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Published in: Arthritis Research & Therapy 1/2021

01-12-2021 | Rheumatoid Arthritis | Research article

Mobile App-based documentation of patient-reported outcomes — 3-months results from a proof-of-concept study on modern rheumatology patient management

Authors: Jutta G. Richter, Christina Nannen, Gamal Chehab, Hasan Acar, Arnd Becker, Reinhart Willers, Dörte Huscher, Matthias Schneider

Published in: Arthritis Research & Therapy | Issue 1/2021

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Abstract

Background

Mobile medical applications (Apps) offer innovative solutions for patients’ self-monitoring and new patient management opportunities. Prior to routine clinical application feasibility and acceptance of disease surveillance using an App that includes electronic (e) patient-reported outcome measures (PROMs) warrant evaluation. Therefore, we performed a proof-of-concept study in which rheumatoid arthritis (RA) patients used an App (RheumaLive) to document their disease.

Methods

Accurate PROM reporting via an App in comparison to paper-based versions was investigated to exclude media bias. Sixty participants recruited from 268 consecutive RA outpatients completed paper-based and electronic PROMs (Hannover Functional Questionnaire/derived HAQ; modified RA disease activity index) using the App at baseline and follow-up visits. Between visits, patients used their App on their own smartphone according to their preferences. The equivalence of PROM data and user experiences from patients and physicians were evaluated.

Results

Patients’ (78.3% female) mean (SD) age was 50.1 (13.1) years, disease duration 10.5 (9.1) years, and paper-based HAQ 0.78 (0.59). Mean confidence in Apps scored 3.5 (1.1, Likert scale 1 to 6). ePROMs’ scores obtained by patients’ data entry in the App were equivalent to paper-based ones and preferred by the patients. After 3 months, the App retention rate was 71.7%. Patients' overall satisfaction with the App was 2.2 (0.9, Likert scale 1 to 6). Patients and physicians valued the App, i.e., for patient-physician interaction: 87% reported that it was easier for them to document the course of the disease using the App than “only” answering questions about their current health during routine outpatient visits. Further App use was recommended in 77.3% of the patients, and according to physicians, in seven patients, the App use contributed to an increased adherence to therapy.

Conclusion

Our study provides an essential basis for the broader implementation of medical Apps in routine care. We demonstrated the feasibility and acceptance of disease surveillance using a smartphone App in RA. App use was convincing as a reliable option to perform continuous, remote monitoring of disease activity and treatment efficacy.

