Multicenter Setting Research Articles

Multimodal AI Combining Clinical and Imaging Inputs Improves Prostate Cancer Detection.

Deep learning (DL) studies for the detection of clinically significant prostate cancer (csPCa) on magnetic resonance imaging (MRI) often overlook potentially relevant clinical parameters such as prostate-specific antigen, prostate volume, and age. This study explored the integration of clinical parameters and MRI-based DL to enhance diagnostic accuracy for csPCa on MRI. We retrospectively analyzed 932 biparametric prostate MRI examinations performed for suspected csPCa (ISUP ≥2) at 2 institutions. Each MRI scan was automatically analyzed by a previously developed DL model to detect and segment csPCa lesions. Three sets of features were extracted: DL lesion suspicion levels, clinical parameters (prostate-specific antigen, prostate volume, age), and MRI-based lesion volumes for all DL-detected lesions. Six multimodal artificial intelligence (AI) classifiers were trained for each combination of feature sets, employing both early (feature-level) and late (decision-level) information fusion methods. The diagnostic performance of each model was tested internally on 20% of center 1 data and externally on center 2 data (n = 529). Receiver operating characteristic comparisons determined the optimal feature combination and information fusion method and assessed the benefit of multimodal versus unimodal analysis. The optimal model performance was compared with a radiologist using PI-RADS. Internally, the multimodal AI integrating DL suspicion levels with clinical features via early fusion achieved the highest performance. Externally, it surpassed baselines using clinical parameters (0.77 vs 0.67 area under the curve [AUC], P < 0.001) and DL suspicion levels alone (AUC: 0.77 vs 0.70, P = 0.006). Early fusion outperformed late fusion in external data (0.77 vs 0.73 AUC, P = 0.005). No significant performance gaps were observed between multimodal AI and radiologist assessments (internal: 0.87 vs 0.88 AUC; external: 0.77 vs 0.75 AUC, both P > 0.05). Multimodal AI (combining DL suspicion levels and clinical parameters) outperforms clinical and MRI-only AI for csPCa detection. Early information fusion enhanced AI robustness in our multicenter setting. Incorporating lesion volumes did not enhance diagnostic efficacy.

Patient Satisfaction After 3D Nipple-Areola Complex Tattooing: A Case Series of Hispanic Women Following Breast Reconstruction Surgery.

Breast cancer is a prevalent cancer worldwide, leading many women to undergo mastectomy and breast reconstruction surgery. Nipple-areolar complex (NAC) reconstruction is critical in achieving aesthetic and psychological satisfaction. Recently, three-dimensional (3D) nipple-areola tattooing has become an alternative for this purpose. This study evaluates patient-reported outcomes on satisfaction among Hispanic women who underwent NAC reconstruction using 3D tattooing after breast reconstruction. Data were collected from a retrospective database in multicentric academic settings between 2014 and 2024. Participants included Hispanic women aged 32 to 60 years who received various NAC reconstruction techniques. Follow-up was conducted no more than six months after surgery, utilizing the Breast-Q version 2.0 questionnaire to measure satisfaction in two groups Group 1, in which patients received alternative NAC reconstruction methods, and Group 2, which had 3D nipple-areola tattooing. Patients who underwent 3D nipple-areola tattooing (Group 2) demonstrated increased psychosocial well-being, with a mean score of 84.73 (± 8.56). Regarding surgeon experience, Group 2 achieved a mean score of 86.21 (± 10.33), which was lower than Group 1 mean of 88.70 (± 10.78). Notably, Group 2 expressed greater satisfaction with nipple reconstruction, with a mean score of 3.73 (± 0.44) compared to Group 1 with a mean of 3.48 (± 0.65). The findings indicate that 3D nipple-areola tattooing may enhance aesthetic outcomes of the NAC and psychosocial well-being in Hispanic women. This highlights the importance of incorporating unique techniques in breast reconstruction and the need for a multidisciplinary approach.

Evaluation of a multi-component prevention concept for hazardous substance use among refugees in shared accommodations: study protocol for a cluster randomized controlled trial

BackgroundRefugees are exposed to various risk factors in shared accommodations in Germany where they are housed after their arrival. Due to their often traumatic experiences before, during, and after their flight and socio-structural post-migration stressors, refugees are potentially vulnerable to hazardous substance use. They form a structurally disadvantaged group for substance use prevention and intervention. Various barriers make it difficult for them to access the healthcare system and to get health information. Therefore, a participatory multi-component prevention concept for refugees in shared accommodations was developed. The aim of the trial is to evaluate the efficacy of this concept regarding the increase in knowledge about substance use among refugees living in shared accommodations.MethodsBased on a randomized controlled stepped-wedge design, the study will be conducted in a multicenter setting in nine shared accommodations and will aim to include refugees living in shared accommodations as well as social workers and psychologists working there.DiscussionThis trial will be one of the first to generate evidence about effective participatory prevention concepts for refugees in shared accommodations. Evidence-based concepts for refugees can improve access to health care and might be helpful for the multidisciplinary workforce in shared accommodations.Trial registrationOSF Registry: osf.io/ebnj3. Registered on May 24, 2024. Registration DOI: https://doi.org/10.17605/OSF.IO/EBNJ3.

