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Objective To evaluate the prevalence of symptoms and factors associated with irritable bowel syndrome (IBS) in axial spondyloarthritis (ax-SpA).Methods In a cross-sectional multicentric study, consecutive patients with ax-SpA treated with biologics in five rheumatology departments were asked for IBS Rome IV criteria. Demographic data, lifestyle behaviours and disease characteristics were recorded. Second, a systematic literature review and meta-analysis were performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Results Of the 500 patients with ax-SpA included, 124 reported IBS symptoms (25%). Female gender, unemployment, higher Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and worse Bath Ankylosing Spondylitis Functional Index scores, multiple lines of biologics, fibromyalgia, anxiety, depression and lower physical activity were associated with IBS symptoms. In multivariate model, the risk of IBS was associated with anxiety and physical inactivity. From the literature review, the prevalence of IBS in patients with SpA was 15.4% (8.8% to 23.3%). Meta-analysis of the five studies comparing the presence of IBS in patients with SpA (323/7292) and healthy controls (484/35587) showed a significant increase of IBS in patients with SpA (OR=1.59 (1.05 to 2.40)).Conclusion The prevalence of IBS symptoms was high in the ax-SpA population and should therefore be considered in the presence of gastrointestinal disorders. The presence of IBS symptoms was associated with anxiety and low physical activity in multivariate analysis. Patients with IBS symptoms tended to have more difficult to manage disease characterised by higher activity, worse functional score and multiple lines of treatment in univariate analysis.

Objectives: To compare two strategies-a hydrocortisone replacement strategy and a prednisone tapering strategy-for their success in glucocorticoid discontinuation in patients with rheumatoid arthritis (RA) with low disease activity (LDA)., Methods: The Strategies for glucocorticoid TApering in Rheumatoid arthritis (STAR) study was a double-blind, double-placebo randomised controlled trial including patients with RA receiving a stable dose of glucocorticoid 5 mg/day for ≥3 months and were in LDA for ≥3 months. Patients were randomly assigned in a 1:1 ratio to either replace prednisone with 20 mg/day of hydrocortisone for 3 months, then reduce to 10 mg/day for 3 months before discontinuation or to taper prednisone by 1 mg/day every month until complete discontinuation, contingent on maintaining LDA. The primary outcome was the percentage of patients achieving glucocorticoid discontinuation at 12 months. Other secondary outcomes were proportion of flares, need for additional glucocorticoid use, disease activity, patient-reported outcomes and the results of adrenocorticotropic hormone (ACTH) stimulation tests., Results: Of the 102 patients randomised in the trial (mean age 62.4 years, 70.6% females), 53 had hydrocortisone replacement and 49 tapered prednisone. At 12 months, 29 patients (55%) in the hydrocortisone replacement group and 23 patients (47%) in the prednisone tapering group achieved glucocorticoid discontinuation (p=0.4). No difference was observed between groups in the secondary outcomes. No cases of acute adrenal insufficiency were observed; however, 17 patients still had an abnormal ACTH stimulation test at 12 months, with no differences between arms., Conclusion: A hydrocortisone replacement strategy was not superior to a prednisone tapering strategy for achieving glucocorticoid discontinuation success in patients with RA in LDA., Trial Registration Number: NCT02997605., Competing Interests: Competing interests: AR-W, CB, MM, VB, MN, ChR, AS, PV-S, RMF, MP, J-EG, MS, PD, SL, LZ, GC, JFB, BJ, YD and AC declare no competing interests. HM declared to have received grants from Celltrion, Healthcare, Lilly, Nordic Pharma, Medac, consulting fees from AbbVie, Accord, CellTrion HealthCare, Johnson & Johnson, UCB, honoraria for presentation from AbbVie, Bristol Myers Squibb, CellTrion HealthCare, Fresenius Kabi, Galapagos, Medac, Nordic Pharma, Novartis, Sanofi, UCB, support for attending meeting from CellTrion HealthCare, Fresenius Kabi, UCB, participated in advisory board for Lilly, Pfizer. CS received grant from Novartis, Roche-Chugai, honoraria for presentations from Novartis, Galapagos, Pfizer, Lilly and support for attending meetings from Lilly, Novartis, Galapagos. JM received grants from Bristol Myers Squib, Fresenius Kabi Novartis, Roche Chugai, Pfizer and Lilly, received honoraria for presentation from AbbVie, Boehringer Ingelheim, Biogen, Lilly, Viatris, Pfizer, Sanofi, from Bristol Myers Squib, Fresenius Kabi, Galapagos, Medac, Novartis, Roche Chugai, support for attending meetings from Bristol Myers Squib, Fresenius Kabi, Lilly, participated in advisory boards for AbbVie, Pfizer, Theramex, Galapagos, Fresenius Kabi and Sanofi. CR received grants from Biogen, Lilly, Nordic Pharma, consulting fees from Novartis, Lilly, AstraZeneca, AbbVie, Pfizer and GSK, received honoraria for presentations from AbbVie, Boehringer Ingelheim, Novartis, Lilly, Galapagos, Pfizer, UCB, support for attending meeting from UCB, Novartis and AstraZeneca. LG received grants from AbbVie, Biogen, Lilly, Novartis, UCB, consulting fees from AbbVie, Amgen, BMS, Celltrion, Janssen, Novartis, Pfizer, UCB, honoraria for presentations from AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB, support for attending meeting from MSD, Novartis, Pfizer, participated in advisory boards for Janssen, Pfizer, UCB., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)

