Prospective Multicenter Study Research Articles

Neurocognitive performance of patients undergoing intravenous versus oral opioid agonist treatment: a prospective multicenter study on three-month treatment effects

Neurocognitive performance of patients undergoing intravenous versus oral opioid agonist treatment: a prospective multicenter study on three-month treatment effects

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

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

Prospective multicenter study to identify optimal target population for motorized spiral enteroscopy

Motorized spiral enteroscopy (MSE) enhances small bowel exploration, but the optimal target population for this technique is unknown. We aimed to identify the target population for MSE by evaluating its efficacy and safety, as well as detecting predictors of efficacy. A prospective multicenter observational study was conducted at 9 tertiary hospitals in Spain, enrolling patients between June 2020–2022. Analyzed data included demographics, indications for the procedure, exploration time, depth of maximum insertion (DMI), technical success, diagnostic yield, interventional yield, and adverse events (AE) up to 14 days from enteroscopy. Patients with prior gastrointestinal surgery, unsuccessful balloon enteroscopy and small bowel strictures were analyzed. A total of 326 enteroscopies (66.6% oral route) were performed in 294 patients (55.1% males, 65 years ± 21). Prior abdominal surgery was present in 50% of procedures (13.5% gastrointestinal surgery). Lower DMI (162 vs 275 cm, p = 0.037) and diagnostic yield (47.7 vs 67.5%, p = 0.016) were observed in patients with prior gastrointestinal surgery. MSE showed 92.2% technical success and 56.9% diagnostic yield after unsuccessful balloon enteroscopy (n = 51). In suspected small bowel strictures (n = 49), the finding was confirmed in 23 procedures (46.9%). The total AE rate was 10.7% (1.8% classified as major events) with no differences related to prior gastrointestinal/abdominal surgery, unsuccessful enteroscopy, or suspected small bowel strictures. The study demonstrates that MSE has a lower diagnostic yield and DMI in patients with prior gastrointestinal surgery but is feasible after unsuccessful balloon-enteroscopy and in suspected small bowel strictures without safety concerns.

Clinical utility of plasma microbial cell-free DNA sequencing among immunocompromised patients with pneumonia

Abstract Background Plasma microbial cell-free DNA (mcfDNA) sequencing can establish the etiology of multiple infectious syndromes by identifying microbial DNA in plasma. However, data are needed to define the clinical scenarios where this tool offers the highest clinical benefit. Methods We conducted a prospective multicenter observational study that evaluated the impact of plasma mcfDNA sequencing compared to usual care testing among adults with hematologic malignancies. This is a secondary analysis of an expanded cohort that evaluated the clinical utility of plasma mcfDNA sequencing across prespecified and adjudicated outcomes. We examined the percentage of participants for whom plasma mcfDNA sequencing identified a probable cause of pneumonia or clinically relevant non-pneumonia infection. We then assessed potential changes in antimicrobial therapy based on plasma mcfDNA sequencing results, and the potential for early mcfDNA testing to avoid bronchoscopy and its associated adverse events. Results Of 223 participants, at least one microbial detection by plasma mcfDNA sequencing was adjudicated as a probable cause of pneumonia in 57 (25.6%) and a clinically relevant non-pneumonia infection in 88 (39.5%). A probable cause of pneumonia was exclusively identified by plasma mcfDNA sequencing in 23 (10.3%) participants. Antimicrobial therapy would have changed for 41 (18.4%) participants had plasma mcfDNA results been available in real-time. Among the 57 participants with a probable cause of pneumonia identified by plasma mcfDNA sequencing, bronchoscopy identified no additional probable cause of pneumonia in 52 (91.2%). Conclusions Plasma mcfDNA sequencing could improve management of both pneumonia and other concurrent infections in immunocompromised patients with suspected pneumonia.

Increased risk of severe neonatal opioid withdrawal syndrome in pregnancies with low placental ABCB1 DNA methylation.

