Pooled Data Research Articles

Inappropriate grouping of various kinematic alignment techniques and inconsistent reporting of adverse events invalidate comparison across studies: An umbrella review of meta-analyses.

This umbrella review aimed to identify, synthesise and critically appraise the findings of meta-analyses that compare adverse events-rates of complications, reoperations and revisions-following total knee arthroplasty (TKA) using unrestricted kinematic alignment versus mechanical alignment. Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria, two authors independently screened articles based on inclusion and exclusion criteria, and assessed the methodological quality based on the 16 domains of A MeaSurement Tool to Assess systematic Reviews (AMSTAR-2). Effect sizes of difference in rates of complications were tabulated for each meta-analysis. Studies included in the meta-analyses were assessed to determine if they were on true unrestricted kinematic alignment. A secondary meta-analysis was performed, excluding studies on restricted kinematic alignment techniques, to calculate pooled estimates of adverse events (odds ratio [OR] with its 95% confidence interval [CI]) in a common effects framework with inverse-variance weighting. Of 78 potential records, 13 meta-analyses were eligible for data extraction, which pooled data from 15 clinical studies (10 on unrestricted kinematic alignment, four on restricted kinematic alignment and one on inverse kinematic alignment). None of the meta-analyses fulfilled all seven critical AMSTAR-2 domains. Meta-analyses categorised adverse events differently and used different measures for the effect sizes but revealed no differences between kinematic versus mechanical alignment. Exclusion of studies on restricted kinematic alignment techniques reduced total sample sizes for kinematic alignment from 658 to 318 and for mechanical alignment from 811 to 403. Secondary meta-analyses exclusively on unrestricted kinematic alignment revealed no difference in complications without reoperation, reoperation without implant removal or reoperation with implant removal following kinematic versus mechanical alignment. Meta-analyses do not distinguish between various kinematic alignment techniques, and adverse events are compared using different metrics. Surgeons, researchers and editors should refrain from pooling data on various kinematic alignment techniques, and orthopaedic societies should promote standards for reporting adverse events and effect sizes to facilitate comparisons across future studies. Level III.

Cohort profile: the WHO Child Mortality Risk Stratification Multi-Country Pooled Cohort (WHO-CMRS) to identify predictors of mortality through early childhood

PurposeTo provide details of a pooled data set that will be used to estimate absolute and relative mortality risks and other outcomes among children less than 59 months of age...

The Incidence of Psychosis Among Parkinson's Disease Patients and Associated Factors: A Meta-Analysis

Introduction: Parkinson's-induced psychosis is rather prevalent, and it has continuously been linked to poor outcomes. Therefore, detecting this presentation early on, can enhance the quality of life of Parkinson’s disease patients and is therefore a clinical and societal necessity. This systematic review and meta-analysis aimed to estimate the pooled incidence of induced psychosis or psychosis associated with neurodegeneration in Parkinson’s disease. Materials and Methods: PubMed, Scopus, and Cochrane Library were searched to identify studies reporting the prevalence of psychosis in Parkinson’s disease patients. A random-effect meta-analysis was used to pool data from the included studies. The objectives, inclusion criteria, and methods of analysis for this review were specified in advance and documented in a priori protocol (PROSPERO reg. num. CRD42022318920). Results: Twenty studies including 5,123 Parkinson’s disease patients which explored the incidence of presenting symptoms of psychosis in Parkinson’s disease patients were included in the final analysis. The meta-analysis showed that the incidence of psychosis among Parkinson’s disease patients was 35%. A subgroup analysis was performed which showed that disease duration could explain the statistical heterogeneity in this meta-analysis. Conclusion: This systematic review and meta-analysis revealed that psychotic disorders are highly prevalent among Parkinson’s disease patients, indicating an urgent need for further studies to help develop better mechanisms of prevention, detection, and treatment of those disorders among Parkinson’s disease patients in an effort to improve their quality of life.

