Multicenter Prospective Observational Cohort Study Research Articles

Neurodevelopmental outcomes of permanent and temporary CSF diversion in posthemorrhagic hydrocephalus: a Hydrocephalus Clinical Research Network study.

This study investigated neurodevelopmental outcomes in preterm neonates with posthemorrhagic hydrocephalus (PHH), focusing on the comparative effectiveness of temporary and permanent CSF diversion strategies. This multicenter prospective observational cohort study (2012-2021) involved preterm infants diagnosed with PHH who underwent either initial permanent or temporary CSF diversion. Patients were assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III), at 15-30 months and, when possible, at 36-42 months of corrected age. Statistical analyses included univariable and multivariable regression models to examine the associations between BSID-III scores and various treatment and patient factors. Among 106 patients, 15 (14%) underwent initial permanent CSF diversion, while 91 (86%) received temporary diversion. Patients who underwent permanent diversion had lower cognitive scores (58.2 ± 5.7) compared to those temporized (69.0 ± 15.9) (p = 0.01). Temporized patients who later required conversion to permanent diversion demonstrated poorer composite (66.6 ± 18.0 vs 79.9 ± 18.8, p = 0.02), expressive (4.6 ± 3.2 vs 7.0 ± 3.7, p = 0.03), and receptive (4.2 ± 3.3 vs 6.1 ± 3.0, p = 0.04) language scores compared to those weaned from temporary CSF diversion. No significant difference in outcomes was observed between patients temporized with a ventriculosubgaleal shunt versus a ventricular reservoir. Ventricle size at the time of initial CSF diversion was not associated with BSID-III scores. However, univariable analysis showed that a larger ventricle size at the time of conversion to permanent diversion was associated with lower neurodevelopmental scores across all domains. Multivariate analysis, adjusting for intraventricular hemorrhage (IVH) grade, complex chronic conditions, and postmenstrual age, revealed that larger ventricle size at the time of conversion correlated negatively with composite motor (effect size -0.47, CI -0.82 to -0.11, p = 0.01) and fine motor (-0.08, CI -0.15 to -0.01, p = 0.03) scores. This study suggested that the choice between permanent and temporary CSF diversion as initial treatments may affect neurodevelopmental outcomes in preterm neonates with PHH, which are influenced by IVH severity and timing of intervention. The findings support early temporization and avoiding delays to optimize permanent shunting. Monitoring ventricular size closely during this phase is critical, as larger ventricular size at the time of conversion is associated with poorer outcomes. These results highlight the necessity for adapting treatment strategies on the basis of individual patient characteristics, responses, and progress in managing PHH.

Prognostic utility of non-invasive left atrial stiffness index in patients with heart failure with preserved ejection fraction: insights from EASY-HFpEF study

Abstract Background It is known that an increase left atrial stiffness is associated with poor prognosis in patients with heart failure with preserved ejection fraction (HFpEF). Purpose We evaluated the predictive utility of non-invasive left atrial stiffness index (LASI) in HFpEF patients, comparing it to other clinical prognostic indicators. Methods Patients were recruited from the EASY-HFpEF study, a multicenter prospective observational cohort study in Japan involving patients hospitalized with acute decompensated heart failure and a left ventricular ejection fraction of >40%. Among the patients in the study, those with registered echocardiographic image data of sufficient quality were analyzed for left atrial strain. The LASI was calculated as the ratio of E/e’ to the left atrial reservoir strain. The primary endpoint was a composite outcome of all-cause death and readmission due to heart failure during the 2-year follow-up period. Results We analyzed 95 patients, with a median age of 75 years and including 41% female patients. LASI was associated with an increased risk of composite outcome (adjusted HR 1.10 [95%CI; 1.04-1.17, P=0.001] per 0.1 increase). LASI was non-inferior in predictive ability compared to predictors such as B-type natriuretic peptide (BNP) and H2FPEF score. (AUCLASI=0.79, AUCBNP=0.80 [vs.AUCLASI, P=0.775], AUCH2FPEF =0.75 [vs.AUCLASI, P=0.342]) (Figure 1). The addition of LASI significantly improved the prognostic power of a model containing BNP and H2FPEF score (model of BNP+H2FPEF score, χ2=29.3; model of BNP+H2FPEF+LASI, χ2=40.5, P=0.004) (Figure 2). Conclusion Non-invasive LASI in HFpEF patients is associated with increased risks of all-cause mortality and heart failure readmission, its potential utility in predicting these adverse events.