HPB O06 - A computer tomography-based radiomics signature predicts overall survival following curative resection of colorectal liver metastasis: A multicentre, retrospective study

Abstract Background Colorectal cancer liver metastasis (CRLM) has a heterogeneous outcome and improved prognostic biomarkers are needed to aid patient-tailored management. Here, we assess the value of Computer Tomography (CT)-guided radiomics in the prognostication of post-resection CRLM using data from two large tertiary referral centres in the UK. Method Patient data was extracted from prospectively maintained databases of patients undergoing CRLM resection at two centres. CRLM and regions of interest from background normal liver were segmented. Radiomics features were extracted from portal venous phase CT images using open-source software. Feature selection techniques were applied. Machine learning models incorporating radiomic or clinical features, and their combination, were developed and assessed for mortality prediction at fixed time points. Cox proportional hazard regression was utilised for risk score generation to classify patients as high or low-risk for overall survival estimation. The models were evaluated on unseen testing data. Results Radiomics features (269) were generated from 959 metastases in 399 patients across the two sites. Models with combined clinical and radiomic features performed similarly to those with radiomic features alone, and often outperformed models with clinical features alone demonstrating good discrimination and risk prediction at 2 and 3 years. The computed radiomic scores allowed us to generate Kaplan–Meier curves which showed CRLM patients in the high-risk group had a lower overall survival vs the low-risk group(p&amp;lt;0.05). This risk-score independently predicted mortality in our multivariate Cox proportional-hazards model. Conclusion We demonstrate a robust combination of CT-based radiomics features can predict CRLM outcomes across two different hospital sites. Our radiomic risk-scores predicts overall survival and can prognosticate patients into high and low risk groups. These findings support the prognostic utility of CT-based radiomics in patients undergoing resection of CRLM and provide rationale for further investigation in a prospective, multi-centre setting.

CTNI-27. SYSTEMIC DELIVERY OF LOW ENERGY RADIOFREQUENCY ELECTROMAGNETIC FIELDS FOR THE TREATMENT OF PATIENTS WITH PRIMARY BRAIN TUMORS

Abstract BACKGROUND Tumor Treating Fields plus maintenance temozolomide (mTMZ) showed a survival advantage in the first-line glioblastoma (GBM) treatment. The survival benefit remains limited in patients with unmethylated MGMT gene promoter. The AutEMsys device emits low-energy amplitude modulated systemic electromagnetic fields (EMF) at patient specific frequencies. It is an outpatient procedure that can be integrated with mTMZ. METHODS This study involved a prospective compassionate access program targeting adult GBM patients using an intrabuccal EMF exposure via AutEMsys in addition to chemoRT+mTMZ. The program explored the effects on survival and patients’ reported quality-of-life (QOL) by EORTC-QL-C30. Patients underwent a 90-minute session of EMF exposure therapy repeated every 2 weeks until progression, deterioration in QOL or death. All patients had pathological specimens for diagnosis, IDH mutation status through NGS techniques, and MGMT promoter region methylation status. RESULTS 31 participants were enrolled, including 29 with GBM and 2 with diffuse midline glioma. 14 patients (45%) received EMF+chemoRT followed by EMF+mTMZ and 17 patients (55%) received EMF+mTMZ (post chemoRT). Survival time was measured from the start of mTMZ to the date of the last follow-up. The median overall survival (mOS) for all 31 patients was 26.0 months (95% CI: 14.4 – 37.2 months). Specifically for 21 patients with unmethylated MGMT, the mOS was 25.0 months (95% CI: 15.9 – 34.1 months). Similarly, for the 28 patients with IDH wildtype status, the mOS remained 26.0 months (95% CI: 9.6 – 42.4 months). The addition of AutEMsys with chemoRT+mTMZ demonstrated an improved role functioning in 79% of patients with 25% of these with &amp;gt;10-point score. CONCLUSION The AutEMsys device has shown promising initial results when added to chemoRT+mTMZ treatment of GBM. These findings warrant further prospective investigation and validation in a multicenter clinical trial setting.

Temperature guided high and very high-power short duration ablation for atrial fibrillation treatment - The peQasus multicentre study.

