Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial.

PURPOSE: The purpose of this study was to evaluate the safety and efficacy of transient genicular artery embolization (GAE) using an ethiodized oil-based emulsion for the treatment of knee osteoarthritis (KOA). MATERIALS AND METHODS: This prospective, single-arm, open-label, multicenter, first-in-human cohort trial was registered on ClinicalTrials.gov (NCT04733092). The main inclusion criterion was diagnosis of KOA according to a visual analogue scale (VAS) pain score ≥ 40 mm (score range: 0-100 mm), despite conservative treatment for at least three months. Treatment efficacy was assessed using changes in VAS pain score, Mean Western Ontario & McMaster Universities osteoarthritis (WOMAC) function score (normalized to 100; score ranging from 0 to100) and outcome measures in rheumatoid arthritis clinical trials (OMERACT)-Osteoarthritis Research Society (OARSI) set of responder criteria. RESULTS: Twenty-two consecutive participants (13 women; mean age, 66 ± 9 [standard deviation (SD)]) were included and underwent GAE. Emulsion consisted in a mixture of ioversol and ethiodized oil (ratio 1:3, respectively) prepared extemporaneously. The rate of serious adverse events attributed to GAE within one month was 5% (1/22), corresponding to reversible worsening of renal function. Immediate technical success rate was 100%. Mean VAS pain score dropped from 74.4 ± 16.5 (SD) mm at baseline to 37.2 ± 26.7 (SD) mm at three months (P < 0.001). Mean WOMAC function score (normalized to 100: score ranging from 0 to 100) decreased from 57.3 ± 17.1 (SD) at baseline to 33.5 ± 25.9 (SD) at three months (P < 0.001). At three months, 16 out of 22 participants (73%) were considered responders according to the OMERACT-OARSI set of responder criteria, including high improvement in either pain or WOMAC function, or improvement in both pain and WOMAC function. CONCLUSION: GAE using an ethiodized oil-based emulsion is safe and improves pain and function in participants with KOA for at least three months.

Early shoulder-girdle MRI findings in severe COVID-19-related intensive care unit-acquired weakness: a prospective cohort study.

OBJECTIVE: To describe clinical and early shoulder-girdle MR imaging findings in severe COVID-19-related intensive care unit-acquired weakness (ICU-AW) after ICU discharge. METHODS: A single-center prospective cohort study of all consecutive patients with COVID-19-related ICU-AW from November 2020 to June 2021. All patients underwent similar clinical evaluations and shoulder-girdle MRI within the first month and then 3 months (± 1 month) after ICU discharge. RESULTS: We included 25 patients (14 males; mean [SD] age 62.4 [12.5]). Within the first month after ICU discharge, all patients showed severe proximal predominant bilateral muscular weakness (mean Medical Research Council total score = 46.5/60 [10.1]) associated with bilateral, peripheral muscular edema-like MRI signals of the shoulder girdle in 23/25 (92%) patients. At 3 months, 21/25 (84%) patients showed complete or quasi-complete resolution of proximal muscular weakness (mean Medical Research Council total score > 48/60) and 23/25 (92%) complete resolution of MRI signals of the shoulder girdle, but 12/20 (60%) patients experienced shoulder pain and/or shoulder dysfunction. CONCLUSIONS: Early shoulder-girdle MRI findings in COVID-19-related ICU-AW included muscular edema-like peripheral signal intensities, without fatty muscle involution or muscle necrosis, with favorable evolution at 3 months. Precocious MRI can help clinicians distinguish critical illness myopathy from alternative, more severe diagnoses and can be useful in the care of patients discharged from intensive care with ICU-AW. KEY POINTS: • We describe the clinical and shoulder-girdle MRI findings of COVID-19-related severe intensive care unit-acquired weakness. • This information can be used by clinicians to achieve a nearly specific diagnosis, distinguish alternative diagnoses, assess functional prognosis, and select the more appropriate health care rehabilitation and shoulder impairment treatment.

Differences in Disability Perception in Systemic Sclerosis: A Mirror Survey of Patients and Health Care Providers.

