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Background This study aimed to describe the efficacy of veno-arterial extracorporeal life support (VA-ECLS) through early lactate clearance and pH restoration and assess the potential association with 30-day survival following hospital discharge. Methods Data of patients receiving VA-ECLS for at least 24 h were retrospectively compiled. Blood lactate levels, liver enzymes, and kidney parameters prior to VA-ECLS initiation and at 2, 8, 14, 20, and 26 h of support had been recorded as part of clinical care. The primary outcome was 30-day survival. Results Of 77 patients who underwent VA-ECLS for refractory cardiogenic shock, 44.2% survived. For all non-survivors, ECLS was initiated after eight hours ( p = .008). Blood pH was significantly higher in survivors compared to non-survivors at all time points except for pre-ECLS. Lactate levels were significantly lower in survivors (median range 1.95-4.70 vs 2.90-6.70 mmol/L for survivors vs non-survivors, respectively). Univariate and multivariate analyses indicated that blood pH at 24 h (OR 0.045, 95% CI: 0.005-0.448 for pH

Introduction One out of four former preeclamptic women shows aberrant cardiac remodelling consistent with subclinical heart failure (HF). These women are prone for the development of remote symptomatic HF, stressing the need to develop a predictive multimarker model for persistent aberrant cardiac geometry postpartum. Objective To develop a potential predictive multimarker model for aberrant cardiac remodelling in former PE patients. Methods In this cross-sectional study, we included 752 women with a history of PE. These women underwent cardiovascular screening between 6 months and 5 years postpartum consisting of echocardiography, systolic and diastolic blood pressure (sys- and diasBP), plasma volume (PV) measurements and venapunction to assess uric acid, C-reactive protein (CRP) and fibrinogen. Determinants for cardiac geometry (left ventricular mass (LVM) and relative wall thickness (RWT)) where assessed with cardiac ultrasound. We used ANCOVA to perform univariate and multivariate analysis. Results Multivariable analysis showed that both SysBP and PV were independently correlated with RWT and LVMi ((b = 0.06, 95% CI 0.03–0.08 and b = 26.24, 95%CI18.07–34.41, P < 0.01 respectively) and (b = 0.02 95% CI = 0.04–0.00, P < 0.05 and b = 9.01, 95% CI = 2.81–15.35, P < 0.01 respectively). CRP ((b = 0.00, 95% CI = 0.00–0.01, P< 0.01) and uric acid ((b = 0.02, 95% CI = 0.00–0.03, P < 0.05) where only independently related to RWT. Fibrinogen did not relate to either LVMi or RWT. Discussion This study shows a potential role for SysBP, PV, CRP, and uric acid as markers to predict persistent aberrant cardiac remodelling in former preeclamptic women. Future studies should evaluate the predictive value of this model prospectively. [ABSTRACT FROM AUTHOR]

Objective: To examine (a) the association between metabolic factors and chronic musculoskeletal pain (CMP), (b) metabolic predictors of CMP 10 years later, and (c) the association and evolution of metabolic factors across different CMP trajectory groups., Design: Data from the longitudinal Doetinchem Cohort Study were used. We used round 4 (2003-2007), with 4519 participants aged 36-75 years, as the baseline for the present study, with follow-up measurements in round 5 (2008-2012), and 6 (2013-2017), including self-reported pain and metabolic factors, which were measured either via self-report or physical assessment. For the three research aims, (a) generalized linear mixed-effects models, (b) binary logistic regression analyses and (c) linear mixed-effects models were used., Results: (a) Female sex, higher age, presence of diabetes, higher BMI, lower diastolic blood pressure (BP), and elevated cystatin C were significantly associated with CMP in multivariable logistic analyses. (b) Female sex and elevated BMI were predictors of CMP 10 years later. (c) Those pain-free for 10 years had the lowest BMI levels compared to other CMP groups (development, recovery, persistent, and recurrent CMP). BMI was higher in the persistent CMP group than in the development and recovery groups. The pain-free group had higher diastolic BP compared to those in the persistent CMP group. Participants in the persistent CMP group had higher Cystatin C levels than the free, development and recovery CMP groups. Regarding the evolution of metabolic factors over time, BMI, glucose and diastolic BP evolved differently across the CMP trajectory groups., Conclusion: Our findings indicate the importance of metabolic factors, especially BMI, in the onset and progression of CMP. These findings underscore the need to consider metabolic health in the prevention and treatment of CMP. Key Points • Metabolic factors are associated with the presence of chronic musculoskeletal pain. • Female sex and elevated BMI are predictive of musculoskeletal pain (MP) 10 years later. • Metabolic factors evolve differently over time across different pain trajectory groups, with variations in BMI, glucose, and diastolic blood pressure., Competing Interests: Declarations. Conflict of interest: The authors declare that they have no conflict of interest., (© 2024. The Author(s), under exclusive licence to International League of Associations for Rheumatology (ILAR).)

Objectives: Previous analyses of the volume-outcome relationship have focused on short-term outcomes such as early mortality. The current study aims to update a novel statistical methodology, facilitating the evaluation of the relation between procedural volume and time-to-event outcomes such as long-term survival, using surgery for acute type A aortic dissection as an illustrative example., Methods: This study employed an existing dataset of type A dissection outcomes, retrieved from literature. Studies were included when reporting on annual case load and long-term survival, which served as the primary outcome of interest. Individual patient data were reconstructed from the included studies, and a hazard ratio was determined per study in relation to overall survival, after which the calculated hazard ratios were incorporated in a restricted cubic spline model, facilitating the application of the elbow-method., Results: Fifty-two studies were included (n = 14878 patients), with a median follow-up of 5 years. One-, 3-, 5-, and 10-year survival of the overall cohort were 82% (95% CI 82-83%), 79% (95% CI 78-80%), 74% (95% CI 74-75%), and 60% (95% CI 59-62%) respectively. A significant non-linear volume-outcome relation for long-term survival was observed in both the unadjusted and adjusted analyses (p = 0.030 and p = 0.002), with an optimal annual case load of 32 cases/year (95% CI 31-33)., Conclusions: Based on the available data, these findings imply that the annual case volume to achieve optimal long-term survival is located near a procedural volume of 32 cases/year. After accrual of more annual procedures, long-term survival may no longer significantly improve any further., (© The Author(s) 2025. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background: More self-efficacy leads to greater confidence in one's ability to perform actions to achieve treatment goals. Therefore, self-efficacy may affect patient recovery and health-related quality of life (HRQoL) after ICU discharge., Aim: In a cohort of mechanically ventilated COVID-19 survivors, we examined the associations between self-efficacy at 3 months and HRQoL at 3, 12 and 24 months after discharge., Study Design: Mechanically ventilated survivors of the MaastrICCht cohort that completed a self-efficacy assessment with the General Self-Efficacy Scale (GSES) were included. HRQoL was measured using the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L), subdivided into a health utility score (EQ-HUS) and visual analogue scale (EQ-VAS). Linear regression models were used to investigate associations between self-efficacy and HRQoL and were adjusted for age, sex, body mass index (BMI), Acute Physiology and Chronic Health Evaluation II (APACHE II) score, ICU length of stay and hospital discharge location., Results: In 87 ICU survivors, more self-efficacy at 3 months after ICU discharge was associated with longitudinally higher EQ-HUS (β = 0.01; 95% CI: 0.01-0.02; p < 0.001) and higher EQ-VAS (β = 1.00; 95% CI: 0.66-1.35; p < 0.001) up to 2 years after ICU discharge. After adjustment for age, sex, BMI, APACHE II score, ICU length of stay, and hospital discharge location, associations were similar., Conclusions: More self-efficacy at 3 months after ICU discharge was associated with longitudinally higher HRQoL up to 2 years after ICU discharge in mechanically ventilated COVID-19 survivors., Relevance to Clinical Practice: Screening for self-efficacy in patients post-ICU as well as developing interventions to improve self-efficacy are a target post-ICU to enhance HRQoL over the long term., (© 2025 The Author(s). Nursing in Critical Care published by John Wiley & Sons Ltd on behalf of British Association of Critical Care Nurses.)

