scholarly journals Evaluation of quantitative fFn test in predicting the risk of preterm birth

2017 ◽  
Vol 45 (1) ◽  
Author(s):  
Michela Centra ◽  
Giuliana Coata ◽  
Elena Picchiassi ◽  
Luisa Alfonsi ◽  
Samanta Meniconi ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Diagnostic Accuracy ◽  
Roc Curve ◽  
Predictive Value ◽  
Preterm Labour ◽  
Signs And Symptoms ◽  
Singleton Pregnancy ◽  
Fetal Fibronectin ◽  
Prediction Risk ◽  
Risk Categories

AbstractObjective:To evaluate diagnostic accuracy of quantitative fetal fibronectin (qfFN) test in predicting preterm birth (PTB) risk <34 weeks’ gestation or within 14 days from testing. We explored the predictive potential of the test in five-predefined PTB risk categories based on predefined qfFN thresholds (<10, 10–49, 50–199, 200–499 and ≥500 ng/mL).Methods:Measurement of cervicovaginal qfFN with Rapid fFN 10Q System (Hologic) in 126 women with singleton pregnancy (23–33 weeks’ gestation) reporting signs and symptoms indicative of preterm labour (PTL).Results:For PTB prediction risk <34 weeks’ gestation, sensitivity decreased from 100% to 41.7% and specificity increased from 0% to 99.1% with increasing fFN thresholds. Positive predictive value (PPV) increased from 9.5% to 83.3% with increasing qfFN thresholds, while negative predictive value (NPV) was higher than 90% among the fFN-predefined categories. Diagnostic accuracy results showed an area under a receiving operator characteristic (ROC) curve of 84.5% (95% CI, 0.770–0.903). For delivery prediction within 14 days from the testing, sensitivity decreased from 100% to 42.8% and specificity increased from 0% to 100% with increasing fFN thresholds. Diagnostic accuracy determined by the ROC curve was 66.1% (95% CI, 0.330–0.902).Conclusions:The QfFN thresholds of tests are a useful tool to distinguish pregnant women for PTB prediction risk <34 weeks’ gestation.

scholarly journals COMPARISON OF THE PREDICTIVE VALUE OF TRANSVAGINAL CERVICAL LENGTH AT 11-14 WEEKS AND AT 20-22 WEEKS OF GESTATION IN PRETERM LABOUR

2020 ◽  
pp. 41-43
Author(s):  
Sudha Rani Mangalampeta
Keyword(s):  
Preterm Birth ◽  
Preterm Delivery ◽  
Gestational Age ◽  
Predictive Value ◽  
Preterm Labour ◽  
Statistical Significance ◽  
Cervical Length ◽  
Low Risk ◽  
Singleton Pregnancy ◽  
Low Risk Women

Background: Preterm labour is defined as the onset of labour before 37 weeks of gestation, in pregnancy beyond 20 weeks of gestation, and is responsible for nearly 75% of all neonatal mortality and neurological morbidity. Cervical length (CL) is one of the major determinants of preterm delivery. Several studies have been able to conclude that transvaginal CL assessment may be a useful tool for the prediction of preterm delivery. The risk of preterm birth varies inversely with CL measured by ultrasound in low-risk women. Objective: To evaluate and compare the predictive value of transvaginal cervical length between 11-14 weeks and 20- 22 weeks of gestation in preterm labour. Material and Methods: A total of 264 pregnant women who were primigravida, singleton pregnancy, and women at gestational age 11-14 weeks and 20-22 weeks were included in the study. They were subjected for CL measurement at 11-14 and 20-22 weeks of gestation using transvaginal ultrasonography with the standard longitudinal view of the cervix while the patient’s bladder was empty. GEL VOLUSON 730 PRO Trans Vaginal Ultrasound (TVS) probe IC 5-9 H instrument with 5-9 MHz was used to measure CL. Results: The variables analyzed were the mean cervical length at 11-14 weeks and 20-22 weeks, the rate of shortening of cervical length in those who deliver at term and preterm and the cervical length at 11-14 weeks 20-22 weeks was correlated with gestational age at delivery and the predictive value of the same was determined. Cut-off of cervical length at 11-14 and 20-22 weeks of gestation was 3.73 cm and 2.89 and was statistically significant for the prediction of pre-term labour. Reduction in cervical length from 11-14 weeks to 20-22 weeks of gestation of more than 0.7 cm is predictive of preterm labour with statistical significance (p<0.001). Conclusion: Routine mid-pregnancy cervical length assessment in low-risk women can be a cost-effective method of preterm birth reduction but the implementation of such a policy is highly dependent upon local factors. If it is to be undertaken, cervical length assessment should be performed according to a standardized technique.

