Using a novel smartphone application for capturing of patient-reported outcome measures among patients with inflammatory arthritis:A randomized, crossover, agreement study

Abstract

Objectives: In Denmark, patients with inflammatory arthritis (IA) have completed patient-reported outcome measures (PROMs) via touchscreens in the outpatient clinic since 2006. However, current technology makes it possible for patients to use their own smartphone via an application (app) developed for the Danish Rheumatology Database (DANBIO). This study aims to evaluate the agreement of PROMs between the DANBIO app and outpatient touchscreen in patients with IA.

Method: Patients with IA (rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis) were enrolled in a randomized, crossover, agreement study. Participants answered PROMs through the two device types in a randomized order. Differences in PROM scores with 95% confidence intervals (CIs) were evaluated for similarity according to prespecified equivalence margins.

Results: The touchscreen invitation was accepted by 138 patients. Sixty patients (20 with each diagnosis) were included. The difference in Health Assessment Questionnaire Disability Index between the two device types was −0.007 (95% CI −0.043 to 0.030); thus, equivalence was demonstrated. In addition, all other PROMs obtained with the two device types were equivalent, except for the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), which was within the limits of minimally clinically important difference (MCID). In total, 78.3% preferred the DANBIO app.

Conclusion: In patients with IA, equivalence was demonstrated between two device types for all PROMs except BASDAI; however, BASDAI was within the limits of the MCID. Implementation of the DANBIO app is expected to optimize outpatient visits, thereby improving healthcare for the individual patient and society.

Acknowledgements

The authors thank the two patient research partners for their contribution to the trial and to the national implementation of the DANBIO app in Denmark. Furthermore, the authors thank Carsten Juhl for providing statistical assistance regarding commands in STATA. PCT thanks the National Institute of Health Research for their funding of The NIHR Biomedical Research Centre in Musculoskeletal Disease at Oxford University Hospitals NHS Trust and the University of Oxford.

Authors’ contributions

LU, SK, and AS conceived the trial hypothesis, and LU, SK, AS, EMH, and RC designed the trial. LU is the sponsor-investigator. NSK and MKA developed the DANBIO app and provided technical support. LU, SK, AS, EMH, RC, and LD were responsible for the conduct of the trial, data analyses, and publication. LU wrote this article, and SK, AS, LD, EMH, RC, NSK, MKA, and PCT contributed with refinement and approved the final draft.

This work was supported by Aalborg University Hospital (150 000 d.kr. in salary to LU). Zitelab ApS funded the development of the DANBIO app and has the ownership; however, the company had no influence on the study design, data collection, or data analyses, or on the writing or submission of this article. The Musculoskeletal Statistics Unit at the Parker Institute is supported by a core grant from the Oak Foundation [OCAY-18-774-OFIL].

Data availability statement

All data generated or analysed during this study are included in this published article (and its supplementary information files) clinicaltrials.gov/ct2/show/NCT03486613?cond=Psoriatic+Arthritis&cntry=DK&city=Aalborg&draw=2&rank=4.

Disclosure statement

LU: Speakers bureau (Abbvie, Eli Lilly, Novartis), RC: Honorarium paid to Parker Institute (Biogen, Celgene, Eli Lilly, LEO, Mundipharma, Novartis, Pfizer, Orkla Health) LD: Grants (BMS), Speakers bureau (Galderma), PT: Grants (Celgene, Eli Lilly, Galapagos, Gilead), Consultant (AbbVie, Biogen, Eli Lilly, Fresenius, Galapagos, Gilead, GlaxoSmithKline, Janssen, Nordic Pharma, Bristol-Myers Squibb, Pfizer, Roche, Sanofi), Speakers bureau (Biogen). AS, EMH, NSK, MKA and SK: no potential conflict of interest.

Ethics and consent

The study was approved by the Danish Data Protection Agency (2018-86) but did not require approval by the Ethics Committee (2018-000367) or by the Danish Medical Agency (2018011261). The trial was registered at clinicaltrials.gov (NCT03486613) on 3 April 2018, before the start of participant enrolment. The trial was conducted in compliance with the protocol and the Declaration of Helsinki. Written informed consent was obtained from all patients before enrolment.

Supplementary material

Supplemental data for this article can be accessed here