BACKGROUND:Direct transfer to angiography suite (DTAS) for patients with suspected stroke primarily admitted to an endovascular-capable centre could accelerate in-hospital workflow and improve outcome. We aimed to assess the safety and efficacy of DTAS for patients with acute severe neurological deficit highly suggestive of ischaemic stroke due to a large vessel occlusion (ASND-LVO). METHODS:We did an open-label, multicentre, randomised controlled trial in ten comprehensive stroke centres in France. We enrolled adult patients (age ≤85 years) with ASND-LVO (unilateral motor deficit with a score ≥5 plus a cortical symptom with a score ≥1 based on the National Institues of Health Stroke Scale) admitted within 5 h of symptom onset. Patients were randomly assigned (1:1) with a web-based system to DTAS or conventional pathway (ie, imaging followed by transfer to the angiography suite for endovascular treatment if eligible). The primary outcome was functional independence defined as a modified Rankin Scale score 0 to 2 at 90 days in the intention-to-treat population-ie, all randomly assigned patients in their originally assigned treatment groups, irrespective of diagnosis, imaging findings, or treatments received. Symptomatic intracranial haemorrhage and all-cause mortality at 90 days were the main safety outcomes. This study was registered on ClinicalTrials.gov (NCT03969511). FINDINGS:Between July 9, 2020, and April 18, 2023, 115 patients were randomly assigned to the DTAS group (n=57) or the conventional group (n=58). An interim analysis was done on Sept 27, 2023. The trial steering committee permanently stopped the trial on Dec 1, 2023, for safety reasons after unmasking and analysis of the data. In the intention-to-treat analysis, the risk of symptomatic intracranial haemorrhage was increased in the DTAS group compared with the conventional group (five [15%] of 34 vs zero [0%] of 42; adjusted odds ratio [OR] 11·0 [95% CI 1·28-1406]). All-cause mortality did not differ significantly between groups (ten [18%] of 56 vs six [11%] of 53; adjusted OR 1·65 [95% CI 0·52-5·55]). Functional independence was reached in 20 [36%] of 56 participants in the DTAS group vs 22 [42%] of 53 in the conventional group (adjusted OR 0·73 [95% CI 0·32-1·69]). INTERPRETATION:DTAS for patients with ASND-LVO was associated with an increased risk of symptomatic intracranial haemorrhage without evidence of a beneficial effect on functional outcome at 90 days. However, because the trial was stopped early for safety reasons, the small sample size limits the precision of the effect estimates on the primary outcome and all secondary and safety outcomes. Therefore, further clinical trials are required to firmly conclude on the safety and efficacy of DTAS for patients with suspected acute ischaemic stroke due to a large vessel occlusion. FUNDING:French Ministry of Health and Medtronic.
OBJECTIVE:To investigate the relative contribution of cartilage and synovial turnover to predict progression in patients with knee or hip osteoarthritis (OA). METHODS:A total of 449 patients with symptomatic knee or hip OA (mean age: 62 yr, 62% women) with a Kellgren-Lawrence (KL) score ≥2 from the prospective KHOALA cohort study were investigated. Progression was defined as a one-point increase in the KL scores from knee or hip radiographs and/or a joint replacement during 5 years follow-up. The association of baseline urinary CTX-II and serum Col 3-4, biochemical markers of cartilage and synovial turnover, respectively, with progression was assessed by multivariable discrete-time survival models. RESULTS:Increased baseline CTX-II levels were associated with an increased risk of knee and/or hip OA progression, patients with levels in the fourth quartile having an odds ratio (OR; 95%CI) of 2.57 (1.57-4.18) compared with subjects with levels in first quartile, after adjustment for demographical and OA clinical variables and KL scores. When analyses were restricted to patients with knee or hip OA progression only, similar findings were obtained with corresponding ORs (95% CI) of 2.36 (1.32-4.21) and 3.39 (1.42-8.11), respectively. There was no significant association of baseline Col 3-4 and the risk of knee or hip progression. CONCLUSIONS:Increased urinary CTX-II, but not Col 3-4, is independently associated with a higher risk of structural progression in patients with knee or hip OA. Cartilage turnover may play a more important role than synovial activity as assessed with Col 3-4 to mediate joint damage in established OA. TRIAL REGISTRATION:ClinicalTrials.gov, http://clinicaltrials.gov, NCT00481338.