Temperature-controlled high-power short-duration (HPSD) radiofrequency catheter ablation for pulmonary vein isolation (PVI) utilizing a novel ablation catheter (QDOT Micro) with real-time assessment of catheter tip temperature aims for safer, more effective and faster procedures. The peQasus study is a large European multicenter study set up to assess safety, acute efficacy and outcomes of temperature-controlled HPSD based PVI. The primary endpoints were safety, efficacy and 12-months freedom from atrial tachyarrhythmias. Additionally, two strategies namely very HPSD (90W for 4 seconds) only and a hybrid approach (HPSD with maximum of 50W and vHPSD) were compared. A total of 1,023 AF patients in 15 centers from 9 European countries received PVI with the QDOT. Complete PVI was successfully achieved in all patients. In 699/1023 (68.3%) the vHPSD only approach (vHPSD group) and in 324/(31.7%) patients the hybrid approach (hybrid group) was utilized. The mean procedure duration was 98.4±37.4 min (vHPSD: 88.2±34.9min, hybrid: 117.4±32.7min, p<0.001). The first pass isolation rate of all PVs was 64% (vHPSD: 62.6%, hybrid: 67.1%, p=0.187). Severe adverse events were observed in 1.7% (vHPSD: 1.6%, hybrid: 1.9%, p=0.746). 12-month arrhythmia-recurrence free survival was 77.1% (vHPSD: 76.8%, hybrid: 77.8%, p=0.241). In this large multicentre study temperature-controlled HPSD and vHPSD ablation via a novel ablation catheter provides safe and effective PVI with a relatively short procedure duration. Despite a shorter procedure time no differences in terms of safety and freedom from arrhythmia-recurrence were found irrespective of utilizing vHPSD or the hybrid approach.

Integrated Deep Learning Model for the Detection, Segmentation, and Morphologic Analysis of Intracranial Aneurysms Using CT Angiography.

"Just Accepted" papers have undergone full peer review and have been accepted for publication in Radiology: Artificial Intelligence. This article will undergo copyediting, layout, and proof review before it is published in its final version. Please note that during production of the final copyedited article, errors may be discovered which could affect the content. Purpose To develop a deep learning model for the morphologic measurement of unruptured intracranial aneurysms (UIAs) based on CT angiography (CTA) data and validate its performance using a multicenter dataset. Materials and Methods In this retrospective study, patients with CTA examinations, including those with and without UIAs, in a tertiary referral hospital from February 2018 to February 2021 were included as the training dataset. Patients with UIAs who underwent CTA at multiple centers between April 2021 to December 2022 were included as the multicenter external testing set. An integrated deep-learning (IDL) model was developed for UIA detection, segmentation and morphologic measurement using an nnU-net algorithm. Model performance was evaluated using the Dice similarity coefficient (DSC) and intraclass correlation coefficient (ICC), with measurements by senior radiologists serving as the reference standard. The ability of the IDL model to improve performance of junior radiologists in measuring morphologic UIA features was assessed. Results The study included 1182 patients with UIAs and 578 controls without UIAs as the training dataset (55 years [IQR, 47-62], 1,012 [57.5%] females) and 535 patients with UIAs as the multicenter external testing set (57 years [IQR, 50-63], 353 [66.0%] females). The IDL model achieved 97% accuracy in detecting UIAs and achieved a DSC of 0.90 (95%CI, 0.88-0.92) for UIA segmentation. Model-based morphologic measurements showed good agreement with reference standard measurements (all ICCs > 0.85). Within the multicenter external testing set, the IDL model also showed agreement with reference standard measurements (all ICCs > 0.80). Junior radiologists assisted by the IDL model showed significantly improved performance in measuring UIA size (ICC improved from 0.88 [0.80-0.92] to 0.96 [0.92-0.97], P < .001). Conclusion The developed integrated deep learning model using CTA data showed good performance in UIA detection, segmentation and morphologic measurement and may be used to assist less experienced radiologists in morphologic analysis of UIAs. ©RSNA, 2024.

Effectiveness of transitional care in Inflammatory Bowel Disease; Development, Validation, and Initial outcomes of a Transition Success Score.

The effectiveness of transition programs from paediatric to adult healthcare in adolescents with inflammatory bowel disease is not clear, as prospective studies using validated outcome measures for transition are lacking. This study aimed to develop and validate a quantitative Transition Success Score, and to apply it in a multicenter setting to assess the effectiveness of transitional care. The Top 10 outcome items related to successful transition, identified through an international Delphi study with IBD stakeholders, were integrated into a generic questionnaire, the Transition Success Score. In a prospective, multicenter study, Transition Success Score was scored by adult healthcare providers, young adult patients and caregivers, 9-15 months after transfer of care. In seven Dutch hospitals, 160 patients completed the Transition Success Score. The mean score was 25 (range 17-27), 25.6% of patients achieving maximum score. Hypothesis testing for construct validity revealed significant associations with characteristics related to transitional care, such as knowledge, independence, and quality of life (p <0.005). Structural validation indicated the score was most effective at discerning lower levels of transition success. Internal consistency was acceptable (0.64). High disease burden, exacerbation during or after transfer, and certain personality profiles were associated with lower scores. The Transition Success Score serves as a quantitative tool to evaluate the effectiveness of transitional care interventions and to identify inflammatory bowel disease patients at risk of encountering challenges during the transition to adult healthcare.

Parental Perspectives From the Survey of Sleep Quality in the PICU Validation Study on Environmental Factors Causing Sleep Disruption in Critically Ill Children.

