Mobile App-based documentation of patient-reported outcomes — 3-months results from a proof-of-concept study on modern rheumatology patient management
Tóm tắt
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. 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. 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. 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. ClinicalTrials.gov, NCT02565225 . Registered on September 16, 2015 (retrospectively registered).
Tài liệu tham khảo
citation_title=Electronic patient reported outcome measures (e-PROMS); citation_inbook_title=Patient reported outcome measures in rheumatic diseases; citation_publication_date=2016; citation_pages=371-388; citation_id=CR1; citation_author=JG Richter; citation_author=C Kampling; citation_author=M Schneider; citation_publisher=Springer
USA FDA. Guidance for industry patient-reported outcome measures: use in medical product development to support labeling claims. December 2009.
https://www.fda.gov/downloads/drugs/guidances/ucm193282.pdf
. Accessed 28 Jan 2021.
citation_journal_title=Int J Rheumatol; citation_title=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; citation_author=RM Chua, JN Mecchella, AJ Zbehlik; citation_volume=2015; citation_publication_date=2015; citation_pages=1-4; citation_doi=10.1155/2015/834070; citation_id=CR3
citation_journal_title=Clin Exp Rheumatol; citation_title=Electronic health records in rheumatology: emphasis on automated scoring and additional use; citation_author=JG Richter, G Chehab, M Schneider; citation_volume=34; citation_issue=5 Suppl 101; citation_publication_date=2016; citation_pages=S62-S68; citation_id=CR4
citation_journal_title=Lancet; citation_title=Use of patient-reported outcomes in clinical practice; citation_author=CF Snyder, NK Aaronson; citation_volume=374; citation_issue=9687; citation_publication_date=2009; citation_pages=369-370; citation_doi=10.1016/S0140-6736(09)61400-8; citation_id=CR5
citation_journal_title=Qual Life Res; citation_title=The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature; citation_author=JM Valderas, A Kotzeva, M Espallargues, G Guyatt, CE Ferrans, MY Halyard, DA Revicki, T Symonds, A Parada, J Alonso; citation_volume=17; citation_issue=2; citation_publication_date=2008; citation_pages=179-193; citation_doi=10.1007/s11136-007-9295-0; citation_id=CR6
citation_journal_title=Rheumatol Int; citation_title=Future perspectives of Smartphone applications for rheumatic diseases self-management; citation_author=A Azevedo, HM Sousa, JA Monteiro, AR Lima; citation_volume=35; citation_issue=3; citation_publication_date=2015; citation_pages=419-431; citation_doi=10.1007/s00296-014-3117-9; citation_id=CR7
citation_journal_title=Stud Health Technol Inform; citation_title=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; citation_author=R Grainger, H Townsley, T Langlotz, W Taylor; citation_volume=245; citation_publication_date=2017; citation_pages=1223; citation_id=CR8
citation_journal_title=J Clin Rheumatol; citation_title=Mobile Apps for individuals with rheumatoid arthritis: a systematic review; citation_author=D Luo, P Wang, F Lu, J Elias, JA Sparks, YC Lee; citation_volume=25; citation_issue=3; citation_publication_date=2019; citation_pages=133-141; citation_doi=10.1097/RHU.0000000000000800; citation_id=CR9
citation_journal_title=JMIR Mhealth Uhealth; citation_title=Asynchronous mHealth interventions in rheumatoid arthritis: systematic scoping review; citation_author=BF Seppen, P Boer, J Wiegel, MM Wee, M Leeden, R Vries; citation_volume=8; citation_publication_date=2020; citation_doi=10.2196/19260; citation_id=CR10
Gesetz für eine bessere Versorgung durch Digitalisierung und Innovation (Digitale-Versorgung-Gesetz - DVG) vom 18.12.2019. BGBl Teil I Nr. 49:2562.
https://www.bgbl.de/xaver/bgbl/start.xav?startbk=Bundesanzeiger_BGBl&start=%2F%2F%2A%5B%40attr_id=%27bgbl119s2562.pdf%27%5D#_bgbl_%2F%2F*%5B%40attrid%3D%27bgbl119s2562.pdf%27%5D1618139003609
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.
https://doi.org/10.1111/j.1524-4733.2007.00231.x
.
