Short-term efficacy of platelet-rich plasma in the treatment of persistent olfactory dysfunction: systematic review and meta-analysis.

PURPOSE: To assess the short-term effects of topical platelet-rich plasma (PRP) injection on persistent refractory olfactory dysfunction. METHODS: A comprehensive literature search of the PubMed, SCOPUS, EMBASE, Web of Science, Google Scholar, and Cochrane databases was conducted for articles up to November 2023. The search focused on studies that compared the amelioration of olfactory dysfunction between a topical PRP treatment cohort and a control group (receiving either placebo or no treatment), along with pre- and post-treatment comparisons. Subgroup analysis of the evaluation of olfactory function was also performed. RESULTS: The improvement in olfactory scores 1-3 months post-treatment (standardized mean difference = 1.5354 [95% confidence interval: 0.7992; 2.2716], I2 = 83.8%) was greater in the treatment group than in the control group. In the treatment group, PRP increased the threshold, discrimination, and identification (TDI) score for Sniffin' Sticks by > 5.5 (minimum clinically significant difference; mean difference = 6.1789 [3.9788; 8.3789], I2 = 0.0%), indicating clinically significant improvement based on verified examinations. The rate of significant improvement among patients was 0.6683 [0.5833; 0.7436] after treatment. All TDI subdomains were significantly and similarly improved after treatment. CONCLUSION: This meta-analysis suggests that injection of PRP into the olfactory fissure or surrounding mucosal areas is an effective treatment for persistent refractory olfactory dysfunction in the short term.

Influence of denture-bearing conditions on masticatory function and patient-reported outcomes measures.

PURPOSE: To investigate the influence of different denture-bearing conditions on the masticatory function and patient-reported outcome measures (PROMs) of complete denture wearers. METHODS: Sixty edentulous patients were selected and allocated into two groups according to the American College of Prosthodontics' (ACP) classification: non-atrophic (NAT) (Classes I and II) (n = 24) and atrophic (AT) (Classes III and IV) (n = 36). All patients received new complete dentures (CDs). The objective variables (masticatory performance and swallowing threshold) were assessed as well as the PROMs (oral health-related quality of life (OHIP-EDENT), patient satisfaction) and quality of the prosthesis, at baseline (using the old CD) and after 4 months new prostheses use. Data were analyzed by Mann-Whitney test followed by the Generalized Equations Estimation (GEE), linear regression and Chi-square test. RESULTS: Higher masticatory performance was observed in the NAT group (p < .05) for both time points, baseline and after 4 months. However, compared to baseline, both groups showed significant masticatory improvement after 4 months (p < .05). Satisfaction and overall quality of life improved after 4 months with no difference between groups (p > .05). Regarding the quality of the CD, baseline results were significantly (p < .05) lower in the AT group, but after 4 months, no significant differences were found between groups and in intragroup analysis (p > .05). CONCLUSIONS: The denture-bearing conditions seems to impact masticatory function, but the PROMs are barely affected.

Circulating brain injury biomarkers for prediction of outcome after elective neurosurgery - a scoping review.

OBJECTIVE: There is a need for refined methods to detect and quantify brain injuries that may be undetectable by magnetic resonance imaging and neurologic examination. This review evaluates the potential efficacy of circulating brain injury biomarkers for predicting outcomes following elective neurosurgical procedures. METHODS: A comprehensive search was conducted using the Cochrane, PubMed, and Scopus databases. RESULTS: Analysis of 23 relevant studies revealed that specific biomarkers, including glial fibrillary acidic protein, neurofilament light chain, neuron-specific enolase, S100B, and tau, are significantly associated with the extent of brain injury and could potentially predict postsurgical outcomes. The evaluated studies described intracranial tumor surgeries and miscellaneous neurosurgical interventions, and demonstrated the complex relationship between biomarker levels and patient outcomes. CONCLUSIONS: Circulating brain injury biomarkers show promise for providing objective insights into the extent of perioperative brain injury and improving prognostication of postsurgical outcomes. However, the heterogeneity in study designs and outcomes along with the lack of standardized biomarker thresholds underscore the need for further research.