Differences in disability perception between patients and care providers may impact outcomes. We aimed to explore differences in disability perception between patients and care providers in systemic sclerosis (SSc). We conducted a cross-sectional internet-based mirror survey. SSc patients participating in the online SPIN Cohort and care providers affiliated with 15 scientific societies were surveyed using the Cochin Scleroderma International Classification of Functioning, Disability and Health (ICF)-65 questionnaire, including 65 items (from 0 to 10), representing 9 domains of disability. Mean differences between patients and care providers were calculated. Care providers' characteristics associated with a mean difference ≥ 2 of 10 points were assessed in multivariate analysis. Answers were analyzed for 109 patients and 105 care providers. The mean age of patients was 55.9 (14.7) years and the disease duration was 10.1 (7.5) years. For all domains of the ICF-65, care providers' rates were higher than those of patients. The mean difference was 2.4 (1.0) of 10 points. Care providers' characteristics associated with this difference were organ-based specialty (OR = 7.0 [2.3-21.2]), younger age (OR = 2.7 [1.0-7.1]) and following patients with disease duration ≥5 years (OR = 3.0 [1.1-8.7]). We found systematic differences in disability perception between patients and care providers in SSc.

Chronic Low Back Pain: A Narrative Review of Recent International Guidelines for Diagnosis and Conservative Treatment.

Chronic low back pain (cLBP) is a public and occupational health problem that is a major professional, economic and social burden. We aimed to provide a critical overview of current international recommendations regarding the management of non-specific cLBP. We conducted a narrative review of international guidelines for the diagnosis and conservative treatment of people with non-specific cLBP. Our literature search yielded five reviews of guidelines published between 2018 and 2021. In these five reviews, we identified eight international guidelines that fulfilled our selection criteria. We added the 2021 French guidelines into our analysis. Regarding diagnosis, most international guidelines recommend searching for so-called yellow, blue and black flags, in order to stratify the risk of chronicity and/or persistent disability. The relevance of clinical examination and imaging are under debate. Regarding management, most international guidelines recommend non-pharmacological treatments, including exercise therapy, physical activity, physiotherapy and education; however, multidisciplinary rehabilitation, in selected cases, is the core treatment recommended for people with non-specific cLBP. Oral, topical or injected pharmacological treatments are under debate, and may be offered to selected and well-phenotyped patients. The diagnosis of people with cLBP may lack precision. All guidelines recommend multimodal management. In clinical practice, the management of individuals with non-specific cLBP should combine non-pharmacological and pharmacological treatments. Future research should focus on improving tailorization.

Barriers and facilitators to bracing in adults with painful degenerative scoliosis: a single-centred mixed-method feasibility study.

BACKGROUND: Conservative treatments including bracing and exercise therapy are prescribed on the first-line in adults with degenerative scoliosis. However, adherence to conservative treatments is low. We aimed to assess barriers and facilitators to bracing in adults with painful degenerative scoliosis. METHODS: We conducted a single-centred mixed-method pilot and feasibility study. All patients scheduled for a multidisciplinary custom-made bracing consultation, from July 2019 to January 2020, in a French tertiary care centre, were screened. Patients were eligible if they had painful adult degenerative scoliosis and a prescription for a rigid custom-made lumbar-sacral orthosis. The primary outcome was barriers and facilitators to bracing assessed by a qualitative approach using semi-structured interviews. Secondary outcomes were back pain, spine-specific activity limitations, symptoms of depression and satisfaction with bracing post-intervention assessed by a quantitative approach. RESULTS: Overall, 56 patients were screened and 14 (25%) were included. Mean age was 68.2 (12.3) years. Mean follow-up was 9.8 (2.0) months. Barriers to bracing were increased limitations in some activities, discomfort in hot weather and burden of aesthetic appearance. Facilitators to bracing were reduced pain, improved activities of daily living, suitable weight and improved spinal alignment. Participants self-implemented solutions to enhance adherence. The mean reduction from baseline in pain intensity was 1.7 (2.3) of 10 points, and 6 of 13 patients (46%) had pain intensity < 4 of 10 points. CONCLUSION: Bracing is a feasible intervention for people with painful adult degenerative scoliosis. Patients self-implemented their own solutions to enhance adherence.

Physical activity and low back pain: A critical narrative review.

