Development and Validation of a Self-Administered Questionnaire Measuring Essential Knowledge in Patients With Axial Spondyloarthritis.

OBJECTIVE: To develop and validate a patient knowledge questionnaire regarding axial spondyloarthritis (axSpA). METHODS: Knowledge considered essential for patients with axSpA was identified through Delphi rounds among rheumatologists, healthcare professionals (HCPs), and patients, then reformulated to develop the knowledge questionnaire. Cross-sectional validation was performed in 14 rheumatology departments to assess internal validity (Kuder-Richardson coefficient), external validity, acceptability, reproducibility (Lin concordance correlation coefficient), and sensitivity to change (knowledge score before vs after patient education sessions and effect size). RESULTS: The Spondyloarthritis Knowledge Questionnaire (SPAKE) is a self-administered 42-item questionnaire with a 32-item short form, both scored 0 to 100, assessing knowledge of disease, comorbidities, pharmacological treatments, nonpharmacological treatments, self-care, and adaptive skills. In the validation study (130 patients; 67 [51.5%] male, mean age 43.5 [SD 12.9] yrs), the mean (SD) score of the long-form questionnaire was 71.6 (15.4), with higher scores (better knowledge) in nonpharmacological treatments and adaptive skills and lower scores in cardiovascular comorbidity and pharmacological treatments. Acceptability was good, with no missing data; the internal validity coefficient was 0.85. Reproducibility was good (0.81, 95% CI 0.72-0.89). SPAKE showed good sensitivity to change; scores were 69.2 (15.3) then 82.7 (14.0) after patient education sessions (Hedges effect size = 0.92, 95% CI 0.52-1.31). CONCLUSION: SPAKE is a knowledge questionnaire for patients with axSpA, developed with the involvement of HCPs and patients and reflecting current recommendations for the management of axSpA. SPAKE will be useful in assessing knowledge acquisition and self-management strategies in routine care and research.

Development and real-life use assessment of a self-management smartphone application for patients with inflammatory arthritis. A user-centred step-by-step approach.

BACKGROUND: Mobile health applications (apps) are increasing in interest to enhance patient self-management. Few apps are actually used by patients and have been developed for patients with inflammatory arthritis (IA) treated with disease-modifying anti-rheumatic drugs which use entails risk of adverse effects such as infections. OBJECTIVE: To develop Hiboot, a self-management mobile app for patients with IA, by using a user-centred step-by-step approach and assess its real-life use. METHODS: The app development included first a qualitative study with semi-guided audiotaped interviews of 21 patients to identify the impact of IA on daily life and patient treatments practices and an online cross-sectional survey of 344 patients to assess their health apps use in general and potential user needs. A multidisciplinary team developed the first version of the app via five face-to-face meetings. After app launch, a second qualitative study of 21 patients and a users' test of 13 patients and 3 rheumatologists led to the app's current version. The number of app installations, current users and comments were collected from the Google Play store and the Apple store. RESULTS: The qualitative study revealed needs for counselling, patient-health professional partnership, and skills to cope with risk situations; 86.8% participants would be ready to use an app primarily on their rheumatologist's recommendation. Six functionalities were implemented: a safety checklist before treatment administration, aids in daily life situations based on the French academic recommendations, treatment reminders, global well-being self-assessment, periodic counselling messages, and a diary. The Hiboot app was installed 20,500 times from September 2017 to October 2020, with 4300 regular current users. Scores were 4.4/5 stars at Android and iOS stores. CONCLUSION: Hiboot is a free self-management app for patients with IA developed by a step-by-step process including patients and health professionals. Further evaluation of the Hiboot benefit is needed.

The use of non-steroidal anti-inflammatory drugs (NSAIDs) in COVID-19.

Early in the COVID-19 pandemic, anecdotal reports emerged suggesting non-steroidal anti-inflammatory drugs (NSAIDs) may increase susceptibility to infection and adversely impact clinical outcomes. This narrative literature review (March 2020-July 2021) attempted to clarify the relationship between NSAID use and COVID-19 outcomes related to disease susceptibility or severity. Twenty-four relevant publications (covering 25 studies) reporting original research data were identified; all were observational cohort studies, and eight were described as retrospective. Overall, these studies are consistent in showing that NSAIDs neither increase the likelihood of SARS-CoV-2 infection nor worsen outcomes in patients with COVID-19. This is reflected in current recommendations from major public health authorities across the world, which support NSAID use for analgesic or antipyretic treatment during COVID-19. Thus, there is no basis on which to restrict or prohibit use of these drugs by consumers or patients to manage their health conditions and symptoms during the pandemic.