“A COMPARATIVE STUDY OF RIPASA SCORE AND ALVARADO SCORE IN THE DIAGNOSIS OF ACUTE APPENDICITIS”

2021 ◽  
pp. 25-28
Author(s):  
M. Vijaya Kumar ◽  
Manasa Manasa
Keyword(s):  
Acute Appendicitis ◽  
Diagnostic Accuracy ◽  
Predictive Value ◽  
Scoring System ◽  
Local Population ◽  
Scoring Systems ◽  
Signs And Symptoms ◽  
Alvarado Score ◽  
Predictive Values ◽  
Ripasa Score

Acute appendicitis is the most common condition encountered in the Emergency department .Alvarado and Modied Alvarado scores are the most commonly used scoring system used for diagnosing acute appendicitis.,but its performance has been found to be poor in certain population . Hence our aim was to compare the diagnostic accuracy of RIPASA and ALVARADO Scoring system and study and compare sensitivity, specicity and predictive values of these scoring systems. The study was conducted in Government district hospital Nandyal . We enrolled 176 patients who presented with RIF pain . Both RIPASA and ALVARADO were applied to them. Final diagnosis was conrmed either by CT scan, intra operative nding or post operative HPE report. Sensitivity,specicity, positive predictive value, negative predictive value, diagnostic accuracy was calculated both for RIPASA and ALVARADO. It was found that sensitivity and specicity of the RIPASA score in our study are 98.7% and 83.3%, respectively. PPV and NPV were 98.1% and 88.2% and sensitivity and specicity of the Alvardo score in our study are 94.3% and 83.3%, respectively. PPV and NPV were 98% and 62.5%.Diagnostic accuracy of RIPASA score and Alvarado score are 97% and 93% respectively. RIPASA is a more specic and accurate scoring system in our local population when compared to ALVARADO . It reduces the number of missed appendicitis cases and also convincingly lters out the group of patients that would need a CT scan for diagnosis (score 5-7.5 ) BACKGROUND: Acute appendicitis is one of the most commonly dealt surgical emergencies, with a lifetime prevalence rate of approximately 1 one in seven. The incidence is 1.5–1.9 per 1,000 in the male and female population, and is approximately 1.4 times greater in men than in women. Despite being a common problem, it remains a difcult diagnosis to establish, particularly among the young, the elderly and females of reproductive age, where a host of other genitourinary and gynaecological inammatory conditions can present with signs and symptoms that are 2 similar to those of acute appendicitis. A delay in performing an appendectomy in order to improve its diagnostic accuracy increases the risk of appendicular perforation and peritonitis, which in turn increases morbidity and mortality. A variable combination of clinical signs and symptoms has been used together with laboratory ndings in several scoring systems proposed for suggesting the probability of Acute Appendicitis and the possible subsequent management pathway. The Raja Isteri Pengiran Anak Saleha Appendicitis (RIPASA) and ALVARADO score are new diagnostic scoring systems developed for the diagnosis of Acute Appendicitis and has been shown to have signicantly higher sensitivity, specicity and diagnostic accuracy. AIMS AND OBJECTIVES PRIMARY OBJECT 1. To compare RIPASA Scoring system and ALVARADO Scoring system in terms of diagnostic accuracy in Acute Appendicitis. 2. To study and compare sensitivity, specicity and predictive values of above scoring systems. SECONDARY OBJECT 1. To study the rate of negative appendicectomy based on above scoring systems. CONCLUSION: The RIPASA score is a simple scoring system with high sensitivity and specicity for the diagnosis of acute appendicitis. The 14 clinical parameters are all present in a good clinical history and examination and can be easily and quickly applied. Therefore, a decision on the management can be made early. Although the RIPASA score was developed for the local population of Brunei, we believe that it should be applicable to other regions. The RIPASA score presents greater Diagnostic accuracy and Sensitivity and equal specicity as a diagnostic test compared to the Alvarado score and is helpful in making appropriate therapeutic decisions. In hospitals like ours, the diagnosis of AA relies greatly on the clinical evaluation performed by surgeons. An adequate clinical scoring system would avoid diagnostic errors, maintaining a satisfactory low rate of negative appendectomies by adequate patient stratication, while limiting patient exposure to ionizing radiation, since 21 there is an increased risk of developing cancer with computed tomography, particularly for the paediatric age group.

