Outcome Index Research Articles

Balancing the Extent of Resection and Ischemic Complications in Insular Glioma Surgery: Technical Nuances and Proposal of a Novel Composite Postoperative Outcome Index.

Maximal safe resection remains the most desired goal of insular glioma surgery. Intraoperative surgical adjuncts provide better tumor visualization and real-time "safety" data but remain limited due to a high cost and limited availability. To highlight the importance of anatomical landmarks in insular glioma resection and avoidance of vascular complications. We also propose to objectify the onco-functional balance in insular glioma surgery. Forty-six insular gliomas operated upon by a single surgeon between January 2015 and February 2020 were reviewed, focusing on the operative technique and clinical outcomes. A novel composite postoperative outcome index (CPOI) was designed, comprising the extent of resection and permanent postoperative deficits, and utilized to assess the surgical outcomes. Gross-total, near-total, and subtotal resections were achieved in 10.9%, 52.1% (n = 24), and 36.9% (n = 17) patients, respectively. The median overall survival (OS) was 20 months (95% CI = 9.56-30.43). CPOI was optimal in 38 patients (82.6%). A well-defined tumor margin (P = 0.01) and surgeon's experience (P = 0.04) were significantly associated with an optimal CPOI. Out of seven (15.2%) patients who developed permanent neurological deficits, three (6.5%) patients had severe disability. Favorable prognostic factors of survival included younger age (<40 years) (P = 0.002), tumors with only frontal lobe extension (P = 0.011), tumors with caudate head involvement (P = 0.04), and non-glioblastoma histology (P = 0.006). Tumor margin and increasing surgeon experience are critical to an optimal postoperative outcome. Respecting the basi-sulcal plane is key to lenticulostriate artery preservation. Caudate head involvement is a new favorable prognostic factor in insular gliomas.

Efficacy of thunder-fire moxibustion in treating ankylosing spondylitis of kidney deficiency and governor meridian cold and its influence on TNF-\u03b1 and RANKL: study protocol for a prospective, nonblinded, single-center, randomized controlled trial

BackgroundAnkylosing spondylitis (AS) is a common chronic inflammatory spondyloarthropathy. It is considered in traditional Chinese medicine (TCM) that the pathogenesis of AS is mainly due to Yang deficiency of kidney governor meridian and internal prosperity of cold evil. Thunder-fire moxibustion is a kind of moxibustion that is characterized in abundance in drug composition, high heat radiation, and strong penetration. Thunder-fire moxibustion on the spinal segment of the governor meridian in treating AS seems compatible with the main pathogenesis of kidney deficiency and governor meridian cold. The trial aims to explore the efficacy of thunder-fire moxibustion in patients with AS of kidney deficiency and governor meridian cold and its influence on bone metabolism, through a prospective randomized trial.MethodsSixty patients with AS of kidney deficiency and governor meridian cold will be recruited and randomly assigned to the treatment group (thunder-fire moxibustion three times a week plus basic treatment) and the control group (basic treatment) at the Center of TCM of Beijing Luhe Hospital Affiliated to Capital Medical University (Beijing, China). Each patient will be treated for 4 weeks. The primary outcome is the efficacy of TCM syndrome, and the secondary outcome indexes will include the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Short-Form-36 Questionnaire (SF-36), tumor necrosis factor-α (TNF-α), and receptor activator of nuclear factor-κB ligand (RANKL). TNF-α and RANKL with observation will be determined once respectively before and after treatment, while the other indexes will be observed once prior to the treatment, 2 weeks post-treatment, and at the end of the treatment. Side effects will be recorded and analyzed as well. Inter-group comparison and analysis will be performed based on the intention-to-treat set and per-protocol set.DiscussionThis prospective randomized trial will help verify the efficacy of thunder-fire moxibustion in treating AS of kidney deficiency and governor meridian cold, discuss preliminarily its mechanism in treating this disease, and provide high-quality evidences for scientific researches on clinical treatment with thunder-fire moxibustion against AS.Trial registrationChinese Clinical Trial Registry ChiCTR2100044227. Registered on 12 March 2021

Effect of neuromuscular electrical stimulation on muscle strength in patients with mechanical ventilation in intensive care unit: cumulative Meta-analysis and trial sequential analysis

