scholarly journals Protocol for the development and validation of a risk prediction model for stillbirths from 35 weeks gestation in Australia

2020 ◽  
Author(s):  
Jessica Sexton ◽  
Michael Coory ◽  
Sailesh Kumar ◽  
Gordon Smith ◽  
Adrienne Gordon ◽  
...  

Abstract Background Despite advances in the care of women and their babies in the past century, an estimated 1.7 million babies are born still each year throughout the world. A robust method to estimate a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to inform decision-making around timing of birth to reduce the risk of stillbirth from 35 weeks gestation. Methods This is a protocol for a retrospective cohort study of all late-pregnancy births in Australia (1998-2015) from 35 weeks gestation including 7,200 stillbirths among 4.9 million births at an estimated rate of 1.47 stillbirths per 1000 live births. A multivariable logistic regression model will be developed in line with current T ransparent R eporting of a multivariable prediction model for I ndividual P rognosis or D iagnosis (TRIPOD) guidelines to estimate the gestation-specific probability of stillbirth with prediction intervals. Candidate predictors were identified from systematic reviews and clinical consultation and will be assessed through univariate regression analysis. To generate a final model, elimination by backward stepwise logistic regression will be performed. The model will be internally validated using K-fold cross-validation and externally validated using a geographically unique dataset. Overall model performance will be assessed with R 2 in addition calibration and discrimination. Calibration will be visualized using a calibration plot. Discrimination will be measured by the C- statistic and visualized using area underneath the receiver-operator curves (AUROC). Clinical usefulness will be reported as positive and negative predictive values and a decision curve analysis will be considered. Discussion A robust method to predict a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to inform timely, appropriate care to reduce stillbirth. Among existing prediction models designed for obstetric use, few have been subject to internal and external validation and many fail to meet recommended reporting standards. In developing a risk prediction model for late-gestation stillbirth with both providers and pregnant women in mind, we endeavor to develop a validated model for clinical use in Australia that meets current reporting standards.

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Jessica K. Sexton ◽  
Michael Coory ◽  
Sailesh Kumar ◽  
Gordon Smith ◽  
Adrienne Gordon ◽  
...  

Abstract Background Despite advances in the care of women and their babies in the past century, an estimated 1.7 million babies are born still each year throughout the world. A robust method to estimate a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to inform decision-making around the timing of birth to reduce the risk of stillbirth from 35 weeks of gestation in Australia, a high-resource setting. Methods This is a protocol for a cross-sectional study of all late-pregnancy births in Australia (2005–2015) from 35 weeks of gestation including 5188 stillbirths among 3.1 million births at an estimated rate of 1.7 stillbirths per 1000 births. A multivariable logistic regression model will be developed in line with current TransparentReporting of a multivariable prediction model forIndividualPrognosis orDiagnosis (TRIPOD) guidelines to estimate the gestation-specific probability of stillbirth with prediction intervals. Candidate predictors were identified from systematic reviews and clinical consultation and will be described through univariable regression analysis. To generate a final model, elimination by backward stepwise multivariable logistic regression will be performed. The model will be internally validated using bootstrapping with 1000 repetitions and externally validated using a temporally unique dataset. Overall model performance will be assessed with R2, calibration, and discrimination. Calibration will be reported using a calibration plot with 95% confidence intervals (α = 0.05). Discrimination will be measured by the C-statistic and area underneath the receiver-operator curves. Clinical usefulness will be reported as positive and negative predictive values, and a decision curve analysis will be considered. Discussion A robust method to predict a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to inform timely, appropriate care to reduce stillbirth. Among existing prediction models designed for obstetric use, few have been subject to internal and external validation and many fail to meet recommended reporting standards. In developing a risk prediction model for late-gestation stillbirth with both providers and pregnant women in mind, we endeavor to develop a validated model for clinical use in Australia that meets current reporting standards.


2020 ◽  
Author(s):  
Jessica Sexton ◽  
Michael Coory ◽  
Sailesh Kumar ◽  
Gordon Smith ◽  
Adrienne Gordon ◽  
...  

