Digital Platform for Continuous Monitoring of Patients Using a Smartwatch: Longitudinal Prospective Cohort Study

Imagem de Miniatura
Arquivos
art_BIN_Digital_Platform_for_Continuous_Monitoring_of_Patients_Using_2023.PDF (784.58 KB)
Citações na Scopus
0
Tipo de produção
article
Data de publicação
2023
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
JMIR PUBLICATIONS, INC
Autores
SANCHEZ, Fabio Beltrame
Citação
JMIR FORMATIVE RESEARCH, v.7, article ID e47388, 24p, 2023
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Background: Since the COVID-19 pandemic, there has been a boost in the digital transformation of the human society, where wearable devices such as a smartwatch can already measure vital signs in a continuous and naturalistic way; however, the security and privacy of personal data is a challenge to expanding the use of these data by health professionals in clinical follow-up for decision-making. Similar to the European General Data Protection Regulation, in Brazil, the Lei Geral de Protecao de Dados established rules and guidelines for the processing of personal data, including those used for patient care, such as those captured by smartwatches. Thus, in any telemonitoring scenario, there is a need to comply with rules and regulations, making this issue a challenge to overcome.Objective: This study aimed to build a digital solution model for capturing data from wearable devices and making them available in a safe and agile manner for clinical and research use, following current laws.Methods: A functional model was built following the Brazilian Lei Geral de Protecao de Dados (2018), where data captured by smartwatches can be transmitted anonymously over the Internet of Things and be identified later within the hospital. A total of 80 volunteers were selected for a 24-week follow-up clinical trial divided into 2 groups, one group with a previous diagnosis of COVID-19 and a control group without a previous diagnosis of COVID-19, to measure the synchronization rate of the platform with the devices and the accuracy and precision of the smartwatch in out-of-hospital conditions to simulate remote monitoring at home.Results: In a 35-week clinical trial, >11.2 million records were collected with no system downtime; 66% of continuous beats per minute were synchronized within 24 hours (79% within 2 days and 91% within a week). In the limit of agreement analysis, the mean differences in oxygen saturation, diastolic blood pressure, systolic blood pressure, and heart rate were -1.280% (SD 5.679%), -1.399 (SD 19.112) mm Hg, -1.536 (SD 24.244) mm Hg, and 0.566 (SD 3.114) beats per minute, respectively. Furthermore, there was no difference in the 2 study groups in terms of data analysis (neither using the smartwatch nor the gold-standard devices), but it is worth mentioning that all volunteers in the COVID-19 group were already cured of the infection and were highly functional in their daily work life.Conclusions: On the basis of the results obtained, considering the validation conditions of accuracy and precision and simulating an extrahospital use environment, the functional model built in this study is capable of capturing data from the smartwatch and anonymously providing it to health care services, where they can be treated according to the legislation and be used to support clinical decisions during remote monitoring.
Palavras-chave
smartwatch, digital health, telemedicine, wearable, telemonitoring, mobile health, General Data Protection Regulation, GDPR, Lei Geral de Protecao de Dados, LGPD, digital platform, clinical intervention, sensitive data, clinical trial, mobile phone
URI
https://observatorio.fm.usp.br/handle/OPI/57444
Referências
  1. Alpert BS, 2022, J CLIN HYPERTENS, V24, P513, DOI 10.1111/jch.14464
  2. [Anonymous], 2020, WHO Director-General's opening remarks at the media briefing on COVID-19 -11 March 2020
  3. [Anonymous], Directiva 95/46/CE do Parlamento Europeu e do Conselho, de 24 de Outubro de 1995, relativa a protecgAo das pessoas singulares no que diz respeito ao tratamento de dados pessoais e a livre circulagAo desses dados
  4. [Anonymous], 2020, Evaluating digital health products
  5. [Anonymous], LEI N 13.709, DE 14 DE AGOSTO DE 2018.
  6. [Anonymous], WHO Coronavirus (COVID-19) Dashboard.