Neonatal opioid withdrawal syndrome (NOWS) is unpredictable. We assessed relationships between placental DNA methylation with in-utero opioid exposure and NOWS severity. Secondary analysis of a prospective multicenter cohort study of pregnancies on methadone or buprenorphine, ≥34 weeks, singleton, 18 or greater. Placental biopsies were collected. Placental DNA methylation levels of ABCG1, ABCG2, CYP19A1, and HSD11B2 were quantified via pyrosequencing following bisulfite conversion. CYP19A1 mRNA levels and umbilical cord drug levels were determined by RT-qPCR and LC-MS respectively. Severe NOWS was diagnosed through Finnegan scoring. P value < 0.05 was significant. Thirty-eight dyads were included. Promoter region methylation for placental ABCB1 was lower in severe NOWS compared to non-severe NOWS (p = 0.04). Placental CYP19A1 methylation was inversely related to CYP19A1 mRNA levels and associated with umbilical cord norbuprenorphine levels (p < 0.01), but not umbilical cord methadone levels. Lower placental ABCB1 methylation was associated with severe NOWS. Higher placental CYP19A1 methylation correlated with higher umbilical cord norbuprenorphine levels.

Lung Ultrasound Score in Neonatal RDS: Agreement between Sonography Expert and Neonatologists with Varying Levels of Experience

This study aimed to assess interrater agreement in lung ultrasound scores (LUS) among neonatologists with varying experience levels and an expert sonographer. A post hoc analysis was conducted on data from a prospective multicenter study involving 155 infants born &lt;34 weeks’ gestation, all with respiratory distress syndrome. A total of 629 lung scans were performed and video-recorded by 21 point-of-care sonographers, including both experienced (n = 7) and inexperienced (n = 14) evaluators. Subsequently, a blinded expert sonographer re-evaluated the assigned LUS values. The Cohen’s kappa statistic for individual pulmonary field assessments ranged from 0.89 to 0.93, indicating nearly perfect agreement. The interclass correlation coefficient (ICC) confirmed excellent reliability on total LUS values, demonstrating similar performance of experienced (ICC = 0.92, 95% CI 0.90–0.94) and inexperienced sonographers (ICC = 0.93, 95% CI 0.92–0.94). This study underscores that lung ultrasound is easily learned, and LUS exhibits outstanding reproducibility, irrespective of the sonographer’s level of experience.

Liver stiffness progression in biopsy-proven metabolic dysfunction-associated steatotic disease among people with diabetes versus people without diabetes: A prospective multicenter study.

There are limited data on the progression of liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) in people with type 2 diabetes (T2DM) versus those without T2DM in biopsy-proven metabolic dysfunction-associated steatotic liver disease (MASLD). We examined LSM progression in participants with T2DM versus those without T2DM in a large, prospective, multicenter cohort study. This study included 1,231 adult participants (62% female) with biopsy-proven MASLD who had VCTEs at least one year apart. LSM progression and regression were defined by a ≥ 20% increase and an upward or downward change, respectively, in the LSM category in the Baveno VII categories for compensated advanced chronic liver disease, compared between participants with T2DM (n=680) versus no T2DM (n=551) at baseline. The mean (±SD) age and BMI were 51.8 (±12.0) years and 34.0 (±6.5) kg/m2, respectively. The median (IQR) time between the first and last VCTE measurements was 4.1(2.5-6.5) years. Participants with T2DM had higher LSM progression at 4-years (12% vs. 10%), 6-years (23% vs. 16%), and 8-years (50% vs. 39%), p=0.04. Using a multivariable Cox proportional hazards model adjusted for multiple confounders, the presence of T2DM remained an independent predictor of LSM progression (adjusted HR 1.35, 95% CI 1.01-1.81, p=0.04). T2DM was not associated with LSM regression (p=0.71). Mean HbA1c was significantly associated with LSM progression (p=0.003) and regression (p=0.02). Utilizing serial VCTE data from a multicenter study of participants with biopsy-proven MASLD, we demonstrate that T2DM and HbA1c are associated with LSM progression.

A population pharmacokinetic model for sertraline in women during the perinatal period-A contribution from the ConcePTION project.

