Multicenter Prospective Observational Cohort Study Research Articles

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)

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

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.

Assessing Diagnostic Performance of Molecular Culture for Neonatal Sepsis: Protocol of the CHAMPIONS Study.

Managing neonatal sepsis is challenging due to nonspecific clinical signs, hematological markers with poor accuracy, and a lengthy turnaround time for the identification of microorganisms. Delaying the initiation of antibiotics in truly infected infants can lead to severe morbidity and mortality. Therefore, decisions regarding empiric antibiotic treatment are risk stratified, which exposes many uninfected infants to antibiotics. This causes gut microbiota perturbation, unnecessary hospital admissions, and the generation of multi-resistant organisms. High-speed diagnostic assays could expedite discontinuation or avert the initiation of antibiotics in uninfected infants. This study will evaluate the diagnostic performance of molecular culture (MC), a rapid broad-range PCR-based bacterial profiling technique, for diagnosing neonatal sepsis in infants below 90 days old. A multi-center prospective observational cohort study will include infants evaluated for early and late-onset sepsis. Routine evaluation for suspected sepsis includes microbiological cultures of blood. Additionally, blood for MC will be collected. For early-onset sepsis, umbilical cord blood may be used alternatively. Primary outcome is the agreement between MC and conventional blood culture results. Secondary outcome is the agreement of both assays with clinical sepsis using four different, commonly used definitions. Faster diagnostic pathways for sepsis may reduce antibiotic exposure time. Broad-range molecular assays may identify pathogens undetectable by conventional methods. Employment of umbilical cord blood samples for early-onset sepsis diagnosis can resolve challenges in collecting adequate blood volume and could further expedite treatment decisions.

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.

Long-term outcomes of the first prospective study of active surveillance for prostate cancer in Japan.

Active surveillance for prostate cancer was initiated in the early 2000s. We assessed the long-term outcomes of active surveillance in Japan. This multicenter prospective observational cohort study enrolled men aged 50-80years with stage cT1cN0M0 prostate cancer in 2002 and 2003. The eligibility criteria included serum prostate-specific antigen level ≤ 20ng/mL, ≤ 2 positive cores per 6-12 biopsy samples, Gleason score ≤ 6, and cancer involvement < 50% in the positive core. Patients were encouraged to undergo active surveillance. Prostate-specific antigen levels were measured bimonthly for 6months and every 3months thereafter. Triggers for recommending treatment were prostate-specific antigen doubling time of < 2years and pathological progression on repeat biopsy. Among 134 patients, 118 underwent active surveillance. The median age, prostate-specific antigen level at diagnosis, and maximum cancer occupancy were 70years, 6.5ng/mL, and 11.2%, respectively. Ninety-one patients had only one positive cancer core. The median observation period was 10.7years. At 1year, 65.7% underwent a repeat biopsy, and 37% of patients experienced pathological progression. The active surveillance continuation rates at 5, 10, and 15years were 28%, 9%, and 4%, respectively. One prostate cancer-related death occurred in a patient who refused treatment despite pathological progression at the one-year repeat biopsy. Active surveillance according to this study protocol was associated with conversion to the next treatment without delay, when indicated, despite the selection criteria and follow-up protocols being less rigorous than those recommended in current international guidelines.

Root causes of first-case start time delays for elective surgical procedures: a prospective multicenter observational cohort study in Ethiopia

BackgroundDelays in surgery start times can lead to poor patient outcomes and considerable increases in healthcare expenditures. This is especially true in developing countries that often face systemic inefficiencies, such as a shortage of operating rooms and trained surgical personnel. With substantial effects on patient outcomes, healthcare efficiency, and resource allocation, identifying delays in first-case elective surgery is a crucial area of research.MethodsA multicenter observational study was conducted at three comprehensive and specialized hospitals in the Amhara region of Ethiopia from May 1 to October 30, 2023. The primary aim of the study was to determine the occurrence of late first-case start times, defined as a patient being in the operating room at or after the hospital’s incision time of 2:30 a.m. The secondary aim was to discover potential root causes of delayed first-case start times. All patients scheduled for elective surgery as the first case on the operating list throughout the study period were included in the study. Every emergency, day case, after-hours case, and canceled case was excluded.ResultsA total of 530 surgical patients were included during the study window from May 1 to October 1, 2023. Of these, 41.5% were general surgeries, 20.4% were gynecology and obstetrics surgeries, and 13.2% were orthopedic surgery procedures. Before the procedure started, nine (1.7%) of the participants had prolonged discussion with a member of the surgical team. Patients who arrived in the operating room waiting area at or after 2:30 a.m. were 2.5 times more likely to experience a first-case start time delay than those who arrived before or at 2:00 a.m. (AOR = 2.50; 95% CI: 1.13–5.14). Furthermore, participants with abnormal investigation results were 2.4 times more likely to have a late first-case start time (AOR = 2.41; 95% CI: 1.06, 5.50). Moreover, the odds of a late first-case start time were increased by 10.53 times with the surgeon being in the operating room at or after 2:30 a.m. (AOR = 10.53; 95% CI: 5.51, 20.11).ConclusionThe research highlights a significant occurrence of delayed start times for the first elective surgical procedures. Therefore, directing attention to aspects such as ensuring patients and surgical teams arrive promptly (by or before 2:00 a.m.) and timely evaluation and communication of investigative findings before the scheduled surgery day could facilitate efforts to maximize operating room efficiency and enhance patient health outcomes.