Background: Regional lymph node (LN) status is a key prognostic factor in oesophageal cancer (OeC). Tumour-derived antigens can activate immune reactions in LNs, potentially reflecting the host's anti-tumour immune response. It remains unclear whether this response is homogeneous across all tumour negative LNs (LNneg) within individual OeC patients., Purpose: To investigate the hypotheses: (1) the host anti-tumour immune response is similar in all LNneg from an individual OeC patient reflected in a similar microarchitecture in all LNneg; and (2) immune response measured in the largest LNneg can represent that of all LNnegs., Methods: (y)pN0 patients from the Oe02 trial with at least two LNneg were included. Microarchitectural LN features (germinal centres (GermC), lymphocytes outside GermCs (lymphocytes), histiocytes) were morphometrically quantified. Linear mixed-effects models, intraclass correlation coefficients (ICC) and Bland-Altman plots were used to determine systematic bias, reliability/variability and agreement of LNneg microarchitecture measurements., Results: Linear mixed-effects models showed no systematic bias in LNneg microarchitectural features within a patient. The ICC revealed moderate variability for lymphocytes (ICC: 0.39; 95 %CI: 0.01- 0.61, p = 0.02)) and GermC (ICC: 0.50; 95 %CI: 0.22-0.68, p < 0.001), and high variability for histiocytes (ICC: 0.07 (95 %CI: -0.45-0.40, p = 0.38). Bland-Altman plots showed that 5.0 % of GermC, 5.0 % of histiocytes and 8.5 % of lymphocyte measurements were outside the 95 % limits of agreement., Conclusions: This is the first study to systematically assess agreement of microarchitectural features in LNneg within an individual (y)pN0 OeC patient. The absence of systematic bias supports using largest LNneg as surrogate for OeC patient's overall anti-tumour immune response., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: HG has received honoraria from Astra Zeneca and BMS for scientific advisory board activities not related to the current study. MK has received honoraria from Takeda and BeiGene for scientific advisory board activities not related to the current study. DC has received grant funding from MedImmune, Clovis, Eli Lilly, 4SC, Bayer, Celgene, Leap and Roche not related to the current study., (Copyright © 2025 The Authors. Published by Elsevier GmbH.. All rights reserved.)

Background: Lumbar facet joints are the source of pain in 15%-41% of individuals experiencing low back pain (LBP). Conventional lumbar facet radiofrequency ablation (RFA) has Level II evidence for improving pain and function. The best proven technique, the parallel technique, is technically challenging, time-consuming, and often uncomfortable for the patient. A novel RFA technique using a 3-tined cannula offers a potentially less complex and shorter procedure. Objectives: To describe the novel lumbar facet joint RFA technique with the 3-tined cannula and to evaluate its efficacy in treating chronic lumbar facet joint pain. Methods: Eligible adult patients with chronic lumbar facet joint pain, confirmed by positive medial branch blocks (MBBs), refractory to conservative treatment, received the novel RFA treatment with the 3-tined cannula. The change in pain intensity at 2 months follow-up compared to baseline, percentage of patients reporting a ≥ 30% and ≥ 50% reduction of pain intensity, patient global impression of change (PGIC), need for pain medication, walking ability, sleep quality, and patient satisfaction were evaluated. Results: A total of 44 patients were included. Patients experienced a clinically meaningful and significant pain relief at follow-up and 41% of the patients reported ≥ 50% reduction of pain. Forty-eight percent experienced at least a score of "much improved" on the PGIC. No severe side effects or complications were observed. Conclusions: Our observational study suggests that lumbar facet joint RFA using the novel technique achieves significant pain relief. The larger lesions decrease the likelihood of missing the target nerve while obviating the need to conduct numerous lesions. Limiting is the single-center set-up with a relatively short-term follow-up duration. Randomized controlled clinical trials are warranted to confirm the efficacy of the novel RFA technique to treat lumbar facet joint pain., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Andrea Künzle et al.)

Scope: The emergence of post-COVID-19 condition (PCC) after SARS-CoV-2 infection underscores the critical need for preparedness in addressing future post-acute infection syndromes (PAIS), particularly those linked to epidemic outbreaks. The lack of standardized clinical and epidemiological data during the COVID-19 pandemic has significantly hindered timely diagnosis and effective treatment of PCC, highlighting the necessity of pre-emptively standardizing data collection in clinical studies to better define and manage future PAIS. In response, the Cohort Coordination Board, a consortium of European-funded COVID-19 research projects, has reviewed data from PCC studies conducted by its members. This paper leverages the Cohort Coordination Board's expertise to propose a standardized catalogue of variables, informed by the lessons learned during the pandemic, intended for immediate use in the design of future observational studies and clinical trials for emerging infections of epidemic potential., Recommendations: The early implementation of standardized data collection, facilitated by the PAIS data catalogue, is essential for accelerating the identification and management of PAIS in future epidemics. This approach will enable more precise syndrome definitions, expedite diagnostic processes, and optimize treatment strategies, while also supporting long-term follow-up of affected individuals. The availability of harmonized data collection protocols will enhance preparedness across European and international cohort studies, and trials enabling a prompt and coordinated response, as well as more efficient resource allocation, in the event of emerging infections and associated PAIS., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The 'CPPopt-Guided Therapy: Assessment of Target Effectiveness' (COGiTATE) randomised controlled trial demonstrated the feasibility and safety of targeting an automated cerebral perfusion pressure (CPP) tailored to optimize cerebrovascular autoregulation (CPPopt) in patients with traumatic brain injury (TBI) requiring intracranial pressure management. The average values of the autoregulation index known as the pressure reactivity index (PRx) were not different between the intervention (CPP target = CPPopt) and control (CPP target = 60-70 mmHg) groups of the trial. This secondary analysis was performed to investigate whether: (1) in the intervention group, PRx was closer to PRxopt (PRx at CPPopt) values, indicating a more preserved reactivity, as opposed to in the control group; (2) in the intervention group, patients experienced lower hourly PRx when CPP was close to the CPPopt-based target., Methods: We analyzed data from the 28 and 32 patients randomized to the control and intervention groups of the COGiTATE study, respectively. We compared hourly averaged ΔPRx (PRx minus PRxopt, where PRxopt is PRx at CPPopt) between the two groups, focusing on periods of globally preserved/homogeneous autoregulation (negative PRxopt). For each patient in the intervention group, PRx values in periods when ΔCPP (CPP minus CPPopt target) was between -5 and + 5 mm Hg were compared to values in periods when ΔCPP was outside this range., Results: The median ΔPRx was significantly lower in the intervention group for negative PRxopt (Mann-Whitney U-test, p < 0.001). For each patient in this group, the median PRx was lower in periods when CPP was close to the CPPopt-based target (Wilcoxon test, p < 0.001)., Conclusions: Despite no statistically significant difference in the grand mean PRx, our results suggest that targeting CPPopt does provide a way of improving cerebrovascular reactivity in patients with TBI, offering a rational intervention for trials that address this issue. We also bring insight into aspects of the PRx/CPP relationship that should be considered for autoregulation-guided management for future clinical protocols and trials design., Competing Interests: Conflicts of Interest: PS and MC receive part of the licensing fees for multimodal brain monitoring software ICM + , licensed by Cambridge Enterprise Ltd, University of Cambridge, UK. DKM reports research funding or consultancy agreements with the following entities: Calico Inc; GlaxoSmithKline Ltd; Integra LifeSciences; Lantmannen AB; NeuroTrauma Sciences; and PressuraNeuro Ltd. All the other authors report no conflicts of interest. Ethical Approval/Informed Consent: This analysis was a secondary analysis on the data of the COGiTATE trial. The main study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Maastricht University Medical Center (December 29, 2017/METC171023), the Health Research Authority National Health System United Kingdom (October 30, 2017, Research Ethics Reference 17/LO/119), the Ethics Committee of Academic Hospital Leuven (January 9, 2018, B322201834820), and the Ethics Committee of Radboud University Medical Center (February 20, 2019, RvB19.51633). For the COGiTATE study, informed consent was obtained from individual participants included in the study or their legal representatives according to the local country laws., (© 2024. The Author(s).)

