis without results, and data analysis will be carried out after the protocol. We will share our findings in the fourth quarter of 2021.

Conclusion:

This study will provide recommendations for the effectiveness and safety of Sun tip-flexible ureterorenoscope for patients with kidney stones (KS), which may help to guide clinician.

Ethics and dissemination:

Ethical approval is not required as the review is a secondary study based on published literature. The results of the study will be published in peer-reviewed publications and disseminated electronically or in print.

Protocol registration number:

INPLASY2020110099
Efficacy and safety evaluation of hyperbaric oxygen therapy for patients with ulcerative colitis
Authors: Wang Wei , He Ying , Wen Dou , Jiang Shangshang , Zhao Xiaodong
Published: January 2021

Background:

Ulcerative colitis (UC) belongs to chronic colitis whose etiology and pathogenesis still have remained unclear. Hyperbaric oxygen therapy (HBOT) has been demonstrated to be effective for UC therapy. Still, evidence of its efficacy and safety is inconclusive. The purpose of the protocol is to evaluate the efficacy and safety of HBOT in UC therapy.

Methods:

This systematic review will retrieve studies that meet the requirements in Embase, MEDLINE, PubMed, Web of Science, Cochrane Library Central Register of Controlled Trials, the Chinese Biomedical Literature Database (CBM), China national knowledge infrastructure database (CNKI), Wei Pu database, Wan fang database, SinoMed, Google scholar, and Baidu Scholar from their inception to November 2020. Two authors are to be independent in their article selection, data collection, and research quality assessments. The primary outcome is the clinical effectiveness. And the secondary outcomes will include 4 criteria. RevMan 5.3 software will be utilized for analysis of the data.

Results:

The results of this study are to be submitted via a peer-reviewed journal.

Conclusions:

The study is to assess the effectiveness and safety of HBOT for UC and provide valid and reliable evidence regarding HBOT for UC.

INPLASY registration number:

INPLASY2020100118.