Effect of Nutrient Management and Mulching on Growth Parameters, Yield Attributes and Yield of Pearl Millet [Pennisetum glaucum (L.) R. Br. Emend Stuntz] in Western Region of India

Aim: To assessed the effect of nutrient management and mulching on growth parameters, yield attributes and yield of pearl millet. Place and Duration of Study: A field experiment was conducted during two consecutive year 2021 and 2022 at Agronomy farm, S.K.N. College of Agriculture, Jobner (Rajasthan). Study Design and Methodology: The 16 treatment combinations consist different nutrients and mulching sources with replicated four times and laid out in split plot design. Various plant growth parameters, yield attributes and yield were recorded with standard procedures. Results: Results showed that Mustard straw mulch @ 2.5 t/ha gave significantly higher growth parameters (plant height, dry matter accumulation, number of tillers per plant, number of leaves per plant and chlorophyll content), yield attributes (number of effective tillers per metre row length, ear head length, ear head diameter, weight of grains per ear and number of grains per ear) leading to increased grain yield (1930 kg/ha), stover yield (3748 kg/ha) and biological yield (5678 kg/ha) over control on pooled data basis. Results showed that Liquid Azospirillium gave significantly higher growth parameters (plant height, dry matter accumulation, number of tillers per plant, number of leaves per plant and chlorophyll content), yield attributes (number of effective tillers per metre row length, ear head length, ear head diameter, weight of grains per ear and number of grains per ear) leading to increased grain yield (1954 kg/ha), stover yield (3742 kg/ha) and biological yield (5697 kg/ha) over control on pooled data basis. Results further indicated that among nitrogen management practices 50% RDN through urea + 0.2% foliar spray of nano urea at 30 DAS proved significantly superior for growth parameters (plant height, dry matter accumulation, number of tillers per plant, number of leaves per plant and chlorophyll content), yield attributes (number of effective tillers per metre row length, ear head length, ear head diameter, weight of grains per ear, number of grains per ear and test weight) and grain yield (1919 kg/ha), stover yield (3742 kg/ha), biological yield (5661 kg/ha) over control and remained at par with treatment RDN through urea and 0.2% foliar spray of nano urea on mean pooled data basis. Among all the treatments, 50% RDN through urea + 0.2% foliar spray of nano urea at 30 DAS, Mustard straw mulch @ 2.5 t/ha and Liquid Azospirillium are fond best with respect to growth parameters, yield attributes and yield.

Corporate social responsibility and firm performance: the role of firm reputation

Purpose This study aims to examine the role of firm reputation as a mediator in the relationship between corporate social responsibility and firm performance, along with the underlying mechanism. Design/methodology/approach This research is quantitative research that aims to explain the phenomenon of the relationship between the implementation of corporate social responsibility and firm performance. A total of 573 companies listed on the Indonesia Stock Exchange for the 2019–2021 period were sampled in this study. The analysis method in this study combines time series data and cross-section data called pooled data. Findings This research found a significant positive association between corporate social responsibility and firm reputation as well firm reputation is positively related to firm performance. In contrast, corporate social responsibility directly affects firm performance insignificantly. Based on the analyses, firm reputation mediates the effect of corporate social responsibility on firm performance. Research limitations/implications This study is limited due to its reliance on secondary data related to publicly listed companies from 2019 to 2021, which involves various downsides, that is many businesses still have not disclosed their engagement in corporate social responsibility practices. This study will ultimately yield practical implications for organizational managers, as it emphasizes the significance of corporate social responsibility in enhancing firm success. Originality/value The research presented in this paper contributes to the existing body of knowledge on corporate social responsibility by examining the impact of corporate social responsibility on firm performance. Furthermore, this study provides additional evidence for shared value creation by explaining the impact of corporate social responsibility on firm performance.

Investing in Tomorrow: How Indonesian Firms Allocate Free Cash Flow for Sustainability Development Strategy

Objective: This study is to investigates and prove the role of management ownership in the use of free cash flow to fund the social environment financing (Sustainability Accounting), and as the company's sustainability development strategic objectives. Theoretical Framework: Sustainability accounting has long been disputed in developing nations and certain industrial settings, and it remains among its most crucial issues in the business sector. Sustainability accounting is also used to assess or evaluate firm performance, provide accounting information, and make economic assessments relating to investment and managerial decisions, total asset expenditures, capital costs, or other strategic decisions for companies related to social responsibility, meaning that companies do not only prioritize profit but also deserves attention to the social-environmental factors of the communities in which they operate. This policy is aimed at preventing conflicts of interest between internal and external stakeholders of the organization, and can protect the company's reputation Method: The method utilizes pure-moderated regression model and using the purposive sampling method, data pooling is based on the company's ISX-listed financial statements on 2016-2020 period, and has an Environmental Performance Management index on Green-Gold PROPER. Results and Discussion: The results of the t-test showed a significance value of pure-moderating effect of managerial ownership to intervene free cash flow in sustainability accounting. This means that in order to overcome the socio-ecological accounting crisis, in addition to profit orientation, companies make sustainability responsibility one of the most important factors in their business operations. Research Implications: Management ownership plays a positive role and has a significant impact on sustainability accounting. Even if they hold a relatively small number of shares, they can influence the use of free cash flow for the benefit of sustainability accounting. Free cash flow is not only used to return profits to shareholders, but also to benefit social and environmental programs when companies make strategic decisions. This result in line with the legitimacy theory, which states that the existence and sustainability of corporate operations is confirmed by their conformity with the interests and expectations of the community. Originality/Value: This study contributes to clarifying why a company's sustainability can be verified through sustainable accounting. This research suggests that one essential aspect in resolving the socio-environmental accounting crisis was sustainability responsibility.

