Multicenter Prospective Cohort Study Research Articles

The External Validation of a Multivariable Prediction Model for Recurrent Pelvic Organ Prolapse After Native Tissue Repair: A Prospective Cohort Study

Background/Objectives: A prediction model for anatomical cystocele recurrence after native tissue repair was developed and internally validated in 2016. This model estimates a patients’ individual risk of recurrence and can be used for counseling. Before implementation in urogynecological clinical practice, external validation is needed. The aim of this study was to assess the external validity of this previously developed prediction model. The secondary aim was to test the performance of this model with a composite and subjective outcome of pelvic organ prolapse (POP) recurrence. Furthermore, the aim was to investigate whether risk factors for POP recurrence were in line with the population in which the original model was developed. Methods: In this prospective multicenter cohort study, 246 patients who underwent anterior colporrhaphy were included. Inclusion criteria were patients scheduled to undergo a primary anterior colporrhaphy (with a POP Quantification (POPQ) stage ≥ 2 cystocele). A combination of a primary anterior colporrhaphy with other POP or incontinence surgery (without the use of vaginal or abdominal mesh material) was permitted. Patients with prolapse or incontinence surgery prior to index surgery could not participate. All patients filled in questionnaires, pelvic floor ultrasound was performed preoperatively, and data from the medical file concerning POPQ stage and obstetric and general history were obtained. Results: Thirty women (12.2%) were lost at follow up. Anatomical cystocele recurrence was present in 107/216 (49.5%), subjective recurrence in 19/208 (9.1%), and 39/219 (17.8%) patients met the criteria for composite outcome. The area under the receiver operating characteristic curves for anatomical, composite, and subjective recurrence were 65.5% (95% CI: 58.7–72.4), 55.8% (95% CI 47.3–64.3%, NS), and 55.1% (95% CI 45.1–65.2%), respectively. In the multivariable analysis, preoperative cystocele stage 3 or 4 and a complete levator defect on ultrasound were independent risk factors for anatomical recurrence. For composite recurrence, younger age and an active employment status were only risk factors in univariable analysis. No significant risk factors for subjective recurrence could be identified. Conclusions: This external validation study showed a moderate performance for a prediction model for anatomical recurrence. The model cannot be used for a composite or subjective outcome prediction because of poor performance. For composite and subjective recurrence, new prediction models need to be developed.

Association Between Surgeon Stress and Major Surgical Complications.

Surgeon stress can influence technical and nontechnical skills, but the consequences for patient outcomes remain unknown. To investigate whether surgeon physiological stress, as assessed by sympathovagal balance, is associated with postoperative complications. This multicenter prospective cohort study included 14 surgical departments involving 7 specialties within 4 university hospitals in Lyon, France. Exclusion criteria consisted of patient age younger than 18 years, palliative surgery, incomplete operative time-stamping data, procedures with a duration of less than 20 minutes, and invalid surgeon heart rate variability (HRV) data. Data were accrued between November 1, 2020, and December 31, 2021, with 30-day follow-up completed on May 8, 2022. Analyses were performed from January 1 to May 31, 2024. Sympathovagal balance of the attending surgeon in the first 5 minutes of surgery. Major surgical complications, extended intensive care unit stay, and mortality within 30 days, after adjustment via mixed-effects multivariable logistic regression for surgeon age, professional status, the time of incision, the random effect of the surgeon, and a composite risk score incorporating patient comorbidities and surgery characteristics. Sympathovagal balance was quantified by the low frequency to high frequency (LF:HF) ratio derived from HRV data measured by chest monitors worn intraoperatively. The LF:HF ratio was normalized at the surgeon level to the median value observed for each surgeon during the study period to control for baseline differences. A total of 793 surgical procedures performed by 38 attending surgeons were included in the analysis. Median patient age was 62 (IQR, 47-72) years, and 412 (52.0%) were female, with a median of 2 (IQR, 1-4) comorbidities. Median surgeon age was 46 (IQR, 39-52) years, 39 (78.9%) were male, and 22 (57.9%) were professors. Median surgeon heart rate was 88 (IQR, 77-99) beats per minute. Median surgeon LF:HF ratio was 7.16 (IQR, 4.52-10.72) before and 1.00 (IQR, 0.71-1.32) after normalization. Increased surgeon sympathovagal balance during the first 5 minutes of surgery was associated with significantly reduced major surgical complications (adjusted odds ratio [AOR], 0.63; 95% CI, 0.41-0.98; P = .04), though not with reduced intensive care unit stay (AOR, 0.34; 95% CI, 0.11-1.01; P = .05) or mortality (AOR, 0.18; 95% CI, 0.03-1.03; P = .05). Increased surgeon stress at the beginning of a procedure was associated with improved clinical patient outcomes. The results are illustrative of the complex relationship between physiological stress and performance, identify a novel association between measurable surgeon human factors and patient outcomes, and may highlight opportunities to improve patient care.