To evaluate the effect of neuromuscular electrical stimulation (NMES) on muscle strength and duration of mechanical ventilation through cumulative Meta-analysis and sequential trial analysis (TSA). Randomized controlled trial (RCT) of NMES intervention in intensive care unit (ICU) patients with mechanical ventilation were searched from PubMed database of US National Library of Medicine, EMbase database of Netherlands Medical Abstract, Web of Science, SinoMed database of China, CNKI, Wanfang data, VIP and other Chinese and English databases from database construction to July 15, 2021. The control group received ICU routine nursing or rehabilitation exercise; the experimental group received NMES (low frequency electric current through electrode stimulation to make muscle groups twitch or contract) based on routine care in ICU. Relevant data were screened, evaluated and extracted by two researchers independently. After extracting data, STATA 15.0 and TSA software were used to analyze the data and evaluate the research results. A total of 9 studies were enrolled, including 619 subjects. Among the 9 articles included, 2 were grade A and 7 were grade B, indicating good overall quality. Cumulative Meta-analysis showed that compared with ICU routine care, NMES improved muscle strength of patients undergoing mechanical ventilation [standardized mean difference (SMD) = 0.64, 95% confidence interval (95%CI) was 0.07 to 1.21] and shortened the duration of mechanical ventilation (SMD = -1.84, 95%CI was -2.58 to -1.10). TSA analysis of the two outcomes showed that the sample size of muscle strength outcome index (n = 518) and mechanical ventilation outcome index (n = 419) did not meet the expected information (RIS; n values of 618 and 685); the cumulative Z-value line of the muscle strength outcome index crossed the traditional boundary line and TSA boundary line, indicating that more tests were not needed to verify this result. In the outcome index of mechanical ventilation duration, it was found that the cumulative Z-value line only crossed the traditional boundary line, but did not cross the TSA boundary line, indicating that further studies in this area should be carried out in the future to demonstrate this result. NMES can improve ICU patients' muscle strength and reduce the duration of mechanical ventilation.

Prediction of Patient Hepatic Encephalopathy Risk with Freiburg Index of Post-TIPS Survival Score Following Transjugular Intrahepatic Portosystemic Shunts: A Retrospective Study.

BackgroundHepatic encephalopathy is a complication of portal hypertension. The Freiburg index of transjugular portosystemic shunt (TIPS) and patient outcomes have recently been described. This retrospective study was conducted at a single center in China and included 241 patients with portal hypertension who underwent TIPS implantation to evaluate the Freiburg index of post-TIPS survival score (FIPS) to predict hepatic encephalopathy.MethodsA single-center retrospective study including 241 patients who underwent TIPS operation between April 2015 and July 2019 was conducted. Clinical demographics and relevant clinical parameters within 24h after admission were collected. The prediction performances of FIPS, Child–Pugh and the model for end-stage liver disease (MELD) scores were compared by decision curve analysis and receiver operating characteristic (ROC) curve analysis. In addition, multivariate analyses were performed to identify independent predictors.ResultsEighty-three out of 241 patients (34.4%) finally developed post-TIPS hepatic encephalopathy. The area under the ROC curve of FIPS was 0.744 (95% confidence interval: 0.684–0.798). FIPS was identified as an independent risk factor for post-TIPS hepatic encephalopathy (hazard ratio: 2.23, 95% confidence interval: 1.71–2.90, p<0.001). Moreover, we further grouped the FIPS scores into two categories (FIPS ≤-0.97, low-risk; FIPS >-0.97, high risk) to improve its applicability. Patients with high FIPS scores had a significantly higher incidence of hepatic encephalopathy than patients with low FIPS scores (P<0.05).ConclusionThis study showed that FIPS could be used to evaluate the risk of hepatic encephalopathy in this patient group with improved predictive performance when compared with the Child–Pugh and MELD scores.

Reliability of facet fluid on preoperative MRI for prediction of segmental instability after decompression surgery for degenerative lumbar spinal stenosis.

The purpose of this study is to determine whether preoperative facet fluid on MRI can help predict segmental instability (SI) after decompression surgery. We analyzed 34 patients (14 men and 20 women, a total of 37 segments) who underwent decompression for degenerative lumbar spinal stenosis from June 2011 to August 2019 at a single institution. Mean age at the time of operation was 67.8. Postoperative assessment was performed uniformly 12 months (11~15 months) after the surgery. Preoperative facet fluid on MRI, pre- and postoperative slip percentage and segmental motion on lumbar lateral neutral and flexion-extension (LFE) radiographic images were measured. Visual analog scale (VAS) and necessities of interventional procedure or medication was also assessed for clinical outcomes. No significant association was found between preoperative facet fluid indices and pre- or post-operative slip percentage (P=0.134) and segmental motion (p=0.936). There were no significant association also between facet fluid indices and VAS of back or leg (p=0.997 and p=0.437 respectively). Preoperative facet fluid is not a predictive index of postoperative segmental instability or clinical outcome. Without segmental instability on LFE radiographic images, the presence of facet fluid in MRI is not an absolute indication for fusion.