scholarly journals Three-hour post-ERCP amylase level: a useful indicator for early prediction of post-ERCP pancreatitis

2020 ◽  
Author(s):  
Ze-Hui Lv ◽  
Da-Qing Kou ◽  
Shi-Bin Guo
Keyword(s):  
Confidence Interval ◽  
Diagnostic Accuracy ◽  
Roc Curve ◽  
Predictive Value ◽  
Serum Amylase ◽  
Roc Curves ◽  
Amylase Level ◽  
Early Prediction ◽  
Serum Amylase Level ◽  
Significant Difference

Abstract Background: To evaluate the value of the 3-hour post-ERCP serum amylase level for early prediction of post-ERCP pancreatitis (PEP). Method: A study of 206 patients performed ERCP was analysed. The patients with PEP were recorded. ROC curves were used to statistically analyze the data. Results: PEP occurred in 21 patients (10.19%). The 3-hour post-ERCP pancreatic amylase level was used as the test variable, and the PEP occurrence as the state variable to plot ROC curve. The area under the curve (AUC) was 0.816 , and was statistically significant (P<0.001). The standard error (SE) was 0.0507, the 95% confidence interval (CI) was 0.756-0.866, and the optimal cut-off value was 351U/L (sensitivity 76.19%, specificity 83.24%, positive likelihood ratio 4.55, negative likelihood ratio 0.29, Youden index 59.43%). The ROC curves were plotted for both serum amylase and lipase respectively. The areas under the ROC curves were statistically significant(P<0.001). The area under the ROC curve for the 3-hour post-ERCP lipase was 0.778, the 95% confidence interval was 0.673-0.862, and optimal cut-off value was 1834 U/L. The area under the ROC curve for the 3-hour post-ERCP serum amylase was 0.780, and the 95% confidence interval was 0.676-0.864. The optimal cut-off is 380U/L, and there was no statistically significant difference between the two for diagnostic accuracy. According to gender, there was no statistically significant difference in the diagnostic accuracy. In the male group, 436 U/L serum amylase provided the greatest diagnostic accuracy with sensitivity(SE) of 70.5%, specificity(SP) of 89.2%, positive predictive value (PPV) 87.5%, and negative predictive value (NPV) 78.1%. Whereas, in the female group, 357U/L serum amylase provided the greatest diagnostic accuracy with sensitivity of 76.9%, specificity of 81.2%, positive predictive value of 80.4%, negative predictive value of 77.9%. Conclusions: 1. The 3-hour post-ERCP serum amylase level is a useful measurement for predicting post-ERCP pancreatitis. 2. There was no significant difference between serum amylase and lipase 3-hour post-ERCP for predicting PEP. 3. There was no statistically significant difference between male and female using the 3-hour post-ERCP serum amylase level to predict PEP. For female, the optimal cut-off value was 357 U/L, whereas male 436U/L .