Aim: The aim was to determine the interdependence of targets for glucose management indicator (GMI), time within the ranges of 70-180 mg/dL (TIR) and 70-140 mg/dL (time in tight glucose range [TITR]), time above 180 mg/dL (TA180) and 250 mg/dL (TA250) and time below 70 mg/dL (TB70) and 54 mg/dL (TB54) and its implications for setting targets in automated insulin delivery (AID)., Materials and Methods: Real-world data from individuals with type 1 diabetes using the 780G system were used to calculate the receiver operating characteristic curves and establish interdependent targets for time in ranges based on several GMI benchmarks. Correlation, regression and principal component analysis were used to determine their association and dimensionality., Results: In individuals aged >15 years (n = 41 692), a GMI <6.5% required targets of >81%, >58%, <15% and <1.9% for TIR, TITR, TA180 and TA250, respectively, with high sensitivity, specificity and accuracy (>90%), whereas these values were poor for time in hypoglycaemia and GMI, which had a modest correlation (-0.21 to -0.43). Two dimensions emerged: (1) GMI, TIR, TITR, TA180 and TA250, and (2) TB70 and TB54, explaining 95% of total variability. GMI (or TIR) and TB70 explained >81% of the variability in the remaining continuous glucose monitoring (CGM) metrics, providing accurate predictions. Individuals aged ≤15 years (n = 14 459) showed similar results., Conclusion: We developed a methodology to establish interdependent CGM targets for therapies with CGM data outputs. In AID with the 780G system, a GMI <7% requires time in ranges close to consensus targets. Targets for GMI, TIR, TITR, TA180 and TA250 could be reduced to targets for GMI or TIR, whereas targets for time in hypoglycaemia are not inherently tied to GMI/TIR targets., (© 2024 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Objective: To evaluate whether physical function and quality of life was influenced by discharge on the same-day after a total laparoscopic hysterectomy., Design: Multicentre non-inferiority randomised controlled trial., Setting: Five teaching hospitals and two university hospitals in the Netherlands., Population: Patients undergoing laparoscopic hysterectomy for benign or premalignant disease., Methods: Following informed consent, participants were allocated 1:1 either to same-day discharge (SDD) or next-day discharge (NDD)., Main Outcome Measures: The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ-5D-5L)., Results: Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07-0.57]). As the upper limit of the 95% CI does not exceed the non-inferiority margin of 4 points, non-inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found., Conclusion: This research demonstrates same-day discharge after laparoscopic hysterectomy is non-inferior to next day discharge in physical function 7 days after surgery., (© 2024 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Background: Reconstructive surgeons have shifted from correcting contour irregularities using autologous fat transfer (AFT) toward reconstructing full breasts. Although several studies have researched the volumetric aspects of AFT, some outcomes such as volume retention, viability, and possible confounders for graft survival, remain unclear. This study aimed to answer these questions., Methods: Post-mastectomy women of the multicenter prospective BREAST-trial were randomized to either AFT breast reconstruction or implant-based reconstruction (IBR). Volumes were assessed using the Vectra 3D imaging system and compared at 12 months post-operative. Volume retention was defined as the augmented volume divided by the lipofilling volume. Significant confounders for graft survival were identified using multivariable regression analysis., Results: A total of 148 patients (75 AFT, 73 IBR) were included in the final analyses. Post-operative volumes differed significantly at 12 months in favor of the IBR group (83.8 ml, p < 0.001). For AFT patients, graft survival did not decrease between 6 and 12 months, with a mean graft survival of 37.1% at 12 months. Significant confounders for graft survival included chest circumference (β = 1.107, p = 0.001), comorbidities (β = 28.567, p = 0.002), age (β = -0.514, p = 0.007), and total lipofilling (β = -0.028, p < 0.001)., Conclusion: Plastic surgeons can reconstruct voluminous breasts post-mastectomy using only AFT, and these breast volumes stabilize at 6 months and VECTRA 3D is reliable for breast volume measurement. Approximately a third of the grafted fat was calculated to survive post-operatively and reconstructive surgeons should be aware not to transfer too much fat in one session., (Copyright © 2024. Published by Elsevier Ltd.)

Introduction: After a previous caesarean section, morbidity in the subsequent delivery in general is considered to depend on the probability of a vaginal birth after caesarean. However counselling could be improved by adding individualized probability of serious morbidity following either trial of labour or elective repeat caesarean section. The objective of this study was to develop prediction models for morbidity for both a repeat caesarean section and a trial of labor for a Dutch population., Material and Methods: In this cohort study, data were joined from three previous studies (SIMPLE 1, SIMPLE 2 and SIMPLE 2-implementation study). A cohort of 2592 women with one previous caesarean section and a singleton pregnancy who delivered ≥37 weeks, without a contraindication for vaginal delivery was formed. Maternal morbidity was defined as postpartum hemorrhage, blood transfusion, uterine rupture, ICU admittance or death. Neonatal morbidity was defined as asphyxia, NICU-admittance or death. Potential predictors for morbidity were chosen based on literature and expert opinion. Logistic regression was used to develop the models. Internal validation was intended using bootstrapping techniques. Main outcome measures were predictors for morbidity and for validation of the model we used the area under the receiver operating characteristic curve for discriminative capacity and calibration for accuracy., Results: In 324 out of the 2592 cases (12.7 %) maternal or fetal complications occurred. In general total morbidity was higher in women choosing TOL as compared to ERCS (p < 0.001). The performance of the several developed models was insufficient, the area under the receiver operating characteristic curve did not rise above 0.6. Due to poor model performance, before correction for overfitting, interval validation was not conducted., Conclusion: In this large cohort, developing a Dutch population based prediction model that aimed to improve counselling on the mode of delivery, by predicting individual chances of morbidity for different delivery modes was not possible, due to lack of performance. Further study could be directed to cut off on VBAC success rates to a more general advice regarding the safest mode of delivery., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)

Background and Purpose: Percutaneous cement augmentation has been reported as an effective salvage procedure for frail patients with spinal instrumentation failure, such as screw loosening, hardware breakage, cage subsidence, and fractures within or adjacent to stabilized segments. Favorable results were reported during a median follow-up period of 16 months in a retrospective analysis of 31 consecutive procedures performed in 29 patients. In the present study, the long-term effectiveness of this treatment in avoiding or postponing revision surgery is reported., Materials and Methods: Clinical and radiologic data of our original cohort of patients were retrospectively collected and reviewed to provide an extended follow-up assessment. The need for revision spinal surgery was assessed as the primary outcome, and the radiologic stability of the augmented spinal implants was considered as the secondary outcome., Results: An extended radiologic follow-up was available in 27/29 patients with an average of 50.9 months. Overall, 18 of 27 (66.7%) patients, originally candidates for revision surgery, avoided a surgical intervention after a cement augmentation rescue procedure. In the remaining patients, the average interval between the rescue cement augmentation and the revision surgery was 22.5 months. Implant mobilization occurred in 2/27 (7.4%) patients; rod breakage, in 1/27 (3.7%); a new fracture within or adjacent to the instrumented segment occurred in 4/27 (14.8%) patients; and screw loosening at rescued levels occurred in 5/27 (18.5%) patients., Conclusions: In this cohort, cement augmentation rescue procedures were found to be effective in avoiding or postponing revision surgery during long-term follow-up., (© 2024 by American Journal of Neuroradiology.)

Introduction: Literature shows differences in pain experiences between sexes. The exact influence of thermal liver ablation on experienced pain is still not well-known. This study aims to investigate the maximum pain intensity at the recovery between men and women after percutaneous thermal liver ablation., Methods: Patients treated with percutaneous thermal liver ablation (radiofrequency or microwave ablation) in Maastricht University Medical Center + between 2018 and 2022 for primary or secondary liver tumors were included retrospectively. Outcomes included maximum numerical rating scale (NRS, scale:0-10) score at the recovery room, prevalence of post-procedural pain (defined as NRS score ≥ 4), duration of anesthesia, length of stay at recovery, and complications. Regression analyses were adjusted for age, ASA-score, BMI, tumor type, maximum diameter of lesion, chronic pain in patients' history, and history of psychological disorder., Results: 183 patients were included of which 123 men (67%). Results showed higher average maximum NRS scores in women patients compared to men (mean:3.88 versus 2.73), but not after adjustments (aß:0.75, 95%CI:-0.13-1.64). Women suffered more from acute post-procedural pain (59% versus 35%; aOR:2.50, 95%CI:1.16-5.39), and needed analgesics more often at the recovery room (aOR:2.43, 95%CI:1.07-5.48) compared to men. NRS score at recovery arrival did not significantly differ (aß:0.37, 95%CI:-0.48-1.22). No differences were seen in the length of stay at the recovery, duration of anesthesia, procedure time, and complication rate. Location of the tumor (subcapsular or deep), total tumors per patient, and distinction between primary and secondary tumors had no influence on the NRS., Conclusion: This retrospective single-center study shows higher post-procedural pain rates after thermal liver ablation in women, resulting in higher analgesics use at the recovery room. The results suggest considering higher dosage of analgesics during thermal liver ablation in women to reduce post-procedural pain. LEVEL OF EVIDENCE 3: Non-controlled retrospective cohort study., (© 2024. The Author(s).)

Background: Although attempts have been made in the past to establish consensus regarding the definitions and grading of the severity of colorectal anastomotic leakage, widespread adoption has remained limited., Objective: A systematic review of the literature was conducted to examine the various elements used to report and define anastomotic leakage in colorectal cancer resections., Data Sources: A systematic review was conducted using the PubMed, Embase, and Cochrane Library Database., Study Selection: All published randomized controlled trials, systematic reviews, and meta-analyses containing data related to adult patients undergoing colorectal cancer surgery and reporting anastomotic leakage as a primary or secondary outcome, with a definition of anastomotic leakage were included., Main Outcome Measures: Definitions of anastomotic leakage, clinical symptoms, radiological modalities and findings, findings at reoperation, and grading terminology or classifications for anastomotic leakage., Results: Of the 471 articles reporting anastomotic leakage as a primary or secondary outcome, a definition was reported in 95 studies (45 randomized controlled trials, 13 systematic reviews, and 37 meta-analyses) involving a total of 346,140 patients. Of these 95 articles, 68% reported clinical signs and symptoms of anastomotic leakage, 26% biochemical criteria, 63% radiological modalities, 62% radiological findings, and 13% findings at reintervention. Only 45% (n = 43) of included studies reported grading of anastomotic leakage severity or leak classification, and 41% (n = 39) included a time frame for reporting., Limitations: There was a high level of heterogeneity between the included studies., Conclusions: This evidence synthesis confirmed incomplete and inconsistent reporting of anastomotic leakage across the published colorectal cancer literature. There is a great need to develop and implement a consensus framework for defining, grading, and reporting anastomotic leakage., Registration: Prospectively registered at PROSPERO (ID 454660)., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Colon and Rectal Surgeons.)