Abstract Background: Despite advances in the care of women and their babies in the past century, an estimated 1.7 million babies are born still each year throughout the world. A robust method to estimate a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to inform decision-making around timing of birth to reduce the risk of stillbirth from 35 weeks gestation in Australia, a high-resource setting.Methods: This is a protocol for a cross-sectional study of all late-pregnancy births in Australia (2005-2015) from 35 weeks gestation including 5,188 stillbirths among 3.1 million births at an estimated rate of 1.7 stillbirths per 1000 births. A multivariable logistic regression model will be developed in line with current Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) guidelines to estimate the gestation-specific probability of stillbirth with prediction intervals. Candidate predictors were identified from systematic reviews and clinical consultation and will be described through univariable regression analysis. To generate a final model, elimination by backward stepwise multivariable logistic regression will be performed. The model will be internally validated using bootstrapping with 1000 repetitions and externally validated using a temporally unique dataset. Overall model performance will be assessed with R2, calibration, and discrimination. Calibration will be reported using a calibration plot with 95% confidence intervals (α=0.05). Discrimination will be measured by the C-statistic and area underneath the receiver-operator curves. Clinical usefulness will be reported as positive and negative predictive values and a decision curve analysis will be considered.Discussion: A robust method to predict a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to inform timely, appropriate care to reduce stillbirth. Among existing prediction models designed for obstetric use, few have been subject to internal and external validation and many fail to meet recommended reporting standards. In developing a risk prediction model for late-gestation stillbirth with both providers and pregnant women in mind, we endeavor to develop a validated model for clinical use in Australia that meets current reporting standards.


2020 ◽  
Author(s):  
Jessica Sexton ◽  
Michael Coory ◽  
Sailesh Kumar ◽  
Gordon Smith ◽  
Adrienne Gordon ◽  
...  

Abstract Background: Despite advances in the care of women and their babies in the past century, an estimated 1.7 million babies are born still each year throughout the world. A robust method to estimate a pregnant woman’s individualized risk of late-pregnancy stillbirth may inform decision-making around timing of birth to reduce the risk of stillbirth from 35 weeks gestation in Australia, a high-resource setting.Methods: This is a protocol for a cross-sectional study of all late-pregnancy births in Australia (2005-2015) from 35 weeks gestation including 5,188 stillbirths among 3.1 million births at an estimated rate of 1.7 stillbirths per 1000 births. A multivariable logistic regression model will be developed in line with current Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) guidelines to estimate the gestation-specific probability of stillbirth with prediction intervals. Candidate predictors were identified from systematic reviews and clinical consultation and will be assessed through univariable regression analysis. To generate a final model, elimination by backward stepwise multivariable logistic regression will be performed. The model will be internally validated using bootstrapping with 1000 repetitions and externally validated using a temporally unique dataset. Overall model performance will be assessed with R2, calibration, and discrimination. Calibration will be reported using a calibration plot with 95% confidence intervals (α=0.05). Discrimination will be measured by the C-statistic and area underneath the receiver-operator curves. Clinical usefulness will be reported as positive and negative predictive values and a decision curve analysis will be considered. Discussion: A robust method to predict a pregnant woman’s individualized risk of late-pregnancy stillbirth may inform timely, appropriate care to reduce stillbirth. Among existing prediction models designed for maternity use, few have been subject to internal and external validation and many fail to meet recommended reporting standards. In developing a risk prediction model for late-gestation stillbirth with both providers and pregnant women in mind, we endeavor to develop a validated model for clinical use in Australia that meets current reporting standards.


2021 ◽  
Author(s):  
Jun Chen ◽  
Yimin Wang ◽  
Xinyang Shou ◽  
Qiang Liu ◽  
Ziwei Mei