Pallidal and Thalamic Deep Brain Stimulation in the Treatment of Unilateral Dystonia: A Prospective Assessment.

BACKGROUND: The complexities of unilateral dystonia have led to exploring simultaneous (dual) globus pallidus internus (GPi) and motor ventral thalamus (Vim/Vop) deep brain stimulation (DBS), yet detailed assessments are lacking. OBJECTIVES: To assess the efficacy of GPi, Vim/Vop, and dual DBS in unilateral dystonia. METHODS: Three patients with unilateral dystonia (two idiopathic, one acquired), implanted with two DBS electrodes targeting ipsilateral Vim/Vop and GPi, were included. Three stimulation modalities were assessed. First, one electrode was activated, then the other, and finally, both electrodes were activated simultaneously. RESULTS: DBS yielded substantial symptomatic reductions in all three evaluated stimulation modalities. Patients exhibited varying responses regarding quality-of-life and depressive symptoms. Treatment satisfaction didn't align with clinical improvements, potentially affected by unrealistic expectations. CONCLUSIONS: This study contributes critical insights into GPi, Vim/Vop and simultaneous stimulation for unilateral dystonia. The safety of the procedure underscores the promise of this approach.

Postoperative Outcomes in Surgical Coronavirus Disease 2019 Patients: A Retrospective Cohort Study.

PURPOSE: Patients infected with severe acute respiratory syndrome coronavirus-2 (SARS-COV-2) who require surgical procedures are likely to experience higher postoperative mortality and morbidity. Our objective was to evaluate the perioperative course of patients infected with SARS-COV-2 undergoing surgical procedures. The purpose of this study was to describe the characteristics, outcomes, and the effect of the presence of symptoms. DESIGN: Retrospective cohort. METHODS: We analyzed the records of patients with SARS-CoV-2 infection who underwent surgical procedures from March 2020 to March 2021. Patients with ongoing infection at the time of surgery and those who had recently recovered were included. The primary outcome measure was 30-day in-hospital mortality after surgery. Secondary outcomes were intensive care unit (ICU) admission, length of stay in ICU, postoperative length of stay, and complications. FINDINGS: Data from 102 patients were analyzed. Twenty-four patients (23.5%) died postoperatively in the hospital within 30 days. Forty-four patients required ICU admission (average stay 13 days). The median postoperative length of stay was 8 days (interquartile range, 3.75 to 19.25 days). Pulmonary, thromboembolic, and surgical complications were noted in 29 (28.4%), 14 (13.7%), and 18 (17.6%), respectively. Patients aged 41 to 60 years experienced higher rates of pulmonary and thromboembolic complications. Comparison of asymptomatic versus symptomatic patients revealed significantly higher 30-day in-hospital mortality (9 [15%] vs 15 [35.7%], P = .019), ICU admission (17 [28.3%] vs 27 [64.3%], P < .001), length of stay in ICU (3 [2 to 11.5] vs 18 [7 to 27], P = .001), postoperative length of stay (6 [3 to 10.75] vs 12 [5 to 25.25], P = .016) and pulmonary complication rates (11 [18.3%] vs 18 [42.9%], P = .008) in the symptomatic patients. CONCLUSIONS: Symptomatic SARS-COV-2 patients undergoing surgical procedures experience significantly higher 30-day in-hospital mortality, ICU admission, longer ICU and hospital stay, and pulmonary complications.

Development of a core outcome set for physiotherapy trials in adults with bronchiectasis (the COS-PHyBE study): A Delphi study and consensus meeting.