D-dimer cutoff values for predicting functional prognosis in patients with severe head trauma: a multi-centre prospective observational study.

D-dimer, a fibrinolysis indicator, may predict functional and life outcomes in traumatic brain injury (TBI) patients. We aimed to identify optimal D-dimer cutoff values for poor functional outcomes in severe TBI. We used data from a multi-centre prospective observational cohort study that included patients with TBI with a Glasgow Coma Scale (GCS) score ≤ 8 within 48h after injury or required neurosurgical procedures. We selected patients admitted ≤ 1h after injury. Neurological function at discharge was assessed using the modified Rankin Scale (mRS). The association between D-dimer levels at admission and neurological function (mRS ≥ 4 or < 4), adjusted for age, GCS, systolic blood pressure, and head abbreviated injury scale (AIS) score, was determined by logistic regression analysis. The predictive utility of D-dimer levels was assessed using the area under the receiver operating characteristic curve (AUC), with the cutoff value being determined using Youden's index. Among the 336 patients, most were male; approximately half had experienced motor vehicle accidents. The median (interquartile range) of age, GCS scores, and head AIS scores were 65 (40.25 - 78.75) years, 7 (4 - 9), and 5 (4 - 5), respectively. Overall, 214 (63.7%) patients had poor neurological function (mRS ≥ 4). D-dimer levels > 28µg/mL predicted poor functional prognosis (odds ratio = 3.84 [95% confidence interval 1.62 - 9.11]); the AUC and cutoff values were 0.73 and 27.2µg/mL, respectively. A cutoff value of 27.2µg/mL for early-stage D-dimer levels could predict the functional prognosis of patients with severe isolated TBI.

Sex Differences in Sudden Cardiac Death During Long-Term Follow-up in Patients With Chronic Heart Failure ― A Report From the CHART-2 Study ―

Although sudden cardiac death (SCD) generally occurs more frequently in men than in women, there are limited data on sex differences in SCD in patients with chronic heart failure (HF) across a range of left ventricular ejection fraction (LVEF). We examined sex differences in SCD incidence, timing, and risk factors in 4,683 patients with chronic HF (3,186 men, 1,497 women) from a multicenter prospective observational cohort study (CHART-2). Over a median follow-up of 8.8 years after study enrollment, there were 215 SCDs (160 in men, 55 in women). The SCD incidence rates in men and women were 6.1 and 4.6 per 1,000 person-years, respectively (P=0.088). Among women, more than half the SCDs occurred in the first 5 years of follow-up. Beyond 5 years, the SCD incidence rate was significantly lower in women than in men (3.6 vs. 5.9 per 1,000 person-years, respectively; P=0.044). After adjusting for confounders, age, increased B-type natriuretic peptide, and LVEF <50% were common prognostic factors. After 5 years of follow-up, left ventricular (LV) enlargement was a risk factor for SCD in both sexes. These results indicate that there are sex differences in SCD, especially beyond 5 years of follow-up, with a lower prevalence in women. LV enlargement is a common long-term prognostic factor in both sexes, suggesting the importance of preventing LV remodeling in HF management.

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...

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.

Impact of 30 mL/kg fluid resuscitation completed within one hour on elderly septic shock patient

Objective This study aimed to investigate the prognostic impact of completing 30 mL/kg fluid resuscitation within 1 h in elderly septic shock patients. Methods This was a multicenter prospective observational cohort study. We applied logistic regression to assess the impact of completing 30 mL/kg fluid resuscitation within 1 h on respiratory support escalation including new-onset mechanical ventilation, bilevel positive airway pressure (BiPAP), and high-flow nasal cannula (HFNC) as well as heart failure (HF). We plotted Kaplan-Meier (K-M) curves to evaluate survival in patients completing 30 mL/kg fluid resuscitation within 1 h. We performed mediation analyses to determine the influence of HF on mortality associated with completing 30 mL/kg fluid resuscitation within 1 h. Results Completing 30 mL/kg fluid resuscitation within 1 h increased the odds ratios of new-onset BiPAP (adjusted OR = 3.411; 95% confidence interval (CI) = [1.526, 7.620]) and HFNC (adjusted OR = 2.576; 95% CI = [1.252, 5.297]) within 24 h as well as the odds ratio of HF (adjusted OR = 2.291; 95% CI = [1.266, 4.149]). The adjusted K-M curve showed that patients completing 30 mL/kg fluid resuscitation within 1 h had higher 30-d mortality than those completing it over longer periods. The mediation effect suggested that completing 30 mL/kg fluid resuscitation within 1 h could be fatal primarily because it increased the risk of HF. Conclusion For elderly patients with septic shock, completing 30 ml/kg of fluid resuscitation within 1 h ought to be more cautious, particularly considering the patient’s cardiac function and overall clinical status.