Impact of comorbid constipation on the survival of patients with heart failure: a multicenter, prospective cohort study conducted in Japan

BackgroundConstipation frequently affects heart failure patients because of medication side effects and physiological effects of the condition. Although recent speculation suggests that comorbid constipation may affect cardiovascular disease onset and survival rates, this relationship remains unclear. We examined the effect of comorbid constipation on the survival of patients with heart failure.MethodsWe conducted a multicenter prospective cohort study (the Kochi YOSACOI study) of patients hospitalized for acute decompensated heart failure. The influence of comorbid constipation on survival was evaluated using Cox regression analysis with 2-year survival as the index. Patients were divided into two groups based on the presence of comorbid constipation. The patient background was adjusted using propensity score matching, and the evaluation included assessing the 2-year survival and cardiovascular mortality occurrence using the log-rank test.ResultsAmong 1,061 patients hospitalized for acute decompensated heart failure, 715 with complete data (124 with comorbid constipation and 591 without) were analyzed. Comorbid constipation was identified as a risk factor for poorer survival in the Cox regression model (hazard ratio: 1.90, 95% confidence interval: 1.3–2.8, P < 0.001). Propensity score matching included 104 patients in each group. Survival analysis using the log-rank test indicated worse survival (P = 0.023) and higher cardiovascular mortality (P = 0.043) in the comorbid constipation group.ConclusionConstipation can negatively affect the survival of patients with heart failure. Although the causal link between constipation and decreased survival remains unclear, identifying comorbid constipation is essential for identifying heart failure patients at a higher risk of poor outcomes.

Downstaging of hepatocellular carcinoma before liver transplantation: Results from a national multi-center prospective cohort study.

Patients with hepatocellular carcinoma (HCC) meeting UNOS-downstaging (DS) criteria have excellent post-liver transplantation (LT) outcomes. Studies on HCC beyond UNOS-DS criteria ("All-comers" (AC)) have been limited by small sample size and short follow-up time, prompting this analysis. 326 patients meeting UNOS-DS and 190 meeting AC criteria from 9 LT centers across 5 UNOS regions were enrolled from 2015 to 2023 and prospectively followed. Competing risk analysis and Kaplan-Meier method were used to evaluate downstaging and LT outcomes, and Fine-and-Gray and Cox models were used to identify predictors of outcomes. AC and UNOS-DS had similar median alpha-fetoprotein (15 vs. 12ng/mL;p=0.08), MELD (9 vs. 9;p=0.52), and Child-Pugh (A vs. A;p=0.30). At 2 years from first local regional therapy, 82% of UNOS-DS and 66% of AC were successfully downstaged (p<0.001). In AC, DS rates were 72% for tumor number plus diameter of largest lesion<10, 51% for sum 10-12, and 39% for sum>12 (p=0.01). Y-90 achieved higher DS success than transarterial chemoembolization (TACE) in AC (74% vs. 65%;p<0.001). 48% of UNOS-DS and 40% of AC underwent LT (p=0.10). 5-year post-LT survival was similar between UNOS-DS and AC (74% vs. 72%;p=0.77), although 5-year post-LT recurrence was higher in AC (30% vs. 14%;p=0.02). Despite higher HCC recurrence and lower ITT survival in AC, post-LT survival was comparable between UNOS-DS and AC. Y-90 attained higher DS success than TACE in AC. LT after downstaging is feasible in AC, though defining an upper limit in tumor burden may be necessary.

Baseline characteristics of patients in the Chinese Bronchiectasis Registry (BE-China): a multicentre prospective cohort study.