Background: Physiotherapy is recommended for bronchiectasis management, but there is disparity in evidence supporting its use. This is partly because of inconsistency and poor reporting of outcomes in available studies. A Core Outcome Set (COS) may improve trial consistency and decrease reporting bias. This study aimed to develop a COS for physiotherapy clinical trials in adults with bronchiectasis. Methods: A comprehensive list of outcomes was developed using a systematic review and qualitative semi-structured interviews with patients with bronchiectasis and physiotherapists.An international two-round online Delphi survey was conducted. Outcomes scored 7-9 (crucial) by ≥ 70 % of participants and 1-3 (not that important) by ≤ 15 % of participants from each stakeholder in the Likert scale were nominated for inclusion in the COS. Nominated outcomes and those considered crucial by only one of the stakeholders' groups were further discussed and voted in an international consensus meeting. Results: A list of 137 outcomes was generated; 104 from literature and 33 from interviews. A Delphi survey containing 59 outcomes was completed by 171 participants from 20 countries. After the consensus meeting, representatives agreed on seven outcomes: health-related quality of life, respiratory symptoms, physical functioning, emotional and psychological functioning, fatigue, adherence to treatment, and functional exercise capacity. Conclusion: A minimum set of seven outcomes are recommended to be included as measurements in future trials evaluating physiotherapy interventions for bronchiectasis.

Disparities in perioperative mortality outcomes between First Nations and non-First Nations peoples in Australia: protocol for a systematic review and planned meta-analysis.

BACKGROUND: Health inequities persist among First Nations people living in developed countries. Surgical care is pivotal in addressing a significant portion of the global disease burden. Evidence regarding surgical outcomes among First Nations people in Australia is limited. The perioperative mortality rate (POMR) indicates timely access to safe surgery and predicts long-term survival after major surgery. This systematic review will examine POMR among First Nations and non-First Nations peoples in Australia. METHODS: A systematic search strategy using MEDLINE, Embase, Emcare, Global Health, and Scopus will identify studies that include First Nations people and non-First Nations people who underwent a surgical intervention under anaesthesia in Australia. The primary focus will be on documenting perioperative mortality outcomes. Title and abstract screening and full-text review will be conducted by independent reviewers, followed by data extraction and bias assessment using the ROBINS-E tool. Meta-analysis will be considered if there is sufficient homogeneity between studies. The quality of cumulative evidence will be evaluated following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria. DISCUSSION: This protocol describes the comprehensive methodology for the proposed systematic review. Evaluating disparities in perioperative mortality rates between First Nations and non-First Nations people remains essential in shaping the discourse surrounding health equity, particularly in addressing the surgical burden of disease. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021258970.

Filling the "GAP" in Real-World Assessment of Psoriatic Arthritis Disease Activity: Performance Characteristics of a Global/Pain Composite Endpoint.

INTRODUCTION: Some retrospective data sources, such as electronic health records in the USA, report composite outcome measures not fully validated in psoriatic arthritis (PsA). However, they often contain global assessments, such as a Physician Global Assessment (PhGA) and Patient Global Assessment (PatGA), along with patient-reported pain scores, which individually are considered validated in PsA. This research described the performance characteristics of a 3-item global assessment and pain (GAP) composite endpoint using data from the ixekizumab phase 3 PsA clinical trial program. METHODS: Discrimination of GAP was assessed by comparing placebo to active treatment arms. The magnitude of treatment effect and responsiveness were compared to Disease Activity Index for PsA (DAPSA), clinical DAPSA, DAPSA28, and Psoriatic Arthritis Disease Activity Score (PASDAS) using effect size (ES) and standardized response mean (SRM), respectively. Construct validity was evaluated through correlation among the composite endpoints, and with other physician- and patient-reported outcomes. Change in GAP was compared in patients who reached low disease activity (LDA) levels based on DAPSA, cDAPSA, and PASDAS vs those who did not. RESULTS: GAP discriminated between active treatment and placebo with statistically significant separation as early as week 1. The largest ES/SRM was seen with GAP (2.29/1.74) and PASDAS (2.47/1.68). GAP had the strongest correlation with PASDAS (0.81-0.92) and showed moderate correlations with patient-assessed physical function, low correlations with physician-assessed skin and nail psoriasis, and low to moderate correlation with physician-assessed enthesitis. A significantly greater improvement in GAP was seen in the groups achieving LDA states compared to those not (p < 0.001). CONCLUSION: The GAP composite, an abbreviated endpoint comprising measures common in electronic health records, has promising performance characteristics and could be used to address important clinical questions regarding outcomes and impact of PsA in existing datasets. CLINTRIALS. GOV IDENTIFIER: NCT01695239; NCT02349295.