BackgroundChronic pain affects approximately 30% of the general population, severely degrades quality of life (especially in older adults) and professional life (inability or reduction in the ability to work and loss of employment), and leads to billions in additional health care costs. Moreover, available painkillers are old, with limited efficacy and can cause significant adverse effects. Thus, there is a need for innovation in the management of chronic pain. Better characterization of patients could help to identify the predictors of successful treatments, and thus, guide physicians in the initial choice of treatment and in the follow-up of their patients. Nevertheless, current assessments of patients with chronic pain provide only fragmentary data on painful daily experiences. Real-life monitoring of subjective and objective markers of chronic pain using mobile health (mHealth) programs can address this issue. ObjectiveWe hypothesized that regular patient self-monitoring using an mHealth app would lead physicians to obtain deeper understanding and new insight into patients with chronic pain and that, for patients, regular self-monitoring using an mHealth app would play a positive therapeutic role and improve adherence to treatment. We aimed to evaluate the feasibility and acceptability of a new mHealth app called eDOL. MethodsWe conducted an observational study to assess the feasibility and acceptability of the eDOL tool. Patients completed several questionnaires using the tool over a period of 2 weeks and repeated assessments weekly over a period of 3 months. Physicians saw their patients at a follow-up visit that took place at least 3 months after the inclusion visit. A composite criterion of the acceptability and feasibility of the eDOL tool was calculated after the completion of study using satisfaction surveys from both patients and physicians. ResultsData from 105 patients (of 133 who were included) were analyzed. The rate of adherence was 61.9% (65/105) after 3 months. The median acceptability score was 7 (out of 10) for both patients and physicians. There was a high rate of completion of the baseline questionnaires and assessments (mean 89.3%), and a low rate of completion of the follow-up questionnaires and assessments (63.8% (67/105) and 61.9% (65/105) respectively). We were also able to characterize subgroups of patients and determine a profile of those who adhered to eDOL. We obtained 4 clusters that differ from each other in their biopsychosocial characteristics. Cluster 4 corresponds to patients with more disabling chronic pain (daily impact and comorbidities) and vice versa for cluster 1. ConclusionsThis work demonstrates that eDOL is highly feasible and acceptable for both patients with chronic pain and their physicians. It also shows that such a tool can integrate many parameters to ensure the detailed characterization of patients for future research works and pain management. Trial RegistrationClinicalTrial.gov NCT03931694; http://clinicaltrials.gov/ct2/show/NCT03931694

Axial Spondyloarthritis (axSpA) patients with inflamed intestines have higher SpA activity. Diets that modulate microbiota may influence inflammation and SpA activity. Today, data concerning the impact of diet on SpA activity are scarce. SANUT was a single-center, noninterventional, cohort study that assessed dietetic profiles associated with SpA activity in axSpA. Demographic, clinical, SpA-related, quality of life (QoL), fatigue, physical activity, and dietary data were collected. SpA activity was assessed by Ankylosing Spondylitis Disease Activity Score (ASDAS) and by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). We assessed whether high SpA activity was associated with nutriment consumption. Between 12 February 2018 and 12 February 2020, 278 patients participated. High SpA activity, as measured by ASDAS and BASDAI, was significantly associated with higher body mass index and waist circumference, negative HLA-B27, lower QoL, higher fatigue, and higher digestive-symptom scores. Furthermore, high SpA activity, as measured by BASDAI, was associated with female sex, smoking status, patients who were not actively employed, reduced physical activity, and high intake of ultra-transformed foods, while high SpA activity, as measured by ASDAS, was associated with low intake of omega-3 PUFAs and fiber. Therefore, low intakes of omega-3 PUFAs and fiber, and high intake of ultra-transformed foods, are associated with high SpA activity.

