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Background: In glioblastoma (GBM), tumor progression occurs mainly within the irradiated tumor volume. To address this challenge, a radiosensitization strategy with intravenous gadolinium-based theranostic nanoparticles (AGuIX) is being explored in the NANO-GBM phase1b/2R trial (NCT04881032). Here, we present the results of the phase 1b part, which is the first-in-human use of these nanoparticles with radiotherapy and chemotherapy for the treatment of newly diagnosed GBM. Material and Methods: Eligible patients were aged 18 to 75 years with newly diagnosed and histologically confirmed GBM, with incomplete resection (biopsy or partial surgery). The phase 1b part was a dose escalation approach (Time-to-event Continuous Reassessment Method) with three dose levels: 50, 75, and 100 mg/kg. Patients were treated with RT (60 Gy), and concomitant and adjuvant TMZ, and 4 injections of AGuIX (D-3/-7, D1, D8, and D15). Dose-limiting-toxicity (DLT) was defined as any grade 3–4 adverse event (CTCAE v5.0), excluding alopecia, nausea, and rapidly controlled vomiting. Pharmacokinetic (PK), and biodistribution based on MRI were evaluated. Results: Between March 2022 and March 2023, eight patients were enrolled: 1 at 50 mg/kg, 1 at 75 mg/kg, and 6 at 100 mg/kg. All patients received the four AGuIX injections. Only one patient experienced a DLT (at 100 mg/kg): a grade 3 lymphopenia (related to TMZ). The RP2D of AGuIX was determined as 100 mg/kg. AGuIX mean AUC increased with dose. Regions of GBM with moderate (36–123 µM), and high (123–291 µM) or very high (>291 µM) AGuIX concentrations accounted in average for 38.7 and 26.8 %, respectively. Conclusion: These results confirm the lack of AGuIX-related toxicity and the widespread dispersion of nanoparticles throughout GBM. This supports progression to the randomized phase 2 part, utilizing an RP2D of AGuIX of 100 mg/kg (4 injections).

Objectives: A "patient-researcher" training intervention was designed to improve participants' empowerment by building on their level of critical health literacy and to build a trustful partnership between participants and researchers, with the longer-term objective of co-constructing a community-based research project. The participants in the training intervention were recruited through the collaborative research platform "Seintinelles". This training intervention was aimed at patients or former patients suffering from cancer. The study's objective is to identify intervention's elements that appear to be relevant and those that should be improved for future implementation., Methods: This study is descriptive research in the form of a case study. A questionnaire (post-intervention) and logbook were designed to analyze the implementation of patient-researcher training., Results: Results suggest that the intervention should be flexible to adapt content to formal and informal exchanges. Participants were satisfied, although the intervention did not completely meet their expectations. Following the intervention, most participants felt able to participate in a research study., Conclusion: At the end of this analysis, we can conclude that the 'patient-researcher' training intervention fulfilled its two objectives. First, it provided the knowledge and skills necessary for the implementation of a community-based research study and helped participants feel that they could take part in the different stages of such a study. Second, it initiated the construction of an alliance between 'lived experience' experts and scientific experts., Competing Interests: Conflicts of interest None of the authors have any conflicts of interest to declare., (Copyright © 2024 Elsevier Masson SAS. All rights reserved.)

Objective: The OMERACT Composite Working Group hosted a workshop at OMERACT 2023 to explore the complexities of weighting components in the development of composite outcomes. This study presents the methodology and findings of this workshop, exploring the complexities of weighting the individual components of composite outcome measures., Methods: The workshop featured a multifaceted program, beginning with a plenary session that introduced the concept of composite outcomes, shared a patient's journey with rheumatic disease through a narrative, illustrated a composite outcome for Osteoarthritis Flares, and outlined the five domains selected for this composite outcome. A breakout exercise engaged participants in ranking and assigning weights to these domains, followed by group discussions to reach a consensus on weights. The workshop concluded with another plenary session that discussed various weighting approaches, including discrete choice and conjoint analysis from the ANCA-Associated Vasculitis working group, and outlined future directions for research on composite outcome methods., Results: The breakout exercise revealed the challenges in assigning relative importance to different domains, highlighting the variability in participant perspectives. Consensus discussions highlighted the diversity in approaches to weighting, the need for appropriate methods to determine domain weights and the impact of such weights on the interpretation of composite scores., Conclusion: The OMERACT 2023 workshop underscored the significance of a systematic approach to weighting components in composite outcome development. It highlighted the complexity of achieving consensus on the importance of domains and the role of incorporating the perspectives of patient research partners in this process. Future research directions include refining weighting methodologies, moving composites through the OMERACT Filter and enhancing understanding of their implications for clinical trials. The findings contribute to the ongoing discourse on optimizing composite outcome measures in rheumatology and beyond, advocating for a balanced integration of scientific rigour and patient-centeredness in their development., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Peter Tugwell receives consulting fees from Reformulary Group for providing independent medical consultation professional services to the firms listed in this section. Participation on a Data Safety Monitoring Board or Advisory Board for UCB Biopharma GmbH & SPRL Parexel International Prahealth Sciences. Is an independent Committee Member for clinical trial Data Safety Monitoring Boards for FDA approved trials being conducted by: UCB Biopharma GmbH & SPRL Parexel International Prahealth Sciences Other financial or non-financial interests with Abbvie, Astra Zenaca, Aurinia, BMS, Centrexion, GSK, Horizon Pharma Inc, Janssen, Novartis, Pfizer & Sparrow. He is [unpaid] Chair of the Management Group of a registered non-profit independent medical research organization, OMERACT, whose goal is to improve and advance the health outcomes for patients suffering from musculoskeletal conditions. OMERACT receives arms-length funding from 8 companies. Dorcas Beaton has an unpaid leadership role as a member of the Management team at OMERACT, co-chair of the methods group, and technical advisory group of OMERACT. Maarten de Wit receives consulting fees from Evidera (Patient Partner Advisory Council), honoraria from UCB 2022, 2023 for facilitating a workshop. Sara Monti received consulting fees from CLS-Vi for AstraZeneca All other authors have no conflicts to declare., (Copyright © 2024. Published by Elsevier Inc.)

Objective: The 2023 American College of Rheumatology/EULAR antiphospholipid syndrome (APS) classification criteria development, which aimed to identify patients with high likelihood of APS for research, employed a four-phase methodology. Phase I and II resulted in 27 proposed candidate criteria, which are organized into laboratory and clinical domains. Here, we summarize the last stage of phase III efforts, employing a consensus-based multicriteria decision analysis (MCDA) to weigh candidate criteria and identify an APS classification threshold score., Methods: We evaluated 192 unique, international real-world patients referred for "suspected APS" with a wide range of APS manifestations. Using proposed candidate criteria, subcommittee members rank ordered 20 representative patients from highly unlikely to highly likely to have APS. During an in-person meeting, the subcommittee refined definitions and participated in an MCDA exercise to identify relative weights of candidate criteria. Using consensus decisions and pairwise criteria comparisons, 1000Minds software assigned criteria weights, and we rank ordered 192 patients by their additive scores. A consensus-based threshold score for APS classification was set., Results: Premeeting evaluation of 20 representative patients demonstrated variability in APS assessment. MCDA resolved 81 pairwise decisions; relative weights identified domain item hierarchy. After assessing 192 patients by weights and additive scores, the Steering Committee reached consensus that APS classification should require separate clinical and laboratory scores, rather than a single-aggregate score, to ensure high specificity., Conclusion: Using MCDA, candidate criteria preliminary weights were determined. Unlike other disease classification systems using a single-aggregate threshold score, separate clinical and laboratory domain thresholds were incorporated into the new APS classification criteria., (© 2024 American College of Rheumatology.)

The multifaceted implications of global population aging require regular assessments of the current state of aging-related social science research and the identification of potential future research priorities in this important area. Given the multi-, inter-, and transdisciplinary nature of this field, such assessments typically require the involvement of experts from diverse backgrounds to ensure a comprehensive picture and to synthesize understudied and newly emerging topics into a future research agenda. We explored to what extent ChatGPT (version GPT-4, OpenAI) might be a useful tool for synthesizing the current state of research and identifying promising future research areas, which could feed into expert panel discussions for priority setting. ChatGPT proposed a long list of topics and specific research questions that are useful in summarizing current views on research priorities across diverse sources. To illustrate, the top five priorities for future aging research identified by ChatGPT were digital integration, climate change and older populations, mental health and aging, aging in diverse contexts, and post-pandemic aging. In conclusion, ChatGPT may be a useful tool for identifying research agenda priorities across organizations present in the web, but the lack of transparency requires that experts critically evaluate the values and views underlying selected priorities.

Traditionally, postoperative whole-brain radiation therapy (WBRT) has been used for resected brain metastases, reducing local and intracerebral relapses. However, WBRT is associated with cognitive deterioration. Postoperative stereotactic radiotherapy (SRT) has emerged due to its neurocognitive preservation benefits. Despite its advantages, postoperative SRT has several drawbacks, including difficulties in target volume delineation, increased risk of radionecrosis (RN) and leptomeningeal disease (LMD), and prolonged treatment duration. Preoperative SRT has been proposed as a potential alternative, offering promising results in retrospective studies. Retrospective studies have suggested that preoperative SRT could achieve high local control rates with fewer LMD and RN rates compared to postoperative SRT. However, preoperative SRT is primarily based on retrospective data, and no phase 2/3 trials have been published to date. Ongoing clinical trials are expected to provide further insights into the efficacy and safety of preoperative SRT, addressing key questions regarding fractionation, dose, and timing relative to surgery., (Copyright © 2024 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)