When doctors are assessing patients with psoriatic arthritis in clinical trials, they use tools, which include questions that patients answer and questions that doctors answer, in addition to a physical exam, to help evaluate how patients are doing. In a routine clinical practice setting, all of these same tools may not be used because they take a longer time to document information during a patient office visit. The goals of this research were to (1) create a new tool, which uses questions that patients and doctors answer, to help doctors evaluate how patients with psoriatic arthritis are doing in routine clinical practice, and (2) to assess if this new tool works as well as older tools. The new tool has fewer questions for the doctor and patient to answer and may take less time to document information but may result in some symptoms that patients experience not being regularly assessed. Data from clinical trials were used to compare the new tool to older tools to evaluate if doctors are able to assess psoriatic arthritis the same way. The results of the study showed that doctors are able to assess patients with psoriatic arthritis similarly with the new tool compared to older tools. This information will increase awareness of the new tool and could make it easier for doctors to evaluate patients with psoriatic arthritis in routine clinical practice.

Effect of a self-care promoting program on engagement in self-care behaviors and health-related outcomes among persons with type 2 diabetes and diabetic retinopathy: A single-blind randomized controlled trial.

Background: Diabetic retinopathy (DR) is the most common microvascular complication of diabetes, leading to visual impairment and eventual blindness. Promoting self-care behaviors is crucial in controlling DR progression and preventing blindness. Objective: This study aimed to investigate the effects of a Self-Care Promoting Program (SCPP) on engagement in self-care behaviors, HbA1c levels, visual acuity (VA), severity of DR, and vision-related quality of life (VRQoL) among individuals with type 2 diabetes and DR. Methods: This study employed a single-blind randomized controlled trial design to compare SCPP with conventional diabetic care interventions (standard care). The SCPP was based on the Self-Care of Chronic Illness Theory, Self-efficacy theory, and the Association of Diabetic Care and Education Specialist (ADCES) guidelines incorporating health education, self-care maintenance, monitoring, and management skills training over 12 weeks. Ninety-eight participants were randomly allocated to the experimental or control group (n = 49 per group). While the experimental group received SCPP alongside standard care, the control group received standard care alone. Data collection occurred between May 2022 and March 2023 and included demographic information, the Self-Care of Diabetes Index questionnaire (SCODI), the self-care for diabetes eye care questionnaire (SCFDE), the impact of visual impairment questionnaire (IVI-Thai version), and retinal images for DR severity grading. Data analysis utilized descriptive statistics, Chi-Square tests, t-tests, and MANOVA. Results: Following 8 and 16 weeks of SCPP, the experimental group had significantly higher mean scores in engagement with self-care and eye-care behaviors compared to the control group (p <0.001). The highest scores were observed in self-care and eye-care confidence behaviors, followed by maintenance, monitoring, and management. Furthermore, HbA1c levels and VRQoL significantly decreased and were lower than those of the control group at week 16 (p <0.001 and p <0.05, respectively). However, there were no significant differences in VA, and DR severity increased in both groups by week 16. Conclusion: SCPP benefits individuals with DR, enhancing their confidence and ability to perform, monitor, and manage self-care behaviors. These strategies contribute to improved diabetes management, enhanced quality of life, and reduced DR-related blindness. Integrating SCPP into routine DR management is recommended, with nurses playing a pivotal role in overseeing and driving this integration, highlighting the critical role of nurses in managing this widespread global disease. Trial Registry Number: Thai Clinical Trials Registration (TCTR20230302002).

Adaptability of prognostic prediction models for patients with acute coronary syndrome during the COVID-19 pandemic.