Update to: Study Pre-protocol for “BronchStart - The Impact of the COVID-19 Pandemic on the Timing, Age and Severity of Respiratory Syncytial Virus (RSV) Emergency Presentations; a Multi-Centre Prospective Observational Cohort Study”

Background In 2021 we launched the BronchStart study, which collected information on 17,899 presentations in children with serious respiratory tract infections following the release of lockdown restrictions. Our study informed the Joint Committee on Vaccination and Immunisation’s decision to recommend the introduction maternal respiratory syncytial virus (RSV) vaccination, which was introduced in the United Kingdom in August/September 2024. Study question We modified our original protocol to conduct a United Kingdom-wide assessment of maternal vaccination against RSV. Methods and likely impact We will conduct a multi-centre study, utilising the PERUKI network used in the original BronchStart study, to assess the effectiveness of maternal vaccination using a test-negative study design. We will gather detailed clinical information on children admitted with bronchiolitis in the post-RSV vaccination era, and understand possible reasons for incomplete vaccine uptake.

Cervical ripening at home or in hospital during induction of labour: the CHOICE prospective cohort study, process evaluation and economic analysis.

Around one in three pregnant women undergoes induction of labour in the United Kingdom, usually preceded by in-hospital cervical ripening to soften and open the cervix. This study set out to determine whether cervical ripening at home is within an acceptable safety margin of cervical ripening in hospital, is effective, acceptable and cost-effective from both National Health Service and service user perspectives. The CHOICE study comprised a prospective multicentre observational cohort study using routinely collected data (CHOICE cohort), a process evaluation comprising a survey and nested case studies (qCHOICE) and a cost-effectiveness analysis. The CHOICE cohort set out to compare outcomes of cervical ripening using dinoprostone (a prostaglandin) at home with in-hospital cervical ripening from 39weeks of gestation. Electronic maternity record data were collected from 26 maternity units. Following pilot analysis, the primary comparison was changed to ensure feasibility and to reflect current practice, comparing home cervical ripening using a balloon catheter with in-hospital cervical ripening using any prostaglandin from 37weeks of gestation. Analysis involved multiple logistic regression for the primary outcome and descriptive statistics for all other outcomes. The qCHOICE study reported descriptive statistics of quantitative survey data and thematic analysis of focus group and interview data. The economic analysis involved a decision-analytic model from a National Health Service and Personal Social Services perspective, populated with CHOICE cohort and published data. Secondary analysis explored the patient perspective utilising cost estimates from qCHOICE data. Twenty-six United Kingdom maternity units. Women with singleton pregnancies at or beyond 37weeks of gestation having induction with details of cervical ripening method and location recorded. Neonatal unit admission within 48hours of birth for 48hours or more. Maternal and staff experience of cervical ripening. Incremental cost per neonatal unit admission within 48hours of birth avoided. Electronic maternity records from 26 maternity units; survey and interviews with service users/maternity staff; focus groups with maternity staff; published literature on economic aspects. CHOICE cohort: A total of 515 women underwent balloon cervical ripening at home and 4332 underwent in-hospital cervical ripening using prostaglandin in hospitals that did not offer home cervical ripening. Neonatal unit admission within 48hours of birth for 48hours or more following home cervical ripening with balloon was not increased compared with in-hospital cervical ripening with prostaglandin. However, there was substantial uncertainty with the adjusted analysis consistent with a 74% decrease in the risk through to an 81% increase. Important aspects of service users' experience of home cervical ripening were quality of information provided, support and perception of genuine choice. Home cervical ripening with balloon led to cost savings of £993 (-£1198, -£783) per woman and can be considered the dominant strategy. Circumstances relating to the COVID-19 pandemic limited the number of participating maternity units and the duration for which units participated. Low numbers of women having at-home cervical ripening limited the power to detect differences in safety, effectiveness, cost and acceptability between study groups. Home cervical ripening using balloon catheter may be as safe for babies as using prostaglandins in hospital in low and moderate-risk groups, but there is substantial uncertainty. Home cervical ripening with balloon is likely to be cost saving. Impacts on workload, service user and staff experiences were complex. Future research should focus on optimising experience and logistics of home cervical ripening within busy maternity services. Current Controlled Trials ISRCTN32652461. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127569) and is published in full in Health Technology Assessment; Vol. 28, No. 81. See the NIHR Funding and Awards website for further award information.

