scholarly journals Efficacy of live attenuated and inactivated influenza vaccines among children in rural India: A 2-year, randomized, triple-blind, placebo-controlled trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (4) ◽  
pp. e1003609
Author(s):  
Anand Krishnan ◽  
Lalit Dar ◽  
Siddhartha Saha ◽  
Venkatesh Vinayak Narayan ◽  
Rakesh Kumar ◽  
...  
Keyword(s):  
Influenza Virus ◽  
Influenza Vaccine ◽  
Proportional Hazards Model ◽  
Controlled Trial ◽  
Influenza Virus Infection ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rural India ◽  
Relative Efficacy ◽  
Indian Children

Background Influenza is a cause of febrile acute respiratory infection (FARI) in India; however, few influenza vaccine trials have been conducted in India. We assessed absolute and relative efficacy of live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) among children aged 2 to 10 years in rural India through a randomized, triple-blind, placebo-controlled trial conducted over 2 years. Methods and findings In June 2015, children were randomly allocated to LAIV, IIV, intranasal placebo, or inactivated polio vaccine (IPV) in a 2:2:1:1 ratio. In June 2016, vaccination was repeated per original allocation. Overall, 3,041 children received LAIV (n = 1,015), IIV (n = 1,010), nasal placebo (n = 507), or IPV (n = 509). Mean age of children was 6.5 years with 20% aged 9 to 10 years. Through weekly home visits, nasal and throat swabs were collected from children with FARI and tested for influenza virus by polymerase chain reaction. The primary outcome was laboratory-confirmed influenza-associated FARI; vaccine efficacy (VE) was calculated using modified intention-to-treat (mITT) analysis by Cox proportional hazards model (PH) for each year. In Year 1, VE was 40.0% (95% confidence interval (CI) 25.2 to 51.9) for LAIV and 59.0% (95% CI 47.8 to 67.9) for IIV compared with controls; relative efficacy of LAIV compared with IIV was −46.2% (95% CI −88.9 to −13.1). In Year 2, VE was 51.9% (95% CI 42.0 to 60.1) for LAIV and 49.9% (95% CI 39.2 to 58.7) for IIV; relative efficacy of LAIV compared with IIV was 4.2% (95% CI −19.9 to 23.5). No serious adverse vaccine-attributable events were reported. Study limitations include differing dosage requirements for children between nasal and injectable vaccines (single dose of LAIV versus 2 doses of IIV) in Year 1 and the fact that immunogenicity studies were not conducted. Conclusions In this study, we found that LAIV and IIV vaccines were safe and moderately efficacious against influenza virus infection among Indian children. Trial registration Clinical Trials Registry of India CTRI/2015/06/005902.

scholarly journals Teaching Endotracheal Intubation Using a Cadaver Versus a Manikin-based Model: a Randomized Controlled Trial

2019 ◽  
Vol 21 (1) ◽  
pp. 108-114
Author(s):  
Ryan Pedigo ◽  
Juliana Tolles ◽  
Daena Watcha ◽  
Amy Kaji ◽  
Roger Lewis ◽  
...  
Keyword(s):  
Endotracheal Intubation ◽  
Proportional Hazards Model ◽  
Controlled Trial ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Optimal Method ◽  
Similar Time ◽  
Study Objective ◽  
Median Difference ◽  
First Pass

