Oxytocin (OT), a neuropeptide best known for its role in emotional and social behaviors, has been linked to osteoarthritis (OA). This study aimed to investigate the serum OT level in hip and/or knee ...OA patients and to study its association with disease progression. Patients from the KHOALA cohort with symptomatic hip and/or knee OA (Kellgren and Lawrence (KL) scores of 2 and 3) and follow-up at 5 years were included in this analysis. The primary endpoint was structural radiological progression, which was defined as an increase of at least one KL point at 5 years. Logistic regression models were used to estimate the associations between OT levels and KL progression while controlling for gender, age, BMI, diabetes and leptin levels. Data from 174 hip OA patients and 332 knee OA patients were analyzed independently. No differences in OT levels were found between the 'progressors' and 'non-progressors' groups among the hip OA patients and knee OA patients, respectively. No statistically significant associations were found between the OT levels at baseline and KL progression at 5 years, the KL score at baseline or the clinical outcomes. Higher structural damage at baseline and severe structural progression of hip and knee osteoarthritis did not appear to be associated with a low serum OT level at baseline.
The incidence of multiple sclerosis (MS) changes from generation to generation in ethnically different immigrants compared with native-born people. We aimed to determine whether there are ...generational changes in MS phenotypes among North African immigrants in France.
Cohort study with data from a population-based MS registry to compare the clinical characteristics of 80 first (NAG1) and 167 second (NAG2) generation North Africans with MS living in France with 5200 native-born Europeans. Adjusted Cox models were used to test the association between scores of 3 and 6 on the expanded disability status scale (EDSS) and the "origin/generation" variable.
Cox models for EDSS scores 3 and 6 showed a higher risk of score 3 (hazard ratio = 1.738, 95% confidence interval 1.237 to 2.444; P = .002) and 6 (hazard ratio = 2.372, 95% confidence interval 1.626 to 3.462; P<.0001) for NAG1 than Europeans. Being NAG2 was not significantly associated with higher hazards of scores 3 and 6.
We found two different phenotypes among NAG1 and NAG2 MS patients in France. NAG1, but not NAG2, have a higher risk of disability than Europeans. This raises the question of environmental factors in MS expression, and advocates appropriate patient management according to generation in immigrants.
Objective
To determine whether patient global assessment of disease activity (PtGA) over the first year of disease course, as part of a Boolean‐based definition of remission and considered ...individually, had a significant relationship with structural progression over 3 years in patients with early arthritis.
Methods
We conducted a prospective, observational study using ESPOIR (Étude et Suivi des Polyarthrites Indifférenciées Récentes) cohort data. Remission states were defined as 1) 4‐variable remission, which included a tender joint count in 28 joints, a swollen joint count in 28 joints (SJC28), a C‐reactive protein (CRP; mg/dl) level, and PtGA (scored 0–10, all scores of ≤1); 2) PtGA near remission, which included the same parameters as 4‐variable remission with only PtGA >1 (of a maximum possible score of 10); 3) 3‐variable remission (sum of the proportion of patients in 4‐variable remission and the proportion of patients in PtGA near remission); or 4) nonremission. The strictest status satisfied both at 6 and 12 months was considered. Radiographic progression was determined as a change of ≥5 points in the total Sharp/van der Heijde score (ΔSHS) from baseline to 3 years. The predictive capacities for radiographic damage of different remission definitions were assessed by odds ratio (OR). The association between each individual component of remission with ΔSHS was tested through multivariate linear regression analyses.
Results
Among 520 patients, 7% achieved 4‐variable remission and 12% achieved PtGA near remission. Radiographic progression was observed in 29% of patients who achieved 4‐variable remission (OR versus nonremission; OR 0.32 95% confidence interval (95% CI) 0.15, 0.68) and in 45% of patients with PtGA near remission (OR 0.65 95% CI 0.38, 1.11); the comparison was not statistically different (OR 0.49 95% CI 0.20, 1.18). In 3‐variable remission, radiographic progression was observed in 39%. Of the individual components, only the SJC28 and CRP level were associated with radiographic progression.
Conclusion
All definitions of remission led to low structural degradation in early arthritis, and 4‐variable remission led to less radiographic progression than PtGA near remission, but without a statistically significant difference. Both 4‐variable remission and 3‐variable remission appear to be useful targets when aiming for structural nonprogression.
There is a lack of consensus about the definition of flare of rheumatoid arthritis (RA) and a measurement tool.
