"We Live Our Life Normal": A Qualitative Analysis of Nigerian Women's Health-Seeking Behavior during the COVID-19 Pandemic.

BACKGROUND: This study examined where women sought healthcare during the COVID-19 pandemic and their reasons for doing so. We aim to understand further how women accessed care during the COVID-19 pandemic to inform future preparedness and response efforts. This knowledge gained from this study can inform strategies to address existing gaps in access and ensure that women's health needs are adequately considered during emergencies. METHODS: This study used an interpretive phenomenological-analysis approach to analyze data on women's experiences with healthcare in Nigeria as the COVID-19 pandemic progressed. Semi-structured interviews were conducted with 24 women aged 15 to 49 between August and November 2022 and were supplemented with three focus-group discussions. RESULTS: Following our analysis, three superordinate themes emerged: (i) barriers to seeking timely and appropriate healthcare care, (ii) the influence of diverse health practices and beliefs on health-seeking behavior, and (iii) gendered notions of responsibility and of coping with financial challenges. CONCLUSIONS: This paper examined women's decision to seek or not seek care, the type of care they received, and where they went for care. Women felt that the COVID-19 pandemic affected their decision to seek or not seek care.

The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring.

The next generation of surgical robotics is poised to disrupt healthcare systems worldwide, requiring new frameworks for evaluation. However, evaluation during a surgical robot's development is challenging due to their complex evolving nature, potential for wider system disruption and integration with complementary technologies like artificial intelligence. Comparative clinical studies require attention to intervention context, learning curves and standardized outcomes. Long-term monitoring needs to transition toward collaborative, transparent and inclusive consortiums for real-world data collection. Here, the Idea, Development, Exploration, Assessment and Long-term monitoring (IDEAL) Robotics Colloquium proposes recommendations for evaluation during development, comparative study and clinical monitoring of surgical robots-providing practical recommendations for developers, clinicians, patients and healthcare systems. Multiple perspectives are considered, including economics, surgical training, human factors, ethics, patient perspectives and sustainability. Further work is needed on standardized metrics, health economic assessment models and global applicability of recommendations.

Interpreting frequentist hypothesis tests: insights from Bayesian inference.

Randomized controlled trials are one of the best ways of quantifying the effectiveness of medical interventions. Therefore, when the authors of a randomized superiority trial report that differences in the primary outcome between the intervention group and the control group are "significant" (i.e., P ≤ 0.05), we might assume that the intervention has an effect on the outcome. Similarly, when differences between the groups are "not significant," we might assume that the intervention does not have an effect on the outcome. Nevertheless, both assumptions are frequently incorrect.In this article, we explore the relationship that exists between real treatment effects and declarations of statistical significance based on P values and confidence intervals. We explain why, in some circumstances, the chance an intervention is ineffective when P ≤ 0.05 exceeds 25% and the chance an intervention is effective when P > 0.05 exceeds 50%.Over the last decade, there has been increasing interest in Bayesian methods as an alternative to frequentist hypothesis testing. We provide a robust but nontechnical introduction to Bayesian inference and explain why a Bayesian posterior distribution overcomes many of the problems associated with frequentist hypothesis testing.Notwithstanding the current interest in Bayesian methods, frequentist hypothesis testing remains the default method for statistical inference in medical research. Therefore, we propose an interim solution to the "significance problem" based on simplified Bayesian metrics (e.g., Bayes factor, false positive risk) that can be reported along with traditional P values and confidence intervals. We calculate these metrics for four well-known multicentre trials. We provide links to online calculators so readers can easily estimate these metrics for published trials. In this way, we hope decisions on incorporating the results of randomized trials into clinical practice can be enhanced, minimizing the chance that useful treatments are discarded or that ineffective treatments are adopted.

