{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:44:06Z","timestamp":1785545046689,"version":"3.56.0"},"reference-count":48,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Med Internet Res"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec sec-type=\"background\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Digital health technologies (DHTs) are increasingly integrated into clinical practice, yet economic evaluations remain scarce, particularly in the early development stages. Within the NICE (National Institute for Health and Care Excellence) Evidence Standards Framework, Tier C DHTs comprise technologies with direct clinical implications and measurable health outcomes, for which robust economic evidence is essential. Early-stage assessments are particularly important to inform subsequent development, refinement, and adoption decisions across the digital health lifecycle.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"objective\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aims to explore the feasibility of integrating a full trial-based economic evaluation within an early-stage pilot comparing a chatbot-supported remote patient monitoring (RPM) solution for anticoagulation management with the standard of care (SOC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"methods\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A cost-effectiveness analysis was performed alongside a pilot crossover trial among adult cardiac surgery patients receiving vitamin K antagonists. Participants were allocated to two 6-month sequences (SOC\u2192RPM or RPM\u2192SOC). The intervention consisted of a rule-based chatbot integrated with home-based international normalized ratio self-testing using portable coagulometers to support communication and therapy management. Effectiveness was measured as time in therapeutic range (TTR), and costs were estimated from the Portuguese National Health Service and a limited societal perspective over a 1-year horizon. The analysis 1 applied a within-patient cost-effectiveness approach to estimate incremental costs, incremental TTR, and incremental cost-effectiveness ratios. Uncertainty was explored through nonparametric bootstrapping (5000 replications) and deterministic sensitivity analyses. Complementary comparisons examined differences between sequences (analysis 2), between periods (analysis 3), and within each sequence (analysis 4).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"results\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 19 patients were included in the analyses. In analysis 1, RPM improved anticoagulation control, with a mean within-patient increase of 10.43 percentage points in time in TTR. The mean incremental costs were \u20ac198.61 (\u20ac1=US $1.08) from the Servi\u00e7o Nacional de Sa\u00fade perspective and \u20ac270.05 from the limited societal perspective. The corresponding incremental cost-effectiveness ratios were \u20ac19.03 and \u20ac25.88 per additional percentage point of TTR gained. Sensitivity analyses produced consistent estimates across parameter variations. Complementary analyses (2-4) suggested that RPM tended to be more cost-effective when implemented after the initial 6-month postoperative period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec sec-type=\"conclusions\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This proof-of-concept study demonstrates that a full trial-based economic evaluation can feasibly be embedded within an early-stage Tier C DHT. The intervention showed improved anticoagulation control alongside higher costs, providing initial insights into its cost-effectiveness profile. Positioned within the digital health evidence continuum, such assessments can function as a learning stage within the lifecycle. To address the persistent adoption-evidence gap, tier- and stage-aligned frameworks are needed to guide the economic evaluation of DHTs. This study contributes to that goal by providing a set of recommendations specifically for Tier C DHTs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/85430","type":"journal-article","created":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T18:10:07Z","timestamp":1780337407000},"page":"e85430-e85430","source":"Crossref","is-referenced-by-count":0,"title":["Cost-Effectiveness Analysis of Chatbot-Supported Remote Patient Monitoring for Anticoagulation Management: Health Economic Evaluation Within a Pilot Crossover Trial"],"prefix":"10.2196","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-4150-3642","authenticated-orcid":false,"given":"Ana