citation_journal_title=Ann Rheum Dis; citation_title=Self-assessments of patients via tablet PC in routine patient care: comparison with standardised paper questionnaires; citation_author=JG Richter, A Becker, T Koch, M Nixdorf, R Willers, R Monser, B Schacher, R Alten, C Specker, M Schneider; citation_volume=67; citation_issue=12; citation_publication_date=2008; citation_pages=1739-1741; citation_doi=10.1136/ard.2008.090209; citation_id=CR13
citation_journal_title=Health Qual Life Outcomes; citation_title=Equivalence of electronic and paper administration of patient-reported outcome measures: a systematic review and meta-analysis of studies conducted between 2007 and 2013; citation_author=W Muehlhausen, H Doll, N Quadri, B Fordham, P O’Donohoe, N Dogar, DJ Wild; citation_volume=13; citation_publication_date=2015; citation_pages=46; citation_doi=10.1186/s12955-015-0362-x; citation_id=CR14
citation_journal_title=Cochrane Database Syst Rev; citation_title=Comparison of self-administered survey questionnaire responses collected using mobile apps versus other methods; citation_author=JS Marcano Belisario, J Jamsek, K Huckvale, J O'Donoghue, CP Morrison, J Car; citation_volume=7; citation_publication_date=2015; citation_id=CR15
citation_journal_title=Value Health; citation_title=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; citation_author=SJ Coons, CJ Gwaltney, RD Hays, JJ Lundy, JA Sloan, DA Revicki, WR Lenderking, D Cella, E Basch; citation_volume=12; citation_issue=4; citation_publication_date=2009; citation_pages=419-429; citation_doi=10.1111/j.1524-4733.2008.00470.x; citation_id=CR16
citation_journal_title=Telemed J E Health; citation_title=Smartphone interventions for long-term health management of chronic diseases: an integrative review; citation_author=J Wang, Y Wang, C Wei, NA Yao, A Yuan, Y Shan, C Yuan; citation_volume=20; citation_issue=6; citation_publication_date=2014; citation_pages=570-583; citation_doi=10.1089/tmj.2013.0243; citation_id=CR17
citation_journal_title=Z Rheumatol; citation_title=Comparative evaluation of a German version of the Health Assessment Questionnaire and the Hannover Functional Capacity Questionnaire; citation_author=J Lautenschlager, W Mau, T Kohlmann, HH Raspe, F Struve, W Bruckle, H Zeidler; citation_volume=56; citation_issue=3; citation_publication_date=1997; citation_pages=144-155; citation_doi=10.1007/s003930050030; citation_id=CR18
citation_journal_title=Arthritis Rheum; citation_title=A self-administered rheumatoid arthritis disease activity index (RADAI) for epidemiologic research. Psychometric properties and correlation with parameters of disease activity; citation_author=G Stucki, MH Liang, S Stucki, P Bruhlmann, BA Michel; citation_volume=38; citation_issue=6; citation_publication_date=1995; citation_pages=795-798; citation_doi=10.1002/art.1780380612; citation_id=CR19
citation_title=Rheumatoide Arthritis; citation_inbook_title=Medal Rheumatologie. Kriterien für die Klassifikation, Diagnose, Aktivität und Prognose rheumatologischer Erkrankungen; citation_publication_date=2006; citation_pages=9-11; citation_id=CR20; citation_author=J Andresen; citation_author=JL Hülsemann; citation_publisher=Wiskon
citation_journal_title=BMC Rheumatol; citation_title=Use of a “critical difference” statistical criterion improves the predictive utility of the Health Assessment Questionnaire-Disability Index score in patients with rheumatoid arthritis; citation_author=F Behrens, M Koehm, EC Schwaneck, M Schmalzing, H Gnann, G Greger, HP Tony, H Burkhardt; citation_volume=3; citation_issue=1; citation_publication_date=2019; citation_pages=51; citation_doi=10.1186/s41927-019-0095-2; citation_id=CR21
citation_journal_title=Qual Life Res; citation_title=Equivalence of electronic and paper-based patient-reported outcome measures; citation_author=N Campbell, F Ali, AY Finlay, SS Salek; citation_volume=24; citation_issue=8; citation_publication_date=2015; citation_pages=1949-1961; citation_doi=10.1007/s11136-015-0937-3; citation_id=CR22
citation_journal_title=Value Health; citation_title=Standards for instrument migration when implementing paper patient-reported outcome instruments electronically: recommendations from a qualitative synthesis of cognitive interview and usability studies; citation_author=W Muehlhausen, B Byrom, B Skerritt, M McCarthy, B McDowell, J Sohn; citation_volume=21; citation_issue=1; citation_publication_date=2018; citation_pages=41-48; citation_doi=10.1016/j.jval.2017.07.002; citation_id=CR23
citation_journal_title=Value Health; citation_title=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; citation_author=B Byrom, H Doll, W Muehlhausen, E Flood, C Cassedy, B McDowell, J Sohn, K Hogan, R Belmont, B Skerritt, M McCarthy; citation_volume=21; citation_issue=5; citation_publication_date=2018; citation_pages=581-589; citation_doi=10.1016/j.jval.2017.10.008; citation_id=CR24
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.
