Multicenter Prospective Cohort Study Research Articles

Impact of altitude on the development of low bone mineral density and osteoporosis in individuals aged 50 years and older: protocol for a multicentre prospective cohort study

IntroductionOsteoporotic fractures are a leading cause of disability and contribute significantly to medical care costs worldwide. Variations in bone mineral density and the risk of osteoporosis are notably influenced by...

Circulating cell-free and extracellular vesicles-derived microRNA as prognostic biomarkers in patients with early-stage NSCLC: results from RESTING study

BackgroundFactors to accurately stratify patients with early-stage non-small cell lung cancer (NSCLC) in different prognostic groups are still needed. This study aims to investigate 1) the prognostic potential of circulating cell-free (CF) and extracellular vesicles (EVs)-derived microRNA (miRNAs), and 2) their added value with respect to known prognostic factors (PFs).MethodsThe RESTING study is a multicentre prospective observational cohort study on resected stage IA-IIIA patients with NSCLC. The primary end-point was disease-free survival (DFS), and the main analyses were carried out separately for CF- and EV-miRNAs. CF- and EV-miRNAs were isolated from plasma, and miRNA-specific libraries were prepared and sequenced. To reach the study aims, three statistical models were specified: one using the miRNA data only (Model 1); one using both miRNAs and known PFs (age, gender, and pathological stage) (Model 2), and one using the PFs alone (Model 3). Five-fold cross-validation (CV) was used to assess the predictive performance of each. Standard Cox regression and elastic net regularized Cox regression were used.ResultsA total of 222 patients were enrolled. The median follow-up time was 26.3 (95% CI 25.4–27.6) months. From Model 1, three CF-miRNAs and 21 EV-miRNAs were associated with DFS. In Model 2, two CF-miRNAs (miR-29c-3p and miR-877-3p) and five EV-miRNAs (miR-181a-2-3p, miR-182-5p, miR-192-5p, miR-532-3p and miR-589-5p) remained associated with DFS. From pathway enrichment analysis, TGF-beta and NOTCH were the most involved pathways.ConclusionThis study identified promising prognostic CF- and EV-miRNAs that could be used as a non-invasive, cost-effective tool to aid clinical decision-making. However, further evaluation of the obtained miRNAs in an external cohort of patients is warranted.

Pregnancy Outcomes in Patients With Hepatitis C Virus Infection.

To evaluate the risks of adverse maternal and neonatal outcomes associated with pregnancies complicated by hepatitis C virus (HCV) infection. This is a secondary analysis of a multicenter prospective cohort study of HCV infection in pregnancy. Participants were screened for HCV infection with serum antibody tests, and each participant with a positive HCV result (case group) was matched with up to two individuals with negative HCV results (control group) prospectively by gestational age (±2 weeks) at enrollment. Maternal outcomes included gestational diabetes, abruption, preeclampsia or gestational hypertension, cholestasis, and preterm delivery. Neonatal outcomes included hyperbilirubinemia, admission to neonatal intensive care (NICU); small-for-gestational-age (SGA) birth weight; and neonatal infection, defined as sepsis or pneumonia. Models were adjusted for maternal age, body mass index, injection drug use, and maternal medical comorbidities. The 249 individuals in the case group were prospectively matched to 486 individuals in the control group who met eligibility criteria. There were significant differences in demographic characteristics between the groups, including race, socioeconomic markers, education, insurance status, and drug and tobacco use. The frequencies of maternal outcomes of gestational diabetes, preeclampsia, and abruption were similar between the case and control groups. Preterm birth was similar between groups, but neonates born to individuals in the case group were more likely to be admitted to the NICU (45.1% vs 19.0%, adjusted odds ratio [aOR] 2.6, 95% CI, 1.8-3.8) and to have SGA birth weights below the 5th percentile (10.6% vs 3.1%, aOR 2.9, 95% CI, 1.4-6.0). There were no increased odds of hyperbilirubinemia or neonatal infection. Despite no increased odds of preterm birth or other adverse maternal outcomes in adjusted analyses, maternal HCV infection was associated with twofold increased odds of NICU admission and nearly threefold increased odds of SGA birth weight below the 5th percentile.

Effectiveness and Safety of Qishen Yiqi Dripping Pill in Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention: 3-Year Results from a Multicentre Cohort Study.

