Patient acceptable symptom state for patient-reported outcomes in people with non-specific chronic low back pain.

BACKGROUND: The patient acceptable symptom state (PASS) is a treatment-response criterion developed to determine the clinical relevance of a treatment effect. Its estimates for some patient-reported outcomes (PROs) in non-specific chronic low back pain (cLBP) are lacking and the stability of PRO estimates between independent cLBP populations is unknown. We hypothesized that these PRO estimates will be stable. OBJECTIVES: To estimate and compare the PASS for PROs between 2 independent cLBP populations. METHODS: We conducted a secondary analysis of a randomized controlled trial (PREDID) and a cohort of outpatients with non-specific cLBP. Using an anchoring question, participants who self-rated their health as "excellent", "very good" or "good" at 1 month were considered to have an acceptable symptom state. PASS estimates for 5 PROs were calculated by using the 75th percentile method. Estimates were compared between the 2 populations with bootstrap resampling. RESULTS: A total of 256 participants with non-specific cLBP were included: 135 patients with cLBP and active discopathy from the PREDID trial and 121 outpatients with cLBP without active discopathy followed up in an independent cohort. Overall, 137/256 (54%) participants had an acceptable symptom state at 1 month. PASS estimates were 47.5 (95% confidence interval [CI] 40.0 to 50.0)/100 for lumbar pain (0, no pain and 100, maximal pain), 30.5 (30.0 to 40.0)/100 for radicular pain, 39.3 (33.6 to 45.3)/100 for Quebec Back Pain Disability score (0, no disability and 100, maximal disability), 10.0 (9.2 to 10.0)/21 for the Hospital Anxiety Depression anxiety subscale (0, no anxiety, and 21, maximal anxiety) and 6.7 (6.0 to 8.0)/21 for the depression subscale (0, no depression, and 21, maximal depression). PASS estimates did not differ between the 2 populations. CONCLUSIONS: Our study provides PASS estimates for 5 PROs commonly used in cLBP. Our estimates were stable between 2 independent populations of people with cLBP. The stability of our PASS estimates suggests that they are relevant for interpreting PRO values in clinical trials and practice. ClinicalTrials.gov no. (PREDID trial) NCT00804531.

Intra-articular botulinum toxin A injection for painful base-of-thumb osteoarthritis: a double-blind, randomised, controlled, phase 3 trial (RHIBOT).

BACKGROUND: Intra-articular botulinum toxin A injection might have analgesic effects in patients with joint diseases. We aimed to compare the effects of intra-articular botulinum toxin A injection with those of intra-articular saline injection for patients with painful base-of-thumb osteoarthritis. METHODS: RHIBOT was a double-blind, randomised, controlled, phase 3 trial conducted at Cochin Hospital, Paris, France. We recruited adult patients with x-ray evidence of trapeziometacarpal osteoarthritis who fulfilled the 1990 American College of Rheumatology criteria for hand osteoarthritis and reported a pain intensity score of at least 30 on an 11-point numeric rating scale (0: no pain to 100: maximal pain). Participants were randomly assigned (1:1), using a computer-generated randomisation list with permuted blocks of variable size (4 or 6), to receive an ultrasound-guided injection of either botulinum toxin A (50 Allergan units) in 1 mL of saline (experimental group) or 1 mL of saline alone (control group) in the trapeziometacarpal joint, in addition to custom-made rigid splinting. The primary outcome was the mean change from baseline in base-of-thumb pain in the previous 48 h on a numeric rating scale at 3 months after injection, analysed by intention to treat. This study is registered with ClinicalTrials.gov, NCT03187626. FINDINGS: Between Nov 2, 2018, and Nov 3, 2020, we assessed 370 individuals for eligibility and recruited 60 (16%) participants (mean age 64·9 years [SD 9·4], 47 [78%] women and 13 [22%] men), of whom 30 (50%) participants were randomly assigned to the experimental group and 30 (50%) to the control group. At baseline, base-of-thumb pain score was 60·0 of 100·0 (SD 15·9). At 3 months, the mean reduction in base-of-thumb pain was -25·7 (95% CI -35·5 to -15·8) in the experimental group and -9·7 (-17·1 to -2·2) in the control group (absolute difference -16·0 [-28·1 to -3·9]; p=0·043). Overall, 51 adverse events were reported in both groups: 27 (53%) in the experimental group and 24 (47%) in the control group. During follow-up, 14 (47%) participants in the experimental group and two (7%) participants in the control group reported mild transient motor deficit of the thenar muscle. No serious adverse events were reported. INTERPRETATION: Botulinum toxin A could be considered as a fast-acting, intra-articular therapy targeting chronic pain in individuals with base-of-thumb osteoarthritis. Future studies are needed to investigate the potential mechanism of the effects observed in this trial, to replicate our findings, and to assess the effects of repeated injections over time and their clinical effectiveness, including an analysis of cost-effectiveness. FUNDING: Assistance Publique-Hôpitaux de Paris.