citation_journal_title=RMD Open; citation_title=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; citation_author=A Najm, E Nikiphorou, M Kostine, C Richez, JD Pauling, A Finckh, V Ritschl, Y Prior, P Balážová, S Stones, Z Szekanecz, A Iagnocco, S Ramiro, F Sivera, M Dougados, L Carmona, G Burmester, D Wiek, L Gossec, F Berenbaum; citation_volume=5; citation_issue=2; citation_publication_date=2019; citation_doi=10.1136/rmdopen-2019-001014; citation_id=CR26
citation_journal_title=Arthritis Rheum; citation_title=Daily health status registration (patient diary) in patients with rheumatoid arthritis: a comparison between personal digital assistant and paper-pencil format; citation_author=T Heiberg, TK Kvien, Ø Dale, P Mowinckel, GJ Aanerud, AB Songe-Møller, T Uhlig, KB Hagen; citation_volume=57; citation_issue=3; citation_publication_date=2007; citation_pages=454-460; citation_doi=10.1002/art.22613; citation_id=CR27
citation_journal_title=Rheumatology (Oxford); citation_title=Disease activity dynamics in rheumatoid arthritis: patients’ self-assessment of disease activity via WebApp; citation_author=UA Walker, RB Mueller, VK Jaeger, R Theiler, A Forster, P Dufner, F Ganz, D Kyburz; citation_volume=56; citation_issue=10; citation_publication_date=2017; citation_pages=1707-1712; citation_doi=10.1093/rheumatology/kex229; citation_id=CR28
citation_journal_title=Ther Clin Risk Manag; citation_title=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; citation_author=F Salaffi, M Carlo, M Carotti, S Farah, M Gutierrez; citation_volume=12; citation_publication_date=2016; citation_pages=631-642; citation_doi=10.2147/TCRM.S101619; citation_id=CR29
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.
citation_journal_title=JMIR Form Res; citation_title=Feasibility of Self-monitoring rheumatoid arthritis with a Smartphone App: results of two mixed-methods pilot studies; citation_author=BF Seppen, J Wiegel, MJ L'ami, S Duarte Dos Santos Rico, FS Catarinella, F Turkstra; citation_volume=4; citation_publication_date=2020; citation_doi=10.2196/20165; citation_id=CR31
citation_journal_title=J Am Med Inform Assoc; citation_title=Usability of a computer-assisted interview system for the unaided self-entry of patient data in an urban rheumatology clinic; citation_author=CA Williams, T Templin, AD Mosley-Williams; citation_volume=11; citation_issue=4; citation_publication_date=2004; citation_pages=249-259; citation_doi=10.1197/jamia.M1527; citation_id=CR32
citation_journal_title=Rheumatol Int; citation_title=Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients’ needs; citation_author=A Azevedo, M Bernardes, J Fonseca, A Lima; citation_volume=35; citation_issue=10; citation_publication_date=2015; citation_pages=1675-1685; citation_doi=10.1007/s00296-015-3270-9; citation_id=CR33
citation_journal_title=JMIR Mhealth Uhealth; citation_title=Mobile health features supporting self-management behavior in patients with chronic arthritis: mixed-methods approach on patient preferences; citation_author=J Geuens, L Geurts, TW Swinnen, R Westhovens, AV Vanden; citation_volume=7; citation_issue=3; citation_publication_date=2019; citation_doi=10.2196/12535; citation_id=CR34
citation_journal_title=JMIR Mhealth Uhealth.; citation_title=Needs, experiences, and views of people with rheumatic and musculoskeletal diseases on self-management mobile health apps: mixed methods study; citation_author=A Najm, H Lempp, L Gossec, F Berenbaum, E Nikiphorou; citation_volume=8; citation_issue=4; citation_publication_date=2020; citation_doi=10.2196/14351; citation_id=CR35
