Publications by authors named "Francis Guillemin"

311 Publications

Trajectories in early rheumatoid arthritis related fatigue over 10 years: results from the ESPOIR cohort.

Clin Exp Rheumatol 2021 Sep 21. Epub 2021 Sep 21.

Department of Rheumatology, CHU Montpellier, University of Montpellier, France.

Objectives: In a cohort of early rheumatoid arthritis (RA) patients, we aimed to determine and characterise fatigue trajectories over 10 years of follow-up and identify predictors of trajectory membership.

Methods: We selected patients fulfilling the 2010 ACR/EULAR criteria for RA included in the ESPOIR cohort. We used a cluster analysis to obtain fatigue (assessed by fatigue visual analogue scale) trajectories over the course of 10 years from enrolment. Chi-square tests or ANOVA were performed to evaluate differences of baseline variables between fatigue trajectories. Using a multinomial logistic regression we were able to identify predictors of trajectory membership.

Results: We analysed 598 patients with mean disease duration at enrolment of 26.2±40.9 days. Cluster analysis revealed 3 trajectories: high (18%), moderate (52%) and low fatigue (30%). Compared to patients with moderate or low fatigue trajectory, patients with high fatigue trajectory were predominantly women and reported significantly higher duration and intensity of morning stiffness, HAQ score, tender joints count, levels of pain, number of awakenings due to arthritis, frequency of fibromyalgic RA, levels of physician and patient global assessment, more frequent sleep problems, and increased psychological distress. Female patients with pain, psychological distress and presence of sicca symptoms had a higher risk of being in the high trajectory group.

Conclusions: These findings suggest that levels of fatigue are rather stable over time in each trajectory. Baseline clinical measures and baseline patient-reported measures of functional status better distinguished the three fatigue trajectories. We did not find any differences between trajectories in baseline laboratory measures. Inflammatory activity was not a predictor of being in the high trajectory fatigue group.
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September 2021

Web-based and machine learning approaches for identification of patient-reported outcomes in inflammatory bowel disease.

Dig Liver Dis 2021 Sep 26. Epub 2021 Sep 26.

CHRU-Nancy, INSERM, Université de Lorraine, CIC 1433 Clinical Epidemiology, F-54000 Nancy, France; Université de Lorraine, APEMAC, F-54000 Nancy, France. Electronic address:

Background: Messages from an Internet forum are raw material that emerges in a natural setting (i.e., non-induced by a research situation).

Aims: The FLARE-IBD project aimed at using an innovative approach consisting of collecting messages posted by patients in an Internet forum and conducting a machine-learning study (data analysis/language processing) for developing a patient-reported outcome measuring flare in inflammatory bowel disease meeting international requirements.

Methods: We used web-based and machine learning approaches, in the following steps. 1) Web-scraping to collect all available posts in an Internet forum (23 656 messages) and extracting metadata from the forum. 2) Twenty patients were randomly assigned 50 extracted messages; participants indicated whether the message corresponded or not to the flare phenomenon (labeling). If yes, participants were asked to identify excerpts from the text they considered significant flare markers (annotation). 3) The set of annotated messages underwent a vocabulary analysis.

Results: The phenomenon of flare was circumscribed with the identification of 20 surrogate flare markers classified into five dimensions with their frequency within extracted labeled data: impact on life, symptoms, extra-intestinal manifestations, drugs and environmental factors. Web-based and machine-learning approaches met international recommendations to inform the content and structure for the development of patient-reported outcomes.
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http://dx.doi.org/10.1016/j.dld.2021.09.005DOI Listing
September 2021

Recherche sur la fin de vie, la nécessité d’un consensus : premiers résultats.

Sante Publique 2021 March-April;33(2):191-198

During the past 15 years, in France, like in many European countries, the attention paid to patients at the end of their lives has continued to grow. But in the meantime, only a few researchers have managed to collect reliable data on End-of-Life Care and to implement scientific studies describing the reality of these situations. This difficulty is due in particular to the lack of a recognized and operational definition of the end of life.Our objective is to explore the possibility of achieving consensus around a definition based on the isolated elements in the literature.A Delphi consensus approach has been conducted. A “Delphi” approach allows consensus to be achieved without the influence of leadership effects.The population of this study is the group of care providers who are members of the Société Française d’Accompagnement et de Soins Palliatifs (SFAP), whether they are professionals or volunteers. An electronic survey asked for the degree of approval of individuals for each of the proposed definitions on a Lickert scale. The first round of Delphi was proposed at the end of 2019 among palliative care actors. 1463 people responded to this questionnaire in one month. Two types of definition seem to dominate the other proposals. The first is related to an estimate of life expectancy: life expectancy of less than 15 days and less than one month. The second emerging definition is related to the evolution of a pathology: based on the fact of being in advanced or terminal phase of an incurable pathology.These results confirm that the end-of-life period can be seen from two points of view, the first in relation to the time left to live and the other in relation of the terminal phase of the disease which calls for a less clearly defined time.These two definitions are based on different approaches, one temporal and the other disease-centered. An alternative definition emerges from this study and will be tested in the second round of Delphi.
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http://dx.doi.org/10.3917/spub.212.0191DOI Listing
September 2021

French nurses' and allied health professionals' perception of research in their fields: A descriptive qualitative study.

Int Nurs Rev 2021 Sep 12. Epub 2021 Sep 12.

CHRU-Nancy, INSERM, Université de Lorraine, CIC 1433 Clinical Epidemiology, Nancy, France.