Abstract BACKGROUND Despite the large number of studies focus on the prognosis and in-hospital outcomes risk factors of patients with takotsubo syndrome, there was still lack of utility and visual risk prediction model for predicting the in-hospital mortality of patients with takotsubo syndrome. OBJECTIVES Our study aimed to establish a utility risk prediction model for the prognosis of in-hospital patients with takotsubo syndrome (TTS). METHODS The study is a retrospective cohort study. Model of in-hospital mortality of TTS patients was developed by multivariable logistic regression analysis. Calibration and discrimination were used to assess the performance of the nomogram. The clinical utility of the model was evaluated by decision curve analysis (DCA). RESULTS Overall, 368 TTS patients (320 Survivals and 48 deaths) were included in our research from MIMIC-IV database. The incidence of in-hospital mortality with TTS is 13.04%. Lasso regression and multivariate logistic regression model verified that potassium, pt, age, myocardial infarction, WBC, hematocrit, anion gap and SOFA score were significantly associated with in-hospital mortality of TTS patients. The nomogram demonstrated a good discrimination with a AUC of ROC 0.811(95%Cl: 0.746-0.876) in training set and 0.793(95%Cl: 0.724-0.862) in test set. The calibration plot of risk prediction model showed predicted probabilities against observed death rates indicated excellent concordance. DCA showed that the nomogram has good clinical benefits. Conclusion We developed a nomogram that predict hospital mortality in patients with TTS according to clinical data. The nomogram exhibited excellent discrimination and calibration capacity, favoring its clinical utility.


2021 ◽  
Vol 14 ◽  
Author(s):  
Wenjun Cao ◽  
Chenghan Luo ◽  
Mengyuan Lei ◽  
Min Shen ◽  
Wenqian Ding ◽  
...  

PurposeWhite matter damage (WMD) was defined as the appearance of rough and uneven echo enhancement in the white matter around the ventricle. The aim of this study was to develop and validate a risk prediction model for neonatal WMD.Materials and MethodsWe collected data for 1,733 infants hospitalized at the Department of Neonatology at The First Affiliated Hospital of Zhengzhou University from 2017 to 2020. Infants were randomly assigned to training (n = 1,216) or validation (n = 517) cohorts at a ratio of 7:3. Multivariate logistic regression and least absolute shrinkage and selection operator (LASSO) regression analyses were used to establish a risk prediction model and web-based risk calculator based on the training cohort data. The predictive accuracy of the model was verified in the validation cohort.ResultsWe identified four variables as independent risk factors for brain WMD in neonates by multivariate logistic regression and LASSO analysis, including gestational age, fetal distress, prelabor rupture of membranes, and use of corticosteroids. These were used to establish a risk prediction nomogram and web-based calculator (https://caowenjun.shinyapps.io/dynnomapp/). The C-index of the training and validation sets was 0.898 (95% confidence interval: 0.8745–0.9215) and 0.887 (95% confidence interval: 0.8478–0.9262), respectively. Decision tree analysis showed that the model was highly effective in the threshold range of 1–61%. The sensitivity and specificity of the model were 82.5 and 81.7%, respectively, and the cutoff value was 0.099.ConclusionThis is the first study describing the use of a nomogram and web-based calculator to predict the risk of WMD in neonates. The web-based calculator increases the applicability of the predictive model and is a convenient tool for doctors at primary hospitals and outpatient clinics, family doctors, and even parents to identify high-risk births early on and implementing appropriate interventions while avoiding excessive treatment of low-risk patients.


Author(s):  
Masaru Samura ◽  
Naoki Hirose ◽  
Takenori Kurata ◽  
Keisuke Takada ◽  
Fumio Nagumo ◽  
...  

Abstract Background In this study, we investigated the risk factors for daptomycin-associated creatine phosphokinase (CPK) elevation and established a risk score for CPK elevation. Methods Patients who received daptomycin at our hospital were classified into the normal or elevated CPK group based on their peak CPK levels during daptomycin therapy. Univariable and multivariable analyses were performed, and a risk score and prediction model for the incidence probability of CPK elevation were calculated based on logistic regression analysis. Results The normal and elevated CPK groups included 181 and 17 patients, respectively. Logistic regression analysis revealed that concomitant statin use (odds ratio [OR] 4.45, 95% confidence interval [CI] 1.40–14.47, risk score 4), concomitant antihistamine use (OR 5.66, 95% CI 1.58–20.75, risk score 4), and trough concentration (Cmin) between 20 and <30 µg/mL (OR 14.48, 95% CI 2.90–87.13, risk score 5) and ≥30.0 µg/mL (OR 24.64, 95% CI 3.21–204.53, risk score 5) were risk factors for daptomycin-associated CPK elevation. The predicted incidence probabilities of CPK elevation were <10% (low risk), 10%–<25% (moderate risk), and ≥25% (high risk) with the total risk scores of ≤4, 5–6, and ≥8, respectively. The risk prediction model exhibited a good fit (area under the receiving-operating characteristic curve 0.85, 95% CI 0.74–0.95). Conclusions These results suggested that concomitant use of statins with antihistamines and Cmin ≥20 µg/mL were risk factors for daptomycin-associated CPK elevation. Our prediction model might aid in reducing the incidence of daptomycin-associated CPK elevation.


