Novel optical spectral transmission (OST)-guided versus conventionally disease activity-guided treatment: study protocol of a randomized clinical trial on guidance of a treat-to-target strategy for early rheumatoid arthritis

Besselink, N.J.; Westgeest, Anton; Klaasen, Ruth; Gamala, Mihaela; Woerkom, J M van; Tekstra, Janneke; Verhoeven, Maxime M A; Spil, W.E. van; Lafeber, Floris P. J. G.; Marijnissen, A.C.; Laar, Jacob M van; Jacobs, Johannes W. G.

doi:10.1186/s13063-019-3285-8

Cited by 6 publications

(5 citation statements)

References 14 publications

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“…The HandScan is a device that measures within ~1.5 minutes inflammation of the wrist and small hand joints (i.e., metacarpophalangeal [MCP] 1–5, proximal interphalangeal [PIP] 1–5) using optical spectral transmission (OST) (5). Importantly, a HandScan measurement can be performed by a health care worker without a medical background (6). This procedure is more objective and less painful than assessment of joint counts.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Rheumatoid Arthritis Disease Activity Indices Including HandScan (Optical Spectral Transmission) Scores

Verhoeven

Westgeest²,

Schwarting

et al. 2022

Arthritis Care & Research

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Objective To develop and validate a composite rheumatoid arthritis (RA) disease activity index using optical spectral transmission (OST) scores obtained with the HandScan, replacing tender and swollen joint counts. Methods RA patients from a single center routinely undergoing HandScan measurements with at least 1 concurrent OST score and Disease Activity Score in 28 joints (DAS28) were included. Data were extracted from medical records. Linear regression analyses with the DAS28 as the outcome were performed to create a disease activity index (DAS‐OST). OST score, erythrocyte sedimentation rate (ESR), and patient global assessment (PtGA) visual analog scale (VAS), sex, age, disease duration, and rheumatoid factor status were evaluated as independent variables. Final models were derived based on the statistical significance of coefficients and model fit. Of the data, two‐thirds were used for development and one‐third for validation; external validation was performed in a cohort from another center. Agreement between DAS‐OST and DAS28 was assessed using the Bland‐Altman plot method and intraclass correlation coefficient (ICC). Diagnostic value of the DAS‐OST was determined for established definitions of remission, low disease activity (LDA), and high disease activity (HDA). Results Data of 3,358 observations from 1,505 unique RA patients were extracted. DAS‐OST was defined as: –0.44 + OST × 0.03 + male × –0.11 + LN(ESR) × 0.77 + PtGA VAS × 0.03. The ICCs between DAS‐OST and DAS28 were 0.88 (95% confidence interval [95% CI] 0.87–0.90) and 0.82 (95% CI 0.75–0.86) and measurement errors were 0.58 and 0.87 in internal and external validation, respectively. Sensitivity for remission, LDA, and HDA was 79%, 91%, and 43%, respectively, and specificity was 92%, 80%, and 96% in external validation. Conclusion Using the HandScan, RA disease activity can be accurately estimated if combined with ESR, PtGA VAS, and sex into a disease activity index (DAS‐OST).

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Section: Introductionmentioning

confidence: 99%

Development and Validation of Rheumatoid Arthritis Disease Activity Indices Including HandScan (Optical Spectral Transmission) Scores

Verhoeven

Westgeest²,

Schwarting

et al. 2022

Arthritis Care & Research

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“…total OST score). A HandScan measurement can be performed at any location, if the device is available, within 5 min, without taking much time of a health-care professional [ 6 ]. More detailed information is provided in Supplementary Data S1 , available at Rheumatology Advances in Practice online.…”

Section: Introductionmentioning

confidence: 99%

Utility of the HandScan in monitoring disease activity and prediction of clinical response in rheumatoid arthritis patients: an explorative study

