Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)

Reginster, Jean-Yves; Arden, N K; Haugen, Ida K.; Rannou, François; Cavalier, Étienne; Bruyère, Olivier; Branco, Jaime; Chapurlat, Roland; Basset, Sabine Collaud; Al-Daghri, Nasser M.; Dennison, Elaine; Herrero‐Beaumont, Gabriel; Laslop, Andrea; Leeb, Burkhard F.; Maggi, Stefania; Mkinsi, Ouafa; Повзун, А С; Prieto‐Alhambra, Daniel; Thomas, Thierry; Uebelhart, Daniel; Veronese, Nicola; Cooper, Cyrus

doi:10.1016/j.semarthrit.2017.12.003

Cited by 25 publications

(35 citation statements)

References 58 publications

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“…Osteoarthritis and Musculoskeletal Diseases (ESCEO) [32,33]. Introducing the FIHOA to Japan will not only stimulate Japanese research but also add to the cumulative knowledge of hand OA.…”

Section: International (Oarsi) and European Society On Clinical And Ementioning

confidence: 99%

Cross-cultural translation, adaptation and validation of a Japanese version of the Functional Index for Hand Osteoarthritis (J-FIHOA)

Nakagawa

Kurimoto

Maheu

et al. 2020

Preprint

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Background: Hand osteoarthritis (OA) has a wide spectrum of clinical presentations and physical function is one of the core domains where patients suffer. The Functional Index for Hand Osteoarthritis (FIHOA) is a leading assessment tool for hand dysfunction. Our objective was to make a Japanese version of FIHOA (J-FIHOA) and validate it among Japanese hand OA patients. Methods: Forward and backward translation processes were completed to create a culturally adapted J-FIHOA. A prospective, observational multicenter study was undertaken for the validation process. Seventeen collaborating hospitals recruited Japanese hand OA patients who met the American College of Rheumatology criteria. A medical record review and responses to the following patient-rated questionnaires were collected: J-FIHOA, Hand20, Health Assessment Questionnaire (HAQ), numerical rating scale for pain (NRS pain) and Short Form 36 Health Survey (SF-36). We explored the structure of J-FIHOA using factor analysis. Cronbach’s alpha coefficients and item-total correlations were calculated. Correlations between J-FIHOA and other questionnaires were evaluated for construct validity. Participants in clinically stable conditions repeated J-FIHOA at a one- to two-week interval to assess test-retest reliability. To evaluate responsiveness, symptomatic patients who started new pharmacological treatments had a 1-month follow-up visit and completed the questionnaires twice. Effect size (ES) and standardized response mean (SRM) were calculated with pre- and post-treatment data sets. We assessed responsiveness, comparing ES and SRM of J-FIHOA with other questionnaires (construct approach). Results: A total of 210 patients participated. J-FIHOA had unidimensional structure. Cronbach’s alphas (0.914 among females and 0.929 among males) and item-total correlations (range, 0.508 to 0.881) revealed high internal consistency. Hand20, which measures upper extremity disability, was strongly correlated with J-FIHOA (r=0.82) while the mental and role-social component of SF-36 showed no correlations (r=−0.24 and −0.26, respectively). Intraclass correlation coefficient for test-retest reliability was 0.83 and satisfactory. J-FIHOA showed the highest ES and SRM (−0.68 and −0.62, respectively) among all questionnaires, except for NRS pain. Conclusions: Our results showed J-FIHOA had good measurement properties to assess physical dysfunction in Japanese patients both for ambulatory follow-up in clinical practice, and clinical research and therapeutic trials.

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“…Osteoarthritis and Musculoskeletal Diseases (ESCEO) [32,33]. Introducing the FIHOA to Japan will not only stimulate Japanese research but also add to the cumulative knowledge of hand OA.…”

Section: International (Oarsi) and European Society On Clinical And Ementioning

confidence: 99%

Cross-cultural translation, adaptation and validation of a Japanese version of the Functional Index for Hand Osteoarthritis (J-FIHOA)

Nakagawa

Kurimoto

Maheu

et al. 2020

Preprint

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“…Treatment and rehabilitation for severe acute musculoskeletal injuries or chronic mobility disorders can take many years [11,12]. It is therefore important to demonstrate that high density, high compliance monitoring in an uncontrolled environment is possible over such a time.…”