Development of a new patient-reported outcome measure assessing activities and participation in people with lumbar spinal stenosis: The Cochin Spinal Stenosis 19-item questionnaire.

BACKGROUND: Lumbar spinal stenosis (LSS) is the leading cause of spinal surgery in people over 65-years old. In people with LSS, generic self-administered questionnaires are the most commonly used PROs to assess health-related quality of life, global activity limitation, and low back pain-located activity limitation. AIM: The aim was to develop a new patient-reported outcome measure assessing activities and participation in people with LSS. DESIGN: Observation, prospective and qualitative study. SETTING: For the qualitative study, were enrolled in- and outpatients with LSS from 2 French tertiary care centers (Department of PRM of Cochin Hospital and Department of Rheumatology of Limoges Hospital). For the Internet E-survey, screened the electronic medical records of the Department of PRM of Cochin Hospital. POPULATION: From February to April 2018 were enrolled patients older than 50-years and symptomatic LSS. METHODS: We used a 2-step approach. In a first step, we conducted a qualitative study using in-depth semi-structured interviews in 20 patients with LSS to collect meaningful concepts and to develop a provisional questionnaire. In a second step, using the provisional questionnaire, we conducted an Internet E-survey in an independent sample of 200 patients with LSS. RESULTS: Concepts collected from patients generated a 48-item provisional questionnaire. Overall, 63/200 (31.5%) patients completed the provisional questionnaire. Item reduction resulted in a 19-item questionnaire, the Cochin Spinal Stenosis 19-item (CSS-19) questionnaire. Principal component analysis extracted 3 factors. In confirmatory analysis, factor 1 influenced all items. We found convergent validity with low back pain, LSS-specific disability and divergent validity with mental health-related quality of life. Cronbach α coefficient (95% CI) was 0.96 (0.94; 0.97). ICC was 0.90 (0.70; 0.97). Bland and Altman analysis found no systematic trend for test-retest. CONCLUSIONS: CSS-19 is a new patient-reported outcome measure assessing activities and participation in people with LSS. Its construction prioritized patients' perspectives at all stages. Its content and construct validities are good. CLINICAL REHABILITATION IMPACT: Instruments able to capture specific needs of people with LSS in terms of activities and participation are lacking.

Evaluation of the impact of a nurse-led program of patient self-assessment and self-management in axial spondyloarthritis: results of a prospective, multicentre, randomized, controlled trial (COMEDSPA).

OBJECTIVE: To evaluate the impact of a nurse-led program of self-management and self-assessment of disease activity in axial spondyloarthritis. METHODS: Prospective, randomized, controlled, open, 12-month trial (NCT02374749). Participants were consecutive axial spondyloarthritis patients (according to the rheumatologist) and nurses having participated in a 1-day training meeting. The program included self-management: educational video and specific video of graduated, home-based exercises for patients; and self-assessment: video presenting the rationale of tight monitoring of disease activity with composite scores (Ankylosing Spondylitis Disease activity Score, ASDAS/Bath Ankyslosing Spondylitis Disease Activity Index, BASDAI). The nurse trained patients to collect, calculate and report (monthly) ASDAS/BASDAI. Treatment allocation was by random allocation to this program or a comorbidities assessment (not presented here and considered here as the control group). RESULTS: A total of 502 patients (250 and 252 in the active and control groups, respectively) were enrolled (age: 46.7 (12.2) years, male gender: 62.7%, disease duration: 13.7 (11.0) years). After the one-year follow-up period, the adherence to the self-assessment program was considered good (i.e. 79% reported scores >6 times). Despite a lack of statistical significance in the primary outcome (e.g. coping) there was a statistically significant difference in favor of this program for the following variables: change in BASDAI, number and duration of the home exercises in the active group, and physical activity (international physical activity score, IPAQ). CONCLUSION: This study suggests a short-term benefit of a nurse-led program on self-management and self-assessment for disease activity in a young axial spondyloarthritis population in terms of disease activity, exercises and physical activity.

Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial.

OBJECTIVE: To evaluate the impact of a nurse-led program of systematic screening for the management (detection/prevention) of comorbidities. METHODS: Prospective, randomized, controlled, open, 12-month trial (NCT02374749). PARTICIPANTS: consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM: A nurse collected data on comorbidities during a specific outpatient visit. In the event of non-agreement with recommendations, the patient was informed and a specific recommendation was given to the patient (orally and in a with a detailed written report). Patients were seen after one year in a nurse-led visit. TREATMENT ALLOCATION: random allocation (i.e. either this program or an educational program not presented here and considered here as the control group). MAIN OUTCOME: change after one year of a weighted comorbidity management score (0 to 100 where 0= optimal management). RESULTS: 502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y. After one year, no differences were observed in a weighted comorbidity management score. However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). CONCLUSIONS AND RELEVANCE: This study suggests the short-term benefit of a single-visit nurse-led program for systematic screening of comorbidities for its management in agreement with recommendations, even in this young population of patients with axSpA.

Lumbosacral immobilization following glucocorticoid intradiscal injection in patients with chronic low back pain and active discopathy: A feasibility study.

BACKGROUND: In people with chronic low back pain (cLBP) and active discopathy, glucocorticoid intradiscal injection (GC IDI) reduces LBP in the short-term. Lumbosacral immobilization may be useful to obtain long-term results. OBJECTIVE: To assess the feasibility of a lumbosacral immobilization using a pantaloon cast following GC IDI in people with cLBP sand active discopathy. METHODS: We conducted a retrospective feasibility study. Participants were allocated to experimental or control groups by preferences. The experimental group received lumbosacral immobilization using a custom-made pantaloon cast worn continuously for one week following a GC IDI of 25 mg of prednisolone acetate. The control group received GC IDI alone. The primary endpoint was the feasibility of lumbosacral immobilization assessed by the rate of refusal and early withdrawal of the cast. RESULTS: Twelve patients were offered lumbosacral immobilization following GC IDI: the rate of refusal was 3/12 (25.0%) and was 3/9 (33.3%) of early withdrawal. Mean (95% CI) acceptability of the procedure was 55.0 (26.9-83.1)/100 in the experimental group (N= 6) and 61.6 (25.1-98.2)/100 in the control group (N= 6). CONCLUSIONS: We found high rates of refusal and early withdrawal of the lumbosacral immobilization using a pantaloon cast following GC IDI in people with nonspecific cLBP and active discopathy.

Psychometric validation of the Hand Disability in Systemic Sclerosis-Digital Ulcers (HDISS-DU®) patient-reported outcome instrument.

BACKGROUND: We aimed to develop a patient-reported outcome measure, in accordance with the US Food and Drug Administration guidance, to capture the impact of systemic sclerosis-related digital ulcers (SSc-DUs) on hand function. Psychometric analyses were conducted to evaluate and document the measurement properties of the resulting instrument-the Hand Disability in Systemic Sclerosis-Digital Ulcers (HDISS-DU®). METHODS: The HDISS-DU was developed through a series of confirmatory, qualitative concept-elicitation interviews (N = 36) to provide supportive evidence that the instrument captures all relevant issues and functional limitations relating to SSc-DUs in this patient population. Psychometric analyses used blinded data from two randomised, controlled, phase 3 trials in patients with SSc-DUs (N = 517). The analyses included assessment of reliability, construct validity, responsiveness and thresholds for meaningful change. RESULTS: Qualitative interviews confirmed that the HDISS-DU had good content coverage and patients understood the HDISS-DU instructions, items and response scale. The HDISS-DU demonstrated excellent internal consistency and test-retest reliability, with satisfactory construct validity. Overall, the HDISS-DU was highly responsive to change in digital ulcer severity: the no-change group (for other criterion measures) had mean differences and effect sizes close to 0, while mean differences were mostly negative (indicating improvement) for the improvement groups (for other criterion measures) and vice versa. The preliminary threshold for meaningful change was a 0.50 difference in HDISS-DU score. CONCLUSIONS: Using data from two large studies of SSc-DU patients, these psychometric analyses support the reliability, validity, discriminating ability and responsiveness to change of the HDISS-DU for evaluating treatment outcomes in future clinical studies and clinical practice.