scholarly journals Development and Validation of a Deep Learning Algorithm to Automatic Detection of Pituitary Microadenoma From MRI

2021 ◽  
Vol 8 ◽  
Author(s):  
Qingling Li ◽  
Yanhua Zhu ◽  
Minglin Chen ◽  
Ruomi Guo ◽  
Qingyong Hu ◽  
...  
Keyword(s):  
Deep Learning ◽  
Diagnostic Accuracy ◽  
Roc Curve ◽  
Predictive Value ◽  
Computer Aided Diagnosis ◽  
Validation Dataset ◽  
Cad System ◽  
Pituitary Microadenoma ◽  
Computer Aided ◽  
Aided Diagnosis

Background: It is often difficult to diagnose pituitary microadenoma (PM) by MRI alone, due to its relatively small size, variable anatomical structure, complex clinical symptoms, and signs among individuals. We develop and validate a deep learning -based system to diagnose PM from MRI.Methods: A total of 11,935 infertility participants were initially recruited for this project. After applying the exclusion criteria, 1,520 participants (556 PM patients and 964 controls subjects) were included for further stratified into 3 non-overlapping cohorts. The data used for the training set were derived from a retrospective study, and in the validation dataset, prospective temporal and geographical validation set were adopted. A total of 780 participants were used for training, 195 participants for testing, and 545 participants were used to validate the diagnosis performance. The PM-computer-aided diagnosis (PM-CAD) system consists of two parts: pituitary region detection and PM diagnosis. The diagnosis performance of the PM-CAD system was measured using the receiver operating characteristics (ROC) curve and area under the ROC curve (AUC), calibration curve, accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score.Results: Pituitary microadenoma-computer-aided diagnosis system showed 94.36% diagnostic accuracy and 98.13% AUC score in the testing dataset. We confirm the robustness and generalization of our PM-CAD system, the diagnostic accuracy in the internal dataset was 96.50% and in the external dataset was 92.26 and 92.36%, the AUC was 95.5, 94.7, and 93.7%, respectively. In human-computer competition, the diagnosis performance of our PM-CAD system was comparable to radiologists with &gt;10 years of professional expertise (diagnosis accuracy of 94.0% vs. 95.0%, AUC of 95.6% vs. 95.0%). For the misdiagnosis cases from radiologists, our system showed a 100% accurate diagnosis. A browser-based software was designed to assist the PM diagnosis.Conclusions: This is the first report showing that the PM-CAD system is a viable tool for detecting PM. Our results suggest that the PM-CAD system is applicable to radiology departments, especially in primary health care institutions.

scholarly journals A comparative study of RIPASA score and ALVARADO score in diagnosis of acute appendicitis

2018 ◽  
Vol 5 (3) ◽  
pp. 796
Author(s):  
Vamsavardhan Pasumarthi ◽  
C. P. Madhu
Keyword(s):  
Acute Appendicitis ◽  
Positive Predictive Value ◽  
Diagnostic Accuracy ◽  
Roc Curve ◽  
Predictive Value ◽  
Scoring System ◽  
Alvarado Score ◽  
Predictive Values ◽  
Sensitivity Specificity ◽  
Ripasa Score