Sertraline is frequently prescribed for mental health conditions in both pregnant and breastfeeding women. According to the limited available data, only small amounts of sertraline are transferred into human milk, yet with a large amount of unexplained interindividual variability. This study aimed to develop a population pharmacokinetic (popPK) model to describe the pharmacokinetics of sertraline during the perinatal period and explain interindividual variability. Pregnant women treated with sertraline were enrolled in the multicenter prospective cohort SSRI-Breast Milk study. A popPK model for sertraline maternal plasma and breast milk concentrations was developed and allowed estimating the milk-to-plasma ratio (MPR). An additional fetal compartment allowed cord blood concentrations to be described. Several covariates were tested for significance. Ultimately, model-based simulations allowed infant drug exposure through placenta and breast milk under various conditions to be predicted. Thirty-eight women treated with sertraline were included in the study and provided 89 maternal plasma, 29 cord blood and 107 breast milk samples. Sertraline clearance was reduced by 42% in CYP2C19 poor metabolizers compared to other phenotypes. Doubling milk fat content increased the MPR by 95%. Simulations suggested a median daily infant dosage of 6.9μg kg-1 after a 50 mg maternal daily dose, representing 0.95% of the weight-adjusted maternal dose. Median cord blood concentrations could range from 3.29 to 33.23 ng mL-1 after maternal daily doses between 25 and 150 mg. Infant exposure to sertraline, influenced by CYP2C19 phenotype and breast milk fat content, remains low, providing reassurance regarding the use of sertraline during pregnancy and breastfeeding.

Diagnostic agreement between emergency medical service and emergency department physicians, a prospective multicentre study

IntroductionEarly and adequate preliminary diagnosis reduce emergency department (ED) and hospital stay and may reduce mortality. Several studies demonstrated adequate preliminary diagnosis as stated by emergency medical services (EMS) ranging between 61 and 77%. Dutch EMS are highly trained, but performance of stating adequate preliminary diagnosis remains unknown.MethodsThis prospective observational study included 781 patients (> 18years), who arrived in the emergency department (ED) by ambulance in two academic hospitals. For each patient, the diagnosis as stated by EMS and the ED physician was obtained and compared. Diagnosis was categorized based on the International Classification of Diseases, 11th Revision.ResultsThe overall diagnostic agreement was 79% [95%-CI: 76–82%]. Agreement was high for traumatic injuries (94%), neurological emergencies (90%), infectious diseases (84%), cardiovascular (78%), moderate for mental and drug related (71%), gastrointestinal (70%), and low for endocrine and metabolic (50%), and acute internal emergencies (41%). There is no correlation between 28-day mortality, the need for ICU admission or the need for hospital admission with an adequate preliminary diagnosis.ConclusionIn the Netherlands, the extent of agreement between EMS diagnosis and ED discharge diagnosis varies between categories. Accuracy is high in diseases with specific observations, e.g., neurological failure, detectable injuries, and electrocardiographic abnormalities. Further studies should use these findings to improve patient outcome.

Cost-effectiveness of a new multi-lumen infusion device to reduce central venous line-associated bloodstream infections in neonates

A new medical device was developed for multi-infusion in neonatal intensive care units (NICUs) with the aim to address issues related to drug incompatibilities and central line-associated bloodstream infections (CLABSI). To assess the cost-effectiveness of implementing this new perfusion system in a NICU setting. We conducted a single-centre, observational study in all infants admitted to the NICU within the first 3 days after birth and who required central-venous line, to evaluate the cost and effectiveness before (Year 2019) and after (Year 2020) the implementation of the new perfusion system. We calculated the costs from the hospital perspective, and we examined the incidence of CLABSI, over a time horizon spanning from admission to NICU discharge. We measured the resource utilisation (infusion medical device, infection treating drugs and biological analyses), and valued corresponding costs using tariffs for year 2019. We calculated incremental cost-effectiveness ratio (ICER) expressed as euros per CLABSI avoided, and conducted one-way and multivariate sensitivity analyses. Among 609 infants selected, clinical characteristics were similar across both periods. The CLABSI rate significantly decreased (rate ratio: 0.22; IC95% [0.07-0.56]), and total costs were reduced (from €65,666 to €63,932 per 1000 catheter days respectively; p<0.001), yielding to an ICER of €251 saved per CLABSI avoided. The majority of sensitivity analyses showed the new intervention remaining economically dominant. This single-centre study showed a significant decrease in the incidence of CLABSI without incurring additional costs. Further prospective multicentre randomised studies are needed to confirm these results in other NICU.

Malignant glaucoma treated by low-dose laser cycloplasty: a 1-year multicenter prospective non-comparative study.