To evaluate the effectiveness and safety of Qishen Yiqi Dripping Pill (QSYQ) in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). This multicentre prospective cohort study was conducted at 40 centers in China. Patients with ACS after PCI entered either the QSYQ or Western medicine (WM) groups naturally based on whether they had received QSYQ before enrollment. QSYQ group received QSYQ (0.52 g, 3 times a day for 12 months) in addition to WM. The primary endpoint included cardiac death, non-fatal myocardial infarction, and urgent revascularization. The secondary endpoint included rehospitalization due to ACS, heart failure, stroke, and other thrombotic events. Quality of life was assessed by the Seattle Angina Questionnaire (SAQ). A total of 936 patients completed follow-up of the primary endpoint from February 2012 to December 2018. Overall, 487 patients received QSYQ and WM. During a median follow-up of 566 days (inter quartile range, IQR, 517-602), the primary endpoint occurred in 46 (9.45%) and 65 (14.48%) patients in QSYQ and WM groups respectively [adjusted hazard ratio (HR) 0.60, 95% confidence interval (CI) 0.41-0.90; P=0.013]. The secondary endpoint occurred in 61 (12.53%) and 74 (16.48%) patients in QSYQ and WM groups, respectively (adjusted HR 0.76, 95% CI 0.53-1.09; P=0.136). In sensitivity analysis, the results still demonstrated that WM combined with QSYQ reduced the risk of the primary endpoint (HR 0.67, 95% CI 0.46-0.98; P=0.039). Moreover, QSYQ improved the disease perception domain of the SAQ (P<0.05). In patients with ACS after PCI, QSYQ combined with WM reduced the incidence of the primary endpoint. These findings provide a promising option for managing ACS after PCI and suggest the potential treatment for reducing the risk of primary endpoint included cardiac death, non-fatal myocardial infarction, and urgent revascularization through intermittent administration of QSYQ (Registration No. ChiCTR-OOC-14005552).

Is it feasible to develop a supervised learning algorithm incorporating spinopelvic mobility to predict impingement in patients undergoing total hip arthroplasty?

Precise implant positioning, tailored to individual spinopelvic biomechanics and phenotype, is paramount for stability in total hip arthroplasty (THA). Despite a few studies on instability prediction, there is a notable gap in research utilizing artificial intelligence (AI). The objective of our pilot study was to evaluate the feasibility of developing an AI algorithm tailored to individual spinopelvic mechanics and patient phenotype for predicting impingement. This international, multicentre prospective cohort study across two centres encompassed 157 adults undergoing primary robotic arm-assisted THA. Impingement during specific flexion and extension stances was identified using the virtual range of motion (ROM) tool of the robotic software. The primary AI model, the Light Gradient-Boosting Machine (LGBM), used tabular data to predict impingement presence, direction (flexion or extension), and type. A secondary model integrating tabular data with plain anteroposterior pelvis radiographs was evaluated to assess for any potential enhancement in prediction accuracy. We identified nine predictors from an analysis of baseline spinopelvic characteristics and surgical planning parameters. Using fivefold cross-validation, the LGBM achieved 70.2% impingement prediction accuracy. With impingement data, the LGBM estimated direction with 85% accuracy, while the support vector machine (SVM) determined impingement type with 72.9% accuracy. After integrating imaging data with a multilayer perceptron (tabular) and a convolutional neural network (radiograph), the LGBM's prediction was 68.1%. Both combined and LGBM-only had similar impingement direction prediction rates (around 84.5%). This study is a pioneering effort in leveraging AI for impingement prediction in THA, utilizing a comprehensive, real-world clinical dataset. Our machine-learning algorithm demonstrated promising accuracy in predicting impingement, its type, and direction. While the addition of imaging data to our deep-learning algorithm did not boost accuracy, the potential for refined annotations, such as landmark markings, offers avenues for future enhancement. Prior to clinical integration, external validation and larger-scale testing of this algorithm are essential.

Recruitment and retention of pediatric participants for pandemic preparedness research: Experience from the PREMISE EV-D68 Pilot Study

Recruitment and retention are challenges for prospective pediatric cohort studies, particularly those involving serial venipunctures. We investigated factors underlying enrollment and retention in the Pandemic Response Repository through Microbial and Immune Surveillance and Epidemiology (PREMISE) Enterovirus D68 (EV-D68) Pilot Study, a multicenter prospective longitudinal cohort study assessing the utility of immunologic surveillance for pandemic preparedness. This study enrolls children ≤10 years for two blood draws, pre- and post-EV-D68 season, separated by 6–18 months. Overall, 174 children were enrolled in Cohort 1 of the study and 120 (69 %) of children completed the study, with follow-up blood samples obtained from 101 (58 %) of participants. Families were primarily motivated to participate by a desire to help other children, advance science, and better prepare for the next pandemic. Adding research blood draws to clinically indicated blood draws improved enrollment, and multiple study touch points facilitated retention. These findings can be applied to improve recruitment and retention in future pandemic preparedness efforts and longitudinal pediatric cohort studies.