Bronchiectasis is a disease with a global impact, but most published data come from high-income countries. We aimed to describe the clinical characteristics of patients with bronchiectasis in China. The Chinese Bronchiectasis Registry (BE-China) is a prospective, observational cohort enrolling patients from 111 hospitals in China. Data on demographics, comorbidities, and aetiological testing results were collected from adult patients with bronchiectasis at baseline and annual follow-up. Patients who met the inclusion criteria (age ≥18 years; received chest high-resolution CT in the past year showing bronchiectasis affecting one or more lung lobes; and clinical history consistent with bronchiectasis, including chronic cough, daily sputum production, and history of exacerbations) were included. Patients with known cystic fibrosis were excluded. To investigate variations according to different economic regions, two groups were compared based on whether per capita disposable income of residents was greater than US$5553. Clinical characteristics were compared with the European (EMBARC) registry and other national registries. Between Jan 10, 2020, and March 31, 2024, 10 324 patients from 97 centres were included in the study. Among 9501 participants with available data, the most common cause of bronchiectasis was post-infective disease (4101 [43·2%] patients), followed by idiopathic (2809 [29·6%] patients). 6676 (70·0%) of 9541 patients with available data had at least one exacerbation in the year before enrolment and 5427 (57·2%) of 9489 patients with available data were hospitalised at least once due to exacerbations. Treatments commonly used in high-income countries, such as inhaled antibiotics and macrolides, were infrequently used in China. Implementation of airway clearance in China was scarce, with only 1177 (12·2%) of 9647 patients having used at least one method of airway clearance. Compared with upper-middle-income regions, patients from lower-middle-income regions were younger (61·0 years [SD 14·0] vs 63·9 years [14·2]) with a higher proportion of pulmonary comorbidities (521 [17·8%] of 2922 patients vs 639 [8·6%] of 7402 with chronic obstructive pulmonary disease and 194 [6·6%] of 2922 patients vs 364 [4·9%] of 7402 patients with asthma), a higher tuberculosis burden (442 [16·0%] of 2768 patients vs 715 [10·6%] of 6733 patients), more severe radiological involvement (1160 [42·4%] of 2736 patients vs 2415 [35·4%] of 6816 patients with cystic bronchiectasis), more exacerbations (median 1·4 [IQR 0-2] in both groups; mean 1·4 [SD 1·6] vs 1·2 [1·4] in the previous year) and hospitalisations (1662 [60·6%] of 2743 patients vs 3765 [55·8%] of 6746 patients hospitalised at least once in the previous year), and poorer quality of life (median 57·4 [IQR 53·5-63·1] vs 58·7 [54·8-64·8] assessed by the Bronchiectasis Health Questionnaire). The clinical characteristics of patients with bronchiectasis in China show differences compared with cohorts in Europe and India. Bronchiectasis is more severe with a higher burden of exacerbations in lower-income regions. The management of patients with bronchiectasis in China urgently needs standardisation and improvement. National Natural Science Foundation of China, Innovation Program of the Shanghai Municipal Education Commission, Program of the Shanghai Municipal Science and Technology Commission, and Program of the Shanghai Shenkang Development Center. For the Chinese translation of the abstract see Supplementary Materials section.

Use of a Non-Endoscopic Capsule-Sponge Triage Test for Reflux Symptoms: Results From the NHS England Prospective Real-World Evaluation.

Acid reflux is a common presentation in primary care leading to a high volume of referrals to endoscopy that are often normal. To determine whether a non-endoscopic capsule sponge biomarker test could triage patients with low-risk reflux symptoms, reduce endoscopy waiting lists and identify Barrett's oesophagus in a real-world setting. Patients with reflux symptoms on NHS endoscopy waiting lists who were offered a capsule sponge (test group) between February 2021 and August 2022 were included in this national multicentre prospective cohort study and compared with eligible patients on the standard endoscopy pathway (counterfactual group). Two thousand one hundred seventy patients from 23 hospitals undertook a capsule sponge triage test and submitted follow-up data, of whom 1694 (78%) were discharged without endoscopy and 476 (22%) were referred for endoscopy. In a detailed subgroup analysis 1411/1549 (92%) attended and successfully swallowed the capsule of whom 307/1411 (21.8%) required endoscopy. Of 111 patients with positive capsule sponge biomarker results who had endoscopy, 19.8% had Barrett's oesophagus. In comparison, in patients with negative sponge biomarkers who were referred for endoscopy due to ongoing symptoms, none had Barrett's oesophagus (p = 0.0002). Eighty-two percent surveyed (267/357) were satisfied with the alternative pathway. Capsule sponge triage is feasible, safe and acceptable. It substantially reduces the endoscopy burden for routine reflux referrals with a favourable diagnostic yield for Barrett's oesophagus. Longer term follow-up will help to confidently assess the impact of the programme and place of capsule sponge in the diagnostic pathway.