Background: Monitoring health-related physical fitness (HRPF) may benefit proactive Inflammatory Bowel Disease (IBD) management. However, knowledge regarding HRPF in patients with IBD is limited and gold standard tests are impractical for widespread use, necessitating simpler methods., Aim: This study evaluated the criterion validity of screening tools and field-based tests compared to gold standard tests for HRPF in patients with IBD., Methods: Adult patients with IBD completed screening tools, field-based tests, and gold standard tests for HRPF. Criterion validity was examined through (intraclass) correlation coefficients and Bland-Altman plots. Predictive capacity of the screening tools was examined with receiver operating curve analysis., Results: Among 53 included patients, screening tools demonstrated poor-to-moderate validity compared to the cardiopulmonary exercise test (CPET) for cardiorespiratory fitness. Very strong correlations were found for four-site skinfold thickness and multi-frequency bioimpedance analysis (BIA) with deuterium oxide dilution for body fat percentage (ICC = 0.90, ICC = 0.93), and between the steep ramp test and CPET (r = 0.95) for cardiorespiratory fitness. The steep ramp test also correlated strongly with isokinetic quadriceps (r > 0.75) and hamstring (r > 0.74) strength. Hand-held dynamometry and the sit-to-stand test showed strong correlations with hamstring strength (r > 0.80, r > 0.76). Negligible correlations were found for field-based tests compared to isokinetic quadriceps and hamstring endurance., Conclusions: Four-site skinfold thickness and BIA showed good agreement with the gold standard for body fat measurement. The steep ramp test demonstrated strong correlations with the gold standard tests for cardiorespiratory fitness and quadriceps and hamstring strength, while hand-held dynamometry and the sit-to-stand test showed strong correlations with hamstring strength., Competing Interests: Declarations Conflict of interest Daisy M.A.E. Jonkers reports grant from the public-private partnership grants of Dutch Top Institute of Food and Nutrition (TIFN), Top Knowledge Institute (TKI) Agri&Food and Health Holland, by the Carbokinetics program as part of the NWO-CCC Partnership Program, by Organic A2BV/Mothersfinest BV and, EU/FP7 SysmedIBD/305564, BIOM/305479 and Character/305676, H2020 DISCOvERIE/848228, all outside the submitted work. Marieke J. Pierik reports grants and non-financial support from Falk Pharma, grants from European commission, grants from ZONMW (Dutch national research fund), grants and non-financial support from Takeda, grants and non-financial support from Johnson and Johnson, grants and non-financial support from Abbvie, non-financial support from Ferring, non-financial support from Immunodiagnostics, non-financial support from MSD, all outside the submitted work. Laurents P.S. Stassen serves on the advisory board of Diagnostic Green Gmbh and has served as a speaker and received research support from Takeda, outside the submitted work. For the remaining authors none were declared. Ethical approval This study was conducted in compliance with the Declaration of Helsinki and was approved by the Medical Ethical Committee of the Maastricht University Medical Center + (registration no. 22–012). Consent to participate Informed consent was obtained from all individual participants included in the study., (© 2024. The Author(s).)

Most published prediction models for Coronavirus Disease 2019 (COVID-19) were poorly reported, at high risk of bias, and heterogeneous in model performance. To tackle methodological challenges faced in previous prediction studies, we investigated whether model updating and extending improves mortality prediction, using the Intensive Care Unit (ICU) as a proxy. All COVID-19 patients admitted to seven ICUs in the Euregio-Meuse Rhine during the first pandemic wave were included. The 4C Mortality and SEIMC scores were selected as promising prognostic models from an external validation study. Five predictors could be estimated based on cohort size. TRIPOD guidelines were followed and logistic regression analyses with the linear predictor, APACHE II score, and country were performed. Bootstrapping with backward selection was applied to select variables for the final model. Additionally, shrinkage was performed. Model discrimination was displayed as optimism-corrected areas under the ROC curve and calibration by calibration slopes and plots. The mortality rate of the 551 included patients was 36%. Discrimination of the 4C Mortality and SEIMC scores increased from 0.70 to 0.74 and 0.70 to 0.73 and calibration plots improved compared to the original models after updating and extending. Mortality prediction can be improved after updating and extending of promising models., (© 2024. The Author(s).)

Purpose: Pre- and post-endovascular treatment (EVT) imaging may aid in predicting functional outcomes in acute middle cerebral artery (MCA) ischemic stroke. Low post-EVT contrast extravasation (CE)-ASPECTS is associated with poor functional outcomes. Besides the MCA regions included in the ASPECTS score, CE may be seen in the mesial temporal (MT) region. In this study, we investigated the frequency and prognostic implication of MT-CE in acute ischemic stroke patients., Methods: Patients with an acute ischemic stroke due to anterior large vessel occlusion who received EVT and post-EVT DECT between 2010 and 2019 were included. Iodine overlay maps of DECT were assessed for the occurrence of CE, using the ASPECTS for occurrence in the MCA region and, calculating a CE-ASPECTS, for whether the MT region was involved. Multivariable linear and logistic regression were used to assess the relationship between involvement of MT-CE and 24-48h NIHSS, mRS, and mortality on a multiple imputed dataset. All models were adjusted significant variables in univariate analyses and for total CE-ASPECTS., Results: 501/651 patients met the inclusion criteria. MT-CE occurred in 97 (19 %) patients, and was more often present in patients with internal carotid artery occlusions. MT-CE was associated with higher NIHSS scores at 24-hours (aβ 2.2, 95 % CI 0.09-4.31), with increased risk of higher mRS scores (acOR 1.88, 95 % CI 1.16-3.06), and with increased risk of mortality (aOR 2.12, 95 % CI 1.16-3.86)., Conclusion: MT-CE is a common finding on post-EVT DECT and is an independent predictor for worse functional outcomes., Competing Interests: Declaration of competing interest W.Z reports consulting fees from Philips, and speaker fees from Stryker, Cerenovus, and Nicolab (all paid to the institution). Moreover, he is participating in the Safety Monitoring Board or Advisory Board of WeTrust (Philips), InEcxtremis (CHU Montpellier), ANAIS (Anaconda), and DISTAL (University of Hospital Basal) studies. A.P received an institutional grant from Siemens Healthineers and Bayer Healthcare. Other co-authors have nothing to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Shared decision-making (SDM) aims to improve patients' experiences with care, treatment adherence, and health outcomes. However, the effectiveness of SDM in patients with a recent fracture who require anti-osteoporosis medication (AOM) is unclear. The objective of this study was to assess the effectiveness of a multicomponent adherence intervention (MCAI) including a patient decision aid (PDA) and motivational interviewing at Fracture Liaison Services (FLS) on multiple outcomes compared with usual care (UC). This pre-post superiority study included patients with a recent fracture attending FLS and with AOM treatment indication. The primary outcome was 1-year AOM persistence measured by pharmacy records. Secondary outcomes included treatment initiation, AOM adherence (measured by medication possession ratio [MPR]), decision quality (SDM process; 0-100, best), and decisional conflict (0-100, highest conflict), subsequent fractures, and mortality. Outcomes were tested in MCAI and UC groups at the first FLS visit and 4 and 12 months afterwards. Multiple imputation and uni- and multivariable analyses were performed. Post hoc analyses assessed the role of health literacy level. In total, 245 patients (MCAI: n = 136, UC: n = 109) were included. AOM persistence was 80.4% in the MCAI and 76.7% in the UC group (p=.626). SDM process scores were significantly better in MCAI (60.4 vs 55.1; p = .003). AOM initiation (97.8% vs 97.5%), MPR (90.9% vs 88.3%, p=.582), and decisional conflict (21.7 vs 23.0; p = .314) did not differ between groups. Results did not change importantly after adjustment. Stratified analyses by health literacy showed a better effect on MPR and SDM in those with adequate health literacy. This study showed no significant effect on AOM persistence; however, it demonstrated a significant positive effect of MCAI on SDM process in FLS attendees. (Netherlands Trial Registry, Trial NL7236 [NTR7435]; version 1.0; 26-11-2020 https://onderzoekmetmensen.nl/nl/trial/22858)., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Society for Bone and Mineral Research.)