BACKGROUND: The detrimental repercussions of the COVID-19 pandemic on the quality of care and clinical outcomes for patients with acute coronary syndrome (ACS) necessitate a rigorous re-evaluation of prognostic prediction models in the context of the pandemic environment. This study aimed to elucidate the adaptability of prediction models for 30-day mortality in patients with ACS during the pandemic periods. METHODS: A total of 2041 consecutive patients with ACS were included from 32 institutions between December 2020 and April 2023. The dataset comprised patients who were admitted for ACS and underwent coronary angiography for the diagnosis during hospitalisation. The prediction accuracy of the Global Registry of Acute Coronary Events (GRACE) and a machine learning model, KOTOMI, was evaluated for 30-day mortality in patients with ST-elevation acute myocardial infarction (STEMI) and non-ST-elevation acute coronary syndrome (NSTE-ACS). RESULTS: The area under the receiver operating characteristics curve (AUROC) was 0.85 (95% CI 0.81 to 0.89) in the GRACE and 0.87 (95% CI 0.82 to 0.91) in the KOTOMI for STEMI. The difference of 0.020 (95% CI -0.098-0.13) was not significant. For NSTE-ACS, the respective AUROCs were 0.82 (95% CI 0.73 to 0.91) in the GRACE and 0.83 (95% CI 0.74 to 0.91) in the KOTOMI, also demonstrating insignificant difference of 0.010 (95% CI -0.023 to 0.25). The prediction accuracy of both models had consistency in patients with STEMI and insignificant variation in patients with NSTE-ACS between the pandemic periods. CONCLUSIONS: The prediction models maintained high accuracy for 30-day mortality of patients with ACS even in the pandemic periods, despite marginal variation observed.

Modification of a parent-report sleep scale for individuals with CDKL5 deficiency disorder: a psychometric study.

STUDY OBJECTIVES: Sleep difficulties are common in CDKL5 deficiency disorder (CDD), a developmental and epileptic encephalopathy (DEE). This study evaluated the factor structure of the Disorders of Initiating and Maintaining Sleep (DIMS), Disorders of Excessive Daytime Somnolence (DOES) and Sleep Breathing Disorders (SBD) domains of the Sleep Disturbance Scale for Children (SDSC) for CDD. METHODS: A cross-sectional psychometric study design was used. Data were collected for 125 individuals aged 3 years or older who attended a US Centers of Excellence clinic or registered with the International CDKL5 Disorder Database. RESULTS: The median age was 10.3 years (range 3.2 - 40.7 years) and 105 (84%) were female. Two of the three SBD items related were not observed by most respondents and analysis was restricted to the DIMS and DOES domains. Using all items in the initial confirmatory factor analysis, two items in the DIMS domain and one item in the DOES domain loaded poorly. After deleting these items and repeating the analysis, item loading (0.524-0.814) and internal consistency (DIMS: 0.78, DOES: 0.76) statistics were good. The square of the inter-domain correlation coefficient was 0.17, less than Average Variance Extracted values for both domains and indicating good discriminant validity. The Tucker-Lewis and Comparative Fit indices were slightly lower than the threshold of >0.9 for establishing goodness of fit. CONCLUSIONS: The modified DIMS and DOES domains from the SDSC could be suitable clinical outcome assessments of insomnia and related impairments in CDD and potentially other DEE conditions.

Development of the Cutaneous Dermatomyositis Investigator Global Assessment (CDM-IGA): A De Novo IGA of Cutaneous Manifestations of Dermatomyositis.

INTRODUCTION: Dermatomyositis (DM) is a rare systemic autoimmune disease characterized by a distinctive debilitating skin rash and skeletal muscle weakness. It is unclear if existing clinical outcome assessment (COA) measures include the concepts of priority to patients and those necessary to fully capture improvements in the active cutaneous manifestations of DM. This study aimed to develop the Cutaneous Dermatomyositis Investigator Global Assessment (CDM-IGA), a de novo IGA, for use in clinical trials of adult DM. METHODS: Eight DM clinical experts participated in 60-min qualitative interviews consisting of concept elicitation and cognitive debriefing methodologies. Concept elicitation comprised open-ended questions with follow-up probes to explore clinicians' experiences of treating patients with DM, the impact of symptoms on patients' quality of life, and the severity levels of disease characteristics to explore DM progression. Cognitive debriefing required the clinical experts to perform a review of the CDM-IGA, designed to assess the severity of cutaneous disease activity of DM. After the interviews, a consensus meeting with three clinical experts was held to agree on any outstanding issues relating to the CDM-IGA. RESULTS: The CDM-IGA was iteratively developed using the opinions of nine clinical experts. Feedback provided by all clinicians agreed that erythema was the main active cutaneous manifestation of DM and should be the primary characteristic on the CDM-IGA, split by erythema color and extent. To determine cutaneous disease severity, experts suggested adding a metric called secondary changes, which combined erosion/ulceration and lichenification, which could modify the patient's final score. Three clinical experts suggested that a photo-guide to support assessments of erythema across different skin tones could be beneficial. CONCLUSIONS: A novel CDM-IGA was developed for use with adult patients with DM in clinical trials, based on an iterative development process that combined qualitative feedback from clinical experts of DM and importantly adult patients living with DM.