What is the lower limb length discrepancy after arthroplasty for proximal femoral fracture? A prospective, multicenter observational study of 590 hips.

Lower limb length discrepancy (LLD) following hip arthroplasty after proximal femoral fracture (PFFA) is little studied. The aim of this work was to answer the following questions: 1) What are the incidence and mean values ​​of LLD after PFFA? 2) What are the clinical consequences (tolerance) of LLD after PFFA? 3) Can we identify risk factors for LLD after PFFA? 4) Is there a significant difference in terms of LLD after PFFA to treat intra- versus extra-capsular fractures? LLD after proximal femoral fracture arthroplasty is rare but has good clinical tolerance, given the low functional demands of the patients. This is a multicenter prospective observational cohort study (15 centers), including 590 patients, operated on for hip arthroplasty for proximal femur fracture between May 2022 and June 2023. The mean age was 81.74 years (±10.72). The clinical and radiological measurement of LLD was carried out between the 6th week and the 6th month postoperatively. A positive LLD meant that the operated side was lengthened, a negative LLD meant that it was shortened. Clinical tolerance was measured using objective (Merle d'Aubigné (PMA) and Harris (HHS)) and subjective (Oxford-12 and Forgotten Joint Score (FJS)) functional scores as well as autonomy measured using the Parker score. Clinical and radiological measurements of LLD were highly correlated (p < 0.001), and showed an overall shortening trend of -0.03 mm (±4.99). In total, 265/590 patients (45%) had a LLD greater than 3 mm, 131/590 (22%) had an LLD greater than 5 mm, and 24/590 (4%) had a LLD greater than 10 mm. A LLD beyond ±3 mm significantly worsened all functional scores compared to an LLD below this threshold (PMA: 12.2 ± 3.2 vs. 12.9 ± 3.6 (p = 0.020); HHS: 62.7 ± 20.3 vs. 66.5 ± 19.3 (p = 0.027); FJS: 61.5 ± 28.8 vs. 72.5 ± 25.6 (p < 0.001); and the Oxford-12 score: 29.2 ± 9.7 vs. 26 ± 9.4 (p < 0.001)). However, no significant difference was observed for the autonomy (Parker score 4.7 ± 2.5 versus 4.8 ± 2.7 (p = 0.58)). Female gender (+0.43 mm ± 4.71 (p < 0.001)) and cementing of the femoral implant (+0.42 mm ± 4.57 (p = 0.014)) were associated to lengthening. Cementless stems (-0.41 mm ± 5.29 (p = 0.014)), general anesthesia without curare (-1.8 mm ± 5.96 (p = 0.007)), and the Röttinger and Watson-Jones approaches (-1.34 mm ± 4.57 (p = 0.04)) were associated to shortening. There was no difference between LLD after intracapsular fracture (-0.06 mm ± 5) and extracapsular fracture (+0.9 mm ± 3 (p = 0.45)). Our results are consistent with the literature data which is sparse on the subject, with 78% of LLD in our series ranging between +5 and -5 mm. Functional consequences were observed as soon as the 3 mm threshold was exceeded but without effect on autonomy. Only 4% of patients had a centimeter inequality. IV; prospective study without control group.