citation_journal_title=Ann Rheum Dis; citation_title=Validation and patient acceptance of a computer touch screen version of the WOMAC 3.1 osteoarthritis index; citation_author=HA Bischoff-Ferrari; citation_volume=64; citation_issue=1; citation_publication_date=2005; citation_pages=80-84; citation_doi=10.1136/ard.2003.019307; citation_id=CR36
citation_journal_title=CA Cancer J Clin; citation_title=Electronic patient-reported outcome systems in oncology clinical practice; citation_author=AV Bennett, RE Jensen, E Basch; citation_volume=62; citation_publication_date=2012; citation_pages=336-347; citation_doi=10.3322/caac.21150; citation_id=CR37
citation_journal_title=J Am Med Inform Assoc; citation_title=Incorporating the patient’s voice into electronic health records through patient-reported outcomes as the “review of systems”; citation_author=AE Chung, EM Basch; citation_volume=22; citation_issue=4; citation_publication_date=2015; citation_pages=914-916; citation_doi=10.1093/jamia/ocu007; citation_id=CR38
citation_journal_title=Med Care; citation_title=The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care; citation_author=RE Jensen, NE Rothrock, EM DeWitt, B Spiegel, CA Tucker, HM Crane; citation_volume=53; citation_issue=2; citation_publication_date=2015; citation_pages=153-159; citation_doi=10.1097/MLR.0000000000000289; citation_id=CR39
citation_journal_title=Med Sci Sports Exerc; citation_title=Evaluation of a cell phone–based physical activity diary; citation_author=B Sternfeld, S Jiang, T Picchi, L Chasan-Taber, B Ainsworth, CP Quesenberry; citation_volume=44; citation_issue=3; citation_publication_date=2012; citation_pages=487-495; citation_doi=10.1249/MSS.0b013e3182325f45; citation_id=CR40
citation_journal_title=Diabetes Technol Ther; citation_title=Performance of an electronic diary system for intensive insulin management in global diabetes clinical trials; citation_author=EJ Bastyr, S Zhang, J Mou, AP Hackett, SA Raymond, AM Chang; citation_volume=17; citation_issue=8; citation_publication_date=2015; citation_pages=571-579; citation_doi=10.1089/dia.2014.0407; citation_id=CR41
citation_journal_title=JMIR Form Res; citation_title=A companion app to support rheumatology patients treated with Certolizumab Pegol: results from a usability study; citation_author=B Domańska, S Vansant, I Mountian; citation_volume=4; citation_issue=7; citation_publication_date=2020; citation_doi=10.2196/17373; citation_id=CR42
citation_journal_title=J Diabetes Sci Technol; citation_title=Unknown safety and efficacy of smartphone bolus calculator apps puts patients at risk for severe adverse outcomes; citation_author=IB Hirsch, CG Parkin; citation_volume=10; citation_issue=4; citation_publication_date=2016; citation_pages=977-980; citation_doi=10.1177/1932296815626457; citation_id=CR43
Bundesinstitut für Arzneimittel und Medizinprodukte. Orientierungshilfe Medical Apps. 2015.
https://www.bfarm.de/DE/Medizinprodukte/Abgrenzung/MedicalApps/_node.html
. Accessed 28 Jan 2021.
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).
citation_journal_title=J Biomed Inform; citation_title=Healthcare in the pocket: mapping the space of mobile-phone health interventions; citation_author=P Klasnja, W Pratt; citation_volume=45; citation_issue=1; citation_publication_date=2012; citation_pages=184-198; citation_doi=10.1016/j.jbi.2011.08.017; citation_id=CR46
citation_journal_title=JMIR Form Res.; citation_title=Mobile app to help people with chronic illness reflect on their strengths: formative evaluation and usability testing; citation_author=OB Kristjansdottir, E Børøsund, M Westeng, C Ruland, U Stenberg, HA Zangi, K Stange, J Mirkovic; citation_volume=4; citation_issue=3; citation_publication_date=2020; citation_doi=10.2196/16831; citation_id=CR47