RéSUMé: Les études randomisées contrôlées constituent l'un des meilleurs moyens de quantifier l'efficacité des interventions médicales. Par conséquent, lorsque les autrices et auteurs d'une étude randomisée superiorité signalent que les différences dans le critère d'évaluation principal entre le groupe d'intervention et le groupe témoin sont « significatives ¼ (c.-à-d. P ≤ 0,05), nous pourrions supposer que l'intervention a un effet sur le critère d'évaluation. De même, lorsque les différences entre les groupes ne sont « pas significatives ¼, nous pourrions supposer que l'intervention n'a pas d'effet sur le critère d'évaluation. Pourtant, ces deux hypothèses s'avèrent souvent incorrectes.Dans cet article, nous explorons la relation qui existe entre les effets réels d'un traitement et les déclarations de signification statistique fondées sur les valeurs P et les intervalles de confiance. Nous expliquons pourquoi, dans certaines circonstances, la probabilité qu'une intervention soit inefficace lorsque P ≤ 0,05 dépasse 25 % et la probabilité qu'une intervention soit efficace lorsque P > 0,05 dépasse 50 %.Au cours de la dernière décennie, nous avons assisté à un intérêt croissant pour les méthodes bayésiennes comme alternative aux tests d'hypothèses fréquentistes. Nous proposons une introduction robuste mais non technique à l'inférence bayésienne et expliquons pourquoi une distribution postérieure bayésienne surmonte bon nombre des problèmes associés aux tests d'hypothèses fréquentistes.Malgré l'intérêt actuel pour les méthodes bayésiennes, les tests d'hypothèses fréquentistes restent la méthode par défaut pour l'inférence statistique en recherche médicale. Par conséquent, nous proposons une solution provisoire au « problème de signification ¼ basée sur des mesures bayésiennes simplifiées (par exemple, facteur de Bayes, risque de faux positifs) qui peuvent être rapportées en même temps que les mesures traditionnelles des valeurs P et des intervalles de confiance. Nous calculons ces paramètres pour quatre études multicentriques bien connues. Nous fournissons des liens vers des calculatrices en ligne afin que les lectrices et lecteurs puissent facilement estimer ces mesures pour les études publiées. De cette façon, nous espérons que les décisions sur l'intégration des résultats des études randomisées dans la pratique clinique pourront être améliorées, minimisant ainsi le risque que des traitements utiles soient rejetés ou que des traitements inefficaces soient adoptés.

Benefits and harms of perioperative high fraction inspired oxygen for surgical site infection prevention: a protocol for a systematic review and meta-analysis of individual patient data of randomised controlled trials.

INTRODUCTION: The use of high fraction of inspired oxygen (FiO2) intraoperatively for the prevention of surgical site infection (SSI) remains controversial. Promising results of early randomised controlled trials (RCT) have been replicated with varying success and subsequent meta-analysis are equivocal. Recent advancements in perioperative care, including the increased use of laparoscopic surgery and pneumoperitoneum and shifts in fluid and temperature management, can affect peripheral oxygen delivery and may explain the inconsistency in reproducibility. However, the published data provides insufficient detail on the participant level to test these hypotheses. The purpose of this individual participant data meta-analysis is to assess the described benefits and harms of intraoperative high FiO2compared with regular (0.21-0.40) FiO2 and its potential effect modifiers. METHODS AND ANALYSIS: Two reviewers will search medical databases and online trial registries, including MEDLINE, Embase, CENTRAL, CINAHL, ClinicalTrials.gov and WHO regional databases, for randomised and quasi-RCT comparing the effect of intraoperative high FiO2 (0.60-1.00) to regular FiO2 (0.21-0.40) on SSI within 90 days after surgery in adult patients. Secondary outcome will be all-cause mortality within the longest available follow-up. Investigators of the identified trials will be invited to collaborate. Data will be analysed with the one-step approach using the generalised linear mixed model framework and the statistical model appropriate for the type of outcome being analysed (logistic and cox regression, respectively), with a random treatment effect term to account for the clustering of patients within studies. The bias will be assessed using the Cochrane risk-of-bias tool for randomised trials V.2 and the certainty of evidence using Grading of Recommendations, Assessment, Development and Evaluation methodology. Prespecified subgroup analyses include use of mechanical ventilation, nitrous oxide, preoperative antibiotic prophylaxis, temperature (<35°C), fluid supplementation (<15 mL/kg/hour) and procedure duration (>2.5 hour). ETHICS AND DISSEMINATION: Ethics approval is not required. Investigators will deidentify individual participant data before it is shared. The results will be submitted to a peer-review journal. PROSPERO REGISTRATION NUMBER: CRD42018090261.

Methodological and reporting quality assessment of network meta-analyses in anesthesiology: a systematic review and meta-epidemiological study.