How intervention studies measure the effectiveness of medication safety-related clinical decision support systems in primary and long-term care: a systematic review.

BACKGROUND: Medication errors and associated adverse drug events (ADE) are a major cause of morbidity and mortality worldwide. In recent years, the prevention of medication errors has become a high priority in healthcare systems. In order to improve medication safety, computerized Clinical Decision Support Systems (CDSS) are increasingly being integrated into the medication process. Accordingly, a growing number of studies have investigated the medication safety-related effectiveness of CDSS. However, the outcome measures used are heterogeneous, leading to unclear evidence. The primary aim of this study is to summarize and categorize the outcomes used in interventional studies evaluating the effects of CDSS on medication safety in primary and long-term care. METHODS: We systematically searched PubMed, Embase, CINAHL, and Cochrane Library for interventional studies evaluating the effects of CDSS targeting medication safety and patient-related outcomes. We extracted methodological characteristics, outcomes and empirical findings from the included studies. Outcomes were assigned to three main categories: process-related, harm-related, and cost-related. Risk of bias was assessed using the Evidence Project risk of bias tool. RESULTS: Thirty-two studies met the inclusion criteria. Almost all studies (n = 31) used process-related outcomes, followed by harm-related outcomes (n = 11). Only three studies used cost-related outcomes. Most studies used outcomes from only one category and no study used outcomes from all three categories. The definition and operationalization of outcomes varied widely between the included studies, even within outcome categories. Overall, evidence on CDSS effectiveness was mixed. A significant intervention effect was demonstrated by nine of fifteen studies with process-related primary outcomes (60%) but only one out of five studies with harm-related primary outcomes (20%). The included studies faced a number of methodological problems that limit the comparability and generalizability of their results. CONCLUSIONS: Evidence on the effectiveness of CDSS is currently inconclusive due in part to inconsistent outcome definitions and methodological problems in the literature. Additional high-quality studies are therefore needed to provide a comprehensive account of CDSS effectiveness. These studies should follow established methodological guidelines and recommendations and use a comprehensive set of harm-, process- and cost-related outcomes with agreed-upon and consistent definitions. PROSPERO REGISTRATION: CRD42023464746.

Outcomes of direct oral anticoagulants with aspirin vs warfarin with aspirin: a registry-based cohort study.

Background: For patients anticoagulated with direct oral anticoagulants (DOACs) or warfarin and on aspirin (ASA) for nonvalvular atrial fibrillation and/or venous thromboembolism, it is unclear if bleeding outcomes differ. Objectives: To assess bleeding rates for ASA with DOACs vs warfarin and one another. Methods: Registry-based cohort study of patients followed by a 6-center quality improvement collaborative in Michigan using data from 2009 to 2022. The study included adults on ASA with warfarin or DOACs for atrial fibrillation and/or venous thromboembolism without a recent myocardial infarction or heart valve replacement. Results: After propensity matching by anticoagulant class, we compared 2 groups of 1467 patients followed for a median of 18.0 months. Any bleeding and nonmajor bleeding was increased with DOACs + ASA compared with warfarin + ASA (32.2 vs 27.8 and 27.1 vs 22.9 events/100 patient-years; relative risks [RRs], 1.1 and 1.2; 95% CIs, 1.1-1.2 and 1.1-1.3, respectively). After matching by drug, patients on apixaban + ASA vs warfarin + ASA had more bleeding (31.2 vs 27.8 events/100 patient-years; RR, 1.1; 95% CI, 1.0-1.2) and nonmajor bleeding but less major bleeding (3.8 vs 4.7 events/100 patient-years; RR, 0.8; 95% CI, 0.6-1.0) and emergency room visits for bleeding. Patients on rivaroxaban + ASA vs warfarin + ASA had more bleeding (39.3 vs 26.3 events/100 patient-years, RR, 1.5; 95% CI, 1.3-1.6), nonmajor bleeding, and thrombosis. Patients on apixaban + ASA vs rivaroxaban + ASA had significantly less bleeding (22.5 vs 39.3/100 patient-years; RR, 0.6; 95% CI, 0.5-0.7), nonmajor bleeding, major bleeding (2.1 vs 5.5 events/100 patient-years; RR, 0.4; 95% CI, 0.2-0.6), emergency room visits for bleeding, and thrombotic events. Conclusion: Patients on DOAC + ASA without a recent myocardial infarction or heart valve replacement had more nonmajor bleeding but otherwise similar outcomes compared with warfarin + ASA. Patients treated with rivaroxaban + ASA experienced more adverse clinical events compared with warfarin + ASA or apixaban + ASA.