Females have lower salivary flow than males, before and after radiation therapy for head/neck cancer.

To compare salivary flow rates between females and males, before and after radiation therapy (RT) for head and neck cancer (HNC). Prospective observational multicenter cohort study (OraRad). Stimulated whole salivary flow was measured before RT and at 6 and 18 months after RT. Mean (95% confidence interval) salivary flow in g/min before RT was 0.81 (0.71, 0.90) in females (n = 107) and 1.20 (1.15, 1.25) in males (n = 391) (p < 0.001); at 6 months was 0.34 (0.24, 0.44) in females and 0.50 (0.44, 0.55) in males (p = 0.01); at 18 months was 0.49 (0.38, 0.59) in females and 0.70 (0.64, 0.75) in males (p < 0.001). Median nadir salivary flow after RT was 0.22 in females and 0.35 in males (p < 0.001). A lower nadir salivary flow in females, but not males, was associated with an increased risk for tooth failure (p = 0.02). Females with HNC have lower stimulated whole salivary flow than males, before and after RT. Low salivary flow after RT may be a risk factor for tooth failure among females. The lower pre-RT salivary flow rates in females, combined with prior literature in other populations, indicates that, in general, females have lower stimulated salivary flow than males.

Health Care Access, Socioeconomic Status, and Acute Kidney Injury Outcomes: A Prospective National Study

Acute kidney injury (AKI) incidence and outcome in Kuwait are unknown. Moreover, non-Kuwaitis, who represent 66% of the population, have lower income, and their access to public health services is restricted compared with Kuwaitis who have free full access. Observational prospective multicenter cohort study. Adult inpatients with AKI in 7 public hospitals from January 1 to December 31,2021. AKI identified using Kidney Disease: Improving Global Outcomes serum creatinine-based criteria. For hospitalized patients with AKI, the outcomes included 30-day outcomes of mortality, need for dialysis, kidney recovery rates, and differences in outcomes between Kuwaitis and non-Kuwaitis. A backward stepwise multiple logistic regression analysis was performed to assess possible independent risk factors for the outcomes. We recruited 3,744 patients (mean age: 63 years; mean baseline estimated glomerular filtration rate [eGFR]: 66.7mL/min; non-Kuwaitis: 42.3%), representing 3.2% of hospitalizations and 19.5% of intensive care unit (ICU) admissions. Non-Kuwaitis were significantly younger (57.6 vs 66.9 years), with higher baseline eGFR (73.1 vs. 62mL/min), more frequent community acquired AKI (53.8% vs 46.7%), and AKI in summer (34.7% vs 26.9%). Dialysis was provided to 33.5% of patients, with a higher need for non-Kuwaitis (35.5% vs 32.1%). At 30 days, 34.4% of patients died, representing 24.8% of hospital mortality and 59.8% of ICU mortality. No differences in mortality or kidney recovery were noted between Kuwaitis and non-Kuwaitis. Low eGFR did not affect the mortality rate. Observational nature and short follow-up period of 30 days only. AKI was associated with high dialysis need and mortality. Non-Kuwaitis accounted for less cases despite representing 66% of the population because they were younger with higher baseline eGFR and fewer comorbid conditions. Non-Kuwaitis had higher rates of community acquired AKI and AKI in summer and a higher need for dialysis but had similar mortality and complete kidney recovery rates.

Usefulness of the one-step technique in functional end-to-end anastomosis for colonic surgery: results of a prospective multicentre cohort study from the Japanese KYCC group.

