Abstract Objectives To analyse the differences in disease expression of European SLE patients based on gender, age at diagnosis, and ethnicity. Methods A two-year, retrospective, multicentre, ...observational study was carried out in five countries (France, Germany, Italy, Spain and the UK). Patients' clinical manifestations including disease activity, organ involvement, organ damage and flares were analysed. Results Thirty-one centres enrolled 412 consecutive eligible patients (90.5% of women), with active disease, stratified by disease severity (half severe and half non-severe). Baseline characteristics included; mean (SD) age: 43.3 (13.6) years, SLE duration: 10.7 (8.0) years and age at disease diagnosis: 32.6 (13.0) years old. The mean (SD) SELENA-SLEDAI and SLICC/ACR scores were: 8.1 (6.7) and 0.82 (1.36), respectively. Over half of patients experienced flares (54.9%). The average number of annual flares was 1.01 (0.71) flares/year. In males compared to females, the renal system was more frequently active (53.8% vs 30.0%, p = 0.002), the mean SLICC/ACR score was higher (1.15 vs 0.79, p = 0.039) and the pulmonary system was more likely to be damaged (12.8% vs 3.8%, p = 0.010). Furthermore, patients diagnosed at younger age displayed more renal system activity (young: 56.3% vs adult: 33.4% vs elder: 8.9%, p < 0.001) and renal damage (25.0% vs 6.9% vs 2.2%, p = 0.018) compared to the others. The annual number of flares (1.13 vs 1.05 vs 0.81 flares/year, p < 0.0001), including the occurrence of severe flares (0.58 vs 0.51 vs 0.20, p < 0.0001), was also higher in these patients. Conversely, greater organ damage was observed in patients diagnosed at an older age compared to the others. The mean SLICC/ACR score was higher (1.31 vs young: 0.88 and adult: 0.78, p < 0.001) in patients diagnosed in the older age groups. The pulmonary (13.3% vs younger: 0% vs adult: 3.7%, p = 0.030) and cardiovascular (17.8% vs younger: 0% vs adult: 2.9%, p < 0.001) systems were more frequently damaged in these patients. Black African descents showed greater disease activity compared to Caucasian patients. They flared more often (77.1% vs 48.6%, p = 0.001) and experienced a greater number of annual flares (1.57 vs 0.89 flares/year, p < 0.0001), mainly more severe flares (0.89 vs 0.38/year, p < 0.0001). They also were more likely to experience renal system damage. Conclusion The study showed clearly two patient subsets. The disease was the most active in Black African descents, and this phenomenon has never been described before in continental Europe. The disease was also more active in patients diagnosed at a younger or adult. Greater disease damage was observed in males and in patients diagnosed at an older age.
Fatigue in multiple sclerosis is a frequent and disabling symptom that can interfere in daily functioning. The aim of this study is to demonstrate the relationship between fatigue and disability, ...disease course, depression and quality of life.
We administered French valid versions of the Fatigue Impact Scale (EMIF-SEP), the short form of the Beck depression inventory (13 items) and the SF-36 to 237 out of 312 patients with clinically definite multiple sclerosis with EDSS
≤
6.5.
The EMIF-SEP is composed of four dimensions (cognitive, physical, social role and psychological) and allows a multidimensional evaluation.
Using a multivariate analysis, EMIF-SEP total scores with physical and social role subscales were highly correlated with EDSS (
p
<
0.0001). Cognitive and psychological dimensions of the EMIF-SEP were not linked to EDSS. EMIF-SEP was not correlated with disease course after adjusting for EDSS. EMIF-SEP scores were significantly associated with depression scores (
r
=
0.74,
p
<
0.0001). The multivariate analysis also showed a significant impact of fatigue on each scale of quality of life of the SF-36.
These data confirm that fatigue is correlated with disability, but cognitive and psychological dimensions of fatigue remain independent. Fatigue is also associated with depression and quality of life.
PURPOSEAlthough three-dimensional conformal radiotherapy (3D-CRT) remains the gold standard as a curative treatment for NSCLC when surgery is not possible, intensity modulated radiotherapy (IMRT) is ...increasingly used routinely. The purpose of this study was to assess the clinical (immediate toxicities) and dosimetric impact of IMRT compared to 3D-CRT in the treatment of locally advanced (stages IIIA to IIIC) non-small cell lung cancer (NSCLC) treated with concomitant radiochemotherapy, while IMRT in lung cancer was implemented in the radiotherapy department of the Jean-Perrin Center. PATIENTS AND METHODSBetween March 2015 and October 2019, 64 patients treated with concomitant radiochemotherapy were retrospectively included. Thirty-two received 3D-CRT and 32 IMRT. The radiotherapy prescription was 66Gy in 33 fractions of 2Gy. RESULTSIMRT has improved coverage of target volumes (V95 increased by 14.81% in IMRT; P<0.001) without increasing doses to OARs and reducing dysphagia (RR=0.67; P=0.027). Low doses to the lung were not significantly increased in IMRT (pulmonary V5 increased by 7.46% in IMRT). CONCLUSIONIntensity modulated radiotherapy, compared with the standard RC3D technique, improve the coverage of target volumes without increasing the dose to the OARs. It also improves the immediate tolerance of the treatment by reducing the number of dysphagia.