Aim: To gather information from nurses and allied health professionals in the French context of the emergence of research in the field so as to inform the development of a new tool: The research in nursing and allied health sciences' Ideas Generator (GénI) capable of sustaining the identification of research ideas from professionals in the field.

Background: In many countries, research in nursing and allied health sciences remains underdeveloped.

Introduction: Before developing the Ideas Generator tool, it was essential to explore professionals' basis of reference in providing care, then investigate (1) their representation of research in this field of science and (2) their perception of needs for and obstacles to starting a research process.

Methods: The qualitative research design used focus groups. The study population included 24 participants naive to research in four hospitals in eastern France (13 nurses and 11 allied health professionals). Thematic analysis was used to analyze the data. The study was reported in compliance with the consolidated criteria for reporting qualitative research criteria.

Findings: Professionals used tacit knowledge and their experiences to address care, but the culture of scientific evidence was clearly missing (lack of knowledge of the origin of care guidelines, few bibliographic skills). Participation in a research process could hardly be envisaged without a supervised collaboration with a physician. Research was perceived not to be part of professionals' culture. They self-censured for lack of methodological competencies.

Discussion: Findings underlined some leverage, obstacles, and need to consider to generate a stimulation in the field, especially in countries where such research is still in its infancy.

Implication For Nursing, Health, And Education Policy: Strengthening the field of nursing and allied health research is essential to extend the skills of nurses and allied health workers and to improve the quality of patient care by taking into account results from the literature. The Ideas Generator tool will be implemented to sustain learning the skills of research through education and training.
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http://dx.doi.org/10.1111/inr.12709DOI Listing
September 2021

Comparative effectiveness of dimethyl fumarate in multiple sclerosis.

Br J Clin Pharmacol 2021 Sep 9. Epub 2021 Sep 9.

Univ. Bordeaux, INSERM CIC-P1401, Bordeaux PharmacoEpi, Bordeaux, France.

Aims: To assess the effectiveness of dimethyl fumarate (DMF) on annual rate of relapse subject to treatment (ARRt) and disability progression in multiple sclerosis (MS) compared to injectable immunomodulators (IMM), teriflunomide (TERI) and fingolimob (FTY), in real-life setting.

Methods: A population-based cohort study was conducted using data of the French nationwide claims database, SNDS. All patients initiating IMM, TERI, FTY or DMF between 1 July 2015 and 12 December 2017, with 4.5 years of database history and 1-3.5 years of follow-up were included in this study. DMF patients were 1:1 matched to IMM, TERI or FTY using a high dimensional propensity score. Negative binomial regression and a logistic regression model were used to estimate the relative risk (RR ± [95% CI]) of ARRt and the odds ratio (OR ± [95% CI]) of disability progression, respectively.

Results: Overall, 9304 subjects were identified: 29.0% initiated DMF, 33.2% TERI, 5.6% FTY and 32.2% an IMM. The matched cohorts consisted of 1779 DMF-IMM patients, 1679 DMF-TERI patients, and 376 DMF-FTY patients. DMF significantly reduced ARRt compared to IMM (RR 0.72 [0.61-0.86]) and TERI (0.81 [0.68-0.96]) and did not show any significant difference when compared with FTY. The risk of the progression of MS-specific disability was not significantly different for any matched cohorts.

Conclusion: DMF is associated with lower risk of treated relapse for patients with RRMS than other first-line RRMS agents (TERI and IIM).
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http://dx.doi.org/10.1111/bcp.15071DOI Listing
September 2021

Value of infarct location in the prediction of functional outcome in patients with an anterior large vessel occlusion: results from the HERMES study.

Neuroradiology 2021 Sep 3. Epub 2021 Sep 3.

Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.

Purpose: Follow-up infarct volume (FIV) is moderately associated with functional outcome. We hypothesized that accounting for infarct location would strengthen the association of FIV with functional outcome.

Methods: We included 252 patients from the HERMES collaboration with follow-up diffusion weighted imaging. Patients received endovascular treatment combined with best medical management (n = 52%) versus best medical management alone (n = 48%). FIV was quantified in low, moderate and high modified Rankin Scale (mRS)-relevant regions. We used binary logistic regression to study the relation between the total, high, moderate or low mRS-relevant FIVs and favorable outcome (mRS < 2) after 90 days. The strength of association was evaluated using the c-statistic.

Results: Small lesions only occupied high mRS-relevant brain regions. Lesions additionally occupied lower mRS-relevant brain regions if FIV expanded. Higher FIV was associated with a higher risk of unfavorable outcome, as were volumes of tissue with low, moderate and high mRS relevance. In multivariable modeling, only the volume of high mRS-relevant infarct was significantly associated with favorable outcome. The c-statistic was highest (0.76) for the models that included high mRS-relevant FIV or the combination of high, moderate and low mRS-relevant FIV but was not significantly different from the model that included only total FIV (0.75).

Conclusion: This study confirms the association of FIV and unfavorable functional outcome but showed no strengthened association if lesion location was taken into account.
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http://dx.doi.org/10.1007/s00234-021-02784-xDOI Listing
September 2021

Health Literacy throughout adolescence: Invariance and validity study of three measurement scales in the general population.

Patient Educ Couns 2021 Jul 28. Epub 2021 Jul 28.

Paris-Saclay University, UVSQ, Inserm, CESP, Paris, France. Electronic address:

Objective: To simultaneously investigate the psychometric properties of three recently developed health literacy measurement scales throughout adolescence in the general population.