To report a one-year clinical outcomes of low-dose laser cycloplasty (LCP) among malignant glaucoma patients. In this prospective, multicenter, non-comparative clinical study, participants with malignant glaucoma were recruited and underwent LCP at eight ophthalmic centers in China. Patients were followed up at 1wk, 1, 3, 6, and 12mo. Intraocular pressure (IOP), number of glaucoma medications, anterior chamber depth (ACD), and complications were recorded. Anatomical success was defined as the reformation of the anterior chamber based on slit-lamp biomicroscopy. Recurrence was defined by the presence of a shallow or flat anterior chamber after initial recovery from treatment. A total of 34 eyes received LCP. Mean IOP and medications decreased from 36.1±11.5 mm Hg with 3.3±1.5 glaucoma medications pre-treatment to 20.9±9.8 mm Hg (P<0.001) with 2.9±1.6 medications (P=0.046) at 1d, and 17.4±6.7 mm Hg (P<0.001) with 1.3±1.7 medications (P<0.001) at 12mo. The ACD increased from 1.1±0.8 mm at baseline to 1.7±1.0 mm and to 2.0±0.5 mm at 1d and 12mo, respectively. A total of 32 (94.1%) eyes achieved initial anatomical success. During follow-up, 2 (5.9%) eyes failed and 8 (23.5%) eyes relapsed, yielding a 12-month anatomical success rate of 64.3%. Complications including anterior synechia (8.82%), choroidal/ciliary detachment (5.88%) and hypopyon (2.94%) were observed within 1wk. LCP is simple, safe, and effective in reforming the anterior chamber in malignant glaucoma.

Serological responses to vaccination in children exposed in utero to ustekinumab or vedolizumab: cross-sectional analysis of a prospective multicentre cohort.

Evidence on serological responses to vaccination in children exposed to ustekinumab (UST) or vedolizumab (VDZ) in utero is lacking. This multicentre prospective study aimed to assess the impact of prenatal exposure to UST or VDZ due to maternal inflammatory bowel disease (IBD) on serological responses to vaccination and other immunological parameters in exposed children. Children aged ≥ 1year who were exposed in utero to UST or VDZ and completed at least 1-year of mandatory vaccination were included. We assessed the serological response to vaccination (non-live: tetanus, diphtheria, and Haemophilus influenzae B; live: mumps, rubella, and measles), whole blood count, and immunoglobulin levels. The control group comprised unexposed children born to mothers without IBD. A total of 23 children (median age, 25months) exposed to UST (n = 13) or VDZ (n = 10) and 10 controls (median age, 37months) were included. The serological response to vaccination was comparable between the UST and VDZ groups and controls, with an adequate serological response rate of ≥ 80%. Only children exposed to UST showed a slightly reduced serological response to mumps (67% vs. 86% in controls), whereas all children exposed to VDZ showed an adequate response. The majority of the exposed children had normal levels of individual immunoglobulin classes, similar to the controls. No severe pathology was observed in any of the children.Conclusion: Despite the limited sample size, our findings suggest that in utero exposure to VDZ or UST does not significantly impair the vaccine response or broader immunological parameters in exposed children.

Correlation between serum sex hormone-binding globulin levels and nutrition indicators and malnutrition exposure risk in men and postmenopausal women with type 2 diabetes

BackgroundThis study sought to investigate the correlation between serum sex hormone-binding globulin (SHBG) levels and nutrition indicators and the malnutrition exposure risk in men and postmenopausal women with type 2 diabetes mellitus (T2DM).MethodsA cross-sectional analysis was conducted, involving patients diagnosed with T2DM at the Guangdong Provincial People’s Hospital between May 2018 and December 2019.ResultsThe study comprised 551 participants (363 men, mean age of 55.55 ± 11.57 years), among whom 167 (30.31%) were classified as with malnutrition exposure risk (GNRI ≤ 98). Multivariable logistic regression analysis revealed that SHBG (OR = 1.04, 95% CI: 1.02–1.05, P < 0.001), glycated hemoglobin (OR = 1.36, 95% CI: 1.22–1.51, P < 0.001), hemoglobin (OR = 0.96, 95% CI: 0.94–0.97, P < 0.001), and non-alcoholic fatty liver disease (OR = 0.41, 95% CI: 0.23–0.73, P < 0.003) were independently associated with the malnutrition exposure risk. SHBG was inversely correlated with body mass index (males: r = -0.34; postmenopausal females: r = -0.22), albumin (males: r = -0.30; postmenopausal females: r = -0.20), transferrin (males: r = -0.28; postmenopausal females: r = -0.19), and prealbumin (males: r = -0.35; postmenopausal females: r = -0.30) (all P < 0.05).ConclusionsSerum SHBG levels are correlated with nutritional indicators and the risk of malnutrition in men and postmenopausal women with T2DM. A multicenter prospective study is imperative to verify this result in the future.

