Protocol Registration Research Articles

Privacy-Enhanced AKMA for Multi-Access Edge Computing Mobility

Multi-access edge computing (MEC) is an emerging technology of 5G that brings cloud computing benefits closer to the user. The current specifications of MEC describe the connectivity of mobile users and the MEC host, but they have issues with application-level security and privacy. We consider how to provide secure and privacy-preserving communication channels between a mobile user and a MEC application in the non-roaming case. It includes protocols for registration of the user to the main server of the MEC application, renewal of the shared key, and usage of the MEC application in the MEC host when the user is stationary or mobile. For these protocols, we designed a privacy-enhanced version of the 5G authentication and key management for applications (AKMA) service. We formally verified the current specification of AKMA using ProVerif and found a new spoofing attack as well as other security and privacy vulnerabilities. Then we propose a fix against the spoofing attack. The privacy-enhanced AKMA is designed considering these shortcomings. We formally verified the privacy-enhanced AKMA and adapted it to our solution.

Efficacy of adjunctive intensive transcranial direct current stimulation of different cortices in treatment-resistant depression: a study protocol for a randomized double-blinded sham-controlled trial

BackgroundTreatment-resistant depression (TRD) carries a high economic burden worldwide. Transcranial direct current stimulation (tDCS) is advantageous for improving cognition and can be safely used in the treatment of depression. The effectiveness of tDCS of the left and right orbitofrontal cortex (OFC) as adjuvant treatment in patients with TRD has rarely been explored. Therefore, the objective of this trial is to evaluate the effectiveness there of when administering left dorsolateral prefrontal cortex (DLPFC) positive stimulation or OFC negative stimulation in patients with TRD.MethodsNinety eligible participants will be recruited to receive intervention at Shanghai Mental Health Center. Treatment will be randomly assigned in a double-blind fashion. Participants will receive either DLPFC (n = 30), OFC (n = 30), or sham (n = 30) tDCS, while continuing their usual pharmacotherapy at a stable dosage for at least 2 weeks before enrollment and throughout the stimulation period. All participants will receive 20 weekday stimulation sessions of 60 minutes duration each. Participants in the active group will be stimulated at 2 mA throughout the session, whereas the sham group will receive only a brief period of stimulation to mimic the sensation. After 20 stimulation sessions, no further treatment will be administered. Measurements will be conducted at regular points throughout and at 8 weeks after trial completion. The primary outcome is the change in the 17-item Hamilton Depression Rating Scale (HAMD-17) score after 20 sessions. Secondary outcomes were defined as changes in other measurement scales, cognitive function, resting-state functional magnetic resonance imaging (rs-fMRI), and serum biomarkers.DiscussionWe hypothesize that, in contrast to the sham group, both the active DLPFC and OFC tDCS groups will show superiority in HAMD-17 score reduction after 5, 10, and 20 sessions. Moreover, associations of the improvement of depressive symptoms with variations in rs-fMRI and TRD-related biomarkers will be evaluated. Our study may suggest that adjunctive intensive tDCS with left DLPFC positive stimulation or right OFC negative stimulation may be effective as a novel method to relieve depressive symptoms in patients with TRD. The variation of rs-fMRI, biomarkers could be used as a potential prediction model of treatment efficacy in TRD.Trial registrationThe trial protocol is registered with www.chictr.org.cn under protocol registration number ChiCTR2200058030. Date of registration: March 27, 2022. Recruitment started in September 2022 and is ongoing.