Aims: Cardiac conduction disorders are common in haemodialysis patients, with a relatively high rate of pacemaker implantations. Pacemaker-related complications, especially lead infections and central venous stenosis, pose significant challenges in this population. This study aims to compare single-chamber leadless pacemaker to single-chamber transvenous pacemakers in terms of survival and related complications in haemodialysis patients., Methods and Results: This retrospective study included adult haemodialysis patients who received a first single-chamber transvenous or leadless pacemaker between January 2017 and December 2020. Data were obtained from the French national REIN registry matched to the national health databases (Système National des Données de Santé). Propensity score matching was used to balance baseline characteristics. Survival and complications were compared between groups by Cox regression and by competitive risk models, respectively. One hundred and seventy-eight patients were included after propensity score matching, with 89 patients in each group. The median follow-up time was 24 (range 7-37) months. Leadless pacemakers were associated with significantly lower all-cause mortality rates compared to transvenous pacemakers [hazard ratio (HR) = 0.68, 95% confidence interval (CI) (0.47-0.99)]. Device-related infections are significantly lower with leadless pacemakers throughout the follow-up period (HR 0.43, 95% CI 0.21-0.86). Leadless pacemaker recipients also required fewer vascular access interventions [odds ratio 0.53, 95% CI (0.33-0.68)] on arteriovenous fistula., Conclusion: With the limitations of its observational design, this study suggests that leadless pacemakers are associated with a lower rate of complications and better survival as compared with transvenous VVI pacemakers in haemodialysis patients, supporting to consider their preferential use in this population., Competing Interests: Conflict of interest: E.M. is a consultant and received research grants from Medtronic. All remaining authors have declared no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Although at the base of the pyramid-shaped organization of the Rwandan health system, community health workers (CHWs) are central to the community-based management of disease outbreaks., Objective: This mixed methods study aimed to explore the feasibility, acceptability, satisfaction, and challenges of a mobile health (mHealth) tool for community-based COVID-19 screening in Rwanda., Methods: Two urban (Gasabo and Nyarugenge) and 2 rural (Rusizi and Kirehe) districts in Rwanda participated in the project (smartphone app for COVID-19 screening). A mixed methods approach was used to inform the feasibility (awareness and expectation), acceptability (use and perceived benefits), satisfaction, and challenges of the mHealth intervention. At the end of the project, CHWs were asked to complete a quantitative questionnaire on the use of and satisfaction with the app. Then, in-depth interviews and focus group discussions were organized with CHWs. A content analysis was performed on the transcripts., Results: Overall, 383 CHWs were recruited and trained; 378 CHWs participated in the study. The mean age of CHWs was 36.7 (SD 6.6) to 45.3 (SD 9.9) years and most were women (237/378, 62.7%). More than 7000 people were registered with the use of the app and 20% were referred to a local COVID-19 testing facility. According to CHW reporting, the median number of people screened by each CHW ranged from 152 (IQR 70-276) for Nyarugenge to 24 (IQR 16-90) for Rusizi. COVID-19 positivity rates were higher in urban than rural districts: more than half of the CHWs in Gasabo reported a confirmed positive case versus only 2.4% for Kirehe and 15.4% for Rusizi. Despite the app being a novel tool, CHWs were well aware of the use of such a tool and had appropriate expectations. Acceptability and satisfaction were very high, with differences between urban and rural districts. Satisfaction was higher in Nyarugenge (72.8/100) and Gasabo (80.7/100) than in Kirehe (61.6/100) and Rusizi (64.5/100). More than 80% of the CHWs were willing to continue using the e-ASCov app, with the exception of CHWs in Kirehe (56.7%). The app was perceived as a tool to generate information on COVID-19, inform on the status of the pandemic, and help curb the spread of the pandemic in Rwanda. CHWs were satisfied with the app at all stages of its implementation in their districts., Conclusions: In this proof-of-concept study, a smartphone app for screening COVID-19 was useful as an mHealth tool to be used by CHWs, with the potential to increase health system efficiency in an epidemic context. The context should be analyzed for generalization on a country-wide scale, both in case of an epidemic and to take into account certain conditions at the community level. Information is needed on the conditions of generalization and transferability of this type of app to other health conditions so that CHWs can be given their full place in a pyramidal health system., (© Abdou Y Omorou, Pacifique Ndishimye, Bruno Hoen, Léon Mutesa, Prosper Karame, Ladislas Nshimiyimana, Simon Galmiche, Hassan Mugabo, Janvier Murayire, Muco Mugisha, Marie Michele Umulisa, Yvonne Uwera, Clarisse Musanagabanwa, Noella Bigirimana, Sabin Nsanzimana, Francis Guillemin, Jean-Paul Rwabihama. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org).)

Objectives: This study aims to compare methods of constructing a composite score for the Flare-OA-16 self-reported questionnaire., Methods: Participants with knee and hip osteoarthritis (OA) completed a validated 16-item questionnaire assessing five domains of flare. Three estimation methods were compared: (i) second-order confirmatory factor analysis (CFA); (ii) logistic regression, according to the participant's self-report of flare (yes/no); and (iii) Rasch method, with weighted scores in each dimension. The distribution (floor effect [FF] and ceiling effect [CF]) were described and the known-group validity (by self-reported flare) tested by Wilcoxon rank-sum test. Similarity between the scores was analyzed by intraclass correlation coefficient (ICC) and their performance against self-report compared by areas under ROC curves (AUC). Intrascore test-retest reliability at 14 days was assessed by ICC., Results: In a sample of 381 participants, 247 reported having a flare. CFA showed fit indices (comparative fit index [CFI] = 0.95; root mean square error of approximation [RMSEA] = 0.08) and estimated composite mean score = 4.33(SD = 2.85) (FF = 14.9%, CF = 0%). For the logistic regression estimation, the mean composite score was 6.48 (SD = 3.13) (FF = 0%; CF = 0%). With Rasch model, the mean composite score was 4.35 (SD = 2.60) (FF = 14.9%; CF = 0%). Similarity analysis indicated a greater concordance between CFA and Rasch scores (ICC = 0.98) than between logistic regression score and the two others (ICC = 0.88 with Rasch score and 0.90 with CFA score). The AUC indicated similar performance of all methods: logistic model (AUC = 0.89 [0.85-0.92]), CFA, and Rasch model (AUC = 0.86 [0.82-0.90]). The difference between groups was significant (P < .05) for scores estimated by CFA (3.98), Rasch model (4.95), and logistic regression (4.30). The reproducibility was ICC = 0.84 (0.75-0.90) for Rasch and CFA scores and ICC = 0.78(0.66-86) for logistic model., Conclusion: Three alternatives explored to build a composite score showed similar construct validity. Some metric superiority (better score distribution and reproducibility) of the Rasch model is promising for the detection of occurrence and assessment of severity of a flare in OA., Competing Interests: Declaration of competing interest The authors declare that they have no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The recent Flare-OA questionnaire measuring flare in knee and hip osteoarthritis (OA) (19 items in 5 domains, numerical rating scale) showed good psychometric properties along with classical test theory. This study aimed to determine its scaling properties by Rasch analysis and to present evidence for a refined scalable version., Study Design and Setting: The participants were 398 subjects (mean age 64 years [standard deviation = 8.1], 70.4% women) recruited from Australia, France, and the United States, with clinically and radiologically symptomatic knee or hip OA, who completed an online survey. The sample was split into derivation and validation subsamples, stratified by country and joint. Rasch analysis examined differential item functioning (DIF) for sex, age, country, and joint. A confirmatory factor analysis and an analysis of convergent validity were performed to document the psychometric properties of the short version., Results: To fit the Rasch model, we reordered thresholds of answering modalities when necessary. Two items were removed. A local dependency between 2 items was solved by combining items modalities into a super-item. A uniform DIF (expected and nonremoved) was identified for one item that was split by joint, and a nonuniform DIF for one item for age and country (removed). The person-item threshold distribution showed a well-focused scale; the confirmatory factor analysis and the analysis of convergent validity showed good fit indicators for the short version., Conclusion: The Rasch analysis was helpful in guiding the decision to refine the measurement instrument. After analysis, the 16-item Flare-OA self-report questionnaire is available for use in clinical research., Competing Interests: Declaration of competing interest The authors declare that they have no conflict of interest., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Functional outcomes in patients with acute ischemic stroke (AIS) with large vessel occlusion (LVO) undergoing endovascular treatment (EVT) with poor reperfusion were compared with patients with AIS-LVO treated with best medical management only., Methods: Data are from the HERMES collaboration, a patient-level meta-analysis of seven randomized EVT trials. Baseline characteristics and functional outcomes (modified Rankin Scale (mRS) score at 90 days) were compared between patients with poor reperfusion (defined as modified Thrombolysis in Cerebral Infarction Score 0-1 on the final intracranial angiography run as assessed by the central imaging core laboratory) and patients in the control arm with multivariable logistic ordinal logistic regression adjusted for pre-specified baseline variables., Results: 972 of 1764 patients from the HERMES collaboration were included in the analysis: 893 in the control arm and 79 in the EVT arm with final mTICI 0-1. Patients with poor reperfusion who underwent EVT had higher baseline National Institutes of Health Stroke Scale than controls (median 19 (IQR 15.5-21) vs 17 (13-21), P=0.011). They also had worse mRS at 90 days compared with those in the control arm in adjusted analysis (median 4 (IQR 3-6) vs median 4 (IQR 2-5), adjusted common OR 0.59 (95% CI 0.38 to 0.91)). Symptomatic intracranial hemorrhage was not different between the two groups (3.9% vs 3.5%, P=0.75, adjusted OR 0.94 (95% CI 0.23 to 3.88))., Conclusion: Poor reperfusion after EVT was associated with worse outcomes than best medical management, although no difference in symptomatic intracranial hemorrhage was seen. These results emphasize the need for additional efforts to further improve technical EVT success rates., Competing Interests: Competing interests: JO received consulting fees from Nicolab. SBB receives support from the University of Calgary and is on the data safety and monitoring advisory board of the TESLA study. RVM is a shareholder of Collavidence. MDH received support from Medtronic via a grant to the University of Calgary for the HERMES collaboration (now complete and inactive). He reports additional support from Boehringer Ingelheim to the University of Calgary for the TEMPO-2 trial, from Biogen to the University of Calgary, and from NoNo to the University of Calgary for the ESCAPE-NA1 trial and the ESCAPE-NEXT trial, as well as money from the Canadian Institutes for Health Research for the ESCAPE-NA1 and ESCAPE-NEXT trials, as well as from Alberta Innovates to the University of Calgary for the QuICR Alberta Stroke Program for the ESCAPE-NA1 trial. He additionally reports paid work for the adjudication of clinical trial outcomes from Sun Pharma and Brainsgate. He is on the data safety monitoring board for the RACECAT trial, Oncovir Hiltonel trial, DUMAS trial, ARTESIA trial, and BRAIN-AF trial. He is the president of the Canadian Neurological Sciences Federation and Canadian Stroke Consortium. He has private stocks in Circle Inc and PureWeb Inc. KWM has received grants from the British Heart Foundation, The Stroke Association, and Innovate UK for the ATTEST-2 and TEMPO-2 trials. He has accepted consulting fees from Boehringer-Ingelheim, Abbvie, and Biogen. He has received lecture fees from Boehringer Ingelheim. He is on the data safety and monitoring board of the ARREST trial. PJM has received royalties or licenses from Medtronic and Stryker for institutional research support, and support from Stryker, Medtronic, and Microvention for attending meetings and/or travel. MG has received grants from NoNo, Medtronic, and Cerenovus via the University of Calgary. He has received royalties or licenses from GE Healthcare and Microvention. He has received consulting fees from Microvention, Medtronic, Stryker, and Mentice. He has stock or stock options in Circle Neurovascular., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Clinicians need simple and highly predictive prognostic scores to assist practical decision-making. We aimed to develop a simple outcome prediction score applied 24 hours after anterior circulation acute ischemic stroke treatment with endovascular thrombectomy and validate it in patients treated both with and without endovascular thrombectomy., Methods: Using the HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) collaboration data set (n=1764), patients in the endovascular thrombectomy arm were divided randomly into a derivation cohort (n=430) and a validation cohort (n=441). From a set of candidate predictors, logistic regression modeling using forward variable selection was used to select a model that was both parsimonious and highly predictive for modified Rankin Scale (mRS) ≤2 at 90 days. The score was validated in validation cohort, control arm (n=893), and external validation cohorts from the ESCAPE-NA1 (Efficacy and Safety of Nerinetide for the Treatment of Acute Ischaemic Stroke; n=1066) and INTERRSeCT (Identifying New Approaches to Optimize Thrombus Characterization for Predicting Early Recanalization and Reperfusion With IV Alteplase and Other Treatments Using Serial CT Angiography; n=614)., Results: In the derivation cohort, we selected 2 significant predictors of mRS ≤2 (National Institutes of Health Stroke Scale score at 24 hours and age [β-coefficient, 0.34 and 0.06]) and derived the HERMES-24 score: age (years)/10+National Institutes of Health Stroke Scale score at 24 hours. The HERMES-24 score was highly predictive for mRS ≤2 (c-statistic 0.907 [95% CI, 0.879-0.935]) in the derivation cohort. In the validation cohort and the control arm, the HERMES-24 score predicts mRS ≤2 (c-statistic, 0.914 [95% CI, 0.886-0.944] and 0.909 [95% CI, 0.887-0.930]). Observed provability of mRS ≤2 ranged between 3.1% and 3.4% when HERMES-24 score ≥25, while it ranged between 90.6% and 93.0% when HERMES-24 score <10 in the derivation cohort, validation cohort, and control arm. The HERMES-24 score also showed c-statistics of 0.894 and 0.889 for mRS ≤2 in the ESCAPE-NA1 and INTERRSeCT populations., Conclusions: The post-treatment HERMES-24 score is a simple validated score that predicts a 3-month outcome after anterior circulation large vessel occlusion stroke regardless of intervention, which helps prognostic discussion with families on day 2., Competing Interests: Dr Brown reports consulting for B. Braun Interventional Systems, Inc, Medtronic, MicroVention, Inc, and the University of Calgary and is employed by BRIGHT Research Partners. Dr Goyal reports grants from Medtronic, Stryker, MicroVention, and Mentice; consulting for Stryker, Microvention, and Mentice; and a patent for systems and methods for acute stroke diagnosis with GE Healthcare. Dr Menon reports stock holdings in Circle Neurovascular Imaging and compensation from Roche and Boehringer Ingelheim. Dr Campbell reports grants from Covidien, Medtronic, and the National Health and Medical Research Council of Australia and fellowships from the National Heart Foundation of Australia, the National Stroke Foundation of Australia, and the Royal Australasian College of Physicians. Dr Mitchell reports consulting for Stryker and MicroVention and grants from Medtronic and Stryker. Dr Jovin reports consulting for Contego Medical; grants/contracts from Medtronic and Stryker; data safety monitoring board participation with Johnson & Johnson CERENOVUS; and stock holdings in Anaconda, Basking, Freeox Biotech, Galaxy, Gravity, Kandu, Methinks, Route92, StataDX, and Vizai. Dr Saver reports consulting for Abbott Laboratories, Aeromics, Biogen, Boehringer Ingelheim, BrainQ, BrainsGate, CSL Behring, Johnson & Johnson Health Care Systems, Medtronic, MindRhythm, Roche, and Stream Medical; data safety monitoring board participation with MIVI Neuroscience; and stock holdings in Neuronics Medical and Rapid Medical. Dr Muir reports consulting for Boehringer Ingelheim, Bayer, and Daiichi Sankyo. Dr White reports consulting for MicroVention and grants from the UK National Institutes for Health Research, MicroVention, Stryker, Medtronic, and Penumbra. Dr Bracard reports grants from the French Ministry of Health; others from GE Medical Systems; and nonfinancial support from MicroVention Europe. Dr Roos reports stock holdings in Nicolab. Dr van Zwam reports grants/contracts from Bayer HealthCare Pharmaceuticals, Stryker, and Johnson & Johnson; employment by Maastricht Universitair Medisch Centrum; and data safety monitoring board participation with Philips. Dr Hill reports consulting for BrainsGate; grants/contracts from Biogen, Boehringer Ingelheim, the Canadian Institutes of Health Research, Medtronic MicroVention, and NoNO; end point review committee participation with Merck; employment by the University of Calgary; and a patent for Systems and Methods for Assisting in Decision-Making and Triaging for Acute Stroke Patients with Circle Neurovascular Imaging. Dr Demchuk reports consulting for Boehringer Ingelheim, HLS Therapeutics, Hoffmann-La Roche, Medtronic, Nova-Signal, and Servier; data safety monitoring board participation with Philips and Lumosa; others from Novo Nordisk AS, Pfizer, and Astra Zeneca; and stock and patent for Stroke imaging software with Circle Neurovascular Imaging. The other authors report no conflicts.