Procedural and clinical outcomes of Adiana® hysteroscopic tubal occlusion in the Netherlands

Background: The Adiana® Permanent Contraception System was a hysteroscopic tubal occlusion device but was withdrawn from the market in 2012. Objective: To evaluate the safety, feasibility and efficacy of the Adiana hysteroscopic tubal occlusion. Materials and Methods: A prospective observational multicentre cohort study of 300 women undergoing hysteroscopic sterilisation using the Adiana® was conducted in the Netherlands between 2009 and 2012. All procedures were performed using the same study protocol. Three months after bilateral placement a hysterosalpingography (HSG) was performed to confirm tubal occlusion. In 2018-2020 follow-up questionnaires were sent to all women. Main Outcome Measures: The primary outcome was the success rate of the Adiana tubal occlusion technique. Successful tubal occlusion was defined as an uneventful procedure with occluded fallopian tubes according to the HSG after 3 months. Secondary outcomes were the success rate of the device placement, the number of complications during placement and the pregnancy rate. Results: Bilateral placement of Adiana devices was achieved in 93.5% of cases. Bilateral confirmed occlusion by HSG was accomplished in 87.9% of cases with successful Adiana placement. This was 77.1% in the intention-to-treat group. Complications and side effects were reported in 4.4% of women. The pregnancy rate was 3.6% in women with proven bilateral tubal occlusion. Conclusion: Hysteroscopic tubal occlusion using the Adiana technology is associated with a pregnancy rate of 3.6%. Although this technology was removed from the commercial market, this evaluation of the Adiana technology could provide useful information for the development of potential new, more effective hysteroscopic tubal occlusion devices. What’s new? Hysteroscopic tubal occlusion techniques are no longer available on the market. This evaluation of Adiana could provide useful information for the development of potential new hysteroscopic tubal occlusion devices.

Outcomes of Adjunct Emergent Stenting Versus Mechanical Thrombectomy Alone: The RESCUE-ICAS Registry.

Underlying intracranial stenosis is the most common cause of failed mechanical thrombectomy in acute ischemic stroke patients with large vessel occlusion. Adjunct emergent stenting is sometimes performed to improve or maintain reperfusion, despite limited data regarding its safety or efficacy. We conducted a prospective multicenter observational international cohort study. Patients were enrolled between January 2022 and December 2023 at 25 thrombectomy capable centers in North America, Europe, and Asia. Consecutive patients treated with mechanical thrombectomy were included if they were identified as having underlying intracranial stenosis, defined as 50-99% residual stenosis of the target vessel or intra-procedural re-occlusion. The primary outcome was functional independence, defined as modified Rankin Scale of 0-2 at 90 days. After applying inverse probability of treatment weighting (IPTW) based on propensity scores, we compared outcomes among patients who underwent adjunct emergent intracranial stenting (stenting) versus those who received mechanical thrombectomy alone. A total of 417 patients were included; 218 patients treated with mechanical thrombectomy alone (168 anterior circulation) and 199 with mechanical thrombectomy plus stenting (144 anterior circulation). Patients in the stenting group were less likely to be non-Hispanic White (51.8% vs 62.4%, p=0.03), and less likely to have diabetes (33.2% vs 43.1%, p=0.037) or hyperlipidemia (43.2% vs 56%, p= 0.009). In addition, there was a lower rate of IV thrombolysis use in the stenting group (18.6% vs 27.5%, p=0.03). There was a higher rate of successful reperfusion (modified Treatment In Cerebral Infarction score ≥ 2B) in the stenting versus mechanical thrombectomy alone group (90.9% vs 77.9%, p<0.001) and a higher rate of a 24-hour infarct volume of <30 mL (n=260, 67.9% vs 50.3%, p=0.005). The overall complication rate was higher in the stenting group (12.6% vs 5%, p=0.006), but there was not a significant difference in the rate of symptomatic hemorrhage (9% vs 5.5%, p=0.162). Functional independence at 90 days was significantly higher in the stenting group (42.2% vs. 28.4%, adjusted odds ratio 2.67; 95% CI, 1.66-4.32). In patients with underlying stenosis who achieved reperfusion with mechanical thrombectomy, adjunct emergent stenting was associated with better functional outcome without a significantly increased risk of symptomatic hemorrhage. https://clinicaltrials.gov/study/NCT05403593.

The Association Between Perioperative Red Blood Cell Transfusions and 1-Year Mortality After Major Cancer Surgery: An International Multicenter Observational Study.