Serum D-dimer level as a predictor of neurological functional prognosis in cases of head injuries caused by road traffic accidents

BackgroundThe number of traffic fatalities is declining in Japan; however, a large proportion of head injuries are still attributable to traffic accidents. Severe head trauma may cause progressive and devastating coagulopathy owing to exacerbated coagulation and fibrinolysis, which results in massive bleeding and poor patient outcomes. D-dimer is a fibrinolytic marker, which remarkably increases in severe coagulopathy due to the exacerbated fibrinolytic system. Because the degree of coagulopathy is associated with patient outcomes, the D-dimer level is a useful prognostic predictor in patients with head trauma. However, the usefulness of D-dimer in cases of head trauma caused by road traffic accidents remains inadequately explored. In this study, we investigated the relationship between D-dimer levels and outcomes in head injuries caused by traffic accidents.MethodsWe extracted data on traffic injuries from Japan Neuro-Trauma Data Bank Project 2015, which is a prospective multicenter registry of head injuries. The analysis included 335 individuals with no missing data. The outcome variable was the score of the Glasgow Outcome Scale (GOS), a neurological outcome index. The participants were categorized into the favorable outcome (GOS score ≥ 4) and poor outcome (GOS score ≤ 3) groups. The serum D-dimer levels at the time of admission were divided into four categories at the quartiles, and the reference category was less than the first quartile (< 17.4 µg/mL). We performed a logistic regression analysis with GOS as the dependent variable and D-dimer as a predictor and performed a multivariate analysis that was adjusted for 10 physiological parameters.ResultsIn the univariate analysis, all groups with serum D-dimer values ≥ 17.4 μg/dL showed significantly poorer outcomes than those of the reference group. In the multivariate analysis, after adjusting for other factors, D-dimer levels ≥ 89.3 μg/dL were an independent predictor of poor outcome.ConclusionAfter adjusting for physiological parameters, high serum D-dimer levels can be an independent factor for predicting neurological prognosis in head trauma caused by road traffic accidents.

Analysis of clinical application effects and challenges of early warning system for the high-risk obstetric women of China: A scoping review.

Obstetric critical illness is an important factor that leads to an increase in maternal mortality. Early warning assessment can effectively reduce maternal and neonatal mortality and morbidity. However, there are multiple early warning systems, and the effect and applicability of each system in China still need to be explored. To elaborate on the application, effectiveness and challenges of the existing early warning systems for high-risk obstetric women in China and to provide a reference for clinical practice. A scoping review guided by the Arksey and O'Malley framework and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis for scoping review (PRISMA-ScR) guidelines. We included original studies related to early warning and excluded those that were guidelines, consensus and reviews. The included studies were published in Chinese or English by Chinese scholars as of June 2021. CNKI, Wanfang, VIP, Cochrane, CINAHL, Embase, PubMed and Web of Science databases were searched systematically, and the reference sections of the included papers were snowballed. In total, 598 articles were identified. These articles were further refined using keyword searches and exclusion criteria, and 17 articles met the inclusion criteria. We extracted data related to each study's population, methods and results. Early warning tools, outcome indices, effects and challenges are discussed. Although all studies have shown that early warning systems have good application effects, the use of early warning systems in China is still limited, with poor regional management and poor sensitivity for specific obstetric women. Future research needs to develop more targeted early warning tools for high-risk obstetric women and address the current challenges in clinical applications.