Diagnosis and management of lumbar spinal stenosis in primary care in France: a survey of general practitioners.

BACKGROUND: Lumbar spinal stenosis (LSS) is a common spinal condition and the most frequent indication for spinal surgery in elderly people. General practitioners (GPs) are on the 1st line for its diagnosis and treatment. We aimed to assess how GPs diagnose and treat people with LSS in France. METHODS: We conducted a cross-sectional survey in a primary care setting. French GPs were selected by a random draw from the French Medical Board. The questionnaire was designed by 3 physicians specialized in physical and rehabilitation medicine and a resident in general practice. A provisional questionnaire was tested in a pilot survey of 11 French GPs. Participants' feedbacks served to build the final questionnaire. This latter was submitted by e-mail or mail to 330 GPs. GPs were surveyed about the 3 main domains relevant to the management of people with LSS in primary care: 1/ diagnosis, 2/ pharmacological treatments and 3/ non-pharmacological treatments, using self-administered open- and closed-ended questions and visual analog scales. RESULTS: Overall, 90/330 (27.3%) GPs completed the survey. 51/89 (57.3%) GPs were confident with managing people with LSS. Low back pain 51/87 (58.6%), neurogenic claudication 38/87 (43.7%) and paresthesia in the lower limbs 31/87 (35.6%) were the 3 most frequently cited clinical signs leading to the diagnosis of LSS. Improvement with lumbar flexion was mentioned by 9/87 (10.3%) GPs. 85/86 (98.8%) would consider prescribing lumbar imaging, 60/84 (71.4%) corticoid spinal injections and 42/79 (53.2%) would never prescribe lumbar flexion-based endurance training. All GPs would refer people with LSS to another specialist. CONCLUSIONS: French GPs lack confidence with diagnosing LSS and prescribing pharmacological and non-pharmacological treatments for people with LSS.

Construction of an ICF core set and ICF-based questionnaire assessing activities and participation in patients with systemic sclerosis.

OBJECTIVES: To develop an International Classification of Functioning, Disability and Health (ICF) core set for SSc and to conceive a patient-centred ICF-based questionnaire assessing activities and participation in patients with SSc. METHODS: The construction of the ICF core set followed two steps. In the first step, meaningful concepts related to SSc were collected using data source triangulation from patients (n = 18), experts (n = 10) and literature (n = 174 articles). In the second step, concepts were linked to the best-matching ICF categories by one reviewer according to prespecified linking rules. Finally, patient-reported activities and participation categories of the ICF core set were translated into understandable questions. RESULTS: After linking concepts to ICF categories, 150 ICF categories were collected from focus groups, 22 from experts and 82 from literature. After fusion of the sources and removal of duplicates, the ICF core set included 164 categories: one at the first level, 157 at the second level and six at the third level, with 50 categories on body functions, 15 on body structures, 52 on activities and participation, and 47 on environmental factors. Patient-reported ICF categories on activities and participation were translated into a patient-centred ICF-based 65-item questionnaire. CONCLUSION: The present study proposes an ICF core set that offers a conceptual framework for SSc patients' care and health policy. Using a patient-centred approach, a patient-centred ICF-based questionnaire, the Cochin Scleroderma ICF-65 questionnaire, assessing activities and participation in patients with SSc, was conceived. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01848418.

Contribution of chronic diseases to educational disparity in disability in France: results from the cross-sectional "disability-health" survey.