Methods: French versions of the Health Literacy for School-Aged Children (HLSAC, unidimensional) scale, the Health Literacy Assessment Scale for Adolescents (HAS-A, multidimensional) and the 16-item European Health Literacy Survey questionnaire (HLS-EU-Q16, unidimensional) were completed by 1 444 adolescents in 8th, 9th, 11th grade in general school and 11-12th grade in vocational school. Psychometric properties were studied using confirmatory factor analysis, McDonald's omega coefficient and hypothesis testing.

Results: Structural validity was acceptable (HLS-EU-Q16) to good (HAS-A and HLSAC), no measurement invariance issue was found and internal consistency was acceptable for the three scales (0.68-0.84). Convergent validity was low (Pearson correlation coefficients<0.5) and the only scale for which results were in agreement with a priori hypotheses was the HLSAC.

Conclusions: Our results were supportive of the use of HLSAC to assess health literacy during adolescence but the HAS-A, with a slightly better structural validity, can also be promoted due to its three measured dimensions.

Practice Implications: The use of these scales in practice will help to focus on health literacy, a critical factor for prevention and health promotion in adolescence.
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http://dx.doi.org/10.1016/j.pec.2021.07.044DOI Listing
July 2021

Association of Baseline Cardiovascular Diseases with 5-Year Knee and Hip Osteoarthritis Progression in Non-Obese Patients: Data from the KHOALA Cohort.

J Clin Med 2021 Jul 29;10(15). Epub 2021 Jul 29.

Department of Rheumatology, Nice Hospital, University Cote d'Azur, 06003 Nice, France.

We aimed to explore the relationship between comorbidities and the structural progression in symptomatic knee and/or hip osteoarthritis (OA) patients. We analyzed the 5-year outcome of non-obese participants (body mass index (BMI) < 30 kg/m) from the KHOALA cohort having symptomatic hip and/or knee OA (Kellgren and Lawrence (KL) ≥ 2). The primary endpoint was radiological progression, defined as ΔKL ≥ 1 of the target joint at 5 years. The secondary outcome was the incidence of total knee or hip replacement over 5 years. Dichotomous logistic regression models assessed the relationship of comorbidities with KL progression and joint replacement while controlling for gender, age and BMI. Data from 384 non-obese participants were analyzed, 151 with hip OA and 254 with knee OA. At 5 years, cardiovascular diseases (CVD) were significantly associated with the 5-year KL change in both knee (OR = 2.56 (1.14-5.78), = 0.02) and hip OA (OR = 3.45 (1.06-11.17), = 0.04). No significant relationship was found between any type of comorbidities and knee or hip arthroplasty. This 5-year association between CVD and radiological progression of knee and hip OA in non-obese participants argue for an integrated management of CVD in knee and hip OA non-obese patients.
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http://dx.doi.org/10.3390/jcm10153353DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8348958PMC
July 2021

Seroprevalence of SARS-CoV-2, Symptom Profiles and Sero-Neutralization in a Suburban Area, France.

Viruses 2021 06 4;13(6). Epub 2021 Jun 4.

CIC Epidémiologie Clinique, CHRU-Nancy, Inserm, Université de Lorraine, F-54000 Nancy, France.

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%, = 0.02) and with than without intra-family infection ( < 10). Moreover, 25% of participants presented at least one COVID-19 symptom associated with SARS-CoV-2 positivity ( < 10), 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.
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http://dx.doi.org/10.3390/v13061076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8230202PMC
June 2021

Best-practice clinical management of flares in people with osteoarthritis: A scoping review of behavioral, lifestyle and adjunctive treatments.

Semin Arthritis Rheum 2021 08 5;51(4):749-760. Epub 2021 May 5.

Institute of Bone and Joint Research, Kolling Institute, The University of Sydney, Sydney, Australia; Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia.

Introduction: Transient episodes of increased pain, stiffness or swelling are common in people with osteoarthritis (OA). Yet, evidence-based management strategies for lessening the impact of OA flares are rarely covered in clinical guidelines and have been identified as a gap by clinicians delivering OA care. We aimed to identify evidence on behavioral, lifestyle or other adjunctive flare management strategies that could be used by clinicians or consumers.

Materials And Methods: A literature search between 1990-2020 was performed in three databases using a scoping methodology. We included qualitative or quantitative studies, and reviews that examined OA flare management, or that reported OA flare outcomes at timepoints ≤2 weeks post-intervention. Outcomes included any physical or psychological OA outcome treatable with a therapeutic intervention.

Results: We included 9 studies, all of which examined the relationship between therapeutic exercise/ physical activity and OA flares. All studies reported pain outcomes at the knee. Two also included the hip. Only two studies examined specific management strategies for OA flares. Both favorably reported the benefits of undertaking an exercise program modified accordingly during an episode, but the quality of the evidence was low.

Discussion: This scoping review highlights the paucity of evidence available on non-pharmacological treatments of OA flare management that could influence clinical practice. At present, there is no robust evidence to support or reject any specific therapies for OA flare management in clinical practice. Future work is needed, particularly around outcomes beyond pain, trajectories of symptom improvement, and for joints other than the knee.
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http://dx.doi.org/10.1016/j.semarthrit.2021.04.017DOI Listing
August 2021

Patient preferences to value health outcomes in rheumatology clinical trials: Report from the OMERACT special interest group.