Survival impact of response within the first year in a multicenter prospective observational study of chronic GVHD in a Japanese cohort.

A prospective multicenter observational study of organ response was conducted in patients with chronic GVHD diagnosed by the NIH criteria. When response was assessed at 12months (12M) in 118 patients, 74.6% were classified as responders and 25.4% as non-responders. The skin and oral cavity were the most frequent organs used as the basis for determining overall response. The lungs, liver, and eyes were also used in 20% of patients. Non-response decisions at 12M were most frequent in the lungs. A significantly higher percentage of responders than non-responders completed systemic treatment (24.3% vs. 3.3%, P = 0.02). Global scoring showed significant changes, with improvement in responders and worsening in non-responders throughout the observation period. Two-year transplant-related mortality, using the 12M assessment as the landmark, was significantly worse in non-responders (28.5% vs. 2,7%, P = 0.0001), while the 2-year recurrence rate was equivalent (5.4% vs. 4.8%, P = 0.78). Consequently, the 2-year overall survival rate from the 12M assessment was significantly better in responders than non-responders (95% vs. 65.3%, P = 0.0001). Our data suggests that patients who do not achieve a response within the first year should be candidates for clinical studies on chronic GVHD.

Patients with and without history of atrial fibrillation after percutaneous coronary intervention increased focus on modifiable risk factors

Abstract Background Atrial fibrillation (AF) and coronary artery disease (CAD) have several common risk factors, and 10-15% of patients with AF undergo percutaneous coronary intervention (PCI). Little is known about the changes over time in modifiable risk factors for AF and CAD and self-reported health when comparing patients with and without history of AF after PCI. Purpose To determine and compare changes in modifiable risk factors and self-reported health in patients with and without history of AF after PCI, from the index admission to 2-, 6- and 12 months after hospital discharge. Methods CONCARDPCI, a prospective multicentre cohort study including 3417 consecutive patients after PCI, was conducted at seven high-volume PCI centres in Norway and Denmark. Of these, 408 patients had a history of AF. Socio-demographic characteristics were self-reported at baseline. Medical history (medical and cardiovascular comorbidities), and clinical status (body weight and height) were collected from patients’ medical records and national registries at baseline. Information about the patients’ comorbidities was used to identify modifiable risk factors for AF and CAD in this study population. Smoking status and physical activity were self-reported at baseline and the 2-, 6- and 12-month follow-up. Self-reported health was assessed with RAND-12 Item Short Form Health Survey and the Myocardial Infarction Dimensional Assessment Scale (MIDAS). Results Eighty one percent of the patients with history of AF were men, and the mean age was 72 (SD 9, range 43-93). In patients without AF, 78% were men and the mean age was 65 (SD 11, range 20-96). In patients with history of AF, the proportion of smokers increased from 2- to 12 months (p=0.041). In patients without AF, there was a reduction in proportion of smokers from baseline to six months (p&amp;lt;0.001). No significant differences between the patients with history of AF and without AF regarding changes in physical activity over time were found (p=0.452). Most patients in both groups did not adhere to the guideline recommended 150 minutes of physical activity per week. Patients with a history of AF reported a poorer general physical health at baseline. However, the general physical (p=0.012) and mental (p&amp;lt;0.001) health improved from baseline to the six-month follow-up in both groups. For MIDAS, the patients with AF reported a poorer health regarding emotional reactions (p=0.029) and insecurity (p=0.015) from two- to twelve-month follow-up. Conclusion Lifestyle interventions might be beneficial to further improve self-reported health, as well as modifiable risk factors, among patients with and without history of AF after PCI. Considering the complex treatment of patients with AF after PCI, more attention is needed to improve the follow-up care regarding modifiable risk factors for this patient population.

Using an Innovative Model to Improve Performance of the Infant Hip Examination.