PURPOSE: The scientific rigour of the conduct and reporting of anesthesiology network meta-analyses (NMAs) is unknown. This systematic review and meta-epidemiological study assessed the methodological and reporting quality of NMAs in anesthesiology. METHODS: We searched four databases, including MEDLINE, PubMed, Embase, and the Cochrane Systematic Reviews Database, for anesthesiology NMAs published from inception to October 2020. We assessed the compliance of NMAs against A Measurement Tool to Assess Systematic Reviews (AMSTAR-2), Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement for Network Meta-Analyses (PRISMA-NMA), and PRISMA checklists. We measured the compliance across various items in AMSTAR-2 and PRISMA checklists and provided recommendations to improve quality. RESULTS: Using the AMSTAR-2 rating method, 84% (52/62) of NMAs were rated "critically low." Quantitatively, the median [interquartile range] AMSTAR-2 score was 55 [44-69]%, while the PRISMA score was 70 [61-81]%. Methodological and reporting scores showed a strong correlation (R = 0.78). Anesthesiology NMAs had a higher AMSTAR-2 score and PRISMA score if they were published in higher impact factor journals (P = 0.006 and P = 0.01, respectively) or followed PRISMA-NMA reporting guidelines (P = 0.001 and P = 0.002, respectively). Network meta-analyses from China had lower scores (P < 0.001 and P < 0.001, respectively). Neither score improved over time (P = 0.69 and P = 0.67, respectively). CONCLUSION: The current study highlights numerous methodological and reporting deficiencies in anesthesiology NMAs. Although the AMSTAR tool has been used to assess the methodological quality of NMAs, dedicated tools for conducting and assessing the methodological quality of NMAs are urgently required. STUDY REGISTRATION: PROSPERO (CRD42021227997); first submitted 23 January 2021.

RéSUMé: OBJECTIF: La rigueur scientifique de la conduite et de la communication des méta-analyses en réseau (MAR) en anesthésiologie est inconnue. Cette revue systématique et étude méta-épidémiologique a évalué la qualité méthodologique et de communication des MAR en anesthésiologie. MéTHODE: Nous avons mené des recherches dans quatre bases de données, soit MEDLINE, PubMed, Embase et la base de données des revues systématiques Cochrane, pour trouver des MAR en anesthésiologie publiées depuis la création de ces bases de données jusqu'en octobre 2020. Nous avons évalué la conformité des MAR par rapport à trois outils, soit : AMSTAR-2 (outil de mesure pour évaluer les revues systématiques), PRISMA-NMA et les listes de contrôle PRISMA. Nous avons mesuré la conformité de divers éléments des listes de contrôle AMSTAR-2 et PRISMA et formulé des recommandations pour améliorer la qualité. RéSULTATS: En utilisant la méthode de notation AMSTAR-2, 84 % (52/62) des MAR ont reçu la cote « extrêmement faible ¼. Quantitativement, le score médian [écart interquartile] sur l'AMSTAR-2 était de 55 [44-69] %, tandis que le score PRISMA était de 70 [61-81] %. Les scores méthodologiques et de communication ont montré une forte corrélation (R = 0,78). Les MAR en anesthésiologie avaient un score AMSTAR-2 et un score PRISMA plus élevés si elles étaient publiées dans des revues à facteur d'impact plus élevé (P = 0,006 et P = 0,01, respectivement) ou avaient suivi les lignes directrices de PRISMA-NMA en matière de communication des résultats (P = 0,001 et P = 0,002, respectivement). Les méta-analyses en réseau provenant de Chine avaient des scores plus faibles (P < 0,001 et P < 0,001, respectivement). Aucun des deux scores ne s'est amélioré au fil du temps (P = 0,69 et P = 0,67, respectivement). CONCLUSION: La présente étude met en évidence de nombreuses lacunes méthodologiques et de communication dans les MAR en anesthésiologie. Bien que l'outil AMSTAR ait été utilisé pour évaluer la qualité méthodologique des MAR, il est urgent de disposer d'outils spécialisés pour mener des MAR et en évaluer la qualité méthodologique. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42021227997); soumis pour la première fois le 23 janvier 2021.

Minimum false-positive risk of primary outcomes and impact of reducing nominal P-value threshold from 0.05 to 0.005 in anaesthesiology randomised clinical trials: a cross-sectional study.

