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

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

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).

Keywords: Digital health; Electronic patient reported outcomes; Mobile Apps; Rheumatoid arthritis.

Conflict of interest statement

See funding. HA, AB, DH, CN and RW declare that they have no competing interests. GC, JGR and MS received unrestricted grants from UCB Pharma. JGR received a speaker`s fee from UCB Pharma. MS was medical adviser for UCB Pharma.

Figures

Fig. 1
Fig. 1
Bland-Altman plots for HAQ at baseline (BL) and RADAI after 3 months

References

    1. Richter JG, Kampling C, Schneider M. Electronic patient reported outcome measures (e-PROMS) In: El Miedany Y, editor. Patient reported outcome measures in rheumatic diseases. Cham: Springer; 2016. pp. 371–388.
    1. USA FDA. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. December 2009. . Accessed 28 Jan 2021.
    1. Chua RM, Mecchella JN, Zbehlik AJ. Improving the measurement of disease activity for patients with rheumatoid arthritis: validation of an electronic version of the routine assessment of patient index data 3. Int J Rheumatol. 2015;2015:1–4. doi: 10.1155/2015/834070.
    1. 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–S68.
    1. Snyder CF, Aaronson NK. Use of patient-reported outcomes in clinical practice. Lancet. 2009;374(9687):369–370. doi: 10.1016/S0140-6736(09)61400-8.
    1. Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008;17(2):179–193. doi: 10.1007/s11136-007-9295-0.
    1. Azevedo A, de Sousa HM, Monteiro JA, Lima AR. Future perspectives of Smartphone applications for rheumatic diseases self-management. Rheumatol Int. 2015;35(3):419–431. doi: 10.1007/s00296-014-3117-9.
    1. 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.
    1. Luo D, Wang P, Lu F, Elias J, Sparks JA, Lee YC. Mobile Apps for individuals with rheumatoid arthritis: a systematic review. J Clin Rheumatol. 2019;25(3):133–141. doi: 10.1097/RHU.0000000000000800.
    1. 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. doi: 10.2196/19260.
    1. Gesetz für eine bessere Versorgung durch Digitalisierung und Innovation (Digitale-Versorgung-Gesetz - DVG) vom 18.12.2019. BGBl Teil I Nr. 49:2562.
    1. Gwaltney CJ, Shields AL, Shiffman S. Equivalence of electronic and paper-and-pencil administration of patient-reported outcome measures: a meta-analytic review. Value Health. 2008;11(2):322–33. 10.1111/j.1524-4733.2007.00231.x.
    1. Richter JG, Becker A, Koch T, Nixdorf M, Willers R, Monser R, Schacher B, Alten R, Specker C, Schneider M. Self-assessments of patients via tablet PC in routine patient care: comparison with standardised paper questionnaires. Ann Rheum Dis. 2008;67(12):1739–1741. doi: 10.1136/ard.2008.090209.
    1. 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. doi: 10.1186/s12955-015-0362-x.
    1. 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.
    1. 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):419–429. doi: 10.1111/j.1524-4733.2008.00470.x.
    1. Wang J, Wang Y, Wei C, Yao NA, Yuan A, Shan Y, Yuan C. Smartphone interventions for long-term health management of chronic diseases: an integrative review. Telemed J E Health. 2014;20(6):570–583. doi: 10.1089/tmj.2013.0243.
    1. Lautenschlager J, Mau W, Kohlmann T, Raspe HH, Struve F, Bruckle W, Zeidler H. Comparative evaluation of a German version of the Health Assessment Questionnaire and the Hannover Functional Capacity Questionnaire. Z Rheumatol. 1997;56(3):144–155. doi: 10.1007/s003930050030.
    1. Stucki G, Liang MH, Stucki S, Bruhlmann P, Michel BA. A self-administered rheumatoid arthritis disease activity index (RADAI) for epidemiologic research. Psychometric properties and correlation with parameters of disease activity. Arthritis Rheum. 1995;38(6):795–798. doi: 10.1002/art.1780380612.
    1. 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. pp. 9–11.
    1. Behrens F, Koehm M, Schwaneck EC, Schmalzing M, Gnann H, Greger G, Tony HP, Burkhardt H. Use of a “critical difference” statistical criterion improves the predictive utility of the Health Assessment Questionnaire-Disability Index score in patients with rheumatoid arthritis. BMC Rheumatol. 2019;3(1):51. doi: 10.1186/s41927-019-0095-2.
    1. Campbell N, Ali F, Finlay AY, Salek SS. Equivalence of electronic and paper-based patient-reported outcome measures. Qual Life Res. 2015;24(8):1949–1961. doi: 10.1007/s11136-015-0937-3.
    1. Muehlhausen W, Byrom B, Skerritt B, McCarthy M, McDowell B, Sohn J. Standards for instrument migration when implementing paper patient-reported outcome instruments electronically: recommendations from a qualitative synthesis of cognitive interview and usability studies. Value Health. 2018;21(1):41–48. doi: 10.1016/j.jval.2017.07.002.