BACKGROUND: This study aimed 1) to assess whether the contribution of chronic conditions to disability varies according to the educational attainment, 2) to disentangle the contributions of the prevalence and of the disabling impact of chronic conditions to educational disparities. METHODS: Data of the 2008-09 Disability Health Survey were examined (N = 23,348). The disability indicator was the Global Activity Limitation Indicator (GALI). The attribution method based on an additive hazard model was used to estimate educational differences in disabling impacts and in the contributions of diseases to disability. Counterfactual analyses were used to disentangle the contribution of differences in disease prevalence vs. disabling impact. RESULTS: In men, the main contributors to educational difference in disability prevalence were arthritis (contribution to disability prevalence: 5.7% (95% CI 5.4-6.0) for low-educated vs. 3.3% (3.0-3.9) for high-educated men), spine disorders (back/neck pain, deformity) (3.8% (3.6-4.0) vs. 1.9% (1.8-2.1)), chronic obstructive pulmonary diseases (2.4% (2.3-2.6) vs. 0.6% (0.5-0.7)) and ischemic heart /peripheral artery diseases (4.1% (3.9-4.3) vs. 2.4% (2.2-3.0)). In women, arthritis (9.5% (9.1-9.9) vs. 4.5%, (4.1-5.2)), spine disorders (4.5% (4.3-4.7) vs. 2.1% 1.9-2.3) and psychiatric diseases (3.1% (3.0-3.3) vs. 1.1% (1.0-1.3)) contributed most to education gap in disability. The educational differences were equally explained by differences in the disease prevalence and in their disabling impact. CONCLUSIONS: Public health policies aiming to reduce existing socioeconomic disparities in disability should focus on musculoskeletal, pulmonary, psychiatric and ischemic heart diseases, reducing their prevalence as well as their disabling impact in lower socioeconomic groups.

Patient acceptable symptom state and minimal clinically important difference for patient-reported outcomes in systemic sclerosis: A secondary analysis of a randomized controlled trial comparing personalized physical therapy to usual care.

BACKGROUND: To estimate patient acceptable symptom state (PASS) and minimal clinically important difference (MCID) for patient-reported outcomes in systemic sclerosis (SSc). METHODS: We conducted a secondary analysis of the SCLEREDUC trial, a 12-month randomized controlled trial comparing the efficacy of physical therapy to usual care in 220 SSc patients followed-up from September 2005 to October 2010. Self-rated state and change in patient health at 12 months were assessed by using 2 external anchors extracted from the Medical Outcomes Study 36-Item Short-Form. Patients who self-rated their health as "excellent", "very good" or "good" were the PASS group and those who self-rated their health change as "somewhat better" were the MCID group. Main outcomes were the estimates of PASS by using the 75th percentile method and of MCID by using the mean change in scores method for pain and activity limitation. RESULTS: PASS (95% confidence interval) and mean (SD) MCID estimates at 12 months were 53.75 (34.00 to 68.00) and -6.74 (32.02) for the joint-pain visual analog scale (range 0-100), 1.41 (1.13 to 1.63) and -0.21 (0.48) for the Health Assessment Questionnaire (HAQ, range 0-3), 1.27 (1.07 to 1.62) and -0.13 (0.45) for the scleroderma HAQ (range 0-3), 26.00 (17.00 to 37.00) and -3.38 (9.87) for the Cochin Hand Function Scale (range 0-90), and 19.40 (17.20 to 21.90) and -5.69 (6.79) for the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (range 0-30), respectively. CONCLUSIONS: We provide, for the first time, the PASS and MCID estimates for pain and activity limitation in SSc. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00318188. First Posted: April 26, 2006.

Agreement among physiotherapists in assessing patient performance of exercises for low-back pain.

BACKGROUND: There is no agreement for the performance assessment of patients who practice exercises.. (2 points to withdraw) This assessment is currently left to the physiotherapist's personal judgement. We studied the agreement among physiotherapists in rating patient performance during exercises recommended for chronic low-back pain (LBP). METHODS: A vignette-based method was used. We first identified ten exercises recommended for LBP in the literature. Then, 42 patients with chronic LBP participating in a rehabilitation program were videotaped during their performance of one of the ten exercises. A vignette was an exercise video preceded by clinical information. Ten physiotherapists from primary (4) and tertiary care (6) viewed the 42 vignettes twice, one month apart, and rated patient performance from zero (worse performance) to ten (excellent performance) by considering the position and duration of the contraction or stretching. Intra-class correlation coefficients (ICCs) and 95% confidence intervals (95% CIs) were computed to assess inter- and intra-rater reliability. RESULTS: The overall inter-rater agreement was fair (ICC 0.48 [95% CI 0.33-0.56]) but was better for stretching exercises (0.55 [0.35-0.64]) than strengthening exercises (0.42 [0.20-0.52]) and for tertiary-care physiotherapists (0.66 [0.54-0.76]) than primary-care physiotherapists (0.28 [0.09-0.37]). The intra-rater agreement was overall good (0.72 [0.57-0.81] to 0.88 [0.79-0.94]). It was better for stretching exercises (from 0.68 [0.46-0.81] to 0.96 [0.91-0.98]) than strengthening exercises (from 0.68 [0.38-0.84]) to 0.82 [0.56-0.92]). CONCLUSION: The agreement in rating patient performance of exercises for LBP is good among physiotherapists trained in managing LBP but is low among non-trained physiotherapists.