Barriers and Expectations for Patients in Post-Osteoporotic Fracture Care in France: The EFFEL Study.

OBJECTIVES: This study aimed to quantify the relative importance of barriers to better secondary prevention of osteoporotic fractures and of care expectations expressed by patients with osteoporotic fractures in France. METHODS: A qualitative exploration of potential barriers to care and expectations was undertaken through a systematic literature review and in-depth patients interviews. A list of 21 barriers and 21 expectations was identified. These were presented to 324 subjects with osteoporotic fractures, identified in a representative sample of the French population, in the form of best-worst scaling questionnaires. Patients rated the relative importance of the attributes, and arithmetic mean importance scores were calculated and ranked. A Bayesian hierarchical model was also performed to generate a relative importance score. Latent class analysis was performed to identify potential subgroups of patients with different response profiles. RESULTS: A total of 7 barriers were rated as the most important, relating to awareness of osteoporosis and coordination of care. The highest-ranked barrier, "my fracture is not related to osteoporosis," was significantly more important than all the others (mean importance score 0.45; 95% confidence interval 0.33-0.56). A similar ranking of attributes was obtained with both the arithmetic and the Bayesian approach. For expectations, no clear hierarchy of attributes was identified. Latent class analysis discriminated 3 classes of respondents with significant differences in response profiles (the educated environmentalists, the unaware, and the victims of the system). CONCLUSIONS: Better quality of care of osteoporosis and effective secondary fracture prevention will require improvements in patient education, training of healthcare professionals, and coordination of care.

Development and validation of a self-administered questionnaire measuring essential knowledge in patients with rheumatoid arthritis.

To develop and validate a questionnaire assessing patient knowledge in rheumatoid arthritis (RA). Knowledge considered essential for patients with RA was identified through a series of Delphi rounds among rheumatologists, health professionals (HPs), patients, and then reformulated to construct the knowledge questionnaire. Cross-sectional multicenter validation was performed in 12 rheumatology departments to assess internal validity (Kuder-Richardson coefficient), external validity, acceptability, reproducibility (Lin's concordance correlation coefficient) and sensitivity to change (difference in total score before and after patient education sessions). Associations between patient variables and knowledge levels were evaluated. RAKE (RA Knowledge questionnairE) is a self-administered 45-item questionnaire scored 0-100, with a 32-item short-form survey assessing knowledge of disease, comorbidity, pharmacological treatments, non-pharmacological treatments, self-care and adaptative skills. Of 130 patients included in the validation study, 108 were women. Acceptability was good with < 5% missing data. Internal validity coefficient was 0.90. Mean (standard deviation) long-form score was 72.8 ± 17.8, with lower scores in comorbidity and self-care and higher scores in adaptive skills. Reproducibility was good (0.86 [0.80; 0.92]). RAKE score was positively correlated with the patients' level of education and the HPs' opinion on the patients' knowledge. RAKE score showed good sensitivity to change: 66.8 ± 16.4 then 83.8 ± 12.7, representing a hedges effect size of 1.14 [95% CI 0.73; 1.55]. RAKE is an updated questionnaire assessing essential knowledge for patients with RA to enhance self-management according to current guidelines and the patients' perspective. RAKE can usefully inform patient education interventions, routine care and research.

Assessment of impact of the COVID-19 pandemic from the perspective of patients with rheumatic and musculoskeletal diseases in Europe: results from the REUMAVID study (phase 1).

AIM: To assess the impact of the COVID-19 pandemic on patients with rheumatic and musculoskeletal diseases (RMDs). METHODS: REUMAVID is a cross-sectional study using an online survey developed by an international multidisciplinary patient-led collaboration across seven European countries targeting unselected patients with RMDs. Healthcare access, daily activities, disease activity and function, well-being (WHO Five Well-Being Index (WHO-5)), health status, anxiety/depression (Hospital Anxiety and Depression Scale (HADS)) and access to information were evaluated. Data were collected in April-July 2020 (first phase). RESULTS: Data from the first phase included 1800 patients with 15 different RMDs (37.2% axial spondyloarthritis, 29.2% rheumatoid arthritis, 17.2% osteoarthritis and others). Mean age was 53, 80% female and 49% had undertaken university studies. During the beginning of the pandemic, 58.4% had their rheumatology appointment cancelled and 45.6% reported not having received any information relating to the possible impact of SARS-CoV-2 infection in their RMDs, with the main source being patient organisations (27.6%).Regarding habits, 24.6% increased smoking, 18.2% raised their alcohol consumption, and 45.6% were unable to continue exercising. Self-reported disease activity was high (5.3±2.7) and 75.6% reported elevated pain. Half the patients (49.0%) reported poor well-being (WHO-5) and 46.6% that their health had changed for the worse during lockdown. According to HADS, 57.3% were at risk of anxiety and 45.9% of depression. CONCLUSION: Throughout the first wave of the COVID-19 pandemic, patients with RMDs have experienced disruption in access to healthcare services, poor lifestyle habits and negative effects on their overall health, well-being and mental health. Furthermore, information on COVID-19 has not reached patients appropriately.