BackgroundThe use of eHealth tools (eg, the internet, mobile apps, and connected devices) in the management of chronic diseases and for rheumatoid arthritis is growing. eHealth may improve the overall quality of care provided to patients with chronic diseases. ObjectiveThe primary objective of this study was to describe eHealth use by patients with rheumatoid arthritis in France. The secondary objectives were to identify associations between patient demographics and disease characteristics and the use of eHealth tools, and assess their expectations of eHealth. MethodsIn this cross-sectional, multicenter study, patients with rheumatoid arthritis, according to the 2010 ACR/EULAR classification criteria, were recruited from 5 university hospitals (Bordeaux, Clermont-Ferrand, Limoges, Montpellier, and Toulouse). Patients completed an anonymous self-questionnaire, including demographic data, evaluating their eHealth use (ie, access, support, frequency of use, type of use, and reason for use). The rheumatologist in charge of each patient completed an independent medical questionnaire on disease characteristics, activity of rheumatoid arthritis, and treatments. Data were collected between December 2018 and July 2019. ResultsQuestionnaires were completed by 575 participants, with a mean age of 62 (SD 13) years, 447 (77.7%) of whom were female. Overall, 82.2% (473/575) of the participants had access to eHealth through a computer (402/467, 86.1%), tablet (188/467, 40.2%), or smartphone (221/467, 47.3%). Of these, 36.4% (170/467) of the participants used the internet for health in general, and 28.7% (134/467) used it specifically for rheumatoid arthritis–related reasons. All these 134 patients used eHealth to learn about disease pathology, and 66.4% (89/134) of them used it as a tool to help monitor rheumatoid arthritis. Most patients (87/125, 69.6%) had a paper file, 19.2% (24/125) used a digital tool (spreadsheets, 10/125, 8%; mobile app, 9/125, 7.2%; or website, 5/125, 4%), and 24.8% (31/125) did not use any tools for monitoring. Few patients (16/125, 12.8%) used tools for treatment reminders. About 21.6% (27/125) of the patients using eHealth used a specific app for rheumatoid arthritis. Univariate analysis showed that age, education level, employment status, treatment, comorbidities, membership of a patient association, and patient education program were associated with eHealth use for rheumatoid arthritis. Multivariate analysis showed that membership of a patient association (odds ratio [OR] 5.8, 95% CI 3.0-11.2), use of biologic disease-modifying antirheumatic drugs (OR 0.6, 95% CI 0.4-1.0), and comorbidities (OR 0.7, 95% CI 0.6-0.8) remained associated with eHealth use for rheumatoid arthritis. Recommendation by a doctor (225/330, 68.2%), ease of use (105/330, 31.8%), and data security (69/330, 20.9%) were factors favoring the use of eHealth. ConclusionsTo date, few patients have used eHealth for disease management. The use of a reliable and validated eHealth tool for rheumatoid arthritis could therefore be promoted by rheumatologists and could optimize therapeutic adherence.

For the first time, ruthenium-based assemblies have been used as carriers for photosensitizers in the treatment of rheumatoid arthritis by photodynamic therapy (PDT). These metallacages are totally soluble in physiological media and can transport photosensitizers (PS) in their cavity. After an incubation period, the PS is released in the cytoplasm and irradiation can take place. This strategy allows photosensitizers with low or null solubility in biological media to be evaluated as PDT agents in rheumatoid arthritis. The systems in which 21H,23H-porphine and 29H,31H-phthalocyanine are encapsulated show excellent photocytotoxicity and no toxicity in the dark. On the other hand, systems in which metalated derivatives such as Mg(II)-porphine and Zn(II)-phthalocyanine are used show good photocytotoxicity, but to a lesser extent than the previous two. Furthermore, the presence of Zn(II)-phthalocyanine significantly increases the toxicity of the system. Overall, fifteen different host–guest systems have been evaluated, and based on the results obtained, they show high potential for treating rheumatoid arthritis by PDT.