Background: The RIPASA Score is a new diagnostic scoring system developed for the diagnosis of Acute Appendicitis which showed higher sensitivity, specificity and diagnostic accuracy compared to ALVARADO Score, particularly when applied to Asian population. Not many studies have been conducted to compare RIPASA and ALVARADO scoring systems. Hence, author want to compare prospectively Alvarado and RIPASA score by applying them to the patients attending the hospital with right iliac fossa pain that could probably be acute appendicitis.Methods: A prospective analysis of 116 cases admitted with RIF pain during a 2 years period was performed. Patients between 15-60 years were scored as per Alvarado and RIPASA scoring system. Histopathological reports of the cases were collected and compared with the scores. ROC curve area analysis was performed to examine diagnostic accuracy of RIPASA and ALVARADO scores.Results: The sensitivity of ALVARADO score is estimated to be 52.08 for a cut off of 6. The specificity is 80%, positive predictive value is 92.59, negative predictive value is 25.81. The Diagnostic accuracy of ALVARADO scoring is found to be 56.9. The sensitivity, specificity, positive predictive value and negative predictive values of RIPASA scoring system are 75%, 65%, 91.14%, 35.14%. The diagnostic accuracy of RIPASA score is 73.28.Conclusions: The difference in the diagnostic accuracy between ALVARADO and RIPASA scoring system is significant indicating that the RIPASA score is a much better diagnostic tool for the diagnosis of acute appendicitis. When the ROC curve was observed the area under the curve is high for RIPASA scoring system.

scholarly journals Retrospective validation of a new volumetric capnography parameter for the exclusion of pulmonary embolism at the emergency department

2018 ◽  
Vol 4 (4) ◽  
pp. 00099-2018
Author(s):  
Timon M. Fabius ◽  
Michiel M.M. Eijsvogel ◽  
Marjolein G.J. Brusse-Keizer ◽  
Olivier M. Sanchez ◽  
Franck Verschuren ◽  
...  
Keyword(s):  
Carbon Dioxide ◽  
Emergency Department ◽  
Pulmonary Embolism ◽  
Diagnostic Accuracy ◽  
Roc Curve ◽  
Predictive Value ◽  
Area Under The Curve ◽  
Carbon Dioxide Production ◽  
Pulmonary Angiography ◽  
Volumetric Capnography

Volumetric capnography might be used to exclude pulmonary embolism (PE) without the need for computed tomography pulmonary angiography. In a pilot study, a new parameter (CapNoPE) combining the amount of carbon dioxide exhaled per breath (carbon dioxide production (VCO2)), the slope of phase 3 of the volumetric capnogram (slope 3) and respiratory rate (RR) showed promising diagnostic accuracy (where CapNoPE=(VCO2×slope 3)/RR).To retrospectively validate CapNoPE for the exclusion of PE, the volumetric capnograms of 205 subjects (68 with PE) were analysed, based on a large multicentre dataset of volumetric capnograms from subjects with suspected PE at the emergency department. The area under the curve (AUC) of the receiver operating characteristic (ROC) curve and diagnostic accuracy of the in-pilot established threshold (1.90 Pa·min) were calculated. CapNoPE was 1.56±0.97 Pa·min in subjects with PE versus 2.51±1.67 Pa·min in those without PE (p<0.001). The AUC of the ROC curve was 0.714 (95% CI 0.64–0.79). For the cut-off of ≥1.90 Pa·min, sensitivity was 64.7%, specificity was 59.9%, the negative predictive value was 77.4% and the positive predictive value was 44.4%.The CapNoPE parameter is decreased in patients with PE but its diagnostic accuracy seems too low to use in clinical practice.

scholarly journals High diagnostic accuracy of automated rapid Strep A test reduces antibiotic prescriptions for children in the United Arab Emirates

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Salama Bin Hendi ◽  
Zainab A. Malik ◽  
Amar Hassan Khamis ◽  
Fadil Y. A. Al-Najjar
Keyword(s):  
Diagnostic Accuracy ◽  
United Arab Emirates ◽  
Predictive Value ◽  
High Sensitivity ◽  
Signs And Symptoms ◽  
Throat Culture ◽  
Clinical Criteria ◽  
Variable Sensitivity ◽  
High Level ◽  
Sensitivity Specificity