To develop health promotion (HP) in sports clubs (SCs), stakeholders need to know the HP expectations of sports participants. However, the literature does not provide information on these aspects, which exacerbates the difficulty for SCs to provide an environment, activities and organization that promote health and to play the role entrusted to them in the integration of vulnerable populations. To fill this gap, this study explores the HP expectations and perceptions of sports participants, with a particular focus on ethnocultural characteristics, and documents participants' understanding of HP. A descriptive qualitative study comprising semi-structured interviews was carried out with 22 French and Quebec sports participants. Because they have little experience with HP in their SC, participants do not seem to have many expectations of their SC in terms of HP. Nevertheless, they felt that SCs can play an important role in health and suggested several themes and types of action, such as seminars on nutrition, activities outside the SC to develop cohesion or health monitoring. Sports participants from ethnocultural minorities seem to appreciate the programs designed to integrate them. There is a predominantly physical conception of health and the contribution of SCs to health, and the relationship between the types of health determinants (economic, environmental, organizational and social) and health is not clear. This study shows that the idea of a health-promoting SC appeals to SC participants, but this approach has not yet taken root in this setting or in society as a whole., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: In glioblastoma (GBM), tumor progression occurs mainly within the irradiated tumor volume. To address this challenge, a radiosensitization strategy with intravenous gadolinium-based theranostic nanoparticles (AGuIX) is being explored in the NANO-GBM phase1b/2R trial (NCT04881032). Here, we present the results of the phase 1b part, which is the first-in-human use of these nanoparticles with radiotherapy and chemotherapy for the treatment of newly diagnosed GBM., Material and Methods: Eligible patients were aged 18 to 75 years with newly diagnosed and histologically confirmed GBM, with incomplete resection (biopsy or partial surgery). The phase 1b part was a dose escalation approach (Time-to-event Continuous Reassessment Method) with three dose levels: 50, 75, and 100 mg/kg. Patients were treated with RT (60 Gy), and concomitant and adjuvant TMZ, and 4 injections of AGuIX (D-3/-7, D1, D8, and D15). Dose-limiting-toxicity (DLT) was defined as any grade 3-4 adverse event (CTCAE v5.0), excluding alopecia, nausea, and rapidly controlled vomiting. Pharmacokinetic (PK), and biodistribution based on MRI were evaluated., Results: Between March 2022 and March 2023, eight patients were enrolled: 1 at 50 mg/kg, 1 at 75 mg/kg, and 6 at 100 mg/kg. All patients received the four AGuIX injections. Only one patient experienced a DLT (at 100 mg/kg): a grade 3 lymphopenia (related to TMZ). The RP2D of AGuIX was determined as 100 mg/kg. AGuIX mean AUC increased with dose. Regions of GBM with moderate (36-123 µM), and high (123-291 µM) or very high (>291 µM) AGuIX concentrations accounted in average for 38.7 and 26.8 %, respectively., Conclusion: These results confirm the lack of AGuIX-related toxicity and the widespread dispersion of nanoparticles throughout GBM. This supports progression to the randomized phase 2 part, utilizing an RP2D of AGuIX of 100 mg/kg (4 injections)., Competing Interests: 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., (© 2024 The Authors.)

Interventions aiming to reduce social inequalities of weight status in adolescents usually focus on lifestyle behaviours, but their effectiveness is limited. This study analysed the effect of achieving levels of dietary intake (DI) and/or physical activity (PA) guidelines on reducing social inequalities in weight status among adolescents. We included adolescents from the PRomotion de l'ALIMentation et de l'Activité Physique - INÉgalité de Santé (PRALIMAP-INÈS) trial with weight status data available at baseline and 1-year follow-up ( n 1130). PA and DI were measured using the International Physical Activity Questionnaire and a validated FFQ, respectively. We estimated the likelihood of a 1-year reduction in BMI z-score (BMIz) and population risk difference (PRD) under hypothetical DI and PA levels and socio-economic status using the parametric G-formula. When advantaged and less advantaged adolescents maintained their baseline DI and PA, we found social inequalities in weight status, with a PRD of a 1-year reduction in BMIz of -1·6 % (-3·0 %, -0·5 %). These inequalities were not observed when less advantaged adolescents increased their proportion of achieving DI guidelines by 30 % (PRD = 2·2 % (-0·5 %, 5·0 %)) unlike the same increase in PA (PRD = -3·9 % (-6·8 %, -1·3 %)). Finally, social inequalities of weight status were not observed when levels of achievement of both PA and DI guidelines increased by 30 % (PRD = 2·2 % (-0·5 %, 4·0 %)). Enhancing DI rather than PA could be effective in reducing social inequalities in weight status among adolescents. Future interventions aiming to reduce these inequalities should mostly target DI to be effective.