Packed red blood cell (pRBC) transfusions in patients undergoing surgery for cancer are given to treat anemia or acute hemorrhage. Evidence indicates that pRBC transfusions are associated with poor perioperative and oncological outcomes. The ARCA-1 (Perioperative Care in the Cancer Patient-1) study was designed to test the association between perioperative pRBC transfusions and postoperative morbidity and mortality in patients undergoing cancer surgery. The primary hypothesis of our study was that perioperative pRBC transfusions have a negative impact on postoperative morbidity and 1-year mortality. ARCA-1 was an international multicenter prospective observational cohort study. Participating centers enrolled a minimum of 30 consecutive adult patients with cancer who underwent surgery with curative intent. The primary end point was all-cause mortality 1 year after major cancer surgery. Secondary end points were rates of perioperative blood product use, 1-year cancer-specific mortality, overall survival, and 30-day morbidity and mortality. We performed a propensity score matching analysis to adjust for selection bias. A multivariable logistic regression model was fitted to estimate the effects of significant covariates on 1-year mortality, cancer-related mortality, and overall survival. A total of 1079 patients were included in the study. The rate of perioperative pRBC transfusions was 21.1%. Preoperative comorbidities, including anemia, American Society of Anesthesiologists (ASA) score of III to IV, a history of coronavirus disease 2019 (COVID-19), myocardial infarction, stroke, need for dialysis, history of blood transfusions, and metastatic disease were statistically significantly more frequent in transfused patients compared to nontransfused patients. The 1-year mortality rate was higher in transfused patients before (19.7% vs 6.5%; P < .0001) and after (17.4% vs 13.2%; P = .29) propensity score matching. 1-year mortality was 1.97 times higher in transfused than in no-transfused patients (odd ratio [OR], 1.97; 95% confidence interval [CI], 1.13-3.41). The odds of 1-year cancer mortality for patients who had perioperative pRBCs was 1.82 times higher (OR, 1.82; 95% CI, 0.97-3.43) compared to those who did not receive perioperative pRBC transfusion. The effect of perioperative pRBC transfusion on overall survival was also significant (hazard ratio [HR], 1.85; 95% CI, 1.15-2.99). Transfused patients also had a higher rate of 30-day postoperative mortality before (3.5% vs 0.7%; P = .0009) and after propensity score matching (4.2% vs 1.8%; P = .34). This international, multicenter observational study showed that perioperative pRBC transfusion was associated with an increased mortality risk.

Salt Based or BaLanced SolUtion-Trends Existing in Indian Intensive Care Units: A Multicenter Prospective Observational Cohort Study (SOLUTE Study).

Fluid administration is a commonly practiced intervention in the intensive care unit (ICU) with normal saline being the preferred fluid. We sought to understand the current practice of fluid administration and choice of fluids in Indian ICUs and its effect on renal outcomes. The Indian Society of Critical Care Medicine (ISCCM)-endorsed multicenter prospective observational study was conducted on practice of fluid administration in critically ill patients between May 1, 2020, and January 31, 2023. SPSS software was used for statistical analysis. Private sector hospitals contributed 79.16% of data out of 144 ICUs. Around 961 patients belonged to the normal saline (NS) group, 672 to the Ringer's lactate (RL) group, and 891 to the balanced salt solution (BSS) group out of 2,452 patients. Patients with chronic obstructive pulmonary disease were more in the BSS and NS group as compared to RL group (p < 0.00001). Acute kidney injury (AKI) incidence was higher in the NS group, followed by RL and BSS (p < 0.0001). The serum creatinine rise was higher in the NS group on the first 2 days (p < 0.001). Daily fluid balance, urine output, and renal replacement therapy (RRT) needs were similar among the groups. The BSS group had shorter ICU and hospital length of stay (LOS) than the NS group (p < 0.001). The ICU survival was 63.3% in the NS group and 79.44% in the BSS group (p < 0.001). The AKI patients had higher survival in the BSS group (78.81%) as compared to the NS group (63.08%) (p < 0.001). Balanced salt solution is the preferred intravenous fluid with a safe renal profile among critically ill patients. The AKI patients had shorter hospital and ICU LOS with BSS as compared to NS. Gupta S, Dixit S, Tomar DS, Zirpe K, Govil D, Choudhry D, et al. Salt Based or BaLanced SolUtion-Trends Existing in Indian Intensive Care Units: A Multicenter Prospective Observational Cohort Study (SOLUTE Study). Indian J Crit Care Med 2024;28(11):1028-1037.