Systemic assessment of manual circular stapler versus powered circular stapler for anastomosis in rectal cancer: A large-scale Chinese multicenter prospective cohort study.

Mechanical anastomosis in rectal cancer surgery offers several advantages but is plagued by complications like leaks and strictures. Variations in surgeons' experiences affect outcomes, but powered circular anastomosis has emerged as a promising solution, ensuring uniform staple formation and reducing manual manipulation. This multicenter, randomized, parallel-controlled study in China compared IntoCare™'s powered circular staplers (ICS) with manual circular staplers (MCS) in 382 patients (195 ICS, 187 MCS). Both groups had comparable anastomotic leakage rates. ICS significantly reduced anastomosis time while maintaining similar safety profiles. Postoperative recovery and complication rates were closely matched. The use of ICS in rectal cancer surgeries effectively reduces anastomosis time without compromising safety, offering a promising innovation to enhance the efficacy of rectal cancer surgeries while maintaining patient safety.

The impact of quality of life on the survival of elderly patients with end-stage renal disease: a prospective multicenter cohort study in Korea.

Quality of life (QOL) is associated with mortality in dialysis patients. However, the impact of QOL index or score on elderly patients undergoing maintenance dialysis is unclear. We analyzed the relationship between QOL domains and survival in elderly end-stage renal disease (ESRD) patients on dialysis. We included 492 incident ESRD patients aged ≥65years from a Korean nationwide prospective cohort study who were assessed for QOL with a follow-up duration of 67.3±34.6months after dialysis initiation. Their QOL was evaluated using the Kidney Disease Quality of Life (KDQOL) instrument, and the effect of each QOL domain on mortality was analyzed. Multivariable Cox regression analysis was performed to identify independent risk factors for death after adjusting for confounding factors. Low physical component summary (PCS) and Short Form-36 score were significantly associated with low survival rate (P<.001 and P=.017, respectively), whereas the mental component summary and ESRD-targeted item scores were not correlated with survival rate. Multivariable Cox regression analysis confirmed that only a high PCS score was associated with better survival (hazard ratio 0.71; 95% confidence interval 0.52-0.97; P=.031). Linear regression analysis revealed that age, sex, modified Charlson comorbidity index, albumin and intact parathyroid hormone were associated with PCS. Among the PCS items, only the physical functioning score was significantly associated with mortality (P=.017). PCS was an independent risk factor for death in elderly ESRD patients. A higher physical functioning score was associated with a better outcome, suggesting the importance of physical condition in elderly dialysis patients.

Impact of early myocardial injury on patients with severe pneumonia.

Pneumonia often causes myocardial damage. This study sought to understand how early myocardial injury affects severe pneumonia patients' prognoses. This multi-center prospective cohort study from March 2020 to October 2023 comprised severe pneumonia patients. Binary logistic regression analysis examined how myocardial damage affects cardiac complications and acute renal injury (AKI). We used Spearman correlation analysis to examine the relationship between troponin I levels and the vasoactive inotropic score (VIS) in shock patients with myocardial injury. We used the Kaplan-Meier survival curve to evaluate the impact of myocardial injury on 30-day and 1-year survival rates. Mediation investigations examined how AKI and cardiac complications mediate myocardial injury and death. This study included 363 severe pneumonia patients, of whom 204 (56.2%) developed myocardial damage, 132 (36.4%) had cardiac problems, and 146 (40.2%) had AKI. Myocardial damage independently elevated the incidence of cardiac complications (OR = 2.548, 95% CI = 1.404-4.303, P = 0.002) and AKI (OR = 1.946, 95% CI = 1.177-3.219, P = 0.009). There was a positive link between troponin I and VIS in myocardial injury and shock patients (r = 0.43, P < 0.001). COX regression found myocardial injury to be a death risk (HR = 1.472, 95% CI = 1.043-2.077, P = 0.028). Adjusted Kaplan-Meier survival analysis showed significantly decreased short-term and long-term survival rates with myocardial injury (log-rank test P < 0.05). The mediation study showed that cardiac complications and AKI mediated myocardial injury and death by 19.30% and 17.18%, respectively. Early myocardial injury in severe pneumonia patients raises the likelihood of cardiac problems, AKI, and refractory shock, reducing short- and long-term survival.

Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma (preSINO trial): A prospective multicenter diagnostic cohort study in Asia.