Sleep promotion bundles being tested in PICUs use elements adapted from adult bundles. As children may react differently than adults in ICU environments, this study investigated what parents report disrupted the sleep of their child in a PICU. Secondary analysis of a multicenter validation study of the Survey of Sleep quality in the PICU. Four Northeastern U.S. PICUs, one hospital-based pediatric sleep laboratory. Parents sleeping at the bedside of a child in the PICU or hospital-based sleep laboratory. Anonymous one-time survey eliciting parts of hospital or ICU environments that have been described as disruptive to sleep in validated adult ICU and pediatric inpatient questionnaires. Level of sleep disruption was scored by Likert scale, with higher scores indicating more disruption. Age, demographics, baseline sleep, and PICU exposures were used to describe causes of sleep disruption in a PICU. Of 152 PICU parents, 71% of their children's sleep was disrupted significantly by at least one aspect of being in the PICU. The most prevalent were "being in pain or uncomfortable because they are sick" (38%), "not sleeping at home" (30%), "alarms on machines" (28%), and "not sleeping on their home schedule" (26%). Only 5% were disrupted by excessive nocturnal light exposure. Overall sleep disruption was not different across four PICUs or in those receiving sedation. The validation study control group, healthy children undergoing polysomnography, had less sleep disruption than those in a PICU despite sleeping in a hospital-based sleep laboratory. There are multiple aspects of critical care environments that affect the sleep of children, which are different from that of adults, such as disruption to home schedules. Future interventional sleep promotion bundles should include sedated children and could be applicable in multicenter settings.

Generalizable Magnetic Resonance Imaging-based Nasopharyngeal Carcinoma Delineation: Bridging Gaps Across Multiple Centers and Raters With Active Learning

PurposeTo develop a deep learning (DL) method exploiting active learning and source-free domain adaptation for gross tumor volume (GTV) delineation in nasopharyngeal carcinoma (NPC), addressing the variability and inaccuracy when deploying segmentation models in multi-center and multi-rater settings. Materials and Methods1057 MRI scans of NPC patients from five hospitals were retrospectively collected and annotated by experts from the same medical group with consensus for multi-center adaptation evaluation. One dataset was used for model development (source domain), with the remaining four for adaptation testing (target domains). Meanwhile, another 170 NPC patients with annotations delineated by four independent experts were built for multi-rater adaptation evaluation. We evaluated the pre-trained model's migration ability to the four multi-center and four multi-rater target domains. Dice similarity coefficient (DSC), 95% Hausdorff distance (HD95) and other metrics were used for quantitative evaluations. ResultsIn the adaptation of dataset5 to other datasets, our source-free active learning adaptation method only requires limited labeled target samples (only 20%) to achieve a median DSC ranging from 0.70 to 0.86 and a median HD95 ranging from 3.16mm to 7.21mm for four target centers, and 0.78 to 0.85 and 3.64mm to 6.00mm for four multi-rater datasets. For DSC, our results for three of four multi-center datasets and all multi-rater datasets showed no statistical difference compared to the fully supervised U-Net model (P-values > 0.05) and significantly surpassed comparison models for three multi-center datasets and all multi-rater datasets (P-values < 0.05). Clinical assessment showed that our method-generated delineations can be used both in multi-center and multi-rater scenarios after minor refinement (revision ratio < 10% and median time < 2 minutes). ConclusionThe proposed method effectively minimizes domain gaps and delivers encouraging performance compared with fully supervised learning models with limited labeled training samples, offering a promising and practical solution for accurate and generalizable GTV segmentation in NPC.

Conduction-System pacing Italian Network Group (C-SING): insights from a Nationwide Multicenter Observational Study

Abstract Background/Introduction Conduction system pacing (CSP), encompassing His bundle pacing (HBP) and left bundle branch area pacing (LBBAP), has gained prominence in treating bradycardia and heart failure in recent years. Despite its increasing utilization, data on real-world adoption of CSP are limited. Purpose The C-SING study aimed at assessing patient characteristics, implant success, procedural details, and safety of CSP when performed in routine clinical practice. Methods Periprocedural data from 27 experienced CSP centers across Italy were collected on patients undergoing CSP implantation for various indications between January 2021 and January 2024. Results The study comprised 1,317 patients (median age 78 years [interquartile range, 71-83], male 66.2%). Leading indications included atrioventricular (AV) block (40.8%), sinus node dysfunction (12.1%), atrial fibrillation with bradycardia (9.7%), AV node ablation (9.5%), and heart failure (12.5%). Pacemakers were implanted in 77.3% of patients, cardiac resynchronization devices in 21.7%, and implantable cardioverter-defibrillators in 1.0%. Stylet-driven and lumenless CSP leads were utilized in 64.7% and 35.3% of procedures, respectively. Final 12-lead ECG assessment revealed LBBAP capture in 88.7% patients, HBP in 8.4% (selective 4.2%, non-selective 4.2%), and no CSP capture in 3.0%, resulting in a 97.0% CSP lead implantation success rate. In patients with LBBAP, predominant capture types were left bundle branch pacing (19.6%), left posterior fascicular pacing (19.2%), and left septal fascicular pacing (14.8%). Comparing HBP to LBBAP, the latter showed shorter procedural time (60 minutes [45-80] vs. 70 minutes [60-95], p=0.003), but similar fluoroscopy time (6.0 minutes [3.3-10.8] vs. 6.1 minutes [4-10], p=0.735). Paced QRS duration was longer in LBBAP (118 ms [105-130]) compared to HBP (110 ms [101-122], p&amp;lt;0.001). LBBAP showed lower capture thresholds (0.6 V [0.5-0.9] @0.4 ms vs. 0.8 V [0.5-1.5] @1.0 ms, p&amp;lt;0.001) and higher R-wave sensing (10.7 mV [8-16] vs. 4.5 mV [2.4-9.9], p&amp;lt;0.001). The rate of periprocedural complications was higher in patients with LBBAP than HBP (7.3% vs. 1.8%, p=0.03), with the most frequent events being intraprocedural perforation into the left ventricular cavity during lead screwing (2.6%) and CSP lead dislodgment before hospital discharge (1.4%). These occurrences necessitated lead repositioning without additional complications. Conclusion CSP demonstrated feasibility as a primary pacing strategy for various indications in a real-world, multicenter setting. LBBAP, more frequently used than HBP, exhibited shorter procedural time and superior acute electrical parameters. LBBAP revealed a higher rate of minor procedural complications than HBP. Further investigations, supported by additional long-term outcome data, are essential to comprehensively assess CSP performance.