This nationwide multidisciplinary survey found dissatisfaction among physicians with current osteoporotic vertebral compression fracture care, revealing significant disparities in diagnosis, treatment, and follow-up practices. Issues include poor communication and differing guidelines. Improving interdisciplinary collaboration and standardized care strategies is essential for better patient outcomes., Purpose: This survey aims to assess current preferred care practices for symptomatic osteoporotic vertebral compression fractures (OVCF) in the Netherlands, focusing on guideline adherence, identifying knowledge gaps, and clarifying consensus and collaboration across medical disciplines in OVCF treatment., Methods: This cross-sectional study was conducted via Qualtrics (Provo, UT) using a self-administered online survey distributed to 238 general practitioners and physicians in orthopedics, traumatology, internal medicine, rheumatology, and geriatrics working at 51 hospitals in the Netherlands. The survey, conducted in Dutch, included 36 multiple-choice and two open questions and was accessible via an anonymous email link or QR code. General practitioners received additional questions specific to their role. Data was anonymized, stored securely, and analyzed using descriptive statistics in Microsoft Excel and SPSS (Version 24). Open-ended responses were coded and categorized. The survey was conducted prior to the publication of the updated Federation of Medical Specialists guidelines in 2024., Results: Physicians across various disciplines uniformly expressed dissatisfaction with current OVCF care. The survey highlighted significant disparities in diagnosis, treatment, and follow-up practices. A lack of communication between primary and secondary care providers and differing guidelines further complicate OVCF management. These issues point to considerable variation in clinical practice and gaps in interdisciplinary collaboration., Conclusion: Addressing the identified issues requires fostering interdisciplinary collaboration and creating cohesive care strategies. Ensuring access to diagnostic resources in both primary and secondary care and establishing coordinated care models promises more structured and standardized treatment. These steps are crucial for enhancing patient outcomes in OVCF management., (© 2024. The Author(s).)

Symptomatic aortic stenosis and frailty reduce health-related quality of life (HrQoL). Transcatheter aortic valve implantation (TAVI) in patients at high to extreme risk has been proven to have a beneficial effect on HrQoL. Currently, TAVI is also considered in patients at intermediate risk. Our meta-analysis investigates whether benefits to HrQoL after TAVI is more pronounced in frail patients and patients at high to extreme vs. intermediate surgical risk. A systematic search of the literature was performed in November 2021 and updated in November 2023 in PUBMED, EMBASE, and the Cochrane Controlled Trials Register. Statistical analysis was performed according to the inverse variance method and the random effects model. A total of 951 studies were assessed, of which 19 studies were included. Meta-analysis showed a mean increase in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score of 29.6 points (6.0, 33.1) in high to extreme risk patients versus 21.0 (20.9, 21.1) in intermediate risk patients ( p < 0.00001) and 24.6 points (21.5, 27.8) in frail patients versus 26.8 (20.2, 33.4) in the general TAVI population ( p = 0.55). However, qualitative analyses of non-randomized studies showed the opposite results. In conclusion, TAVI improves HrQoL more in high to extreme than intermediate risk patients. Frailty's impact on HrQoL post-TAVI is inconclusive due to varying outcomes in RCTs vs. non-RCTs.

Growing evidence indicates an important role of neurovascular unit (NVU) dysfunction in the pathophysiology of cerebral small vessel disease (cSVD). Individually measurable functions of the NVU have been correlated with cognitive function, but a combined analysis is lacking. We aimed to perform a unified analysis of NVU function and its relation with cognitive performance. The relationship between NVU function in the white matter and cognitive performance (both latent variables composed of multiple measurable variables) was investigated in 73 patients with cSVD (mean age 70 ± 10 years, 41% women) using canonical correlation analysis. MRI-based NVU function measures included (1) the intravoxel incoherent motion derived perfusion volume fraction (f) and microvascular diffusivity (D*), reflecting cerebral microvascular flow; (2) the IVIM derived intermediate volume fraction (f int ), indicative of the perivascular clearance system; and (3) the dynamic contrast-enhanced MRI derived blood-brain barrier (BBB) leakage rate (K i ) and leakage volume fraction (V L ), reflecting BBB integrity. Cognitive performance was composed of 13 cognitive test scores. Canonical correlation analysis revealed a strong correlation between the latent variables NVU function and cognitive performance (r 0.73; p = 0.02). For the NVU, the dominating variables were D*, f int , and K i . Cognitive performance was driven by multiple cognitive tests comprising different cognitive domains. The functionality of the NVU is correlated with cognitive performance in cSVD. Instead of focusing on individual pathophysiological mechanisms, future studies should target NVU dysfunction as a whole to acquire a coherent understanding of the complex disease mechanisms that occur in the NVU in cSVD.Trial registration: NTR3786 (Dutch Trial Register)., (© 2024. The Author(s).)

Background: Cardiac magnetic resonance (CMR)-guided catheter ablation of the cavotricuspid isthmus (CTI) has been proven feasible, but determinants of local electrogram (EGM) voltage drops during radiofrequency (RF) applications are unknown., Objective: The purpose of this study was to investigate local atrial bipolar EGM voltage drops and the association with delivered RF energy and anatomical information derived from peri-procedural CMR imaging., Methods: In consecutive patients undergoing CMR-guided CTI ablation procedures, relative EGM voltage drops for RF applications ≥20 seconds were calculated. Pre- and post-ablation CMR imaging was performed. Associations of relative EGM voltage drops with patient characteristics, delivered RF energy, and CTI anatomy were analyzed., Results: In total, 216 RF applications were evaluated from 12 patients (18 ± 5 applications/patient). EGM voltage amplitude at baseline was significantly higher in the group with the strongest relative EGM voltage drop ( P < .05), whereas RF ablation settings (duration, power, temperature) and lesion characteristics (impedance drop, slope of impedance drop) did not differ. The EGM voltage amplitude at baseline ( P < .001), left ventricular ejection fraction (LVEF) ( P = .020), right atrium volume index (RAVI) ( P = .027), and CTI line length ( P = .026) showed the strongest association with relative EGM voltage drop. Four of 12 patients (33%) underwent a re-do procedure, 2 patients showed a regional late reconnection, which could be visually identified in the T 2 -weighted images (T2WI) of the index procedure., Conclusion: Local EGM voltage amplitude, LVEF, RAVI, and CTI length are associated with relative EGM voltage drop during CMR-guided CTI ablation. Post-ablation CMR imaging during the index procedure may help to identify areas of late reconnection., Competing Interests: All authors have no conflicts to disclose., (© 2024 Heart Rhythm Society. Published by Elsevier Inc.)

Background: Manually derived electrocardiographic (ECG) parameters were not associated with mortality in mechanically ventilated COVID-19 patients in earlier studies, while increased high-sensitivity cardiac troponin-T (hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) were. To provide evidence for vectorcardiography (VCG) measures as potential cardiac monitoring tool, we investigated VCG trajectories during critical illness., Methods: All mechanically ventilated COVID-19 patients were included in the Maastricht Intensive Care Covid Cohort between March 2020 and October 2021. Serum hs-cTnT and NT-proBNP concentrations were measured daily. Conversion of daily 12-lead ECGs to VCGs by a MATLAB-based script provided QRS area, T area, maximal QRS amplitude, and QRS duration. Linear mixed-effect models investigated trajectories in serum and VCG markers over time between non-survivors and survivors, adjusted for confounders., Results: In 322 patients, 5461 hs-cTnT, 5435 NT-proBNP concentrations and 3280 ECGs and VCGs were analyzed. Non-survivors had higher hs-cTnT concentrations at intubation and both hs-cTnT and NT-proBNP significantly increased compared with survivors. In non-survivors, the following VCG parameters decreased more when compared to survivors: QRS area (-0.27 (95% CI) (-0.37 to -0.16, p < .01) μVs per day), T area (-0.39 (-0.62 to -0.16, p < .01) μVs per day), and maximal QRS amplitude (-0.01 (-0.01 to -0.01, p < .01) mV per day). QRS duration did not differ., Conclusion: VCG-derived QRS area and T area decreased in non-survivors compared with survivors, suggesting that an increase in myocardial damage and tissue loss play a role in the course of critical illness and may drive mortality. These VCG markers may be used to monitor critically ill patients., (© 2024 The Author(s). Annals of Noninvasive Electrocardiology published by Wiley Periodicals LLC.)