196 Background: The benefit of standard esophagectomy in patients with clinical complete response (cCR) after neoadjuvant chemoradiotherapy (nCRT) is disputable and the alternative of active surveillance should be studied. PreSANO study demonstrated that clinical response evaluations (CREs) are accurate to detect residual tumor after nCRT in patients with mainly adenocarcinoma, however, its applicability to esophageal squamous cell carcinoma (ESCC) is unknown. The preSINO trial (NCT03937362) aimed to assess the accuracy of CREs based on bite-on-bite biopsy, endoscopic ultrasonography with fine needle aspiration (EUS-FNA) of suspected lymph nodes, PET-CT in patients with ESCC, and to provide a basis for organ-sparing strategy of ESCC in Asia. Methods: Patients were eligible when they were planned for nCRT (CROSS regimen) followed by standard surgery. Patients received the first CRE (bite-on-bite biopsies) 4-6 weeks after completion of nCRT. Patients with locoregional residual tumor and without distant metastases underwent immediate surgery. In patients with a cCR at CRE-1, a second CRE (CRE-2) was done 10-12 weeks after completion of nCRT using PET-CT, bite-on-bite biopsies and EUS-FNA of suspicious lymph nodes. All patients underwent surgery irrespective of the outcome of CRE-2, in the absence of distant metastases. Circulating tumor DNA (ctDNA) analyses based on tumor-informed assay were performed at baseline and CREs for exploratory analysis. Primary endpoint was the accuracy of CREs for detecting TRG3-4 or TRG1-2 with ypN+ residual tumor. A false-negative rate (FNR) of 19.5% was considered acceptable according to the study protocol. Results: From Aug 20, 2019, to Jan 15, 2023, 309 patients were included of whom 250 patients underwent nCRT plus surgery. Eighteen of 133 patients with TRG3-4 or TRG1-2 with ypN+ residual tumor were not detected by bite-on-bite biopsies and EUS-FNA (FNR: 13.5%). Sensitivity, specificity, negative predictive value and positive predictive value of detecting any residual tumor were 82%, 93%, 69% and 97%, respectively. PET-CT detected interval distant metastases in 13 (5%) of 268 patients prior to surgery. Postoperative distant recurrence rate among patients with ctDNA-positive and ctDNA-negative during CREs were 15.1% (11/73) and 3.3% (2/59), respectively. Conclusions: Bite-on-bite biopsies and EUS-FNA for lymph nodes were accurate for detecting locoregional residual disease after nCRT in patients with ESCC. Post-nCRT ctDNA-positive during CREs may indicate an increased risk of long-term distant metastasis, potentially serving as a diagnostic tool to identify patients who would benefit from postponement of surgery and additional systemic therapy. The long-term follow-up results of this trial will further answer this question. Clinical trial information: NCT03937362 .

Factors associated with precancerous stomach lesions and progresion: A 7-year multi-center prospective cohort study on the low incidence of gastric cancer in central Saudi Arabia.

In Saudi Arabia (SA) no data are available on precancerous stomach lesions (PSLs) or the associated risk factors. We aimed to identify PSLs and investigate factors associated with PSLs and their progression. This 7-year prospective study screened for PSLs in asymptomatic Saudi patients aged 45-75 years in central SA (n = 35,640). Those who had high-sensitivity guaiac fecal occult blood tests (HSgFOBT+) and negative colonoscopy results (n = 1242) were subjected to upper GI endoscopy to identify PSLs and were followed up every 3 years or earlier, depending on the type of PSL. Factors associated with PSLs were investigated. The 7-year participation rate was 86.9% (1080/1242). The 7-year prevalence of PSLs was 30.9% (334/1080). The incidence rate of PSLs was 134 new cases/100,000 population/year, total population at risk - 35,640 and 44.3 new cases/1,000 persons/year among the 1080 participants with HSgFOBT+ and negative colonoscopy results. Among the 334 participants with PSLs, 8 (2.4%) had neoplastic progression to GC during the surveillance period. Age, Helicobacter pylori infection, smoking status, a diet with preserved salty foods, low income, and a family history of GC were associated with PSLs. The incidence of GC is low in central SA, but screening for PSLs among participants with HSgFOBT+ and negative colonoscopy findings may contribute to the early detection and subsequent treatment of GC. HP eradication, not smoking, normal body weight, and adhering to a healthy diet seem to be potential factors associated with the development of PSLs. Further studies are needed to search if such interventions would decrease the incidence of PSLs and progression to early GC.