Although functional end-to-end anastomosis (FEEA) using a stapler in the colorectal field has been recognised worldwide, the technique varies by surgeon, and the safety of anastomosis using different techniques is unknown. This multicentre prospective observational cohort study was conducted by the KYCC Study Group in Yokohama, Japan, and included patients who underwent colonic resection at seven centres between April 2020 and March 2022. This study compared the incidence of surgery-related abdominal complications (SAC: anastomotic leakage [AL], anastomotic bleeding, intra-abdominal abscess, enteritis, ileus, surgical site infection, and other abdominal complications) between two different methods of FEEA (one-step [OS] method: simultaneous anastomosis and bowel resection; two-step [TS] method: anastomosis after bowel resection). Complications of Clavien-Dindo classification grade2 or higher were assessed. Among 293 eligible cases, the OS and TS methods were used in 194 (66.2%) and 99 (33.8%) patients, respectively. The baseline characteristics were similar between the groups. The OS method used fewer staplers (three vs. four staplers, p < 0.00001). There were no significant differences in SAC rate between the OS (19.1%) and the TS (16.2%) groups (p = 0.44). The OS group had four cases (2.1%) of AL (two patients; grade3, two patients; grade2) while the TS group had one case (1.0%) of grade2 AL (p = 0.67). Multivariate logistic regression analysis showed that male sex (odds ratio [OR] 3.95; p < 0.00001), an open surgical approach (OR 2.36; p = 0.03), and longer operative duration (OR,2.79; p = 0.002) were independent predictors of complications, whereas the OS method was not an independent predictor (OR 1.17; p = 0.66). The OS and the TS technique for stapled colonic anastomosis in a FEEA had a similar postoperative complication rate. UMIN000039902 (registration date 23 March 2020).

Associations of early changes in lung ultrasound aeration scores and mortality in invasively ventilated patients: a post hoc analysis

BackgroundLung ultrasound (LUS) in an emerging technique used in the intensive care unit (ICU). The derivative LUS aeration score has been shown to have associations with mortality in invasively ventilated patients. This study assessed the predictive value of baseline and early changes in LUS aeration scores in critically ill invasively ventilated patients with and without ARDS (Acute Respiratory Distress Syndrome) on 30- and 90-day mortality.MethodsThis is a post hoc analysis of a multicenter prospective observational cohort study, which included patients admitted to the ICU with an expected duration of ventilation for at least 24 h. We restricted participation to patients who underwent a 12-region LUS exam at baseline and had the primary endpoint (30-day mortality) available. Logistic regression was used to analyze the primary and secondary endpoints. The analysis was performed for the complete patient cohort and for predefined subgroups (ARDS and no ARDS).ResultsA total of 442 patients were included, of whom 245 had a second LUS exam. The baseline LUS aeration score was not associated with mortality (1.02 (95% CI: 0.99 – 1.06), p = 0.143). This finding was not different in patients with and in patients without ARDS. Early deterioration of the LUS score was associated with mortality (2.09 (95% CI: 1.01 – 4.3), p = 0.046) in patients without ARDS, but not in patients with ARDS or in the complete patient cohort.ConclusionIn this cohort of critically ill invasively ventilated patients, the baseline LUS aeration score was not associated with 30- and 90-day mortality. An early change in the LUS aeration score was associated with mortality, but only in patients without ARDS.Trial registrationClinicalTrials.gov, ID NCT04482621.

Cost-effectiveness and safety of continuous pulse oximetry for management of undiagnosed obstructive sleep apnea in bariatric surgery: a nationwide cohort study

BackgroundUndetected obstructive sleep apnea (OSA) is highly prevalent in patients undergoing bariatric surgery and increases perioperative risks. Screening for OSA using preoperative polygraphy (PG) with subsequent continuous positive airway pressure (CPAP) is costly and time-consuming. Postoperative continuous pulse oximetry (CPOX) is less invasive, and is hypothesized to be a safe and cost-effective alternative. ObjectivesThis nationwide multicenter prospective observational cohort study compared CPOX monitoring with OSA-screening using PG. SettingHigh-volume bariatric centers. MethodsPatients were either postoperatively monitored using CPOX without preoperative OSA-screening, or underwent preoperative PG and CPAP treatment when OSA was diagnosed. Cohort placement was based on local hospital protocols. Cost-effectiveness was analyzed using quality adjusted life years (QALYs) and healthcare costs. Surgical outcomes were also analyzed. Propensity score matching was used in sensitivity analyses. ResultsA total of 1390 patients were included. QALYs were similar between groups at baseline and 1-year postoperatively. Postoperative complications, intensive care unit (ICU)-admissions and admissions, particularly OSA-related, did not differ between groups. Mean costs per patient/year in the CPOX group was €3094 versus €3680 in the PG group; mean difference €−586 (95% CI €−933–€−242). Following propensity score matching, 1090 of 1390 included patients remained, and similar findings for cost-effectiveness, complications, and ICU admissions were observed. ConclusionCPOX monitoring without preoperative OSA-screening was not associated with higher complication or readmission rates compared to PG. CPOX resulted in lower costs from a healthcare perspective and can therefore be considered a cost-effective alternative to routine OSA-screening in patients undergoing bariatric surgery.