Context: Strong opioids are the cornerstone in the treatment of cancer-related pain., Objectives: This study aims to compare analgesic effectiveness of different strong opioids for the treatment of cancer-related pain., Methods: PubMed and Embase were searched for RCTs that compared strong opioids for treatment of cancer-related pain against one another. A network meta-analysis was conducted and the related Surface Under the Cumulative RAnking (SUCRA)-based treatment ranks were calculated. Primary outcome was pain intensity (numerical rating scale (NRS)) and/or the percentage of patients with ≥50% pain reduction, after 1 and 2-4 weeks., Results: Sixteen RCTs (1813 patients) were included. Methadone showed, with a high certainty of evidence, increased ORs for treatment success at 1 week, compared with morphine, buprenorphine, fentanyl, and oxycodone, range 3.230-36.833. Methadone had the highest likelihood to be the treatment of preference (ToP) (SUCRA 0.9720). For fentanyl, ORs were lower, however significant and with high certainty. After 2-4 weeks, methadone again showed the highest likelihood for ToP, however, with moderate certainty and nonsignificant ORs. The combination of morphine/methadone, compared with morphine, buprenorphine, fentanyl, hydromorphone, methadone, and oxycodone achieved a treatment effect of mean NRS difference after 2-4 weeks between -1.100 and -1.528 and had the highest likelihood for ToP., Conclusion: The results suggest that methadone possibly deserves further promotion as first-line treatment for the treatment of cancer-related pain., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: In up to 72 % of HER2+ invasive breast cancer (IBC), a ductal carcinoma in situ (DCIS) component is present. The presence of DCIS is associated with increased positive surgical margins after breast-conserving surgery (BCS). The aim of this study was to assess surgical margins, recurrence and survival in a nationwide cohort of HER2+ IBC with versus without a DCIS component, treated with neoadjuvant systemic therapy (NST) and BCS., Materials and Methods: Women diagnosed with HER2+ IBC treated with NST and BCS, between 2010 and 2019, were selected from the Netherlands Cancer Registry and linked to the Dutch Nationwide Pathology Databank. Kaplan-Meier and Cox regression analyses were performed to determine locoregional recurrence rate (LRR) and overall survival (OS) and associated clinicopathological variables. Surgical outcomes and prognosis were compared between IBC only and IBC+DCIS., Results: A total of 3056 patients were included: 1832 with IBC and 1224 with IBC+DCIS. Patients with IBC+DCIS had significantly more often positive surgical margins compared to IBC (12.8 % versus 4.9 %, p < 0.001). Five-year LRR was significantly higher in patients with IBC+DCIS compared to IBC (6.8 % versus 3.6 %, p < 0.001), but the presence of DCIS itself was not significantly associated with LRR after adjusting for confounders in multivariable analysis. Five-year OS did not differ between IBC+DCIS and IBC (94.9 % versus 95.7 %, p = 0.293)., Conclusion: The presence of DCIS is associated with higher rates of positive surgical margins, but not with LRR and lower OS when adjusted for confounders. Further research is necessary to adequately select IBC+DCIS patients for BCS after NST., Competing Interests: Declaration of competing interest Prof. Dr. Smidt reports grants from Nutricia and Servier Pharmaceuticals for microbiome research in colorectal cancer, and use of material from Illumina, not related to this study. Dr. T. van Nijnatten received institutional grant support from Bayer, and speaker honoraria from GE Healthcare and Bayer, not related to this study. L. Kooreman reports consulting fees from Novartis and educational fees from SCEM, not related to this study. All author authors report no declarations of interest., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The MR CLEAN-LATE trial provided evidence for the safety and efficacy of endovascular treatment for acute ischaemic stroke within the late window (after 6-24 h) in patients who were preselected based on the presence of collateral flow on CT angiography. We aimed to evaluate clinical outcomes 2 years after randomisation., Methods: MR CLEAN-LATE was a phase 3, multicentre, open-label, blinded-endpoint, randomised controlled trial conducted at 18 stroke intervention centres in the Netherlands. If endovascular treatment could be initiated within 6-24 h of symptom onset or last seen well, patients (aged 18 years or older) with an acute ischaemic stroke due to a large vessel occlusion in the anterior circulation and at least some collateral flow in the affected middle cerebral artery territory on CT angiography were randomly assigned (1:1) to either endovascular treatment with best medical treatment (endovascular treatment group) or best medical treatment alone (control group). Web-based randomisation, stratified by centre, was performed with the use of permuted blocks (block size eight to 20). The researchers who collected clinical outcomes and analysed the results were masked to treatment allocation; treating physicians, local investigators, and patients were aware of the received treatment. The primary outcome of MR CLEAN-LATE was the modified Rankin Scale (mRS) score at 90 days after randomisation. For this 2-year prespecified analysis, the primary outcome was mRS score at 2 years (minus 3 months to plus 6 months). Primary and safety analyses were performed based on the modified intention-to-treat principle, and included patients who provided (deferred) consent or died before consent could be obtained. Missing data were handled with multiple imputation by chained equations. The trial is completed and is registered at ISRCTN, ISRCTN19922220., Findings: Between Feb 2, 2018, and Jan 27, 2022, 535 patients were randomly assigned in the MR CLEAN-LATE trial, of whom 502 (94%) gave deferred consent and comprised the modified intention-to-treat population (255 in the endovascular treatment group and 247 in the control group). 261 (52%) patients were female and 241 (48%) were male. Data for mRS score at 2 years were available for 226 (89%) patients in the endovascular treatment group and for 202 (82%) patients in the control group. The median mRS score at 2 years was 4 (IQR 2-6) in the endovascular treatment group and 6 (2-6) in the control group. The endovascular treatment group demonstrated a shift towards better functional outcomes on the mRS (adjusted common odds ratio 1·41 [95% CI 1·00-1·99]; p=0·049). All-cause mortality at 2 years was 34% (87 of 255) in the endovascular treatment group and 41% (101 of 247) in the control group (adjusted hazard ratio 0·81 [95% CI 0·60-1·08]; p=0·15). Major vascular events (ie, transient ischaemic attack, ischaemic stroke, haemorrhagic stroke, and cardiac events) were reported between 90 days and 2 years in 23 patients in the endovascular treatment group and 13 patients in the control group., Interpretation: Our results show that the effectiveness of late-window (after 6-24 h) endovascular treatment in improving clinical outcomes is sustained for up to 2 years in a population preselected based on the presence of collateral flow on CT angiography. This finding might be important for prompting further evaluations of cost-effectiveness, health-care policy development, and clinical decision making., Funding: The Dutch Organization for Health Research and Health Innovation (ZonMW), Collaboration for New Treatments of Acute Stroke Consortium, Dutch Heart Foundation, Stryker, Medtronic, Cerenovus, Health Holland Top Sector Life Sciences & Health, and the Netherlands Brain Foundation., Competing Interests: Declaration of interests RJvO and WHvZ report financial support for the current manuscript from the Collaboration for New Treatments of Acute Stroke (CONTRAST) consortium (which was financed for the current study by the Netherlands Cardiovascular Research Initiative, an initiative of the Dutch Heart Foundation, the Netherlands Brain Foundation, Stryker, Medtronic, and Cerenovus), all paid to their institution. WHvZ reports speakers fees from Stryker, Cerenovus, Nicolab, Philips, Medtronic, and Microvention, and consulting fees from Philips, all paid to their institution; participated in the advisory boards of WeTrust (Philips) and ANAIS (Anaconda), all paid to their institution; and participated in the advisory board of InExtremis (CHU Montpellier, Montpellier, France), for which no payments were received. YBWEMR reports being a minor shareholder of Nicolab. CBLMM reports grants from the Netherlands Cardiovascular Research Initiative, an initiative of the Dutch Heart Foundation, TWIN Foundation, European Commission, Healthcare Evaluation Netherlands, Stryker, and Boehringer Ingelheim (all paid to their institution); and is a (minority interest) shareholder of Nicolab. AvdL reports financial support for this study by grants from The Netherlands Organization for Health Research and Development, and the Netherlands Cardiovascular Research Initiative, an initiative of the Dutch Heart Foundation, Brain Foundation Netherlands, Medtronic, and Cerenovus, all paid to their institution; reports grants from Stryker, Thrombolytic Science, Health Holland Top Sector Life Sciences & Health, Penumbra, GE Healthcare, Philips Healthcare, Boehringer Ingelheim, and Siemens Healthineers, all paid to their institution; participates in the advisory board of ESCAPE-MEVO; reports a speakers fee from Siemens Healthineers (paid to their institution); is a research leader of the CONTRAST consortium; and is part of the Research Cie of the European Society of Radiology. DWJD reports funding from the Dutch Heart Foundation, Netherlands Brain Foundation, the Netherlands Organisation for Health Research and Development, Health Holland Top Sector Life Sciences & Health, Penumbra, Stryker, Medtronic, Thrombolytic Science, and Cerenovus (all unrestricted grants for research), paid to their institution; participated in the data safety monitoring board of the ACT Global, TESLA, and LATE-MT trial; and was the research leader for the CONTRAST Consortium until 2023. AAP reports a grant from Siemens Healthineers, paid to their institution. HDB reports an unrestricted grant from Stryker, paid to their institution. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Objective: To develop and internally validate a prognostic model to predict chronic pain after a new episode of acute or subacute non-specific idiopathic, non-traumatic neck pain in patients presenting to physiotherapy primary care, emphasising modifiable biomedical, psychological and social factors., Design: A prospective cohort study with a 6-month follow-up between January 2020 and March 2023., Setting: 30 physiotherapy primary care practices., Participants: Patients with a new presentation of non-specific idiopathic, non-traumatic neck pain, with a duration lasting no longer than 12 weeks from onset., Baseline Measures: Candidate prognostic variables collected from participants included age and sex, neck pain symptoms, work-related factors, general factors, psychological and behavioural factors and the remaining factors: therapeutic relation and healthcare provider attitude., Outcome Measures: Pain intensity at 6 weeks, 3 months and 6 months on a Numeric Pain Rating Scale (NPRS) after inclusion. An NPRS score of ≥3 at each time point was used to define chronic neck pain., Results: 62 (10%) of the 603 participants developed chronic neck pain. The prognostic factors in the final model were sex, pain intensity, reported pain in different body regions, headache since and before the neck pain, posture during work, employment status, illness beliefs about pain identity and recovery, treatment beliefs, distress and self-efficacy. The model demonstrated an optimism-corrected area under the curve of 0.83 and a corrected R 2 of 0.24. Calibration was deemed acceptable to good, as indicated by the calibration curve. The Hosmer-Lemeshow test yielded a p-value of 0.7167, indicating a good model fit., Conclusion: This model has the potential to obtain a valid prognosis for developing chronic pain after a new episode of acute and subacute non-specific idiopathic, non-traumatic neck pain. It includes mostly potentially modifiable factors for physiotherapy practice. External validation of this model is recommended., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Increased protein provision might ameliorate muscle wasting and improve long-term outcomes in critically ill patients. The aim of the PRECISe trial was to assess whether higher enteral protein provision (ie, 2·0 g/kg per day) would improve health-related quality of life and functional outcomes in critically ill patients who were mechanically ventilated compared with standard enteral protein provision (ie, 1·3 g/kg per day)., Methods: The PRECISe trial was an investigator-initiated, double-blinded, multicentre, parallel-group, randomised controlled trial in five Dutch hospitals and five Belgian hospitals. Inclusion criteria were initiation of invasive mechanical ventilation within 24 h of intensive care unit (ICU) admission and an expected duration of invasive ventilation of 3 days or longer. Exclusion criteria were contraindications for enteral nutrition, moribund condition, BMI less than 18 kg/m 2 , kidney failure with a no dialysis code, or hepatic encephalopathy. Patients were randomly assigned to one of four randomisation labels, corresponding with two study groups (ie, standard or high protein; two labels per group) in a 1:1:1:1 ratio through an interactive web-response system. Randomisation was done via random permuted-block randomisation in varying block sizes of eight and 12, stratified by centre. Participants, care providers, investigators, outcome assessors, data analysts, and the independent data safety monitoring board were all blinded to group allocation. Patients received isocaloric enteral feeds that contained 1·3 kcal/mL and 0·06 g of protein/mL (ie, standard protein) or 1·3 kcal/mL and 0·10 g of protein/mL (ie, high protein). The study-nutrition intervention was limited to the time period during the patient's ICU stay in which they required enteral feeding, with a maximum of 90 days. The primary outcome was EuroQoL 5-Dimension 5-level (EQ-5D-5L) health utility score at 30 days, 90 days, and 180 days after randomisation, adjusted for baseline EQ-5D-5L health utility score. This trial was registered with ClinicalTrials.gov (NCT04633421) and is closed to new participants., Findings: Between Nov 19, 2020, and April 14, 2023, 935 patients were randomly assigned. 335 (35·8%) of 935 patients were female and 600 (64·2%) were male. 465 (49·7%) of 935 were assigned to the standard protein group and 470 (50·3%) were assigned to the high protein group. 430 (92·5%) of 465 patients in the standard protein group and 419 (89·1%) of 470 patients in the high protein group were assessed for the primary outcome. The primary outcome, EQ-5D-5L health utility score during 180 days after randomisation (assessed at 30 days, 90 days, and 180 days), was lower in patients allocated to the high protein group than in those allocated to the standard protein group, with a mean difference of -0·05 (95% CI -0·10 to -0·01; p=0·031). Regarding safety outcomes, the probability of mortality during the entire follow-up was 0·38 (SE 0·02) in the standard protein group and 0·42 (0·02) in the high protein group (hazard ratio 1·14, 95% CI 0·92 to 1·40; p=0·22). There was a higher incidence of symptoms of gastrointestinal intolerance in patients in the high protein group (odds ratio 1·76, 95% CI 1·06 to 2·92; p=0·030). Incidence of other adverse events did not differ between groups., Interpretation: High enteral protein provision compared with standard enteral protein provision resulted in worse health-related quality of life in critically ill patients and did not improve functional outcomes during 180 days after ICU admission., Funding: Netherlands Organisation for Healthcare Research and Development and Belgian Health Care Knowledge Centre., Competing Interests: Declaration of interests EDW receives honoraria for scientific lectures from Baxter Healthcare, Nutricia–Danone, and Nestlé. ARHvZ receives grants from AOP Pharma, Nutricia–Danone, Fresenius Kabi, PAION, and Rousselot; receives consulting fees from AOP Pharma, Medcaptain, and PAION; receives honoraria for lectures from Abbott, AOP Pharma, Baxter, Nestlé, Nutricia–Danone, Fresenius Kabi, GE Healthcare, and Dutch Medical Food; receives support for travel from Nutricia–Danone and Dutch Medical Food; is a member of the adult intensive care unit patient nutrition guideline committee of the European Society for Clinical Nutrition and Metabolism, the executive team of SepsisNet Netherlands, and the executive team of the Netherlands Society for Parenteral and Enteral Nutrition; and is the European Society of Intensive Care Medicine Section Feeding, Rehabilitation Endocrinology and Metabolism chair. ZP receives grants from Fresenius Kabi, Nestlé, and Baxter; receives consulting fees from Fresenius Kabi, Nestlé, Baxter, Faraday Pharmaceuticals, and Bioage Pharmaceuticals; and receives honoraria for lectures from Baxter, Nestlé, Fresenius Kabi, and Nutricia. MCGvdP receives grants from the Netherlands Organisation of Health Research and Development and the Belgian Health Care Knowledge Centre; receives in-kind support from Nutricia; receives consulting fees from Nutricia and Nestlé; and receives honoraria for lectures and support for travel from Nutricia. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background: Pelvic organ prolapse (POP) affects many women and is often managed with pessary treatment, yet predicting the success of fitting remains challenging. This study aims to identify anatomical parameters associated with successful and unsuccessful pessary treatment using dynamic magnetic resonance imaging (dMRI). Methods: A cross-sectional study in Maastricht University Medical Centre (MUMC+), the Netherlands. Sixteen women with a cystocele and/or descensus uteri minimal POP-Q stage 2, using pessary treatment, were included. All women underwent a dynamic MRI of the pelvic floor at rest, during contraction and on Valsalva. The anatomical parameters evaluated included various lengths and angles. The association between the anatomical parameters and pessary fitted is assessed using partial least squares regression. The predictive accuracy was tested using cross-validation based on the partial least squares model with the most important variables. Results: Seven of the sixteen women (43.8%) were in the non-fitting group (due to movement, rotation or expulsion of the pessary), and nine women (56.3%) were in the fitting group. Participants in the non-fitting group had a significantly lower body mass index (BMI). Variables such as total vaginal length (TVL) and certain angles were highly predictive of pessary fitting success, with variable importance of projection (VIP) scores indicating their importance. The prediction models showed accuracies ranging from 53.3% to 80.0%. Conclusions: In this explorative study, TVL, cervical length (CL), sacrococcygeal angle and pubococcygeal angle were key variables associated with pessary fitting success. These findings offer valuable insights for optimizing pessary fitting procedures and the development of new pessaries.