Verhoeven

Tekstra

Marijnissen

et al. 2021

Rheumatology Advances in Practice

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Objectives To determine the ability of the HandScan (assessing inflammation in hand and wrist joints using optical spectral transmission, OST) to longitudinally measure RA disease activity compared to DAS28, and to determine whether short-term (i.e., 1 month) OST-score changes can predict treatment response at 3 or 6 months. Methods Participants visited the out-patient-clinic before start of (additional) RA-medication and 1, 3 and 6 months thereafter. Disease activity was monitored at each visit with the HandScan and DAS28 in parallel. A mixed effects model with DAS28 as outcome variable with a random intercept at patient level, visit month and DAS28 one visit earlier was used to evaluate whether OST-score changes are related to changes in DAS28. Binary logistic regression was used to test the predictive value of short-term OST-score changes together with baseline OST-score for achievement of treatment response (EULAR or ACR criteria). All models were adjusted for RA stage (early or established). Results In total 64 RA patients were included. One unit OST-score change was found to be related to an average DAS28 change of 0.03 (95%CI 0.01–0.06), p = 0.03. When adding OST-score as variable in the longitudinal model, the model’s ability to estimate DAS28 (i.e., explained variance) increased with 2%, to 59%. Neither baseline OST-score, nor short-term OST-score change was predictive for treatment response at 3 or at 6 months. Conclusion A longitudinal association of OST-score with DAS28 exists, although explained variance is low. The predictive ability of short-term changes in HandScan for treatment response is limited.

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“…Die Rolle des Handscan oder der OST als interpretationsunabhängiges Bildgebungsverfahren im Screening und bei der Diagnose von Arthritis wird in mehreren Studien hervorgehoben [22][23][24]. Die Perfusion hängt neben der Entzündungsaktivität von einer Vielzahl von Faktoren ab, auf die man durch dieses Verfahren Rückschlüsse ziehen kann, so möglicherweise auch über die Einschätzung der Lymphzirkulation.…”

Section: Materials Und Methodenunclassified

Handscupe: Ergonomische Handauflage bei Patient*innen mit rheumatischen Erkrankungen – eine explorative Pilotstudie

Marinoska,

Triantafyllias,

Dreher

et al. 2024

Physikalische Medizin, Rehabilitationsmedizin, Kurortmedizin

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Zusammenfassung Hintergrund Der „Handscupe“ ist eine ergonomische medizinische Handauflage, welche zur Verbesserung von Handfunktion und Symptomen von Patient*innen mit rheumatischen Erkrankungen entwickelt wurde. Material und Methoden Das Ziel dieser prospektiven, explorativen Kohortenstudie zum Medizinprodukt „Handscupe“ war es, die klinische Relevanz für rheumatologische Patient*innen zu erfassen. Der „Handscupe“ wurde von 30 Patient*innen während eines dreiwöchigen Rehabilitationsprogramms verwendet. Folgende Parameter wurden dabei erfasst: objektive Maße der Handfunktion, patientenerfasste Parameter (standardisierte Fragebögen) und subjektive Zufriedenheit basierend auf einer visuellen Analogskala. Darüber hinaus wurden bei jedem Termin Laborparameter und die Krankheitsaktivität bestimmt. Ergebnisse Über alle untersuchten Krankheitsentitäten hinweg waren 97% der Patient*innen zufrieden mit der Anwendung des „Handscupe“, obwohl weder die Arthrosonographie noch die Krankheitsaktivitätsscore eindeutige Veränderungen zeigten. Die Mehrheit der Patient*innen zeigte eine Zunahme der Handgriffstärke, eine Schmerzlinderung, eine Verbesserung des allgemeinen Wohlbefindens und es wurde eine Verbesserung des Handscan-Scores festgestellt. Schlussfolgerung Diese explorative Studie zeigte einen klinisch relevanten Nutzen der Verwendung des „Handscupe“ bei Patient*innen mit rheumatischen Erkrankungen. Die klinische Umgebung in einer Rehabilitationsabteilung trug dazu bei, die tägliche Anwendung und Compliance sicherzustellen. Die beobachteten Effekte müssen jedoch aufgrund der gleichzeitig durchgeführten multi-professionellen Rehabilitationsmaßnahmen mit Vorsicht interpretiert werden. Daher ist eine bestätigende prospektive klinische Studie über die Wirkungen geplant.

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Novel optical spectral transmission (OST)-guided versus conventionally disease activity-guided treatment: study protocol of a randomized clinical trial on guidance of a treat-to-target strategy for early rheumatoid arthritis

Cited by 6 publications

References 14 publications

Development and Validation of Rheumatoid Arthritis Disease Activity Indices Including HandScan (Optical Spectral Transmission) Scores

Development and Validation of Rheumatoid Arthritis Disease Activity Indices Including HandScan (Optical Spectral Transmission) Scores

Utility of the HandScan in monitoring disease activity and prediction of clinical response in rheumatoid arthritis patients: an explorative study

Handscupe: Ergonomische Handauflage bei Patient*innen mit rheumatischen Erkrankungen – eine explorative Pilotstudie

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