Background: Immunotherapy using immune checkpoint inhibitors is not devoid of immune-related adverse events (irAEs) including rheumatological conditions., Case Report: We report a rare case of a 47-year-old woman with metastatic melanoma who developed systemic scleroderma after initiating nivolumab. The patient displayed inflammatory arthralgias, morning stiffness, and classical cutaneous manifestations of the disease. Clinical evaluations also revealed carpal tunnel syndrome, cardiac involvement, and dyspnea. RNA-Polymerase III antibodies were positive. Nivolumab, an anti-PD-1 antibody, was considered as a potential trigger for this condition., Conclusion: To our knowledge, this is the first case of nivolumab-induced systemic scleroderma in the context of melanoma described in the literature that fulfills the classification criteria of the disease. This case underscores the need for increased awareness of immune-related adverse events in patients receiving immune checkpoint inhibitors, emphasizing timely intervention and further research., (Copyright © 2024, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Introduction: The second cycle of medical studies is a key time for developing interpersonal skills and the doctor-patient relationship. High-fidelity simulation is an initial learning option that enables learners to confront situations involving empathy., Methods: This is a feedback report from May 2023 on the implementation of simulation as a training tool for 2nd cycle medical students in the announcement consultation. The training consists of two parts: theoretical teaching via a digital platform with an assessment of theoretical knowledge and a practical part with a simulation session with an actress playing a standardized patient. The acquisition of skills and the reflexivity of learners are assessed by means of a pre- and post-test., Results: Twenty-nine externs took part in this project. Student satisfaction was 96 %. The feedback was very positive, both in terms of the quality of the sessions and the briefings/debriefings. Almost all the students wanted to repeat the experience. The simulation exercise was beneficial for the students in terms of the development (before vs. after) of their skills (verbal, emotional and relational) (1.05±0.25 vs. 1.22±0.19, P=0.047) and appeared to be relevant to the development of reflexivity (3.29±0.72 vs. 3.48±0.9, P=0.134)., Conclusion: This first published French study demonstrates the feasibility and value of training in announcing a diagnosis, combining teaching via a digital platform and high-fidelity simulation for second cycle medical students., (Copyright © 2023 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Objective: To evaluate the prevalence of symptoms and factors associated with irritable bowel syndrome (IBS) in axial spondyloarthritis (ax-SpA)., Methods: In a cross-sectional multicentric study, consecutive patients with ax-SpA treated with biologics in five rheumatology departments were asked for IBS Rome IV criteria. Demographic data, lifestyle behaviours and disease characteristics were recorded. Second, a systematic literature review and meta-analysis were performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines., Results: Of the 500 patients with ax-SpA included, 124 reported IBS symptoms (25%). Female gender, unemployment, higher Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and worse Bath Ankylosing Spondylitis Functional Index scores, multiple lines of biologics, fibromyalgia, anxiety, depression and lower physical activity were associated with IBS symptoms. In multivariate model, the risk of IBS was associated with anxiety and physical inactivity. From the literature review, the prevalence of IBS in patients with SpA was 15.4% (8.8% to 23.3%). Meta-analysis of the five studies comparing the presence of IBS in patients with SpA (323/7292) and healthy controls (484/35587) showed a significant increase of IBS in patients with SpA (OR=1.59 (1.05 to 2.40))., Conclusion: The prevalence of IBS symptoms was high in the ax-SpA population and should therefore be considered in the presence of gastrointestinal disorders. The presence of IBS symptoms was associated with anxiety and low physical activity in multivariate analysis. Patients with IBS symptoms tended to have more difficult to manage disease characterised by higher activity, worse functional score and multiple lines of treatment in univariate analysis., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Axial Spondyloarthritis (axSpA) patients with inflamed intestines have higher SpA activity. Diets that modulate microbiota may influence inflammation and SpA activity. Today, data concerning the impact of diet on SpA activity are scarce. SANUT was a single-center, noninterventional, cohort study that assessed dietetic profiles associated with SpA activity in axSpA. Demographic, clinical, SpA-related, quality of life (QoL), fatigue, physical activity, and dietary data were collected. SpA activity was assessed by Ankylosing Spondylitis Disease Activity Score (ASDAS) and by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). We assessed whether high SpA activity was associated with nutriment consumption. Between 12 February 2018 and 12 February 2020, 278 patients participated. High SpA activity, as measured by ASDAS and BASDAI, was significantly associated with higher body mass index and waist circumference, negative HLA-B27, lower QoL, higher fatigue, and higher digestive-symptom scores. Furthermore, high SpA activity, as measured by BASDAI, was associated with female sex, smoking status, patients who were not actively employed, reduced physical activity, and high intake of ultra-transformed foods, while high SpA activity, as measured by ASDAS, was associated with low intake of omega-3 PUFAs and fiber. Therefore, low intakes of omega-3 PUFAs and fiber, and high intake of ultra-transformed foods, are associated with high SpA activity.