The video Animated Activity Questionnaire (AAQ) was developed to assess the impact of lower limb osteoarthritis (OA) on daily functional activities. The objective of the study was to compare the ...video and the HOOS/KOOS paper questionnaires and to assess the effect of order of administration.
Patients recruited in the KHOALA cohort were randomized in two groups: AAQ questionnaire first (AAQ-first group) and HOOS (hip)/KOOS (knee) questionnaire first (H/KOOS-first group). Within group differences between AAQ and HOOS/KOOS scores were compared using a Student t-test. The Spearman correlation coefficient between AAQ score and HOOS/KOOS score was calculated in each group then compared, using Fisher z-transformation.
Among 200 randomized patients, 188 (65.8 years, 66.0% women) completed the questionnaires: 99 in the AAQ-first group and 89 in the H/KOOS-first group. The AAQ score was 85.9 (SD: 13.7) in the AAQ-first versus 87.8 (SD: 13.1) in the H/KOOS-first group (p = 0.34). The H/KOOS score was 72.5 (SD: 21.2) in the AAQ-first versus 73.5 (SD: 18.4) in the H/KOOS-first group (p = 0.71). The Spearman correlation coefficient between AAQ and H/KOOS in the AAQ-first was 0.840.77-0.89 and 0.730.61-0.81 in H/KOOS-first group. These correlations differed between groups significantly (p = 0.02).
This study found video AAQ and paper HOOS/KOOS questionnaire highly correlated, with a moderate but significant effect of order administration of video and paper questionnaires evidencing a stronger correlation when the videos were viewed first.
To determine, in a cohort of patients with early rheumatoid arthritis (RA), factors associated with fatigue at baseline, describe its evolution over 5 years of follow-up, and determine baseline ...predictors of persistent fatigue.
We selected patients fulfilling the 2010 American College of Rheumatology/European League Against Rheumatism criteria for RA included in the ESPOIR cohort. Using bivariable and multivariable logistic regression models, we examined baseline variables associated with baseline fatigue (defined by visual analogue scale fatigue > 20) and baseline predictors of persistent fatigue (if the patient experienced fatigue at all visits during the 5 year follow-up period).
We analysed 673 patients; 80.7% reported fatigue at baseline. At baseline, fatigue was associated with female gender, younger age, greater severity of morning stiffness, sleep problems, higher Health Assessment Questionnaire levels, presence of sicca symptoms, history of thyroid problems, and presence of psychological distress (depressive or anxiety symptoms). At 5 years of follow-up, the percentage of fatigued patients who reported fatigue at all time-points since baseline was 24.6% (referred to as 'persistent fatigue'). Independent baseline predictors were presence of sicca symptoms, greater severity of morning stiffness, and psychological distress.
Fatigue is a frequent symptom in RA. The presence of sicca symptoms, greater severity of morning stiffness, and presence of psychological distress at baseline were associated with baseline fatigue and persistent fatigue at 5 years. We did not observe any association between baseline fatigue or persistent fatigue and the Disease Activity Score based on 28-joint count-erythrocyte sedimentation rate.
Summary Given the dramatic increase in the number of total knee replacement (TKR) surgeries in developed countries, the issue of the best time for surgery needs to be addressed from an economic ...perspective. Objective To assess, from the perspective of the healthcare payer, the cost-utility of two surgical strategies in which knee replacement is performed at the early or late stage of the disease in patients with knee osteoarthritis (OA). Design Patient data and evidence from published literature on economic costs and outcomes in OA, including utilities, non-pharmacological, pharmacological and surgical options, combined with population life tables were entered in a Markov model of OA. The model represented the lifetime experience of a cohort of patients following their therapeutic management, discounting costs (euros) and utilities (quality-adjusted life-years) at 4% annually. Results In the base-case scenario, early TKR cost €6,624 more than late TKR (€76,223 vs €69,599) with a 0.15 gain in QALYs (18.675 vs 18.524). This yielded an incremental cost-utility ratio (ICUR) of 43,631 €/QALY. Sensitivity analyses of the most influential uncertain parameters were performed and did not modify the direction of the conclusions: early TKR cost between €3,655 and €7,194 more than late TKR with a gain in QALYs between 0.15 and 0.39. The ICUR ranged from 17,131 €/QALY to 48,241 €/QALY. Conclusion Our data do not support the early TKR strategy over the late TKR strategy in knee OA patients from a medico-economic perspective.