Rita","family":"Santos","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5540-9853","authenticated-orcid":false,"given":"Filipa","family":"Sampaio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2762-0333","authenticated-orcid":false,"given":"Federico","family":"Guede-Fern\u00e1ndez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6634-9000","authenticated-orcid":false,"given":"Julian","family":"Perelman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8002-6790","authenticated-orcid":false,"given":"Ana","family":"Londral","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,6,17]]},"reference":[{"issue":"6","key":"R1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph17062119","article-title":"How to value digital health interventions? A systematic literature review","volume":"17","author":"Kolasa","journal-title":"Int J Environ Res Public Health"},{"key":"R2","doi-asserted-by":"publisher","DOI":"10.2196\/48694","article-title":"Methodological frameworks and dimensions to be considered in digital health technology assessment: scoping review and thematic analysis","volume":"26","author":"Segur-Ferrer","journal-title":"J Med Internet Res"},{"issue":"9","key":"R3","doi-asserted-by":"publisher","first-page":"179","DOI":"10.12700\/APH.19.9.2022.9.10","article-title":"Paying for digital health interventions-what evidence is needed?","volume":"19","author":"Zah","journal-title":"Acta Polytech Hung"},{"issue":"4","key":"R4","doi-asserted-by":"publisher","first-page":"367","DOI":"10.1007\/s40273-022-01130-0","article-title":"Economic evaluation of digital health interventions: methodological issues and recommendations for practice","volume":"40","author":"Gomes","journal-title":"Pharmacoeconomics"},{"key":"R5","unstructured":"Assessing the impact of digital transformation of health services. European Commission; 2019. URL: https:\/\/health.ec.europa.eu\/system\/files\/2019-11\/022_digitaltransformation_en_0.pdf [Accessed 05-06-2026]"},{"issue":"1","key":"R6","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-020-00314-2","article-title":"Challenges for the evaluation of digital health solutions-a call for innovative evidence generation approaches","volume":"3","author":"Guo","journal-title":"NPJ Digit Med"},{"issue":"1","key":"R7","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-024-01263-w","article-title":"Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning","volume":"7","author":"Tarricone","journal-title":"NPJ Digit Med"},{"issue":"2","key":"R8","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1016\/j.jval.2025.09.012","article-title":"Mapping methodologies for economic evaluation of digital health technologies: a scoping review","volume":"29","author":"Santos","journal-title":"Value Health"},{"key":"R9","unstructured":"Evidence standards framework for digital health technologies. National Institute for Health and Care Excellence (NICE); 2022. URL: https:\/\/www.nice.org.uk\/corporate\/ecd7\/resources\/evidence-standards-framework-for-digital-health-technologies-pdf-1124017457605 [Accessed 05-06-2026]"},{"key":"R10","unstructured":"Monitoring and evaluating digital health interventions: a practical guide to conducting research and assessment. World Health Organization; 2016. URL: https:\/\/iris.who.int\/server\/api\/core\/bitstreams\/0036e491-a9f4-450e-8943-11225d1c7ddf\/content [Accessed 05-06-2026]"},{"key":"R11","doi-asserted-by":"publisher","DOI":"10.1186\/s12962-017-0067-6","article-title":"Defining a staged-based process for economic and financial evaluations of mHealth programs","volume":"15","author":"LeFevre","journal-title":"Cost Eff Resour Alloc"},{"issue":"Suppl 1","key":"R12","doi-asserted-by":"publisher","first-page":"73","DOI":"10.1002\/hec.4505","article-title":"Recommendations for developing a lifecycle, multidimensional assessment framework for mobile medical apps","volume":"31","author":"Tarricone","journal-title":"Health Econ"},{"issue":"1","key":"R13","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1038\/s41591-023-02732-7","article-title":"The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring","volume":"30","author":"Marcus","journal-title":"Nat Med"},{"issue":"1","key":"R14","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-022-08370-y","article-title":"Standardization of the assessment process within telerehabilitation in chronic diseases: a scoping meta-review","volume":"22","author":"Chapel","journal-title":"BMC Health Serv Res"},{"key":"R15","doi-asserted-by":"publisher","DOI":"10.1177\/20552076241269515","article-title":"Enhancing postoperative anticoagulation therapy with remote patient monitoring: a pilot crossover trial study to evaluate portable coagulometers and chatbots in cardiac surgery follow-up","volume":"10","author":"Guede-Fern\u00e1ndez","journal-title":"Digit Health"},{"key":"R16","unstructured":"Piloting digital technologies in a health or care service. National Institute for Health and Care