Real-world effectiveness of belimumab in patients with lupus in China: RELIABLE observational cohort study protocol.

INTRODUCTION: The efficacy of belimumab in SLE has been demonstrated in randomised clinical trials, and its real-world effectiveness has been shown in studies in several countries. While belimumab was approved for treating SLE in China in 2019, data on its benefit in clinical practice are limited. This study will evaluate belimumab's effectiveness in China, using practical clinical measures, such as Lupus Low Disease Activity State (LLDAS), to add to the body of real-world evidence. METHODS AND ANALYSIS: The Real-world Effectiveness of beLImumAB in patients with systemic Lupus Erythematosus in China (RELIABLE) is an ambidirectional, observational descriptive cohort study across approximately 15 centres in China. Adults with SLE newly initiating belimumab with ≥1 measure of all five LLDAS components (SLE Disease Activity Index-2000; no new lupus disease activity; Physician Global Assessment; prednisolone-equivalent dose; immunosuppressants/biologics use) in the 3 months preceding belimumab initiation (index date) will be eligible and retrospectively and/or prospectively enrolled, depending on data availability. The retrospective follow-up will be ≤6 months, and retrospective and prospective patients will have a maximum 24-month follow-up. The primary objectives will be to describe the proportion of patients achieving LLDAS at 12 and 24 months post-index. The key secondary objective will be to describe the proportion of patients achieving LLDAS and each component at 3, 6, 9 and 18 months post-index. All data will be analysed descriptively; a statistical estimand will be applied to account for intercurrent events expected in a real-world setting. ETHICS AND DISSEMINATION: This study will comply with all applicable laws regarding patient privacy; institutional review board approval will be obtained before the study commencement. CONCLUSIONS: This study will evaluate belimumab's effectiveness in patients with SLE initiating belimumab in clinical practice in China. Using LLDAS will provide clinicians with valuable insights into the impact of belimumab on the treat-to-target strategy with a relevant measure that can be repeated across the clinical practice.

Factors associated with postoperative nausea and vomiting after laparoscopic cholecystectomy at the National Referral Hospital, Bhutan: a cross-sectional study.