Background: Robust collateral circulation has been linked with better reperfusion and clinical outcomes. It remains unclear how individual assessments of collateral circulation may be translated into clinical practice., Methods: The pooled Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials (HERMES) angiography dataset was analyzed by a centralized, independent imaging core blinded to other clinical data. Conventional angiography was acquired immediately prior to endovascular therapy. Collaterals were graded with the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN) system and associated with baseline patient characteristics, reperfusion, and day 90 modified Rankin Score (mRS). Both 90-day all-cause mortality and day 90 mRS were modeled via multivariable logistic regression., Results: Angiography was available in 376/605 (62%) patients. Baseline ASPECTS (Alberta Stroke Program Early CT Score) (p=0.043), history of diabetes mellitus (p=0.048), site of occlusion (p<0.001), and degree of subsequent Thrombolysis in Cerebral Infarction (TICI) reperfusion (p<0.001) were associated with collateral grades. ASITN collateral grade was strongly associated with ordinal mRS from baseline to 90 days in an unadjusted analysis (p<0.001). Multivariable regression demonstrated that collateral status is a strong determinant of mRS outcome in the presence of other predictors (OR=1.37 per grade, 95% CI [1.05 to 1.74], p=0.018). By comparing ORs, 1 unit of ASITN was determined to be approximately equivalent to 4.5 points of NIHSS, 11 years of age, 1.5 points of ASPECTS, or 100 min less delay from onset to puncture, in terms of impact on mRS., Conclusions: Individual collateral physiology may contribute significantly to reperfusion success and clinical outcomes after acute ischemic stroke. Building a consensus for the role of angiographic collateral assessment in the allocation of adjuvant reperfusion therapies may help galvanize a precision medicine approach in stroke., Competing Interests: Competing interests: DSL reports having received grant funding from NINDS and consulting fees as an imaging core laboratory from Cerenovus, Genentech, Medtronic, Stryker, and Rapid Medical. RJ reports consulting with Phenox Medical, Microvention Terumo, and RapidPulse Inc. CBLMM reports having received grant funding from the CVON/Dutch Heart Foundation, Healthcare Evaluation Netherlands, European Commission, TWIN Foundation, and unrestricted grants from Stryker and Boehringer Ingelheim (all paid to institution) and is shareholder of Nicolab (minority interest). AvdL reports consulting fees from Stryker and grant funding from the Dutch Heart Foundation, AngioCare BV, Medtronic/Covidien/EV3®, MEDAC Gmbh/LAMEPRO, Penumbra Inc., Top Medical/Concentric, and Stryker, received by the Erasmus University Medical Center. LSR serves on a Data and Safety Monitoring Board (DSMB) for somatosensory evoked potentials (SEP) monitoring in patients with acute ischemic stroke and large anterior vessel occlusion undergoing endovascular thrombectomy. A clinical validation of the Brain20® medical device, Promise20. AD reports grants from the Dutch Heart Foundation, Brain Foundation Netherlands, The Netherlands Organisation for Health Research and Development, Health Holland Top Sector Life Sciences & Health and unrestricted grants from Penumbra Inc., Stryker, Medtronic, and Thrombolytic Science, all for research. JLS reports consulting fees for advising on rigorous and safe clinical trial design and conduct from Abbott, Acticor, Aeromics, Amgen, Argenica, Astrocyte, Bayer, Biogen, Boehringer Ingelheim, BrainsGate, BrainQ, CSL Behring, Filterlex, Genentech, Johnson & Johnson, MindRhythm, Medtronic, NeuroMerit, Neuronics, Novo Nordisk, Occlutech, Phenox, Phillips, QuantalX, Rapid Medical, Roche, and Stream Biomedical. PJM reports unrestricted institutional scientific grants from Stryker and Medtronic. KWM reports consultancies with Boehringer Ingelheim, Biogen, Hyperfine, and lecture fees from Boehringer Ingelheim, IschemaView, and Brainomix. PW discloses institutional research grant support within the last 2 years from Microvention Terumo. He declares the following relevant professional relationships: Chair of the European Society of Minimally Invasive Neurotherapeutics Guidelines Committee, sits on the Policy Working Group for Thrombectomy of NHS England, and represents the Royal College of Radiologists on the UK Intercollegiate Stroke Working party - none of these are associated with financial reimbursement. He reports the following modest consultancy work: member of Stryker’s Global Hemorrhagic Stroke Advisory Board and educational consultancy work for Microvention Terumo. He has no other interests to declare. MG reports being the principal investigator of an unrestricted research grant to the University of Calgary for the HERMES collaboration by Medtronic. He also reports consulting services with Medtronic, Stryker, Microvention, and Cerenovus, and a licensing agreement with GE Healthcare regarding systems of acute stroke diagnosis., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Many interventions are implemented in the public health context to overcome social inequalities of weight status in adolescents, but their effectiveness is challenged. This study aimed to examine the effectiveness of these interventions with a systematic review and meta-analysis. We systematically searched for reports of randomized control trials and quasi-experimental studies aiming to reduce social inequalities of weight status in adolescents in five electronic databases. The primary outcomes were social inequalities in weight-related outcomes (body mass index [BMI], BMI z score, waist circumference, percent body fat, prevalence of overweight/obesity). Interventions were effective when they reduced social inequalities in at least one weight-related outcome. Meta-analyses involved using random-effects models. The review included 38 publications (33 studies) with interventions mostly targeting disadvantaged adolescents (n = 29 studies), showing effectiveness in half of the studies (n = 19/33, 57.6%). The meta-analysis (27 studies) revealed that targeted interventions significantly reduced BMI z score (β = -0.04 [95% CI -0.08, -0.01]), BMI (β = -0.32 [-0.47, -0.18]), and waist circumference (β = -0.84 [-1.48, -0.21]) but not percent body fat (β = -0.27 [-0.71, 0.17]) or prevalence of overweight/obesity (odds ratio = 1.06 [0.85, 1.31]). This review shows moderate effectiveness of interventions targeting disadvantaged adolescents to reduce social inequalities of weight status. High-quality research with better implementation to reach their full potential is required to strengthen their effectiveness., (© 2024 World Obesity Federation.)

Introduction: The growing recognition of holistic patient care highlights the various factors shaping the quality of life of individuals with autoimmune and rheumatic diseases (AIRDs). Beyond the traditional disease measures, there is an emerging acknowledgment of the less-explored aspects, including subjective well-being, social determinants of health, comorbidities, mental health, and medication adherence. Moreover, digital health services have empowered patients to engage actively in decision-making alongside clinicians. To explore these domains within the context of AIRDs, the "Collating the Voice of People with Autoimmune Diseases" COVAD survey was conceived, a successor of the previous two COVAD surveys. In this document, we present the study protocol in comprehensive detail., Methods: The COVAD-3 survey is a cross-sectional patient self-reported e-survey incorporating multiple widely accepted scales/scores to assess various aspects of patients' lifestyles objectively. To ensure the survey's accuracy and usability across diverse regions, it will be translated into multiple languages and subjected to rigorous vetting and pilot testing. It will be distributed by collaborators via online platforms and data will be collected from patients with AIRDs, and healthy individuals over eight months. Data analysis will focus on outcome measures related to various social, demographic, economic, and psychological factors., Conclusion: With the increasing awareness to adopt a holistic treatment approach encompassing all avenues of life, the COVAD-3 survey aims to gain valuable insights into the impact of social, demographic, economic, and psychological determinants of health on the subjective well-being in patients with AIRDs, which will contribute to a better understanding of their overall health and well-being., (© 2024. The Author(s).)

Objective: To increase awareness and understanding of the principles of Equity, Diversity, and Inclusivity (EDI) within Outcome Measures in Rheumatology's (OMERACT) members. For this, we aimed to obtain ideas on how to promote and foster these principles within the organization and determine the diversity of the current membership in order to focus future efforts., Methods: We held a plenary workshop session at OMERACT 2023 with roundtable discussions on barriers and solutions to increased diversity within OMERACT. We conducted an anonymous, web-based survey of members to record characteristics including population group, gender identity, education level, age, and ability., Results: The workshop generated ideas to increase diversity of participants across the themes of building relationships [12 topics], materials and methods [5 topics], and conference-specific [6 topics]. Four hundred and seven people responded to the survey (25 % response rate). The majority of respondents were White (75 %), female (61 %), university-educated (94 %), Christian (42 %), spoke English at home (60 %), aged 35 to 55 years (50 %), and did not report a disability (64 %)., Conclusion: OMERACT is committed to improving its diversity. Next steps include strategic recruitment of members to the EDI working group, drafting an EDI mission statement centering equity and inclusivity in the organization, and developing guidance for the OMERACT Handbook to help all working groups create actionable plans for promoting EDI principles., Competing Interests: Declaration of competing interest GS, AA, JLB, SG, CH, CB, EN, PH, JP, BJS have no relevant conflicts of interest to disclose. LJM is a paid staff member of OMERACT. GCW has received fees, research grants from AbbVie, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Gilead Sciences, GSK, Janssen Biotech, Novartis, Pfizer, Sanofi Genzyme, UCB FG received a grant from NOVARTIS paid to his institution. WC reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie and Einstein Medical College; support for attending meetings and/or travel for previous OMERACT and GRAPPA meetings; and was past GRAPPA PRP Chair. NG reports support by OMERACT to attend the 2023 OMERACT in person meeting. Owner of stock in Abcuro and UCB and stock option grant at TrialSpark. TrialSpark grant expires 11 Oct 2023. Minority holder in all companies. Former employee of TrialSpark, Inc. (position terminated 11 Jul 2023). LSS is on the Management Committee of OMERACT and is Chair, Finance Committee of OMERACT. PT: Consulting Fees from Reformulary Group. An independent Committee Member for clinical trial Data Safety Monitoring Boards for FDA approved trials being conducted by: UCB Biopharma GmbH & SPRL, Parexel International, Prahealth Sciences. I am [unpaid] Chair of the Management Group of a registered non-profit independent medical research organization, OMERACT, whose goal is to improve and advance the health outcomes for patients suffering from musculoskeletal conditions. OMERACT receives arms-length funding from 11 companies: Abbvie, Astra Zenaca, Aurinia, BMS, Centrexion, GSK, Horizon Pharma Inc, Janssen, Novartis, Pfizer & Sparrow., (Copyright © 2024. Published by Elsevier Inc.)