Pulmonary aspiration after activated charcoal in unintentional acute poisonings in childhood

IntroductionAlthough the administration of activated charcoal (AC) is considered safe, the associated risk of pulmonary aspiration explains certain reluctance of physicians to use this procedure. The objective of this study...

Robot-assisted Kidney Transplantation: The 8-year European Experience.

Evidence regarding perioperative results and long-term functional outcomes of robotic-assisted kidney transplantation (RAKT) is limited. We evaluated perioperative surgical results and long-term functional outcomes of RAKT in patients receiving kidney transplants from living donors. This retrospective analysis is based on a prospective multicenter cohort study conducted from July 2015 to October 2023 across ten European centers. A total of 624 patients who underwent heterotopic RAKT from living donors were included, excluding those who received orthotopic RAKT. The primary outcomes measured were long-term renal function, perioperative complications, and survival rates. Renal function was assessed with the estimated glomerular filtration rate (eGFR). The Clavien-Dindo classification (CDC) was used to describe early (within 30d) and late (from 31 to 90d) postoperative complications. The probabilities of dialysis, graft nephrectomies, and any-cause mortality during follow-up were reported in terms of the 5-yr cumulative incidence. A total of 624 patients with a median age of 35yr (interquartile range [IQR]: 26-52) underwent RAKT. Preemptive RAKT was performed in 52% of cases, and the majority (84%) had the transplant in the right iliac fossa. The median operative time was 210 min (IQR: 180-262), with a rewarming time of 43 min (IQR: 38-50). Intraoperative complications were rare (1.1%), and postoperative graft nephrectomy occurred in 1.9% of patients. High-grade (CDC grade ≥3) early and late postoperative complications were observed in 7.7% and 2.3% of patients, respectively. Rates of incisional hernias, ureteral stenosis, and arterial stenosis were 1.4%, 1.1%, and 0.2%, respectively. The median eGFR values were 19, 52, and 53 ml/min/1.73m2 on the 1st postoperative day, on the 7th postoperative day, and at 6 mo, respectively. Over a median follow-up of 23mo (IQR: 6-49), 17 patients received dialysis, 11 patients underwent graft nephrectomy, and four patients died. None of the deaths were due to RAKT. The main limitation is the absence of a comparator group. With the largest experience worldwide on RAKT, we confirm the perioperative safety and excellent long-term functional outcomes of this procedure. Given the benefits of a minimally invasive robotic approach, these findings support the broader adoption of RAKT as a viable option for kidney transplantation.

Associations of Causes of Chronic Kidney Disease with Disease Progression and Mortality: Insights from the Fukuoka Kidney disease Registry (FKR) Study.