Clinical characteristics, predisposing factors and outcomes for Enterococcus faecalis versus Enterococcus faecium bloodstream infections: a prospective multicentre cohort study

PurposesEnterococcal BSI is associated with significant morbidity and mortality, with fatality rates of approximately 20–30%. There are microbiological and clinical differences between E. faecalis and E. faecium infections. The aim of this study was to investigate differences in predisposing factors for E. faecalis and E. faecium BSI and to explore prognostic factors.MethodsThis study was a post-hoc analysis of PROBAC, a Spanish prospective, multicenter, cohort in 2016–2017. Patients with E. faecalis or E. faecium BSI were eligible. Independent predictors for BSI development in polymicrobial and monomicrobial BSI and in-hospital mortality in the monomicrobial group were identified by logistic regression.ResultsA total of 431 patients were included. Independent factors associated with E. faecium BSI were previous use of penicillins (aOR 1.99 (95% CI 1.20–3.32)) or carbapenems (2.35 (1.12–4.93)), hospital-acquired BSI (2.58 (1.61–4.12)), and biliary tract source (3.36 (1.84–6.13)), while congestive heart failure (0.51 (0.27–0.97)), cerebrovascular disease (0.45 (0.21–0.98)), and urinary tract source (0.49 (0.26–0.92)) were associated with E. faecalis BSI. Independent prognostic factors for in-hospital mortality in E. faecalis BSI were Charlson Comorbidity Index (1.27 (1.08–1.51)), SOFA score (1.47 (1.24–1.73)), age (1.06 (1.02–1.10)), and urinary/biliary source (0.29 (0.09–0.90)). For E. faecium BSI, only SOFA score (1.34 (1.14–1.58) was associated with in-hospital mortality.ConclusionsThe factors associated with E. faecium and E. faecalis BSI are different. These variables may be helpful in the suspicion of one or other species for empiric therapeutic decisions and provide valuable information on prognosis.

Long-Term Effectiveness and Reasons for Discontinuation of Dupilumab in Patients With Atopic Dermatitis

Limited data are available on the long-term effectiveness and safety of dupilumab for atopic dermatitis (AD) in daily practice. To evaluate clinical effectiveness and reasons for discontinuation of dupilumab treatment in children, adults, and older adults with AD with up to 5 years of treatment in daily practice. This prospective multicenter cohort study was conducted using the BioDay registry (4 academic and 10 nonacademic hospitals in the Netherlands) to identify patients with AD of all ages who were treated with dupilumab between October 2017 and December 2022. Clinical effectiveness was evaluated by the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), and numeric rating scale (NRS) for pruritus, stratified by children (<18 years), adults (18-64 years), and older adults (≥65 years). In addition, time to response, treatment responders, EASI subscores, second treatment episodes, and thymus- and activation-related chemokine and eosinophil levels were assessed. For patients who discontinued dupilumab, the reason for discontinuation was evaluated. In total, 1286 patients with AD (median [IQR] age, 38 [26-54] years; 726 [56.6%] male) were treated with dupilumab, including 130 children, 1025 adults, and 131 older adults. The median (IQR) follow-up time was 87.5 (32.0-157.0) weeks. Most patients maintained controlled AD, with EASI of 7 or lower and NRS for pruritus of 4 or lower varying between 78.6% and 92.3% and 72.2% and 88.2% for up to 5 years of treatment, respectively, while up to 70.5% of all patients prolonged the dosing interval to mostly 300 mg every 3 or 4 weeks. Mean EASI and NRS for pruritus were 2.7 (95% CI, 1.2-4.2) and 3.5 (95% CI, 2.7-4.3), respectively, after 5 years of treatment. Statistically significant differences between age groups were found over time for EASI and IGA; however, differences were rather small (week 52: EASI, 0.3-1.6; IGA, 0.12-0.26). No statistically significant differences between age groups were found for NRS for pruritus. Median thymus- and activation-related chemokine levels considerably decreased from 1751 pg/mL (95% CI, 1614-1900 pg/mL) to 390 pg/mL (95% CI, 368-413 pg/mL) after 6 months of treatment and remained low. Median eosinophil levels temporarily increased up to week 16, with a subsequently statistically significant decrease over time. In total, 306 patients (23.8%) discontinued dupilumab after a median (IQR) of 54.0 (29.0-110.00) weeks, with adverse events among 98 patients (7.6%) and ineffectiveness among 85 patients (6.6%) as the most frequently reported reasons. Forty-one patients (3.2%) restarted dupilumab, and most of these patients recaptured response. In this cohort study with up to 5 years of follow-up, dupilumab maintained its clinical effectiveness, while two-thirds of patients tapered to a dosing interval of every 3 or 4 weeks. Treatment was discontinued in 23.8% of patients mainly due to adverse events and/or ineffectiveness.

Associations between readmission and patient-reported measures in acute psychiatric inpatients: a multicenter prospective longitudinal study.