BACKGROUND: Non-specific low back pain (LBP) is the leading cause of years lived with disability worldwide. Physical activity is an integral part of LBP treatment. OBJECTIVE: To critically review available evidence regarding the efficacy of physical activity for people with LBP. METHODS: Up to date critical narrative review of the efficacy of physical activity for the managment LBP. The process of article selection was unsystematic; articles were selected based on authors' expertise, self-knowledge and reflective practice. RESULTS: Therapeutic physical activity for LBP includes a wide range of non-specific and specific activities. The efficacy of physical activity on pain and activity limitations has been widely assessed. In acute and subacute LBP, exercise did not reduce pain compared to no exercise. In chronic low back pain (CLBP), exercise reduced pain at the earliest follow-up compared with no exercise. In a recent systematic review, exercise improved function both at the end of treatment and in the long-term compared with usual care. Exercice also reduced work disability in the long-term. We were unable to establish a clear hierarchy between different exercise modalities. Multidisciplinary functional programs consistently improved pain and function in the short- and long-term compared with usual care and physiotherapy and improved the long-term likelihood of returning to work compared to non-multidisciplinary programs. CONCLUSION: Physical activity of all types is an effective treatment for CLBP.

Patient Acceptable Symptom State for Burden From Appearance Changes in People With Systemic Sclerosis: A Cross-sectional Survey.

OBJECTIVE: People with systemic sclerosis (SSc) often report substantial burden from appearance changes. We aimed to estimate the patient acceptable symptom state (PASS) for burden from appearance changes in people with SSc. METHODS: We conducted a secondary analysis of the SCISCIF II study, a cross-sectional survey of 113 patients with SSc from France enrolled in the Scleroderma Patient-centered Intervention Network Cohort. Burden from appearance changes was assessed with a self-administered numeric rating scale (0, no burden to 10, maximal burden). Acceptability of the symptom state was assessed with a specific anchoring question. Participants who answered yes were in the group of patients who considered their symptom state as acceptable. The PASS for the burden from appearance changes was estimated with the 75th percentile method. RESULTS: Assessments of burden from appearance changes and answers to the anchoring question were available in 82/113 (73%) participants from the SCISCIF II study. Median age was 55 (IQR 24) years, mean disease duration 9.6 (SD 6.5) years and 32/80 (40%) participants had diffuse cutaneous SSc. The PASS estimate for the burden from appearance changes was 4.8 (95% CI 1.0-7.0) of 10 points. CONCLUSION: Our study provides a PASS estimate for burden from appearance changes. Our estimate could serve as a binary response criterion to assess the efficacy of treatments targeting burden from appearance changes.

Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial.

Importance: Multidisciplinary prehabilitation before total knee replacement (TKR) for osteoarthritis may improve outcomes in the postoperative period. Objective: To compare multidisciplinary prehabilitation with usual care before TKR for osteoarthritis in terms of functional independence and activity limitations after surgery. Design, Setting, and Participants: This prospective, open-label randomized clinical trial recruited participants 50 to 85 years of age with knee osteoarthritis according to the American College of Rheumatology criteria for whom a TKR was scheduled at 3 French tertiary care centers. Recruitment started on October 4, 2012, with follow-up completed on November 29, 2017. Statistical analyses were conducted from March 29, 2018, to March 6, 2019. Interventions: Four supervised sessions of multidisciplinary rehabilitation and education (2 sessions per week, at least 2 months before TKR, delivered to groups of 4-6 participants at each investigating center; session duration was 90 minutes and included 30 minutes of education followed by 60 minutes of exercise therapy) or usual care (information booklet and standard advice by the orthopedic surgeon) before TKR. Main Outcomes and Measures: The short-term primary end point was the proportion of participants achieving functional independence a mean (SD) of 4 (1) days after surgery defined as level 3 on the 4 functional tests. The midterm primary end point was activity limitations within 6 months after TKR assessed by the area under the receiver operating characteristic curve of the self-administered Western Ontario Questionnaire and McMaster Universities Osteoarthritis Index function subscale. Results: A total of 262 patients (mean [SD] age, 68.6 [8.0] years; 178 women [68%]) were randomized (131 to each group). A mean (SD) of 4 (1) days after surgery, 34 of 101 (34%) in the experimental group vs 26 of 95 (27%) in the control group achieved functional independence (risk ratio, 1.4; 97.5% CI, 0.9-2.1; P = .15). At 6 months, the mean (SD) area under the curve for the Western Ontario Questionnaire and McMaster Universities Osteoarthritis Index function subscale was 38.1 (16.5) mm2 in the experimental group vs 40.6 (17.8) mm2 in the control group (absolute difference, -2.8 mm2; 97.5% CI, -7.8 to 2.3; P = .31 after multiple imputation). No differences were found in secondary outcomes. Conclusions and Relevance: This randomized clinical trial found no evidence that multidisciplinary prehabilitation before TKR for osteoarthritis improves short-term functional independence or reduces midterm activity limitations after surgery. Trial registration: ClinicalTrials.gov Identifier: NCT01671917.