The Kidney Disease: Improving Global Outcomes guidelines recognize the importance of causes of chronic kidney disease (CKD), glomerular filtration rate, and albuminuria as predictors of kidney outcome and prognosis. However, compared with biopsy-proven causes, there has been limited research regarding the relationship between clinically diagnosed causes of CKD and patient prognosis. We examined 3,119 patients with non-dialysis-dependent CKD who participated in the Fukuoka Kidney disease Registry Study, a multicenter prospective cohort study. Patients were divided into six groups: IgA nephropathy, chronic glomerulonephritis (non-biopsy-proven), diabetic nephropathy, hypertensive nephrosclerosis, chronic interstitial nephritis, and polycystic kidney disease. The primary outcomes included a composite kidney outcome, defined as a 1.5-fold increase in serum creatinine and/or the development of end-stage kidney disease, and all-cause mortality. The risks of these outcomes were estimated using a Fine-Gray proportional subdistribution hazards model. Patients with IgA nephropathy, the most prevalent primary glomerulonephritis, served as the reference group. During the median follow-up period of 5 years, 1,221 patients developed the composite kidney outcome, and 346 patients died. Compared with IgA nephropathy, the multivariable-adjusted subdistribution hazard ratios (sHRs) for the composite kidney outcome were significantly higher in diabetic nephropathy (sHR 1.45) and polycystic kidney disease (sHR 2.07) groups, whereas the chronic interstitial nephritis group had a significantly lower risk (sHR 0.71). The risk of all-cause mortality was significantly higher in the hypertensive nephrosclerosis group (sHR 1.90). The causes of CKD were associated with risks of the composite kidney outcome and all-cause mortality, highlighting their clinical relevance in predicting prognosis. These findings suggest that different causes of CKD have distinct impacts on patient outcomes, emphasizing the importance of tailoring management strategies according to the underlying causes.

Blood neurofilament light chain and S100B as biomarkers of neurological involvement and functional prognosis in COVID-19: a multicenter study.

COVID-19 is associated with neurological complications, termed neuro-COVID, affecting patient outcomes. We aimed to evaluate the association between serum neurofilament light chain (NfL) and S100B biomarkers with the presence of neurological manifestations and functional prognosis in COVID-19 patients. A multicenter prospective cohort study was conducted in three hospitals in the Emilia-Romagna region, Italy, from March 2020 to April 2022. Hospitalized patients with PCR-confirmed COVID-19 were enrolled. Serum S100B and NfL levels were measured in the acute or subacute phase after admission. Diagnostic accuracy was assessed using receiver operating characteristic (ROC) analyses. Statistical analyses were performed to evaluate the association between biomarkers, clinical/laboratory variables, and prognosis, specifically focusing on worsening of the modified Rankin Scale (mRS) from admission to discharge. A total of 279 patients (153 males, median age 76.7years) were included. Among them, 69 (24.7%) developed neuro-COVID. Serum NfL levels were significantly higher in the neuro-COVID group (median 110 vs 68.3; p = 0.035) and correlated with severe encephalopathy and extracranial neurologic manifestations. The ROC analysis showed low accuracy in the discrimination between the two groups for both NfL and S100B. Key predictors of worsening mRS included mechanical ventilation (OR = 9.56, 95% CI = 1.67-54.75; p = 0.011), severe encephalopathy (OR = 5.10, 95% CI = 1.58-16.19; p = 0.006), and elevated S100B levels (OR = 2.62, 95% CI = 1.10-6.46; p = 0.037). Serum NfL and S100B biomarkers were not accurate in discriminating neuro-COVID patients, however NfL levels were associated with severe and extracranial neuro-COVID, while S100B with functional outcomes, potentially informing clinical management.

Thoracolumbar kyphosis prognoses poor results after proximal femoral fracture: a 3-year multicenter prospective cohort study.

Proximal femoral fractures are critically associated with increased risk of mortality and secondary fractures. Identifying prognosis predictors related to sagittal imbalance that are known to have negative impact on fracture risk and mortality is crucial. This study aimed to explore the relationship between various sagittal imbalance parameters and the prognosis of proximal femoral fractures to identify the most important prognostic indicators. This multi-center prospective cohort study included patients with proximal femoral fractures treated surgically from April 2020 to March 2021. Spinal standing radiographs were obtained to measure various sagittal spine parameters. Postoperative follow-ups were conducted at 6, 12, 18, 24, and 36months to assess mortality and secondary fracture rates and examine the predictors and their effects. Among the 137 patients who underwent spinal standing radiographs, 22 died and 23 developed secondary fractures. Multivariate analyses identified the number of previous vertebral fractures and thoracolumbar kyphosis (TLK) as significant risk factors for mortality and secondary fractures. Survival analysis revealed that patients with TLK < 20° had significantly higher survival rates than those with TLK ≥ 20° (P = 0.002 and P < 0.001 for mortality and secondary fractures, respectively). In addition, serum albumin was associated with mortality, and the intake of sleeping pills and antidepressants was associated with secondary fractures. TLK after surgery and the number of previous vertebral fractures affected both mortality and secondary fractures. When each risk factor, such as low serum albumin levels, intake of sleeping pills and antidepressants, was also considered, it was found that comprehensive postoperative care is essential.