This study examined whether patient-reported measures (PRMs) addressing quality of life, personal agency, functional impairment, and treatment satisfaction at hospital discharge were associated with future readmission during a 12-month follow-up period. The study also examined whether readmission influenced changes in the same measures. A multicenter prospective cohort study was conducted at 21 psychiatric hospitals in Japan. Participants completed the EuroQol-five-dimensions-five-level (EQ-5D), the Five-item Subjective Personal Agency Scale, and the Sheehan Disability Scale (SDS) at the time of index admission (T1), discharge from index admission (T2), and 6months (T3) and 12months (T4) after discharge. Inpatient treatment satisfaction was assessed at T2. Readmission and variables potentially associated with hospitalization and PRMs were evaluated using mixed-effects logistic regression models and mixed models for repeated measures. A total of 491 participants were followed for 12months (attrition rate: 19.4%), and 480 were included in the EQ-5D analysis. The most common diagnoses were schizophrenia (59%), depression (14%), and bipolar disorder (13%). No patient-reported measures were significantly associated with readmission over the follow-up period. Interaction of readmission and time did not significantly affect changes in EQ-5D. Readmission did significantly influence SDS score changes between T2 and T3 (B = 1.78, 95% CI = 0.30-3.25, p = 0.018) and between T3 and T4 (B = 1.43, 95% CI = 0.14-2.72, p = 0.029).The same influence of readmission on SDS score changes was not observed in the model which adjusted for all potential covariates. Readmission was potentially associated with changes in self-reported functional impairment. Findings highlight the potential role of intensive post-discharge services in preventing readmission, rather than relying on time-of-discharge PRMs in order to predict readmission risk. This study was registered in UMIN Clinical Trials Registry (UMIN000034220).

The Number of Patellar Dislocation Events Is Associated With Increased Chondral Damage of the Trochlea.

Patellofemoral instability is associated with chondral injuries to the patella, trochlea, and lateral femoral condyle. Although studies have demonstrated an association between patellar dislocations and chondral injuries, the influence of the number of dislocations on chondrosis is not established. To elucidate the precise association between the number of patellar dislocation events and the severity of chondral injuries in a multicenter cohort study at the time of patellar stabilization procedures. Cross-sectional study; Level of evidence, 2. A prospective multicenter cohort study (JUPITER [Justifying Patellar Instability Treatment by Early Results]) database was queried for cases of primary patellofemoral instability procedures from December 2016 to September 2022. Cartilage lesions were classified using the International Cartilage Repair Society (ICRS) classification system during an arthroscopic or open evaluation (direct visualization), with grades 2 to 4 considered abnormal. The number of dislocations was categorized as 1, 2-5, and >5. Categorical variables were compared with the chi-square test, and binary logistic regression was performed to identify predictors of the presence of chondral lesions. A total of 938 knees (mean age, 16.2 ± 3.8 years; 61.4% female) were included, with 580 (61.8%) demonstrating a chondral injury. The most affected region was the patella (n = 498 [53.1%]), followed by the lateral femoral condyle (n = 117 [12.5%]) and trochlea (n = 109 [11.6%]). There were no differences in the presence (P = .17) or grade (P = .63) of patellar lesions by the number of dislocations. Patients with >5 dislocations more frequently had trochlear chondral lesions (19.8%) compared with those with fewer dislocations (1, 7.6%; 2-5, 11.0%; P < .001). More dislocations were also associated with a higher proportion of ICRS grade 2 to 4 trochlear lesions (>5, 15.3%; 2-5, 10.0%; 1, 6.9%; P = .015). Combined patellar and trochlear lesions were also more common in those with >5 dislocations (P = .001). In multivariable regression, >5 dislocations was the only variable predictive of a trochlear lesion (odds ratio, 3.03 [95% CI, 1.65-5.58]; P < .001). This large prospective cohort study demonstrated that recurrent patellar dislocations can lead to more severe chondral damage in specific locations in the knee. More than 5 dislocations was associated with a >3-fold increase in the incidence and severity of trochlear chondral injuries. There were no differences in the presence or grade of patellar lesions by the number of dislocations. These findings should caution surgeons regarding prolonged nonoperative treatment.

Development of a new definition of maternal near miss based on organ dysfunction in Latin America and the Caribbean: Aprospective multicenter cohort study.