Ruthenium-based assemblies containing tetrapyridylporphyrins (TPyP) in their structure have been evaluated as photosensitizers (PS) to treat rheumatoid arthritis (RA) by photodynamic therapy (PDT). TPyP is useless by itself as a PS due to its low solubility in biological media, however, incorporated in metallacages it can be internalized in cells. The study shows a cellular antiproliferative activity in fibroblast-like synoviocyte (FLS) in the lower nanomolar range in the presence of light, and no dark toxicity at 1 μM concentration, thus having an excellent photoactivity index. The presence of diamagnetic (Zn 2+ ) and paramagnetic (Co 2+ ) metals in the center of TPyP impairs the effectiveness of PDT, showing no (Co) or reduced (Zn) photoactivity. A total of five metallacages with different structural characteristics have been evaluated, and our results suggest that the incorporation of PS in metalla-assemblies is not only an elegant method to increase solubility in biological media for TPyP but also appears to be an efficient hybrid system to treat RA by PDT.

Background: Fibromyalgia is a chronic painful condition without real, effective treatment. The administration of repetitive transcranial magnetic stimulation (rTMS) has been shown to have a therapeutic effect on pain, but there are still questions about the maintenance of its effect over time. Continuation of the treatment upon clinical response through maintenance sessions is promising and merits further exploration., Materials and Methods: We conducted a randomized, parallel-group, controlled study involving 78 patients to evaluate the effect of rTMS vs sham stimulation after a three-week induction treatment and six months of maintenance treatment (three-week periodicity) on 22 patients who presented a clinical response to the induction treatment. The clinical response was defined as a ≥30% decrease of the baseline visual analog scale (VAS) for pain and a score for the Patient Global Impression of Change (PGIC) >5. The clinic global impression, fibromyalgia impact questionnaire, symptom severity score, and Beck's depression inventory were also studied., Results: A significant clinical response to treatment with rTMS was observed after the induction phase and maintained over six months, particularly as measured by the PGIC parameter of pain, as well as of the intensity of fatigue and depression, with an absence of adverse effects induced by this method., Conclusion: A three-week rTMS treatment, characterized by a reduction in pain, as evaluated by VAS, should be continued with the administration of rTMS maintenance sessions for an additional six months to maintain the best possible long-term effects., (Copyright © 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Background: There is no recommendation in Europe for the use of ketamine in patients with chronic pain. The heterogeneity of practice highlights the need to seek the advice of experts in order to establish a national consensus. This Delphi survey aimed to reach a national consensus on the use of ketamine in chronic pain in Pain clinics., Methods: A collaborative four-round internet-based questionnaire was used. It was created after literature search on ketamine administration in chronic pain and included about 96 items. It discussed utility and advantages, adverse events and deleterious aspects, methods of administration, concomitant treatments and assessment of results., Results: Twenty-eight experts completed all rounds of the survey with a total of 81.3% items reaching a consensual answer. Neuropathic pain represents the first indication to use ketamine, followed, with a good to moderate utility, by other situations (fibromyalgia, complex regional pain syndrome, central neuropathic pain, peripheral neuropathic pain, nociceptive pain, sensitization, opioid withdrawal, palliative care, depression). Experts agreed on the rare occurrence of adverse events. Concerning routes of administration, intravenous infusion with doses of 0.5-0.9 mg/kg/d for 4 days of treatment is preferred. Place of care is hospital, as in- or out-patient, with a quarterly administration of ketamine. Finally, ketamine effectiveness is assessed 1 month after infusion, and experts encourage combination with non-pharmacological treatment., Conclusions: This Delphi survey established a consensus of pain specialists on the use of ketamine in refractory chronic pain, thus providing a basis for future comparative trials., Significance: This Delphi survey in chronic pain reached agreement on four main aspects: (1) Priority to treat neuropathic pain with evaluation of effectiveness at 1 month; (2) No deleterious effects in the majority of listed diseases/situations with the absence or <3% of suggested adverse events; (3) 0.5-0.9 mg/kg/d IV infusion; (4) Combination with non-pharmacological treatment., (© 2022 European Pain Federation - EFIC®.)