Section: Participant Compliancementioning

confidence: 99%

Continuous Monitoring of Patient Mobility for 18 Months Using Inertial Sensors following Traumatic Knee Injury: A Case Study

et al. 2018

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Continuous patient activity monitoring during rehabilitation, enabled by digital technologies, will allow the objective capture of real-world mobility and aligning treatment to each individual’s recovery trajectory in real time. To explore the feasibility and added value of such approaches, we present a case study of a 36-year-old male participant monitored continuously for activity levels and gait parameters using a waist-worn inertial sensor following a tibial plateau fracture on the right side, sustained as a result of a high-energy trauma during a sporting accident. During rehabilitation, data were collected for a period of 553 days, with > 80% daytime compliance, until the participant returned to near full mobility. The participant completed a daily diary with the annotation of major events (falls, near falls, cycling periods, or physiotherapy sessions) and key dates in the patient’s recovery, including medical interventions, transitioning off crutches, and returning to work. We demonstrate the feasibility of collecting, storing, and mining of continuous digital mobility data and show that such data can detect changes in mobility and provide insights into long-term rehabilitation. We make both raw data and annotations available as a resource with the aspiration that further methods and insights will be built on this initial exploration of added value and continue to demonstrate that continuous monitoring can be deployed to aid rehabilitation.

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“…Терапия структурно-модифицирующими препаратами замедленного действия (Symptomatic slow acting drugs for OA -SYSADOA) на сегодняшний день является ключевым методом управления остеоартритом (ОА) [1]. Вместе с тем продолжается дискуссия относительно эффективности применения SYSADOA у больных ОА.…”

Section: Introductionunclassified

Effectiveness of drugs with delayed-release structurally modified action depending on the phenotype of osteoarthritis

Кабалык

2020

Medicinskij sovet

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Aim. To evaluate the effectiveness of a fixed combination of honadroitin and glucosamine sulfate (Teraflex, Bayer) in the treatment of osteoarthritis (OA), depending on the molecular phenotype of the disease.Materials and methods. A 6-month prospective, open, randomized trial included 65 patients with OA of the knee joints who were prescribed therapy with Teraflex (Bayer) daily dose of 1500 mg + 1200 mg. Kinetic assessment of articular status was performed using a visual analogue pain scale and a WOMAC questionnaire, and serum concentrations of CRTAP (cartilage-associated protein), OSGIN-1 (oxidative stress-induced growth inhibitor 1), IL-1β (interleukin-1 beta) were determined in blood serum. Measurements of these parameters were made at the beginning of the study, after 3 and 6 months.Results. It was established that the rate of onset of the therapeutic effect and the effect on the molecular patterns of inflammation and oxidative stress depend on the phenotype of the disease. So, with oxidative and mixed phenotypes of the disease, clinical efficacy is observed in the treatment of teraflex after 3 months from the start of therapy. Indicators of oxidative stress during treatment decreased in the group of patients with the oxidative phenotype of the disease, while the level of interleukin-1 significantly decreased only in groups of patients with inflammatory and mixed OA phenotypes.Conclusions. The results indicate the effectiveness and safety of the drug Teraflex (Bayer) for the treatment of patients with OA. The results of the study indicate the targeted effect of a fixed combination of chondroitin + glucosamine on the molecular mechanisms of the disease.

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Guidelines for the conduct of pharmacological clinical trials in hand osteoarthritis: Consensus of a Working Group of the European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO)

Abstract: While the working group acknowledges that the methodology for performing clinical trials in hand OA will evolve as knowledge of the disease increases, it is hoped that this guidance will support the development of new pharmacological treatments targeting hand OA.

Cited by 25 publications

References 58 publications

Cross-cultural translation, adaptation and validation of a Japanese version of the Functional Index for Hand Osteoarthritis (J-FIHOA)

Cross-cultural translation, adaptation and validation of a Japanese version of the Functional Index for Hand Osteoarthritis (J-FIHOA)

Continuous Monitoring of Patient Mobility for 18 Months Using Inertial Sensors following Traumatic Knee Injury: A Case Study

Effectiveness of drugs with delayed-release structurally modified action depending on the phenotype of osteoarthritis

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