Trial registration

ClinicalTrials.gov, NCT02565225. Registered on September 16, 2015 (retrospectively registered).
Literature
3.
4.
go back to reference Richter JG, Chehab G, Schneider M. Electronic health records in rheumatology: emphasis on automated scoring and additional use. Clin Exp Rheumatol. 2016;34(5 Suppl 101):S62–8.PubMed Richter JG, Chehab G, Schneider M. Electronic health records in rheumatology: emphasis on automated scoring and additional use. Clin Exp Rheumatol. 2016;34(5 Suppl 101):S62–8.PubMed
8.
go back to reference Grainger R, Townsley H, Langlotz T, Taylor W. Patient-clinician co-design co-participation in design of an app for rheumatoid arthritis management via telehealth yields an app with high usability and acceptance. Stud Health Technol Inform. 2017;245:1223.PubMed Grainger R, Townsley H, Langlotz T, Taylor W. Patient-clinician co-design co-participation in design of an app for rheumatoid arthritis management via telehealth yields an app with high usability and acceptance. Stud Health Technol Inform. 2017;245:1223.PubMed
10.
go back to reference Seppen BF, den Boer P, Wiegel J, Ter Wee MM, van der Leeden M, de Vries R, et al. Asynchronous mHealth interventions in rheumatoid arthritis: systematic scoping review. JMIR Mhealth Uhealth. 2020;8:e19260.CrossRefPubMedPubMedCentral Seppen BF, den Boer P, Wiegel J, Ter Wee MM, van der Leeden M, de Vries R, et al. Asynchronous mHealth interventions in rheumatoid arthritis: systematic scoping review. JMIR Mhealth Uhealth. 2020;8:e19260.CrossRefPubMedPubMedCentral
14.
go back to reference Muehlhausen W, Doll H, Quadri N, Fordham B, O’Donohoe P, Dogar N, Wild DJ. Equivalence of electronic and paper administration of patient-reported outcome measures: a systematic review and meta-analysis of studies conducted between 2007 and 2013. Health Qual Life Outcomes. 2015;13:46.CrossRef Muehlhausen W, Doll H, Quadri N, Fordham B, O’Donohoe P, Dogar N, Wild DJ. Equivalence of electronic and paper administration of patient-reported outcome measures: a systematic review and meta-analysis of studies conducted between 2007 and 2013. Health Qual Life Outcomes. 2015;13:46.CrossRef
15.
go back to reference Marcano Belisario JS, Jamsek J, Huckvale K, O'Donoghue J, Morrison CP, Car J. Comparison of self-administered survey questionnaire responses collected using mobile apps versus other methods. Cochrane Database Syst Rev. 2015;7:MR000042. Marcano Belisario JS, Jamsek J, Huckvale K, O'Donoghue J, Morrison CP, Car J. Comparison of self-administered survey questionnaire responses collected using mobile apps versus other methods. Cochrane Database Syst Rev. 2015;7:MR000042.
16.
go back to reference Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, Lenderking WR, Cella D, Basch E, ISPOR ePRO Task Force. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO good research practices task force report. Value Health. 2009;12(4):419–29. https://doi.org/10.1111/j.1524-4733.2008.00470.x.CrossRefPubMed Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, Lenderking WR, Cella D, Basch E, ISPOR ePRO Task Force. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO good research practices task force report. Value Health. 2009;12(4):419–29. https://​doi.​org/​10.​1111/​j.​1524-4733.​2008.​00470.​x.CrossRefPubMed
20.
go back to reference Andresen J, Hülsemann JL. Rheumatoide Arthritis. In: Kuipers JG, Zeidler H, Köhler L, editors. Medal Rheumatologie. Kriterien für die Klassifikation, Diagnose, Aktivität und Prognose rheumatologischer Erkrankungen. Friedrichshafen: Wiskon; 2006. p. 9–11. Andresen J, Hülsemann JL. Rheumatoide Arthritis. In: Kuipers JG, Zeidler H, Köhler L, editors. Medal Rheumatologie. Kriterien für die Klassifikation, Diagnose, Aktivität und Prognose rheumatologischer Erkrankungen. Friedrichshafen: Wiskon; 2006. p. 9–11.
24.
go back to reference Byrom B, Doll H, Muehlhausen W, Flood E, Cassedy C, McDowell B, Sohn J, Hogan K, Belmont R, Skerritt B, McCarthy M. Measurement equivalence of patient-reported outcome measure response scale types collected using bring your own device compared to paper and a provisioned device: results of a randomized equivalence trial. Value Health. 2018;21(5):581–9. https://doi.org/10.1016/j.jval.2017.10.008.CrossRefPubMed Byrom B, Doll H, Muehlhausen W, Flood E, Cassedy C, McDowell B, Sohn J, Hogan K, Belmont R, Skerritt B, McCarthy M. Measurement equivalence of patient-reported outcome measure response scale types collected using bring your own device compared to paper and a provisioned device: results of a randomized equivalence trial. Value Health. 2018;21(5):581–9. https://​doi.​org/​10.​1016/​j.​jval.​2017.​10.​008.CrossRefPubMed