Semin Arthritis Rheum 2021 08 24;51(4):919-924. Epub 2021 May 24.

Department of Community Health Sciences, University of Calgary, Calgary, Canada; Department of Medicine, University of Calgary, Calgary, Canada. Electronic address:

Objective: To inform a research plan for future studies by obtaining stakeholder input on the application of preference-based methods to clinical trial design.

Methods: We conducted a virtual OMERACT session to encourage stakeholder engagement. We developed materials for the session to facilitate discussion based on identified case examples and feedback sessions.

Results: Participants prioritized incorporating patient preferences in all aspects of trial design with an emphasis on outcome selection. Participants highlighted the need for careful consideration around preference heterogeneity and equity factors.

Conclusion: Including patient preferences in trial design was considered a priority requiring further exploration to develop comprehensive guidance.
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http://dx.doi.org/10.1016/j.semarthrit.2021.05.008DOI Listing
August 2021

Clinical imaging factors of excellent outcome after thrombolysis in large-vessel stroke: a THRACE subgroup analysis.

Stroke Vasc Neurol 2021 Jun 8. Epub 2021 Jun 8.

Department of Neurology-Stroke Unit, CIC-P 1433, INSERMU1116, Université de Lorraine, Nancy Regional University Hospital Center, Nancy, France

Background: For patients with stroke with large-vessel occlusion (LVO), study of factors predicting response to intravenous thrombolysis (IVT) would allow identifying subgroups with high expected gain, and those for whom it could be considered as futile, and even detrimental. From patients included in the Mechanical Thrombectomy After Intravenous Alteplase vs Alteplase Alone After Stroke trial, we investigated clinical-imaging factors associated with optimal response to IVT.

Methods: We included patients receiving IVT alone. Excellent outcome was defined by a 3-month modified Rankin Scale (mRS) score ≤1. Clinical-imaging predictors were assessed on multivariate analysis after multiple imputations. The predictive performance of the model was assessed with the C-statistic.

Results: Among 247 patients with LVO treated with IVT alone, 77 (31%) showed 3-month mRS ≤1. Predictors of 3-month mRS ≤1 were no medical history of hypertension (OR 2.43; 95% CI 1.74 to 3.38; p=0.007); no current smoking (OR 2.76; 95% CI 1.79 to 4.26; p=0.02); onset-to-IVT time (OR 0.47 per hour increase; 95% CI 0.23 to 0.78; p=0.003); diffusion-weighted imaging (DWI) volume (OR 0.78 per 10 mL increase; 95% CI 0.68 to 0.89; p=0.0004); presence of susceptibility vessel sign (SVS) (OR 7.89; 95% CI 1.65 to 37.78; p=0.01) and SVS length (OR 0.87 per mm increase; 95% CI 0.80 to 0.94; p=0.001). The prediction models showed a C-statistic=0.79 (95% CI 0.79 to 0.80).

Conclusions: In patients with stroke with anterior-circulation LVO treated with IVT alone, predictors of excellent outcome at 3 months were no medical history of hypertension or current smoking, reduced onset-to-IVT time, small DWI volume, presence of SVS and short SVS length. These predictive factors could help practitioners in decision-making for IVT implementation in reperfusion strategies, all the more for the drip and ship paradigm.

Trial Registration Number: NCT01062698.
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http://dx.doi.org/10.1136/svn-2020-000852DOI Listing
June 2021

Sociodemographic and psychological characteristics associated with discrepancy between body satisfaction and weight change among adolescents.

Prev Med 2021 09 1;150:106668. Epub 2021 Jun 1.

Université de Lorraine, APEMAC, F-54000 Nancy, France; CHRU-Nancy, INSERM, Université de Lorraine, CIC, Epidémiologie Clinique, F-54000 Nancy, France.

This study aimed to describe the discrepancy between body satisfaction change and weight change among adolescents following a 2-year school-based intervention, to identify associated sociodemographic factors, and to explore possible associations with perceived health indicators. We used data from a northeastern France representative adolescents sample (14-18 years old) who participated in the PRALIMAP (PRomotion de l'ALIMentation et de l'Activité Physique) study (2006-2009). Weight change was measured by the change in body mass index z-score from the start to the end of the study. Body satisfaction and self-perceived health (anxiety, depression, eating disorder and quality of life) changes were assessed using self-administered questionnaires. Discrepancy between body satisfaction change and weight change was described with cross-tabulations, and subdivided into optimism/pessimism (i.e. positive/negative body satisfaction change compared to weight change). Sociodemographic factors associated with discrepancy were determined by multivariate logistic regression models. Adjusted linear regression models described 2-year change in weight and self-perceived health according to discrepancy. Among the 3279 adolescents included (aged 15.1 ± 0.6 years), the proportion of discrepancy was 74.8% (pessimism = 41.6%; optimism = 33.2%). Discrepancy, especially pessimism, was higher in boys than in girls (OR = 1.44 [1.19; 1.74], p = .0002), and in socially advantaged adolescents (OR = 1.82 [1.20; 2.74], p = .004) than in disadvantage ones. Body satisfaction change was rather in line with anxiety, depression and quality of life changes than weight change. Body satisfaction change should be considered in overweight and obesity prevention interventions alongside body weight change, and could be used as indicator of long-term behavior maintenance. Clinical trials registry and number:ClinicalTrials.gov (NCT01688453).
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http://dx.doi.org/10.1016/j.ypmed.2021.106668DOI Listing
September 2021

Early Acceptability of a Mobile App for Contact Tracing During the COVID-19 Pandemic in France: National Web-Based Survey.

