OBJECTIVES: To prospectively validate the diagnostic performance of a non-invasive point-of-care tool (Rapid IAI System), including vaginal alpha-fetoprotein and interleukin-6, to predict the occurrence of intra-amniotic inflammation in a Spanish cohort of patients admitted with a diagnosis of preterm labor and intact membranes. METHODS: From 2017 to 2022, we prospectively evaluated a cohort of pregnant women diagnosed with preterm labor and intact membranes admitted below 34+0 weeks who underwent amniocentesis to rule-in/out intra-amniotic infection and/or inflammation. Vaginal sampling was performed at the time of amniocentesis or within 24-48 h. Amniotic fluid IL-6, vaginal alpha-fetoprotein and vaginal IL-6 concentrations were measured using a point-of-care tool provided by Hologic Inc., "Rapid IAI System". We defined intra-amniotic inflammation when amniotic fluid IL-6 values were greater than 11.3 ng/mL. During recruitment, clinicians were blinded to the results of the point-of-care tool. The original prediction model proposed by Hologic Inc. to predict intra-amniotic inflammation was validated in this cohort of patients. RESULTS: We included 151 patients diagnosed with preterm labor and intact membranes. Among these, 29 (19.2 %) had intra-amniotic inflammation. The algorithm including vaginal IL-6 and alpha-fetoprotein showed an area under curve to predict intra-amniotic inflammation of 80.3 % (±5.3 %) with a sensitivity of 72.4 %, specificity of 84.6 %, positive predictive valuve (PPV) of 52.5 %, negative predictive value (NPV) of 92.9 %, and a positive likelihood ratio (LR+) of 4.6 and negative likelihood ratio (LR-) of 0.33. CONCLUSIONS: External validation of a non-invasive rapid point-of-care tool, including vaginal alpha-fetoprotein and IL-6, showed very good diagnostic performance for predicting the absence of intra-amniotic inflammation in women with preterm labor and intact membranes.

• MeSH
• alpha-Fetoproteins * analysis   metabolism   MeSH
• Amniocentesis methods   MeSH
• Chorioamnionitis * diagnosis   MeSH
• Adult MeSH
• Risk Assessment methods   MeSH
• Interleukin-6 * analysis   blood   metabolism   MeSH
• Humans MeSH
• Amniotic Fluid * metabolism   chemistry   MeSH
• Point-of-Care Testing MeSH
• Obstetric Labor, Premature * diagnosis   MeSH
• Predictive Value of Tests MeSH
• Prospective Studies MeSH
• Pregnancy MeSH
• Vagina metabolism   MeSH
• Point-of-Care Systems MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Pregnancy MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Validation Study MeSH

AIM: A diabetes-related foot ulcer (DFU) is a major risk factor for lower-extremity amputation (LEA). To help clinicians predict the risk of LEA in people with DFU, the Diabetic Foot Risk Assessment (DIAFORA) system was developed but has never been externally validated. METHODS: In this study, 317 people presenting with a new DFU were included. At baseline, participants were grouped into three groups based on their DIAFORA score: low-risk (<15), medium-risk (15-25), and high-risk (>25). Participants were followed until healing, LEA, death, or at least 3 months. Discriminative accuracy was evaluated using sensitivity, specificity, likelihood ratios (LRs) and the area under the curve (AUC). RESULTS: All 317 participants completed at least 3 months of follow-up for a median duration of 146 days, during which 12.6% underwent minor amputation and 2.5% major amputation. People in the low- and medium-risk categories had major amputation rates of 0.9% and 2.1%, respectively, and negative LR of major LEA of 0.10 and 0.38, respectively, while the people in the high-risk category had an amputation rate of 25.0% and a positive LR of 12.9. The DIAFORA risk groups had a sensitivity of 75.0% and a specificity of 65.7%, with a corresponding AUC of 0.78 (95% CI 0.68-0.87) for the prediction of major LEA. CONCLUSION: The DIAFORA score is a useful tool for risk stratification of people presenting with a newly occurred DFU, with the external validation presenting results similar to those presented in the original study. The DIAFORA score may guide clinicians towards more individualized DFU treatment regimens.