25.
go back to reference Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
26.
go back to reference Najm A, Nikiphorou E, Kostine M, Richez C, Pauling JD, Finckh A, Ritschl V, Prior Y, Balážová P, Stones S, Szekanecz Z, Iagnocco A, Ramiro S, Sivera F, Dougados M, Carmona L, Burmester G, Wiek D, Gossec L, Berenbaum F. EULAR points to consider for the development, evaluation and implementation of mobile health applications aiding self-management in people living with rheumatic and musculoskeletal diseases. RMD Open. 2019;5(2):e001014. https://doi.org/10.1136/rmdopen-2019-001014.CrossRefPubMedPubMedCentral Najm A, Nikiphorou E, Kostine M, Richez C, Pauling JD, Finckh A, Ritschl V, Prior Y, Balážová P, Stones S, Szekanecz Z, Iagnocco A, Ramiro S, Sivera F, Dougados M, Carmona L, Burmester G, Wiek D, Gossec L, Berenbaum F. EULAR points to consider for the development, evaluation and implementation of mobile health applications aiding self-management in people living with rheumatic and musculoskeletal diseases. RMD Open. 2019;5(2):e001014. https://​doi.​org/​10.​1136/​rmdopen-2019-001014.CrossRefPubMedPubMedCentral
27.
go back to reference Heiberg T, Kvien TK, Dale Ø, Mowinckel P, Aanerud GJ, Songe-Møller AB, Uhlig T, Hagen KB. Daily health status registration (patient diary) in patients with rheumatoid arthritis: a comparison between personal digital assistant and paper-pencil format. Arthritis Rheum. 2007;57(3):454–60. https://doi.org/10.1002/art.22613.CrossRefPubMed Heiberg T, Kvien TK, Dale Ø, Mowinckel P, Aanerud GJ, Songe-Møller AB, Uhlig T, Hagen KB. Daily health status registration (patient diary) in patients with rheumatoid arthritis: a comparison between personal digital assistant and paper-pencil format. Arthritis Rheum. 2007;57(3):454–60. https://​doi.​org/​10.​1002/​art.​22613.CrossRefPubMed
30.
go back to reference de Souza S, Galloway J, Simpson C, Chura R, Dobson J, Gullick NJ, et al. Patient involvement in rheumatology outpatient service design and delivery: a case study. Health Expect. 2017;20(3):508–18. https://doi.org/10.1111/hex.12478. Epub 2016 Jun 27. de Souza S, Galloway J, Simpson C, Chura R, Dobson J, Gullick NJ, et al. Patient involvement in rheumatology outpatient service design and delivery: a case study. Health Expect. 2017;20(3):508–18. https://​doi.​org/​10.​1111/​hex.​12478. Epub 2016 Jun 27.
31.
go back to reference Seppen BF, Wiegel J, L'ami MJ, Duarte Dos Santos Rico S, Catarinella FS, Turkstra F, et al. Feasibility of Self-monitoring rheumatoid arthritis with a Smartphone App: results of two mixed-methods pilot studies. JMIR Form Res. 2020;4:e20165.CrossRefPubMedPubMedCentral Seppen BF, Wiegel J, L'ami MJ, Duarte Dos Santos Rico S, Catarinella FS, Turkstra F, et al. Feasibility of Self-monitoring rheumatoid arthritis with a Smartphone App: results of two mixed-methods pilot studies. JMIR Form Res. 2020;4:e20165.CrossRefPubMedPubMedCentral
37.
go back to reference Bennett AV, Jensen RE, Basch E. Electronic patient-reported outcome systems in oncology clinical practice. CA Cancer J Clin. 2012;62:336–47.CrossRef Bennett AV, Jensen RE, Basch E. Electronic patient-reported outcome systems in oncology clinical practice. CA Cancer J Clin. 2012;62:336–47.CrossRef
45.
go back to reference Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance). Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).
Metadata
Title
Mobile App-based documentation of patient-reported outcomes — 3-months results from a proof-of-concept study on modern rheumatology patient management
Authors
Jutta G. Richter
Christina Nannen
Gamal Chehab
Hasan Acar
Arnd Becker
Reinhart Willers
Dörte Huscher
Matthias Schneider
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Arthritis Research & Therapy / Issue 1/2021
Electronic ISSN: 1478-6362
DOI
https://doi.org/10.1186/s13075-021-02500-3

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