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1.
Trials ; 20(1): 226, 2019 Apr 17.
Article in English | MEDLINE | ID: mdl-30999969

ABSTRACT

BACKGROUND: Assessment of disease activity is a critical component of tight-control, treat-to-target treatment strategies of rheumatoid arthritis (RA). Recently, the HandScan has been validated as a novel method for objectively assessing RA disease activity in only 1.5 min, using optical spectral transmission (OST) in hands and wrists. We describe the protocol of a randomized controlled clinical trial (RCT) to investigate whether HandScan-guided treatment aimed at 'HandScan remission' (HandScan arm) is at least as effective as and more cost-effective than clinically guided treatment aimed at ACR/EULAR 2011 Boolean remission (DAS arm). METHODS/DESIGN: The study is a multi-center, double-blind, non-inferiority RCT of 18 months duration. Patients ≥ 18 years with newly diagnosed, disease-modifying antirheumatic drug (DMARD)-naïve RA according to the ACR 2010 classification criteria, will be randomized to the DAS arm or the HandScan arm. The efficacy of the arms will be compared by evaluating Health Assessment Questionnaire (HAQ) scores (primary outcome) after 18 months of DMARD therapy, aimed at remission. The equivalence margin in HAQ scores between study arms is 0.2. Secondary outcomes are differences in cost-effectiveness and radiographic joint damage between treatment arms. The non-inferiority sample size calculation to obtain a power of 80% at a one-sided p value of 0.05, with 10% dropouts, resulted in 61 patients per arm. In both arms, DMARD strategy will be intensified monthly according to predefined steps until remission is achieved; in both arms DMARDs and treatment steps are identical. If sustained remission, defined as remission that persists consistently over three consecutive months, is achieved, DMARD therapy will be tapered. DISCUSSION: The study protocol and the specifically designed decision-making software application allow for implementation of this RCT. To test a novel method of assessing disease activity and comparing (cost-)effectiveness with the contemporary method in treat-to-target DMARD strategies in early RA patients. TRIAL REGISTRATION: Dutch Trial Register, NTR6388. Registered on 6 April 2017 ( NL50026.041.14 ). Protocol version 3.0, 19-01-2017.


Subject(s)
Antirheumatic Agents/administration & dosage , Arthritis, Rheumatoid/drug therapy , Hand Joints/drug effects , Optical Imaging/methods , Wrist Joint/drug effects , Arthritis, Rheumatoid/diagnostic imaging , Arthritis, Rheumatoid/economics , Arthritis, Rheumatoid/physiopathology , Clinical Decision-Making , Cost-Benefit Analysis , Double-Blind Method , Equivalence Trials as Topic , Hand Joints/diagnostic imaging , Hand Joints/physiopathology , Health Care Costs , Humans , Multicenter Studies as Topic , Netherlands , Optical Imaging/economics , Predictive Value of Tests , Remission Induction , Severity of Illness Index , Time Factors , Treatment Outcome , Wrist Joint/diagnostic imaging , Wrist Joint/physiopathology
2.
PLoS One ; 14(2): e0209761, 2019.
Article in English | MEDLINE | ID: mdl-30794572

ABSTRACT

OBJECTIVE: To determine whether optical spectral transmission (OST) can be used to assess synovitis in hand and wrist joints of patients with hand osteoarthritis (OA). DESIGN: Hand and wrist joints of 47 primary hand OA patients with at least one clinically inflamed hand or wrist joint were assessed for synovitis by OST and ultrasound (US). Associations between standardized OST and US synovitis were studied in linear mixed effects models, across all joint types together and individually for wrist, proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints, and were adjusted for OA features that showed associations with US synovitis. Diagnostic performance was determined using receiver operator characteristic (ROC) curves analysis, with US as reference standard. RESULTS: Altogether, 6.7% of joints showed US synovitis. Statistically significant associations between OST scores and US synovitis were found for all joints combined (Δ0.37SD, p<0.001) and PIP joints (Δ0.81SD, p<0.001), but not for DIP (Δ0.14SD, p = 0.484) or wrist joints (Δ0.37SD, p = 0.178). All associations were independent of other OA features, i.e. osteophytes and dorsal vascularity. Analysis of diagnostic performance of OST, revealed an area under the ROC curve (AUC-ROC) of 0.74 for all joints together (p<0.001), 0.69 for PIP joints (p<0.001), 0.54 for DIP joints (p = 0.486), and 0.61 for wrist joints (p = 0.234). CONCLUSIONS: OST scores and US synovitis are statistically significantly associated, independent of osteophytes and dorsal vascularity. At this stage, OST performs fair in the assessment of synovitis in PIP joints of hand OA patients.