Excellence (NICE). URL: https:\/\/web.archive.org\/web\/20260307155221\/https:\/\/digitalregulations.innovation.nhs.uk\/regulations-and-guidance-for-adopters\/all-adopters-guidance\/piloting-digital-technologies-in-a-health-or-care-service\/ [Accessed 08-06-2026]"},{"issue":"36","key":"R17","doi-asserted-by":"publisher","first-page":"3314","DOI":"10.1093\/eurheartj\/ehae176","article-title":"2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS)","volume":"45","author":"Van Gelder","journal-title":"Eur Heart J"},{"issue":"46","key":"R18","doi-asserted-by":"publisher","first-page":"776","DOI":"10.3238\/arztebl.2018.0776","article-title":"Oral anticoagulation","volume":"115","author":"Altiok","journal-title":"Dtsch Arztebl Int"},{"issue":"13","key":"R19","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.120.017559","article-title":"Direct oral anticoagulant use: a practical guide to common clinical challenges","volume":"9","author":"Chen","journal-title":"J Am Heart Assoc"},{"issue":"6","key":"R20","doi-asserted-by":"publisher","first-page":"800","DOI":"10.1515\/cclm-2016-0381","article-title":"Point-of-care testing INR: an overview","volume":"55","author":"Barcellona","journal-title":"Clin Chem Lab Med"},{"issue":"9","key":"R21","doi-asserted-by":"publisher","first-page":"1971","DOI":"10.1111\/jth.15800","article-title":"Structural and cellular basis of vitamin K antagonism","volume":"20","author":"Liu","journal-title":"J Thromb Haemost"},{"issue":"6","key":"R22","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2015-007758","article-title":"Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation","volume":"5","author":"Sharma","journal-title":"BMJ Open"},{"key":"R23","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S395578","article-title":"The value of anticoagulation management combining telemedicine and self-testing in cardiovascular diseases: a meta-analysis of randomized controlled trials","volume":"19","author":"Huang","journal-title":"Ther Clin Risk Manag"},{"issue":"1","key":"R24","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1097\/MAT.0000000000001572","article-title":"Time in therapeutic range significantly impacts survival and adverse events in destination therapy patients","volume":"68","author":"Macaluso","journal-title":"ASAIO J"},{"issue":"11","key":"R25","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0188482","article-title":"The importance of mean time in therapeutic range for complication rates in warfarin therapy of patients with atrial fibrillation: a systematic review and meta-regression analysis","volume":"12","author":"Vestergaard","journal-title":"PLoS ONE"},{"issue":"2","key":"R26","doi-asserted-by":"publisher","first-page":"84","DOI":"10.1161\/CIRCOUTCOMES.108.796185","article-title":"Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review","volume":"1","author":"Wan","journal-title":"Circ Cardiovasc Qual Outcomes"},{"issue":"9","key":"R27","doi-asserted-by":"publisher","first-page":"1061","DOI":"10.1007\/s11606-016-3700-8","article-title":"At-home versus in-clinic INR monitoring: a cost\u2013utility analysis from the home INR study (THINRS)","volume":"31","author":"Phibbs","journal-title":"J Gen Intern Med"},{"issue":"1","key":"R28","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1016\/j.jval.2021.11.1351","article-title":"Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations","volume":"25","author":"Husereau","journal-title":"Value Health"},{"key":"R29","unstructured":"Perelman J Soares M Duarte A et al. Methodological guidelines for economic evaluation studies of health technologies. INFARMED - National Authority of Medicines and Health Products; 2019. URL: https:\/\/www.infarmed.pt\/documents\/15786\/4001413\/Orienta%C3%A7%C3%B5es+metodol%C3%B3gicas+para+estudos+de+avalia%C3%A7%C3%A3o+econ%C3%B3mica+de+tecnologias+de+sa%C3%BAde+%28EN%29\/ebcfd930-94e2-c7e1-100a-ee1df3d76882 [Accessed 28-02-2025]"},{"issue":"7","key":"R30","doi-asserted-by":"publisher","first-page":"993","DOI":"10.1007\/s10198-017-0947-x","article-title":"Consensus-based cross-European recommendations for the identification, measurement and valuation of costs in health economic evaluations: a European Delphi study","volume":"19","author":"van Lier","journal-title":"Eur J Health Econ"},{"issue":"4","key":"R31","doi-asserted-by":"publisher","first-page":"209","DOI":"10.2165\/00148365-200605040-00003","article-title":"Handling value added tax (VAT) in economic evaluations: should prices include VAT?","volume":"5","author":"Bech","journal-title":"Appl Health Econ Health Policy"},{"issue":"6","key":"R32","doi-asserted-by":"publisher","first-page":"632","DOI":"10.1111\/j.1365-2141.2006.06243.x","article-title":"Patient self-management of anticoagulation therapy: a