Feasibility and efficacy assessment of a novel size-adjustable cryoballoon for ablation of atrial fibrillation in a multicenter clinical setting

Abstract Background The POLARx-FIT cryoballoon (CB) system introduces a unique feature, allowing the selection of two distinct balloon sizes within a single catheter. This innovation holds promise for treating larger pulmonary veins (PV), providing increased flexibility to achieve optimal occlusions. However, there is a scarcity of clinical data supporting its application in this context. Purpose To compare the benefits and safety of the new POLARx-FIT system to those of the existing POLARx system currently in use for PV isolation (PVI) in patients with atrial fibrillation (AF). Methods The first 140 consecutive patients who underwent CB-based PVI with the POLARx-FIT system were retrospectively compared with 300 consecutive patients treated with the POLARx system. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred &amp;gt;60 sec or when time to isolation was not available. The ablation endpoint was PVI as assessed by entrance and exit block. In the POLARx-FIT group the choice of balloon size (28 or 31 mm) was determined during the procedure while attempting to occlude each vein. Results Two-thousand one-hundred fifty-five cryo-applications (CBA) from 440 patients were analysed (300, 68.2% POLARx; 140, 31.8% POLARx-FIT). PVI was achieved with cryoablation only in all patients. The mean number of freeze applications per patient was similar between groups (5.0±1.4 in the POLARx-FIT vs 5.3±1.8 in the POLARx group, p=0.207) whereas the number of PVs treated in a single-shot fashion was higher in the POLARx-FIT group (444, 80.7% with one shot; 75, 13.7% with 2 shots; 31, 5.6% with more than 2 shots) than in the POLARx one (1168, 70.2% with one shot, p=0.0002; 294, 17.7% with two shots and 143, 8.6% with more than two shots). Among the POLARx-FIT cases, in 54.2% (n=298) of applications, the 31-mm diameter was employed as a first choice, while in the remaining 45.8% (n=252) of applications, the 28-mm diameter was adopted. A switch to a different balloon diameter was applied in 11.6% of cases. The first pass isolation (i.e. a single shot CBA to achieve PVI) was slightly higher when using a 31 mm diameter (n=250, 83.9%) than a 28 mm diameter (n=194, 77.0%, p=0.05). Three (0.7%) transient phrenic nerve palsy were observed (all in the POLARx group, 0.9%, p=0.554), with full recovery in the 48-h post procedure; no major procedure-related adverse events were reported at 30 days post-procedure. Conclusion In this first multicentric experience in a clinical practice setting, this novel cryo-balloon system proved to be safe and effective and resulted in a high proportion of successful single-freeze isolation. The intraprocedural flexibility of balloon size contributed to its versatility, leading to a variation in balloon diameter in about 12% of freeze applications.

A multicenter study of clinical predictors of positive pyrophosphate scintigraphy findings in the diagnosis of transthyretin amyloidosis