Inconsistent Outcome Reporting in Heart Failure Randomized Controlled Trials

Randomized controlled trials (RCTs) may report outcomes different from those prespecified on trial-registration websites, protocols and statistical analysis plans (SAPs). This study sought to investigate the prevalence and characteristics of heart failure (HF) RCTs that report outcomes different from those prespecified. MEDLINE via PubMed was searched to include phase II-IV HF RCTs in 9 high-impact journals from 2010 to 2020. Outcomes reported in trial publications were compared with prespecified outcomes in protocols, registration websites and SAPs. We used the χ2 or Fisher exact test to analyze correlations between trial characteristics and inconsistencies. Among 216 trials, 32 inconsistencies were observed in 28 trials (13.0%). Among 32 inconsistencies, 2 (6.3%) pertained to omission of prespecified primary outcomes, 4 (12.5%) to omission of prespecified secondary outcomes, 2 (6.3%) to changing prespecified primary outcomes to secondary outcomes, and 2 (6.3%) to changing prespecified secondary outcomes to primary outcomes. Of the inconsistencies, 3 (9.4%) pertained to addition of new primary outcomes, 17 (53.1%) to addition of new secondary outcomes, and 2 (6.3%,) to changes in the timing of assessment of primary outcomes. The majority of the inconsistencies favored statistically significant findings; 78 (36.1%) were registered retrospectively. Single-center recruitment was associated with outcome inconsistencies (β = -0.14; 95% CI, -0.22 - -0.01; P = 0.035). More than 1 in 10 trials reported outcomes inconsistent with those specified in trial registration websites, SAPs and protocols. An action plan is warranted to minimize selective reporting and improve transparency.

Efficacy of Fu's Subcutaneous Needling in Treating Soft Tissue Pain of Knee Osteoarthritis: A Randomized Clinical Trial.

Fu's subcutaneous needling (FSN) is a new acupuncture technique that produces a long-lasting effect in soft-tissue injuries. In patients with degenerative knee osteoarthritis (OA), myofascial trigger points (MTrPs) are common in the lower-limb muscles. In this randomized clinical trial, we evaluated the immediate, 1-week and 2-week effectiveness of FSN therapy in the treatment of degenerative knee OA. We randomly divided 32 patients with knee OA into the FSN group (mean age: 65.73 ± 6.79 years) or the transcutaneous electrical nerve stimulation (TENS) group (mean age: 62.81 ± 5.72 years). The pressure pain threshold (PPT) and tissue hardness (TH) of the muscle and tendon attachment sites, knee range of motion, and physical ability (average walking speed) were measured. The subjective pain intensity index, Western Ontario and McMaster Universities OA Index (WOMAC), and Lequesne index were used to determine the efficacy of FSN on MTrP-induced soft-tissue pain compared with that of TENS. A significantly greater improvement in pain qualities in the VAS (p < 0.05) was found in the FSN group. Moreover, in muscle and tendon qualities (including PPT and TH), a significant difference in the PPT of the quadriceps muscle (p < 0.05) was also observed among the immediate treatments in the FSN group. As for the functional index questionnaire assessment, the FSN group exhibited significant improvements among the immediate, 1-week and 2-week efficacies in terms of WOMAC (p < 0.05) and Lequesne index scores (p < 0.05). FSN was effective in treating soft-tissue pain in degenerative knee OA in terms of alleviating pain, strengthening walking ability, and improving overall functional performance. Pain relief was the primary benefit of FSN and a significant correlation between pain relief and knee joint mobility improvement was found. ClinicalTrials.gov Protocol Registration and Results System (registration number: NCT04356651).

Anastomotic leak test using indocyanine green during laparoscopic Roux-en-Y gastric bypass: A cohort study.

Indocyanine green (ICG) can be injected into the human bloodstream and it allows us to show stomach vascularity in real time. The aim of our study is to observe the preliminary results of the application of indocyanine green fluorescence (IGF) during laparoscopic Roux-en-Y Gastric Bypass (RYGB in our center and how the perfusion of the gastro-jejunal anastomosis affects the onset of fistula. 30 consecutive patients underwent RYGB with ICG fluorescence angiography at our center from January 2020 to December 2021.5ml of ICG were then injected intravenously to identify the blood supply of the stomach and the gastro-jejunal anastomosis. The UIN for ClinicalTrial.gov Protocol Registration and Results System is: NCT05476159 for the Organization UFoggia. In the RYGB tested with ICG, we all have adequate perfusion but despite this a methylene blue test was positive and allowed us to reinforce the suture of the gastro-jejunal anastomosis. Intraoperative ICG testing during laparoscopic RYGB may be helpful in determining which patients are at an increased risk for leakage but multiple factors concur to the pathophysiology and the incidence of gastric fistula not only the perfusion.