There has been debate over whether the existing World Health Organization (WHO) criteria accurately represent the severity of maternal near misses. This study assessed the diagnostic accuracy of two WHO clinical and laboratory organ dysfunction markers for determining the best cutoff values in a Latin American setting. A prospective multicenter cohort study was conducted in five Latin American countries. Patients with severe maternal complications were followed up from admission to discharge. Organ dysfunction was determined using clinical and laboratory data, and participants were classified according to severe maternal outcomes. This study compares the diagnostic criteria of Latin American Centre for Perinatology, Network for Adverse Maternal Outcomes (CLAP/NAMO) to WHO standards. Of the 698 women studied, 15.2% had severe maternal outcomes. Most measured variables showed significant differences between individuals with and without severe outcomes (all P-values <0.05). Alternative cutoff values suggested by CLAP/NAMOs include pH ≤7.40, lactate ≥2.3 mmol/L, respiratory rate ≥ 24 bpm, oxygen saturation ≤ 96%, PaO2/FiO2 ≤ 342 mmHg, platelet count ≤189 × 109 × mm3, serum creatinine ≥0.8 mg/dL, and total bilirubin ≥0.67 mg/dL. No significant differences were found when comparing the diagnostic performance of the CLAP/NAMO criteria to that of the WHO standards. The CLAP/NAMO values were comparable to the WHO maternal near-miss criteria, indicating that the WHO standards might not be superior in this population. These findings suggest that maternal near-miss thresholds can be adapted regionally, improving the identification and management of severe maternal complications in Latin America.

A multicenter study on the effects of congenital cytomegalovirus infection on hearing loss

Objective: To assess the clinical features and effectiveness of antiviral therapy in newborns with sensorineural hearing loss (SNHL) caused by congenital congenital cytomegalovirus (cCMV) infection, and to speculate the risk factors for poor hearing outcomes. Methods: A multicenter prospective cohort study wasconducted, enrolling 176 newborns diagnosed with cCMV at four research centers in Zhejiang Province from March 1, 2021, to April 30, 2024. Clinical characteristics at birth were recorded and hearing was followed up. The children were divided into groups based on their condition at birth, specifically into asymptomatic, mild symptom, and moderate to severe symptom groups. Additionally, they were divided into SNHL and normal hearing groups based on the results of air conduction brainstem audiometry at birth. And they were also divided into treatment and untreated groups according to antiviral treatment. Mann Whitney U test, and chi square test were used for inter group comparison to analyze the differences in clinical features between different disease groups, and to analyze the effects of clinical features, antiviral therapy, and other factors on hearing improvement. Logistic regression analysis was employed to identify the risk factors influencing hearing outcomes. Results: Among the cohort of 176 children diagnosed infection with cCMV, 90 cases were male and 86 cases were female. Of these, 79 cases were asymptomatic, 12 cases classified as mild cCMV and 85 cases as moderate to severe cCMV. Fifty cases belonged to SNHL group, with different degrees of severity, including 30 cases of mild, 9 cases of moderate, 5 cases of severe, and 6 cases of extremely severe SNHL. Among the 121 cases in the normal hearing group, 2 cases (1.7%) exhibited late-onset hearing loss despite having normal hearing at birth. Among 81 cases (46.0%) who completed the hearing follow-up, 71 cases (87.7%) had good hearing outcomes and 10 cases (12.3%) had poor hearing outcomes. Among the 81 children, 29 cases (35.8%) had SNHL at birth. During follow-up, the hearing threshold improved in 19 cases (65.5%), remained stable in 7 cases (24.1%) and progressed in 3 cases (10.3%). A total of 26 cases in the treatment group and 55 cases in the untreated group completed the hearing follow-up assessment. The rate of hearing improvement in the treatment group was found to be higher compared to the untreated group (13 cases (50.0%) vs. 6 cases (10.9%), χ2=15.00, P<0.01), with individuals in the treatment group having a 4.58 times greater likelihood of experiencing hearing improvement (RR=4.58,95%CI 1.96-10.70, P<0.05). However, no statistically significant difference was observed in hearing outcomes between the antiviral treatment group and the untreated group (RR=0.90, 95%CI 0.57-1.41, P=0.517). Multivariate analysis further confirmed SNHL (OR=11.58, 95%CI 2.10-63.93, P=0.005) and preterm birth (OR=4.98, 95%CI 1.06-23.41, P=0.042) as independent risk factors for poor hearing outcomes. Conclusions: SNHL resulting from cCMV infection presents symptoms at birth and can be improved by antiviral therapy. Poor hearing outcomes are associated with SNHL and prematurity.

Alcohol and drug use in adults younger than 60 years with hip fracture – A comparison of validated instruments and the clinical eye: A prospective multicenter cohort study of 218 patients