The development and validation of the \u2018Good Life in the Community Scale\u2019 (GLiCS): a validation study with women migrants living in high income countries

BackgroundTo date, few assessment instruments have been developed to quantitatively measure the mental health status of migrant populations specifically. This paper describes the development and preliminary assessment of the ‘Good Life in the Community Scale’ (GLiCS). GLiCS is a wellbeing measure for migrant women in high-income settings that was coproduced with experts by experience across two phases.MethodsThe study used a mixed-methods approach and was composed of two phases. Phase I: 88 initial items generated using qualitative data collected in a previous study were reduced to 42 through consultation with expert advisory panels, based on whether each item was considered understandable and relevant Phase II: these 42 items were piloted with a sample of migrant women (N = 109). A preliminary exploratory factor analysis was conducted using Oblique rotation. Internal consistency was measured using McDonald’s ω. Convergent validity was tested by correlating the GLiCS with the Oxford Capabilities Questionnaire Mental Health (OxCAP-MH), WHO-5 wellbeing index and Objective Social Outcomes Index (SIX). Incremental validity was tested using hierarchical regression analysis to ascertain the effect on the WHO-5 wellbeing index of: age, migration status, SIX, OxCAP-MH and GLiCS. Known groups validity, the ability a measure has to discriminate between groups likely to differ on the variables of interest, was tested between the different migrant categories using a simple between subjects ANOVA.ResultsExploratory factor analysis confirmed a 17-item (three-factor: (i) access to resources, (ii) belonging and contributing, (iii) independence) scale with high internal consistency (McDonald’s ω = 0.91). Convergent and incremental validity were also evidenced.ConclusionThe GLiCS has demonstrable good internal consistency and construct validity, and it presents a promising wellbeing measure for better understanding the experience of migrant women.

The Effect of Personalized Feedback on Small Enterprises’ Finances in Uganda

This RCT examines the effect of a new style finance training during which participants are given personalized feedback on their financial business outcomes in addition to a “rules-of-thumb” training approach. We compare this to the effects of a “rules-of-thumb” training by itself and to a control group. Targeting about 500 small and micro entrepreneurs in Kampala, Uganda, we find that the personalized feedback training significantly improves outcomes at the six-months horizon. The index of primary outcomes increases by 0.258 SD units and overall savings improve by 0.257 SD units. Analyzing the feedbacks provided we find evidence that feedback works by increasing motivation, in line with “feedback-intervention-theory.” (This abstract was borrowed from another version of this item.)

The efficacy and safety of combined traditional Chinese and western medicine in the treatment of chronic obstructive pulmonary disease complicated with respiratory failure: a systematic review and meta-analysis study.

The conventional drugs to treat chronic obstructive pulmonary disease (COPD) complicated with respiratory failure (RF) (COPD + RF) in western medicine include antibiotics, etc., but the patients have serious adverse reactions and are prone to drug resistance. This study aims to analyze the curative effect of traditional Chinese medicine (TCM) combined with Western medicine (WM) in treating COPD + RF. Randomized controlled studies on the treatment of COPD with RF were searched in PubMed, Web of Science, Embase, and The Cochrane Library. Outcome measures were treatment efficiency, oxygen partial pressure (PO2), partial pressure of carbon dioxide (PCO2), and pulmonary function [forced expiratory volume in 1 second (FEV1)%]. The Cochrane Reviewer's Handbook 4.2.5 was adopted for quality assessment of studies, and the data was analyzed using RevMan 5.3. Seven suitable articles were selected, including 490 patients. The literature quality met the requirements of this article, and there was no obvious publication bias. The effective rate of patients in the combined TCM and WM treatment group and control group (WM treatment) was analyzed as odds ratio (OR) [95% confidence interval (CI): 5.40 (3.14 to 9.29)], and statistically tested as Z=6.09 (P<0.00001). The analysis structure of PO2 after treatment was mean difference (MD) (95% CI): 5.92 (2.27 to 9.56), and the statistical analysis suggested Z=3.18, P=0.001. The analysis of PCO2 after treatment was MD (95% CI): -4.53 (-7.14 to -1.92), and Z=3.40, P=0.0007. The analysis structure of lung function index data was MD (95% CI): 8.16 (2.57 to 13.75), and Z=2.86 (P=0.004). The TCM combined with WM can effectively treat the symptoms related to COPD; the treatment efficiency is significantly improved compared with traditional WM; and the PO2, PCO2, and lung function (FEV1%) are improved for sure after treatment. Data of this study show that the combined treatment of TCM and WM has a good therapeutic effect on the acute exacerbation of COPD complicated with RF, which is worthy of clinical application. However, the included outcome indexes in this study were not sufficient, and the sample size and outcome indexes should be further expanded in the future.

Effects of Early Palliative Care in Advanced Cancer Patients: A Meta-Analysis.