• MeSH
• Amputation, Surgical * statistics & numerical data   MeSH
• Diabetic Foot * surgery   epidemiology   MeSH
• Lower Extremity surgery   MeSH
• Risk Assessment methods   MeSH
• Cohort Studies MeSH
• Middle Aged MeSH
• Humans MeSH
• Predictive Value of Tests MeSH
• Prospective Studies MeSH
• Risk Factors MeSH
• Aged MeSH
• Sensitivity and Specificity MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Validation Study MeSH
• Geographicals
• Denmark MeSH

BACKGROUND: Optimal management of outpatients with heart failure (HF) requires serially updating the estimates of their risk for adverse clinical outcomes to guide treatment. Patient-reported outcomes (PROs) are becoming increasingly used in clinical care. The purpose of this study was to determine whether the inclusion of PROs can improve the risk prediction for HF hospitalization and death in ambulatory patients with HF. METHODS AND RESULTS: We included consecutive patients with HF with reduced ejection fraction (HFrEF) and HF with preserved EF (HFpEF) seen in a HF clinic between 2015 and 2019 who completed PROs as part of routine care. Cox regression with a least absolute shrinkage and selection operator regularization and gradient boosting machine analyses were used to estimate risk for a combined outcome of HF hospitalization, heart transplant, left ventricular assist device implantation, or death. The performance of the prediction models was evaluated with the time-dependent concordance index (Cτ). Among 1165 patients with HFrEF (mean age 59.1 ± 16.1, 68% male), the median follow-up was 487 days. Among 456 patients with HFpEF (mean age 64.2 ± 16.0 years, 55% male) the median follow-up was 494 days. Gradient boosting regression that included PROs had the best prediction performance - Cτ 0.73 for patients with HFrEF and 0.74 in patients with HFpEF, and showed very good stratification of risk by time to event analysis by quintile of risk. The Kansas City Cardiomyopathy Questionnaire overall summary score, visual analogue scale and Patient Reported Outcomes Measurement Information System dimensions of satisfaction with social roles and physical function had high variable importance measure in the models. CONCLUSIONS: PROs improve risk prediction in both HFrEF and HFpEF, independent of traditional clinical factors. Routine assessment of PROs and leveraging the comprehensive data in the electronic health record in routine clinical care could help more accurately assess risk and support the intensification of treatment in patients with HF.

• MeSH
• Risk Assessment methods   MeSH
• Patient Reported Outcome Measures * MeSH
• Hospitalization statistics & numerical data   MeSH
• Quality of Life * psychology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Follow-Up Studies MeSH
• Retrospective Studies MeSH
• Aged MeSH
• Heart Failure * physiopathology   psychology   therapy   diagnosis   mortality   MeSH
• Stroke Volume physiology   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

BACKGROUND: Prostate Imaging Reporting and Data System (PI-RADS) 3 lesions, identified through multiparametric magnetic resonance imaging (mpMRI), present a clinical challenge due to their equivocal nature in predicting clinically significant prostate cancer (csPCa). Aim of the study is to improve risk stratification of patients with PI-RADS 3 lesions and candidates for prostate biopsy. METHODS: A cohort of 4841 consecutive patients who underwent MRI and subsequent MRI-targeted and systematic biopsies between January 2016 and April 2023 were retrospectively identified from independent prospectively maintained database. Only patients who have PI-RADS 3 lesions were included in the final analysis. A multivariable logistic regression analysis was performed to identify covariables associated with csPCa defined as International Society of Urological Pathology (ISUP) grade group ≥2. Performance of the model was evaluated using the area under the receiver operating characteristic curve (AUC), calibration, and net benefit. Significant predictors were then selected for further exploration using a Chi-squared Automatic Interaction Detection (CHAID) analysis. RESULTS: Overall, 790 patients had PI-RADS 3 lesions and 151 (19%) had csPCa. Significant associations were observed for age (OR: 1.1 [1.0-1.1]; p = 0.01) and PSA density (OR: 1643 [2717-41,997]; p < 0.01). The CHAID analysis identified PSAd as the sole significant factor influencing the decision tree. Cut-offs for PSAd were 0.13 ng/ml/cc (csPCa detection rate of 1% vs. 18%) for the two-nodes model and 0.09 ng/ml/cc and 0.16 ng/ml/cc for the three-nodes model (csPCa detection rate of 0.5% vs. 2% vs. 17%). CONCLUSIONS: For individuals with PI-RADS 3 lesions on prostate mpMRI and a PSAd below 0.13, especially below 0.09, prostate biopsy can be omitted, in order to avoid unnecessary biopsy and overdiagnosis of non-csPCa.