Purpose: In this study, we evaluated readability and understandability of nine French-language Patient-Reported Outcome Measures (PROMs) that are currently used in a contemporary longitudinal cohort of breast cancer survivors as part of an effort to improve equity in cancer care and research., Methods: Readability of PROMs was assessed using the Flesh Reading Ease Score (FRES), the Gunning's Fog Index (FOG), and the FRY graphics. Readability was considered ideal if mean score ≤ 6th-grade level and acceptable if between 6th and 8th grade. Understandability was evaluated using the Patient Education Materials Assessment Tool and defined as ideal if PEMAT ≥ 80%. The Evaluative Linguistic Framework for Questionnaires (ELF-Q) provided additional qualitative elements to assess understandability. Plain-language best practice was met if both readability and understandability were ideal., Results: None of the 9 PROMs evaluated had ideal readability scores and only 1 had an acceptable score. Understandability ranged from 55% to 91%, and only 3 PROMs had ideal scores. ELF-Q identified points for improvement in several understandability dimensions of the PROMs. None of the instruments met the definition of plain-language best practice., Conclusion: None of the studied PROMs met the standards of readability and understandability. Future development and translation of PROMs should follow comprehensive linguistic and cultural frameworks to ensure plain-language standards and enhance equitable patient-centered care and research., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objectives: The standard treatment for short bowel syndrome is home parenteral nutrition. Patients' strict adherence to protocols is essential to decrease the risk of complications such as infection or catheter thrombosis. Patient training can even result in complete autonomy in daily care. However, some patients cannot or do not want too much responsibility. However, doctors often encourage them to acquire these skills. Based on qualitative investigations with patients, we wanted to document issues of importance concerning perceptions of autonomy in daily care., Methods: Semistructured interviews were conducted with 13 adult patients treated by home parenteral nutrition using a maximum variation sampling strategy. We proceeded to a thematic analysis following an inductive approach., Results: After achieving clinical management of symptoms, a good quality of life is within the realm of possibility for short bowel syndrome patients with home parenteral nutrition. In this context, achieving autonomy in home parenteral nutrition could be a lever to sustain patients' quality of life by providing better life control. However, counterintuitively, not all patients aim at reducing constraints by reaching autonomy in home parenteral nutrition. First, they appreciate the social contact with the nurses, which is particularly true among patients who live alone. Second, they can feel safer with the nurse's visits. Regaining freedom was the main motivation for patients in the training program and the main benefit for those who were already autonomous., Conclusions: Medical teams should consider patients' health locus of control (internal or external) for disease management to support them concerning the choice of autonomy in daily care for parenteral nutrition., (© 2024. The Author(s), under exclusive licence to Springer Nature Limited.)

Background: The pandemic presented unique challenges for individuals with autoimmune and rheumatic diseases (AIRDs) due to their underlying condition, the effects of immunosuppressive treatments, and increased vaccine hesitancy., Objectives: The COVID-19 vaccination in autoimmune diseases (COVAD) study, a series of ongoing, patient self-reported surveys were conceived with the vision of being a unique tool to gather patient perspectives on AIRDs. It involved a multinational, multicenter collaborative effort amidst a global lockdown., Methods: Leveraging social media as a research tool, COVAD collected data using validated patient-reported outcomes (PROs). The study, comprising a core team, steering committee, and global collaborators, facilitated data collection and analysis. A pilot-tested, validated survey, featuring questions regarding COVID-19 infection, vaccination and outcomes, patient demographics, and PROs was circulated to patients with AIRDs and healthy controls (HCs)., Discussion: We present the challenges encountered during this international collaborative project, including coordination, data management, funding constraints, language barriers, and authorship concerns, while highlighting the measures taken to address them., Conclusion: Collaborative virtual models offer a dynamic new frontier in medical research and are vital to studying rare diseases. The COVAD study demonstrates the potential of online platforms for conducting large-scale, patient-focused research and underscores the importance of integrating patient perspective into clinical care. Care of patients is our central motivation, and it is essential to recognize their voices as equal stakeholders and valued partners in the study of the conditions that affect them., (© 2024 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.)

Background: one of the most important therapeutic goals in relapse-onset multiple sclerosis is to preclude conversion to secondary progression. Our objective was to determine the risk of progression associated with natalizumab treatment in an registry-based cohort of patients and to identify determinant factors., Methods: Patients with relapse-onset multiple sclerosis from the Registre Lorrain des Scléroses en Plaques (ReLSEP) were included if they had received one infusion of natalizumab between 2002 and 2021. The risk of secondary progression was determined using a standardized definition and a multi-state estimator to account for the possibility of stopping natalizumab before progression, and analyzed with multivariate Cox models., Results: 574 patients were followed up for a median of 6.7 years. Of the 304 who stopped NTZ before progression onset, the probabilities (95% confidence interval) to convert to progression after 1, 2, 5 and 10 years were 3.2% (2.0-4.8%), 5.3% (3.6-7.3%), 17.5% (14.3-21.3%) and 28.3% (23.7-33.7%), respectively. Discontinuation of NTZ during follow-up was significantly associated with an increased risk of conversion in case of no resumption of a highly active treatment thereafter (adjusted hazard ratio = 2.7; 95% confidence interval 1.5-4.9; p = 0.001). The use of such a treatment was associated with a lower risk of progression (adjusted hazard ratio = 0.42; 95% confidence interval 0.23-0.79; p = 0.007)., Conclusion: the risk of conversion to secondary progression associated with natalizumab treatment is relatively low but increases in case of natalizumab discontinuation in the absence of switch to highly active immunosuppressant., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Purpose: Annually, the French Ministry of Health funds clinical research projects based on a national call for projects. Since 2013, the Ministry has prioritized funding of primary care. Projects selected for funding are made public without distinguishing the specific area of research. The objective of this study was to identify and describe the evolution of the primary care research projects funded by the Ministry of Health between 2013 and 2019., Method: We reviewed all of the 1796 medical research projects funded between 2013 and 2019 and categorized projects as primary care projects by using a list of specific keywords. This list was established through two approaches: (1) selected by an expert committee, the RECaP primary care working group, and (2) using an automated textual analysis of published articles in the field. The keywords were used to screen the titles of the medical research projects funded. The abstracts (at www., Clinicaltrials: gov ) or details (from project leaders) were then analyzed by two independent reviewers to determine true primary care projects., Results: Finally, 49 primary care projects were identified, representing 2.7% of all medical research projects funded, without any significant change over the period. These projects were predominantly interventional (69%), with a median number of patients expected per project of 902., Conclusion: Despite the prioritization of primary care research in 2013 by the French ministry of health, the number and proportion of projects funded remains low, with no significant change over the years., Trial Registration: Not applicable., (© 2024. The Author(s).)

Sports clubs (SCs) are an ideal setting for promoting health. However existing health promotion (HP) interventions in SCs mainly target a single health behavior and men who do sports, and evaluations of such interventions provides little information about their deployment. To overcome these limitations, the PROSCeSS intervention was co-constructed based on the theoretical model of the health-promoting SC and multi-level, multi-determinant health strategies. The aim of this pilot study was to evaluate the deployment of the PROSCeSS intervention and identify the factors influencing its deployment. A qualitative study, using recordings of meetings, email and telephone exchanges, and interviews with project leaders of fourteen SC, was carried out. Although a low number of SCs had completed the intervention, they all considered that they have a role to play in helping their members maintain good health. Their ability to develop HP activities and to implement the intervention was influenced by the resources available, the support they received from their sports federation, and the ability of each project leader to get involved in the intervention. The SCs that deployed the intervention implemented several strategies enabling them to integrate health into the organizational, social, economic, and environmental habits of the SCs and to develop new HP activities, such as adapted sports activity sessions and activities to teach members about first aid, nutrition, and good practices for warming up. This study highlights the importance of understanding the specificities of the contexts in which HP interventions are deployed. Having led to a reworking of the intervention steps and the development of an appropriate evaluation design, it also highlights the essential role of pilot studies in the development and evaluation of interventions.

Background: Ischemic stroke lesion volume at follow-up is an important surrogate outcome for acute stroke trials. We aimed to assess which differences in 48-hour lesion volume translate into meaningful clinical differences., Methods: We used pooled data from 7 trials investigating the efficacy of endovascular treatment for anterior circulation large vessel occlusion in acute ischemic stroke. We assessed 48-hour lesion volume follow-up computed tomography or magnetic resonance imaging. The primary outcome was a good functional outcome, defined as modified Rankin Scale (mRS) scores of 0 to 2. We performed multivariable logistic regression to predict the probability of achieving mRS scores of 0 to 2 and determined the differences in 48-hour lesion volume that correspond to a change of 1%, 5%, and 10% in the adjusted probability of achieving mRS scores of 0 to 2., Results: In total, 1665/1766 (94.2%) patients (median age, 68 [interquartile range, 57-76] years, 781 [46.9%] female) had information on follow-up ischemic lesion volume. Computed tomography was used for follow-up imaging in 83% of patients. The median 48-hour lesion volume was 41 (interquartile range, 14-120) mL. We observed a linear relationship between 48-hour lesion volume and mRS scores of 0 to 2 for adjusted probabilities between 65% and 20%/volumes <80 mL, although the curve sloped off for lower mRS scores of 0-2 probabilities/higher volumes. The median differences in 48-hour lesion volume associated with a 1%, 5%, and 10% increase in the probability of mRS scores of 0 to 2 for volumes <80 mL were 2 (interquartile range, 2-3), 10 (9-11), and 20 (18-23) mL, respectively. We found comparable associations when assessing computed tomography and magnetic resonance imaging separately., Conclusions: A difference of 2, 10, and 20 mL in 48-hour lesion volume, respectively, is associated with a 1%, 5%, and 10% absolute increase in the probability of achieving good functional outcome. These results can inform the design of future stroke trials that use 48-hour lesion volume as the primary outcome., Competing Interests: Disclosures Dr Rinkel is supported by the Niels Stensen Fellowship. Dr Ospel reports consulting fees from NICOLAB. Dr Brown reports consulting fees from the University of Calgary during the conduct of the HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) collaboration and reports consulting fees from MicroVention. Dr Goyal reports that Medtronic provided a grant to the University of Calgary and consulting fees from Medtronic, Philips, Microvention, Stryker, and Mentice. Dr Muir reports a grant from Boehringer-Ingelheim paid to the institution for support of the ATTEST-2 (Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis); consulting fees from Boehringer-Ingelheim, AbbVie, and Biogen; and British Heart Foundation-funded data safety and monitoring board participation (ARREST [Advanced Reperfusion Strategies for Patients With Out-of-Hospital Cardiac Arrest and Refractory Ventricular Fibrillation]). Dr White reports unrestricted grants from Stryker, Medtronic (Covidien), and Penumbra paid to the institution. Dr Jovin reports honoraria from Stryker, Silk Road Medical, Blockade Medical, FreeOx Biomedical, Route 92, Neurotrauma Science, vizai, Corindus, Anaconda, Medtronic, Contego, and Methinks as a consultant; and has consulted for Cerenovus as a steering committee member and Stryker Neurovascular as a principal investigator of DAWN (Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo) and AURORA (Analysis of Pooled Data From Randomized Studies of Thrombectomy More Than 6 Hours After Last Known Well). Dr Hill reports grant/contracts from Biogen Inc, Boehringer-Ingelheim, Canadian Institutes of Health Research, Micorvention, Medtronic, NoNO, Inc, consultant for Brainsgate Ltd, End point review committee at Merck, employment at the University of Calgary, and patent for stroke imaging software with Circle NVI. Dr Mitchell reports speaking engagements from Stryker and Medtronic and research institutional support from Stryker Neurovascular and Medtronic. Dr Saver is a consultant for Johnson & Johnson Health Care Systems, Inc, Medtronic USA, Inc, Boehringer-Ingelheim, MIVI Neuroscience, Stryker Corporation, Abbott Laboratories, Aeromics, Biogen, BrainQ, Brainsgate, CSL Behring, Roche, stock options (Rapid Medical, MindRhythm, Neuronics Medical). Dr Muir reports consulting for AbbVie, Biogen, Boehringer-Ingelheim, Woolsey Pharma and IschemiaView. Dr Jovin reports stock options from Anaconda, Freeox Biotech, Kandu, Galaxy, Methinks, Route92, vizai, consulting for Contego Medical, Inc, data and safety monitoring at Johnson & Johnson Cerenovus, grant/contract from Medtronic USA, Inc, Stryker and employment at Cooper University Healthcare. Dr Demchuk reports compensation from Boehringer-Ingelheim, HLS Therapeutics, Hoffman-Laroche, Medtronic, Nova-Signal, and Servier for consultant services, others from AstraZeneca, Novo Nordisk, and Pfizer, data safety monitoring board participation with Philips, and stock and patent for stroke imaging software with Circle NVI. Dr Majoie reports grants from the Dutch Heart Foundation, European Commission, Health Evaluation Netherlands, Stichting Toegepast Wetenschappelijk Instituut voor Neuro-modulatie Foundation (TWIN Foundation), and Stryker (all paid to institution); and is a (minority interest) shareholder of Nicolab. Dr Dippel reports unrestricted research grants from the Dutch Heart Foundation, Brain Foundation Netherlands, The Netherlands Organisation for Health Research and Development, Health Holland Top Sector Life Sciences and Health, and unrestricted grants from Medtronic, Penumbra, Stryker, Thrombolytic Science, and Cerenovus (all paid to institution).