Objective: Advanced cancer patients often suffer from a reduced quality of life (QoL) and cancer-related symptoms. Early palliative care may improve their QoL and symptom severity. Methods: We conducted a meta-analysis of the effects of early palliative care on QoL, symptom severity, and other outcomes in advanced cancer patients, and searched PubMed, Embase, CINAHL, MEDLINE, and the Cochrane Library databases for potential randomized controlled trials (RCTs). The primary outcome was QoL. The secondary outcomes were symptom intensity and functional well-being (Trial Outcome Index, TOI). The study protocol has been registered and approved by PROSPERO (CRD42020164047). Results: We obtained 12 RCTs enrolling 2980 participants. Compared with the usual care, early palliative care significantly improved QoL at ≤ 3 months (SMD = .16, 95% CI = .05-.27) and when treated more 3months (SMD = .26, 95% CI = .11-.40). Compared with usual treatment, patients who received early palliative care exhibited a significant reduction in symptom intensity when treated more than 3months (SMD = .18, 95% CI = .06-.31) and in TOI ≤ 3months (SMD = .28, 95% CI = .11-.45). Conclusions: Early palliative care improves QoL, symptom intensity, and TOI in advanced cancer patients. We recommend introducing early palliative care for advanced cancer patients as the approach provides additional clinical benefits compared with usual care.

Impact of the implementation of the WHO Safe Childbirth Checklist on essential birth practices and adverse events in two Brazilian hospitals: a before and after study

ObjectiveThe WHO Safe Childbirth Checklist (SCC) is a promising initiative for safety in childbirth care, but the evidence about its impact on clinical outcomes is limited. This study analysed the...

Maternal Body Mass Index and Risk of Obstetric, Maternal and Neonatal Outcomes: A Cohort Study of Nulliparous Women With Spontaneous Onset of Labor

(Acta Obstet Gynecol Scand. 2021;100:521–530. doi: 10.1111/aogs.14017. Epub November 27, 2020) Worldwide obesity and body mass index (BMI) have dramatically increased in the past few decades. As obesity can increase risk for serious health problems, understanding its impact on pregnancy and delivery is essential to improve patient care, labor outcomes, and health outcomes. Despite past work, there is still a need for studies examining impact of BMI on nulliparous women versus multiparous women and on induced and spontaneous onset of labor. This study focuses on nulliparous women with a singleton fetus in cephalic presentation with spontaneous onset of labor at term within the Ten-Group Classification System (TGCS) group 1. The aim of this study was to analyze those within TGCS group 1 and investigate the relational effect of early-pregnancy maternal BMI and obstetric, maternal, and neonatal outcomes.

External Treatment With Chinese Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy: A Systematic Review and Meta-Analysis.

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse reaction of chemotherapy. Many studies have confirmed that traditional Chinese medicine (TCM) has unique advantages for treating CIPN. However, there is no standard TCM prescription in clinical practice or objective outcome index, and similar efficacy varies. Therefore, in this study, a systematic review of randomized controlled trials (RCTs) was performed to evaluate the clinical efficacy of external treatment with Chinese herbal medicine (CHM) for CIPN. This analysis provides evidence-based medical support for the use of CHM for external treatment of CIPN. Methods: Relevant RCTs assessing CHM external treatment of CIPN were searched in nine electronic databases, including the China National Knowledge Infrastructure Database, China Biology Medicine Disc, China Science and Technology Journal Database, Wanfang Database, PubMed, Cochrane Library, MEDLINE, Web of Science, and OVID, from inception to July 2021. A meta-analysis was performed on these studies using RevMan5.3 software. Results: Based on the inclusion and exclusion criteria, 33 clinical studies were included, while 1,354 studies were screened out. There were 2,356 patients in total, including 1,208 in the treatment group and 1,148 in the control group. In the treatment group, peripheral neurotoxicity rate, total effect rate, KPS score, TCM syndrome score and efficacy, pain NRS score, and pain relief rate were significantly improved compared with those of the control group (p < 0.01). Furthermore, the peroneal and median nerve conduction velocities were also improved compared with those in the control group (p < 0.05). By creating a funnel plot for the incidence of peripheral neurotoxicity and the total effect rate, we showed that the left and right sides were symmetrical, and that the publication bias was low. Conclusion: CHM external treatment was found to be an effective method for treating CIPN as it significantly improved clinical symptoms and quality of life in patients with CIPN. Clinical Trial Registration: identifier ChiCTR1900024617

Effects of Pain Neuroscience Education Combined with Lumbar Stabilization Exercise on Strength and Pain in Patients with Chronic Low Back Pain: Randomized Controlled Trial.

