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Validation and predictive capacity of a Dutch version of the FLARE-RA questionnaire within the context of a TNFi-tapering trial

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A LETTER TO THE EDITOR to this article was published on 28 September 2023

Abstract

Flare Assessment in Rheumatoid Arthritis (FLARE-RA) is a self-administered tool aiming to capture current or recent flares in rheumatoid arthritis (RA). We aimed to externally validate the FLARE-RA instrument and its existing cutoffs for flare detection within a bDMARD-tapering context in established RA. Data were analyzed from the Tapering Etanercept in Rheumatoid Arthritis (TapERA) trial, which studied the feasibility of tapering etanercept in patients with established RA in sustained remission. The English FLARE-RA was translated and cross-culturally adapted into Dutch, and internal consistency and test–retest reliability were evaluated with Crohnbach’s alpha and intraclass correlation coefficient (ICC). Participants completed the FLARE-RA 3-monthly for 12 months. Accuracy and optimal cutoffs of FLARE-RA to detect DAS28-defined flares were assessed using area under the receiver operating characteristic curves (AUC). Association of FLARE-RA scores with current and future flares was studied using logistic generalized estimating equations (GEE). The Dutch FLARE-RA showed excellent internal consistency and test–retest reliability (Cronbach’s alpha 0.96; ICC 0.96 [95% CI 0.70–1.00]). Discriminatory capacity of FLARE-RA to detect flares was acceptable (AUC 0.77, 0.80, and 0.72 for global, arthritis, and general symptoms subscales, respectively), with an optimal global score cutoff of 4/10. In GEE-models, higher FLARE-RA scores were associated with increased odds of both current and future flares. We successfully translated and cross-culturally adapted the FLARE-RA into a Dutch version and validated its capacity to detect flares in a bDMARD-tapering context in established RA. Finally, higher FLARE-RA scores might indicate an increased risk of future flares.

Trial registration: EU Clinical Trials Register, https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004631-22/BE, EudraCT number 2012–004,631-22.

Key Points

• Translation and cross-cultural adaptation of the FLARE-RA resulted in a Dutch version with excellent internal consistency and test–retest reliability.

• The FLARE-RA is a valid instrument to detect current OMERACT-defined flares within a bDMARD tapering setting, with an optimal global score cutoff of 4/10.

• Higher scores on the FLARE-RA are associated with increased risk of future flares, which could be particularly relevant when considering DMARD tapering.

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Acknowledgements

We would like to show our gratitude to all the participants of the TapERA trial, as well as the investigators and staff of the including centers: University Hospitals Leuven, Reuma Instituut Hasselt, Heilig Hart Ziekenhuis Leuven, ZNA Jan Palfijn Antwerpen, GZA Sint- Augustinus Antwerpen, and ULB Hôpital Erasme Bruxelles.

Funding

MD has received a Strategic Basic Research Fellowship grant from Fonds Wetenschappelijk Onderzoek (FWO) (grant number 1S85521N). No financial funding was received for the trial itself.

Author information

Author notes

  1. Michaël Doumen and Delphine Bertrand contributed equally.

Authors and Affiliations

  1. Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Herestraat 49, 3000, Leuven, Belgium

    Michaël Doumen, Delphine Bertrand, Sofia Pazmino, Diederik De Cock, Veerle Stouten, Johan Joly, René Westhovens & Patrick Verschueren

  2. KU Leuven University Hospitals Leuven, Leuven, Belgium

    Michaël Doumen, René Westhovens & Patrick Verschueren

  3. Biostatistics and Medical Informatics Research Group, Department of Public Health, Vrije Universiteit Brussel, Brussels, Belgium

    Diederik De Cock

  4. Department of Epidemiology and Public Health, Sciensano, Brussels, Belgium

    Veerle Stouten

  5. Reuma Instituut Hasselt, Hasselt, Belgium

    Isabelle de Wergifosse

  6. VITAZ Sint-Niklaas Moerland, Sint-Niklaas, Belgium

    Anneleen Moeyersoons

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  1. Michaël Doumen
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Correspondence to Michaël Doumen.

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The study protocol (S54805) was approved by the University Hospitals Leuven Ethics Committee.

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Doumen, M., Bertrand, D., Pazmino, S. et al. Validation and predictive capacity of a Dutch version of the FLARE-RA questionnaire within the context of a TNFi-tapering trial. Clin Rheumatol 42, 39–45 (2023). https://doi.org/10.1007/s10067-022-06320-x

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