Background:Adherence research has historically focused on medication-taking behaviors. While evidence suggests that males are generally more adherent to medication regimens than females, the influence of sex on overall adherence behaviors remains unclear. We explored how sex influences a multidimensional profile of adherence beyond medication using the Generic French Adherence in Chronic Diseases Profile (GACID-P). Methods:We conducted a cross-sectional study using data from the validation of the GACID-P. Participants were adults (>18 years) with chronic conditions attending specialist care across the Grand-Est region of France. The 25-item self-report GACID-P assesses four domains of adherence - Intention to comply with treatment, Forgetting to take medication, Healthy lifestyle, and Limitation of risk-related consumer habits - with scores ranging from 0 (worst) to 10 (best), except for forgetting, which is reverse scored. Analyses included sex-stratified comparisons, multivariable linear regression models, and multivariate analysis of variance to examine sex-based adherence patterns within and across domains. Results:Among 397 participants (53% male; mean age: males 57.1 ± 10.7, females 59.3 ± 11.7), domain scores indicated generally good adherence. Within domains, males had higher scores than females for Intention to comply (9.18 ± 1.15 vs 8.96 ± 1.51), less Forgetting to take medication (1.35 ± 2.42 vs 1.82 ± 2.85), more Healthy lifestyle (6.92 ± 1.95 vs 6.61 ± 2.00), while females scored higher for Limitation of risk-related consumer habits (6.15 ± 2.14 vs 5.24 ± 2.14); however, none of these differences reached statistical significance. Across domains, a multivariate analysis suggested a sex effect (Wilks' Lambda = 0.84, F(4,73) = 3.58, p=0.010), driven primarily by differences in Forgetting to take medication where males reported less forgetting than females, when adherence patterns are considered jointly across domains (F(1,76) = 10.39, p = 0.0019). Conclusion:Despite the absence of statistically significant sex-based differences within individual GACID-P domains, a multivariate analysis suggested potential differences when adherence behaviors were considered jointly. While these findings should be interpreted cautiously, they support consideration of a sex-based lens to better understand adherence.
OBJECTIVE:The 2023 American College of Rheumatology (ACR)/EULAR antiphospholipid syndrome (APS) classification criteria aim to identify patients with a high likelihood of APS for research. Phases I/II of our four-phase methodologic approach resulted in 27 candidate criteria organized in clinical and laboratory domains. Here, we summarize phase III efforts to reduce and refine criteria using patient scenarios. METHODS:Using standardized definitions for candidate criteria, the Steering Committee collected antiphospholipid antibody (aPL)-positive cases referred for "suspected APS." Treating physicians assessed APS case likelihood using a Likert scale. Poisson regression calculated risk ratios (RRs) and 95% confidence intervals (CIs) to quantify the direction and size of the association of candidate criteria with "highly likely" versus "equivocal or unlikely" APS, which guided Steering Committee candidate criteria refinement and organization. RESULTS:We collected 314 suspected APS cases (137 [44%] highly likely and 177 [56%] equivocal/unlikely APS). Provoking venous thromboembolism (VTE) or arterial thrombosis (AT) risk factors reduced the size of the association with highly likely APS (RR 4.31 [95% CI 2.11-8.78] to RR 1.56 [95% CI 0.89-2.75] for VTE and RR 3.48 [95% CI 1.91-6.32] to RR 1.64 [95% CI 0.77-3.51] for AT). Persistent lupus anticoagulant, anticardiolipin IgG antibody ≥40 U, and anti-β2-glycoprotein-I IgG antibody ≥40 U were positively associated with highly likely APS (all P < 0.05). Eventually, items within eight additive and independent clinical and laboratory domains were refined. CONCLUSION:Referred suspected APS cases provided insight into associations of individual candidate criteria with APS likelihood. RR analyses helped refine items and organize the draft classification system into eight additive and independent clinical and laboratory domains.