Recommendations of the French Society of Rheumatology on pharmacological treatment of knee osteoarthritis.

OBJECTIVES: To establish recommendations for pharmacological treatment of knee osteoarthritis specific to France. METHODS: On behalf of the French Society of Rheumatology (SFR), a bibliography group analyzed the literature on the efficacy and safety of each pharmacological treatment for knee osteoarthritis. This group joined a multidisciplinary working group to draw up recommendations. Strength of recommendation and quality of evidence level were assigned to each recommendation. A review committee gave its level of agreement. RESULTS: Five general principles were established: 1) need to combine pharmacological and non-pharmacological treatments, 2) personalization of treatment, 3) symptomatic and/or functional aim of pharmacological treatments, 4) need to regularly re-assess the treatments and 5) discussion about arthroplasty if medical treatment fails. Six recommendations involved oral treatments: 1) paracetamol should not necessarily be prescribed systematically and/or continuously, 2) NSAIDs, possibly as first-line, 3) weak opioids, 4) strong opioids, 5) symptomatic slow-acting drugs of osteoarthritis, and 6) duloxetine (off-label use). Two recommendations involved topical agents (NSAIDs and capsaicin<1%). Three recommendations involved intra-articular treatments: corticosteroid or hyaluronic acid injections that can be proposed to patients. The experts did not draw a conclusion about the benefits of platelet-rich plasma injections. CONCLUSION: These are the first recommendations of the SFR on the pharmacological treatment of knee osteoarthritis.

Part of pain labelled neuropathic in rheumatic disease might be rather nociplastic.

Pain in rheumatic diseases is primarily due to mechanical or inflammatory mechanism, but neuropathic pain (NP) component is also occurring in many conditions and is probably underdiagnosed. The purpose of this article is to provide an overview of prevalence, pathophysiological and currently available treatment of NP in rheumatic diseases. When associated with clinical evaluation assessing neurological clinical signs and neuroanatomical distribution, Douleur Neuropathique 4 Questions, painDETECT, Leeds assessment of neuropathic symptoms and signs and Neuropathic Pain Questionnaire can detect NP component. Inflammatory or connective diseases, osteoarthritis, back pain or persistent pain after surgery are aetiologies that all may have a neuropathic component. Unlike nociceptive pain, NP does not respond to usual analgesics such as paracetamol and non-steroidal anti-inflammatory drugs. Entrapment neuropathy, peripheral neuropathy or small-fibre neuropathy are different aetiologies that can lead to NP. A part of the pain labelled neuropathic is rather nociplastic, secondary to a central sensitisation mechanism. Identifying the right component of pain (nociceptive vs neuropathic or nociplastic) could help to better manage pain in rheumatic diseases with pharmacological and non-pharmacological treatments.

Real-world care for individuals aged over fifty with fractures in France: Evidence for a wide care gap-The EPIFRACT Study.

OBJECTIVES: To describe the care trajectories of adults aged ≥50 years with fragility fractures in France. METHODS: A postal questionnaire was sent to 15,000 individuals aged ≥50 years extracted from a representative panel of the French population (METASKOPE) in April-May 2018. Respondents experiencing a single fragility fracture in the previous three years constituted the study population. Information was collected regarding diagnosis, hospitalisations, physician visits and treatment related to the fractures. RESULTS: 13,914 participants returned a questionnaire (92.8%), of whom 436 reported a single fragility fracture. Their mean age was 68.7±10.3 years. 11.9% of this sample had undergone bone densitometry (DXA) prior to the fracture and 11.9% had received a diagnostic of osteoporosis. Following the fracture, a further 17.4% underwent DXA and 8.5% were diagnosed with osteoporosis. 74.3% of fractures were initially managed in an emergency department and 29.6% led to immediate hospitalisation. Prior to fracture, 3.4% received a specific anti-osteoporotic treatment, 10.1% vitamin D and 6.4% calcium supplementation. After the fracture, these figures rose to 10.8%, 26.8% and 19.0% respectively. 86.2% participants made at least one follow-up visit to a physician. CONCLUSIONS: The rate of DXA screening following fragility fractures in subjects over fifty is very low. Most patients with fragility fractures did not receive a diagnosis of osteoporosis. The proportion of patients treated with a specific anti-osteoporotic treatment after a fracture is low even though around half consulted their general practitioner after the fracture. Practice guidelines are thus not being adhered to in everyday clinical practice in France.