Introduction: The optimal method to train novice learners to perform endotracheal intubation (ETI) is unknown. The study objective was to compare two models: unembalmed cadaver vs simulation manikin. Methods: Fourth-year medical students, stratified by baseline ETI experience, were randomized 1:1 to train on a cadaver or simulation manikin. Students were tested and video recorded on a separate cadaver; two reviewers, blinded to the intervention, assessed the videos. Primary outcome was time to successful ETI, analyzed with a Cox proportional hazards model. Authors also compared percentage of glottic opening (POGO), number of ETI attempts, learner confidence, and satisfaction. Results: Of 97 students randomized, 78 were included in the final analysis. Median time to ETI did not differ significantly (hazard ratio [HR] 1.1; 95% CI [confidence interval], 0.7-1.8): cadaver group = 34.5 seconds (interquartile ratio [IQR]: 23.3-55.8) vs manikin group = 35.5 seconds (IQR: 23.8-80.5), with no difference in first-pass success (odds ratio [OR] = 1; 95% CI, 0.1-7.5) or median POGO: 80% cadaver vs 90% manikin (95% CI, -14-34%). Satisfaction was higher for cadavers (median difference = 0.5; p = 0.002; 95% CI, 0-1) as was change in student confidence (median difference = 0.5; p = 0.03; 95% CI, 0-1). Students rating their confidence a 5 (“extremely confident”) demonstrated decreased time to ETI (HR = 4.2; 95% CI, 1.0-17.2). Conclusion: Manikin and cadaver training models for ETI produced similar time to ETI, POGO, and first-pass success. Cadaver training was associated with increased student satisfaction and confidence; subjects with the highest confidence level demonstrated decreased time to ETI.

scholarly journals Plasma Levels of Mid-Regional Proadrenomedullin Accurately Identify H1N1pdm09 Influenza Virus Patients with Risk of Intensive Care Admission and Mortality in the Emergency Department

2022 ◽  
Vol 12 (1) ◽  
pp. 84
Author(s):  
Blanca Valenzuela-Méndez ◽  
Francisco Valenzuela-Sánchez ◽  
Juan Francisco Rodríguez-Gutiérrez ◽  
Rafael Bohollo-de-Austria ◽  
Ángel Estella ◽  
...  
Keyword(s):  
Emergency Department ◽  
Influenza Virus ◽  
Hospital Admission ◽  
Influenza A ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Adverse Outcomes ◽  
Cox Proportional Hazards Model ◽  
Survival Prediction ◽  
Influenza Virus A

Early identification of severe viral pneumonia in influenza virus A (H1N1pdm09) patients is extremely important for prompt admission to the ICU. The objective is to evaluate the usefulness of MR-proadrenomedullin (MR-proADM) compared to C reactive protein (CRP), procalcitonin (PCT), and ferritin in the prognosis of influenza A pneumonia. This prospective, observational, multicenter study included one hundred thirteen patients with confirmed influenza virus A (H1N1pdm09) admitted to an Emergency Department and ICUs of six hospitals in Spain. Measurements and Main Results: one-hundred thirteen patients with confirmed influenza virus A (H1N1pdm09) were enrolled. Seventy-five subjects (mortality 29.3%) with severe pneumonia caused by influenza A H1N1pdm09 virus (H1N1vIPN) were compared with 38 controls (CG).The median MR-proADM levels at hospital admission were 1.2 nmol/L (IQR (0.8–2.6) vs. 0.5 nmol/L (IQR 0.2–0.9) in the CG (p = 0.01), and PCT levels were 0.43 μg/L (IQR 0.2–1.2) in the H1N1vIPN group and 0.1 μg/L (IQR 0.1–0.2) in the CG (p < 0.01). CRP levels at admission were 15.5 mg/dL(IQR 9.2–24.9) in H1N1vIPN and 8.6 mg/dL(IQR 3–17.3) in the CG (p < 0.01). Ferritin levels at admission were 558.1 ng/mL(IQR 180–1880) in H1N1vIPN and 167.7 ng/mL(IQR 34.8–292.9) in the CG (p < 0.01). A breakpoint for hospital admission of MR-proADM of 1.1 nmol/L showed a sensitivity of 55% and a specificity of 90% (AUC-ROC0.822). Non-survivors showed higher MR-proADM levels: median of 2.5 nmol/L vs. 0.9 nmol/L among survivors (p < 0.01). PCT, CRP, and ferritin levels also showed significant differences in predicting mortality. The MR-proADM AUC-ROC for mortality was 0.853 (p < 0.01). In a Cox proportional hazards model, MR-proADM levels > 1.2 nmol/L at hospital admission were significant predictive factors for ICU and 90-day mortality (HR: 1.3). Conclusions: the initial MR-proADM, ferritin, CRP, and PCT levels effectively determine adverse outcomes and risk of ICU admission and mortality in patients with influenza virus pneumonia. MR-proADM has the highest potency for survival prediction.