BACKGROUND: Reproducibility of research is poor; this may be because many articles report statistically significant findings that are false positives. Two potential solutions are to lower the P-value for statistical significance testing from 0.05 to 0.005 and to report the minimum false-positive risk (minFPR). This study determined these metrics for randomised controlled trials (RCTs) in general anaesthesiology journals. METHODS: We identified superiority RCTs published between January 1, 2019 and March 15, 2021 from seven leading anaesthesia journals. P-values for primary outcomes were collected, and minFPRs for these outcomes were calculated using a formula assuming a 50% prior probability of an intervention being effective (minFPR50). The primary outcomes were the percentage of RCTs maintaining statistical significance at P<0.005 and minFPR50. RESULTS: We included 318 RCTs. P-values below 0.05 were reported in 205/318 (64%) of RCTs. Of these 205 RCTs, 119/205 (58%) maintained statistical significance at the P<0.005 threshold. The mean (standard deviation) minFPR50 was 22% (20). At P=0.005, the minFPR50 was approximately 5%. CONCLUSIONS: These proposed metrics aimed at mitigating reproducibility concerns would call a significant portion of the anaesthesiology literature into question. We found a minFPR of 22% and determined that 42% of primary outcomes would not maintain statistical significance if the P-value threshold changed from 0.05 to 0.005. These findings could partially explain the lack of reproducibility of research findings.

Performance of administrative database frailty instruments in predicting clinical outcomes and cost for patients undergoing transcatheter aortic valve implantation: a historical cohort study.

PURPOSE: Frailty instruments may improve prognostic estimates for patients undergoing transcatheter aortic valve implantation (TAVI). Few studies have evaluated and compared the performance of administrative database frailty instruments for patients undergoing TAVI. This study aimed to examine the performance of administrative database frailty instruments in predicting clinical outcomes and costs in patients who underwent TAVI. METHODS: We conducted a historical cohort study of 3,848 patients aged 66 yr or older who underwent a TAVI procedure in Ontario, Canada from 1 April 2012 to 31 March 2018. We used the Johns Hopkins Adjusted Clinical Group (ACG) frailty indicator and the Hospital Frailty Risk Score (HFRS) to assign frailty status. Outcomes of interest were in-hospital mortality, one-year mortality, rehospitalization, and healthcare costs. We compared the performance of the two frailty instruments with that of a reference model that adjusted baseline covariates and procedural characteristics. Accuracy measures included c-statistics, Akaike information criterion (AIC), Bayesian information criterion (BIC), integrated discrimination improvement (IDI), net reclassification index (NRI), bias, and accuracy of cost estimates. RESULTS: A total of 863 patients (22.4%) were identified as frail using the Johns Hopkins ACG frailty indicator and 865 (22.5%) were identified as frail using the HFRS. Although agreement between the frailty instruments was fair (Kappa statistic = 0.322), each instrument classified different subgroups as frail. Both the Johns Hopkins ACG frailty indicator (rate ratio [RR], 1.13; 95% confidence interval [CI], 1.06 to 1.20) and the HFRS (RR, 1.14; 95% CI, 1.07 to 1.21) were significantly associated with increased one-year costs. Compared with the reference model, both the Johns Hopkins ACG frailty indicator and HFRS significantly improved NRI for one-year mortality (Johns Hopkins ACG frailty indicator: NRI, 0.160; P < 0.001; HFRS: NRI, 0.146; P = 0.001) and rehospitalization (Johns Hopkins ACG frailty indicator: NRI, 0.201; P < 0.001; HFRS: NRI, 0.141; P = 0.001). These improvements in NRI largely resulted from classification improvement among those who did not experience the event. With one-year mortality, there was a significant improvement in IDI (IDI, 0.003; P < 0.001) with the Johns Hopkins ACG frailty indicator. This improvement in performance resulted from an increase in the mean probability of the event among those with the event. CONCLUSION: Preoperative frailty assessment may add some predictive value for TAVI outcomes. Use of administrative database frailty instruments may provide small but significant improvements in case-mix adjustment when profiling hospitals for certain outcomes.