BackgroundThe prevalence of wild-type transthyretin (ATTR) amyloidosis is increasing with advancements in diagnostic techniques and growing awareness of the disease worldwide. 99mTc-labeled pyrophosphate (99mTc-PYP) scintigraphy exhibits high performance in diagnosing ATTR cardiac amyloidosis. This study aimed to validate the characteristics of patients with positive 99mTc-PYP scintigraphy results in a multicenter setting to provide more accurate case selection criteria. Methods and resultsIn total, 180 patients with suspected ATTR amyloidosis underwent 99mTc-PYP scintigraphy in participating institutions in Japan between January 2018 and July 2022. Of 135 patients included in the analysis, 62 were 99mTc-PYP-positive. Logistic regression analysis was performed, and the following five factors were adopted to create a scoring system, with each weighted according to its odds ratio value; 1 point was scored for the absence of hypertension, existence of peripheral entrapment neuropathy (carpal tunnel syndrome or spinal canal stenosis), conduction disturbance (the presence of QRS complex ≥120 ms, first-degree atrioventricular block, higher degree of atrioventricular block, or presence of pacemaker implantation), and left ventricular hypertrophy and 2 points for troponin I/T ≥ 0.06 ng/mL. 99mTc-PYP scintigraphy positivity rate in the 0-point group was 0 %, whereas that in the 6-point group was 100 %. The area under the curve of the criteria was 0.820 (95 % confidence interval, 0.752–0.888; P < 0.001). ConclusionsThe combination of clinical information, which is easily available in local clinics, can provide accurate pretest prediction of positive 99mTc-PYP scintigraphy results. This will help clinicians to make an early diagnosis of ATTR amyloidosis.

Multicenter validation of automated detection of paramagnetic rim lesions on brain MRI in multiple sclerosis.

Paramagnetic rim lesions (PRLs) are an MRI biomarker of chronic inflammation in people with multiple sclerosis (MS). PRLs may aid in the diagnosis and prognosis of MS. However, manual identification of PRLs is time-consuming and prone to poor interrater reliability. To address these challenges, the Automated Paramagnetic Rim Lesion (APRL) algorithm was developed to automate PRL detection. The primary objective of this study is to evaluate the accuracy of APRL for detecting PRLs in a multicenter setting. We applied APRL to a multicenter dataset, which included 3-Tesla MRI acquired in 92 participants (43 with MS, 14 with clinically isolated syndrome [CIS]/radiologically isolated syndrome [RIS], 35 without RIS/CIS/MS). Subsequently, we assessed APRL's performance by comparing its results with manual PRL assessments carried out by a team of trained raters. Among the 92 participants, expert raters identified 5637 white matter lesions and 148 PRLs. The automated segmentation method successfully captured 115 (78%) of the manually identified PRLs. Within these 115 identified lesions, APRL differentiated between manually identified PRLs and non-PRLs with an area under the curve (AUC) of.73 (95% confidence interval [CI]: [.68,.78]). At the subject level, the count of APRL-identified PRLs predicted MS diagnosis with an AUC of.69 (95% CI: [.57,.81]). Our study demonstrated APRL's capability to differentiate between PRLs and lesions without paramagnetic rims in a multicenter study. Automated identification of PRLs offers greater efficiency over manual identification and could facilitate large-scale assessments of PRLs in clinical trials.

Modern CRRT systems are associated with lower risk of hypothermia.

One risk of continuous renal replacement therapy (CRRT) is inadvertent hypothermia (IH), which is defined as a non-therapeutic core temperature decrease below normal. In continuous renal replacement therapy, heat loss will always occur from blood pumped through the dialysis circuit to cooler environment, predisposing for hypothermia. Blood flow and effluent flows are the most important parameters causing heat loss. We investigated and compared the novel TherMax warmer to previous generation technologies during CRRT in a multicenter setting. This was a prospective observational multicenter study with historic single-center controls. The study group consisted of 100 patients in eight Swedish ICUs with clinical indication for CRRT, using the PrisMax platform and TherMax warmer. Both patient and set warmer temperatures were recorded hourly for the first 24h. The presence of treatment hours in hypothermia (< 36.0 Celsius) and the difference between set warmer temperature and measured patient temperature in the multi-center study cohort were compared to a matched single-center historic control cohort treated with the old Prismaflex platform and adjacent Barkey warmer. In the TherMax group 77/100 (77.0%) of patients, and for controls 26/86 (30.2%) of patients were free of hypothermia (Chi square, p < 0.001). The mean number of hours spent in hypothermia was (mean ± SD) 0.66 ± 1.60 and 6.92 ± 7.79h in the TherMax and control groups, respectively (Chi square p < 0.001).In the study group the patient temperature was higher than the set temperature on the warmer with a difference of Δ0.47 ± 0.80°C (minor difference), whereas in the control group the set temperature on the warmer was higher than the patient temperature with a difference of Δ4.55 ± 1.00°C (over-correction).The novel TherMax warmer technology protected against hypothermia and was significantly more accurate than the Barkey warmer.

Stress CMR Perfusion Imaging in the Medicare-Eligible Population: Insights From the SPINS Study.