Subject(s)
Hand Joints/diagnostic imaging , Osteoarthritis/diagnostic imaging , Synovitis/diagnostic imaging , Aged , Female , Humans , Linear Models , Male , Middle Aged , Osteoarthritis/complications , ROC Curve , Synovitis/complications , Ultrasonography/methods
3.
Ann Rheum Dis ; 75(3): 511-8, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26452538

ABSTRACT

OBJECTIVES: In rheumatoid arthritis (RA), treat-to-target strategies require instruments for valid detection of joint inflammation. Therefore, imaging modalities are increasingly used in clinical practice. Optical spectral transmission (OST) measurements are non-invasive and fast and may therefore have benefits over existing imaging modalities. We tested whether OST could measure disease activity validly in patients with RA. METHODS: In 59 patients with RA and 10 patients with arthralgia, OST, joint counts, Disease Activity Score (DAS) 28 and ultrasonography (US) were performed. Additionally, MRI was performed in patients with DAS28<2.6. We developed and validated within the same cohort an algorithm for detection of joint inflammation by OST with US as reference. RESULTS: At the joint level, OST and US performed similarly inproximal interphalangeal-joints (area under the receiver-operating curve (AUC) of 0.79, p<0.0001) andmetacarpophalangeal joints (AUC 0.78, p<0.0001). Performance was less similar in wrists (AUC 0.62, p=0.006). On the patient level, OST correlated moderately with clinical examination (DAS28 r=0.42, p=0.001), and US scores (r=0.64, p<0.0001). Furthermore, in patients with subclinical and low disease activity, there was a correlation between OST and MRI synovitis score (RAMRIS (Rheumatoid Arthritis MRI Scoring) synovitis), r=0.52, p=0.005. CONCLUSIONS: In this pilot study, OST performed moderately in the detection of joint inflammation in patients with RA. Further studies are needed to determine the diagnostic performance in a new cohort of patients with RA.


Subject(s)
Arthritis, Rheumatoid/diagnosis , Hand Joints/pathology , Synovitis/diagnosis , Adult , Aged , Arthralgia/diagnosis , Case-Control Studies , Female , Hand Joints/diagnostic imaging , Humans , Magnetic Resonance Imaging , Male , Middle Aged , Optical Imaging , Pilot Projects , Severity of Illness Index , Spectrum Analysis , Ultrasonography
4.
Ned Tijdschr Geneeskd ; 152(12): 657-62, 2008 Mar 22.
Article in Dutch | MEDLINE | ID: mdl-18438058

ABSTRACT

Eosinophilic fasciitis (EF) is a disease with unknown aetiology, although an immunologic pathogenesis is suspected. The characteristic features of this inflammatory disease include scleroderma-like skin indurations, predominantly on the extremities, and peripheral blood eosinophilia. Internal organs are generally not affected. Initiation of systemic glucocorticoid therapy at an early stage results in a good response and remission of symptoms. This is illustrated in 3 cases of EF to demonstrate the importance of early detection in this disease.


Subject(s)
Eosinophilia/diagnosis , Fasciitis/diagnosis , Glucocorticoids/therapeutic use , Contracture/diagnosis , Contracture/etiology , Contracture/pathology , Eosinophilia/drug therapy , Eosinophilia/pathology , Fasciitis/drug therapy , Fasciitis/pathology , Female , Humans , Male , Middle Aged , Skin/pathology , Time Factors , Treatment Outcome
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