RéSUMé: OBJECTIF: L'utilisation d'indicateur de fragilité pourrait améliorer l'évaluation pronostique des patients bénéficiant d'un remplacement valvulaire aortique par voie percutanée (procédure TAVI). Peu d'études ont évalué et comparé la performance des instruments d'évaluation de la fragilité développés à partir de données administratives chez les patients bénéficiant d'un TAVI. Nous avions pour objectif d'examiner la performance des instruments d'évaluation de la fragilité développés à partir de données administratives dans la prédiction des issues cliniques et des coûts chez les patients ayant bénéficié d'un TAVI. MéTHODE: Nous avons réalisé une étude de cohorte historique auprès de 3848 patients âgés de 66 ans ou plus qui ont bénéficié d'une procédure TAVI en Ontario, Canada, du 1er avril 2012 au 31 mars 2018. Nous avons utilisé l'indicateur de fragilité ACG (Adjusted Clinical Group) de Johns Hopkins et le score de risque de fragilité à l'hôpital (HFRS) pour définir la fragilité. Les critères d'évaluation étaient la mortalité hospitalière, la mortalité à un an, la réhospitalisation et les coûts des soins de santé. Nous avons comparé la performance des deux instruments d'évaluation de la fragilité à celle d'un modèle de référence qui ajustait les covariables de base et les caractéristiques procédurales. Les mesures d'exactitude comprenaient l'analyse statistique c, le critère d'information d'Akaike (AIC), le critère d'information bayésien (BIC), l'amélioration de la discrimination intégrée (IDI), l'indice NRI (net reclassification index), le biais et l'exactitude des estimations de coûts. RéSULTATS: Au total, 863 patients (22,4 %) ont été identifiés comme fragiles à l'aide de l'indicateur de fragilité ACG de Johns Hopkins, et 865 (22,5 %) ont été identifiés comme fragiles à l'aide du HFRS. Bien que l'agrément entre les instruments d'évaluation de la fragilité ait été acceptable (statistique de Kappa = 0,322), chaque instrument a classé des sous-groupes différents comme étant fragiles. L'indicateur de fragilité ACG de Johns Hopkins (rapport de taux [RR], 1,13; intervalle de confiance à 95 % [IC], 1,06 à 1,20) et le HFRS (RR, 1,14; IC 95 %, 1,07 à 1,21) étaient associés de façon significative à une augmentation des coûts sur un an. Par rapport au modèle de référence, l'indicateur de fragilité ACG de Johns Hopkins améliorent de façon significative le NRI pour la mortalité (l'indicateur de fragilité ACG de Johns Hopkins: NRI, 0.160; P < 0.001; HFRS: NRI, 0.146; P = 0.001) et la réhospitalisation (l'indicateur de fragilité ACG: NRI, 0.201; P < 0.001; HFRS: NRI, 0.141; P = 0.001) à un an. Ces améliorations du NRI résultent en grande partie de l'amélioration de la classification chez ceux qui n'ont pas bénéficié d'un TAVI. En ce qui a trait à la mortalité à un an, il y a eu une amélioration significative de l'IDI (IDI, 0,003; P < 0,001) avec l'indicateur de fragilité ACG de Johns Hopkins. Cette amélioration de la performance résultait d'une augmentation de la probabilité moyenne de TAVI chez les personnes ayant vécu l'événement. CONCLUSION: L'évaluation préopératoire de la fragilité peut ajouter une certaine valeur prédictive aux issues cliniques suivant une procédure de TAVI. L'utilisation d'instruments d'évaluation de la fragilité développés à partir de données administratives peut apporter des améliorations mineures mais significatives pour l'ajustement de risque lors de l'évaluation des hôpitaux en fonction de certaines issues cliniques.

Epidemiological, methodological, and statistical characteristics of network meta-analysis in anaesthesia: a systematic review.

BACKGROUND: Network meta-analyses (NMAs) combine direct and indirect estimates to provide mixed (or network) estimates of effect sizes. The scientific rigour of the conduct and reporting of anaesthesia NMAs is unknown. This review assessed the epidemiological, methodological, and statistical characteristics of anaesthesia NMAs. METHODS: We searched four databases for anaesthesia NMAs and developed a 64-item checklist to evaluate NMAs. For 29 binary items, we defined compliance as 'the ratio of NMAs that was awarded a 'yes' for that item, divided by the total number of NMAs. The compliance of such binary items was reclassified as very low (≤25%), low (26-50%), fair (51-75%), and high (>75%). We amalgamated findings from 29 key items to provide specific recommendations (post hoc). We compared the compliance of NMAs in anaesthesia across 26 items, with that of cancer NMAs and Cochrane NMAs, and analysed improvement over time (post hoc). RESULTS: Among 62 included NMAs, compliance was low (26-50%) for protocol registration, use of PRISMA-NMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses for NMA), publication bias assessment, evidence appraisal, reporting of Bayesian methodology and consistency evaluation. Compliance was very low (≤25%) for bias assessment, biostatistician involvement, search specialist, and use of predefined important differences. CONCLUSIONS: Anaesthesia NMAs need improvement in their conduct and reporting. Anaesthesia journals should mandate the registration of protocols and reporting of NMAs using PRISMA-NMA. Authors should carefully assess publication bias, and use updated bias assessment tools, and evidence appraisal methods designed for NMAs. SYSTEMATIC REVIEW PROTOCOL: PROSPERO CRD42021227608.

Air Pollution and Incidence of Dementia: A Systematic Review and Meta-analysis.