Objective: To predict birth weight at various potential gestational ages of delivery based on data routinely available at the first antenatal visit., Design: Individual participant data meta-analysis., Data Sources: Individual participant data of four cohorts (237 228 pregnancies) from the International Prediction of Pregnancy Complications (IPPIC) network dataset., Eligibility Criteria for Selecting Studies: Studies in the IPPIC network were identified by searching major databases for studies reporting risk factors for adverse pregnancy outcomes, such as pre-eclampsia, fetal growth restriction, and stillbirth, from database inception to August 2019. Data of four IPPIC cohorts (237 228 pregnancies) from the US (National Institute of Child Health and Human Development, 2018; 233 483 pregnancies), UK (Allen et al, 2017; 1045 pregnancies), Norway (STORK Groruddalen research programme, 2010; 823 pregnancies), and Australia (Rumbold et al, 2006; 1877 pregnancies) were included in the development of the model., Results: The IPPIC birth weight model was developed with random intercept regression models with backward elimination for variable selection. Internal-external cross validation was performed to assess the study specific and pooled performance of the model, reported as calibration slope, calibration-in-the-large, and observed versus expected average birth weight ratio. Meta-analysis showed that the apparent performance of the model had good calibration (calibration slope 0.99, 95% confidence interval (CI) 0.88 to 1.10; calibration-in-the-large 44.5 g, -18.4 to 107.3) with an observed versus expected average birth weight ratio of 1.02 (95% CI 0.97 to 1.07). The proportion of variation in birth weight explained by the model (R 2 ) was 46.9% (range 32.7-56.1% in each cohort). On internal-external cross validation, the model showed good calibration and predictive performance when validated in three cohorts with a calibration slope of 0.90 (Allen cohort), 1.04 (STORK Groruddalen cohort), and 1.07 (Rumbold cohort), calibration-in-the-large of -22.3 g (Allen cohort), -33.42 (Rumbold cohort), and 86.4 g (STORK Groruddalen cohort), and observed versus expected ratio of 0.99 (Rumbold cohort), 1.00 (Allen cohort), and 1.03 (STORK Groruddalen cohort); respective pooled estimates were 1.00 (95% CI 0.78 to 1.23; calibration slope), 9.7 g (-154.3 to 173.8; calibration-in-the-large), and 1.00 (0.94 to 1.07; observed v expected ratio). The model predictions were more accurate (smaller mean square error) in the lower end of predicted birth weight, which is important in informing clinical decision making., Conclusions: The IPPIC birth weight model allowed birth weight predictions for a range of possible gestational ages. The model explained about 50% of individual variation in birth weights, was well calibrated (especially in babies at high risk of fetal growth restriction and its complications), and showed promising performance in four different populations included in the individual participant data meta-analysis. Further research to examine the generalisability of performance in other countries, settings, and subgroups is required., Trial Registration: PROSPERO CRD42019135045., Competing Interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the National Institute for Health and Care Research Health Technology Assessment UK programme for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Long-term endurance exercise is suspect to elevate the risk of atrial fibrillation (AF), but little is known about cardiovascular outcome and disease progression in this subgroup of AF patients. We investigated whether previous exercise level determines cardiovascular outcome., Methods: In this post hoc analysis of the RACE 4 randomized trial, we analyzed all patients with a completed questionnaire on sports participation. Three subgroups were made based on lifetime sports hours up to randomization and previous compliance to the international physical activity guidelines. High lifetime hours of high dynamic activity patients were defined as more than 150 min·wk -1 of high-intensity physical exercise. The primary endpoint was a composite of cardiovascular death and hospital admissions., Results: A total of 879 patients were analyzed, divided in 203 high lifetime hours of high dynamic activity, 192 high lifetime hours of activity, and 484 low lifetime hours of activity patients. Over a mean follow-up of 36 months (±14), the primary endpoint occurred in 61 out of 203 (30%) high lifetime hours of high dynamic activity, 53 out of 192 (27%) high lifetime hours of activity, and 135 out of 484 (28%) low lifetime hours of activity patients ( P = 0.74). During follow-up, 42 high lifetime hours of high dynamic activity (35%), 43 high lifetime hours of activity (32%), and 104 low lifetime hours of activity patients (34%) with paroxysmal AF received electrical or chemical cardioversion or atrial ablation ( P = 0.90)., Conclusions: In patients included in the RACE 4, there seems to be no relation between previous activity levels and cardiovascular outcome and the need for electrical or chemical cardioversion or atrial ablation. Cardiovascular outcome was driven by AF-related arrhythmic events., (Copyright © 2024 by the American College of Sports Medicine.)