Effectiveness of intensive perioperative nutrition therapy among adults undergoing gastrointestinal and oncological surgery in a public hospital: study protocol for a pragmatic randomized control trial

BackgroundPerioperative malnutrition is common in patients undergoing gastrointestinal-oncology surgery and is associated with longer hospital stays, increased postoperative complications, poorer quality of life, and lower survival rates. Current practice emphasizes the role of early perioperative nutrition therapy as an early intervention to combat the postoperative complications of patients and the implementation is now widely adopted. However, there is still a lack of research on determining the effectiveness of intensive nutrition therapy and providing ONS perioperative locally. This becomes the significance of this study and serves as a basis for management and guideline in the local hospital settings.MethodsThis is a pragmatic randomized control trial study where elective admitted patients will be randomly divided into the intervention (SS) or control (NN) group. All data will be collected during a face-to-face interview, anthropometric measurement, blood sampling (albumin, white blood count, hemoglobin, and c-reactive protein), handgrip strength, and postoperative complications. Group SS will be receiving a tailored lifestyle and intensively supplemented with oral nutrition support as compared to Group NN that will receive standard medical care. The primary outcome for this study is the length of stay in the hospital. Additional outcome measures are changes in biochemical profile and nutritional and functional status. The effects of intervention between groups on the outcome parameters will be analyzed by using the SPSS General Linear Model (GLM) for the repeated measure procedure.DiscussionThe intervention implemented in this study will serve as baseline data in providing appropriate nutritional management in patients undergoing gastrointestinal and oncological surgery.Trial registrationClinicalTrials.gov Protocol Registration and Results System (PRS) NCT04347772. Registered on 20 November 2019.

Evaluation of the Reporting Standard Guidelines of Network Meta-Analyses in Physical Therapy: A Systematic Review.

The concept of network meta-analyses (NMA) has been introduced to the field of physical therapy. However, the reporting standard guidelines of these studies have not been evaluated. In this systematic review, we included all published NMA physical therapy studies that compared the clinical efficacy of three or more interventions to evaluate whether NMAs in physical therapy exhibit adequate reporting recommendations. PubMed, EMBASE, Web of Science, and the Cochrane Library were searched up to 30 June 2022. Among the 252 identified articles, 19 NMAs including 805 randomized controlled trials were included. We applied both preferred reporting items for systematic reviews and meta-analysis (PRISMA) and PRISMA-NMA checklists, which are 27- and 32-item reporting standard guidelines assessment tools, respectively. Protocol registrations (68.4%), risk of bias across studies (63.2%), additional analysis (57.9%), and funding (31.6%) were problematic items considering the PRISMA guidelines. Four studies reported all five new NMA-reporting items, and 15 (78.9%) did not address items S1-5 from the PRISMA-NMA guidelines. The median score (interquartile range) of the reporting standard guidelines was 27.0 (25.8-28.0). The identified shortcomings of published NMAs should be addressed while training researchers, and they should be encouraged to apply PRISMA-NMA, as a recognized tool for assessing NMA reporting guidelines is required.

A double-blinded, randomized controlled clinical trial of hydrogen inhalation therapy for idiopathic sudden sensorineural hearing loss.