JMIR Mhealth Uhealth 2021 07 19;9(7):e27768. Epub 2021 Jul 19.

Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, ISSPAM, Equipe CANBIOS Labellisée Ligue Contre le Cancer, Marseille, France.

Background: Several countries have implemented mobile apps in an attempt to trace close contacts of patients with COVID-19 and, in turn, reduce the spread of SARS-CoV-2. However, the effectiveness of this approach depends on the adherence of a large segment of the population.

Objective: The aims of this study were to evaluate the acceptability of a COVID-19 contact tracing mobile app among the French population and to investigate the barriers to its use.

Methods: The Health Literacy Survey 2019 questioned 1003 people in France during the COVID-19 pandemic on the basis of quota sampling. The survey collected sociodemographic characteristics and health literacy data, as well as information on participants' communication with caregivers, trust in institutions, and COVID-19 knowledge and preventive behaviors. The acceptability of a mobile app for contact tracing was measured by a single question, the responses to which were grouped into three modalities: app-supporting, app-willing, and app-reluctant. Multinomial logistic regression analysis was performed to identify the factors associated with the acceptability of a mobile app during the COVID-19 pandemic.

Results: Only 19.2% (193/1003) of all participants were app-supporting, whereas half of them (504/1003, 50.3%) were reluctant. The factors associated with willingness or support toward the contact tracing app included lower financial deprivation (app-willing: adjusted odds ratio [aOR] 0.8, 95% CI 0.69-0.93; app-supporting: aOR 0.7, 95% CI 0.58-0.84) and higher perceived usefulness of using a mobile app to send completed health questionnaires to doctors (app-willing: aOR 2.3, 95% CI 1.70-3.26; app-supporting: aOR 3.1, 95% CI 2.04-4.82). Furthermore, the likelihood of supporting the mobile app increased with age over 60 years (aOR 1.9, 95% CI 1.13-3.22), trust in political representatives (aOR 2.7, 95% CI 1.72-4.23), feeling concerned about the pandemic situation (aOR 2.2, 95% CI 1.47-3.32), and knowledge about the transmission of COVID-19 (aOR 2.0, 95% CI 1.39-2.96).

Conclusions: The most socioeconomically precarious people, who are at a higher risk of SARS-CoV-2 infection, are also the most reluctant to using a contact tracing mobile app. Therefore, optimal adherence can only be effective with a targeted discourse on public health benefits to adopt such an app, which should be combined with a reduction in inequalities by acting on structural determinants.
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http://dx.doi.org/10.2196/27768DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8291140PMC
July 2021

Healthy Life-Year Costs of Treatment Speed From Arrival to Endovascular Thrombectomy in Patients With Ischemic Stroke: A Meta-analysis of Individual Patient Data From 7 Randomized Clinical Trials.

JAMA Neurol 2021 Jun;78(6):709-717

Department of Neurology, David Geffen School of Medicine, University of California, Los Angeles.

Importance: The benefits of endovascular thrombectomy (EVT) are time dependent. Prior studies may have underestimated the time-benefit association because time of onset is imprecisely known.

Objective: To assess the lifetime outcomes associated with speed of endovascular thrombectomy in patients with acute ischemic stroke due to large-vessel occlusion (LVO).

Data Sources: PubMed was searched for randomized clinical trials of stent retriever thrombectomy devices vs medical therapy in patients with anterior circulation LVO within 12 hours of last known well time, and for which a peer-reviewed, complete primary results article was published by August 1, 2020.

Study Selection: All randomized clinical trials of stent retriever thrombectomy devices vs medical therapy in patients with anterior circulation LVO within 12 hours of last known well time were included.

Data Extraction/synthesis: Patient-level data regarding presenting clinical and imaging features and functional outcomes were pooled from the 7 retrieved randomized clinical trials of stent retriever thrombectomy devices (entirely or predominantly) vs medical therapy. All 7 identified trials published in a peer-reviewed journal (by August 1, 2020) contributed data. Detailed time metrics were collected including last known well-to-door (LKWTD) time; last known well/onset-to-puncture (LKWTP) time; last known well-to-reperfusion (LKWR) time; door-to-puncture (DTP) time; and door-to-reperfusion (DTR) time.

Main Outcomes And Measures: Change in healthy life-years measured as disability-adjusted life-years (DALYs). DALYs were calculated as the sum of years of life lost (YLL) owing to premature mortality and years of healthy life lost because of disability (YLD). Disability weights were assigned using the utility-weighted modified Rankin Scale. Age-specific life expectancies without stroke were calculated from 2017 US National Vital Statistics.

Results: Among the 781 EVT-treated patients, 406 (52.0%) were early-treated (LKWTP ≤4 hours) and 375 (48.0%) were late-treated (LKWTP >4-12 hours). In early-treated patients, LKWTD was 188 minutes (interquartile range, 151.3-214.8 minutes) and DTP 105 minutes (interquartile range, 76-135 minutes). Among the 298 of 380 (78.4%) patients with substantial reperfusion, median DTR time was 145.0 minutes (interquartile range, 111.5-185.5 minutes). Care process delays were associated with worse clinical outcomes in LKW-to-intervention intervals in early-treated patients and in door-to-intervention intervals in early-treated and late-treated patients, and not associated with LKWTD intervals, eg, in early-treated patients, for each 10-minute delay, healthy life-years lost were DTP 1.8 months vs LKWTD 0.0 months; P < .001. Considering granular time increments, the amount of healthy life-time lost associated with each 1 second of delay was DTP 2.2 hours and DTR 2.4 hours.