Update to: Study Pre-protocol for "BronchStart - The Impact of the COVID-19 Pandemic on the Timing, Age and Severity of Respiratory Syncytial Virus (RSV) Emergency Presentations; a Multi-Centre Prospective Observational Cohort Study".

In 2021 we launched the BronchStart study, which collected information on 17,899 presentations in children with serious respiratory tract infections following the release of lockdown restrictions. Our study informed the Joint Committee on Vaccination and Immunisation's decision to recommend the introduction maternal respiratory syncytial virus (RSV) vaccination, which was introduced in the United Kingdom in August/September 2024. We modified our original protocol to conduct a United Kingdom-wide assessment of maternal vaccination against RSV. We will conduct a multi-centre study, utilising the PERUKI network used in the original BronchStart study, to assess the effectiveness of maternal vaccination using a test-negative study design. We will gather detailed clinical information on children admitted with bronchiolitis in the post-RSV vaccination era, and understand possible reasons for incomplete vaccine uptake.

Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT).

Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitating an in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addresses this need by investigating the outcomes of patients with early and locally advanced lung cancer in Italy. With a focus on real-world data and patient registries, this study aims to provide comprehensive insights into clinical, psychosocial, and economic impacts, contributing to informed decision-making in health care. LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasive manual, robot-assisted, or traditional open surgery. The study will develop a web-based registry to collect longitudinal surgical, oncological, and socioeconomic outcome data. The primary objectives include performance assessment through the establishment of national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design ensures a diverse and representative study population. The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzing real-world data, emphasizing the importance of patient-reported outcomes in enhancing the understanding of the disease. By developing a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations of traditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires. Recruitment will be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. The study will be completed in the year 2028. LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thorough evaluation of outcomes and care processes, guiding clinicians and policymakers in optimizing patient management. Furthermore, the study's secondary objectives, focusing on economic and psychosocial impacts, align with the contemporary emphasis on holistic cancer care. Insights gained from this study may influence treatment strategies, resource utilization, and patient well-being, thereby contributing to the ongoing refinement of lung cancer management. ClinicalTrials.gov NCT05851755; https://clinicaltrials.gov/study/NCT05851755. ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140. PRR1-10.2196/57183.

Respiratory viral testing for young febrile infants presenting to emergency care: a planned secondary analysis of the Febrile Infants Diagnostic assessment and Outcome (FIDO) prospective observational cohort study

ObjectiveTo describe the association of respiratory viral test results and the risk of invasive bacterial infection (IBI) for febrile young infants presenting to emergency care.DesignA planned secondary analysis within the...

Association between humoral serological markers levels and risk of SARS-CoV-2 infection after the primary COVID-19 vaccine course among ANRS0001S COV-POPART cohort participants

BackgroundWe assessed the prognostic value of serological humoral markers measured one month after the last dose of the primary COVID-19 vaccine course for predicting the risk of severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 infection over the following six months in specific populations.MethodsANRS0001SCOV-POPART is a French nationwide multicenter prospective observational cohort study assessing the immune response to Covid-19 vaccines routinely administered to 11 subgroups of patients with chronic disease and a control group. Participants from the ANRS0001S COV-POPART were included if they received at least two doses of Covid-19 vaccine for the primary vaccine course, had measurements of anti-Spike, anti-receptor binding domain (RBD) IgG-specific or neutralizing antibodies one month after the end of the primary vaccine course, without being infected by SARS-CoV-2 before the measurement. SARS-CoV-2 infections defined by a positive PCR/antigenic test or seroconversion to detectable anti nucleocapsid antibodies were evaluated until the first COVID-19 booster injection. Cox proportional hazards models taking into account interval-censored data were implemented to estimate the association between each antibody level and the risk of SARS-CoV-2 infection. Predictive performances were evaluated by the area under the receiving operating characteristic curve (AUROC).ResultsTwo thousand five hundred seventy adults from a specific population and 1,123 from the control group were included. The cumulative probabilities of SARS-CoV-2 infections at five months after serological measurement were 6.0% 95% confidence interval: [5.0; 7.9] and 10.1% 95% confidence interval: [8.3; 11.9], respectively. Higher levels of anti-Spike IgG antibody were associated with a lower risk of SARS-CoV-2 infections in the control group, but not in the specific populations. Among the specific populations, AUROC were 74.5%, 74.9%, and 72.4% for anti-Spike IgG, anti-RBD IgG, and neutralizing antibodies, respectively. AUROC were superior in the specific populations, 82.0%, 81.2%, and 81.4% for anti-Spike IgG, anti-RBD IgG, and neutralizing antibodies, respectively.ConclusionsVaccine-induced antibody response after the primary course of Covid-19 infection only moderately discriminated between participants developing a SARS-CoV-2 infection during the Omicron wave.Trial registrationNCT04824651 (first posted: 2021-04-01).