Predictors of cost-related medication nonadherence in Canada: a repeated cross-sectional analysis of the Canadian Community Health Survey.

In Canada, many patients face substantial out-of-pocket costs for prescription medication, which may affect their ability to take their medications as prescribed. We sought to conduct a comprehensive analysis of the burden and predictors of cost-related nonadherence in Canada. Using pooled data from the 2015, 2016, 2018, 2019, and 2020 iterations of the Canadian Community Health Survey, we calculated weighted population estimates of the burden of cost-related nonadherence in the preceding 12 months and used logistic regression models to measure the association of 15 demographic, health, and health system predictors of cost-related nonadherence overall and stratified by sex. We included 223 085 respondents. We found that 4.9% of respondents aged 12 years or older reported cost-related nonadherence. Those who self-identified as female, belonging to a racial or ethnic minority group, or bisexual, pansexual, or questioning were more likely to report cost-related nonadherence. Younger age, higher disease burden, poorer health, non-employer prescription drug coverage, and not living in the province of Quebec were associated with cost-related nonadherence. Our nationally representative findings reveal inequities that disproportionally affect marginalized people at the intersections of sex, race, age, and disability, and vary by province. This foundational understanding of the state of cost-related nonadherence may be used to inform potential expansion of public drug coverage eligibility, premiums, and cost-sharing policies that address financial barriers to medication adherence.

Sex estimation using adult femora and humeri trained on a Portuguese reference sample, and tested on Portuguese and South African samples

ABSTRACT Forensic anthropology involves analysing human skeletal remains to assist legal investigations, with sex estimation being a key component of constructing a biological profile. This study evaluated the feasibility of developing metric methods for sex estimation using femora and humeri across different populations. Logistic regression models were created from Portuguese training samples (360 femora; 329 humeri) and tested on independent Portuguese (200 femora; 150 humeri) and South African (66 femora; 66 humeri) samples. The primary goal was to develop sex estimation models using pooled data from Portuguese samples and assess their reliability across Portuguese and South African populations. Femoral models for the Portuguese testing sample achieved an accuracy between 82.0% and 85.5%, with sex bias from 0.0% to 8.0%. Humeral models showed higher accuracy, between 88.0% and 94.0%, with sex bias from 2.4% to 13.1%. In the South African sample, both femoral and humeral models exceeded 75.0% accuracy but exhibited notable sex bias. The results suggest that using a heterogeneous training set, combining data from diverse populations, offers a broader understanding of sexual dimorphism compared with a homogeneous dataset from a single group. The study emphasizes that relying solely on skeletal samples from one population is insufficient for modern forensic anthropology standards.

Prospective study of the application of a 3D exoscope system (VITOM 3D) in ear surgery compared to conventional surgical microscopes: part I - analysis of objective parameters.