trial-based cost-effectiveness analysis","volume":"134","author":"Jowett","journal-title":"Br J Haematol"},{"key":"R33","unstructured":"Contrato-programa 2023 - CHULC EPE [Report in Portuguese]. Administra\u00e7\u00e3o Central do Sistema de Sa\u00fade (ACSS); 2023. URL: https:\/\/www.ulssjose.min-saude.pt\/wp-content\/uploads\/sites\/3\/2023\/01\/2023-Acordo-Modificativo-2023-CHULC.pdf"},{"issue":"2","key":"R34","first-page":"203","volume":"23","author":"Macedo","journal-title":"Acta Med Port"},{"key":"R35","unstructured":"Portaria n.o 207\/2017, de 11 de julho [Article in Portuguese]. Di\u00e1rio da Rep\u00fablica. URL: https:\/\/diariodarepublica.pt\/dr\/detalhe\/portaria\/207-2017-107669157 [Accessed 28-08-2025]"},{"key":"R36","unstructured":"INFOMED - base de dados para medicamentos de uso humano [Article in Spanish]. URL: https:\/\/extranet.infarmed.pt\/INFOMED-fo\/ [Accessed 01-07-2025]"},{"key":"R37","unstructured":"Resumo das caracter\u00edsticas do medicamento: varfine 5 mg comprimidos [Report in Portuguese]. Teofarma S.r.l.; 2023. URL: https:\/\/www.teofarmasrl.it\/wp-content\/uploads\/2021\/01\/PT_Varfine_RCM.pdf [Accessed 05-06-2026]"},{"key":"R38","unstructured":"Resumo das caracter\u00edsticas do medicamento: sintrom 4 mg comprimidos [Report in Portuguese]. Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios (AEMPS); 2023. URL: https:\/\/cima.aemps.es\/cima\/pdfs\/es\/ft\/25670\/25670_ft.pdf [Accessed 05-06-2026]"},{"key":"R39","unstructured":"Portaria n.o 1553-d\/2008, de 31 de dezembro [Website in Portuguese]. Di\u00e1rio da Rep\u00fablica. 2008. URL: https:\/\/diariodarepublica.pt\/dr\/detalhe\/portaria\/1553-d-2008-243733 [Accessed 20-04-2025]"},{"key":"R40","unstructured":"Decreto-lei n.o 137\/2010, de 28 de dezembro [Website in Portuguese]. Di\u00e1rio da Rep\u00fablica. 2010. URL: https:\/\/diariodarepublica.pt\/dr\/detalhe\/decreto-lei\/137-2010-306615 [Accessed 20-04-2025]"},{"key":"R41","unstructured":"Atualiza\u00e7\u00e3o de valores com base no IPC [Article in Portuguese]. Instituto Nacional de Estat\u00edstica (INE) - Statistics Portugal. URL: https:\/\/www.ine.pt\/xportal\/xmain?xpid=INE&xpgid=ipc [Accessed 26-06-2025]"},{"issue":"3","key":"R42","first-page":"236","volume":"69","author":"Rosendaal","journal-title":"Thromb Haemost"},{"issue":"1","key":"R43","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1007\/s11239-007-0106-9","article-title":"Determinants and measures of quality in oral anticoagulation therapy","volume":"25","author":"Kaatz","journal-title":"J Thromb Thrombolysis"},{"issue":"1","key":"R44","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1111\/jcpt.12215","article-title":"Economic evaluation of a randomized controlled trial of pharmacist-supervized patient self-testing of warfarin therapy","volume":"40","author":"Gallagher","journal-title":"J Clin Pharm Ther"},{"key":"R45","doi-asserted-by":"crossref","unstructured":"Fgaier M Zrubka Z . Cost-effectiveness of using chatbots in healthcare: a systematic review. Presented at: 2022 IEEE 22nd International Symposium on Computational Intelligence and Informatics and 8th IEEE International Conference on Recent Achievements in Mechatronics, Automation, Computer Science and Robotics (CINTI-MACRo); Nov 21-22, 2022; Budapest, Hungary. [doi: 10.1109\/CINTI-MACRo57952.2022.10029478]","DOI":"10.1109\/CINTI-MACRo57952.2022.10029478"},{"issue":"10","key":"R46","doi-asserted-by":"publisher","DOI":"10.2196\/20346","article-title":"The effectiveness of artificial intelligence conversational agents in health care: systematic review","volume":"22","author":"Milne-Ives","journal-title":"J Med Internet Res"},{"issue":"5-6","key":"R47","doi-asserted-by":"publisher","first-page":"253","DOI":"10.1515\/itit-2019-0019","article-title":"A design and evaluation framework for digital health interventions","volume":"61","author":"Kowatsch","journal-title":"Inf Technol"},{"issue":"2","key":"R48","doi-asserted-by":"publisher","first-page":"171","DOI":"10.1007\/s40273-024-01444-1","article-title":"Measuring effectiveness based on patient experience (instead of QALYs) in US value assessments","volume":"43","author":"Jumamyradov","journal-title":"Pharmacoeconomics"}],"container-title":["Journal of Medical Internet Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.jmir.org\/2026\/1\/e85430","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T22:25:47Z","timestamp":1785536747000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jmir.org\/2026\/1\/e85430"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,17]]},"references-count":48,"URL":"https:\/\/doi.org\/10.2196\/85430","relation":{},"ISSN":["1438-8871"],"issn-type":[{"value":"1438-8871","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,17]]},"article-number":"v28i6e85430"}}