Hydrogen (H2) has been reported to be effective in reducing hearing loss due to several causes in animal studies. However, no study has examined the effectiveness of H2 in treating hearing loss in humans. Thus, we investigated whether H2 is effective for the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL). We conducted a double-blind randomized controlled trial at six hospitals between June 2019 and March 2022. The study protocol and trial registration have been published in the Japan Registry of Clinical Trials (jRCT, No. jRCTs06119004). We randomly assigned patients with ISSNHL to receive either H2 (H2 group) or air as a placebo (control group) through inhalation combined with the administration of systemic glucocorticoids and prostaglandin E1. The primary outcome was the hearing threshold and changes in hearing threshold 3 months after therapy. In contrast, the secondary outcomes included the proportion of patients with a good prognosis (complete recovery or marked improvement). Sixty-five patients with ISSNHL (31 and 34 in the H2 and control groups, respectively) were included in this study. The hearing threshold 3 months after treatment was not significantly different between the groups; 39.0 decibels (dB) (95% confidence interval [CI]: 28.7-49.3) and 49.5 dB (95% CI: 40.3-58.7) in the H2 and control groups, respectively. In contrast, the changes in hearing threshold 3 months after treatment was 32.7 dB (95% CI: 24.2-41.3) and 24.2 dB (95% CI: 18.1-30.3) in the H2 and control groups, respectively. Consequently, the changes in hearing threshold were significantly better in the H2 group than in the control group (P = 0.048). However, no adverse effects due to the inhalation of H2 gas have been reported. This is the first study to investigate the efficacy of H2 for the treatment of ISSNHL in humans. The results suggest that H2 therapy may be effective for ISSNHL treatment. [https://jrct.niph.go.jp/re/reports/detail/10442], identifier [jRCTs06119004].

The Scientific Rigor of the Objective Structured Examination for Competency Assessment in Health Sciences Education: A Systematic Review

Background and Purpose. The objective structured clinical examination (OSCE) is widely used as an assessment of competency in health sciences education. The aim of our systematic review was to appraise the scientific rigor of the OSCE as a competency-based assessment in health sciences education, including physical therapy. Methods. Our search was performed in 6 databases—Ovid MEDLINE(R), CINAHL, EMBASE, APA PsycINFO, ERIC, and Web of Science—to identify original data evaluating the OSCE in programs of education in physical therapy and related health sciences disciplines. Data were extracted as per the Utility Model to evaluate the validity, educational impact, reliability, acceptability, and costs of the OSCE in these programs. Results. The search identified 106 records, with 13 studies meeting our eligibility criteria. The OSCE is distinct from traditional clinical assessments, with low-to-fair concurrent validity between the 2 assessment types. The OSCE was used for instructional design, namely, curriculum development and alignment, and for educational practice, namely, making decisions on students' readiness for practice. Limitations of the OSCE include poor-to-low validity to predict practice readiness and low-to-acceptable reliability, with student-specific, domain-specific, and examiner-specific effects on outcomes identified. Strategies were provided which could improve the scientific rigor of the OSCE. Discussion and Conclusion. Based on current evidence, the scientific rigor of the OSCE may be insufficient to support its use to make academic decisions on students' standing in health sciences programs, including physical therapy, and readiness for clinical practice, with confidence. However, the OSCE can play an important role in instructional design and in guiding student learning. Protocol registration: PROSPERO, ID 162338.

Does use of animal therapy during dental care help to reduce anxiety in children and adolescents? A systematic review.

Animal-assisted therapy (AAT) is considered a useful technique to reduce anxiety in children and adolescents in medical settings. To investigate whether the use of AAT helps to reduce anxiety during dental care in children and adolescents. Systematic review that included randomized and nonrandomized clinical trials with children up to 18-years of age undergoing dental appointments. The databases Embase, Cochrane, Pubmed/Medline, LILACS, PsycInfo, Scopus, and Web of Science were searched including gray literature. Random-effects meta-analyses using mean difference (MD) and narrative synthesis (vote counting) were implemented. Risk of bias was assessed using RoB2 for randomized clinical trials. The certainty of the evidence was performed using GRADE. A total of 1103 references were identified, and after a two-phase selection, three studies were included. Anxiety, behavior, and pain were the outcomes. A meta-analysis with 146 participants was performed for anxiety at three time points: before treatment (MD -0.40, CI: -1.06 to 0.26; I2 = 0%; p=.24), during treatment (MD -3.64, CI: -11.18 to 3.91; I2 = 94%; p=.34), and after treatment (MD -5.97, CI: -17.08 to 5.14; I2 = 98% p=.29). There was no difference during dental treatment with or without ATT (dogs), as well as for narrative analysis for any outcome. The risk of bias was high mainly because of the randomization and outcome measurement. There is no evidence to support or refute that the presence of AAT during dental care can help reduce anxiety in children (5-11 years). Studies with larger samples are suggested. Protocol registration (CRD42021293593).

