IntroductionRheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease, for which the introduction of injectable treatments has had a major impact on quality of life directly related to the disease. The purpose of this descriptive study was to evaluate the usability of a new autoinjector, intended for methotrexate self-administration, based on the device’s design and instructions for use (IFU).MethodsThis multicenter trial included three user groups: a group of patients with established RA subdivided into two groups according to their hand disability, and a group of caregivers or nurses. Each subject performed three simulated injections with a water-filled device on a foam pad. The first injection was made just after reading the IFU without further instructions (first phase). The second phase consisted of two injections made after explanations provided upon request of the subject in an optimum environment and in a “worst-case” home environment. The usability of the autoinjector was assessed by a questionnaire (success: ≥75% of positive responses) and by a score card reflecting injection performances (success: execution of ≥75% of handling steps).ResultsForty-two subjects were enrolled in the study. During the first phase, the great majority of subjects succeeded in the usability questionnaire (90.5%) and in the injection performance (95.2%) with no major differences between the user groups. In the Second phase, all subjects from all three user groups succeeded in the usability questionnaire and had a positive rate of device handling, regardless of the environment and of the user group. No safety concerns were raised during the study.ConclusionsThis study found a very high level of usability and subject acceptance of the autoinjector, intended for methotrexate self-administration, regardless of the hand disability and environmental conditions.FundingNordic Group.Trial RegistrationEudraCT reference number: 2014-A0141245.

Introduction: Available short-acting intrathecal anesthetic agents (chloroprocaine and prilocaine) offer an alternative to general anesthesia for short-duration surgical procedures, especially ambulatory surgeries. Factors determining the choice of anesthesia for short-duration procedures have not been previously identified. Methods: This observational, prospective, multicenter, cohort study was conducted between July 2015 and July 2016, in 33 private or public hospitals performing ambulatory surgery. The primary objective was to determine the factors influencing the choice of anesthetic technique (spinal or general anesthesia). Secondary outcomes included efficacy of the anesthesia, time to hospital discharge, and patient satisfaction. Results: Among 592 patients enrolled, 309 received spinal anesthesia and 283 underwent general anesthesia. In both study arms, the most frequently performed surgical procedures were orthopedic and urologic (43.3% and 30.7%, respectively); 66.1% of patients were free to choose their type of anesthesia, 21.8% chose one of the techniques because they were afraid of the other, 16.8% based their choice on the expected ease of recovery, 19.2% considered their degree of anxiety/stress, and 16.9% chose the technique on the basis of its efficacy. The median times to micturition and to unassisted ambulation were significantly shorter in the general anesthesia arm compared with the Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.11210276.

Introduction The objective of the study was to compare compliance and acceptability of a new auto-injector (AI) versus syringe for administration of methotrexate (MTX) in patients with rheumatoid arthritis (RA). Methods We conducted a randomized, open-label, parallel group study comparing AI to pre-filled syringe (PFS). Adult patients with RA (ACR/EULAR 2010) receiving MTX (orally or by injection) for at least 3 months were allocated to AI or PFS for 6 months and then were allocated to AI for 6 further months. Two co-primary endpoints were defined at M6: percentage of patients with compliance at least 80%; change in functional capacity assessed by Health Assessment Questionnaire (HAQ). Secondary endpoints included quality of life (RaQoL), RA activity (DAS28), and acceptability. Local safety at injection site was assessed at each visit. Results Two-hundred and sixty-five patients were randomized. The main analysis was conducted on per protocol set (99 AI and 98 PFS). Compliance was 96.2% in AI and 98.9% in PFS. Good complier rates were 89.9% and 94.9%, thus a difference of − 5.0% (− 18.9%; 8.9%). HAQ remained stable in both groups. No difference was found on RaQoL, change in RA activity, and safety profile. Autonomy, acceptability, and patient satisfaction were better with AI, and patients having had the experience of both AI and PFS preferred AI ( p < 0.001). Conclusions Although this study did not demonstrate non-inferiority of AI versus PFS, compliance was excellent in the two groups, and AI, which was preferred by patients, is a valuable alternative to PFS for administration of MTX. Trial Registration ClinicalTrials.gov identifier, NCT02553018. Funding Nordic Pharma SAS.

Purpose The purpose of the APRIM study (for Adherence Polyarthrite Rhumatoïde Injection Methotrexate) was to investigate the change in treatment adherence of patients with rheumatic arthritis (RA) who switched from oral to subcutaneous methotrexate (MTX). Patients and Methods Prospective, observational study in RA patients treated with MTX and switching from oral to subcutaneous (SC) route in real-life conditions. Data on motivations for switch, disease activity (DAS28-CRP), quality of life (AISM-2 SF), disability (HAQ-DI), and adherence to MTX were collected at inclusion (M0) and 6 months later (M6). Adherence was assessed by the 8-item Morisky Medication Adherence Scale (MMAS-8) and defined as high (MMAS-8 = 8), medium (MMAS-8 = 6 or ≤8) or low (MMAS-8 < 6). The primary evaluation criterion was the proportion of patients who maintained strong adherence or improved adherence by at least one category (from low to medium or strong or from medium to strong) between M0 and M6. Results The analysis involved 207 patients (age 60.4±12.7 years, 75.2% females). 6.7% were in remission and 15.5% had low disease activity (LDA) at baseline. 58.5% reached the primary criterion and strong adherence rate increased from 42.0% to 50.7%. Change of route was combined with increased MTX dose in 34.8% of patients. Switch to SC route increased the proportion of patients with remission or LDA from 22.8% to 52.9% and increased quality of life even in patients with unchanged MTX dose. Conclusion Overall, change from oral to SC route improved adherence to MTX, RA control and quality of life independently of change in MTX dose.

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