Objective To assess prevalence, associated disability and pain burden of the main rheumatic and musculoskeletal diseases (RMDs): rheumatoid and non-rheumatoid inflammatory arthritis, knee, hip and other peripheral joint osteoarthritis, osteoporosis, low back and neck pain, as well as their trends over 15 years in France.Setting Two large nationwide representative surveys conducted in France in 2008 and 2022 that similarly and comprehensively assessed chronic conditions and disabilities.Participants 20 724 participants aged ≥25 years in Disability Healthcare Household Survey (2008) and 18 562 in Autonomy Survey (2022).Main outcome measures Disability and pain profiles with 10 indicators were constructed using the International Classification of Functioning, Disability and Health framework. A multistep approach based on a conceptual model was used to estimate the prevalence and disability burden of RMDs and their trends, controlling for age, education level, obesity and comorbidities.Results Prevalence of knee osteoarthritis and low back pain increased by >50% between 2008 and 2022, while rheumatoid arthritis (both sexes), non-rheumatoid arthritis and neck pain (men) and hip osteoarthritis (women) increased by 25%–50%; osteoporosis remained stable. Large increases in obesity and comorbidities, massively present in RMDs, including cardiovascular and mental disorders, contributed to increasing overall disability for all RMDs. After controlling for comorbidities, the disability burden increased (notably but not exclusively with mobility activities and pain) for low back pain and knee osteoarthritis and decreased for others except rheumatoid arthritis and neck pain, which remained stable.Conclusions Prevalence of most RMDs increased between 2008 and 2022, causing a higher disability burden, partly due to rising levels of obesity and comorbidities. These results should inform surveillance and policies for the development of RMD preventive measures given the massive increase in chronic conditions.
Abstract Background and aims Brain frailty, reflected by structural brain changes on CT, has been linked to heterogeneity in stroke presentation and recovery. In ESCAPE-NA1, CT-based brain frailty markers were associated with higher baseline stroke severity and poorer 90-day outcomes after thrombectomy. We aimed to validate these associations in the HERMES collaboration and determine whether brain frailty modifies thrombectomy treatment effects. Methods We performed a pooled analysis of individual patient data from the HERMES collaboration. Brain frailty imaging markers were assessed on baseline non-contrast CT. Associations with baseline National Institutes of Health Stroke Scale (NIHSS) score and 90d-modified Rankin Scale (90d-mRS) were evaluated using multivariable regression, and interaction with thrombectomy effect analyzed. Results Among 1,730 patients in the pooled HERMES dataset, baseline NIHSS was higher in patients with white matter disease (WMD, adjusted β = 0.54, 95%CI:0.01-1.08) and medial temporal atrophy (adjusted β = 0.39, 95%CI 0.02-0.76). Greater brain frailty was associated with lower odds of favorable 90d-mRS, including for WMD (aOR 0.62, 95%CI 0.50–0.77), global cortical atrophy (GCA; aOR 0.65, 0.55–0.78), medial temporal atrophy (OR 0.70, 0.60–0.80), posterior atrophy (aOR 0.69, 0.58–0.83), and cerebral small vessel disease (CSVD) burden (aOR 0.74, 0.64–0.86). EVT treatment effect modification for 90d-mRS was observed for GCA (P = 0.036) and presence of lacunes (P = 0.034, Figure 1). Conclusions CT-based brain frailty markers are associated with higher baseline stroke severity and worse 90d functional outcome. Thrombectomy remained beneficial across brain frailty strata, but treatment benefit was smaller for patients with greater atrophy and CSVD burden, particularly lacunes. Conflict of interest All authors: nothing to disclose.