Determine if a new teaching bundle targeting developmental dysplasia of the hip screening improved interns' examination skills across multiple pediatric residency programs. This multicenter prospective cohort study included interns across 6 pediatric residency sites within the Academic Pediatric Association's Better Outcomes through Research for Newborns Network in 2022. Participants underwent a baseline hip examination assessment on models using a checklist derived from textbook descriptions of Galeazzi, Ortolani, and Barlow maneuvers before receiving a teaching bundle. Repeat testing occurred after instruction. Data were analyzed using t-test for continuous and χ2 test for categorical variables. Semistructured focus groups provided qualitative feedback regarding the teaching bundle. We enrolled 117 of 155 interns across 6 sites (76%) for participation in the teaching bundle. Only 2% of participants (n = 2) identified a positive Galeazzi sign at baseline, whereas 88% (n = 103, P < .001) did so on the postinstructional assessment. Although 27% of participants (n = 32) correctly identified a positive Barlow sign at baseline, 69% (n = 81, P < .001) did so on the postinstructional assessment. The ability to correctly detect a positive Ortolani sign increased from 22% (n = 26) to 92% (n = 108, P < .001). Fifteen interns participated in the semistructured focus groups, with resultant themes reinforcing the limited experience of the infant hip examination before this intervention and the positive impact of the teaching bundle. Most participants in this study did not have strong infant hip examination skills at entry into residency. A standardized teaching bundle significantly improved skills in examination technique and identifying abnormalities.

Compared burden of psoriasis, atopic dermatitis, hidradenitis suppurativa and chronic urticaria: baseline characteristics of the patients included in the OMCCI cohort, a French, prospective multicentre study of chronic inflammatory dermatoses.

Chronic inflammatory dermatoses (CIDs) can significantly affect patients' lives. The Observatory of Chronic Inflammatory Skin Diseases (OMCCI) cohort was initiated to quantify the impact and disease evolution of four CID over 4 years' follow-up; at least 1,000 patients per CID are planned to be enrolled. To present baseline characteristics of patients included in the OMCCI cohort between December 2020 and September 2022. This French, prospective, multicentre registry included adult patients treated in daily practice for moderate-to-severe psoriasis (PS), atopic dermatitis (AD), hidradenitis suppurativa (HS) or chronic urticaria (CU) starting or modifying a systemic treatment. At the inclusion visit and then every 6 months during 4 years, patient-reported outcomes and data on these diseases and their treatments are recorded. A total of 2,058 patients from 24 centers were included: 1,137 PS, 413 AD, 301 HS, and 207 CU. Of these, 1,950 patients started or changed systemic treatment and 108 reduced the dose of existing systemic treatment. Disease impact was qualified as debilitating by 80.1% (PS), 90.5% (AD), 90.5% (HS), and 89.4% (CU), affecting daily, family, and professional life. According to the SF-12 Survey, the impact of all four diseases was borderline pathological for physical health and severe for mental health. At inclusion, 20.4% of patients were receiving a conventional systemic or biologic treatment. After the first visit this percentage raised to 83.3%. During the 6 months preceding study inclusion, 17.7% (PS), 27.9% (AD), 43.1% (HS), and 43.6% (CU) of patients missed work due to their illness, and 26.3% of patients with HS had been admitted to hospital (vs. 8.1%, 5.8%, and 13% of patients with PS, AD, or CU, respectively). These CIDs (especially HS) had a major impact on all aspects of patients' quality of life. The low baseline use of systemic drugs and the high burden of these CIDs suggests that these agents are underused. Long-term and dynamic evaluation of the changes brought by the initiation or optimization of these treatments on the evolution of patients' lives will be studied prospectively during the 4-year follow-up of the OMCCI.

Predictive Factors for Early Immune Recovery in NHL Patients after Autologous Transplantation: A Multicenter Prospective Study

Early lymphocyte recovery as manifested by an absolute lymphocyte count at d+15 (ALC-15) ≥ 0.5 × 109/L after autologous hematopoietic stem cell transplantation (AHCT) has been associated with a better outcome. This prospective multicenter study aimed to clarify factors associated with ALC-15 ≥ 0.5 × 109/L after AHCT among 178 patients with non-Hodgkin lymphoma. The mobilization capacity, as manifested by peak blood CD34+ cell numbers &gt; 45 × 106/L correlated with higher ALC-15 levels (p = 0.020). In addition, the amount of CD3+CD4+ T cells &gt; 31.8 × 106/kg in the infused graft predicted ALC-15 ≥ 0.5 × 109/L (p &lt; 0.001). Also, the number of infused graft CD3+CD8+ T cells &gt; 28.8 × 106/kg (p = 0.017) and NK cells &gt; 4.4 × 106/kg was linked with higher ALC-15 (p &lt; 0.001). The two-year progression-free survival after AHCT was significantly better in patients with ALC-15 ≥ 0.5 × 109/L (74 vs. 57%, p = 0.027). The five-year OS in patients with higher ALC-15 was 78% vs. 60% in those with lower ALC-15 (p = 0.136). To conclude, the mobilization capacity of CD34+ cells and detailed measures of graft cellular content mark prognostic tools that predict ALC-15 ≥ 0.5 × 109/L, which is associated with a better outcome in NHL patients after AHCT.