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.

Intervertebral disc therapies for non-specific chronic low back pain: a systematic review and meta-analysis.

OBJECTIVES: We aim to evaluate the benefits and harms of intervertebral disc therapies (IDTs) in people with non-specific chronic low back pain (NScLBP). METHODS: We conducted a systematic review and meta-analysis of randomized trials of IDTs versus placebo interventions, active comparators or usual care. EMBASE, MEDLINE, CENTRAL and CINHAL databases and conference abstracts were searched from inception to June 2020. Two independent investigators extracted data. The primary outcome was LBP intensity at short term (1 week-3 months), intermediate term (3-6 months) and long term (after 6 months). RESULTS: Of 18 eligible trials (among 1396 citations), five assessed glucocorticoids (GCs) IDTs and were included in a quantitative synthesis; 13 assessed other products including etanercept (n = 2), tocilizumab (n = 1), methylene blue (n = 2), ozone (n = 2), chymopapaine (n = 1), glycerol (n = 1), stem cells (n = 1), platelet-rich plasma (n = 1) and recombinant human growth and differentiation factor-5 (n = 2), and were included in a narrative synthesis. Standardized mean differences (95% CI) for GC IDTs for LBP intensity and activity limitations were -1.33 (-2.34; -0.32) and -0.76 (-1.85; 0.34) at short term, -2.22 (-5.34; 0.90) and -1.60 (-3.51; 0.32) at intermediate term and -1.11 (-2.91; 0.70) and -0.63 (-1.68; 0.42) at long term, respectively. Odds ratios (95% CI) for serious and minor adverse events with GC IDTs were 1.09 (0.25; 4.65) and 0.97 (0.49; 1.91). CONCLUSION: GC IDTs are associated with a reduction in LBP intensity at short term in people with NScLBP. Positive effects are not sustained. IDTs have no effect on activity limitations. Our conclusions are limited by high heterogeneity and a limited methodological quality across studies. REGISTRATION: PROSPERO: CRD42019106336.

Physical activity for osteoarthritis: Efficiency and review of recommandations.

Physical activity is defined as movement of the body resulting from muscle contraction and inducing energy expenditure. It can be adapted to a person's health status and have the objective of maintaining or improving health status. The link between sedentary lifestyle and the severity of symptoms in osteoarthritis is now well established, making adapted physical activity (APA) a first-line targeted treatment in osteoarthritis, in order to fight against the effects of a sedentary lifestyle, regardless of the phenotype or stage of the disease. The latest recommendations from EULAR, ACR and OARSI consider APA, in the form of structured exercise programmes for muscle strengthening, joint mobility, proprioception and aerobic exercises, as the core treatment for people with osteoarthritis. The benefits of APA in reducing pain and activity limitations in the short, mid and long terms in osteoarthritis, especially of the lower limbs, has been demonstrated in high-level clinical trials and meta-analyses, with effect sizes comparable to those observed with pharmacological treatments. In clinical practice, the prescription of APA in people with osteoarthritis should be encouraged further. Particular attention should also be paid to patients' adherence in the long term.

Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial.