Objective: Atopy has been identified as a risk factor for osteoarthritis, but without specifying its impact on disease severity. We sought to investigate the association between atopy and the symptomatic and structural severity of knee and hip osteoarthritis.Methods: We used data from KHOALA, a French multicentre cohort of patients with knee and/or hip osteoarthritis (OA) investigating “atopic” subjects, defined as those with history of asthma and/or atopic dermatitis (AD) compared to “non-atopic” subjects. We compared: WOMAC pain, stiffness and function scores; and the proportion of having end-stage knee and/or hip radiographic OA (Kellgren Lawrence grade 4). Besides, we studied the cumulative incidence of total knee replacement (TKR) over 7 years of follow-up in patients with knee osteoarthritis in atopic versus non-atopic patients. Linear regression analyses of WOMAC sub-scores were adjusted for age, sex, BMI and GHQ-28 score (psychological well-being), whereas logistic regression and Cox regression analyses of radiographic end-stage disease and TKR were adjusted for age, sex and BMI.Results: The cohort comprised 66 atopic subjects (46 with asthma, 16 with AD and 4 having both) and 651 non-atopic subjects with a mean age of 65.2 years, 68% of whom were women, and a mean BMI of 29.3 kg/m². Atopy was associated with an increased risk of end-stage radiographic OA (adjusted OR 2.46 (1.42 to 4.25), P = 0.001), with 42% of atopic patients having Kellgren Lawrence grade 4 compared with 24% of non-atopic patients. Furthermore, over a 7-year follow-up period, atopy was associated with a two-fold increase in the risk of TKR, with an HR of 1.99 (95% CI: 1.15 to 3.45; P =0.01). Atopy was significantly associated with an increase in WOMAC pain score (7.6/20 ± 3.8 versus 6.4/20 ± 4; P < 0.05) but this association became non-significant after adjustment. Atopy was not associated with worse functional limitations or stiffness.Conclusion: Atopy appears to be associated with the radiographic OA severity and increased requirement of knee joint replacement. These results invite us to consider atopy as a potential new determining factor in the OA disease severity.
ObjectiveTo generate HODs for rheumatoid arthritis (RA) using a customized chatbot and evaluate their quality.MethodsWe developed a Retrieval Augmented Generation (RAG) chatbot in ChatGPT 4.0 to generate HODs for 11 RA outcomes, in standard and short formats (22 in total). The chatbot incorporated four frameworks for improving language complexity, structure, and comprehensibility, and custom, iteratively refined prompts. In a web-based survey, patients, clinicians and researchers from four international groups rated HODs across five quality attributes using Likert scale responses, with acceptable quality defined a priori as ≥70% agreement. Responses were collected in a cross-sectional web-based survey and reported following Checklist for Reporting Results of Internet E-surveys (CHERRIES) guidelines.ResultsThirty panelists completed the survey. Seven of eleven standard HODs (64%), and all eleven (100%) short HODs met the predefined acceptability threshold (≥70% agreement) across all five quality attributes. Standard HODs not meeting the acceptability threshold fell below the criterion in only one attribute, most commonly appropriateness for individuals with low health literacy, where agreement ranged from 50% to 91%. The attribute evaluating technical accuracy had an average rate of agreement of 86% for standard HODs, and 87% for short HODs. The attribute evaluating appropriateness for patients with low literacy had an average rate of agreement of 74% for standard HODs, and 89% for short HODs.ConclusionsHODs generated using a customized GPT4.0 chatbot were rated highly by experts for quality. This structured AI-assisted approach can facilitate the generation of HODs that are acceptable to clinicians and researchers, but still require human oversight and proof-reading.
INTRODUCTION:Tafamidis has been demonstrated to improve survival and quality of life in transthyretin amyloid cardiomyopathy (ATTR-CM). However, its cost-effectiveness has been reported to exceed the threshold of $100,000/quality-adjusted life years [QALY] in the US healthcare system. This study aimed to evaluate costs associated with utilities (QALYs) gained for ATTR-CM in France, Spain, Germany, and the United Kingdom (UK), and to conduct a deterministic modelling study using case-scenarii based on various assumptions at a European level. METHODS:Data on costs and QALY were extracted using MEDLINE. The lack of data on the cost of the cardiac amyloidosis in patients treated with tafamidis led us to modelling our study based on heart failure assumptions. We used QALY gained in the tafamidis group as reported for ATTR-CM patients in the ATTR-ACT trial to determine the incremental cost-effectiveness ratio (ICER) of tafamidis compared with standard care. A sensitivity analysis was conducted with assumptions on costs and QALYs gained. RESULTS:Incremental cost-effectiveness ratios (ICER) for each country largely exceeded the threshold of €100,000/QALY, ranging from €398,136/QALY gained in France to €1,398,706/QALY gained in Germany. The sensitivity analysis revealed large variations of the ICER, with only 27.4%, 0.2%, 13% and 9% probability of cases below the acceptability threshold of €100,000/QALY in France, Spain, Germany and UK, respectively. CONCLUSION:While tafamidis offers a significant improvement in patients' quality of life and survival, these exploratory scenario-based estimates showing high cost-effectiveness ratio in some European countries, may raise public health and cost management concerns.