Conclusions And Relevance: In this study, care delays were associated with loss of healthy life-years in patients with acute ischemic stroke treated with EVT, particularly in the postarrival time period. The finding that every 1 second of delay was associated with loss of 2.2 hours of healthy life may encourage continuous quality improvement in door-to-treatment times.
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http://dx.doi.org/10.1001/jamaneurol.2021.1055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094030PMC
June 2021

Intra-database validation of case-identifying algorithms using reconstituted electronic health records from healthcare claims data.

BMC Med Res Methodol 2021 05 1;21(1):95. Epub 2021 May 1.

INSERM CIC-P1401, Bordeaux PharmacoEpi, Univ. Bordeaux, Bordeaux, France.

Background: Diagnosis performances of case-identifying algorithms developed in healthcare database are usually assessed by comparing identified cases with an external data source. When this is not feasible, intra-database validation can present an appropriate alternative.

Objectives: To illustrate through two practical examples how to perform intra-database validations of case-identifying algorithms using reconstituted Electronic Health Records (rEHRs).

Methods: Patients with 1) multiple sclerosis (MS) relapses and 2) metastatic castration-resistant prostate cancer (mCRPC) were identified in the French nationwide healthcare database (SNDS) using two case-identifying algorithms. A validation study was then conducted to estimate diagnostic performances of these algorithms through the calculation of their positive predictive value (PPV) and negative predictive value (NPV). To that end, anonymized rEHRs were generated based on the overall information captured in the SNDS over time (e.g. procedure, hospital stays, drug dispensing, medical visits) for a random selection of patients identified as cases or non-cases according to the predefined algorithms. For each disease, an independent validation committee reviewed the rEHRs of 100 cases and 100 non-cases in order to adjudicate on the status of the selected patients (true case/ true non-case), blinded with respect to the result of the corresponding algorithm.

Results: Algorithm for relapses identification in MS showed a 95% PPV and 100% NPV. Algorithm for mCRPC identification showed a 97% PPV and 99% NPV.

Conclusion: The use of rEHRs to conduct an intra-database validation appears to be a valuable tool to estimate the performances of a case-identifying algorithm and assess its validity, in the absence of alternative.
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http://dx.doi.org/10.1186/s12874-021-01285-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8088022PMC
May 2021

Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach.

Semin Arthritis Rheum 2021 06 6;51(3):593-600. Epub 2021 Apr 6.

Institute for Work & Health, Institute Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.

Objective: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions.

Methods: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating white-board videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set.

Results: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1- Knowledge of options, their potential benefits and harms; 2- Chosen option aligned with each patient's values and preferences; 3- Confidence in the chosen option; 4- Satisfaction with the decision-making process; 5- Adherence to the chosen option and 6- Potential negative consequences of the SDM intervention.

Conclusion: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set.

Clinical Significance: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers.
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http://dx.doi.org/10.1016/j.semarthrit.2021.03.017DOI Listing
June 2021

OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study.

Semin Arthritis Rheum 2021 06 2;51(3):601-606. Epub 2021 Apr 2.

Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark. Electronic address:

Objectives: To develop an operational definition of contextual factors (CF) [1].

Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.

Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.

Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members.
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http://dx.doi.org/10.1016/j.semarthrit.2021.03.013DOI Listing
June 2021

Clinical and radiological activity of secondary progressive multiple sclerosis in a population-based cohort.

Eur J Neurol 2021 07 18;28(7):2238-2248. Epub 2021 May 18.

Université de Lorraine, Vandoeuvre-Lès-Nancy, France.

Background And Purpose: Patients with secondary progressive multiple sclerosis (SP MS) and clinical and/or radiological activity could be the more likely to benefit from disease-modifying treatments. To evaluate the proportions each year after progression onset, patients with SP MS onset between 2002 and 2012 from a population-based multiple sclerosis registry in northeastern France were studied.

Methods: Progression onset was first identified by the neurologist's diagnosis (N cohort), and then by using an automated data-driven definition (D cohort). In a given year after onset of progression, clinical activity was defined as at least one relapse, and radiological activity as at least one new T2 and/or gadolinium-enhancing lesion. A multivariate mixed logistic regression was used to assess factors associated with activity during the year.

Results: In the N cohort, amongst 833 patients with SP MS with a median follow-up of 8 years, 10.0%-14.8% had at least one relapse in a year during the first 5 years of progression. Including both clinical and radiological activity increased these proportions to 11.9%-23.7%, with the proportion having a magnetic resonance imaging scan in the year ranging from 29.8% to 40.5%. The first year of progression, a young age and a high relapse rate during the 5 years before progression were associated with activity in a given year. The D cohort results confirmed these findings.

Conclusions: A substantial proportion of patients with SP MS present disease activity. Further studies should evaluate the impact of disease-modifying treatments on the disease course of these patients.
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http://dx.doi.org/10.1111/ene.14861DOI Listing
July 2021

EULAR Points to Consider (PtC) for designing, analysing and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis.

Ann Rheum Dis 2021 09 8;80(9):1116-1123. Epub 2021 Apr 8.

Rheumatology, Leiden University Medical Center, Leiden, The Netherlands.