Objective: To gain consensus on the definitions and descriptions of the domains of the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials evaluating shared decision making (SDM) interventions., Methods: Following the OMERACT Handbook methods, our Working Group (WG), comprised of 90 members, including 17 patient research partners (PRPs) and 73 clinicians and researchers, had six virtual meetings in addition to email exchanges to develop draft definitions and descriptions. The WG then conducted an international survey of its members to gain consensus on the definitions and descriptions. Finally, the WG members had virtual meetings and e-mail exchanges to review survey results and finalize names, definitions and descriptions of the domains., Results: WG members contributed to developing the definitions. Fifty-two members representing four continents and 13 countries completed the survey, including 15 PRPs, 33 clinicians and 37 researchers. PRPs and clinicians/researchers agreed with all definitions and descriptions with agreements ranging from 87% to 100%. Respondents suggested wording changes to the names, definitions and descriptions to better reflect the domains. Discussions led to further simplification and clarification to address common questions/concerns about the domains., Conclusion: Our WG reached consensus on the definitions and descriptions of the domains of the core domain set for rheumatology trials of SDM interventions. This step is crucial to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set., Clinical Significance: The current study provides consensus-based definitions and descriptions for the domains of the OMERACT core domain set for shared decision making interventions from patients/caregivers, clinicians and researchers. This is a crucial step to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set for trials of SDM interventions., Competing Interests: Declaration of competing interest Karine Toupin-April, Simon Décary, Maarten de Wit, Florian Naye, Alexa Meara, Jennifer L. Barton, Liana Fraenkel, Linda C. Li, Peter Brooks, Beverley Shea, Dawn Stacey, Cathie Hofstetter, Marieke Voshaar, Maria E. Suarez-Almazor, Tanya Meade, Janet Elizabeth Jull, Willemina Campbell, Rieke Alten, Esi M. Morgan, Ayano Kelly, Lara J. Maxwell, Francis Guillemin, Dorcas Beaton, Yasser El-Miedany, Shikha Mittoo, Tiffany Westrich Robertson, Susan J. Bartlett, Melissa Mannion, Samah Ismail Nasef, Adewale Adebajo, Laurent Arnaud, Tiffany K. Gill, Ellen Moholt, Jennifer Burt, Aruni Jayatilleke, Ihsane Hmamouchi, David Carrott, Kate Mather, Ajesh Maharaj, Saurab Sharma, Francesco Caso, Christopher Fong, Allyson Jones, Regina Greer-Smith, Akpabio Akpabio, Valerie Umaefulam, Sara Monti, Grayson Schultz, Rebecca R. Lee, Glen Stewart Hazlewood, Claire E.H. Barber, Dorthe B. Berthelsen, Laure Gossec, Sabrina May Nielsen, Sabrina Cavallo, Sonam Kiwalkar, Hemalatha Srinivasalu, Deb Constien, Vicki Evans and Peter Tugwell have nothing to disclose. Anne Boel is employed by UCB Pharma, B.V. Netherlands. Simon Stones is employed by Envision Pharma Group, Wilmslow, UK. Robin Christensen reports other potential COI from Lecture: Research Methods (Pfizer, DK; 2017), other from Lecture: GRADE Lecture (Celgene, DK; 2017), other from Ad Board Lecture: CAM (Orkla Health, DK; 2017), other from Project Grant: "GreenWhistle" (Mundipharma, 2019), other from Lecture: Diet in RMD (Novartis, DK; 2019), other from Consultancy Report: Network MA's (Biogen, DK; 2017), other from Ad Board Lecture: GRADE (Lilly, DK; 2017), other from Consultancy Report: GRADE (Celgene, 2018), other from Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation; The Oak Foundation is a group of philanthropic organizations that, since its establishment in 1983, has given grants to not-for-profit organizations around the world. Annelies Boonen reports grants from Abbvie, grants from Celgene, other from UCB, other from Galapagos, other from Eli Lilly, outside the submitted work. Lyn March reports personal fees from Pfizer Australia, personal fees from Abbvie Australia, grants from Janssen Australia, outside the submitted work; Dr March is a member of OMERACT executive that receives arms-length funding from 9 companies. Willemina Campbell received OMERACT funded travel to a conference to attend meetings in regard to this paper. Jasvinder Singh reports personal fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Trio health, Medscape, WebMD, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, Practice Point communications, the National Institutes of Health and the American College of Rheumatology, personal fees from Simply Speaking, other from Vaxart pharmaceuticals and Charlotte's Web Holdings (current); Amarin, Viking, and Moderna (previously owned), non-financial support from FDA Arthritis Advisory Committee, non-financial support from Steering committee of OMERACT, an international organization that develops measures for clinical trials and receives arms’ length funding from 12 pharmaceutical companies, non-financial support from Veterans Affairs Rheumatology Field Advisory Committee, non-financial support from Editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis, outside the submitted work. Francisco J. Blanco reports grants from Gedeon Richter Plc., Bristol-Myers Squibb International Corporation (BMSIC), Sun Pharma Global FZE, Celgene Corporation, Janssen Cilag International N.V, Janssen Research & Development, Viela Bio, Inc., Astrazeneca AB, UCB BIOSCIENCES GMBH, UCB BIOPHARMA SPRL, AbbVie Deutschland GmbH & Co.KG, Merck KGaA, Amgen, Inc., Novartis Farmacéutica, S.A., Boehringer Ingelheim España, S.A, CSL Behring, LLC, Glaxosmithkline Research & Development Limited, Pfizer Inc, Lilly S.A., Corbus Pharmaceuticals Inc., Biohope Scientific Solutions for Human Health S.L., Centrexion Therapeutics Corp., Sanofi, MEIJI FARMA S.A., Kiniksa Pharmaceuticals, Ltd. Grunenthal, Asofarma Mexico, Gebro Pharma, Roche, Galapagos, Regeneron; outside the submitted work. Anthony P. Fernandez reports personal fees and other from AbbVie, grants, personal fees and other from Novartis, grants, personal fees and other from Mallinkrodt, other from Corbus, other from Pfizer, outside the submitted work. Sarah Mackie reports: Consultancy on behalf of her institution for Roche/Chugai, Sanofi, AbbVie, AstraZeneca, Pfizer; Investigator on clinical trials for Sanofi, GSK, Sparrow; speaking/lecturing on behalf of her institution for Roche/Chugai, Vifor, Pfizer, UCB, Novartis and AbbVie; chief investigator on STERLING-PMR trial, funded by NIHR; patron of the charity PMRGCAuk. No personal remuneration was received for any of the above activities. Support from Roche/Chugai to attend EULAR2019 in person and from Pfizer to attend ACR Convergence 2021 virtually. She is supported in part by the NIHR Leeds Biomedical Research Centre. The views expressed in this article are those of the authors and not necessarily those of the NIHR, the NIHR Leeds Biomedical Research Centre, the National Health Service or the UK Department of Health and Social Care. Elena Nikiphorou reports personal fees and other from AbbVie, personal fees and other from Eli-Lilly, personal fees and other from Gilead, personal fees and other from Celltrion, personal fees and other from Pfizer, other from Sanofi, outside the submitted work. Victor S. Sloan reports and paid consultant to various pharmaceutical companies and healthcare consultancies providing advice on clinical research and advisory committee preparation outside the scope of the submitted work. He is a shareholder in UCB Pharma. He is in the Peace Corps. This is his personal work, and does not reflect the opinion of the Peace Corps or the United States Government. Vibeke Strand reports consulting fees from AbbVie, Amgen, Arena, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, CORRONA, Crescendo/Myriad, Equillium, Genentech/Roche, GSK, Horizon, Inmedix, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Samsung, Sandoz, Sanofi, TwoXAR and UCB, outside the submitted work. Esi M. Morgan reports grant support from Agency for Healthcare Research and Quality and Pfizer., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: To describe the evolution of the OMERACT Fellows Program (OM FP) and to evaluate the innovative changes implemented in the 2023 program., Methods: The OM FP, the first of its kind in global rheumatology, was developed in 2000 to mentor early career researchers in methods and processes for reaching evidence-driven consensus for outcome measures in clinical studies. The OM FP has evolved through continuing iterations of face to face and online feedback. Key new features delivered in 2023 included e-learning modules, virtual introductory pre-meetings, increased networking with Patient Research Partners (PRPs), learning opportunities to give and receive personal feedback, ongoing performance feedback during the meeting from Fellow peers, PRPs, senior OMERACTers (members of the OMERACT community) and Emerging Leader mentors, involvement in pitching promotions, two-minute Lightning Talks in a plenary session and an embedded poster tour. An online survey was distributed after the meeting to evaluate the program., Results: OM FP has included 208 fellows from 16 countries across 4 continents covering 47 different aspects of rheumatology outcomes since its inception. Over 50 % have remained engaged with OMERACT work. In 2023, 18 Fellows attended and 15 (83 %) completed the post-meeting survey. A dedicated OM FP was deemed important by all respondents, and 93 % would attend the meeting in future. The PRP/Fellow Connection Carousel and Lightning Talks were rated exceptional by 93 %. Key components to improve included clarification of expectations, overall workload, the Emerging Leaders Mentoring Program, and the content and duration of daily summary sessions., Conclusion: The innovations in the 2023 OM FP were well received by the majority of participants and supports early career rheumatology researchers to develop collaborations, skills and expertise in outcome measurement. Implementation of feedback from Fellows will enhance the program for future meetings, continuing to facilitate learning and succession planning within OMERACT., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Lara Chapman Grants or contracts from any entity: HEE/NIHR Clinical Doctoral Research Fellowship (ID NIHR30217) Nilasha Ghosh Consulting fees: Musculo Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: GoodRx Clinical Review Board Francis Guillemin Grants or contracts from any entity: NOVARTIS Max Weinbrecht-Mischkewitz OMERACT, Minister Erna Hamiltons Legat, and The Parker Institute, Bispebjerg and Frederiksberg Hospital and the Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology, Schlosspark-Klinik, University Medicine Berlin - Funding for OMERACT 2023 registration fee and travel costs Romi Haas Support for attending meetings and/or travel: 2023 Advancing Women's Success Grant, Monash University - Support to attend OMERACT meeting 2023 Colorado Springs Rachael A. Gordon Grants or contracts from any entity: Sjogrens Foundation Pilot Grant - NIH 5T32AI089443–13 - support for attending meetings and/or travel, (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objectives: To generate candidates for contextual factors (CFs) for each CF type (i.e., Effect Modifying Contextual Factors (EM-CFs), Outcome Influencing Contextual Factors (OI-CFs), and Measurement Affecting Contextual Factors (MA-CFs)) considered important within rheumatology., Methods: We surveyed OMERACT working groups and conducted a Special Interest Group (SIG) session at the OMERACT 2023 meeting, where the results were reviewed, and additional CFs suggested., Results: The working groups suggested 44, 49, and 21 generic EM-CFs, OI-CFs, and MA-CFs, respectively. SIG participants added 49, 44, and 55 factors, respectively., Conclusion: Candidate CFs were identified, next step is a consensus-based set of endorsed (important) CFs., Competing Interests: Declaration of competing interest Amye Leong reports unpaid leadership or fiduciary roles at the Arthritis Foundation, the United States Bones and Joint Initiative and the FDA Patient Engagement Advisory Committee. Annelies Boonen reports a research grant from Abbvie and honoraria from Abbvie, Pfizer, UCB, Novartis and Galapagos for lectures or advisory boards, all to her department. Dorthe Bang Berthelsen reports PhD Scholarships from Odense University Hospital and from the Faculty of Health Sciences, University of Southern Denmark. Francis Guillemin reports grant by Novartis, paid to his institution. Irene van der Horst-Bruinsma reports travel support for EULAR 2023 by Pfizer and unpaid membership in the ASAS advisory board. Maria A. Lopez-Olivo reports grants or contracts from the National Cancer Institute, the Rheumatology Research Foundation and the Duncan Family Institute for Cancer Prevention and Risk Assessment, and consulting fees from the American Cancer Society. Niti Goel reports that she is an owner of stock in Abcuro and UCB and that she is a former employee of TrialSpark, Inc. Peter Tugwell reports consulting fees from the Reformulary Group, being independent Committee Member for clinical trial Data Safety Monitoring Boards for UCB Biopharma GmbH & SPRL, Parexel International and PRA Health Sciences and being chair of the Management Group of OMERACT, a registered non-profit independent medical research organization. OMERACT receives arms-length funding from eleven companies (Abbvie, Astra Zenaca, Aurinia, BMS, Centrexion, GSK, Horizon Pharma Inc, Janssen, Novartis, Pfizer, Sparrow). Rieke Alten reports personal and institutional payments from BMS, Galapagos, Janssen, Lilly, Novartis, Pfizer and UCB as wells as institutional payments from Abbvie and Amgen, support for attending meetings from Celltrion, Lilly and UCB, and membership of an advisory board for Pfizer. Saurab Sharma was supported by the International Association for the Study of Pain John J. Bonica Postdoctoral Fellowship (2021-2023) and travel support to the International Association for the Study of Pain (IASP) Congress in Toronto (2022) both unrelated to the current work. Victor S. Sloan reports consulting fees from Boehringer-Ingelheim, stock in UCB Pharma and as an employee of the Peace Corps states: “This is my personal work, and does not reflect the opinion of the Peace Corps or the United States Government.”. The other authors have no conflict of interest relevant to the content of this study., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the domain match (truth) and feasibility of candidate instruments assessing flare in knee and hip osteoarthritis (OA) according to the identified domains., Material and Methods: From a literature review (575 papers), instruments were selected and evaluated using the truth and feasibility elements of the OMERACT Filter 2.2. These were evaluated by 26 experts, including patients, in two Delphi survey rounds. The final selection was obtained by a vote., Results: 44 instruments were identified. In Delphi Round 1, five instruments were selected. In Round 2, all instruments obtained at least 75 % in terms of content match with the endorsed domains and feasibility. In the final selection, the Flare-OA questionnaire obtained 100 % favorable votes., Conclusion: Through consensus of the working group, the Flare-OA questionnaire was selected as the best candidate instrument to move into a full assessment of its measurement properties using the OMERACT Filter 2.2., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: none competing interests, (Copyright © 2024. Published by Elsevier Inc.)