To develop a self-administered tool integrating the perspectives of the patient and the ...rheumatologist, enabling the detection of present or recent-past RA flare.
The patient perspective was explored by semistructured individual interviews of patients with RA. Two health psychologists conducted a content analysis to extract items best describing flare from the interviews. The physician's perspective was explored through a Delphi exercise conducted among a panel of 13 rheumatologists. A comprehensive list of items produced in the first round was reduced in a four-round Delphi process to select items cited by at least 75% of the respondents. The identified elements were assembled in domains-each converted into a statement-to constitute the final self-administered Flare Assessment in Rheumatoid Arthritis (FLARE) questionnaire.
The content of 99 patient interviews was analysed, and 10 domains were identified: joint swelling or pain, night pain, fatigue and different emotional consequences, as well as analgesic intake. The Delphi process for physicians identified eight domains related to objective RA symptoms and drug intake, of which only four were common to domains for patients. Finally, 13 domains were retained in the FLARE questionnaire, formulated as 13 statements with a Likert-scale response modality of six answers ranging from 'absolutely true' to 'completely untrue'.
Two different methods, for patient and physician perspectives, were used to develop the FLARE self-administered questionnaire, which can identify past or present RA flare.
To investigate the validity of the global APS score (GAPSS) to predict thrombosis in patients with autoimmune diseases.
This prospective cohort study included consecutive patients with aPL or SLE. ...aPL, aPS-PT and GAPSS were determined. A Cox proportional hazards model assessed the validity of GAPSS and identified other potential independent predictors of thrombosis.
One hundred and thirty-seven patients 43.5 (s.d. 15.4) years old; 107 women were followed up for a mean duration of 43.1 (s.d. 20.7) months. Mean GAPSS was significantly higher in patients who experienced a thrombotic event compared with those without 10.88 (s.d. 5.06) vs 8.15 (s.d. 5.31), respectively, P = 0.038. In univariate analysis, age hazard ratio (HR) = 1.04 (95% CI 1.01, 1.08) and GAPSS above 16 HR = 6.86 (95% CI 1.90, 24.77) were each significantly associated with thrombosis during follow-up, while history of arterial thrombosis HR = 2.61 (95% CI 0.87, 7.82) failed to reach significance. Among aPL assays, IgG aPS/PT--a component of the GAPSS--was significantly associated with thrombosis HR = 2.95 (95% CI 1.02, 8.51). In multivariate analysis, GAPSS above 16 remained the only significant predictor of thrombosis HR = 6.17 (95% CI 1.70, 22.40).
This first external validation study confirmed that GAPSS can predict thrombosis in patients with aPL and associated autoimmune diseases.
There are few data on the relationship between health-related quality of life (HRQoL) and leisure time physical activity (LTPA) in the general population. We investigated the relationships of meeting ...public health recommendations (PHR) for moderate and vigorous physical activity with HRQoL in French adult subjects.
LTPA and HRQoL were assessed in 1998 in 2333 men and 3321 women from the SU.VI.MAX. cohort using the French versions of the Modifiable Activity Questionnaire (MAQ) and the SF-36 questionnaire, respectively. Relationship between LTPA and HRQoL was assessed using analysis of variance.
Results from multivariate analysis showed that meeting physical activity recommended levels was associated with higher HRQoL scores (except in Bodily pain dimension for women): differences in mean HRQoL scores between subjects meeting or not PHR ranged from 2.4 (Mental health) to 4.5 (Vitality) and from 2.2 (Bodily pain) to 5.7 (Vitality) for women and men, respectively.
Subjects meeting PHR for physical activity had better HRQoL than those who did not. Our data suggest that 30′ of moderate LTPA per day on a regular basis may be beneficial on HRQoL. Higher intensity LTPA is associated with greater HRQoL. This emphasizes the importance to promote at least moderate physical activity.