Background The use of heterogeneous empirical definitions to assess disease activity in adult-onset Still's disease limits evidence on the efficacy of immunosuppressive agents. Thus, we aimed to specifically develop and validate definitions of clinical criteria for the assessment of disease activity in adult-onset Still's disease. Methods We used data from the GIRRCS (Gruppo Italiano Di Ricerca in Reumatologia Clinica e Sperimentale) adult-onset Still's disease cohort to develop and validate clinical criteria for disease activity. From Jan 1, 2022, to Dec 31, 2023, consecutive patients attending the Italian rheumatological centres involved in the GIRRCS adult-onset Still's disease were included if they were aged ≥18 years and fulfilled the Yamaguchi criteria for diagnosis of adult-onset Still's disease. Patients' clinical characteristics were assessed at baseline and 3 months and 6 months. Additionally, we used baseline data from the CONSIDER (Canakinumab for treatment of adult-onset Still's disease to achieve reduction of arthritic manifestation) trial to externally validate the criteria (recruitment June 21, 2012, to May 5, 2018). The item reduction was based on correlations between clinical characteristics and disease activity as scored by physicians, principal component analysis, and a longitudinal linear mixed model with disease activity as the dependent variable. Performance of the developed criteria was evaluated using area under the receiver operating characteristic curves (AUROCs), separately for development and validation data. People with lived experience of adult-onset Still's disease were involved in study design and implementation. Findings 187 patients from GIRRCS (130 [70%] in the development cohort and 57 [30%] in the preliminary validation cohort; 94 [50%] female and 93 [50%] male; mean age 40·8 years [SD 17·3]) and 41 patients from the CONSIDER trial (28 [68%] female and 13 [32%] male; mean age 43·0 years [13·1]) were evaluated. Fever, skin rash, arthritis, patient global assessment of at least 2 cm, and C-reactive protein (CRP) greater than 10 mg/L were selected as the criteria for disease activity assessment. Active adult-onset Still's disease was defined as fever and one of the following criteria: skin rash, arthritis, patient global assessment of at least 2 cm, CRP greater than 10 mg/L; or as no fever but at least three of the other criteria (AUROC of 0·93 in development cohort, 0·85 in the preliminary validation cohort, and 0·88 in the external validation cohort). Patients with no fever and no more than one of the aforementioned criteria were considered to have low disease activity (AUROC of 0·86 at 3 months and 0·94 at 6 months in the preliminary validation cohort). Clinically inactive disease was defined as the absence of all five criteria. Interpretation Disease activity criteria in adult-onset Still's disease were developed to support the attainment of clinically inactive disease as the main treatment target in patient management. Funding None.
To investigate the value of baseline CT imaging for the prediction of functional outcome and benefit of endovascular thrombectomy (EVT) for anterior large vessel occlusion (LVO). We used individual patient data from seven randomized EVT trials and included patients with available baseline CT imaging and outcome data. We developed a model to predict functional outcome and benefit of EVT, including baseline stroke-related and brain frailty CT imaging features alone. We compared the discriminative performance of our model for predicting good functional outcome (modified Rankin Scale [mRS] 0–2) and treatment benefit (difference between the probability of mRS 0–2 with vs without EVT) with MR PREDICTS by calculating the difference in C-statistics (delta C and delta C-for-benefit). We included 1391 patients (median age, 67 years, interquartile range 59–76; 53