Intra-articular botulinum toxin A for base-of-thumb osteoarthritis: protocol for a randomised trial (RHIBOT).

INTRODUCTION: Recent studies have suggested that intra-articular injection of botulinum toxin A (BTA) may have analgesic effects in degenerative joint diseases. We aim to assess the efficacy of intra-articular injection of BTA associated with splinting in patients with trapeziometacarpal osteoarthritis (TMC OA). METHODS AND ANALYSIS: We will conduct a randomised double-blind controlled trial. Overall, 60 individuals with TMC OA fulfilling adapted 1990 American College of Rheumatology criteria for hand OA will be recruited in one tertiary care centre in France and randomised to receive splinting + a single ultrasound-guided injection in the TMC joint of 50 Allergan Units of BTA resuspended in 1 mL saline or splinting +1 mL saline. Randomisation will be centralised. The allocation ratio will be 1:1. The primary outcome will be the mean change from baseline in base-of-thumb pain on a self-administered 11-point Numeric Rating Scale in 10-point increments at 3 months after injection. Secondary outcomes will be the mean change in base-of-thumb pain at 1 and 6 months, mean change in hand-specific activity limitations assessed by the self-administered Cochin Hand Function Scale, proportion of responders assessed by the Osteoarthritis Research Society International -Outcome Measures in Rheumatology (OMERACT) criteria and consumption of analgesics and non-steroidal anti-inflammatory drugs assessed by a self-administered 4-class scale at 3 and 6 months. Cointerventions will be allowed in both groups and will be self-reported. Adverse events will be recorded at 3 and 6 months. Participants, care providers and statisticians will be blinded to the allocated treatment. ETHICS AND DISSEMINATION: The RHIBOT trial has been authorised by the Agence Nationale de Sécurité du Médicament and approved by the Comité de Protection des Personnes de Tours Ouest-1. The findings of the study will be disseminated in peer-reviewed journals and at conferences. If the results are positive, intra-articular BTA could be an efficient and safe complementary therapeutic option for patients with TMC OA. DATE AND VERSION IDENTIFIER OF THE PROTOCOL: 8 January 2018, V. 2.0. TRIAL REGISTRATION NUMBER: NCT03187626; Pre-results.

Bone mineral density and bone remodeling markers in chronic low back pain patients with active discopathy: A case-control exploratory study.

OBJECTIVE: We aimed to compare bone mineral density (BMD) and bone remodeling markers in chronic low back pain (cLBP) patients with and without active discopathy (Modic 1 changes). DESIGN: We conducted a single center case-control exploratory study. For 18 months, all patients referred to a tertiary care physical medicine and rehabilitation department in France were consecutively screened. Patients fulfilling the inclusion criteria were prospectively enrolled. Cases were defined as cLBP patients with lumbar active discopathy detected on MRI and controls as cLBP patients without active discopathy. Bone mineral density (BMD) at the spine, femoral neck and total femur was assessed by dual-energy X-ray absorptiometry, and bone remodeling markers were assessed in fasting serum samples. Overall, 37 cLBP patients (13 cases and 24 controls) fulfilled inclusion criteria and were included. RESULTS: The median age was 42.0 years (Q1-Q3: 36.0-51.0) and mean (SD) LBP duration 72.3 (57.4) months. We found that BMD and levels of bone remodeling markers in cLBP patients did not differ with and without active discopathy. CONCLUSION: Our results do not support the association between active discopathy and systemic bone fragility.

The Scleroderma Patient-Centered Intervention Network Cohort: baseline clinical features and comparison with other large scleroderma cohorts.