BACKGROUND AND OBJECTIVES: Studies of association between air pollution and incidence of dementia have shown discrepant results. The aim of this study was to evaluate the association between air pollution and dementia. METHODS: In this systematic review and meta-analysis, PubMed, MEDLINE, EMBASE, PsycINFO, Scopus, and Web of Science were searched and updated in August 2021. Population-based cohort studies that reported on hazard ratio (HR) of dementia in association with exposure to fine particulate matter (PM2·5), nitrogen oxides (NOX), nitrogen dioxide (NO2), or ozone (O3) in those aged >40 years were included. Data were extracted by 2 independent investigators. The main outcome was the pooled HR for dementia per increment of pollutant, calculated using a random-effects model. Results were reported in accordance with PRISMA guidelines. The protocol was registered in PROSPERO (registration number: CRD42020219036). RESULTS: A total of 20 studies were included in the systematic review, and 17 provided data for the meta-analysis. The total included population was 91,391,296, with 5,521,111 (6%) being diagnosed with dementia. A total of 12, 5, 6, and 4 studies were included in the meta-analyses of PM2·5, NOX, NO2, and O3, respectively. The risk of dementia increased by 3% per 1 µg/m3 increment in PM2·5 (HR, 1.03; 95% CI [1.02-1.05]; I2 = 100%). The association between dementia per 10 µg/m3 increment in NOX (HR, 1.05; 95% CI [0.99-1.13]; I2 = 61%), NO2 (HR, 1.03; 95% CI [1.00-1.07]; I2 = 94%), and O3 levels (HR, 1.01; 95% CI [0.91-1.11]; I2 = 82%) was less clear, although a significant association could not be ruled out, and there was high heterogeneity across studies. DISCUSSION: Existing evidence suggests a significant association between exposure to PM2·5 and incidence of dementia and nonsignificant association between dementia and NOX, NO2, and O3 exposure. However, results should be interpreted in light of the small number of studies and high heterogeneity of effects across studies.

Magnitude of COVID-19 deaths relative to other leading causes of death: a global analysis.

OBJECTIVES: To quantify the burden of death that COVID-19 contributes relative to the top three causes of death for all countries. DESIGN: We performed uncertainty analyses and created contour plots for COVID-19 mortality to place the number of COVID-19 deaths in context relative to the top three causes of death in each country, across a plausible range of values for two key parameters: case fatality rate and magnitude of under-reporting. SETTING: All countries that have reported COVID-19 cases to the WHO and are included in the Global Burden of Disease Study by the Institute of Health Metrics and Evaluation. MAIN OUTCOMES AND MEASURES: Monthly number of deaths caused by COVID-19 and monthly number of deaths caused by the top three causes of death for every country. RESULTS: For countries that were particularly hard hit during the outbreak in 2020, most combinations of model parameters resulted in COVID-19 ranking within the top three causes of death. For countries not as hard hit on a per-capita basis, such as China and India, COVID-19 did not rank higher than the third leading cause of death at any combination of the model parameters within the given ranges. Up-to-date ranking of COVID-19 deaths relative to the top three causes of death for all countries globally is provided in an interactive online application. CONCLUSIONS: Estimating the country-level burden of death that COVID-19 contributes relative to the top three causes of death is feasible through contour graphs, even when the actual number of deaths or cases is unknown. This method can help convey importance by placing the magnitude of COVID-related deaths in context relative to more familiar causes of death by communicating when COVID-related deaths rank among the top three causes of death.

Analgesic Efficacy of Adjuvant Medications in the Pediatric Caudal Block for Infraumbilical Surgery: A Network Meta-Analysis of Randomized Controlled Trials.