Patients aged ≥65 years account for a disproportionately large portion of cardiovascular (CV) events and pose a challenge for noninvasive detection of coronary artery disease. This study sought to determine the prognostic value of stress cardiac magnetic resonance (CMR) in a Medicare-eligible group of patients in a multicenter setting in the United States. From a multicenter U.S. registry, the study identified patients aged≥65 years who were referred for stress CMR for evaluation of myocardial inducible ischemia. The primary outcome was defined as CV death or nonfatal myocardial infarction, whereas the secondary outcome was defined as any primary outcome, hospitalization for unstable angina, hospitalization for congestive heart failure, and unplanned late coronary artery bypass grafting. The associations of CMR findings with CV outcomes adjusted to clinical risk markers and health care cost spending were determined. Among 1,780 patients (aged 73 ± 5.7 years; 46% female), study investigators observed 144 primary eventsand 323 secondary events, over a median follow-up of 4.8 years. The presence of inducible ischemia and late gadolinium enhancement (LGE) was associated with incrementally higher event rates. Patients with neither inducible ischemia nor LGE experienced a<1% annualized rate of primary outcome. In a multivariable model adjusted for CV risk factors, inducible ischemia and LGE maintained an independent association with primary (HR: 2.80 [95%CI: 1.93-4.05]; P< 0.001; and HR: 1.85 [95%CI: 1.21-2.82]; P = 0.004, respectively) and secondary (HR: 2.46 [95%CI: 1.90-3.19]; P< 0.001; and HR: 1.72 [95%CI: 1.30-2.27]; P< 0.001, respectively) outcomes. Rates of revascularization, as well as downstream costs for patients without CMR-detected inducible ischemia, remained low throughout the follow-up period. In a multicenter cohort of Medicare-eligible older patients, stress CMR was effective in providing risk stratification. (Stress CMR Perfusion Imaging in the United States [SPINS] study; NCT03192891).

The Multi-Country Multi-City Collaborative Research Network: An international research consortium investigating environment, climate, and health.

Research on the health risks of environmental factors and climate change requires epidemiological evidence on associated health risks at a global scale. Multi-center studies offer an excellent framework for this purpose, but they present various methodological and logistical problems. This contribution illustrates the experience of the Multi-Country Multi-City Collaborative Research Network, an international collaboration working on a global research program on the associations between environmental stressors, climate, and health in a multi-center setting. The article illustrates the collaborative scheme based on mutual contribution and data and method sharing, describes the collection of a huge multi-location database, summarizes published research findings and future plans, and discusses advantages and limitations. The Multi-Country Multi-City represents an example of a collaborative research framework that has greatly contributed to advance knowledge on the health impacts of climate change and other environmental factors and can be replicated to address other research questions across various research fields.

Efficacy and Tolerance of First-Line Afatinib in Elderly NSCLC Patients with EGFR Mutations in Vietnam: A Multicenter Real-World Study.

Afatinib, a second-generation epidermal growth factor receptor(EGFR) tyrosine kinase, has proven effective for non-small-cell lung cancer (NSCLC) patients with EGFR mutations through randomized controlled trials and real-world studies. Elderly patients exhibit unique characteristics in terms of physical condition and comorbidities, leading to differences in clinical practice for selecting the initial dosage and making dose adjustments compared to younger patients. This study aims to evaluate the effectiveness and adverse effects of first-line Afatinib treatment in elderly patients with NSCLC harboring EGFR mutations in Vietnam in a real-world context. We conducted a retrospective analysis of 135 patients, aged 65 years and older, across nine cancer centers in Vietnam. These patients, who harbored drug-sensitive EGFR mutations (excluding de novo T790M), received first-line Afatinib treatment between April 2018 and June 2022. The primary endpoints, time to treatment failure (TTF), and overall survival (OS) were assessed using the Kaplan-Meier method, and comparisons were conducted using the log-rank test. Secondary endpoints included the overall response rate (ORR) according to RECIST 1.1 and adverse effects as classified by CTCAE 4.0. The median age was 71.2 years (SD ± 5.3). Comorbidities included cardiovascular disease (20.7%), diabetes (5.2%), chronic obstructive pulmonary disease (2.2%), and hepatitis B (0.7%). Common mutations constituted 71.9% of cases, with uncommon mutations representing 28.1%. Brain metastases were observed in 24.4% of patients. Initial treatment doses were 40 mg for 35.6% of patients and 30 mg for 62.2%. With a median follow-up of 34.3 months, the median TTF was 16.3 months (95% CI: 15.4-19.5), and the median OS was 32.9 months (95% CI: 28.9-37.5). Factors associated with decreased OS included poor performance status, current smoking, and the presence of uncommon mutations. The ORR was 77.8%, with a complete response of 11.1% and a disease control rate of 94.1%. The most common toxicities were dermatologic and mucosal, including diarrhea (55.6%), rash (48.9%), and stomatitis (40.7%), predominantly in grades 1 and 2. Initiating treatment at doses below 40 mg significantly reduced most toxicities compared to the 40 mg dose. The presence of brain metastases did not significantly affect ORR, TTF, or OS. Starting treatment at doses below 40 mg significantly lowered the response rate but did not impact TTF or OS. First-line treatment with Afatinib in elderly patients with NSCLC and EGFR mutations demonstrates significant efficacy and manageable toxicity in a Vietnamese multicenter real-life setting. The effectiveness of Afatinib was confirmed, with known and well-controlled adverse effects, supporting its use in this patient population.