Background: Posttraumatic wrist osteoarthritis is an irreversible and often progressive condition. Many surgical treatments, used in (daily) practice, aim to relieve symptoms like pain and restore function. The aim of this systematic review is to assess the patient reported and functional outcomes of the most common surgical interventions in patients with posttraumatic wrist osteoarthritis. This overview can help clinicians select the best treatment and manage patient's expectations., Methods: A literature search was performed in Pubmed, Embase and Cochrane for articles published between 1990 and November 2022 according to the PRISMA guidelines. The study protocol has been registered in the PROSPERO database (CRD42017080427). Studies that describe patient reported outcomes (pain and Disability of Arm, Shoulder and Hand (DASH) -score) and functional outcomes (range of motion (ROM) and grip strength) after surgical intervention with a minimal follow-up of 1 year were included. The identified surgical procedures included denervation, proximal row carpectomy, interpositional- and total arthroplasty, and midcarpal-, radiocarpal- and total arthrodesis. The pre-and postoperative outcomes were pooled and presented per salvage procedure., Results: Data from 50 studies was included. Pain score improved after all surgeries except denervation. Flexion/extension decreased after radiocarpal arthrodesis, did not show significant changes after proximal row carpectomy, and improved for all other surgeries. DASH score improved after arthroplasty, proximal row carpectomy and midcarpal arthrodesis. Grip strength improved after interposition arthroplasty and partial arthrodesis., Conclusion: Evidence from this review did not support the indication for denervation in this particular patient population. In patients with SLAC/SNAC II, proximal row carpectomy might be favourable to a midcarpal arthrodesis solely based on better FE ROM of the radiocarpal joint after proximal row carpectomy. In terms of radiocarpal mobility, total wrist arthroplasty might be preferred to radiocarpal arthrodesis in patients with osteoarthritis after a distal radius fracture. More uniform measurements of outcomes would improve the understanding of the effect of surgical treatments of the posttraumatic osteoarthritic wrist., (© 2024. The Author(s).)

Objectives: Data-driven decision support tools have been increasingly recognized to transform health care. However, such tools are often developed on predefined research datasets without adequate knowledge of the origin of this data and how it was selected. How a dataset is extracted from a clinical database can profoundly impact the validity, interpretability and interoperability of the dataset, and downstream analyses, yet is rarely reported. Therefore, we present a case study illustrating how a definitive patient list was extracted from a clinical source database and how this can be reported., Study Design and Setting: A single-center observational study was performed at an academic hospital in the Netherlands to illustrate the impact of selecting a definitive patient list for research from a clinical source database, and the importance of documenting this process. All admissions from the critical care database admitted between January 1, 2013, and January 1, 2023, were used., Results: An interdisciplinary team collaborated to identify and address potential sources of data insufficiency and uncertainty. We demonstrate a stepwise data preparation process, reducing the clinical source database of 54,218 admissions to a definitive patient list of 21,553 admissions. Transparent documentation of the data preparation process improves the quality of the definitive patient list before analysis of the corresponding patient data. This study generated seven important recommendations for preparing observational health-care data for research purposes., Conclusion: Documenting data preparation is essential for understanding a research dataset originating from a clinical source database before analyzing health-care data. The findings contribute to establishing data standards and offer insights into the complexities of preparing health-care data for scientific investigation. Meticulous data preparation and documentation thereof will improve research validity and advance critical care., Competing Interests: Declaration of competing interest The authors declare that there are no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Introduction: Preoperative aerobic fitness is associated with postoperative outcomes after elective colorectal cancer (CRC) surgery. This study aimed to develop and externally validate two clinical prediction models incorporating a practical test to assess preoperative aerobic fitness to distinguish between patients with and without an increased risk for 1) postoperative complications and 2) a prolonged time to in-hospital recovery of physical functioning after elective colorectal cancer (CRC) surgery., Materials and Methods: Models were developed using prospective data from 256 patients and externally validated using prospective data of 291 patients. Postoperative complications were classified according to Clavien-Dindo. The modified Iowa level of assistance scale (mILAS) was used to determine time to postoperative in-hospital physical recovery. Aerobic fitness, age, sex, body mass index, American Society of Anesthesiologists (ASA) classification, neoadjuvant treatment, surgical approach, tumour location, and preoperative haemoglobin level were potential predictors. Areas under the curve (AUC), calibration plots, and Hosmer-Lemeshow tests evaluated predictive performance., Results: Aerobic fitness, sex, age, ASA, tumour location, and surgical approach were included in the final models. External validation of the model for complications and postoperative recovery presented moderate to fair discrimination (AUC 0.666 (0.598-0.733) and 0.722 (0.651-0.794), respectively) and good calibration. High sensitivity and high negative predictive values were observed in the lower predicted risk categories (<40 %)., Conclusion: Both models identify patients with and without an increased risk of complications or a prolonged time to in-hospital physical recovery. They might be used for improving patient-tailored preoperative risk assessment and targeted and cost-effective application of prehabilitation interventions., Competing Interests: Declaration of competing interest The authors declare no conflict of interest. NvM is professor and executive director of Health∼Holland. No staff member of Health∼Holland (including the executive director) can ever be involved in the assessment, allocation, and board decisions regarding applications. Health∼Holland does not interfere in any way during the implementation of projects. Only after financial and administrative completion of the project, and after delivery of the formal report to Health∼Holland, NvM became involved in the writing and editing of this article. Therefore, the authors declare no conflict of (financial) interest., (© 2024 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).)

This study aimed to estimate societal and healthcare costs incurred before and 1 year after the first fracture liaison services (FLS) visit and to explore differences in fracture type. All costs after 1 year significantly decreased compared to costs preceding the first visit. Fracture type did not significantly affect costs., Introduction: Limited literature is available on resource utilization and costs of patients visiting fracture liaison services (FLS). This study aimed to estimate the societal and healthcare costs incurred by patients with a recent fracture requiring anti-osteoporosis medication before and 1 year after the first FLS visit and to explore differences according to fracture type., Methods: Resource utilization was collected through a self-reported questionnaire with a 4-month recall on health resource utilization and productivity losses immediately following the first FLS visit, and 4 and 12 months later. Unit costs derived from the national Dutch guideline for economic evaluations were used to compute societal and healthcare costs. Linear mixed-effect models, adjusted for confounders, were used to analyze societal and healthcare costs over time as well as the effect of fracture type on societal and healthcare costs., Results: A total of 126 patients from two Dutch FLS centers were included, of whom 72 sustained a major fracture (hip, vertebral, humerus, or radius). Societal costs in the 4 months prior to the first visit (€2911) were significantly higher compared to societal costs 4 months (€711, p-value = 0.009) and 12 months later (€581, p-value = 0.001). Fracture type did not have a significant effect on total societal or healthcare costs. All costs 12 months after the initial visit were numerically lower for major fractures compared to others., Conclusion: Societal and healthcare costs in the year following the first FLS visit significantly decreased compared to those costs preceding the first visit., (© 2024. The Author(s).)