Durable remission after ileocolic resection for Crohn's disease is achievable in selected patients. Long-term results of a prospective multicentric cohort study of the GETAID Chirurgie.

Postoperative recurrence requiring medical treatment intensification or redo-surgery is common after ileocolic resection (ICR) for Crohn's disease (CD). This study aimed to identify a subgroup of CD patients for whom ICR could achieve durable remission. This retrospective follow-up study analyzed 592 CD patients who underwent ICR (2013-2015) in a nationwide prospective cohort. Patients with >36 months follow-up were included. Primary outcome was durable remission, defined as the absence of endoscopic recurrence and/or medical treatment intensification. Uni- and multivariate analyses identified predictive factors for durable remission. Among 268 included patients, 59% had B2 phenotype, 70% had a first ICR and 66% had postoperative medical treatment. After a median follow-up of 85(36-104) months, 52 patients (19%) experienced durable remission, of whom 24 (46%) didn't require medical treatment and 28 (54%) maintained the same postoperative treatment, including anti-TNF in 15/28 patients (54%). Surgery could stabilize the disease course in 112 patients (41.7%), including 22.4% endoscopic recurrence that didn't require CD treatment initiation or intensification. Durable remission rate was significantly increased in B1 phenotype vs. B2/B3 (n=7/18;39% vs n=45/250;18%, p=0.030) and in first ICR vs. redo ICR (n=43/184;23% vs n=9/80;11%, p=0.023). In multivariate analysis, B1 phenotype was the only independent predictive factor for durable remission (OR=3.59, IC95%[1.13-11.37], p=0.030). Surgery for CD achieved durable remission in 20%, rising to 40% in those with a B1 phenotype. These results support surgery as a viable alternative to medical treatment, offering treatment-free durable remission and preserving medical treatment options.

Indication of frailty transitions on 2-year adverse health outcomes among older Chinese inpatients: Insight from a multicenter prospective cohort study.

Frailty is thought to be associated with an increased risk of adverse health outcomes such as death and falls, but comparatively little is known about the impact of frailty transitions on the adverse health outcomes. Moreover, owing to insufficient sample size or a single-center study design, previous studies have not been sufficiently representative of elderly inpatients in China. This study aimed to provide estimates at the population level of the association between frailty transitions and adverse outcomes among elderly inpatients following discharge. This was a large-scale multicenter cohort study conducted from October 2018 to February 2021. The FRAIL scale was used to estimate frailty status. Frailty transitions were derived by considering frailty status at baseline and the 3-month follow-up, which encompassed five patterns: persistent non-frailty, persistent pre-frailty, persistent frailty, improvement in frailty, and worsening of frailty. The outcome variables included mortality, falls, hospital readmissions, and Health-Related Quality of Life (HRQoL). Cox proportional hazard regression, generalized linear models and linear regression was used to examine the association between frailty transitions and adverse health outcomes. A total of 8,256 patients were included in the study, 40.70% of study participants were non-frail, 43.04% were pre-frail, and 16.27% were frail. Compared with patients who persistently non-frail patients, those who frailty improvement, persistent pre-frailty, worsening frailty, and persistent frailty showcased escalated risks of mortality within 2 years after enrollment [HR (95% CI): 1.32 (1.06-1.64)], 1.71 (1.37-2.13), 2.43 (1.95-3.02), and 2.44 (1.81-3.29), respectively. These groups also faced elevated hazards of 2-year falls [OR(95% CI): 1.586(1.13-2.23), 2.21(1.55-3.15), 1.94(1.33-2.82), 2.71(1.59-4.62)] and re-hospitalization risk within 2 years[OR(95% CI): 1.33(1.13-1.56), 1.56(1.32-1.86), 1.53(1.28-1.83), 2.29(1.74-3.01). The number of falls increased by 0.76 over 2 years in frailty-worsened patients and 0.81 in persistently pre-frail patients. The total days of rehospitalization increased by 0.35 over 2 years in frailty-improved patients, by 0.61 in frailty-worsened patients, by 0.66 in elderly in persistently pre-frail patients and by 0.80 in persistently frail patients. Moreover, patients exhibiting frailty-improved [-1.23 (95% CI: -2.12 to -0.35)], persistently pre-frail[-4.95 (95% CI: -5.96 to -3.94)], frailty-worsened [-3.67 (95% CI: -4.71 to -2.62)], and persistently frail [-9.76 (95% CI: -11.60 to -7.93)] displayed inverse correlations with the regression coefficients of HRQoL. Frailty-improved, worsened, persistently pre-frail, and frail inpatients face higher risks of mortality, falls, rehospitalization, reduced HRQoL than consistently non-frail inpatients. Screening for frailty among elderly inpatients can identify individuals at increased risk of adverse health outcomes.