Objectives: Shared decision making (SDM) is a central tenet in rheumatic and musculoskeletal care. The lack of standardization regarding SDM instruments and outcomes in clinical trials threatens the comparative effectiveness of interventions. The Outcome Measures in Rheumatology (OMERACT) SDM Working Group is developing a Core Outcome Set for trials of SDM interventions in rheumatology and musculoskeletal health. The working group reached consensus on a Core Outcome Domain Set in 2020. The next step is to develop a Core Outcome Measurement Set through the OMERACT Filter 2.2., Methods: We conducted a scoping review (PRISMA-ScR) to identify candidate instruments for the OMERACT Filter 2.2 We systematically reviewed five databases (Ovid MEDLINE®, Embase, Cochrane Library, CINAHL and Web of Science). An information specialist designed search strategies to identify all measurement instruments used in SDM studies in adults or children living with rheumatic or musculoskeletal diseases or their important others. Paired reviewers independently screened titles, abstracts, and full text articles. We extracted characteristics of all candidate instruments (e.g., measured construct, measurement properties). We classified candidate instruments and summarized evidence gaps with an adapted version of the Summary of Measurement Properties (SOMP) table., Results: We found 14,464 citations, read 239 full text articles, and included 99 eligible studies. We identified 220 potential candidate instruments. The five most used measurement instruments were the Decisional Conflict Scale (traditional and low literacy versions) (n=38), the Hip/Knee-Decision Quality Instrument (n=20), the Decision Regret Scale (n=9), the Preparation for Decision Making Scale (n=8), and the CollaboRATE (n=8). Only 44 candidate instruments (20%) had any measurement properties reported by the included studies. Of these instruments, only 57% matched with at least one of the 7-criteria adapted SOMP table., Conclusion: We identified 220 candidate instruments used in the SDM literature amongst people with rheumatic and musculoskeletal diseases. Our classification of instruments showed evidence gaps and inconsistent reporting of measurement properties. The next steps for the OMERACT SDM Working Group are to match candidate instruments with Core Domains, assess feasibility and review validation studies of measurement instruments in rheumatic diseases or other conditions. Development and validation of new instruments may be required for some Core Domains., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Anthony P. Fernandez, MD, PhD: Past 36 months: Grants or contracts from any entity: Mallinckrodt, Novartis, Pfizer. Payments to institution and (partial) to me. Consulting fees: AbbVie, Biogen, UCB, BMS, Alexion: Payments to me. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: AbbVie, BMS, Kyowa Kirin, Mallinckrodt: Payments to me. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Board of Directors, American Society of Dermatopathology; Associate Editor, Journal of the American Academy of Dermatology. Arundathi Jayatilleke: Pas 36 months: Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Pennsylvania Rheumatology Society, board member: unpaid. Claire Barber: Pas 36 months: Grants or contracts from any entity: CIHR – 3: Peer reviewed national funding unrelated to current project. CIORA (Canadian Rheumatology Association): Peer reviewed national funding unrelated to current project. Cumming school of medicine Seed Grant: Local university funding, peer reviewed, unrelated to current project. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Past chair Human Resource Committee, Canadian Rheumatology Association: Unrelated to current project. Dorcas Beaton: Past 36 months: Support for attending meetings and/or travel: OMERACT Management Team: OMERACT covers travel costs for members of management team to attend conferences on behalf of OMERACT. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Member of Management team of OMERACT, chair of methodology at OMERACT: I help make decisions on the methods that will be used to come to a decision about core outcome sets at OMERACT. This would have informed methods used in this paper. Dorthe B Berthelsen: Past 36 months: Grants or contracts from any entity: Have received PhD Scholarships from Odense University Hospital and from the Faculty of Health Sciences, University of Southern Denmark. Support for attending meetings and/or travel: Have received a grant from the Erna Hamilton Foundation to cover meeting registration fee and travel costs for OMERACT 2023. Dawn Stacey: Past 36 months: Grants or contracts from any entity: Canadian Institutes of Health Research. Support for attending meetings and/or travel: Beijing University of Chinese Medicine – August 2023. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Co-Chair International Patient Decision Aid Standards Collaboration (unpaid). Karine Toupin-April: Past 36 months: Support for attending meetings and/or travel: OMERACT travel award given to the Shared decision making group to help attend the OMERACT 2023 meeting. Lyn MARCH: Past 36 months: Grants or contracts from any entity: Commonwealth Government of Australia Medical Research Future Fund: RCT for biological tapering in RA and PsA (Utilising shared decision making): Payment to institution. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Chair, Australian Rheumatology Association Research Fund Committee: unpaid. Executive, Global Alliance for MSK Health: unpaid. Maria Suarez-Almazor: Past 36 months: Consulting fees: Pfizer: Consultant. Eli Lilly: Consultant. Syneos Health: Consultant. Participation on a Data Safety Monitoring Board or Advisory Board: Celgene: DSMB member. Maarten de Wit: Past 36 months: Consulting fees: UCB: Payment to Stichting Tools, Netherlands. Peter Tugwell: Past 36 months: Consulting fees: Reformulary Group: Providing independent medical consultation professional services to the firms listed in this section. Participation on a Data Safety Monitoring Board or Advisory Board: UCB Biopharma GmbH & SPRL, Parexel International, Prahealth Sciences: An independent Committee Member for clinical trial Data Safety Monitoring Boards for FDA approved trials being conducted by:  - UCB Biopharma GmbH & SPRL, - Parexel International, - Prahealth Sciences. Other financial or non-financial interests: Abbvie, Astra Zeneca, Aurinia, BMS, Centrexion, GSK, Horizon Pharma Inc, Janssen, Novartis, Pfizer & Sparrow: I am [unpaid] Chair of the Management Group of a registered non-profit independent medical research organization, OMERACT, whose goal is to improve and advance the health outcomes for patients suffering from musculoskeletal conditions. OMERACT receives arms-length funding from 11 companies. Rieke Alten: Past 36 months: Consulting fees: Abbvie, BMS, CELLTRION; Eli Lilly; Galapagos, Janssen, Lilly, Novartis, Pfizer, Roche, UCB, Viatris. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Abbvie, BMS, CELLTRION; Eli Lilly; Galapagos, Janssen, Lilly, Novartis, Pfizer, Roche, UCB, Viatris. Support for attending meetings and/or travel: Abbvie, BMS, CELLTRION; Eli Lilly; Galapagos, Janssen, Lilly, Novartis, Pfizer, Roche, UCB, Viatris. Participation on a Data Safety Monitoring Board or Advisory Board: Abbvie, BMS, CELLTRION; Eli Lilly; Galapagos, Janssen, Lilly, Novartis, Pfizer, Roche, UCB, Viatris. Susan J. Bartlett: Past 36 months: Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: American Thoracic Society Board of Directors: 2020–2022; unpaid. PROMIS Health Organization – President Elect, Board of Directors: unpaid. American College of Rheumatology Association of Rheumatology Professionals Executive Committee: 2021–2023; unpaid. Simon Stones: Past 36 months: Consulting fees: Future Science Group: Payment for document review. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: RAiISE: Director. Stock or stock options: Envision Pharma Group: Related to employment. Other financial or non-financial interests: Envision Pharma Group: Employment. Esi Morgan: Past 36 months: Grants or contracts from any entity: Pfizer, Inc: Educational Program to Optimize Delivery of Care to Families with Juvenile Idiopathic Arthritis Over Telemedicine; Investigator Initiated Grant to Seattle Children's Research Institute, role – co-Investigator. Agency for Healthcare Research and Quality: Informing personalized treatment decision with advanced Bayesian causal inference - A patient-centred evidence-based shared decision making (SDM) digital health technology; Investigator Initiated Grant to Seattle Children's Research Institute, role – PI (multi-PI grant). Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: American College of Rheumatology: Honorarium, Education Conference April 2023. Support for attending meetings and/or travel: American College of Rheumatology: Travel Support Education Exchange Conference April 2023. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: pediatric Rheumatology Care and Outcomes Improvement Network: Principal Investigator. Francis GUILLEMIN: Past 36 months: Grants or contracts from any entity: Novartis: Payment to my institution. Hemalatha Srinivasalu: Past 36 months: Grants or contracts from any entity: CARRA Registry Associate and NIAMS Intramural program. Janet Jull: Past 36 months: Grants or contracts from any entity: Canadian Institutes of Health Research. Jennifer L. Barton: Past 36 months: Grants or contracts from any entity: US Department of Veterans Affairs. Jasvinder A. Singh: Past 36 months: Consulting fees: Crealta/Horizon, Medisys, Fidia, PK Med, Two labs Inc., Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, MedIQ, Jupiter Life Science, UBM LLC, Trio Health, Medscape, WebMD, and Practice Point communications; and the National Institutes of Health and the American College of Rheumatology: Consultant fees paid to me for each entity. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: JAS is on the speaker's bureau of Simply Speaking: Consultant fees paid to me. Support for attending meetings and/or travel: Past steering committee member of OMERACT: I previously received support from the organization to attend their meeting every 2 years. Participation on a Data Safety Monitoring Board or Advisory Board: FDA Arthritis Advisory Committee: JAS serves as a member. No financial support. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Past steering committee member of the OMERACT, an international organization that develops measures for clinical trials and receives arms length funding from 12 pharmaceutical companies: I previously received support from the organization to attend their meeting every 2 years. Co-Chair of the Veterans Affairs Rheumatology Field Advisory Committee: No financial support. Editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite center on Network Meta-analysis: No financial support. Stock or stock options: JAS owns stock options in Atai life sciences, Kintara therapeutics, Intelligent Biosolutions, Acumen pharmaceutical, TPT Global Tech, Vaxart pharmaceuticals, Atyu biopharma, Adaptimmune Therapeutics, GeoVax Labs, Pieris Pharmaceuticals, Enzolytics Inc., Seres Therapeutics, Tonix Pharmaceuticals Holding Corp., and Charlotte's Web Holdings, Inc.: I own stock options. JAS previously owned stock options in Amarin, Viking and Moderna pharmaceuticals: I owned stock options in these companies previously. Saurab Sharma: Past 36 months: Grants or contracts from any entity: I am supported by the International Association for the Study of Pain John J. Bonica Postdoctoral Fellowship. The funder does not have any influence on my research. Support for attending meetings and/or travel: My travel was supported to present a talk (unrelated to the manuscript) at the International Association for the Study of Pain (IASP) Congress in Toronto in 2022. Victor Sloan: Past 36 months: Consulting fees: Boehringer-Ingelheim: Payment to me. Stock or stock options: Stock in UCB Pharma. Willemina Campbell: Past 36 months: Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events: ABBVIE and Einstein Medical School. Support for attending meetings and/or travel: OMERACT and GRAPPA. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: GRAPPA PRP CHAIR-past., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Radiotherapy (RT) plays an important role in the therapeutic management of vestibular schwannoma (VS). Fractionated stereotactic radiotherapy (FSRT) or radiosurgery (SRS) are the two modalities available. The purpose of this article is to review the results of VS RT studies carried out over the last ten years., Materials and Methods: A literature search was performed with PubMed and Medline by using the words vestibular schwannoma, acoustic neuroma, radiotherapy, and radiosurgery., Results: In small (<3 cm) VS, SRS offers a local control rate of >90%, which seems similar to microsurgery, with a favorable tolerance profile. Hypofractionated FSRT (three to five fractions) is a relatively recent modality and has shown similar outcomes to normofractionated FSRT. Hearing preservation may highly differ between studies, but it is around 65% at 5 years., Conclusions: SRS and FRST are non-invasive treatment options for VS. SRS is often preferred for small lesions less than 3 cm, and FSRT for larger lesions. However, no randomized study has compared these modalities.