Chronic low back pain that lasts more than 12 weeks causes mental and physical distress. This study investigated the effects of pain neuroscience education combined with lumbar stabilization exercises on strength, pain, flexibility, and activity disorder index in female patients with chronic low back pain. Thirty-five female patients with chronic low back pain were randomly divided into two groups: the pain neuroscience education (PNE) combined with lumbar stabilization exercises (LSEs) group (n = 18, experimental group) and the lumbar stabilization exercises alone group (n = 17, control group). The experimental group underwent PNE combined with LSEs for 30 min per session, twice per week for 8 weeks, and the control group underwent LSEs only. The primary outcomes were strength (sit-up and back-up movements), Numerical Pain Rating Scale (NPRS), Korean Pain Catastrophizing Scale (K-PCS), and Tampa Scale of Kinesio-phobia-11 (TSK-11) for pain. The secondary outcomes were modified–modified Schober’s test (MMST) and finger to floor test (FFT) for flexibility and activity disorder (Roland–Morris Disability Questionnaire index). A significant difference was observed in the primary outcomes after intervention in the abdominal muscle strength (group difference, mean, −7.50; 95% CI, −9.111 to –5.889, F = 9.598; ANCOVA p = 0.005), the back muscle strength (group difference, mean, −9.722; 95% CI, −10.877 to –8.568, F = 7.102; ANCOVA p = 0.014), the NPRS (group difference, mean, 1.89; 95% CI,1.65 to 2.12, F = 24.286; ANCOVA p < 0.001), K-PCS (group difference, mean, 7.89; 95% CI, 7.02 to 8.76, F = 11.558; ANCOVA p = 0.003), and TSK-11 (group difference, mean, 16.79; 95% CI, 13.99 to 19.59, F = 13.179; ANCOVA p = 0.014) for pain. In the secondary outcomes, there was a significant difference in the FFT (group difference, mean, −0.66; 95%CI, −0.99 to −0.33, F = 4.327; ANCOVA p = 0.049), whereas the difference in flexibility (MMST) and activity disorder index of the secondary outcomes did not reach significance. Therefore, this study confirmed that PNE combined with LSEs is an effective intervention compared to LSE alone in improving muscle strength and pain in female patients with chronic low back pain.

Efficiency of a biodegradable gel containing hyaluronic acid and berberine hydrochloride in endoscopic sinus surgery (ESS): A prospective comparative study

PurposeTo evaluate the efficiency of a biodegradable gel containing hyaluronic acid and berberine hydrochloride in endoscopic sinus surgery. MethodsSixty-six chronic rhinosinusitis patients with or without nasal polyps who underwent bilateral endoscopic sinus surgery (ESS) were randomly received a biodegradable gel containing hyaluronic acid and berberine hydrochloride or merocel in both middle meatal spacers at the end procedure of ESS. Lund–Kennedy endoscopic score (LKES) was used to examine status of nasal cavity on preoperative day and postoperative day 1 to 7. The LKES ratio was calculated as the LKES on postoperative day divided into the LKES on preoperative day. Visual analogue score (VAS) was used to assess patient's status from the first postoperative day to the hospital discharge day. The average VAS during hospital stays was calculated by the sum of VAS in each examination day divided into the number of examined day. The LKES ratio, the average of VAS during hospital stays and length of hospitalized day of the patients were used as clinical outcome indices in early stage after surgery. A general linear model adjusted for confounding factors was used for data analysis. ResultsAdjusted mean of LKES ratio were lower in group used biodegrable gel of hyaruloic acid and berberin hydrochlode (study group) than those in merocele group in the postoperative day 1 to day 7. However, significant difference was found in the adjusted mean of LKES ratio on the postoperative day 2 to 6. Similarly, the adjusted mean of VAS during hospital stays and length of hospitalized day after surgery in study group were significantly decreased as compared with those in merocele group. ConclusionsBiodegradable material containing hyaluronic acid and berberine hydrochloride was more effective than merocel in length of hospital stay, post-operative symptoms, and sinus cavity's status in early stage after ESS.