Abstract Background Diagnosis of Group A Streptococcus (GAS) pharyngitis in children is hindered by variable sensitivity of clinical criteria and rapid Strep A tests (SAT), resulting in reliance on throat cultures as the gold standard for diagnosis. Delays while awaiting culture reports result in unnecessary antibiotic prescriptions among children, contributing to the spread of antimicrobial resistance (AMR). Methods Diagnostic accuracy study of an automated SAT (A-SAT) in children up to 16 years of age presenting to an emergency room with signs and symptoms of pharyngitis between March and June 2019. Paired throat swabs for A-SAT and culture were collected. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for A-SAT were calculated. Results Two hundred and ninety-one children were included in this study. 168 (57.7%) were boys and the mean age was 4.2 years. A-SAT was positive in 94 (32.3%) and throat culture was positive in 90 (30.9%) children. A-SAT and throat culture results showed a high level of consistency in our cohort. Only 6 (2%) children had inconsistent results, demonstrating that the A-SAT has a high sensitivity (98.9%), specificity (97.5%), PPV (94.7%) and NPV (99.5%) for the diagnosis of GAS pharyngitis in children. Only 92 (32%) children were prescribed antibiotics while the vast majority (68%) were not. Conclusions A-SAT is a quick and reliable test with diagnostic accuracy comparable to throat culture. Its widespread clinical use can help limit antibiotic prescriptions to children presenting with pharyngitis, thus limiting the spread of AMR.

scholarly journals LUTS-V: A New Simplified Score for Assessing Lower Urinary Tract Symptoms in Men

2020 ◽  
Author(s):  
Caroline Santos Silva ◽  
Ueslei Menezes de Araujo ◽  
Mateus Andrade Alvaia ◽  
Kátia Santana Freitas ◽  
Cristiano Mendes Gomes ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Roc Curve ◽  
Predictive Value ◽  
Altman Analysis ◽  
Predictive Values ◽  
Bland Altman Analysis ◽  
Discriminating Power ◽  
Urinary Tract Symptoms ◽  
Sensitivity Specificity ◽  
Good Agreement

ABSTRACTOBJECTIVETo validate a new simplified score for the assessment of men with LUTS (LUTS-V).METHODSWe made adjustments to the VPSS, resulting in a new simplified instrument (LUTS visual score – LUTS-V). In a pilot study, LUTS-V was administered to 50 men to identify interpretation issues. We used the International Prostate Symptom Score (IPSS) as the gold standard to validate the new tool in 306 men. The total IPSS and LUTS-V scores for each subject were evaluated and we used Bland-Altman analysis and Pearson’s correlation plot to assess the agreement between the scores. A ROC curve was utilized to determine the diagnostic accuracy of LUTS-V and its diagnostic properties were described in terms of sensitivity, specificity, positive and negative predictive values.RESULTSMedian age was 59 [52-67] years and, according to the IPSS, 26 (8.7%) patients had severe symptoms, while 99 (33%) had moderate symptoms, and 175 (58.3%) had mild symptoms. We found a positive correlation between the IPSS and LUTS-V (r = 0.72; p < 0.0001). Bland-Altman analysis showed good agreement between the two questionnaires. We found LUTS-V to have a diagnostic accuracy to detect more severe cases of 83% (95% CI: [78-87%]; p < 0.001), as estimated by the area under the ROC curve. The cut-off value of ≥ 4 points was the best threshold, with a sensitivity of 74% and a specificity of 78%, which resulted in a negative predictive value of 81% and a positive predictive value of 71% in this scenario. Median completion time was 0.51 [0.41-1.07] min for LUTS-V and 2.5 [2.2-3.4] min for the IPSS (p < 0.0001). In addition, 91.5% of patients completed the questionnaires with no help, while the other 8.5% were interviewed.CONCLUSIONLUTS-V is a simple, self-administered tool with a significant discriminating power to identify patients with moderate to severe symptoms.