Fragility fractures in France: epidemiology, characteristics and quality of life (the EPIFRACT study).

Between 1 and 2% of people aged 50 years and over living at home in France are likely to experience a fragility fracture each year. Three-quarters of these individuals are not diagnosed with osteoporosis and lose the opportunity for appropriate care. PURPOSE: To estimate the incidence of fragility fractures in France and to describe the characteristics of individuals with such fractures and of their fractures. METHODS: In April-May 2018, a postal survey was performed in France targeting a representative panel of 15,000 individuals aged ≥ 50 years, who were invited to complete a questionnaire. If they reported experiencing a fracture in the previous 3 years, they were asked to provide information on demographics, fracture type, risk factors for fractures and osteoporosis diagnosis. Only fragility fractures were considered, and these were classified as major (associated with increased mortality) or minor, based on the fracture site. RESULTS: Around 13,914 panellists returned an exploitable questionnaire (92.8%). About 425 participants reported ≥ 1 fragility fracture (453 fractures), corresponding to a 12-month incidence rate of 1.4% [95%CI: 1.2, 1.6]. Incidence was higher in women (1.99% [1.87, 2.05]) than in men (0.69% [0.38, 0.86]) and increased with age. Around 157 fractures (34.6%) were classified as major. Participants reporting major fractures were older than those reporting minor fractures (mean age: 72.6 ± 11.3 vs 67.1 ± 10.6) and more likely to report previous corticosteroid use (odds ratio: 1.90 [95%CI: 1.13, 3.18]). No other patient characteristic was associated with fracture severity. About 117 participants with fractures (27.5%) had undergone bone densitometry, and 97 (22.8%) declared having received a diagnosis of osteoporosis. CONCLUSIONS: Around 340,000 people aged ≥ 50 years living at home in France are estimated to experience osteoporotic fractures each year. However, > 75% of panellists reporting fractures were never diagnosed with osteoporosis and thus did not have the opportunity to receive appropriate care.

Gait as predictor of physical function in axial spondyloarthritis: the prospective longitudinal FOLOMI (Function, Locomotion, Measurement, Inflammation) study protocol.

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease affecting predominantly sacroiliac joints and axial skeleton. axSpA progression being irregular and hardly predictable, identifying functional decline is particularly important in patient with axSpA to allow delivery of timely and targeted interventions. Pain, reduced range of motion or altered posture can have adverse consequences on gait. Although gait has previously been used as a sensitive measure of physical outcomes in elderly and pathological populations, to the best of our knowledge, no study has used gait as a predictor of physical function in patients with axSpA. The objective of our study is hence to determine if gait parameters measured in patients with axSpA could predict the evaluation at 18 months of physical function as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI). This is a prospective and longitudinal study. Sixty patients with axSpA and 30 healthy age- and sex-matched controls will be included. Patients should be aged 18-65 years at time of their first evaluation, followed at Grenoble Alpes University Hospital for axSpA or ankylosing spondylitis, able to walk 180 m without technical help and with stable treatment for at least 12 months. Clinical characteristics, BASFI, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), clinical and laboratory measurements of gait will be assessed during four visits (at baseline and at months 6, 12, and 18). Similar assessments will be performed once for the healthy control group. A linear mixed model at 6, 12 and 18 months will be constructed to answer to the first objective, with the BASFI as dependent variable and gait parameters as explanatory variables. The data collection started in August 2018 and will be completed with the inclusion and follow-up of all the participants. We believe that the combination of clinical and laboratory measurements of gait in patients with axSpA could strengthen the capacity to monitor disease's evolution and to predict changes in patients' physical function. Results of the present study could ultimately allow delivering targeted, timely, personalized interventions and treatment in patients with axSpA.Trial registration: The study was approved by local ethic committee (CPP Ile De France 1, RCB: 2017-A03468-45, date of agreement: July 17th, last version: V4.0, 2018, March 5th, 2019) and is retrospectively registered in Clinical trials (NCT03761212).

Essential knowledge for patients with rheumatoid arthritis or spondyloarthritis: Results of a multicentric survey in France among health professionals and patients.