Early heart rate variability evaluation enables to predict ICU patients\u2019 outcome

Heart rate variability (HRV) is a mean to evaluate cardiac effects of autonomic nervous system activity, and a relation between HRV and outcome has been proposed in various types of patients. We attempted to evaluate the best determinants of such variation in survival prediction using a physiological data-warehousing program. Plethysmogram tracings (PPG) were recorded at 75 Hz from the standard monitoring system, for a 2 h period, during the 24 h following ICU admission. Physiological data recording was associated with metadata collection. HRV was derived from PPG in either the temporal and non-linear domains. 540 consecutive patients were recorded. A lower LF/HF, SD2/SD1 ratios and Shannon entropy values on admission were associated with a higher ICU mortality. SpO2/FiO2 ratio and HRV parameters (LF/HF and Shannon entropy) were independent correlated with mortality in the multivariate analysis. Machine-learning using neural network (kNN) enabled to determine a simple decision tree combining the three best determinants (SDNN, Shannon Entropy, SD2/SD1 ratio) of a composite outcome index. HRV measured on admission enables to predict outcome in the ICU or at Day-28, independently of the admission diagnosis, treatment and mechanical ventilation requirement.Trial registration: ClinicalTrials.gov identifier NCT02893462.

Efficacy and safety of endothelin receptor antagonists combined with phosphodiesterase 5 inhibitor in the treatment of pulmonary arterial hypertension: a network meta-analysis

Objective: To examine the efficacy and safety of endothelin receptor antagonists (ERA) combined with phosphodiesterase 5 inhibitors (PDE5i) in the treatment of pulmonary artery hypertension (PAH). Methods: Computer-based retrieval was performed on PubMed, Cochrane Library, CNKI, Wanfang, and VIP database (up to February 12th, 2021). Randomized controlled trials about endothelin receptor antagonists (ERAs) or PDE5i in patients with PAH were collected. The change of 6-minute walking distance (6MWD) in 12-16 weeks was used as primary outcome index. Case fatality rate, worsening clinical events, WHO functional class (FC) improvement, adverse events (AEs), serious adverse events (SAE) were the key secondary outcomes indicators. STATA 16.0 software was used for network meta-analysis, and the pooled estimates of odds ratios (ORs) or weighted mean differences (WMDs) and 95% confidence intervals (CIs) of the results were shown. To help explain ORs and WMDs, we used the surface under the cumulative ranking curve (SUCRA) to calculate the probability of each intervention. Results: We included 29 trials with 5 949 participants. In network meta-analysis, Bosentan combined with Sildenafil (WMD=53.93, 95%CI=6.19-101.66) had shown the greatest improvement in 6MWD compared with placebo, followed by Bosentan combined with Tadalafil (WMD=50.84, 95%CI=7.05-94.62), Ambrisentan combined with Tadalafil (WMD=46.67, 95%CI=15.88-77.45), Bosentan (WMD=29.44, 95%CI=5.86-53.02), Ambrisentan (WMD=23.90, 95%CI=0.31-47.48) and Macitentan (WMD=21.57, 95%CI=2.45-40.69). According to SUCRA, the effects of different intervention measures on improving 6MWD in patients with arterial pulmonary hypertension were as follows: Bosentan+Sildenafil (82.9%)>Bosentan+Tadalafil (78.4%)>Ambrisentan+Tadalafil (77.1%)>Bosentan (49.2%)>Sildenafil (48.5%)>Ambrisentan (40.3%)>Macitentan (37.3%)>Tadalafil (33.0%)>Placebo (3.3%). For the WHO functional class, Sildenafil (OR=2.90, 95%CI=1.04-8.08) was optimal compared with placebo, followed by Bosentan (OR=2.15, 95%CI=1.15-4.04), and there was no significant difference in the rest. For clinical worsening, Bosentan combined with Tadalafil (OR=0.08, 95%CI=0.01-0.49) performed best compared with placebo, followed by Bosentan (OR=0.20, 95%CI=0.11-0.38), Bosentan combined with Sildenafil (OR=0.21, 95%CI=0.09-0.46), Ambrisentan combined with Tadalafil (OR=0.27, 95%CI=0.15-0.50), Sildenafil (OR=0.33, 95%CI=0.17-0.66) and Tadalafil (OR=0.44, 95%CI=0.21-0.90). There was no statistical difference between all interventions and placebo in terms of the incidence of adverse events and serious adverse events. For case fatality rate, Ambrisentan (OR=0.28, 95%CI=0.11-0.74) was statistically superior to placebo and there was no statistics difference in the rest. Conclusions: The combination therapy of ERAs and PDE5i performed well in the short-term improvement of motor function. Furthermore, there was no significant difference with monotherapy in terms of safety. However, it is worth emphasizing that the choice of treatment should be based on the patient's individualized situation and the patient's requirements.