scholarly journals Development and validation of a risk prediction model of preterm birth for women with preterm labour symptoms (the QUIDS study): A prospective cohort study and individual participant data meta-analysis

PLoS Medicine ◽  
2021 ◽  
Vol 18 (7) ◽  
pp. e1003686
Author(s):  
Sarah J. Stock ◽  
Margaret Horne ◽  
Merel Bruijn ◽  
Helen White ◽  
Kathleen A. Boyd ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Prediction Model ◽  
Risk Prediction ◽  
Prospective Cohort ◽  
Preterm Labour ◽  
Meta Analysis ◽  
Multiple Pregnancy ◽  
Signs And Symptoms ◽  
Risk Prediction Model ◽  
Spontaneous Preterm Birth

Background Timely interventions in women presenting with preterm labour can substantially improve health outcomes for preterm babies. However, establishing such a diagnosis is very challenging, as signs and symptoms of preterm labour are common and can be nonspecific. We aimed to develop and externally validate a risk prediction model using concentration of vaginal fluid fetal fibronectin (quantitative fFN), in combination with clinical risk factors, for the prediction of spontaneous preterm birth and assessed its cost-effectiveness. Methods and findings Pregnant women included in the analyses were 22+0 to 34+6 weeks gestation with signs and symptoms of preterm labour. The primary outcome was spontaneous preterm birth within 7 days of quantitative fFN test. The risk prediction model was developed and internally validated in an individual participant data (IPD) meta-analysis of 5 European prospective cohort studies (2009 to 2016; 1,783 women; mean age 29.7 years; median BMI 24.8 kg/m2; 67.6% White; 11.7% smokers; 51.8% nulliparous; 10.4% with multiple pregnancy; 139 [7.8%] with spontaneous preterm birth within 7 days). The model was then externally validated in a prospective cohort study in 26 United Kingdom centres (2016 to 2018; 2,924 women; mean age 28.2 years; median BMI 25.4 kg/m2; 88.2% White; 21% smokers; 35.2% nulliparous; 3.5% with multiple pregnancy; 85 [2.9%] with spontaneous preterm birth within 7 days). The developed risk prediction model for spontaneous preterm birth within 7 days included quantitative fFN, current smoking, not White ethnicity, nulliparity, and multiple pregnancy. After internal validation, the optimism adjusted area under the curve was 0.89 (95% CI 0.86 to 0.92), and the optimism adjusted Nagelkerke R2 was 35% (95% CI 33% to 37%). On external validation in the prospective UK cohort population, the area under the curve was 0.89 (95% CI 0.84 to 0.94), and Nagelkerke R2 of 36% (95% CI: 34% to 38%). Recalibration of the model’s intercept was required to ensure overall calibration-in-the-large. A calibration curve suggested close agreement between predicted and observed risks in the range of predictions 0% to 10%, but some miscalibration (underprediction) at higher risks (slope 1.24 (95% CI 1.23 to 1.26)). Despite any miscalibration, the net benefit of the model was higher than “treat all” or “treat none” strategies for thresholds up to about 15% risk. The economic analysis found the prognostic model was cost effective, compared to using qualitative fFN, at a threshold for hospital admission and treatment of ≥2% risk of preterm birth within 7 days. Study limitations include the limited number of participants who are not White and levels of missing data for certain variables in the development dataset. Conclusions In this study, we found that a risk prediction model including vaginal fFN concentration and clinical risk factors showed promising performance in the prediction of spontaneous preterm birth within 7 days of test and has potential to inform management decisions for women with threatened preterm labour. Further evaluation of the risk prediction model in clinical practice is required to determine whether the risk prediction model improves clinical outcomes if used in practice. Trial registration The study was approved by the West of Scotland Research Ethics Committee (16/WS/0068). The study was registered with ISRCTN Registry (ISRCTN 41598423) and NIHR Portfolio (CPMS: 31277).

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