COVID-19 and Female Fertility: An Observational Prospective Multicenter Cohort Study: Upholding Reproductive Rights in Emergency Circumstances.

Currently available research data points to COVID-19-related multi-organ system damage. This study aims to evaluate the impact of SARS-CoV-2 on the reproductive health, that is, plasma levels of FSH, LH, estradiol, AMH, and antral follicular count, of women undergoing level II ART techniques. This is a multicenter, prospective, and observational study by the reproductive medicine centers of Palermo's Ospedali Riuniti Villa Sofia-Cervello Hospital and Vanvitelli University. From September 2022 to March 2024, 203 patients aged 24-43 were enrolled, all with diagnosed infertility and a history of SARS-CoV-2 infection. Symptomatic women, patients testing positive for HIV or other liver viruses, and patients with a history of ovarian cancer or who had taken gonadotoxic drugs were excluded. Plasma measurements of FSH, LH, estradiol, AMH, and antral follicular count were performed before and after infection. The analysis accounting for the concentration of anti-Müllerian hormone (AMH) before and after COVID-19 infection shows an average concentration decrease from 1.33 ng/mL before SARS-CoV-2 infection to 0.97 ng/mL after infection. Average decrease after infection was -27.4%; average reduction of 1 follicle (95% CI: from -0.74 to -1.33) was reported following SARS-CoV-2 infection. Levels of E2 before and after SARS-CoV-2 infection did not vary significantly. Average FSH and LH levels before and after SARS-CoV-2 infection pointed to an increase. SARS-CoV-2 infection damages female reproductive health, causing significant reductions in AMH (-27.4%) and AFC (-1 antral follicle) values and an increase in FSH (+13.6%) and LH (+13.4%) values. No effect on E2 levels was reported. The pandemic has also affected the ability of infertile patients to access ART procedures, and that calls for a novel, updated blueprint designed to enhance our preparedness in the event that similar circumstances should occur again.

Assessment of long-term psychosocial outcomes in N-methyl-D-aspartate receptor encephalitis – the SAPIENCE study protocol

BackgroundN-methyl-D-aspartate-receptor (NMDAR) encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms during the acute phase. Despite good functional neurological recovery, most patients continue to experience cognitive, psychiatric, psychological, and social impairments years after the acute phase. However, the precise nature and evolving patterns over time of these long-term consequences remain unclear, and their implications for the well-being and quality of life of predominantly young patients have yet to be thoroughly examined.MethodsSAPIENCE is a European multi-center (n = 3) prospective observational cohort study studying the long-term cognitive, psychiatric, psychological, and social outcome in patients with NMDAR encephalitis. The study consists of three interconnected levels. Level 1 comprises a qualitative interview and focus groups with patients and their caregivers. Level 2 consists of a condensed form of the interview, standardized questionnaires, and a detailed neuropsychological examination of patients. Level 3 involves an online survey that will be open to patients world-wide and explores patient-reported outcomes (PROMs), and patient-reported experiences (PREMs) in association with clinical and cognitive outcomes. Levels 1 to 3 will progressively contribute developing of structured interviews, survey questions, and treatment guidelines by informing one another.DiscussionSAPIENCE is an in-depth study of the long-term effects of NMDAR encephalitis and bridges the gap between standardized assessments and individual patient experiences, intending to improve patient care and to increase awareness of the psychosocial long-term consequences of the disease. Through collaboration of experts in clinical neurology and social and health psychology across Europe, SAPIENCE aims to create online assessment tools and formulate guidelines for patient-centered post-acute care that will help enhance the quality of life for patients and caregivers.