Age at Exposure to Parental Suicide and the Subsequent Risk of Suicide in Young People

Crisis ◽  
2018 ◽  
Vol 39 (1) ◽  
pp. 27-36 ◽  
Author(s):  
Kuan-Ying Lee ◽  
Chung-Yi Li ◽  
Kun-Chia Chang ◽  
Tsung-Hsueh Lu ◽  
Ying-Yeh Chen
Keyword(s):  
Young People ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Birth Registry ◽  
Data Set ◽  
Parental Suicide ◽  
The Impact ◽  
Age At Exposure

Abstract. Background: We investigated the age at exposure to parental suicide and the risk of subsequent suicide completion in young people. The impact of parental and offspring sex was also examined. Method: Using a cohort study design, we linked Taiwan's Birth Registry (1978–1997) with Taiwan's Death Registry (1985–2009) and identified 40,249 children who had experienced maternal suicide (n = 14,431), paternal suicide (n = 26,887), or the suicide of both parents (n = 281). Each exposed child was matched to 10 children of the same sex and birth year whose parents were still alive. This yielded a total of 398,081 children for our non-exposed cohort. A Cox proportional hazards model was used to compare the suicide risk of the exposed and non-exposed groups. Results: Compared with the non-exposed group, offspring who were exposed to parental suicide were 3.91 times (95% confidence interval [CI] = 3.10–4.92 more likely to die by suicide after adjusting for baseline characteristics. The risk of suicide seemed to be lower in older male offspring (HR = 3.94, 95% CI = 2.57–6.06), but higher in older female offspring (HR = 5.30, 95% CI = 3.05–9.22). Stratified analyses based on parental sex revealed similar patterns as the combined analysis. Limitations: As only register-­based data were used, we were not able to explore the impact of variables not contained in the data set, such as the role of mental illness. Conclusion: Our findings suggest a prominent elevation in the risk of suicide among offspring who lost their parents to suicide. The risk elevation differed according to the sex of the afflicted offspring as well as to their age at exposure.

Proliferation-dominant high-grade astrocytoma: survival benefit associated with extensive resection of FLAIR abnormality region

2020 ◽  
Vol 132 (4) ◽  
pp. 998-1005 ◽  
Author(s):  
Haihui Jiang ◽  
Yong Cui ◽  
Xiang Liu ◽  
Xiaohui Ren ◽  
Mingxiao Li ◽  
...  
Keyword(s):  
Survival Benefit ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Characteristic Curve ◽  
Extent Of Resection ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
High Grade ◽  
Extensive Resection ◽  
High Grade Astrocytoma