Preliminary results from the Polish Infective Endocarditis Registry (POL-ENDO): Time to change clinical practice?

Infective endocarditis (IE) is a severe valvular disease associated with high morbidity and mortality. This preliminary study aimed to evaluate patient profiles and treatment outcomes of IE in Poland and compare them with European IE characteristics. We conducted a prospective multicenter observational cohort study - the POL-ENDO registry - in IE patients from 134 hospitals in Poland recruited between August 2022 and August 2023. We evaluated demographic, clinical, imaging, and treatment outcome data. A comparison of the Polish patients with those assessed in the EURO-ENDO registry between January 2016 and March 2018 was performed. Of a total of 880 IE patients, 622 were male (70.7%). The POL-ENDO participants were older (61.4 [16.7] years vs. 59.25 [18.03] years; P = 0.001). Native-valve IE occurred more often in Poland (82.3% vs. 56.6%; P <0.001). Transthoracic echocardiography was performed more frequently in Poland (93.6% vs. 89.8%; P <0.001). New imaging techniques (computed tomography/magnetic resonance imaging/positron emission tomography/single-photon emission computed tomography) were less frequently used in Poland (computed tomography: 41.3% vs. 53.2%; P <0.001; magnetic resonance imaging: 6.4% vs. 18.7%; P <0.001). Heart failure occurred more often in Poland as an in-hospital complication (31.4% vs. 14.1%; P <0.001). Surgical treatment was less frequently performed in Poland (36.9% vs. 51.2%; P <0.001). In-hospital mortality was higher in Poland (21% vs. 17%; P = 0.008). Polish IE patients were significantly older and had more comorbidities. New imaging techniques are less frequently used in Poland. Echocardiography was performed more frequently in Poland as the diagnostic mainstay. Surgical treatment was significantly less frequent in Poland. In-hospital mortality in Poland is higher.

Clinical phenotypes and outcomes associated with SARS-CoV-2 Omicron sublineage JN.1 in critically ill COVID-19 patients: a prospective, multicenter cohort study in France, November 2022 to January 2024

BackgroundA notable increase in severe cases of COVID-19, with significant hospitalizations due to the emergence and spread of JN.1 was observed worldwide in late 2023 and early 2024. However, no clinical data are available regarding critically-ill JN.1 COVID-19 infected patients.MethodsThe current study is a substudy of the SEVARVIR prospective multicenter observational cohort study. Patients admitted to any of the 40 participating ICUs between November 17, 2022, and January 22, 2024, were eligible for inclusion in the SEVARVIR cohort study (NCT05162508) if they met the following inclusion criteria: age ≥ 18 years, SARS-CoV-2 infection confirmed by a positive reverse transcriptase-polymerase chain reaction (RT-PCR) in nasopharyngeal swab samples, ICU admission for acute respiratory failure. The primary clinical endpoint of the study was day-28 mortality. Evaluation of the association between day-28 mortality and sublineage group was conducted by performing an exploratory multivariable logistic regression model, after systematically adjusting for predefined prognostic factors previously shown to be important confounders (i.e. obesity, immunosuppression, age and SOFA score) computing odds ratios (OR) along with their corresponding 95% confidence intervals (95% CI).ResultsDuring the study period (November 2022–January 2024) 56 JN.1- and 126 XBB-infected patients were prospectively enrolled in 40 French intensive care units. JN.1-infected patients were more likely to be obese (35.7% vs 20.8%; p = 0.033) and less frequently immunosuppressed than others (20.4% vs 41.4%; p = 0.010). JN.1-infected patients required invasive mechanical ventilation support in 29.1%, 87.5% of them received dexamethasone, 14.5% tocilizumab and none received monoclonal antibodies. Only one JN-1 infected patient (1.8%) required extracorporeal membrane oxygenation support during ICU stay (vs 0/126 in the XBB group; p = 0.30). Day-28 mortality of JN.1-infected patients was 14.6%, not significantly different from that of XBB-infected patients (22.0%; p = 0.28). In univariable logistic regression analysis and in multivariable analysis adjusting for confounders defined a priori, we found no statistically significant association between JN.1 infection and day-28 mortality (adjusted OR 1.06 95% CI (0.17;1.42); p = 0.19). There was no significant between group difference regarding duration of stay in the ICU (6.0 [3.5;11.0] vs 7.0 [4.0;14.0] days; p = 0.21).ConclusionsCritically-ill patients with Omicron JN.1 infection showed a different clinical phenotype than patients infected with the earlier XBB sublineage, including more frequent obesity and less immunosuppression. Compared with XBB, JN.1 infection was not associated with higher day-28 mortality.