This prospective study compared the application of a 3D exoscope (VITOM 3D) with surgical microscopes (SM) in ear surgery. 62 patients were included (exoscope group (E+) n = 31; SM group (E-) n = 31). Procedures included cochlea implantation (nE + = 10, nE- = 10), reconstructive middle ear surgery due to chronic otitis media with (COMwC; nE + = 11, nE- = 11) and without cholesteatoma (COMsC; nE + = 10, nE- = 10). Objective (e.g. set-up time and wrap-up time, corrected cut-suture-time, pure operating time, adjustment time, time per adjustment procedure, learning curves) and subjective perioperative parameters were evaluated. This paper only addressed the analysis of the objective parameters. The pooled data showed that the mean time delay in the E + group was significantly higher compared to the E- group with regard to set-up time and wrap-up time, corrected cut-suture time, adjustment time and time per adjustment procedure. Time delay tended to be higher for pure operating time. In all subgroups of the E + group, the objective time parameters also showed at least a tendency to be prolonged on average compared to the corresponding subgroups in the E- group. The learning curve analysis showed that the E + group (corrected cut suture time for CI surgery, mean time per adjustment procedure across all subgroups) approached the times of the E- group during the course of the study. Based on the pooled data from the study arms, the exoscope tends to be inferior to the microscope for the objective time parameters evaluated when used in ear surgery. However, due to the small group sizes, no solid conclusions could be drawn regarding the individual surgical procedures. In addition, further studies with a longer observation period are needed to minimize the influence of the learning curve on the results.

Influence of INM on Yield, Quality of Potato and Soil Status

An experiment was carried out to study the Influence of INM on yield, quality of potato and soil status at Horticulture Research Farm, College of Horticulture, AAU, Anand during the three consecutive years 2020-21, 2021-22 and 2022-23. The experiment was laid out in Randomized Block Design with three replications and ten treatments viz., T1: 100 % RDF (220:110:220), T2: 20 t FYM + 100 % RDF (220:110:220), T3: 75 % RDF + 25 % RDN through FYM, T4: 75 % RDF + 25 % RDN through VC, T5: 50 % RDF + 50 % RDN through FYM, T6: 50 % RDF + 50 % RDN through VC, T7: 50 % RDF + 50 % RDN through FYM + 1 L Bio NPK consortium/ha, T8: 50 % RDF + 50 % RDN through VC + 1 L Bio NPK consortium/ha, T9: 25 % RDF + 50 % RDN through FYM + 1 L Bio NPK consortium/ha + KMB 1 L/ha, T10: 25 % RDF + 50 % RDN through VC + 1 L Bio NPK consortium + KMB 1 L/ha. The treatment T2 [20 t FYM + 100 % RDF (220:110:220] recorded maximum tuber weight per plant (487.13 g), tuber yield (434.8 q/ha) and grade “A” tuber (378.9 q/ha) in pooled analysis. Treatments T7 to T10 received inoculation of Bio NPK consortium showed higher microbial population. Whereas, grade “B” tuber, TSS and soil status after harvest were found non-significant in pooled data.

Potassium disorders at intensive care unit admission and functional outcomes after cardiac arrest

BackgroundAbnormal serum potassium levels are commonly found in the intensive care unit (ICU) population. We aimed to determine the prevalence of potassium disorders at ICU admission and its association with functional outcomes in comatose patients resuscitated from cardiac arrest. MethodsWe performed a post hoc analysis of pooled data from four randomised clinical trials involving comatose post-cardiac arrest patients admitted to ICU after return of spontaneous circulation (ROSC). Reference serum potassium levels were defined as between 3.0 and 4.9 mmol/L. An unfavourable functional outcome was defined as a cerebral performance category of 3 to 5 at 180 days. We compared potassium disturbances categorically in a mixed effects logistic regression model including initial rhythm, delay from collapse to return of spontaneous circulation, bystander cardiopulmonary resuscitation, lactate and urea at ICU admission, with normokalaemia set as the reference group. ResultsWe included 1133 patients (557 from the HYPERION, 346 from the TTH48, 120 from the COMACARE, and 110 from the Xe-HYPOTHECA trials) with a median age of 64 years (interquartile range 55–72) and a predominance of males (72 %); a total of 712 (64 %) patients had unfavourable functional outcomes. On admission, 221 patients (19.5 %) experienced hyperkalaemia and 35 (3.1 %) patients experienced hypokalaemia. Fewer patients in the normokalaemia group (513/877, 58.5 %) had an unfavourable functional outcome compared to the hypokalaemia (24/35, 68.6 %) and hyperkalaemia groups (180/221, 81.4 %; p < 0.001). Hyperkalaemia was associated with higher odds for an unfavourable functional outcome (adjusted odds ratio (OR) 1.85, 95 % confidence interval (CI) 1.10–3.12, p = 0.02), while hypokalaemia was not (OR 1.36 95 % CI 0.51–3.60, p = 0.53). The associations were not significant in a subgroup analysis adjusted for the modified cardiac arrest hospital prognosis score in 833 patients (OR 1.74, 95 % CI 0.91–3.34, p = 0.10 for hyperkalaemia and OR 1.48, 95 % CI 0.40–5.44, p = 0.55 for hypokalaemia). ConclusionsOf the comatose patients admitted to ICU after cardiac arrest, one in five experienced a potassium disorder on ICU admission. Hyperkalaemia was associated with unfavourable functional outcomes at 180 days, while hypokalaemia was not.