OBJECTIVEThe aim of this study was to investigate the relationship between extent of resection (EOR) and survival in terms of clinical, molecular, and radiological factors in high-grade astrocytoma (HGA).METHODSClinical and radiological data from 585 cases of molecularly defined HGA were reviewed. In each case, the EOR was evaluated twice: once according to contrast-enhanced T1-weighted images (CE-T1WI) and once according to fluid attenuated inversion recovery (FLAIR) images. The ratio of the volume of the region of abnormality in CE-T1WI to that in FLAIR images (VFLAIR/VCE-T1WI) was calculated and a receiver operating characteristic curve was used to determine the optimal cutoff value for that ratio. Univariate and multivariate analyses were performed to identify the prognostic value of each factor.RESULTSBoth the EOR evaluated from CE-T1WI and the EOR evaluated from FLAIR could divide the whole cohort into 4 subgroups with different survival outcomes (p < 0.001). Cases were stratified into 2 subtypes based on VFLAIR/VCE-T1WIwith a cutoff of 10: a proliferation-dominant subtype and a diffusion-dominant subtype. Kaplan-Meier analysis showed a significant survival advantage for the proliferation-dominant subtype (p < 0.0001). The prognostic implication has been further confirmed in the Cox proportional hazards model (HR 1.105, 95% CI 1.078–1.134, p < 0.0001). The survival of patients with proliferation-dominant HGA was significantly prolonged in association with extensive resection of the FLAIR abnormality region beyond contrast-enhancing tumor (p = 0.03), while no survival benefit was observed in association with the extensive resection in the diffusion-dominant subtype (p=0.86).CONCLUSIONSVFLAIR/VCE-T1WIis an important classifier that could divide the HGA into 2 subtypes with distinct invasive features. Patients with proliferation-dominant HGA can benefit from extensive resection of the FLAIR abnormality region, which provides the theoretical basis for a personalized resection strategy.

Association of time to surgery with leg pain after lumbar discectomy: is delayed surgery detrimental?

2020 ◽  
Vol 32 (2) ◽  
pp. 160-167 ◽  
Author(s):  
Alessandro Siccoli ◽  
Victor E. Staartjes ◽  
Marlies P. de Wispelaere ◽  
Marc L. Schröder
Keyword(s):  
Rating Scale ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Lumbar Discectomy ◽  
Cox Proportional Hazards Model ◽  
Neurological Deficits ◽  
Leg Pain ◽  
Specific Method ◽  
Time To Surgery ◽  
Patient Reported

OBJECTIVEWhile it has been established that lumbar discectomy should only be performed after a certain waiting period unless neurological deficits are present, little is known about the association of late surgery with outcome. Using data from a prospective registry, the authors aimed to quantify the association of time to surgery (TTS) with leg pain outcome after lumbar discectomy and to identify a maximum TTS cutoff anchored to the minimum clinically important difference (MCID).METHODSTTS was defined as the time from the onset of leg pain caused by radiculopathy to the time of surgery in weeks. MCID was defined as a minimum 30% reduction in the numeric rating scale score for leg pain from baseline to 12 months. A Cox proportional hazards model was utilized to quantify the association of TTS with MCID. Maximum TTS cutoffs were derived both quantitatively, anchored to the area under the curve (AUC), and qualitatively, based on cutoff-specific MCID rates.RESULTSFrom a prospective registry, 372 patients who had undergone first-time tubular microdiscectomy were identified; 308 of these patients (83%) obtained an MCID. Attaining an MCID was associated with a shorter TTS (HR 0.718, 95% CI 0.546–0.945, p = 0.018). Effect size was preserved after adjustment for potential confounders. The optimal maximum TTS was estimated at 23.5 weeks based on the AUC, while the cutoff-specific method suggested 24 weeks. Discectomy after this cutoff starts to yield MCID rates under 80%. The 24-week cutoff also coincided with the time point after which the specificity for MCID first drops below 50% and after which the negative predictive value for nonattainment of MCID first surpasses ≥ 20%.CONCLUSIONSThe study findings suggest that late lumbar discectomy is linked with poorer patient-reported outcomes and that—in accordance with the literature—a maximum TTS of 6 months should be aimed for.

scholarly journals Survival of people living with AIDS with or without tuberculosis in Sao Paulo, Brazil

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
M V Tancredi ◽  
S Sakabe ◽  
C S B Domingues ◽  
G F M Pereira² ◽  
E A Waldman
Keyword(s):  
Proportional Hazards Model ◽  
Universal Access ◽  
Sao Paulo ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Capital City ◽  
São Paulo ◽  
Aids Patients ◽  
Probability Of Survival ◽  
Aids Diagnosis