Examining the empirical evidence for IDEAL 2b studies: the effects of preceding prospective collaborative cohort studies on the quality and impact of subsequent randomized controlled trials of surgical innovations – protocol for a systematic review and case–control analysis

Randomized controlled trials (RCTs) in surgery face methodological challenges, which often result in low quality or failed trials. The Idea, Development, Exploration, Assessment and Long-term (IDEAL) framework proposes preliminary prospective...

Healthcare Resource Utilization and Costs for Empagliflozin Versus Glucagon-Like Peptide-1 Receptor Agonists in Routine Clinical Care in Denmark.

The sodium-glucose cotransporter 2 inhibitor (SGLT2i) empagliflozin has shown reductions in major adverse cardiac events similar to glucagon-like peptide-1 receptor agonists (GLP-1RAs). However, evidence is limited about how these therapies compare regarding overall healthcare resource utilization and costs in routine clinical care. We conducted a comparative cohort study based on linked prospective healthcare databases for the entire population of Denmark during 2015-2018. We included 13,747 new users of empagliflozin and 13,249 new users of GLP-1RAs. Propensity scores were applied to balance potential confounders across the two treatment groups through inverse probability treatment weighting (IPTW). We assessed directly referable costs per person-year associated with healthcare resource utilization (inpatient, emergency room, and outpatient clinic hospital care, primary care health services, and prescription medication costs at pharmacies) among drug initiators while on-treatment. The two IPTW cohorts were well balanced at baseline (median age 61years, 60% men, diabetes duration 6.7years, 19% with pre-existing ischemic heart disease, 8% with pre-existing cerebrovascular disease), with similar healthcare costs in the previous year. During follow-up, average on-treatment costs per person-year were very similar among empagliflozin and GLP-1 RA initiators for the following services: inpatient hospitalizations (13,565 DKK versus 13,275 DKK), hospital outpatient clinic visits (12,007 DKK versus 12,152 DKK), emergency room visits (370 DKK versus 399 DKK), and primary care services (4108 DKK versus 4302 DKK). Total costs for any prescription drugs were clearly lower for empagliflozin initiators than for GLP-1 RA initiators (8946 DKK versus 14,029 DKK). In sum, overall healthcare costs on-treatment were lower for empagliflozin initiators (38,995 DKK per person-year) than for GLP-1RA initiators (44,157 DKK per person-year). In this nationwide population-based cohort study, average healthcare costs after drug initiation and while on treatment were lower for empagliflozin initiators than for GLP-1RAs initiators, driven by lower drug costs. The study protocol and analysis plan have been registered on the website of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) ( http://www.encepp.eu/encepp/viewResource.htm?id=37726 , first protocol registration 4 June 2019), and on clinicaltrials.gov ( https://clinicaltrials.gov/ct2/show/NCT03993132 , first posted 20 June 2019).

Pretreatment "prognostic nutritional index" as an indicator of outcome in lung cancer patients receiving ICI-based treatment: Systematic review and meta-analysis.

The pretreatment prognostic nutritional index (PNI) is an indicator of nutritional and immune status, and has potential use as a predictor of survival in cancer patients. Several retrospective studies have used the PNI to predict the outcome of lung cancer patients receiving different immune checkpoint inhibitors (ICIs), but the results have been inconsistent. The objective of our study is to assess the relationship of pretreatment PNI with survival outcomes in lung cancer patients who received ICI-based treatments by meta-analysis. We searched the EMBASE, PubMed, Cochrane Library, American Society of Clinical Oncology, and European Society of Medical Oncology databases to identify studies that reported overall survival (OS) or progression-free survival (PFS) in eligible patients. Eight studies were eligible based on predefined inclusion and exclusion criteria. Data and pooled indicators were extracted from these studies. Meta-analysis was used to analyze hazard ratios (HRs) and 95% confidence intervals (CIs) for OS and/or PFS and the prognostic value of pretreatment PNI. We completed the registration of the research protocol (Registration number: INPLASY202240087, DOI number: 10.37766/inplasy2022.4.0087). We analyzed data from 8 eligible studies (831 patients). Meta-analysis showed that relative to patients with low pretreatment PNI, those with a high pretreatment PNI had better OS (HR = 2.50, 95% CI = 1.44-4.33, P = .001) and better PFS (HR = 1.94, 95% CI = 1.56-2.42, P < .001). Sensitivity analysis indicated these results were robust. There was also no evidence of publication bias. Lung cancer patients receiving ICI-based treatments who had higher pretreatment PNI had better OS and PFS.