Background: Clinical studies with work participation (WP) as an outcome domain pose particular methodological challenges that hamper interpretation, comparison between studies and meta-analyses.

Objectives: To develop Points to Consider (PtC) for design, analysis and reporting of studies of patients with inflammatory arthritis that include WP as a primary or secondary outcome domain.

Methods: The EULAR Standardised Operating Procedures were followed. A multidisciplinary taskforce with 22 experts including patients with rheumatic diseases, from 10 EULAR countries and Canada, identified methodologic areas of concern. Two systematic literature reviews (SLR) appraised the methodology across these areas. In parallel, two surveys among professional societies and experts outside the taskforce sought for additional methodological areas or existing conducting/reporting recommendations. The taskforce formulated the PtC after presentation of the SLRs and survey results, and discussion. Consensus was obtained through informal voting, with levels of agreement obtained anonymously.

Results: Two overarching principles and nine PtC were formulated. The taskforce recommends to align the work-related study objective to the design, duration, and outcome domains/measurement instruments of the study (PtC: 1-3); to identify contextual factors upfront and account for them in analyses (PtC: 4); to account for interdependence of different work outcome domains and for changes in work status over time (PtC: 5-7); to present results as means as well as proportions of patients reaching predefined meaningful categories (PtC: 8) and to explicitly report volumes of productivity loss when costs are an outcome (PtC:9).

Conclusion: Adherence to these EULAR PtC will improve the methodological quality of studies evaluating WP.
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http://dx.doi.org/10.1136/annrheumdis-2020-219523DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8372378PMC
September 2021

Long-term analysis of patients with benign multiple sclerosis: new insights about the disability course.

J Neurol 2021 Oct 31;268(10):3817-3825. Epub 2021 Mar 31.

Université de Lorraine, EA 4360 APEMAC, 54500, Nancy, France.

Objective: To describe the course of disability in patients with benign multiple sclerosis-i.e., with an expanded disability status scale score < 3 10 years after disease onset-for up to 30 years after disease onset. We evaluated the proportion of patients remaining in the benign state on the long term and the factor associated with this favorable outcome and determined the pattern of disability course after the loss of the benign status.

Methods: Patients were selected from the ReLSEP, a French population-based registry. We studied the probability (Kaplan-Meier method) and predictors (multivariate Cox model) of remaining < 3 after year 10, and the course of disability after score 3 according to the duration of the benign phase in patients with ≥ 30 years of follow-up (graphs of the course of the mean expanded disability status scale scores in subgroups of patients).

Results: 2295/3440 patients had benign multiple sclerosis (66.7%). The probability of remaining benign at year 30 was 0.26 (95% CI 0.26-0.32). A young age at disease onset and a good recovery after the first relapse were associated with remaining benign. Graphs illustrate that those who lost their benign status between years 10 and 30 follow a two-stage course. Beyond score 3, disability accumulation is similar in all but lower disability scores at advanced age are associated with longer benign periods.

Conclusion: The longer a patient remains in the benign state, the lower the final EDSS at advanced age.
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http://dx.doi.org/10.1007/s00415-021-10501-0DOI Listing
October 2021

Cut-off value to identify a flare using the Flare Assessment in Rheumatoid Arthritis (FLARE-RA) questionnaire: analysis of the TOSCA study.

Rheumatology (Oxford) 2021 Mar 31. Epub 2021 Mar 31.

Rheumatology Department, Pitié Salpêtrière hospital, Sorbonne Université - Assistance Publique Hôpitaux de Paris, Paris, France.

Objective: The Flare Assessment in Rheumatoid Arthritis (FLARE-RA) self-administered questionnaire aims to identify patients who had flare in the interval between 2 consultations. This study aimed to establish a threshold for FLARE-RA score to identify RA flare.

Methods: The Tocilizumab SubCutAneous (TOSCA) study evaluated the efficacy and safety of subcutaneous Tocilizumab (TCZ) to patients with active RA. Disease activity was assessed with the DAS28ESR at baseline and at week 2 (W2), W4, W12, and W24. The FLARE-RA questionnaire was administered at W12 and W24. Patient satisfaction, assessed at baseline and W24 with the Patient Acceptable Symptom State (PASS), was used as a surrogate marker of no flare. A correlation was sought between the FLARE-RA score at W12 and W24 and the area under the receiver operating characteristic (ROC) curve (AUC) for monthly DAS28ESR. The optimal FLARE-RA cut-off below which patient satisfaction reached the PASS was explored with an ROC curve.

Results: 139 patients were included (mean age 57.3 ± 13.8 years, 74.1% women, mean RA duration 10.8 ± 9.2 years, mean DAS28ESR 5.8 ± 1.1). The correlation between the FLARE-RA score and DAS28ESR AUC was moderate at all times: rho = 0.41 at W12 (p<0.0001) and 0.51 at W24 (p<0.0001). The optimal cut-off for the FLARE-RA score to identify absence of flare (i.e. an acceptable situation based on the PASS) was 2.3 with an AUC of 0.81.

Conclusion: FLARE-RA and DAS28ESR assessment differ; we propose a FLARE-RA cut-off of 2.3, below which the situation (i.e. without flare) is acceptable for patients.
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http://dx.doi.org/10.1093/rheumatology/keab261DOI Listing
March 2021

Endorsement of the domains of knee and hip osteoarthritis (OA) flare: A report from the OMERACT 2020 inaugural virtual consensus vote from the flares in OA working group.