Background: We investigate whether the NIHSS at 24 hours could serve as an alternative primary outcome measure in acute ischemic stroke trials, and whether combining 90-day modified Rankin Score (mRS) and 24-hour NIHSS in a hierarchical outcome could enhance detection of treatment effect, using EVT as an exemplary study intervention. Methods: Post-hoc analysis from the HERMES collaboration that pooled data from 7 randomized controlled EVT trials. Validity of 24-hour NIHSS as a surrogate outcome for 90-day mRS was assessed in a causal mediation model (Figure 1). A 7-point ordinal NIHSS score was generated by grouping 24-hour NIHSS, including death as a separate category (“ordinal” NIHSS). EVT effect sizes and sample sizes required for detecting EVT benefit with 80% power were compared when using granular 24-hour NIHSS, ordinal 24-hour NIHSS, 90-day mRS, and hierarchical outcome (win-ratio) that combines 90-day mRS and 24-hour NIHSS. Subgroup analyses were performed in patients with baseline NIHSS<10 and ≥25. Results: A total of 1720 patients were included. Median 90-day mRS in the EVT/control arms was 3.0(IQR:1.0-4.0)/4.0(IQR:2.0-5.0) and median 24-hour NIHSS was 9.0(IQR:3.0-17.0)/14.0(IQR:7.5-19.0), see Figure 2. 24-hour NIHSS mediated the association between EVT and 90-day mRS and met the criteria for a surrogate outcome. Effect sizes were highest and sample sizes required to detect EVT benefit smallest for the win ratio approach (228), followed by 90-day mRS(240) and ordinal 24-hour NIHSS(242), see Table 1. In subgroup analyses of patients with baseline NIHSS<10 and≥25, ordinal 24-hour NIHSS resulted in the highest effect size/ smallest sample size. Conclusion: 24-hour NIHSS may be a valid surrogate outcome for 90-day mRS in acute ischemic stroke patients undergoing EVT, with a similar EVT effect size compared to 90-day mRS. It could potentially enhance detection of EVT benefit in patient subgroups with very low or very high baseline NIHSS. Combining 90-day mRS and 24-hour NIHSS in an ordered hierarchical could improve detection of EVT treatment effect compared to 90-day mRS.
OBJECTIVES:The Flare-OA questionnaire is a self-reported instrument developed to assess flare in individuals with knee and/or hip osteoarthritis. This study aimed to translate and culturally adapt both the original and short versions of the Flare-OA into Turkish. METHODS:The Turkish version of the questionnaire was obtained through a process of cross-cultural adaptation and translation. Patients aged 45 years or older with clinically and radiologically confirmed OA of the knee or hip were recruited. The Flare-OA scale, originally consisting of 33 items, was shortened to 19 items and then to a final 16-item version through Rasch analysis. The internal consistency of the Flare-OA was measured using Cronbach's alpha, and its stability over time was tested by evaluating test-retest reliability over a 15-day interval in patients with no clinical changes. The sensitivity to change was determined by calculating the standardized response mean (SRM) in those who reported symptom variation during the follow-up. Convergent validity was assessed by analyzing the correlations between the scale and previously validated measures, including the Hip Disability and Osteoarthritis Outcome Score (HOOS-PS), the Knee Injury and Osteoarthritis Outcome Score (KOOS), and the Mini-Osteoarthritis Knee and Hip Quality of Life Questionnaire (Mini-OAKHQOL). RESULTS:The study included 185 participants, of whom 71.9% were women, with a mean age of 63.2 years (SD:9.1). Of these, 160 patients (86.5%) had knee OA and 25 (13.5%) had hip OA. In the past four weeks, 70 patients (37.8%) reported a worsening of symptoms in the affected joint. Cronbach's alpha coefficient was 0.987 (95% CI 0.984-0.990) for the 33-item and 0.972 (95% CI 0.966-0.978) for the 16-item. The intraclass correlation coefficient was 0.913 and 0.912 for the test-retest reliability (n=79) of the 33- and 16-item tests, respectively. Sensitivity to change was good in 9 patients with flare improvement [SRM 1.2 (95% CI 0.6-1.7), SRM 1 (95% CI 0.5-1.5), for 33- and 16-items, respectively] over the period. Discriminant validity was supported by statistically significant score differences between patients with and without flare for both the 33-item [36.2; 95% CI 29.9-42.6; SEM: 8; p<.0001] and the 16-item [36.7; 95% CI 30.3-43.0; SEM: 8.1; p<.0001] versions. There was a significant and negative correlation between the Flare-OA score and KOOS and mini-OAKHQOL (p<0.05). 16-item Rasch modeling allowed us to reduce the questionnaire to a 16-item version with good fit and a satisfactory interval scale. CONCLUSION:The Turkish versions of the Flare-OA questionnaires (33- and 16-item) showed high reliability, validity, and clinical utility in evaluating flares in knee and hip OA. The 16-item version appears especially useful for routine use, although further validation is needed due to the limited sample size in the hip OA subgroup.