Various adjuvants are added to local anesthetics in caudal block to improve analgesia. The comparative analgesic effectiveness and relative rankings of these adjuvants are unknown. This network meta-analysis (NMA) sought to evaluate the comparative analgesic efficacy and relative ranking of caudal adjuvants added to local anesthetics (versus local anesthetics alone) in pediatric infra-umbilical surgery. We searched the United States National Library of Medicine database (MEDLINE), PubMed, and Excerpta Medica database (Embase) for randomized controlled trials (RCTs) comparing caudal adjuvants (clonidine, dexmedetomidine, ketamine, magnesium, morphine, fentanyl, tramadol, dexamethasone, and neostigmine) among themselves, or to no adjuvant (control). We performed a frequentist NMA and employed Cochrane's 'Risk of Bias' tool to evaluate study quality. We chose the duration of analgesia (defined as 'the time from caudal injection to the time of rescue analgesia') as our primary outcome. We also assessed the number of analgesic dose administrations and total dose of acetaminophen within 24 h. The duration of analgesia [87 randomized control trials (RCTs), 5285 patients] was most prolonged by neostigmine [mean difference: 513 min, (95% confidence interval, CI: 402, 625)]. Dexmedetomidine reduced the frequency of analgesic dose administrations within 24 h [29 RCTs, 1765 patients; -1.2 dose (95% CI: -1.6, -0.9)] and the total dose of acetaminophen within 24 h [18 RCTs, 1156 patients; -350 mg (95% CI: -467, -232)] the most.  Among caudal adjuvants, neostigmine (moderate certainty), tramadol (low certainty), and dexmedetomidine (low certainty) prolonged the duration of analgesia the most. Dexmedetomidine also reduced the analgesic frequency and consumption more than other caudal adjuvants (moderate certainty).

Evaluation of spin in the abstracts of systematic reviews and meta-analyses relating to postoperative nausea and vomiting.

INTRODUCTION: Spin - the beautification of study results to emphasise benefits or minimise harms - is a deceptive reporting strategy with the potential to affect clinical decision-making adversely. Few studies have investigated the extent of spin in systematic reviews. Here, we sought to address this gap by evaluating the presence of the nine most severe forms of spin in the abstracts of systematic reviews on treatments for postoperative nausea and vomiting (PONV). PONV has the potential to increase hospital costs and patient burden, adversely affecting outcomes. METHODS: We developed search strategies for MEDLINE and Embase to identify systematic reviews focused on PONV. Following title and abstract screening of the reviews identified during the initial search, those that met inclusion criteria were evaluated for the presence of spin and received a revised AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews) appraisal by two investigators in a masked, duplicate manner. Study characteristics for each review were also extracted in duplicate. RESULTS: Our systematic search returned 3513 studies, of which 130 systematic reviews and meta-analyses were eligible for data extraction. We found that 29.2% of included systematic reviews contained spin (38/130). Eight of the nine types of spin were identified, with spin type 3 ('selective reporting of or overemphasis on efficacy outcomes or analysis favouring the beneficial effect of the experimental intervention') being the most common. Associations were found between spin and funding source. Spin was more likely in the abstracts of privately funded than nonfunded studies, odds ratio (OR) 2.81 [95% confidence interval (CI), 0.66 to 11.98]. In the abstracts of studies not mentioning funding spin was also more likely than in nonfunded studies, OR 2.30 (95% CI, 0.61 to 8.70). Neither of these results were statistically significant. Significance was found in the association between the presence of spin and AMSTAR-2 ratings: 'low' quality studies were less likely to contain spin than 'high' quality, OR 0.24 (95% CI, 0.07 to 0.88): 'critically low' studies were also less likely to contain spin than 'high' quality studies, OR 0.21 (95% CI, 0.07 to 0.65). There were no other associations between spin and the remaining extracted study characteristics or AMSTAR-2 ratings. CONCLUSION: Spin was present in greater than 29% of abstracts of systematic reviews and meta-analyses regarding PONV. Various stakeholders must take steps to improve the reporting quality of abstracts on PONV.

Autoantibodies in Common Connective Tissue Diseases: A Primer for Laboratory Professionals.

BACKGROUND: Autoimmune connective tissue disorders are a significant health concern throughout the world with an estimated prevalence of 3% to 5%. They are associated with a variety of autoantibodies that play roles in their diagnosis, risk stratification, prognostication, and/or management. While some autoantibodies have been well-characterized for use in clinical laboratories, many more are in the research stage. Rapid transition from research to clinical practice, lack of clinical guidelines, and harmonization across a rapidly growing number of commercially available tests create numerous challenges to clinicians and laboratories. CONTENT: This article briefly discusses common connective tissue disorders and their association with well-known autoantibodies, describes current methods used in clinical laboratories, and outlines their advantages and limitations in the context of these diseases. SUMMARY: Understanding the role of specific autoantibodies and various methodologies for autoantibody testing are important for laboratory professionals who may be introducing/repatriating new tests, updating existing tests, or advising clinicians/patients about testing options/results. Collaboration between laboratory professional staff and clinicians, around the advantages and limitations of each methodology, is also important in their appropriate clinical utilization.

IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage.

OBJECTIVE: To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0). BACKGROUND: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety. METHODS: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects, and minimization of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted. RESULTS: In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness before progression to clinical studies (stage 1). CONCLUSIONS: The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice.