Proton pump inhibitors use and risk of inflammatory bowel diseases: a meta-analysis of observational studies.

Proton Pump Inhibitors (PPIs) reduce gastric acid production and they are indicated for myriad gastrointestinal conditions. Prolonged use of PPI has been linked to the risk of inflammatory bowel disease (IBD) though this fact is not well established. We aimed to conduct a systematic review and meta-analysis to estimate the risk of IBD occurrence with PPI use. The databases such as PubMed, Scopus, and Cochrane Library were accessed from inception to December 2020. Additionally, the bibliographic search and a random search in Google, Google Scholar, and ResearchGate were performed to find additional sources. The observational studies estimating the risk of IBD following the use of PPI, published in the English language were considered for this review. The methodological quality of included studies was assessed using the Modified Downs and Black checklist. Eight out of 2038 studies with 157,758 participants were included in this meta-analysis. A significantly higher risk of IBD (adjusted odds ratio [aOR] 2.43; 95% Confidence Interval [CI] 1.18-5.02; P=0.02; n=6) was observed in participants taking PPIs for any indication. Moreover, a significant association was observed between PPI exposure on the different types of IBD such as ulcerative colitis and Crohn's disease together (aOR: 3.60; 95% CI: 1.10-11.74), collagenous colitis (OR: 4.73; 95% CI: 1.99-11.22) and lymphocytic Colitis (OR: 3.77; 95% CI: 2.91-4.87), but not with ulcerative colitis (P=0.47) and microscopic colitis (P=0.07) alone. Similarly, a significant association was observed among Europeans (aOR: 3.98; 95% CI: 2.36-6.71), but not with North American (aOR: 0.48; 95% CI: 0.01-26.71) studies. Overall the study quality was good. The current evidence indicates that exposure to PPI is significantly associated with increased risk of IBD. Further, adequately powered studies from various parts of the world are needed for better quantification and generalizability of our findings. CRD42020209674.

Effects of the Mediterranean Diet during pregnancy on the onset of allergy in at risk children: A study protocol of a multi-center, randomized- controlled, parallel groups, prospective trial (the PREMEDI study).

IntroductionMaternal diet during pregnancy has been linked to offspring allergy risk and it could represent a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models. Randomized-controlled trials on the effect of MD in preventing pediatric allergic diseases are still needed.Methods and analysisThe Mediterranean Diet during Pregnancy study (PREMEDI) will be a 9-month multi-center, randomized-controlled, parallel groups, prospective trial. Healthy women (20–35 years) at their first trimester of pregnancy at risk for atopy baby, will be randomly allocated to Group 1 (standard obstetrical and gynecological follow-up and nutritional counseling to promote MD) or Group 2 (standard obstetrical and gynecological follow-up alone). 138 mother-child pair per group will be needed to detect a reduction in cumulative incidence of ≥1 allergic disease at 24 months of age. The primary study aim will be the evaluation of the occurrence of allergic disorders in the first 24 months of life. The secondary aims will be the evaluation of maternal weight gain, pregnancy/perinatal complications, growth indices and occurrence of other chronic disorders, mother-child pair adherence to MD and gut microbiome features, breastfeeding duration and breast milk composition, epigenetic modulation of genes involved in immune system, and metabolic pathways in the offspring.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of the University of Naples Federico II (number 283/21) and it will be conducted in accordance with the Helsinki Declaration (Fortaleza revision, 2013), the Good Clinical Practice Standards (CPMP/ICH/135/95), the Italian Decree-Law 196/2003 regarding personal data and the European regulations on this subject. The study has been registered in the Clinical Trials Protocol Registration System.Clinical trial registration[http://clinicaltrials.gov], identifier [NCT05119868].