Proposal of modified textbook outcome for improving the quality of gastric cancer surgery: A single-center study.

270 Background: Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Since 2014, the national healthcare quality assessment has been implemented for gastric cancer in Korea, which has the highest incidence. The proportion of early gastric cancer through early detection is high in Korea, and gastric cancer surgery has a great influence on outcome index. The aim of this study is to find indicators that can improve Textbook outcome (TO) in patients undergoing gastric cancer surgery. Comparing with Western data, we intended to propose a modified TO (mTO). Methods: Using a prospective clinical database, we included consecutive cases of gastrectomy for primary gastric cancer between 2014 and 2016. TO was achieved when 10 original indicators proposed by the DUCA group were satisfied. We propose to adjust the index of the number of retrieved lymph nodes from 15 to 30 as the modified TO(mTO) indicator for improving the quality of gastrectomy. For comparison with Western data, we calculated TO, mTO and survival in stage I versus Stage II and III. Results: A total of 2,153 patients were included. TO was achieved in 80.1 percents by 10 original indicators. Most of the indicators showed more than 90 percents of TO satisfaction. Five-year survival was significantly different between the TO (90.0%) and non-TO (76.1%) groups ( P &lt; 0.001). For 608 patients in stage II and III, TO was 72.9 percents, which was much higher than the Western publications. Five-year survival were 74.8 percents for the TO group and 56.8 percents for the non-TO group in stage II and III patients. We found that the number of metastatic lymph nodes increases as the stage increases and even the number of metastatic lymph nodes in stage IIIC exceeded 19. The modified textbook outcome (mTO) for stage II and III was 65.3 percents, and five–year survival was significantly different between mTO (74.0%) and mnon-TO (62.1%) groups ( P &lt; 0.001). To prevent R1 resection and minimize the proportion of remnant total gastrectomy, we performed frozen study examinations of the proximal and distal margins as to ensure high oncological safety. Conclusions: Data from a high volume gastric cancer center showed the high textbook outcome rates. It suggests that the minimum number of lymph node retrievals should be at least 30, even in advanced gastric cancer, and routine intraoperative frozen study examination are necessary to increase R0 resection.

Extracorporeal Shockwave Therapy as an Adjunctive Therapy for Frozen Shoulder: A Systematic Review and Meta-analysis.

Background:The best nonsurgical treatment for frozen shoulder is still unclear. Extracorporeal shockwave therapy (ESWT) is an innovative adjunctive treatment for frozen shoulder, but its effect is still unclear.Purpose:To evaluate the published literature regarding the potential of ESWT as an adjunctive therapy for frozen shoulder.Study Design:Systematic review; Level of evidence, 1.Methods:Searches were conducted in the PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure (CNKI), and VIP Information databases for relevant studies between inception and November 2020. Included were randomized controlled trials (RCTs) for frozen shoulder that compared ESWT with routine treatments to controls. There were no restrictions on the treatment period, type of ESWT, or severity of symptoms. At least 1 of the following outcome indices was assessed: visual analog scale (VAS) for pain, Constant-Murley score (CMS) for shoulder function assessment, or external rotation range of movement (ER ROM). RevMan 5.3 software was used to evaluate the bias and quality of the included studies. For continuous variables, the mean difference (MD) or standardized MD (SMD) with the 95% CI was extracted. For dichotomous data, event ratios and sample sizes were extracted.Results:Overall, 20 studies were included. The ESWT used as an adjunct to other interventions had better outcomes compared with control groups regarding immediate and short-term analgesic effects (immediate: MD, –1.10 [95% CI, –1.27 to –0.92], P < .00001; short-term: MD, –0.72 [95% CI, –0.94 to –0.50], P < .00001) as well as immediate function (SMD, 1.54 [95% CI, 1.19 to 1.89], P < .00001], I 2 = 0%). There was significant heterogeneity between studies for long-term analgesia (MD, –0.90 [95% CI, –1.40 to –0.41], P < .00001, I 2 = 89%) and ER ROM (MD, 10.31 [95% CI, 3.46 to 17.17], P < .003, I 2 = 93%).Conclusion:ESWT seems to be beneficial to patients with frozen shoulder by alleviating pain and improving function. ESWT could be used as an adjunct therapy to routine treatments, although the quality of the included RCTs was hampered by significant heterogeneity regarding long-term analgesia and joint ROM.