Regarding to the ASTER‐validation cohort, ASPECTS and age were the most robust predictors and they formed the initial model. But the predictive performance was significantly improved by adding ...baseline NIHSS score, history of vascular risk factors and onset‐to‐reperfusion time to build an updated final model. This could help identifying subgroup of patients with defavorable outcome and building a prediction tool to improve care management.
Background and purpose
Intravenous thrombolysis plus mechanical thrombectomy (IVT + MT) is the best current management of acute stroke due to large‐vessel occlusion and results in optimal reperfusion for most patients. Nevertheless, some of these patients do not subsequently achieve functional independence. The aim was to identify baseline factors associated with 3‐month independence after optimal reperfusion and to validate a prediction model.
Methods
All consecutive patients with intracranial anterior large‐vessel occlusion, with indication for IVT + MT and achieving optimal reperfusion (defined as modified Treatment in Cerebral Ischaemia score 2b–3), from the THRACE trial and the ETIS registry, were included in order to identify a prediction model. The primary outcome was 3‐month independence modified Rankin Scale (mRS) score ≤ 2. Multivariate inferences invoked forward logistic regression, multiple imputation and bootstrap resampling. Predictive performance was assessed by c‐statistic. Model validation was conducted on patients from the ASTER trial.
Results
Amongst 139 patients (mean age 65.5 years; 54.3% female), predictors of 3‐month mRS ≤ 2 (n = 82) were younger age odds ratio 0.62 per 10‐year increase; 95% confidence interval (CI) 0.53–0.72 and higher Alberta Stroke Program Early Computed Tomography Score (ASPECTS) (odds ratio 1.65 per 1‐point increase; 95% CI 1.47–1.86) with c‐statistic 0.77. Model validation (n = 104/181 patients with 3‐month mRS ≤ 2) demonstrated a moderate discrimination (c‐statistic 0.74; 95% CI 0.66–0.81) combining age and ASPECTS. The validation model was improved by the adjunction of three candidate variables that were found to be predictors. Addition of baseline National Institutes of Health Stroke Scale (NIHSS) score, history of vascular risk factor and onset‐to‐reperfusion time significantly improved discrimination (c‐statistic 0.85; 95% CI 0.83–0.87).
Conclusions
After optimal reperfusion, younger age, higher ASPECTS, lower NIHSS score, shorter onset‐to‐reperfusion time and absence of vascular risk factor were predictive of independence and could help to guide patient management.
Summary Objective To translate and adapt the Hip disability and Osteoarthritis Outcome Score (HOOS) into French and to evaluate the psychometric properties of this new version, by testing ...feasibility, internal consistency, construct validity, reliability and responsiveness, in patients with hip osteoarthritis (OA). Methods The French version of the HOOS was developed according to published international guidelines to ensure content validity. The new version was then evaluated in two symptomatic hip OA populations, one with no indication for joint replacement (medical group), and the other waiting for total hip replacement (THR) (surgery group). The psychometric properties assessed were feasibility : percentage of responses, floor and ceiling effects; internal consistency using Cronbach's alpha; construct validity by evaluating correlations with the Lequesne's index and the visual analogic scale (VAS) for pain (Pearson's correlation coefficient); reliability : intra-class correlation coefficient (ICC), Bland et Altman representation; responsiveness by comparing the results of before and 1 month after injection of hyaluronic acid (medical group) and by comparing the pre and 3 months post THR results (surgery group) by calculating standardized response mean (SRM) and effect size (ES). Results A total of 88 patients were recruited; 58 in the medicine group (mean age = 61.8 ± 9 years, range 42–81, 70% women) and 30 in the surgery group (mean age = 67.5 ± 9 years, range 50–81, 68% women). The percentage of item responses was excellent (99%). Neither a floor nor a ceiling effect was observed, except for a ceiling effect (17.8% of patients with worst possible score) observed prior to surgery in the sport and recreation subscale. The internal consistency was good for four of the five HOOS subscales. As expected, the strongest correlations were observed between all HOOS subscales and Lequesne's index or VAS pain, indicating good construct validity. The reliability was good, with an ICC > 0.8 for all subscales. The responsiveness was good for all domains 1 month after hyaluronic acid injection (ES ranging from 0.73 to 1.86 and SRM from 0.51 to 1.04) and high for all domains 3 months after THR (ES ranging from 1.47 to 2.08 and SRM ranging from 1.97 to 3.24). Conclusion The French version of HOOS demonstrated good psychometric properties and appears to be useful for the evaluation of patient-relevant outcome whatever the severity of hip OA. This study provides a basis for the use of this French version of the HOOS in future clinical trials.
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