Semin Arthritis Rheum 2021 06 20;51(3):618-622. Epub 2021 Mar 20.

Department of Physical Therapy, The University of British Columbia, Arthritis Research Canada, Canada.

Objective: Towards developing an instrument to measure knee and hip osteoarthritis (KHOA) flare, the Outcome Measures in Rheumatology (OMERACT) Flares in OA Working Group first sought to identify and define relevant domains of flare in KHOA.

Methods: Guided by OMERACT Filter 2.1, candidate domains were identified from data generated in interviews, in English or French, with persons with KHOA and health professionals (HPs) who treat OA. The first and second rounds of an online Delphi process with patients and HPs, including researchers, selected relevant domains. The third round provided agreement on the selected domains and their definitions. At the virtual OMERACT 2020 workshop, the proposed domains and their definitions were discussed in facilitated breakout groups with patients and HPs. Participants then voted, with consensus set at ≥70%.

Results: Qualitative interviews characterizing OA flare were completed with 29 persons with KHOA and 16 HPs. Content was analyzed and grouped into nine clusters. These candidate domains were included in two Delphi rounds, completed by 91 patients and 165 HPs then 50 patients and 116 HPs, per round, respectively. This resulted in selecting five relevant domains. A final Delphi round, completed by 38 patients and 89 HPs, provided agreement on these domains and their definitions. The OMERACT virtual vote included 27 patients and 106 HPs. The domains and their definitions were endorsed with ≥98% agreement. Domains include: Pain, Swelling, Stiffness, Psychological aspects, and Impact of symptoms, all defined "during flare".

Conclusion: Using OMERACT methodology, we have developed five domains of KHOA flare that were highly endorsed by patients and HPs.
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http://dx.doi.org/10.1016/j.semarthrit.2021.03.010DOI Listing
June 2021

Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol.

BMJ Open 2021 03 15;11(3):e040522. Epub 2021 Mar 15.

Interventional Neuroradiology, Fondation Rothschild, Paris, Île-de-France, France.

Introduction: Mechanical thrombectomy (MT) increases functional independence in patients with acute ischaemic stroke with anterior circulation large vessel occlusion (LVO), and the probability to achieve functional independence decreases by 20% for each 1-hour delay to reperfusion. Therefore, we aim to investigate whether direct angiosuite transfer (DAT) is superior to standard imaging/emergency department-based management in achieving 90-day functional independence in patients presenting with an acute severe neurological deficit likely due to LVO and requiring emergent treatment with MT.

Methods And Analysis: DIRECT ANGIO (Effect of DIRECT transfer to ANGIOsuite on functional outcome in patient with severe acute stroke treated with thrombectomy: the randomised DIRECT ANGIO Trial) trial is an investigator-initiated, multicentre, prospective, randomised, open-label, blinded endpoint (PROBE) study. Eligibility requires a patient ≤75 years, pre-stroke modified Rankin Scale (mRS) 0-2, presenting an acute severe neurological deficit and admitted within 5 hours of symptoms onset in an endovascular-capable centre. A total of 208 patients are randomly allocated in a 1:1 ratio to DAT or standard management. The primary outcome is the rate of patients achieving a functional independence, assessed as mRS 0-2 at 90 days. Secondary endpoints include patients presenting confirmed LVO, patients eligible to intravenous thrombolysis alone, patients with intracerebral haemorrhage and stroke-mimics, intrahospital time metrics, early neurological improvement (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0-1 at 24 hours) and mRS overall distribution at 90 days and 12 months. Safety outcomes are death and intracerebral haemorrhage transformation. Medico-economics analyses include health-related quality of life and cost utility assessment.

Ethics And Dissemination: The DIRECT ANGIO trial was approved by the ethics committee of Ile de France 1. Study began in April 2020. Results will be published in an international peer-reviewed medical journal.

Trial Registration Number: NCT03969511.
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http://dx.doi.org/10.1136/bmjopen-2020-040522DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7970280PMC
March 2021

Kidney function monitoring to prevent 5-aminosalicylic acid nephrotoxicity: What the gastroenterologist should know.

Dig Liver Dis 2021 Jun 6;53(6):691-696. Epub 2021 Feb 6.

Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France. Electronic address:

Background: The kidney function monitoring is recommended in routine practice to detect 5-aminosalicylic acid (5-ASA) related nephrotoxicity, although is not standardized. The optimal monitoring is unknown, especially the best timing and which tests to perform. We summarized why, how, and when to perform the monitoring for patients treated with 5-ASA and provided an overview of the current guidelines on this topic.

Method: Relevant studies on this topic were searched in PubMed, Embase, and Web of Science databases from July to August 2020.

Results: Serum creatinine, the estimated glomerular filtration rate, and 24-h proteinuria are the 3 main tests used for the monitoring in daily practice. Regarding the timing, several monitoring strategies have been proposed and guidelines are available too, but they provide conflicting information. To date, there is no medical evidence-based that one strategy is better than another. Comorbidities, chronic renal disease, use of nephrotoxic drugs or concomitant steroid therapy also impact the nephrotoxicity risk. Based on the literature review we proposed a kidney function monitoring strategy to guide physicians in clinical practice.

Conclusion: A baseline assessment should be performed in all patients treated with 5-ASA. The monitoring should be carried out according to the other nephrotoxic factors. A tight monitoring may reduce morbidity and mortality of drug nephrotoxicity.
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http://dx.doi.org/10.1016/j.dld.2021.01.015DOI Listing
June 2021
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