    1. 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):581–589. doi: 10.1016/j.jval.2017.10.008.
    1. 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.
    1. 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. doi: 10.1136/rmdopen-2019-001014.
    1. 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):454–460. doi: 10.1002/art.22613.
    1. Walker UA, Mueller RB, Jaeger VK, Theiler R, Forster A, Dufner P, Ganz F, Kyburz D. Disease activity dynamics in rheumatoid arthritis: patients’ self-assessment of disease activity via WebApp. Rheumatology (Oxford) 2017;56(10):1707–1712. doi: 10.1093/rheumatology/kex229.
    1. Salaffi F, Di Carlo M, Carotti M, Farah S, Gutierrez M. The Psoriatic Arthritis Impact of Disease 12-item questionnaire: equivalence, reliability, validity, and feasibility of the touch-screen administration versus the paper-and-pencil version. Ther Clin Risk Manag. 2016;12:631–642. doi: 10.2147/TCRM.S101619.
    1. 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. 10.1111/hex.12478. Epub 2016 Jun 27.
    1. 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. doi: 10.2196/20165.
    1. Williams CA, Templin T, Mosley-Williams AD. Usability of a computer-assisted interview system for the unaided self-entry of patient data in an urban rheumatology clinic. J Am Med Inform Assoc. 2004;11(4):249–259. doi: 10.1197/jamia.M1527.
    1. Azevedo A, Bernardes M, Fonseca J, Lima A. Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients’ needs. Rheumatol Int. 2015;35(10):1675–1685. doi: 10.1007/s00296-015-3270-9.
    1. Geuens J, Geurts L, Swinnen TW, Westhovens R, Vanden AV. Mobile health features supporting self-management behavior in patients with chronic arthritis: mixed-methods approach on patient preferences. JMIR Mhealth Uhealth. 2019;7(3):e12535. doi: 10.2196/12535.
    1. Najm A, Lempp H, Gossec L, Berenbaum F, Nikiphorou E. Needs, experiences, and views of people with rheumatic and musculoskeletal diseases on self-management mobile health apps: mixed methods study. JMIR Mhealth Uhealth. 2020;8(4):e14351. doi: 10.2196/14351.
    1. Bischoff-Ferrari HA. Validation and patient acceptance of a computer touch screen version of the WOMAC 3.1 osteoarthritis index. Ann Rheum Dis. 2005;64(1):80–84. doi: 10.1136/ard.2003.019307.
    1. Bennett AV, Jensen RE, Basch E. Electronic patient-reported outcome systems in oncology clinical practice. CA Cancer J Clin. 2012;62:336–347. doi: 10.3322/caac.21150.
    1. Chung AE, Basch EM. Incorporating the patient’s voice into electronic health records through patient-reported outcomes as the “review of systems”. J Am Med Inform Assoc. 2015;22(4):914–916. doi: 10.1093/jamia/ocu007.
    1. Jensen RE, Rothrock NE, DeWitt EM, Spiegel B, Tucker CA, Crane HM, et al. The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care. Med Care. 2015;53(2):153–159. doi: 10.1097/MLR.0000000000000289.
    1. Sternfeld B, Jiang S, Picchi T, Chasan-Taber L, Ainsworth B, Quesenberry CP. Evaluation of a cell phone–based physical activity diary. Med Sci Sports Exerc. 2012;44(3):487–495. doi: 10.1249/MSS.0b013e3182325f45.
    1. Bastyr EJ, Zhang S, Mou J, Hackett AP, Raymond SA, Chang AM. Performance of an electronic diary system for intensive insulin management in global diabetes clinical trials. Diabetes Technol Ther. 2015;17(8):571–579. doi: 10.1089/dia.2014.0407.
    1. Domańska B, Vansant S, Mountian I. A companion app to support rheumatology patients treated with Certolizumab Pegol: results from a usability study. JMIR Form Res. 2020;4(7):e17373. doi: 10.2196/17373.
    1. Hirsch IB, Parkin CG. Unknown safety and efficacy of smartphone bolus calculator apps puts patients at risk for severe adverse outcomes. J Diabetes Sci Technol. 2016;10(4):977–980. doi: 10.1177/1932296815626457.
    1. Bundesinstitut für Arzneimittel und Medizinprodukte. Orientierungshilfe Medical Apps. 2015. . Accessed 28 Jan 2021.
    1. 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).
    1. Klasnja P, Pratt W. Healthcare in the pocket: mapping the space of mobile-phone health interventions. J Biomed Inform. 2012;45(1):184–198. doi: 10.1016/j.jbi.2011.08.017.
    1. Kristjansdottir OB, Børøsund E, Westeng M, Ruland C, Stenberg U, Zangi HA, Stange K, Mirkovic J. Mobile app to help people with chronic illness reflect on their strengths: formative evaluation and usability testing. JMIR Form Res. 2020;4(3):e16831. doi: 10.2196/16831.

Source: PubMed

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