INTRODUCTION: Postoperative nausea and vomiting (PONV) are common distressing symptoms experienced after laparoscopic cholecystectomy. We report the rate, and the factors associated with postoperative nausea and vomiting, the patterns of prophylactic antiemetic prescription, and the anesthetic techniques used among patients who underwent laparoscopic cholecystectomy at the Jigme Dorji Wangchuck (JDW) National Referral Hospital, Bhutan. METHODS: A cross-sectional study was conducted at the JDW National Referral Hospital, from January to December 2018. All the patients who underwent laparoscopic cholecystectomy under general anesthesia were included in the study. The demographic variables, premedication, induction agents, muscle relaxants, inhalational agents for maintenance, opioid and adjuvant analgesics, the reversal agents used, and the occurrence of PONV within 24 h were recorded. Data were analyzed using SPSS (version 23). Continuous variables were compared using a t-test or Mann-Whitney test, categorical variables were tested using chi-square or Fisher's exact tests. Binary logistic regression analysis was performed to determine the factors associated with postoperative nausea and vomiting. RESULTS: 190 patients underwent laparoscopic cholecystectomy under general anesthesia. The rate of PONV after laparoscopic cholecystectomy was 31.1% (59/190). Over half (53.7%, 102/190) of the study population were within 21-40 years of age, over 80% (157/190) were female, and 2/3rd were overweight and obese. The most frequently used premedication was ranitidine (39%, 34/87) and metoclopramide (31%, 27/87). More than half (57.4%, 109/190) of the patients received morphine as an opioid analgesic before induction. Sodium thiopentone was a commonly used induction agent (65.8%, 125/190). Succinylcholine and atracurium were mostly preferred muscle relaxants. Isoflurane and air were the most used inhalational anesthetic agents for the maintenance of anesthesia. Ondansetron was the most preferred anti-emetics during the intraoperative period. Previous history of motion sickness (OR 5.8, 95%CI 2.9-11.2, p < 0.001), and use of sodium thiopental (OR 4.1, 95%CI 1.9-9.1, p < 0.001) were independent risk factors for PONV. The use of antiemetics (OR 0.1, 95%CI 0.0-0.4, p = 0.002), propofol (OR 0.2, 95%CI 0.1-0.5, p < 0.001), adjuvant analgesic paracetamol (OR 0.4, 95%CI 0.2-0.8, p = 0.026), and adequate hydration with IV fluids (OR 0.9, 95%CI 0.9-1.0, p = 0.042) were preventive factors for PONV. CONCLUSION: The rate of PONV after laparoscopic cholecystectomy was high. History of motion sickness and use of sodium thiopental for induction were independent risk factors of PONV. The use of multimodal prophylactic antiemetics was robust and superior to monotherapy in preventing PONV. This finding re-emphasizes the need for risk stratification and appropriate use of antiemetics and anesthetic agents to prevent PONV.

Longitudinal changes in sodium concentration and in clinical outcome in mild traumatic brain injury.

Ionic imbalances and sodium channel dysfunction, well-known sequelae of traumatic brain injury (TBI), promote functional impairment in affected subjects. Therefore, non-invasive measurement of sodium concentrations using 23Na MRI has the potential to detect clinically relevant injury and predict persistent symptoms. Recently, we reported diffusely lower apparent total sodium concentrations (aTSC) in mild TBI patients compared to controls, as well as correlations between lower aTSC and worse clinical outcomes. The main goal of this study was to determine whether these aTSC findings, and their changes over time, predict outcomes at 3- and 12-month from injury. Twenty-seven patients previously studied with 23Na MRI and outcome measures at 22 ± 10 days (average ± standard deviation) after injury (visit-1, v1) were contacted at 3- (visit-2, v2) and 12-month after injury (visit-3, v3) to complete the Rivermead post-concussion symptoms questionnaire (RPQ), the extended Glasgow outcome scale (GOSE), and the brief test of adult cognition by telephone (BTACT). Follow-up 1H and 23Na MRI were additionally scheduled at v2. Linear regression was used to calculate aTSC in global grey and white matters. Six hypotheses were tested in relation to the serial changes in outcome measures and in aTSC, and in relation to the cross-sectional and serial relationships between aTSC and outcome. Twenty patients contributed data at v2 and fifteen at v3. Total RPQ and composite BTACT z-scores differed significantly for v2 and v3 in comparison to v1 (each P < 0.01), reflecting longitudinally reduced symptomatology and improved performance on cognitive testing. No associations between aTSC and outcome were observed at v2. Previously lower grey and white matter aTSC normalized at v2 in comparison to controls, in line with a statistically detectable longitudinal increase in grey matter aTSC between v1 and v2 (P = 0.0004). aTSC values at v1 predicted a subset of future BTACT subtest scores, but not future RPQ scores nor GOSE-defined recovery status. Similarly, aTSC rates of change correlated with BTACT rates of change, but not with those of RPQ. Tissue aTSC, previously shown to be diffusely decreased compared to controls at v1, was no longer reduced by v2, suggesting normalization of the sodium ionic equilibrium. These changes were accompanied by marked improvement in outcome. The results support the notion that early aTSC from 23Na MRI predicts future BTACT, but not RPQ scores, nor future GOSE status.