Hospital-, Anesthesiologist-, Surgeon-, and Patient-Level Variations in Neuraxial Anesthesia Use for Lower Limb Revascularization Surgery: A Population-Based Cross-Sectional Study.

Although neuraxial anesthesia may promote improved outcomes for patients undergoing lower limb revascularization surgery, its use is decreasing over time. Our objective was to estimate variation in neuraxial (versus general) anesthesia use for lower limb revascularization at the hospital, anesthesiologist, surgeon, and patient levels, which could inform strategies to increase uptake. Following protocol registration, we conducted a historical cross-sectional analysis of population-based linked health administrative data in Ontario, Canada. All adults undergoing lower limb revascularization surgery between 2009 and 2018 were identified. Generalized linear models with binomial response distributions, logit links and random intercepts for hospitals, anesthesiologists, and surgeons were used to estimate the variation in neuraxial anesthesia use at the hospital, anesthesiologist, surgeon, and patient levels using variance partition coefficients and median odds ratios. Patient- and hospital-level predictors of neuraxial anesthesia use were identified. We identified 11,849 patients; 3489 (29.4%) received neuraxial anesthesia. The largest proportion of variation was attributable to the hospital level (50.3%), followed by the patient level (35.7%); anesthesiologists and surgeons had small attributable variation (11.3% and 2.8%, respectively). Mean odds ratio estimates suggested that 2 similar patients would experience a 5.7-fold difference in their odds of receiving a neuraxial anesthetic were they randomly sent to 2 different hospitals. Results were consistent in sensitivity analyses, including limiting analysis to patients with diagnosed peripheral artery disease and separately to those aged >66 years with complete prescription anticoagulant and antiplatelet usage data. Neuraxial anesthesia use primarily varies at the hospital level. Efforts to promote use of neuraxial anesthesia for lower limb revascularization should likely focus on the hospital context.

Anti-gravity treadmill training for children with cerebral palsy

Background: Walking dysfunction in children with cerebral palsy (CP) contributes to significant limitations in participating properly in daily living activities. Various types of treadmills have emerged to address this obstacle such as the antigravity treadmill (AGT) which aims towards reducing the effect of gravity on its users. Aim: This systematic review examines the literature on the effectiveness of (AGT) on walking abilities in children with CP. Methods: Protocol registration (CRD42020164202) in April 2020 was followed by six electronic database searches for randomized clinical trials (RCTs), examining the effectiveness of AGT on walking and balancing abilities in children with CP. The included studies were assessed for quality using the Physiotherapy Evidence Database (PEDro) scale. Results: Three studies of good quality met the inclusion criteria. AGT was significantly associated with improved walking velocity and cadence, while stride length showed insignificant difference between groups (SMD= 0.07, 95%CI 0.06 to 0.08, p&lt; 0.00001),(SMD= 12.29, 95%CI 9.58 to 14.99, p&lt; 0.00001) and (SMD= 0.07, 95%CI -0.08 to 0.23, p&lt; 0.36).

Promoting the quality and transparency of health research in China

Background and ObjectivesTo review the efforts and progress in promoting quality and transparency of health research in China and to discuss how to improve. MethodsWe focused on three different types of health research: clinical trials, systematic reviews, and clinical practice guidelines, and summarized China's progress from their registration, implementation, and reporting stages. ResultsIn the last 3 decades, China's major works include the following: 1) For registration, the trials and CPGs registries have been set up, and released policies to mandate registration and submission of protocols for trials. 2) For implementation, multiple clinical research and EBM centers have been established. The ResMan platform for data management has been created and required researchers to share results data. 3) For reporting, the Chinese EQUATOR Center has been set up. Translations and extensions of the CONSORT, PRISMA, and RIGHT have been published. 4) For traditional Chinese medicine (TCM), specific guidelines for the registration and reporting of TCM research have been developed. ConclusionChina has made progress in promoting research quality and transparency, especially in research registration and reporting. Nevertheless, more can be done in data management and sharing for research implementation, and good publication practices in TCM.