Association between the intensity of statin therapy and physical activity 1 year after acute coronary syndrome: a multicentre prospective cohort study in Switzerland

ObjectivesTo assess the association between the intensity of statin therapy and the level of physical activity in patients 1 year after an acute coronary syndrome (ACS).DesignProspective cohort study from the...

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.

Study Protocol of the Korean EGFR Registry: A Multicenter Prospective and Retrospective Cohort Study in Nonsmall Cell Lung Cancer Patients With EGFR Mutation.

The provision of treatment for epidermal growth factor receptor (EGFR)-mutated nonsmall cell lung cancer (NSCLC) patients has increased in Korea. However, multicenter studies on the clinicopathologic dataset and treatment outcomes, using a large-scale dataset, have not been conducted. The current study is a prospective and retrospective multicenter observational cohort study that registers all stages of EGFR-mutated NSCLC patients. The Korean EGFR Registry was designed to enroll 2000 patients with all stages of EGFR-mutated NSCLC from 40 university hospitals across Korea. This study, encompassing both retrospective and prospective cohorts, aims to analyze clinical characteristics, treatment modalities, and outcomes in these patients. Data collection will include patient demographics, smoking history, quality of life assessments, pathological data, and treatment outcomes, with follow-up until December 2026. The primary endpoint is disease-free survival in patients who have undergone radical therapy (surgery and radiotherapy) or progression-free survival in those receiving targeted therapy (first, second, and subsequent lines), chemotherapy (first and subsequent lines), combination therapy, and palliative/maintenance therapy according to stages of EGFR-mutated NSCLC. The study will explore the diagnostic methods for EGFR mutations, clinical outcomes based on treatment modalities, and metastatic patterns in EGFR-mutated NSCLC patients. Moreover, it will investigate various aspects, including the safety and efficacy of a new third-generation EGFR tyrosine kinase inhibitor (TKI), lazertinib, approved for both first- and second-line treatments. This study is expected to provide valuable insights into the epidemiology, risk factors, progression, and treatment outcomes of EGFR-mutated NSCLC in Korea. The Korean EGFR Registry will contribute significantly to the understanding of the complex dynamics of EGFR-mutated NSCLC, aiding in the development of more effective and personalized treatment strategies.

Identification of serum metabolite biomarkers in premature infants with bronchopulmonary dysplasia: protocol for a multicentre prospective observational cohort study

IntroductionBronchopulmonary dysplasia (BPD) is one of the most common and significant complications of preterm birth. It ultimately leads to a decrease in the quality of life for preterm infants and...

Association between the HAL score and the development of progressive pulmonary fibrosis in idiopathic interstitial pneumonia: A prospective observational study.

Progressive pulmonary fibrosis (PPF) is a critical concern in interstitial lung disease (ILD) management. The HAL score, which incorporates honeycombing (H), age >75 years (A), and serum lactate dehydrogenase >222 U/L (L), can predict acute exacerbations in patients with idiopathic interstitial pneumonia (IIP). This study aims to evaluate the predictive utility of the HAL score for PPF development. This study was a post-hoc analysis of a multicenter prospective cohort study involving patients with IIP. PPF was diagnosed if at least two of the following three criteria were met: worsening respiratory symptoms, radiological progression, and physiological progression. Among the 144 patients, 29 (22.3%) developed PPF during the observation period. Among the three criteria for PPF, a higher HAL score significantly correlated with worsening respiratory symptoms (p=0.001) and radiological progression (p=0.022), but not with physiological progression (p=0.717). Therefore, a higher HAL score significantly correlated with an increased PPF risk (12.5% for a score of 0, 25.9% for a score of 1, and 33.3% for a score of ≥2; p=0.032). The HAL score also correlated with overall survival (p<0.001). For the 92 patients (70.8%) with non-idiopathic pulmonary fibrosis (IPF), the HAL score was significantly associated with PPF development (p=0.021), while not for the 38 patients (29.2%) with IPF (p=0.872). In patients with non-IPF, the HAL score correlated with PPF development and could be useful to monitor those patients and to avoid missed treatment opportunities.