2021 ◽  
Author(s):  
Jun Yu ◽  
Chao-yi Ren ◽  
Jun Wang ◽  
Wei Cui ◽  
Jin-juan Zhang ◽  
...  

Abstract ObjectiveTo establish a risk prediction model for pancreatic fistula according to the pancreatic fistula standards of the 2016 edition.MethodsClinical data from 182 patients with PD admitted to Tianjin Third Central Hospital from January 2016 to February 2020 were retrospectively analyzed. Patients were divided into modeling (01/2016 to 12/2018) and validation (01/2019 to 02/2020) sets according to the time of admission. The risk factors for postoperative pancreatic fistula (POPF) were screened by univariate and multivariate logistic regression analyses, and a risk prediction model for POPF was established in the modeling set. This score was tested in the validation set.ResultsLogistic regression analysis showed that the main pancreatic duct index and CT value were independent risk factors according to the 2016 pancreatic fistula grading standard, based on which a risk prediction model for POPF was established. Receiver operating characteristic curve analysis showed that the area under the curve was 0.788 in the modeling set and 0.824 in the validation set.ConclusionThe main pancreatic duct index and CT value of the pancreas are closely related to the occurrence of pancreatic fistula after PD, and the established risk prediction model for pancreatic fistula has good prediction accuracy.


Author(s):  
Robertus Dole Guntur ◽  
Jonathan Kingsley ◽  
Fakir M. Amirul Islam

BACKGROUND Malaria is a global pandemic resulting in approximately 228 million cases globally, and 3.5 % of these is in South-East Asian countries including Indonesia. Following the World Health Organization (WHO) initiative, Indonesia is in the process of achieving malaria-free zone status by 2030. However, the Eastern part of Indonesia, including the East Nusa Tenggara Province (ENTP), still suffers from a disproportionately higher rate of malaria. OBJECTIVE The purposes of this cross-sectional study are to: (1) Determine the awareness, knowledge, attitudes, and practices (KAP) towards various aspects of malaria among rural adults and their associated factors including socio-demographic factors and ethnicities; (2) Assess the gap between coverage, access, and use of long-lasting insecticide-treated bed nets (LLINs) among the households; (3) Estimate the prevalence of, and factors associated with, malaria in rural adults; and (4) Develop a risk prediction model of malaria. METHODS A three-stage cluster sampling procedure with a systematic random sampling procedure at cluster level 3 had been applied to recruit 1,470 adults aged 18 years or over from ENTP. Each participant participated in a face-to-face interview to assess their awareness and KAP of malaria, practices of sleeping under LLINs, and malaria history. Information on socio-demographic, environmental, and lifestyle factors was documented. The proportion of malaria KAP and their variations across different socio-demographic and ethnicities will be analysed using descriptive statistics and Chi-square tests. Coverage and access to LLINs will be evaluated based on the WHO recommendation. Malaria risk factors will be analysed using a logistic regression method. Multilevel logistic regression will be applied to estimate the risk score of malaria. RESULTS In total, we interviewed 1495 rural adults from 49 villages in the ENTP from October to December 2019. The study results are expected to publish in September 2020. CONCLUSIONS The best malaria risk prediction model will be developed by this study.We believe that the protocol paper has developed a methodology to provide new evidence to guide health policy in supporting the ENTP government’s expectation to achieve the malaria-free rating by 2030.


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