  7. [Anonymous], 2016, Regulamento (UE) 2016/679 do Parlamento Europeu e do Conselho
  8. [Anonymous], 2020, Analysis of routinely collected data: descriptive studies
  9. Bin KJ, 2023, JMIR FORM RES, V7, DOI 10.2196/39034
  10. Bin KJ, 2022, JMIR FORM RES, V6, DOI 10.2196/40468
  11. Bland JM, 2007, J BIOPHARM STAT, V17, P571, DOI 10.1080/10543400701329422
  12. Bumgarner JM, 2018, J AM COLL CARDIOL, V71, P2381, DOI 10.1016/j.jacc.2018.03.003
  13. Chae SH, 2020, JMIR MHEALTH UHEALTH, V8, DOI 10.2196/17216
  14. Chinoy ED, 2021, SLEEP, V44, DOI 10.1093/sleep/zsaa291
  15. Craig J, 2005, J TELEMED TELECARE, V11, P3, DOI 10.1258/1357633053430494
  16. Dunn J, 2018, PERS MED, V15, P429, DOI 10.2217/pme-2018-0044
  17. Falter M, 2022, FRONT CARDIOVASC MED, V9, DOI 10.3389/fcvm.2022.958212
  18. Ford C, 2022, JACC-CLIN ELECTROPHY, V8, P782, DOI 10.1016/j.jacep.2022.02.013
  19. Greiwe J, 2020, CURR ALLERGY ASTHM R, V20, DOI 10.1007/s11882-020-00927-3
  20. Hafeez Y, 2023, StatPearls
  21. Hahnen C, 2020, JMIR MHEALTH UHEALTH, V8, DOI 10.2196/16811
  22. Hawkings I, A guide to Robotic Process Automation (RPA)
  23. Hayiroglu MI, 2019, ANATOL J CARDIOL, V22, P21, DOI 10.14744/AnatolJCardiol.2019.12525
  24. Helmer P, 2022, J MED INTERNET RES, V24, DOI 10.2196/42359
  25. Kakodkar P, 2020, CUREUS J MED SCIENCE, V12, DOI 10.7759/cureus.7560
  26. Lee HY, 2021, CLIN HYPERTENS, V27, DOI 10.1186/s40885-020-00158-8
  27. Li JPO, 2021, PROG RETIN EYE RES, V82, DOI 10.1016/j.preteyeres.2020.100900
  28. MacEachern SJ, 2021, GENOME, V64, P416, DOI 10.1139/gen-2020-0131
  29. Mishra T, 2020, NAT BIOMED ENG, V4, P1208, DOI 10.1038/s41551-020-00640-6
  30. Nasarre M, 2022, EUROPACE, V24, P406, DOI 10.1093/europace/euab192
  31. Nelson EC, 2019, JMIR MHEALTH UHEALTH, V7, DOI 10.2196/12771
  32. Parant A, 2017, DISABIL REHABIL-ASSI, V12, P681, DOI 10.1080/17483107.2016.1218555
  33. Patel A.K., 2022, StatPearls
  34. Patridge EF, 2018, J MED LIBR ASSOC, V106, P142, DOI 10.5195/jmla.2018.319
  35. Perez MV, 2019, NEW ENGL J MED, V381, P1909, DOI 10.1056/NEJMoa1901183
  36. Quer G, 2021, NAT MED, V27, P73, DOI 10.1038/s41591-020-1123-x
  37. Reeder B, 2016, J BIOMED INFORM, V63, P269, DOI 10.1016/j.jbi.2016.09.001
  38. Samsung Eletronica da Amazonia Ltda, Consultas
  39. Sharma K, 2022, FRONT CARDIOVASC MED, V9, DOI 10.3389/fcvm.2022.910802
  40. Spaccarotella C, 2022, J CLIN MED, V11, DOI 10.3390/jcm11061467
  41. Staplin N, 2023, LANCET, V401, P2041, DOI 10.1016/S0140-6736(23)00733-X
  42. Stergiou GS, 2018, HYPERTENSION, V71, P368, DOI 10.1161/HYPERTENSIONAHA.117.10237
  43. Torp KD, 2022, StatPearls
  44. van Helmond N, 2019, HOSP PRACT, V47, P211, DOI 10.1080/21548331.2019.1656991
  45. Vijayan V, 2021, SENSORS-BASEL, V21, DOI 10.3390/s21165589
  46. Vivilaki VG, 2021, EUR J MIDWIFERY, V5, DOI 10.18332/ejm/142571
  47. Zhang ZX, 2022, LANCET RESP MED, V10, pE47, DOI 10.1016/S2213-2600(22)00103-5
  48. Zugasti Murillo Ana, 2022, Nutr. Hosp., V39, P14

Coleções
Artigos e Materiais de Revistas Científicas - FM/MLS
Artigos e Materiais de Revistas Científicas - COVID-19
Artigos e Materiais de Revistas Científicas - HC/IMREA
Artigos e Materiais de Revistas Científicas - LIM/40