FlexBART: Flexible Bayesian regression trees with categorical predictors

Most implementations of Bayesian additive regression trees (BART) one-hot encode categorical predictors, replacing each one with several binary indicators, one for every level or category. Regression trees built with these indicators partition the discrete set of categorical levels by repeatedly removing one level at a time. Unfortunately, the vast majority of partitions cannot be built with this strategy, severely limiting BART’s ability to partially pool data across groups of levels. Motivated by analyses of baseball data and neighborhood-level crime dynamics, we overcame this limitation by re-implementing BART with regression trees that can assign multiple levels to both branches of a decision tree node. To model spatial data aggregated into small regions, we further proposed a new decision rule prior that creates spatially contiguous regions by deleting a random edge from a random spanning tree of a suitably defined network. Our re-implementation, which is available in the flexBART package, often yields improved out-of-sample predictive performance and scales better to larger datasets than existing implementations of BART.

Sex-specific associations of cigarettes and e-cigarettes use with self-reported premature atherosclerotic cardiovascular disease among adults aged 18–54 in the United States

BackgroundPremature atherosclerotic cardiovascular disease (ASCVD) is increasing in young adults (<55 years old). While research suggests females who smoke cigarettes have a higher risk of ASCVD than males, studies on the impact of exclusive e-cigarette and dual use on premature ASCVD are limited. This study investigated the association between tobacco use and self-reported premature ASCVD and explored potential sex differences. MethodsUsing pooled data from 480,317 adults (ages 18–54; ∼50 % female) from the 2020–2022 Behavioral Risk Factor Surveillance System from the United States, logistic regression models assessed associations between cigarette and e-cigarette use patterns and self-reported premature ASCVD. Tobacco use categories were defined as: non-use, former use (cigarettes, e-cigarettes), and current use (cigarettes, e-cigarettes) and dual use. Self-reported premature ASCVD was defined as self-reported angina or coronary heart disease, heart attack, or stroke. Weighted analyses were conducted for the overall sample and stratified by sex. ResultsAfter controlling for potential confounders, former exclusive cigarette (adjusted OR: 1.47 [95 % CI 1.29, 1.67]), current exclusive cigarette (1.68 [1.47–1.94]) and current dual (2.03 [1.69–2.44]) use were associated with higher odds of self-reported premature ASCVD. There was no significant association for e-cigarette use. Sex-specific analyses revealed similar patterns but the magnitude of these associations varied between males and females. ConclusionBoth sexes showed higher odds of self-reported premature ASCVD for dual and exclusive cigarette use. Although the cross-sectional design precludes causal inferences, the findings suggest comprehensive tobacco cessation programs tailored to diverse use patterns are needed to reduce the burden of premature ASCVD.

Criterion-Related Validity and Reliability of the Six-Minute Run Walk Test Among Children: Findings from a Systematic Review and Meta-Analysis

ABSTRACT The aim of this study is to examine the available scientific evidence on the reliability and criterion validity of 6-minute run walk field-based test when administered to children and adolescents. Systematic searches were performed in three electronic databases (MEDLINE/PubMed, SPORTDiscuss and Scopus) from their inception until February 2024, with an update on August 15, 2024. Studies were considered eligible if they provided information on the criterion-related validity and/or reliability of the 6-minute run walk test when conducted by children (aged 12 years and under) and/or adolescents (aged 13 to 17 years). To examine reliability and validity, two separate meta-analyses were implemented. In the meta-analysis focused on criterion-related validity, the five studies included indicated a fair validity (r = 0.56 [95% CI: 0.44–0.66]) and high homogeneity (I2 0%). In the meta-analysis focused on reliability, the pooled data from the five studies employing Pearson’s correlation coefficient (n = 585) revealed strong reliability values (r = 0.82 [95% CI: 0.75–0.87]), albeit with a moderate level of heterogeneity (I2 71% prediction interval 0.55–0.94). The evidence suggests that the 6-minute run walk field-based test demonstrated fair criterion-related validity and strong test-retest reliability when conducted with children and adolescent.