The World Health Organisation recommends monitoring the circulation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We investigated anti–SARS-CoV-2 total immunoglobulin (IgT) ...antibody seroprevalence and in vitro sero-neutralization in Nancy, France, in spring 2020. Individuals were randomly sampled from electoral lists and invited with household members over 5 years old to be tested for anti–SARS-CoV-2 (IgT, i.e., IgA/IgG/IgM) antibodies by ELISA (Bio-rad); the sero-neutralization activity was evaluated on Vero CCL-81 cells. Among 2006 individuals, the raw seroprevalence was 2.1% (95% confidence interval 1.5 to 2.9), was highest for 20- to 34-year-old participants (4.7% (2.3 to 8.4)), within than out of socially deprived area (2.5% vs. 1%, p = 0.02) and with than without intra-family infection (p < 10−6). Moreover, 25% of participants presented at least one COVID-19 symptom associated with SARS-CoV-2 positivity (p < 10−13), with highly discriminant anosmia or ageusia (odds ratio 27.8 13.9 to 54.5); 16.3% (6.8 to 30.7) of seropositive individuals were asymptomatic. Positive sero-neutralization was demonstrated in vitro for 31/43 seropositive subjects. Regarding the very low seroprevalence, a preventive effect of the lockdown in March 2020 can be assumed for the summer, but a second COVID-19 wave, as expected, could be subsequently observed in this poorly immunized population.
Abstract Objectives The aim of cross-cultural adaptation (CCA) of a questionnaire is to achieve equivalence between the original and adapted questionnaire. Here, we aimed to review the state of the ...art in CCA methods. Study Design and Setting We reviewed cross-disciplinary bibliographic databases for articles on methods and guidelines for CCA of questionnaires. Articles were first selected by their abstract and title, and then, we retrieved full-text English articles. References of selected articles were searched for additional relevant studies. Results We identified 31 guidelines and found no consensus in CCA methods. Most methods included use of committees, focus groups, and back translations. Evidence for the best methods is lacking, although clues indicate that back translation may not be mandatory. Conclusion Several methods are available for CCA of questionnaires. According to experts only, most would achieve comparable results, and choosing one is a matter of preference and logistic. More evidence is needed to support recommendations. Adaptation and validation of a questionnaire are two different processes that should be distinguished and undertaken with care.
To understand the limitations with current patient-reported outcome measures (PROM) used to generate quality-adjusted life-years (QALY) in rheumatology, and set a research agenda.
Two activities were ...undertaken. The first was a scoping review of published studies that have used PROM to generate QALY in rheumatology between 2011 and 2016. The second was an interactive "eyeball test" exercise at Outcome Measures in Rheumatology 13 that compared subdomains of widely used generic PROM, as identified through the scoping review, to subdomains of the Assessment of SpondyloArthritis Health Index (ASAS-HI) condition-specific PROM for ankylosing spondylitis.
The scoping review included 39 studies. Five different PROM have been used to generate QALY in rheumatology; however, the EQ-5D and Short Form 6 Dimensions (SF-6D) were used most frequently (in 32 and 9 of included studies, respectively). Special interest group participants identified energy/drive and sleep as 2 key subdomains of the ASAS-HI instrument that may be missed by the EQ-5D, and sexual function as potentially missed by the SF-6D. Participants also expressed concerns that aspects of the process of care and non-health outcomes may be missed. Three ways of incorporating additional subdomains were discussed, including using an alternative generic PROM, modifying an existing generic PROM with "bolt-on" subdomain(s), and generating societal weights for a condition-specific PROM.
Three priorities for future research were identified: understanding whether the EQ-5D and SF-6D identify what matters to patients with different rheumatic conditions, analyzing how much patients value process or non-health outcomes, and identifying which approaches to incorporating a greater number of subdomains into the QALY are being undertaken in other disease areas.
To identify factors affecting the quality of life (QoL) of disease-free survivors of rectal cancer.
One hundred twenty-one patients in complete remission more than 2 years after diagnosis were asked ...to complete three QoL questionnaires: the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30; its colorectal module, QLQ-CR38; and the Duke generic instrument.
Patients reported less pain (P =.002) than did controls drawn from the general population. EORTC QLQ-C30 physical scores were also higher among rectal cancer survivors than in the general Norwegian or German population (P =.0005 and P =.002, respectively). Unexpectedly, stoma patients reported better social functioning than did nonstoma patients (P =.005), with less anxiety (P =.008) and higher self-esteem (P =.0002). In the present authors' experience, the QLQ-CR38 does not discriminate between these groups. Residual abdominal or pelvic pain and constipation had the most negative influence on QoL.
QoL is high among rectal cancer survivors, including stoma patients. Simultaneous use of several QoL questionnaires appears to have value in follow-up and in monitoring the effects of therapy. The impact of residual pain and constipation on long-term QoL should be considered when establishing a treatment regimen.
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