Impact of COVID-19 on excess mortality, life expectancy, and years of life lost in the United States.

This paper quantifies the net impact (direct and indirect effects) of the pandemic on the United States population in 2020 using three metrics: excess deaths, life expectancy, and total years of life lost. The findings indicate there were 375,235 excess deaths, with 83% attributable to direct, and 17% attributable to indirect effects of COVID-19. The decrease in life expectancy was 1.67 years, translating to a reversion of 14 years in historical life expectancy gains. Total years of life lost in 2020 was 7,362,555 across the USA (73% directly attributable, 27% indirectly attributable to COVID-19), with considerable heterogeneity at the individual state level.

Global surgery, obstetric, and anaesthesia indicator definitions and reporting: An Utstein consensus report.

BACKGROUND: Indicators to evaluate progress towards timely access to safe surgical, anaesthesia, and obstetric (SAO) care were proposed in 2015 by the Lancet Commission on Global Surgery. These aimed to capture access to surgery, surgical workforce, surgical volume, perioperative mortality rate, and catastrophic and impoverishing financial consequences of surgery. Despite being rapidly taken up by practitioners, data points from which to derive the indicators were not defined, limiting comparability across time or settings. We convened global experts to evaluate and explicitly define-for the first time-the indicators to improve comparability and support achievement of 2030 goals to improve access to safe affordable surgical and anaesthesia care globally. METHODS AND FINDINGS: The Utstein process for developing and reporting guidelines through a consensus building process was followed. In-person discussions at a 2-day meeting were followed by an iterative process conducted by email and virtual group meetings until consensus was reached. The meeting was held between June 16 to 18, 2019; discussions continued until August 2020. Participants consisted of experts in surgery, anaesthesia, and obstetric care, data science, and health indicators from high-, middle-, and low-income countries. Considering each of the 6 indicators in turn, we refined overarching descriptions and agreed upon data points needed for construction of each indicator at current time (basic data points), and as each evolves over 2 to 5 (intermediate) and >5 year (full) time frames. We removed one of the original 6 indicators (one of 2 financial risk protection indicators was eliminated) and refined descriptions and defined data points required to construct the 5 remaining indicators: geospatial access, workforce, surgical volume, perioperative mortality, and catastrophic expenditure. A strength of the process was the number of people from global institutes and multilateral agencies involved in the collection and reporting of global health metrics; a limitation was the limited number of participants from low- or middle-income countries-who only made up 21% of the total attendees. CONCLUSIONS: To track global progress towards timely access to quality SAO care, these indicators-at the basic level-should be implemented universally as soon as possible. Intermediate and full indicator sets should be achieved by all countries over time. Meanwhile, these evolutions can assist in the short term in developing national surgical plans and collecting more detailed data for research studies.

Disagreement between Cardiac Troponin Tests Yielding a Higher Incidence of Myocardial Injury in the Emergency Setting.

Differences in patient classification of myocardial injury between high-sensitivity cardiac troponin (hs-cTn) assays have largely been attributed to assay design and analytical sensitivity aspects. Our objective was to compare Ortho Clinical Diagnostics' (OCD) hs-cTnI assay to OCD's contemporary/conventional assay (cTnI ES) and another hs-cTnI assay (Abbott hs-cTnI) in samples obtained from different emergency departments (EDs). Two different sample types were evaluated (lithium heparin and ethylenediaminetetraacetic acid (EDTA) plasma) in a non-selected ED population (study 1, n = 469 samples) and in patients for which ED physicians ordered cardiac troponin testing (study 2, n = 1147 samples), from five different EDs. The incidence of injury in study 1 was higher with the OCD hs-cTnI assay (30.9%; 95% CI: 26.9 to 35.2) compared to that of the Abbott hs-cTnI (17.3%; 95% CI: 14.1 to 21.0) and the OCD cTnI ES (15.4%; 95% CI: 12.4 to 18.9) assays, with repeat testing identifying 4.8% (95% CI: 3.0 to 7.5) of the OCD hs-cTnI results with poor reproducibility. In study 2, 4.6% (95% CI: 3.5 to 6.0) of the results were not reported for the OCD hs-cTnI assay (i.e., poor reproducibility) with 12.7% (95%CI: 8.7 to 17.8) of the OCD hs-cTnI results positive for injury being negative for injury with the Abbott hs-cTnI assay. In summary, the OCD hs-cTnI assay yields higher rates of biochemical injury with a higher rate of poor reproducible results in different ED populations.