Identifying thresholds for meaningful improvements in NTDT-PRO scores to support conclusions about treatment benefit in clinical studies of patients with non-transfusion-dependent beta-thalassaemia: analysis of pooled data from a phase 2, double-blind, placebo-controlled, randomised trial

ObjectivesTo estimate thresholds for defining meaningful within-patient improvement from baseline to weeks 13–24 and interpreting meaningfulness of between-group difference for the non-transfusion-dependent beta-thalassaemia patient-reported outcome (NTDT-PRO) tiredness/weakness (T/W) and shortness...

Endodontic treatment modifies circulatory inflammatory mediator levels: A systematic review with meta-analysis.

There is limited and conflicting data on the reduction of circulatory inflammatory mediators in patients with apical periodontitis (AP) following endodontic treatment. To answer the following research question: in adult healthy patients with AP [Population (P)], is there a difference before [Comparator (C)] and after various endodontic treatments (nonsurgical, surgical or retreatment) [Intervention (I)] on systemic levels of inflammatory biomarkers [Outcome (O)] in the follow-up period[Time (T)]? An electronic literature search was conducted in the databases Scopus, PubMed, Clarivate Analytics' Web of Science, Cochrane Database of Systematic Reviews and Grey literature from inception to July 2024 with no language restrictions. Observational studies examining changes in serum levels of inflammatory mediators were included. Two independent reviewers selected studies, extracted data and critically appraised the included studies. Qualitative and quantitative (meta-analysis) data synthesis methods were employed. The Newcastle-Ottawa Scale was used to assess the quality of the included studies. Sixteen studies met the inclusion criteria, of which six were included in the meta-analysis. These studies were published between 1992 and 2024, involving a total of 596 patients (54% females) aged between 16 and 75 years. The meta-analysis of pooled data showed a significant decrease in high-sensitive C-reactive protein (hs-CRP) levels in the serum of patients with AP 6 months after treatment [2.26 ± 1.76 versus 1.28 ± 1.06 mg/L, (Z = 2.03, p = .04)] and a decrease in interleukin-1β (IL-1β) levels 12 months after treatment [13.01 ± 5.95 versus 10.86 ± 3.52 pg/mL, (Z = 3.72, p < .01)]. One study was assessed as poor quality, while all others were considered high quality. Despite the differences in methodologies across the included studies, it has been established that effective endodontic treatment leads to a reduction in systemic inflammatory biomarkers in the body. Following effective endodontic treatment in patients with AP, the systemic levels of hs-CRP and IL-1β exhibit a significant reduction at 6 and 12 months, respectively. Further clinical studies should investigate whether effective endodontic treatment and reduced levels of investigated biomarkers may change the clinical presentation of systemic diseases. PROSPERO database (CRD42024559271).

Effect of Ischemia Testing and Coronary Revascularization on Mortality and Ventricular Tachycardia Recurrence in Patients With Monomorphic Ventricular Tachycardia Without Acute Coronary Syndrome: A Meta-Analysis and Systematic Review.

Studies show mixed results regarding the effect of coronary revascularization on mortality benefit and ventricular tachycardia (VT) recurrence in patients with monomorphic VT without acute coronary syndrome (ACS). This meta-analysis aimed to assess the effect of ischemia testing and/or coronary revascularization on mortality and VT recurrence in a pooled data set. Databases including PubMed, Google Scholar, and the Cochrane Library were searched from January 2000 to December 2023 for studies reporting event data on mortality and VT recurrence in patients without ACS who presented with monomorphic VT. Data were pooled and analyzed using random effects meta-analysis. The pooled sample consisted of a total of five studies, with 1062 patients, of whom 433 underwent ischemia testing and/or coronary revascularization and 629 did not. There was no statistically significant difference in the mortality and VT recurrence in the patients who underwent ischemia testing and/or revascularization versus those who did not (mortality odds ratio [OR]: 0.98; [95% confidence interval (CI): 0.62 to 1.53]; p = 0.92; VT recurrence OR: 1.07; [95% CI: 0.51 to 2.26]; p = 0.86). No publication bias was detected by examination of the funnel plot, Begg-Mazumdar's test (p = 0.80), and Egger's test (p = 0.91). In conclusion, in patients with sustained monomorphic VT in the absence of ACS, ischemia testing and/or revascularization does not lead to improved mortality or a decrease in the incidence of VT recurrence.