Long-term recovery in critically ill COVID-19 survivors: A prospective cohort study.

Long-term recovery following critical COVID-19 has not been sufficiently studied. The primary objective was to describe changes in functional outcome and Health-Related Quality of Life (HRQoL) between 3 and 12 months in critically ill COVID-19 survivors. The secondary objective was to investigate factors associated with good functional outcome and HRQoL at 12 months. Prospective multicentre cohort study including critically ill COVID-19 patients admitted to six intensive care units in Sweden between May 2020 and May 2021. Surviving patients were invited to face-to-face follow-ups at 3 and 12 months. Functional outcome was assessed using the Glasgow Outcome Scale Extended (GOSE), ranging from 1 to 8. Physical and mental HRQoL was assessed by the physical component summary (PCS) and mental component summary (MCS) scores of the Short form health survey version 2 (SF-36v2®). Multivariable logistic regression models were used to identify factors associated with good functional outcome (GOSE ≥7) and good physical and mental HRQoL (PCS and MCS ≥45) at 12 months. The percentage of participants with a good functional outcome increased from 35% to 64% between 3 and 12 months (p < .001). Mean PCS improved from 40 to 44 between 3 and 12 months (p < .001), while the mean MCS was within the normal range at 3 months, with no change at 12 months (46 vs. 48, p = .05). Increasing age was associated with a good functional outcome. Lower clinical frailty and absence of diabetes mellitus were associated with a good PCS. A shorter duration of mechanical ventilation was associated with a good outcome for all three outcome measures. Survivors of critical COVID-19 showed improved functional outcome and physical HRQoL from 3 to 12 months post-ICU. A shorter duration of mechanical ventilation is associated with good functional outcome and good HRQoL, while older age is associated with good functional outcome. Younger patients and those with comorbidities or higher frailty may require targeted follow-up and rehabilitation. Study registration ClinicalTrials.gov Identifier: NCT04974775, registered April 28, 2020.

Drivers of extended spectrum β-lactamase (ESBL)-producing Enterobacterales colonization among residents of long-term health care facilities: a European multicentric prospective cohort study.

ESBL-producing Enterobacterales (ESBL-PE) are highly prevalent in long-term healthcare (LTCF) settings. In order to estimate the acquisition rate of ESBL-producing Escherichia coli and Klebsiella pneumoniae in LTCF settings and identify clinical and environmental risk factors, a multicentric, prospective cohort study was conducted in six LTCFs in Germany, France, Spain and the Netherlands. Longitudinal screening of residents was performed over 32 weeks, collecting epidemiological and clinical data and environmental samples. The primary outcome was rate of new acquisition of ESBL-PE among LTCF residents. Molecular epidemiology was studied using whole genome sequencing and risk factor analyses using logistic and Poisson regression models. 299 residents provided 1958 samples during follow-up. Prevalence of ESBL-PE colonization at baseline was 16.4%, incidence rate of acquisition was 0.79 per 1000 resident-days, both with high variability among centres. Age ≥80 years, vascular disease, and antibiotic consumption within one year were risk factors for baseline colonization. Lack of hand sanitizers and low nurse to resident ratio were associated with colonization. Presence of medical devices was associated with risk of acquisition. Vascular disease, hemiplegia, antibiotic consumption, and non-availability of private bathrooms were associated with multiple ST carriage. Prevalence of ESBL-PE among environmental samples was 2%, exclusively in centres with high prevalence among residents. Genetic analysis showed a high prevalence of ST10 E. coli and ST405 K. pneumoniae at two study sites. Infection prevention including availability of hand sanitizers, the number of nurses per resident, and antimicrobial stewardship interventions constitute important measures to control ESBL-PE in LTCFs. Genome-based surveillance could guide targeted interventions.