Abstract Background To estimate median survival time of AIDS patients, with and without tuberculosis (TB), in a cohort in Sao Paulo, Brazil, and to investigate survival predictors. Methods Retrospective cohort study of AIDS patients above 12 years old, registered at the Ministry of Health AIDS surveillance system between 2003-2007, and followed until 2014. Survival analysis used the Kaplan-Meier method and Cox proportional hazards model to estimate hazard ratios (HR), with respective 95% confidence intervals (CI = 95%). Results 35,515 patients were included, being 4,581 (12.9%) co-infected with TB. Among the latter, probability of survival 12 years after AIDS diagnosis was 95.2%, 82.9%, and 21.9%, respectively for patients receiving at least one third line ARV (HAART2), receiving triple therapy (HAART1) and the last one not on ARV. In the same period, the probability of survival for patients without TB, in the same order as for the therapeutic regimens, was 95.2%, 90.5%, and 40.9%, respectively. The main factors associated with survival, adjusted for the year of diagnosis, were: Living in the city of Sao Paulo (HR = 1,16;IC95% 1,01-1,32), living away from the capital city (HR = 1.43; 95%CI 1.25-1.62); or on the coast (HR = 1.49; 95%CI 1.21-1.82); having TB (HR = 1.70; 95%CI 1.49-1.87); above 49 years old (HR = 1.35; 95%CI 1.18-1.54); black (HR = 1.27; 95%CI 1.12-1.45); IV drug use (HR = 1.73; 95%CI 1.49-2.02); CD4+ below 200 cell/mm³ at AIDS diagnosis (HR = 2.31; 95%CI 1.97-2.72); viral load above 500 copies at AIDS diagnosis (HR = 1.99; 95%CI 1.72-2.30); HAART1 scheme (HR = 1.94; 95%CI 1.47-2.55); no ARV (HR = 8.22; 95%CI 2.95-22.87). Conclusions A large proportion of patients did not receive ARVs or were late diagnosed with AIDS, especially those with TB, whose survival was shorter. Survival is heterogeneous in the state, being lower in regions with higher TB rates. The results point to the need for specific strategies for patients with TB-HIV co-infection. Key messages Tuberculosis is the main cause of death among HIV-infected people, being responsible for one third of deaths in this group and causing a great impact on the survival of this population. The Brazilian policy of universal access to ARV and treatment for TB has increased the survival of AIDS-TB from 22% to 95% and in patients without TB from 50% to 95% up to 12 years after diagnosis.

scholarly journals Adapting the Default Weighted Survival Analysis Modelling Approach to Model IFRS 9 LGD

Risks ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 103
Author(s):  
Morne Joubert ◽  
Tanja Verster ◽  
Helgard Raubenheimer ◽  
Willem D. Schutte
Keyword(s):  
Survival Analysis ◽  
Financial Reporting ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Survival Curve ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Reporting Standard ◽  
International Financial Reporting Standard ◽  
Ifrs 9

Survival analysis is one of the techniques that could be used to predict loss given default (LGD) for regulatory capital (Basel) purposes. When using survival analysis to model LGD, a proposed methodology is the default weighted survival analysis (DWSA) method. This paper is aimed at adapting the DWSA method (used to model Basel LGD) to estimate the LGD for International Financial Reporting Standard (IFRS) 9 impairment requirements. The DWSA methodology allows for over recoveries, default weighting and negative cashflows. For IFRS 9, this methodology should be adapted, as the estimated LGD is a function of in the expected credit losses (ECL). Our proposed IFRS 9 LGD methodology makes use of survival analysis to estimate the LGD. The Cox proportional hazards model allows for a baseline survival curve to be adjusted to produce survival curves for different segments of the portfolio. The forward-looking LGD values are adjusted for different macro-economic scenarios and the ECL is calculated for each scenario. These ECL values are probability weighted to produce a final ECL estimate. We illustrate our proposed IFRS 9 LGD methodology and ECL estimation on a dataset from a retail portfolio of a South African bank.