BackgroundIt is a common preconception that young individuals sustaining hip fractures have alcohol and/or drug use disorder. It is important to evaluate the actual use to avoid complications and plan the rehabilitation. AimThe primary objective was to assess alcohol and drug consumption in hip fracture patients <60 years using the validated Alcohol Use Disorders Identification Test (AUDIT) and Drug Use Disorders Identification Test (DUDIT) scores. We secondarily investigated the agreement between the instruments and the physicians’ clinical evaluation of usage. Material and methodsThis is a sub-study of 91 women and 127 men from a multicenter cohort study of patients with an acute hip fracture treated at four hospitals in Denmark and Sweden. AUDIT and DUDIT forms were completed by the patients. In addition, the researchers made an evaluation of the patients’ alcohol/drug use based on direct patient contact and information on previous alcohol/drug use from medical charts. AUDIT ranges 0–40 with 6 (women) and 8 (men) as the cut-off for hazardous use. DUDIT ranges 0–44 with cut-offs of 2 and 6 indicating drug-related problems. ResultsAccording to the AUDIT, 29 % of the patients had a hazardous alcohol use (25 % women, 31 % men), whilst the clinical evaluation identified 26 % (24 % women, 28 % men). However, there was a low agreement between “the clinical eye” and AUDIT, as the clinical evaluation only correctly identified 35 of 56 individuals with AUDIT-scores indicating hazardous alcohol use. DUDIT equaled drug related problems in 8 % (5 % women, 10 % men), the clinical evaluation depicted 8 % with drug related problems (4 % women, 10 % men). The agreement was low between “the clinical eye” and DUDIT; only 7 of 15 with DUDIT-scores indicating drug related problems were correctly identified. ConclusionHazardous alcohol consumption is more common in non-elderly hip fracture patients than in the general population. Considering both self-reported alcohol use and clinical evaluation, women have almost as high rate as men. DUDIT indicated drug related problems to be slightly more common than in the population. Still, a majority did not exhibit troublesome use of neither alcohol nor drugs. The two screening methods do not identify the same individuals, and further investigation in clinical practice is needed.

Associations of the EAT-Lancet reference diet with metabolic dysfunction-associated steatotic liver disease and its severity: A multicohort study.

The EAT-Lancet Commission devised a globally sustainable dietary pattern to jointly promote human health and sustainability. However, the extent to which this diet supports metabolic dysfunction-associated steatotic liver disease (MASLD) has not yet been assessed. This study aimed to investigate the association between the EAT-Lancet diet and the risk of MASLD and its severity. This prospective multicohort study included 15,263 adults from the Tianjin Chronic Low-grade Systemic Inflammation and Health (TCLSIH) cohort, 1137 adults from the Guangzhou Nutrition and Health Study (GNHS) cohort, and 175,078 adults from the UK Biobank. In addition, 228 Chinese adults from the Prospective Epidemic Research Specifically of Non-alcoholic Steatohepatitis (PERSONS) with biopsy-proven MASLD were included. An EAT-Lancet diet index was created to reflect adherence to the EAT-Lancet reference diet. The TCLSIH cohort recorded 3010 MASLD cases during 53,575 person-years of follow-up, the GNHS cohort documented 624 MASLD cases during 6454 person-years of follow-up, and the UK Biobank developed 1350 MASLD cases during 1,745,432 person-years of follow-up. In multivariable models, participants in the highest tertiles of the EAT-Lancet diet index had a lower risk of MASLD compared with those in the lowest tertiles (TCLSIH: HR = 0.87, 95% CI: 0.78, 0.96; GNHS: HR = 0.79, 95% CI: 0.64, 0.98; UK Biobank: HR = 0.73, 95% CI: 0.63, 0.85). Moreover, liver-controlled attenuation parameter decreased with increasing the diet index in individuals with biopsy-proven MASLD (β = -5.895; 95% CI: -10.014, -1.775). Adherence to the EAT-Lancet reference diet was inversely associated with the risk of MASLD as well as its severity.

Long-term outcomes and associated factors among intensive care unit survivors in a low-income country: a multicenter prospective cohort study

ObjectivePost-ICU survivors face higher mortality and often require costly rehabilitation or palliative care, such as occupational therapy, physiotherapy and hospice. However, there is a lack of data quantifying the demand for these services, particularly in developing countries like Uganda. Therefore, this prospective cohort study aimed to investigate the 90-day mortality rate, functional status, and mortality risk factors among 121 ICU patients discharged from three tertiary hospital ICUs in Uganda by tracking their vital and physical functional status for three months with follow-ups on days 30, 60, and 90, and identifying risk factors through Cox regression.ResultsThe study revealed that 18 out of 121 ICU patients (14.88%, 95% CI: 9.52-22.51%) died within 90 days post-discharge, while 36.36% achieved normal physical functional status. Factors associated with higher 90-day mortality included raised intracranial pressure (HR 1.92, 95% CI: 1.76–2.79, p = 0.04), acute kidney injury (HR 4.13, 95% CI: 2.16–7.89, p < 0.01), and renal replacement therapy (HR 3.34, 95% CI: 2.21–5.06, p < 0.01). The high mortality rate and the fact that nearly two-thirds of patients did not attain normal functional status 90 days post discharge underscores the need for enhanced post-ICU rehabilitation services.