Importance: Osteopathic manipulative treatment (OMT) is frequently offered to people with nonspecific low back pain (LBP) but never compared with sham OMT for reducing LBP-specific activity limitations. Objective: To compare the efficacy of standard OMT vs sham OMT for reducing LBP-specific activity limitations at 3 months in persons with nonspecific subacute or chronic LBP. Design, Setting, and Participants: This prospective, parallel-group, single-blind, single-center, sham-controlled randomized clinical trial recruited participants with nonspecific subacute or chronic LBP from a tertiary care center in France starting February 17, 2014, with follow-up completed on October 23, 2017. Participants were randomly allocated to interventions in a 1:1 ratio. Data were analyzed from March 22, 2018, to December 5, 2018. Interventions: Six sessions (1 every 2 weeks) of standard OMT or sham OMT delivered by nonphysician, nonphysiotherapist osteopathic practitioners. Main Outcomes and Measures: The primary end point was mean reduction in LBP-specific activity limitations at 3 months as measured by the self-administered Quebec Back Pain Disability Index (score range, 0-100). Secondary outcomes were mean reduction in LBP-specific activity limitations; mean changes in pain and health-related quality of life; number and duration of sick leaves, as well as number of LBP episodes at 12 months; and consumption of analgesics and nonsteroidal anti-inflammatory drugs at 3 and 12 months. Adverse events were self-reported at 3, 6, and 12 months. Results: Overall, 200 participants were randomly allocated to standard OMT and 200 to sham OMT, with 197 analyzed in each group; the median (range) age at inclusion was 49.8 (40.7-55.8) years, 235 of 394 (59.6%) participants were women, and 359 of 393 (91.3%) were currently working. The mean (SD) duration of the current LBP episode was 7.5 (14.2) months. Overall, 164 (83.2%) patients in the standard OMT group and 159 (80.7%) patients in the sham OMT group had the primary outcome data available at 3 months. The mean (SD) Quebec Back Pain Disability Index scores for the standard OMT group were 31.5 (14.1) at baseline and 25.3 (15.3) at 3 months, and in the sham OMT group were 27.2 (14.8) at baseline and 26.1 (15.1) at 3 months. The mean reduction in LBP-specific activity limitations at 3 months was -4.7 (95% CI, -6.6 to -2.8) and -1.3 (95% CI, -3.3 to 0.6) for the standard OMT and sham OMT groups, respectively (mean difference, -3.4; 95% CI, -6.0 to -0.7; P = .01). At 12 months, the mean difference in mean reduction in LBP-specific activity limitations was -4.3 (95% CI, -7.6 to -1.0; P = .01), and at 3 and 12 months, the mean difference in mean reduction in pain was -1.0 (95% CI, -5.5 to 3.5; P = .66) and -2.0 (95% CI, -7.2 to 3.3; P = .47), respectively. There were no statistically significant differences in other secondary outcomes. Four and 8 serious adverse events were self-reported in the standard OMT and sham OMT groups, respectively, though none was considered related to OMT. Conclusions and Relevance: In this randomized clinical trial of patients with nonspecific subacute or chronic LBP, standard OMT had a small effect on LBP-specific activity limitations vs sham OMT. However, the clinical relevance of this effect is questionable. Trial Registration: ClinicalTrials.gov Identifier: NCT02034864.

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.

Core qualities of an educational program to reduce fears and beliefs of GPs about low back pain: Results of a GPs, experts and literature survey.

BACKGROUND: Despite the fact that non-specific low back pain (LBP) is a frequent symptom, its management remains suboptimal in primary care. A plausible reason is the persistence of erroneous fears and beliefs among general practitioners (GPs). OBJECTIVE: We aimed to determine the core qualities an educational program should have to reduce erroneous fears and beliefs about LBP among GPs. METHODS: We used a two step-approach. In the first step, meaningful qualities were collected using comprehensive data source triangulation from GPs, experts and literature. In the second step, qualities were extracted by three independent investigators in a standardized manner using the Template for Intervention Description and Replication checklist. RESULTS: Qualities were collected from 8 GPs, 24 experts and 15 articles. Extraction revealed a wide range of qualities depending on participants' background and literature. After consensus between investigators, the most meaningful qualities included evidence-based messages and web-based interventions (videos and classes) delivered by a multidisciplinary panel of experts. We found no systematic trend for when and how much, and how to tailor the intervention. CONCLUSIONS: Data source triangulation revealed that the core qualities of an educational program targeting fears and beliefs about LBP among GPs should include evidence-based information, web-based interventions and a multidisciplinary panel of experts. Our findings will help us to design a provisional targeted educational intervention. This will be further assessed in a mixed-method feasibility study and then in a randomized controlled trial.

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.