Preoperative Psychopharmacological Treatment Is Not a Risk Factor for Poorer Patient-Reported Improvements 12 months After Hip or Knee Arthroplasty: A Multicenter Registry-Based Cohort Study of 7,247 Procedures

BackgroundPreoperative psychopharmacological treatment (PPT) has been associated with increased hospital length of stay and readmission rate after hip and knee arthroplasty. However, little is known regarding the association between PPT and improvements in patient-reported outcomes postoperatively in a multicenter fast-track setting. Thus, the primary objective was to investigate whether PPT is a risk factor for poorer patient-reported improvements 12 months after surgery. Secondary objectives included assessment of additional time points and subgroups of PPT. MethodsThis multicenter registry-based cohort study included 4,021 primary hip and 3,226 primary knee arthroplasties performed from 2016 to 2020 at three fast-track departments in Denmark due to primary osteoarthritis. The Oxford Hip Score/Oxford Knee Score (OHS/OKS), EuroQol-5 Dimensions-3 Levels/EuroQol-5 Dimensions-5 Levels, and EuroQol visual analog scale were collected at baseline and 3, 6, 12, and 24 months after surgery. Exposure status was assigned using the Danish National Prescription Registry. Marginal mean differences (MD) with 95% confidence intervals (CIs) were estimated using multilevel Tobit regression and adjusted for age, sex, and the Charlson Comorbidity Index obtained from the Danish National Patient Register. ResultsNo associations were found between PPT and improvements in OHS (MD −0.5, CI −1.4 to 0.4) or OKS (MD −0.3, CI −1.2 to 0.5) after 12 months. However, PPT was associated with lower baseline OHS (MD −1.4, CI −2.2 to −0.6) and OKS (MD −2.1, CI −2.9 to −1.3), and 12 months follow-up OHS (MD −1.9, CI −2.8 to −1.1) and OKS (MD −2.4, CI −3.2 to −1.6). Similar findings were observed at other time points, using EuroQol-5 Dimensions-3 Levels/EuroQol-5 Dimensions-5 Levels or EuroQol visual analog scale, and when evaluating PPT subgroups. ConclusionsIn hip and knee arthroplasty, PPT was not a risk factor for poorer patient-reported improvements 12 months after surgery. However, PPT was associated with marginally poorer baseline and follow-up scores. Thus, arthroplasties remain effective treatments despite PPT from a patient-centered perspective.

Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT.

Opioids kill more people than any other drug. Naloxone is an opioid antagonist which can be distributed in take-home 'kits' for peer administration (take-home naloxone). To determine the feasibility of carrying out a definitive randomised controlled trial of take-home naloxone in emergency settings. We used Welsh routine data (2015-21) to test the feasibility of developing a discriminant function to identify people at high risk of fatal opioid overdose. We carried out a cluster randomised controlled trial and qualitative study to examine experiences of service users and providers. We assessed feasibility of intervention and trial methods against predetermined progression criteria related to: site sign-up, staff trained, identification of eligible patients, proportion given kits, identification of people who died of opioid poisoning, data linkage and retrieval of outcomes. This study was carried out in the emergency environment; sites comprised an emergency department and associated ambulance service catchment area. At intervention sites, we invited emergency department clinicians and paramedics to participate. We recruited adult patients who arrived at the emergency department or were attended to by ambulance paramedics for a problem related to opioid use with capacity to consent to receiving the take-home naloxone and related training. Usual care comprised basic life support plus naloxone by paramedics or emergency department staff. The take-home naloxone intervention was offered in addition to usual care, with guidance for recipients on basic life support, the importance of calling the emergency services, duration of effect, safety and legality of naloxone administration. With low numbers of opioid-related deaths (1105/3,227,396) and a high proportion having no contact with health services in the year before death, the predictive link between death and opioid-related healthcare events was weak. Logistic regression models indicated we would need to monitor one-third of the population to capture 75% of the decedents from opioid overdose in 1-year follow-up. Four sites participated in the trial and 299 of 687 (44%) eligible clinical staff were trained. Sixty take-home naloxone kits were supplied to patients during 1-year recruitment. Eligible patients were not offered take-home naloxone kits 164 times: 'forgot' (n = 136); 'too busy' (n = 15); suspected intentional overdose (n = 3). Service users had high levels of knowledge about take-home naloxone. They were supportive of the intervention but noted concerns about opioid withdrawal and resistance to attending hospital for an overdose. Service providers were positive about the intervention but reported barriers including difficulty with consenting and training high-risk opioid users. We were able to calculate costs to train staff at three sites (£40 per AS and £17 in Site 1 ED). No adverse events were reported. Progression criteria were not met - fewer than 50% of eligible staff were trained, fewer than 50% of eligible patients received the intervention and outcomes were not retrieved within reasonable timescales. The take-home naloxone intervention needs to be developed and evaluated in emergency care settings, with appropriate methods. The Take-home naloxone Intervention Multicentre Emergency setting study was interrupted by coronavirus disease. This study did not meet progression criteria for intervention or trial methods feasibility, so outcomes were not followed up and a fully powered trial is not planned. This trial is registered as ISRCTN13232859. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/91/04) and is published in full in Health Technology Assessment; Vol. 28, No. 74. See the NIHR Funding and Awards website for further award information.