Association of MRI findings with paraspinal muscles fat infiltration at lower lumbar levels in patients with chronic low back pain: a multicenter prospective study

ObjectiveIn chronic low back pain (CLBP), the relationship between spinal pathologies and paraspinal muscles fat infiltration remains unclear. This study aims to evaluate the relationship between MRI findings and paraspinal muscles morphology and fat infiltration in CLBP patients by quantitative MRI.MethodsAll the CLBP patients were enrolled from July 2021 to December 2022 in four medical institutions. The cross-sectional area (CSA) and proton density fat fraction (PDFF) of the multifidus (MF) and erector spinae (ES) muscles at the central level of the L4/5 and L5/S1 intervertebral discs were measured. MRI findings included degenerative lumbar spondylolisthesis (DLS), intervertebral disc degeneration (IVDD), facet arthrosis, disc bulge or herniation, and disease duration. The relationship between MRI findings and the paraspinal muscles PDFF and CSA in CLBP patients was analyzed.ResultsA total of 493 CLBP patients were included in the study (198 females, 295 males), with an average age of 45.68 ± 12.91 years. Our research indicates that the number of MRI findings are correlated with the paraspinal muscles PDFF at the L4/5 level, but is not significant. Moreover, the grading of IVDD is the primary factor influencing the paraspinal muscles PDFF at the L4-S1 level (BES at L4/5=1.845, P < 0.05); DLS was a significant factor affecting the PDFF of MF at the L4/5 level (B = 4.774, P < 0.05). After including age, gender, and Body Mass Index (BMI) as control variables in the multivariable regression analysis, age has a significant positive impact on the paraspinal muscles PDFF at the L4-S1 level, with the largest AUC for ES PDFF at the L4/5 level (AUC = 0.646, cut-off value = 47.5), while males have lower PDFF compared to females. BMI has a positive impact on the ES PDFF only at the L4/5 level (AUC = 0.559, cut-off value = 24.535).ConclusionThe degree of paraspinal muscles fat infiltration in CLBP patients is related to the cumulative or synergistic effects of multiple factors, especially at the L4/L5 level. Although age and BMI are important factors affecting the degree of paraspinal muscles PDFF in CLBP patients, their diagnostic efficacy is moderate.

A Decalogue on Enhanced Recovery After Breast Augmentation Surgery (ERABAS).

Medical and technical advances have changed the state of postoperative surgical patient care, allowing for better and faster recovery. Since its publication, predictable 24-hour recovery in breast augmentation surgery has been controversial and has generated discussion. In this study, we present a novel, easy, and reproducible protocol for Enhanced Recovery After Breast Augmentation Surgery (ERABAS), along with a summary of the ten points to follow. We conducted a retrospective study of all primary breast augmentation surgeries performed between 2010 and 2020 by a private activity. All surgeries were performed by the same surgeon according to the same protocol, and all implants were obtained from the same company. Data were evaluated using two binary logistic regression models, taking as variables responses to recovery time and postoperative pain and as predictor or explanatory variables to the factors age, smoking, size, and location of the implant. In total, 2906 patients were included in this study. Of these, 2770 patients (95%) immediately returned to normal life within the first 24h, 129 achievednormal life in four days, and only seven needed a week to recover. In these seven patients, the main acute complications were hemorrhage and acute hematoma. The implants were always round; textured implants were used in 88.8% of patients, while smooth implants were used in 11.2%. A subfascial pocket was used in 934 patients, and a dual-plane pocket was performed for 1972 patients. The only factor that showed a significant effect on recovery time was the location of the implant (p < 0.05), with the dual-plane pocket being the intervention associated with a later recovery, specifically a probability of recovery after 24 hour, 2.86 times greater than subfascial. The ERABAS protocol allowed rapid return to daily activities with low complication rates. Further prospective comparative multicenter studies are required to confirm these results. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.