Background: Chronic pain affects approximately 30% of the general population, severely degrades quality of life (especially in older adults) and professional life (inability or reduction in the ability to work and loss of employment), and leads to billions in additional health care costs. Moreover, available painkillers are old, with limited efficacy and can cause significant adverse effects. Thus, there is a need for innovation in the management of chronic pain. Better characterization of patients could help to identify the predictors of successful treatments, and thus, guide physicians in the initial choice of treatment and in the follow-up of their patients. Nevertheless, current assessments of patients with chronic pain provide only fragmentary data on painful daily experiences. Real-life monitoring of subjective and objective markers of chronic pain using mobile health (mHealth) programs can address this issue., Objective: We hypothesized that regular patient self-monitoring using an mHealth app would lead physicians to obtain deeper understanding and new insight into patients with chronic pain and that, for patients, regular self-monitoring using an mHealth app would play a positive therapeutic role and improve adherence to treatment. We aimed to evaluate the feasibility and acceptability of a new mHealth app called eDOL., Methods: We conducted an observational study to assess the feasibility and acceptability of the eDOL tool. Patients completed several questionnaires using the tool over a period of 2 weeks and repeated assessments weekly over a period of 3 months. Physicians saw their patients at a follow-up visit that took place at least 3 months after the inclusion visit. A composite criterion of the acceptability and feasibility of the eDOL tool was calculated after the completion of study using satisfaction surveys from both patients and physicians., Results: Data from 105 patients (of 133 who were included) were analyzed. The rate of adherence was 61.9% (65/105) after 3 months. The median acceptability score was 7 (out of 10) for both patients and physicians. There was a high rate of completion of the baseline questionnaires and assessments (mean 89.3%), and a low rate of completion of the follow-up questionnaires and assessments (63.8% (67/105) and 61.9% (65/105) respectively). We were also able to characterize subgroups of patients and determine a profile of those who adhered to eDOL. We obtained 4 clusters that differ from each other in their biopsychosocial characteristics. Cluster 4 corresponds to patients with more disabling chronic pain (daily impact and comorbidities) and vice versa for cluster 1., Conclusions: This work demonstrates that eDOL is highly feasible and acceptable for both patients with chronic pain and their physicians. It also shows that such a tool can integrate many parameters to ensure the detailed characterization of patients for future research works and pain management., Trial Registration: ClinicalTrial.gov NCT03931694; http://clinicaltrials.gov/ct2/show/NCT03931694., (©Nicolas Kerckhove, Noémie Delage, Sébastien Cambier, Nathalie Cantagrel, Eric Serra, Fabienne Marcaillou, Caroline Maindet, Pascale Picard, Gaelle Martiné, Rodrigue Deleens, Anne-Priscille Trouvin, Lauriane Fourel, Gaelle Espagne-Dubreuilh, Ludovic Douay, Stéphane Foulon, Bénédicte Dufraisse, Christian Gov, Eric Viel, François Jedryka, Sophie Pouplin, Cécile Lestrade, Emmanuel Combe, Serge Perrot, Dominique Perocheau, Valentine De Brisson, Pascale Vergne-Salle, Patrick Mertens, Bruno Pereira, Abdoul Jalil Djiberou Mahamadou, Violaine Antoine, Alice Corteval, Alain Eschalier, Christian Dualé, Nadine Attal, Nicolas Authier. Originally published in JMIR Formative Research (https://formative.jmir.org), 02.03.2022.)