• MeSH
• Risk Assessment methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Multiparametric Magnetic Resonance Imaging * methods   MeSH
• Prostatic Neoplasms * pathology   diagnostic imaging   diagnosis   blood   MeSH
• Prostate pathology   diagnostic imaging   MeSH
• Prostate-Specific Antigen * blood   MeSH
• Retrospective Studies MeSH
• ROC Curve MeSH
• Aged MeSH
• Neoplasm Grading MeSH
• Image-Guided Biopsy methods   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Publication type
• Journal Article MeSH

Background: Malnutrition is a lack of proper nutrition associated with different chronic diseases, comorbidities, frailty, and a higher prevalence of morbidity and mortality. Aim: The aim of the study was to determine the most appropriate items that reflect nutrition status in this population group and incorporate them into the nutrition risk screening and malnutrition assessment tool. Methods: A cross-sectional validation study was conducted in Bosnia and Herzegovina among 300 individuals older than 65 years. An eight-step approach that included correspondence analysis, generation of the pool item, content validity, internal consistency, construct validity, criterion validity, face validity, and reliability was performed. Results: Correspondence analyses were performed using the contingency table's low-dimensional graphical representation of the rows and columns. After identifying nutrition status assessment-related topics via correspondence analyses, a literature review was performed to determine additional items. The assessment tool's accuracy was measured against clinical judgement as a reference standard. To test face validity of the tool, cognitive interviewing was used. Responses were analyzed and necessary changes were made. The final version of the tool included 14 items. Possible range score on the assessment tool was 0-21. Lower scores indicated nutrition risk. The screening and assessment tool showed acceptable validity and internal consistency.

• MeSH
• Risk Assessment methods   MeSH
• Nutrition Assessment * MeSH
• Humans MeSH
• Nutritional Status MeSH
• Malnutrition prevention & control   MeSH
• Cross-Sectional Studies MeSH
• Aged * MeSH
• Statistics as Topic MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Aged * MeSH
• Female MeSH
• Publication type
• Validation Study MeSH
• Geographicals
• Bosnia and Herzegovina MeSH

Prognostic significance of the timing in the cardiac cycle of the first (TP1) and second (TP2) systolic peak of the central aortic pulse wave is ill-defined. Incidence rates and standardized multivariable-adjusted hazard ratios (HRs) of adverse health outcomes associated with TP1 and TP2, estimated by the SphygmoCor software, were assessed in the International Database of Central Arterial Properties for Risk Stratification (IDCARS) (n = 5529). Model refinement was assessed by the integrated discrimination (ID) and net reclassification (NR) improvement. Over 4.1 years (median), 201 participants died and 248 and 159 patients experienced cardiovascular or cardiac endpoints. Mean TP1 and TP2, standardized for cohort, sex, age, and heart rate, were 103 and 228 ms. Shorter TP1 and TP2 were associated with higher mortality and shorter TP1 with a higher risk of cardiovascular and cardiac endpoints (trend p ≤ 0.004). The HRs relating total mortality and cardiovascular endpoints to TP2 were 0.82 (95% confidence interval [CI]: 0.72-0.94) and 0.87 (0.77-0.98), respectively. The HR relating cardiac endpoints to TP1 was 0.81 (0.68-0.97). For total mortality and cardiovascular endpoints in relation to TP2, NRI was significant (p ≤ 0.010), but not for cardiac endpoints in relation to TP1. Integrated discrimination improvement (IDI) was not significant for any endpoint. The HRs relating total mortality to TP2 were smaller (p ≤ 0.026) in women than men (0.67 vs. 0.95) and in older (≥ 60 years) versus younger (< 60 years) participants (0.80 vs. 0.88). Our study adds to the evidence supporting risk stratification based on aortic pulse analysis by showing that TP2 and TP1 carry prognostic information.