Objectives: The Scleroderma Patient-centered Intervention Network (SPIN) Cohort is a web-based cohort designed to collect patient-reported outcomes at regular intervals as a framework for conducting trials of psychosocial, educational, self-management and rehabilitation interventions for patients with SSc. The aim of this study was to present baseline demographic, medical and patient-reported outcome data of the SPIN Cohort and to compare it with other large SSc cohorts. Methods: Descriptive statistics were used to summarize SPIN Cohort characteristics; these were compared with published data of the European Scleroderma Trials and Research (EUSTAR) and Canadian Scleroderma Research Group (CSRG) cohorts. Results: Demographic, organ involvement and antibody profile data for SPIN (N = 1125) were generally comparable with that of the EUSTAR (N = 7319) and CSRG (N = 1390) cohorts. There was a high proportion of women and White patients in all cohorts, though relative proportions differed. Scl70 antibody frequency was highest in EUSTAR, somewhat lower in SPIN, and lowest in CSRG, consistent with the higher proportion of interstitial lung disease among dcSSc patients in SPIN compared with in CSRG (48.5 vs 40.3%). RNA polymerase III antibody frequency was highest in SPIN and remarkably lower in EUSTAR (21.1 vs 2.4%), in line with the higher prevalence of SSc renal crisis (4.5 vs 2.1%) in SPIN. Conclusion: Although there are some differences, the SPIN Cohort is broadly comparable with other large prevalent SSc cohorts, increasing confidence that insights gained from the SPIN Cohort should be generalizable, although it should be noted that all three cohorts include primarily White participants.

Spanish validation of the Exercise Therapy Burden Questionnaire (ETBQ) for the assessment of barriers associated to doing physical therapy for the treatment of chronic illness / Validación en español del cuestionario «Exercise Therapy Burden Questionnaire» para la evaluación de las barreras asociadas a la práctica de ejercicio físico para el tratamiento de enfermedades crónicas

Background and objetive: To validate the Spanish version of the Exercise Therapy Burden Questionnaire (ETBQ) for the assessment of barriers associated to doing physical therapy for the treatment of chronic ailments. Patientes and methods: A sample of 177 patients, 55.93% men and 44.07% women, with an average age of 51.03±14.91 was recruited. The reliability of the questionnaire was tested with Cronbach's alpha coefficient, and the validity of the instrument was assessed through the divergent validation process and factor analysis. Results: The factor analysis was different to the original questionnaire, composed of a dimension, in this case determined three dimensions: (1) General limitations for doing physical exercise. (2) Physical limitations for doing physical exercise. (3) Limitations caused by the patients’ predisposition to their exercises. The reliability of the test-retest was measured through the intraclass correlation coefficient (ICC) and the Bland-Altman plot. Cronbach's alpha was 0.8715 for the total ETBQ. The ICC of the test-retest was 0.745 and the Bland-Altman plot showed no systematic trend. Conclusion: We have obtained the translated version in Spanish of the ETBQ questionnaire

Antecedentes y objetivo: Validar la versión en español del cuestionario «Exercise Therapy Burden Questionnaire» (ETBQ) para la evaluación de las barreras asociadas a la realización de terapia física para el tratamiento de enfermedades crónicas. Pacientes y métodos: Se reunió una muestra de 177 pacientes, con un 55,93% de varones y un 44,07% de mujeres, y una edad media de 51,03±14,91. Se probó la fiabilidad del cuestionario mediante el coeficiente alfa de Cronbach, y se evaluó la validez del instrumento a través del proceso de validación divergente y el análisis factorial. Resultados: El análisis factorial fue diferente al del cuestionario original, que se componía de una dimensión, y en este caso determinaba 3 dimensiones: 1) Limitaciones generales a la práctica de ejercicio físico; 2) Limitaciones físicas para la realización de ejercicio físico, y 3) Limitaciones causadas por la predisposición de los pacientes a la práctica de ejercicio. La fiabilidad de la prueba-reprueba se midió mediante el coeficiente de correlación intraclase (ICC) y la gráfica de Bland-Altman. El valor alfa de Cronbach fue de 0,8715 para ETBQ total. El ICC para la prueba-reprueba fue de 0,745, y la gráfica de Bland-Altman no reflejó ninguna tendencia sistemática. Conclusión: Hemos obtenido la versión traducida al español del cuestionario ETBQ