OBJECTIVE: Information and education are recommended for patients with inflammatory arthritis including rheumatoid arthritis (RA) and spondyloarthritis (SpA). However, there is no consensus on which knowledge is essential to enhance patients' self-management. The aim of this study was to determine such knowledge. METHODS: Based on published knowledge questionnaires (KQs) collected by a systematic literature review, a list of items was elaborated, classified in domains and sub domains. A Delphi process was performed with rheumatologists, healthcare professionals and patients in 2014-2015, selecting the items considered useful. RESULTS: Three published KQs were analysed: 2 for RA; 1 for SpA and 5 unpublished KQs were collected. In the KQs, 90 knowledge items were mentioned for RA and 67 for SpA. The 1st Delphi round enlarged the list to 322 items for RA and 265 items for SpA. The second round selected 69 and 59 knowledge items for RA and SpA respectively, of which 36 (52%) and 34 (57%) were not present or modified from the published KQs. Key domains included treatment strategies, managing cDMARDs and bDMARDs, managing symptomatic medications. Knowledge on non-pharmacological treatment concerned pain and fatigue, physical activity, adaptative skills to personal and professional environment, patient-HP communication and shared decision-making. CONCLUSION: The present study provides a corpus of knowledge considered essential for patients in the self-management of their arthritis. The selection of many items reflects recent emphasis on professional recommendations and the patients' perspective. Future work should lead to the development of new updated KQs for patients with inflammatory arthritis.

Assessment of the adherence to disease-modifying drugs in patients with chronic inflammatory rheumatic diseases: Results of a survey of 1594 patients.

OBJECTIVES: a) to describe the self-reported adherence to disease modifying drugs (DMARDs) (methotrexate and biological DMARDs) among patients with chronic inflammatory rheumatic diseases (CIRDs); b) to assess factors associated with non-adherence. METHODS: An observational, cross-sectional, nationwide study was conducted through the use of an electronic survey, which was released via patient organizations in France to rheumatic patients. The main outcome was the rate of non-adherence to DMARDs, which was evaluated with the following question "Have you ever tried to stop or space out your treatment in contrast to what was planned with your doctor?" A positive answer was considered "low adherent". Sociodemographic variables, type of CIRD and treatment information were also collected. Factors associated with low adherence to methotrexate and bDMARDs were explored by univariate and multivariate logistic regressions. RESULTS: Among the 1594 participants who completed the survey, 795 (49.9%) were receiving methotrexate and 709 (44.5%) bDMARDs. A total of 159 (20.0%) were identified as low adherents to methotrexate, and being a woman was independently associated with low adherence (OR 1.90 [95% CI 1.07 - 3.36)] to this drug. Regarding bDMARDs, 177 (25.0%) were identified as low adherent, and the factors independently associated with low adherence were being employed (OR 1.47 [95% CI 1.04 - 2.09]) and no concomitant use of methotrexate (OR 0.51 [95% CI 0.36 - 0.73]). CONCLUSIONS: This study suggests that more than 20% of CIRDs patients are low adherent to their DMARDs, and this is more frequent when bDMARDs are administered as a monotherapy.

Prealbumin, platelet factor 4 and S100A12 combination at baseline predicts good response to TNF alpha inhibitors in rheumatoid arthritis.

OBJECTIVES: Tumour necrosis factor-alpha inhibitors (TNFi) are effective treatments for Rheumatoid Arthritis (RA). Responses to treatment are barely predictable. As these treatments are costly and may induce a number of side effects, we aimed at identifying a panel of protein biomarkers that could be used to predict clinical response to TNFi for RA patients. METHODS: Baseline blood levels of C-reactive protein, platelet factor 4, apolipoprotein A1, prealbumin, α1-antitrypsin, haptoglobin, S100A8/A9 and S100A12 proteins in bDMARD naive patients at the time of TNFi treatment initiation were assessed in a multicentric prospective French cohort. Patients fulfilling good EULAR response at 6 months were considered as responders. Logistic regression was used to determine best biomarker set that could predict good clinical response to TNFi. RESULTS: A combination of biomarkers (prealbumin, platelet factor 4 and S100A12) was identified and could predict response to TNFi in RA with sensitivity of 78%, specificity of 77%, positive predictive values (PPV) of 72%, negative predictive values (NPV) of 82%, positive likelihood ratio (LR+) of 3.35 and negative likelihood ratio (LR-) of 0.28. Lower levels of prealbumin and S100A12 and higher level of platelet factor 4 than the determined cutoff at baseline in RA patients are good predictors for response to TNFi treatment globally as well as to Infliximab, Etanercept and Adalimumab individually. CONCLUSION: A multivariate model combining 3 biomarkers (prealbumin, platelet factor 4 and S100A12) accurately predicted response of RA patients to TNFi and has potential in a daily practice personalized treatment.