• MeSH
• Pulse Wave Analysis * methods   MeSH
• Aorta physiopathology   MeSH
• Risk Assessment methods   statistics & numerical data   MeSH
• Hypertension epidemiology   mortality   physiopathology   MeSH
• Cardiovascular Diseases * mortality   epidemiology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Prognosis MeSH
• Risk Factors MeSH
• Aged MeSH
• Heart Rate physiology   MeSH
• Systole physiology   MeSH
• Vascular Stiffness physiology   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

PURPOSE: The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) have proposed procollagen type I N propeptide (PINP) and β isomerized C-terminal telopeptide of type I collagen (β-CTX-I) as reference bone turnover markers (BTMs) for osteoporosis. This report examines the published literature since the 2011 IOF-IFCC position paper in order to determine the clinical potential of the reference BTMs and newer markers for the prediction of fracture risk and monitoring the treatment of osteoporosis. METHODS: Evidence for the relationship between BTMs and subsequent fractures was gathered from prospective studies through literature review of the Medline database from years 2011 to May 2024. The impact of treatment on BTMs was also studied by examining publications in that period. Studies of the accuracy of BTMs in the assessment of bone turnover in the setting of advanced chronic kidney disease were also examined. RESULTS: Increased BTM concentrations are associated with higher fracture risk in postmenopausal women. PINP and β-CTX-I measured in blood are associated with fracture risk but their interaction with other risk factors has not been sufficiently studied limiting their incorporation into fracture risk algorithms. Treatment-induced changes in PINP and β-CTX-I account for a substantial proportion of fracture risk reduction and are useful for improving adherence; they are recommended for inclusion in studies to examine adherence in individual patients. However, total PINP (tPINP) and β-CTX-I may be elevated in CKD due to renal retention. Bone alkaline phosphatase (BALP), intact PINP (iPINP), and tartrate resistant acid phosphatase 5b (TRACP5b) show the most promise in discriminating high and low turnover bone diseases in patients with advanced CKD and for predicting fracture risk, monitoring treatment response, and assessing the risk of treatment-related complications. CONCLUSION: We re-affirm the use of serum/plasma tPINP and plasma β-CTX-I as reference BTMs with appropriate patient preparation and sample handling and measurement by standardized/harmonized assays in clinical studies to accumulate further data, and for monitoring treatment of osteoporosis in the setting of normal renal function in clinical practice. BALP and TRACP5b, measured by standardized assays, are recommended as reference BTMs for CKD-associated osteoporosis and should be included in observational and intervention studies to ascertain their utility for risk-evaluation, treatment initiation, and assessment of treatment response in CKD-associated osteoporosis.

• MeSH
• Biomarkers blood   MeSH
• Risk Assessment methods   MeSH
• Bone Density Conservation Agents therapeutic use   MeSH
• Collagen Type I blood   MeSH
• Consensus MeSH
• Humans MeSH
• Osteoporotic Fractures prevention & control   etiology   MeSH
• Osteoporosis * diagnosis   physiopathology   drug therapy   blood   therapy   MeSH
• Peptide Fragments blood   MeSH
• Peptides blood   MeSH
• Procollagen blood   MeSH
• Bone Remodeling * physiology   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Consensus Development Conference MeSH
• Review MeSH

BACKGROUND: Data on the prognostic impact of type A aortic dissection involving the common carotid arteries (CCAs) are scarce. METHODS: Data on the status of the CCAs were available in 1106 patients who underwent surgery for acute DeBakey type 1 aortic dissection who were recruited in a retrospective, multicentre European registry, that is, the ERTAAD. Postoperative neurological complications were defined as ischaemic stroke, haemorrhagic stroke and/or global brain ischaemia. RESULTS: Patients without carotid artery dissection, those with unilateral or bilateral CCA dissection had in-hospital mortality rates of 19.5%, 16.9% (OR 1.006, 95% CI 0.614 to 1.647) and 27.3% (p<0.001, OR 1.719, 95% CI 1.086 to 2.722), respectively. Bilateral, but not unilateral, dissection of the CCAs increased the risk of neurological complications (40.0% vs 18.9%, OR 2.453, 95% CI 1.683 to 3.576). The negative prognostic effect of bilateral dissection of the CCAs was increased among patients without cerebral malperfusion who underwent surgery with the use of hypothermic circulatory arrest (28.7% vs 4.3%, p=0.014). CONCLUSIONS: Bilateral, but not unilateral, dissection of the CCAs may increase the risk of neurological complications and in-hospital mortality after surgery for DeBakey type 1 aortic dissection. TRIAL REGISTRATION NUMBER: NCT04831073.

