The Flare-OA-16 questionnaire measuring flare in knee and hip osteoarthritis in the patient perspective: scale reduction and validation using a Rasch model.

OBJETIVE: 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 (SD=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 (CFA) 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 non-removed) was identified for one item that was split by joint, and a non-uniform DIF for one item for age and country (removed). The person-item threshold distribution showed a well focused scale; the CFA and the analysis of convergent validity showed good fit indicators for the short version. CONCLUSIONS: The Rasch analysis was helpful in guiding the decision to refine the measurement instrument. After analysis, the Flare-OA-16 questionnaire self-report questionnaire is available for use in clinical research.

Development of the 2023 ACR/EULAR Antiphospholipid Syndrome Classification Criteria, Phase III-D Report: Multi Criteria Decision Analysis.

BACKGROUND: The 2023 ACR/EULAR Antiphospholipid Syndrome (APS) Classification Criteria development, aiming 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, organized into laboratory and clinical domains. Here, we summarize the last stage of Phase III efforts employing a consensus-based multi-criteria decision analysis (MCDA) to weigh candidate criteria and identify an APS classification threshold score. METHODS: We evaluated 192 unique, international real-world cases referred for "suspected APS" with a wide range of APS manifestations. Using proposed candidate criteria, subcommittee members rank-ordered 20 representative cases from highly unlikely to highly likely 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 cases by their additive scores. A consensus-based threshold score for APS classification was set. RESULTS: Pre-meeting evaluation of 20 representative cases demonstrated variability in APS assessment. MCDA resolved 81 pairwise decisions; relative weights identified domain item hierarchy. After assessing 192 cases 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.

Building a composite score for patient self-report of flare in osteoarthritis: a comparison of methods with the Flare-OA-16 questionnaire.

OBJECTIVE: 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). Intra-score 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 (CFI=.95; RMSEA=.08) and estimated composite mean score=4.33(SD=2.85)[FF=14.9%, CF=0%]. For the logistic regression estimation, mean composite score was 6.48 (SD=3.13)[FF=0%, CF=0%]. With Rasch model, 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=.98) than between logistic regression score and the two others (ICC=.88 with Rasch score and .90 with CFA score). The AUC indicated similar performance of all methods: logistic model (AUC=.89 [.85-.92]), CFA and Rasch model (AUC=.86 [.82-.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=.84[.75-.90] for Rasch and CFA scores and ICC=.78[.66-86] for logistic model. CONCLUSIONS: 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.

Collaterals at angiography guide clinical outcomes after endovascular stroke therapy in HERMES.

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.

Health promotion expectations and perceptions of sport club participants.

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.

HERMES-24 Score Derivation and Validation for Simple and Robust Outcome Prediction After Large Vessel Occlusion Treatment.

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 [ß-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.

Role of dietary intake and physical activity in reducing weight social inequalities among adolescents: an application of G-formula to PRALIMAP-INÈS trial.

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.

Listening to patients, for the patients: The COVAD Study-Vision, organizational structure, and challenges.

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.

Effectiveness of interventions to reduce social inequalities of weight status in adolescents: A systematic review and meta-analysis.

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 (ß = -0.04 [95% CI -0.08, -0.01]), BMI (ß = -0.32 [-0.47, -0.18]), and waist circumference (ß = -0.84 [-1.48, -0.21]) but not percent body fat (ß = -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.

Collating the voice of people with autoimmune diseases: Methodology for the Third Phase of the COVAD Studies.

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.

Pilot study of a health promotion intervention in sports clubs / Étude pilote d'une intervention de promotion de la santé au sein de clubs de sport.

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.

Le club de sport (CS) est un milieu de vie privilégié pour promouvoir la santé. Cependant, les interventions de promotion de la santé (PS) existantes dans les CS ciblent majoritairement un seul comportement de santé et des pratiquants sportifs masculins, et leurs évaluations renseignent peu leurs déploiements. Pour dépasser ces limites, l'intervention PROSCeSS a été co-construite à partir du modèle théorique du CS promoteur de santé et de stratégies multi-niveaux et multi-déterminants de santé. L'objectif de cette étude pilote était d'évaluer le déploiement de l'intervention PROSCeSS et d'identifier les facteurs influençant son déploiement. Une étude qualitative comprenant des enregistrements de réunions, des échanges par e-mails et par téléphone, et des entretiens avec les référents de 14 CS a été réalisée. Même si le nombre de CS qui sont allés au bout de l'intervention est faible, ceux-ci considèrent qu'ils ont un rôle à jouer dans la santé de leurs membres. Leur capacité à développer des activités de PS et à déployer les étapes de l'intervention est influencée par les ressources disponibles, le soutien qu'ils reçoivent de leur fédération sportive et la capacité d'un porteur de projet (référent) à s'impliquer. Les CS qui ont déployé l'intervention ont mis en place plusieurs stratégies qui leur permettent d'intégrer la santé dans les habitudes organisationnelles, sociales, économiques et environnementales du CS et de développer de nouvelles activités de PS, telles que des sessions d'activités sportives adaptées et des activités de sensibilisation à l'échauffement, à l'alimentation et aux gestes de premier secours. Cette étude montre qu'il est important de comprendre les spécificités des contextes dans lesquels les interventions de PS sont déployées. Parce qu'elle a conduit à retravailler les étapes de l'intervention et à développer un nouveau design d'évaluation, elle met en évidence le rôle essentiel des études pilotes pour le développement et l'évaluation des interventions.

Evolution of public funding since primary care research was considered as a priority research domain in france.

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.

Embracing unity at OMERACT: Valuing equity, promoting diversity, fostering inclusivity.

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.

What Is a Meaningful Difference When Using Infarct Volume as the Primary Outcome?: Results From the HERMES Database.

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.

An effort to improve the collection of patient-generated data: readability and understandability of patient-reported outcomes measures in a survivorship cohort.

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.

Quality-of-life measures and their psychometric properties used in African chronic kidney disease populations: a systematic review using COSMIN methodology.

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.

Important issues in proposing autonomy training in home parenteral nutrition for short bowel syndrome patients: a qualitative insight from the patients' perspectives.

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.

Risk of secondary progression in patients with highly active multiple sclerosis treated with natalizumab: a real-life study.

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.

Consensus on the definitions and descriptions of the domains of the OMERACT Core Outcome Set for shared decision making interventions in rheumatology trials.

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.

Evolving and evaluating the OMERACT fellows program: insights and implications from OMERACT 2023 fellows.

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.