A meta-epidemiological assessment of transparency indicators of infectious disease models.

Mathematical models have become very influential, especially during the COVID-19 pandemic. Data and code sharing are indispensable for reproducing them, protocol registration may be useful sometimes, and declarations of conflicts of interest (COIs) and of funding are quintessential for transparency. Here, we evaluated these features in publications of infectious disease-related models and assessed whether there were differences before and during the COVID-19 pandemic and for COVID-19 models versus models for other diseases. We analysed all PubMed Central open access publications of infectious disease models published in 2019 and 2021 using previously validated text mining algorithms of transparency indicators. We evaluated 1338 articles: 216 from 2019 and 1122 from 2021 (of which 818 were on COVID-19); almost a six-fold increase in publications within the field. 511 (39.2%) were compartmental models, 337 (25.2%) were time series, 279 (20.9%) were spatiotemporal, 186 (13.9%) were agent-based and 25 (1.9%) contained multiple model types. 288 (21.5%) articles shared code, 332 (24.8%) shared data, 6 (0.4%) were registered, and 1197 (89.5%) and 1109 (82.9%) contained COI and funding statements, respectively. There was no major changes in transparency indicators between 2019 and 2021. COVID-19 articles were less likely to have funding statements and more likely to share code. Further validation was performed by manual assessment of 10% of the articles identified by text mining as fulfilling transparency indicators and of 10% of the articles lacking them. Correcting estimates for validation performance, 26.0% of papers shared code and 41.1% shared data. On manual assessment, 5/6 articles identified as registered had indeed been registered. Of articles containing COI and funding statements, 95.8% disclosed no conflict and 11.7% reported no funding. Transparency in infectious disease modelling is relatively low, especially for data and code sharing. This is concerning, considering the nature of this research and the heightened influence it has acquired.

Kiwifruit and Kiwifruit Extracts for Treatment of Constipation: A Systematic Review and Meta-Analysis.

Introduction This systematic review aimed to summarize evidence to determine the effectiveness of kiwifruit or kiwifruit extracts in the treatment of constipation. Methods Electronic databases were searched from inception to May 2022 without any age or language limitations. Eligible studies enrolled participants with constipation who were randomized to receive kiwifruit or kiwifruit extracts vs. any nonkiwifruit control. Standardized mean difference (SMD) and mean difference (MD) with confidence intervals (CI) were determined for the following outcomes: frequency of spontaneous bowel movements (SBM), abdominal pain and straining, as well as stool type as determined by the Bristol Stool Scale (BSS). The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to rate the certainty of evidence. Our review was registered on PROSPERO (CRD42021239397). Results Seven RCTs, including 399 participants (82% female; mean age: 42 years (SD 14.6)), were included. Compared with placebo (n = 95), kiwifruit extracts might increase the weekly frequency of SBM (MD: 1.36; 95% CI: −0.44, 3.16) with low certainty of evidence; moreover, it had an uncertain effect on BSS (SMD: 1.54; 95% CI: −1.33, 4.41) with very low certainty of evidence. Additionally, compared with placebo (n = 119), kiwifruit or its extracts reduced abdominal pain (SMD: −1.44, 95% CI −2.83, −1.66) with moderate certainty of the evidence and improved frequency of straining (SMD: −0.29; 95% CI: −1.03, 0.47). Compared with psyllium, kiwifruit may increase the weekly frequency of SBM (MD: 1.01; 95% CI: −0.02, 2.04) with moderate certainty evidence, and may increase the value on the BSS (indicating softer stools) (MD: 0.63; 95% CI: 0.01, 1.25)with low certainty of evidence. Compared to placebo, kiwifruit-encapsulated extracts may result in an increase in minor adverse events (relative risk: 4.58; 95% CI: 0.79, 26.4). Conclusions Among individuals with constipation, there is an overall low certainty of evidence indicating that kiwifruit may increase SBM when compared to placebo or psyllium. Although overall results are promising, establishing the role of kiwifruit in constipation requires large, methodologically rigorous trials. Protocol Registration: PROSPERO registration number CRD42021239397.