Psychometric evaluation of the Functional Assessment of chronic illness therapy-fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn's disease.

To provide further evidence on the psychometric properties of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in moderately to severely active Crohn's disease (CD), and to determine thresholds for meaningful improvement in fatigue. The FACIT-Fatigue is a 13-item patient-reported outcome measure (range, 0-52) assessing fatigue over the previous week. Using pooled data from the Phase 3 VIVID-1 study of moderately to severely active CD, psychometric properties of FACIT-Fatigue were evaluated up to Week 52. The Patient Global Rating of Severity (PGRS) and Patient Global Impression of Change (PGIC) were used as primary anchors to estimate the FACIT-Fatigue score change representing meaningful improvement. Psychometric analyses included 1065 adults. The FACIT-Fatigue demonstrated good internal consistency, and correlations between individual items and the total score were moderate to strong. The FACIT-Fatigue score showed moderate to strong correlations with other patient-reported assessments and weak correlations with endoscopic/laboratory assessments. The FACIT-Fatigue differentiated between distinct groups of participants varying in disease severity, quality of life, and fatigue based on PGRS and other assessments. FACIT-Fatigue improvements during the study differed significantly between most PGRS change and PGIC categories. Anchor-based estimates suggested a 6-9-point increase in the FACIT-Fatigue total score as meaningful improvement. The FACIT-Fatigue demonstrated strong psychometric properties in the VIVID-1 population of adults with moderately to severely active CD and determined a FACIT-Fatigue score change threshold representing meaningful improvement. NCT03926130. Registered 23 April 2019, https://clinicaltrials.gov/study/NCT03926130 .

Ocular Pharmacokinetics of Faricimab Following Intravitreal Administration in Patients With Retinal Disease.

To characterize faricimab ocular and systemic pharmacokinetics (PK) in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) and to assess the effect of faricimab ocular exposure on clinical endpoints. A population PK (popPK) model was developed using pooled data from phase 1 to 3 studies in patients with nAMD/DME. The dataset included 1095 faricimab aqueous humor (AH) concentrations from 284 patients and 8372 faricimab plasma concentrations from 2246 patients. Following intravitreal administration, faricimab PK was accurately described by a linear three-compartment model with sequential vitreous humor (VH), AH, and plasma compartments. Faricimab VH elimination to AH is the slowest process, with an estimated half-life (t1/2) of 7.5 days. Due to flip-flop kinetics, plasma, AH, and VH concentrations declined in parallel. Disease had no effect on faricimab PK. Plasma exposure was ∼6000-fold lower than VH exposure. Age, anti-drug antibodies, body weight, and sex statistically significantly influenced PK parameters but had no clinically meaningful effect on ocular and systemic exposure. VH t1/2 alone could not explain faricimab dosing frequency. Exposure-response analyses showed similar gains in best-corrected visual acuity across faricimab exposure ranges and dosing regimens. Faricimab ocular and systemic pharmacokinetics were quantified and accurately described by the popPK model, developed using a large dataset from patients with nAMD/DME. Exposure-response analyses suggest that faricimab phase 3 dosing algorithms are appropriate to select the most suitable dosing regimen. The popPK analysis suggested that faricimab dosing frequency was influenced by several factors and not by VH t1/2 alone.

Improving Subnational Opinion Estimation from Cluster-Sampled Polls

Abstract The development of multilevel regression and poststratification (MRP) has allowed scholars to more accurately estimate subnational public opinion using national polls. However, MRP generally recovers less accurate estimates from polls whose respondents are selected using cluster sampling – also called area-probability sampling. This is in part because cluster-sampled polls rely on a complex form of random sampling focused on national representativeness that may result in small or unrepresentative subsamples in subnational geographies. This has limited MRP’s usefulness in subnational opinion estimation in several contexts, including historical polls in the US, where cluster-sampling was common into the 1980s, and large academic studies in many countries today. In this paper, I propose two approaches to improve estimation from MRP with cluster-sampled polls. The first is pooling data from multiple surveys to produce a larger sample of clusters. The second is clustered MRP (CMRP), which extends MRP by modeling opinion using the geographic information included in a survey’s cluster-sampling procedure. Using simulations, I show that both methods improve upon traditional MRP, and I validate them using historical polls in the US