scholarly journals Risk factors associated with major adverse cardiac and cerebrovascular events following percutaneous coronary intervention: a 10-year follow-up comparing random survival forest and Cox proportional-hazards model

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maryam Farhadian ◽  
Sahar Dehdar Karsidani ◽  
Azadeh Mozayanimonfared ◽  
Hossein Mahjub
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Coronary Intervention ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Hazards Model ◽  
Cerebrovascular Events ◽  
Long Term Follow Up ◽  
Stent Length

Abstract Background Due to the limited number of studies with long term follow-up of patients undergoing Percutaneous Coronary Intervention (PCI), we investigated the occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) during 10 years of follow-up after coronary angioplasty using Random Survival Forest (RSF) and Cox proportional hazards models. Methods The current retrospective cohort study was performed on 220 patients (69 women and 151 men) undergoing coronary angioplasty from March 2009 to March 2012 in Farchshian Medical Center in Hamadan city, Iran. Survival time (month) as the response variable was considered from the date of angioplasty to the main endpoint or the end of the follow-up period (September 2019). To identify the factors influencing the occurrence of MACCE, the performance of Cox and RSF models were investigated in terms of C index, Integrated Brier Score (IBS) and prediction error criteria. Results Ninety-six patients (43.7%) experienced MACCE by the end of the follow-up period, and the median survival time was estimated to be 98 months. Survival decreased from 99% during the first year to 39% at 10 years' follow-up. By applying the Cox model, the predictors were identified as follows: age (HR = 1.03, 95% CI 1.01–1.05), diabetes (HR = 2.17, 95% CI 1.29–3.66), smoking (HR = 2.41, 95% CI 1.46–3.98), and stent length (HR = 1.74, 95% CI 1.11–2.75). The predictive performance was slightly better by the RSF model (IBS of 0.124 vs. 0.135, C index of 0.648 vs. 0.626 and out-of-bag error rate of 0.352 vs. 0.374 for RSF). In addition to age, diabetes, smoking, and stent length, RSF also included coronary artery disease (acute or chronic) and hyperlipidemia as the most important variables. Conclusion Machine-learning prediction models such as RSF showed better performance than the Cox proportional hazards model for the prediction of MACCE during long-term follow-up after PCI.

scholarly journals Elevated plasma growth and differentiation factor 15 predicts incident anemia in older adults aged 60 years and older

2020 ◽  
Author(s):  
Yuko Yamaguchi ◽  
Marta Zampino ◽  
Toshiko Tanaka ◽  
Stefania Bandinelli ◽  
Yusuke Osawa ◽  
...  
Keyword(s):  
Older Adults ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Differentiation Factor ◽  
Hazards Model ◽  
Increased Risk ◽  
The Relationship

Abstract Background Anemia is common in older adults and associated with greater morbidity and mortality. The causes of anemia in older adults have not been completely characterized. Although elevated circulating growth and differentiation factor 15 (GDF-15) has been associated with anemia in older adults, it is not known whether elevated GDF-15 predicts the development of anemia. Methods We examined the relationship between plasma GDF-15 concentrations at baseline in 708 non-anemic adults, aged 60 years and older, with incident anemia during 15 years of follow-up among participants in the Invecchiare in Chianti (InCHIANTI) Study. Results During follow-up, 179 (25.3%) participants developed anemia. The proportion of participants who developed anemia from the lowest to highest quartile of plasma GDF-15 was 12.9%, 20.1%, 21.2%, and 45.8%, respectively. Adults in the highest quartile of plasma GDF-15 had an increased risk of developing anemia (Hazards Ratio 1.15, 95% Confidence Interval 1.09, 1.21, P&lt;.0001) compared to those in the lower three quartiles in a multivariable Cox proportional hazards model adjusting for age, sex, serum iron, soluble transferrin receptor, ferritin, vitamin B12, congestive heart failure, diabetes mellitus, and cancer. Conclusions Circulating GDF-15 is an independent predictor for the development of anemia in older adults.

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