• MeSH
• Aortic Aneurysm surgery   mortality   MeSH
• Carotid Artery, Common surgery   diagnostic imaging   MeSH
• Aortic Dissection * surgery   diagnosis   mortality   MeSH
• Risk Assessment methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Hospital Mortality * trends   MeSH
• Follow-Up Studies MeSH
• Postoperative Complications * epidemiology   MeSH
• Registries * MeSH
• Retrospective Studies MeSH
• Risk Factors MeSH
• Aged MeSH
• Vascular Surgical Procedures adverse effects   methods   MeSH
• Treatment Outcome MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Geographicals
• Europe MeSH

Aim: The study aimed to assess the prevalence of birth trauma in postpartum women and to identify factors that may influence the development of birth trauma. Methods: The sample consisted of 238 women at 6-12 weeks postpartum. Data were collected using the City Birth Trauma Scale (CityBiTS), a standardized tool that identifies a woman's potentially traumatic experiences during or after her last childbirth. The questionnaire was supplemented with sociodemographic data. Results: Nearly 11% of participants experienced some form of post-traumatic stress disorder (PTSD) after childbirth. The most intense symptoms were those belonging to the hyperarousal subscale, especially feelings of nervousness, tension, irritability, and aggression. Statistically significant differences in the prevalence of birth trauma were found with regard to the presence of a birth support person (p = 0.044) and week of gestation at the time of delivery (p = 0.001). Differences related to participants' age, education, and type of delivery were not statistically significant. Conclusion: Our findings suggest that participants only experienced birth trauma symptoms to a small extent. The CityBiTS is a useful tool for measuring postpartum trauma. Women identified as having some form of PTSD should be referred for further psychological testing and psychological care.

• MeSH
• Risk Assessment methods   MeSH
• Humans MeSH
• Postpartum Period psychology   MeSH
• Parturition * psychology   MeSH
• Stress Disorders, Post-Traumatic * diagnosis   epidemiology   etiology   MeSH
• Cross-Sectional Studies MeSH
• Surveys and Questionnaires MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Geographicals
• Czech Republic MeSH

BACKGROUND: The management of patients with non-dialysis dependent chronic kidney disease (NDD-CKD) is challenging due to coexisting diseases, competing risks and uncertainties around optimal transition planning. Such clinical challenges are further exacerbated by physician shortage, coupled with rising service demands, which may hinder timely medical access due to long waiting times. Accurate progression risk assessment may help optimize resource allocation and adapting care based on individual patients' needs. This study validated the Prognostic Reasoning System for Chronic Kidney Disease Progression (PROGRES-CKD) in an Italian public hospital and compared its potential impact on waiting list optimization against physician-based protocols. METHODS: First we first validated PROGRES-CKD by assessing its accuracy in predicting kidney replacement therapy (KRT) initiation within 6 months and 24 months in a historical cohort of patients treated at the San Gerardo Hospital (Italy) between 01-01-2015 and 31-12-2019. In a second study we compared PROGRES-CKD to attending nephrologists' prognostic ratings and simulated their potential impact on a waiting list management protocol. RESULTS: We included 2005 patients who underwent 11,757 outpatient nephrology visits in 4 years. Most visits occurred for NDD-CKD stage 4 patients; the incidence of KRT onset was 10.8 and 9.32/100 patient-years at the 6 and 24-month prediction horizon cohorts, respectively. PROGRES-CKD demonstrated high accuracy in predicting KRT initiation at 6 and 24 months (AUROC = 0.88 and AUROC = 0.85, respectively). Nephrologists' prognostic performance was highly operator-dependent, albeit always significantly lower than PROGRES-CKD. In the simulation exercise, allocation based on PROGRES-CKD resulted in more follow-up visits for patients progressing to end-stage kidney disease (ESKD) and fewer visits for non-progressing patients, compared to allocation determined by nephrologists' prognosis. CONCLUSIONS: PROGRES-CKD showed high accuracy in a real-world application. Waiting list simulation suggests that PROGRES-CKD may enable more efficient allocation of resources.

• MeSH
• Ambulatory Care * MeSH
• Time Factors MeSH
• Renal Insufficiency, Chronic * therapy   diagnosis   MeSH
• Risk Assessment methods   MeSH
• Middle Aged MeSH
• Humans MeSH
• Renal Replacement Therapy statistics & numerical data   MeSH
• Nephrology * MeSH
• Hospitals, Public MeSH
• Prognosis MeSH
• Disease Progression MeSH
• Aged MeSH
• Waiting Lists * MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Validation Study MeSH
• Geographicals
• Italy MeSH