Competing Interests: Competing interests: None declared.

Background: If any benefit is to be derived from the use of the health-related quality of life (HRQoL) questionnaires in chronic kidney disease (CKD) patients, they should be validated and culturally adapted to the target population. We aimed to critically appraise the psychometric properties of HRQoL questionnaires used in African populations with CKD., Methods: Web of Science, Embase, PubMed and PsycINFO databases were searched. Psychometric validation studies of HRQoL questionnaires reporting at least one psychometric property of the COSMIN checklist in CKD African population, published up to October 16, 2023 were included and independently assessed for methodological quality and level of measurement properties by using the COSMIN methodology., Results: From 1163 articles, 5 full-text were included. Only the Kidney Disease Quality-of-Life questionnaire was translated and cross-culturally adapted for studies of patients with CKD. Internal consistency was of doubtful quality in 4 studies and very good in 1. Its measurement was sufficient in 1 study and insufficient in 4. Test-retest reliability was of doubtful quality in 4 studies. Its measurement was sufficient in 3 studies and insufficient in 1. Structural validity was of inadequate quality in 1 study and very good quality in 1. Its measurement was sufficient in both. Construct validity was of inadequate quality in all studies. Their measurement was insufficient in 4 studies and sufficient in 1., Conclusions: This review highlighted that only one HRQoL questionnaire used in studies of African populations with CKD underwent a small number of cultural adaptations and psychometric validations, generally of poor methodological quality. HRQoL validation studies in African CKD populations are needed to better take advantage of the benefits in patient care, population health management, and research., (© 2024. The Author(s).)

Background: Previous cohort studies evaluating the performances of the McDonald criteria suffered from bias regarding real-life conditions. We aimed to evaluate the probability of diagnosing relapsing-remitting multiple sclerosis (MS) at several timepoints from the first medical evaluation and the gain in time-to-diagnosis with the 2017 McDonald criteria compared with the 2001, 2005 and 2010 versions in real life., Methods: Patients with a first demyelinating event suggestive of MS between 2002 and 2020 were included in the ReLSEP, an exhaustive and prospectively incremented registry of MS patients in North-Eastern France. We estimated the probability of being positive at the first medical evaluation and at five timepoints according to the four versions of criteria using Kaplan-Meier estimators and Cox models., Results: A total of 2220 patients were followed up for a median of 7.1 years. At baseline, 31.7%, 32.1%, 36.6% and 54.0% of patients, respectively, fulfilled the 2001, 2005, 2010 and 2017 McDonald criteria. Using the 2017 criteria, the gain in time-to-diagnosis was 3.7 months compared with the 2010 criteria. The presence of intrathecal synthesis of immunoglobulin G in the McDonald 2017 criteria led to a 1.8-month reduction in median time-to-diagnosis compared to a version of McDonald 2017 without this criteria., Conclusions: In real-life, the 2017 McDonald criteria revision undoubtedly shortened time-to-diagnosis., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)