Objective The objective of this study was to analyse the association between body composition and changes in health-related quality of life (HRQoL) of patients followed for hip and knee osteoarthritis (OA).Methods Longitudinal data from the Knee and Hip OsteoArthritis Long-term Assessments (KHOALA) cohort, a multicentre cohort of 878 patients with symptomatic knee and/or hip OA, were used. The main outcome criteria were changes in patient-reported outcomes measures, the Study Short Form-36 (physical functioning, pain, mental health and vitality) and the OsteoArthritis Knee and Hip Quality Of Life (OAKHQOL)(physical activity, pain and mental health). Body composition measurements were obtained from dual X-ray absorptiometry (DXA) scans in a subsample of 381 patients at year 3. Body composition variables were fat mass index (FMI (kg/m²)), percentage of fat mass, trunk to leg fat mass ratio (TFM/LFM) and skeletal muscle mass index (SMI (kg/m²)). To account for the correlation of repeated measures in each individual, GEE models were used.Results 290 patients with knee and 114 patients with hip OA were included in the analysis. In multivariate analysis, higher FMI at baseline and the presence of low lean mass were independently associated with worse physical functioning over time (β −0.02, 95% CI −0.03 to −0.01, p<0.0001 and β −0.21, 95% CI −0.02 to 0.02, p=0.02) for SF-36 dimensions. Higher TFM/LFM and SMI at baseline were associated with better mental health (β 0.09, 95% CI 0.02 to 0.15, p=0.008 and β 0.01, 95% CI 0.006 to 0.02, p<0.0001) and vitality. No association between body composition measures and pain remained in the multivariate analysis.Conclusions Higher FMI at baseline and the presence of low muscle mass were independently associated with worse physical function over 4 years, but not with pain. Higher TFM/LFM and SMI at baseline were associated with better mental health and vitality over time.
OBJECTIVE:To describe the health care use of patients with symptomatic knee or hip OA and to identify factors associated with health care use trajectories over a 10-year period. METHODS:This study used longitudinal data from the multicentre "Knee-and-Hip-OsteoArthritis-Long-term-Assessment" cohort, which comprised 878 patients with OA diagnoses confirmed by both a physician and radiographic evidence. We identified homogeneous subgroups of trajectories based on individual health care consumption over time via latent class growth analysis. Logistic regression analysis determined baseline factors associated with these trajectories. RESULTS:A minority of patients consulted a specialist. Impaired mental health was associated with moderate- and high-probability trajectories of consulting a primary care physician (PCP), a physical therapist and a rheumatologist (ORs 0.7 [0.6-0.9] to 0.9 [0.8-0.96]). High pain levels were associated only with high probability of consulting an orthopaedic surgeon (OS) (OR 0.8 [0.7-0.9]). Rheumatologist consultations were more likely in large cities (OR 2.3 [1.3-4.1]), and OS consultations were associated with a high level of education (OR 3.6 [1.3-7.4]). CONCLUSIONS:PCPs play a central role in OA care. High pain levels were associated mainly with a high probability of consulting an OS, whereas mental health status was a major predictive factor of other health care professional consultations. Mental health state is probably insufficiently accounted for. Social inequalities persist and must be considered in public health policies.
Healthcare claims and survey data are increasingly used to assess the osteoporosis burden, but agreement and comparative validity of derived indicators are poorly documented. We show that no single data source can estimate the osteoporosis burden. Instead, coupling data sources allows assessing its burden and associated treatment and knowledge gaps. Healthcare claims data are increasingly used to assess the burden of osteoporosis and fragility fractures, although comparative evidence with other sources and especially self-reported data remains limited. Using the linkage of the French National Health Data System (SNDS) and Health Care and Insurance Survey (ESPS 2010-2014), we evaluated the agreement and comparative validity (concurrent and predictive) of several osteoporosis and clinical fragility fracture indicators and provided comprehensive estimates of their prevalence. Individual data from 5039 ESPS participants aged ≥ 25 years were linked to SNDS. Follow-up data included a health self-assessment in 2014 and 5-year occurrence of fractures and mortality. Prevalence was estimated for each indicator (self-reported in ESPS, diagnosis and treatment of osteoporosis, and clinical fragility fractures in SNDS) using several combinations and capture-recapture. Kappa statistics assessed agreement between indicators. Multivariate models evaluated determinants of disagreement between sources and associations of indicators with health outcomes and new fractures (concurrent and predictive validity). Prevalence estimated by capture-recapture was 7.6