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Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE
OBJECTIVE: There is a lack of data on the use of telemedicine (TM) in SLE. SLE outcome measures remain complex, and clinicians and clinical trialists have raised concerns about the accuracy of virtual disease activity measures. This study evaluates the level of agreement between virtual SLE outcome...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10335468/ https://www.ncbi.nlm.nih.gov/pubmed/37429672 http://dx.doi.org/10.1136/lupus-2023-000952 |
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author | Askanase, Anca D Aranow, Cynthia Kim, Mimi Y Kamen, Diane L Arriens, Cristina Khalili, Leila Tang, Wei Barasch, Julia Dall'Era, Maria Mackay, Meggan |
author_facet | Askanase, Anca D Aranow, Cynthia Kim, Mimi Y Kamen, Diane L Arriens, Cristina Khalili, Leila Tang, Wei Barasch, Julia Dall'Era, Maria Mackay, Meggan |
author_sort | Askanase, Anca D |
collection | PubMed |
description | OBJECTIVE: There is a lack of data on the use of telemedicine (TM) in SLE. SLE outcome measures remain complex, and clinicians and clinical trialists have raised concerns about the accuracy of virtual disease activity measures. This study evaluates the level of agreement between virtual SLE outcome measures and face-to-face (F2F) encounter. Here, we describe the study design, virtual physical examination protocol and demographics for the first 50 patients evaluated. METHODS AND ANALYSIS: This is an observational, longitudinal study of 200 patients with SLE with varying levels of disease activity from 4 academic lupus centres serving diverse populations. Each study participant will be evaluated at a baseline and a follow-up visit. At each visit, participants are evaluated by the same physician first via a videoconference-based TM and then a F2F encounter. For this protocol, virtual physical examination guidelines relying on physician-directed patient self-examination were established. SLE disease activity measures will be completed immediately after the TM encounter and repeated after the F2F encounter for each visit. The degree of agreement between TM and F2F disease activity measures will be analysed using the Bland-Altman method. An interim analysis is planned after the enrolment of the first 50 participants. ETHICS AND DISSEMINATION: This study has been reviewed by the Columbia University Medical Center Institutional Review Board (IRB Protocol #: AAAT6574). The full results of this study will be published after the final data analysis of 200 patients. The abrupt shift to TM visits due to the COVID-19 pandemic disrupted clinical practice and clinical trials. Establishing a high level of agreement between SLE disease activity measures obtained with videoconference TM and F2F at the same time point, will allow for improved assessment of disease activity when F2F data cannot be acquired. This information may guide both medical decision-making and provide reliable outcome measures for clinical research. |
format | Online Article Text |
id | pubmed-10335468 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-103354682023-07-12 Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE Askanase, Anca D Aranow, Cynthia Kim, Mimi Y Kamen, Diane L Arriens, Cristina Khalili, Leila Tang, Wei Barasch, Julia Dall'Era, Maria Mackay, Meggan Lupus Sci Med Epidemiology and Outcomes OBJECTIVE: There is a lack of data on the use of telemedicine (TM) in SLE. SLE outcome measures remain complex, and clinicians and clinical trialists have raised concerns about the accuracy of virtual disease activity measures. This study evaluates the level of agreement between virtual SLE outcome measures and face-to-face (F2F) encounter. Here, we describe the study design, virtual physical examination protocol and demographics for the first 50 patients evaluated. METHODS AND ANALYSIS: This is an observational, longitudinal study of 200 patients with SLE with varying levels of disease activity from 4 academic lupus centres serving diverse populations. Each study participant will be evaluated at a baseline and a follow-up visit. At each visit, participants are evaluated by the same physician first via a videoconference-based TM and then a F2F encounter. For this protocol, virtual physical examination guidelines relying on physician-directed patient self-examination were established. SLE disease activity measures will be completed immediately after the TM encounter and repeated after the F2F encounter for each visit. The degree of agreement between TM and F2F disease activity measures will be analysed using the Bland-Altman method. An interim analysis is planned after the enrolment of the first 50 participants. ETHICS AND DISSEMINATION: This study has been reviewed by the Columbia University Medical Center Institutional Review Board (IRB Protocol #: AAAT6574). The full results of this study will be published after the final data analysis of 200 patients. The abrupt shift to TM visits due to the COVID-19 pandemic disrupted clinical practice and clinical trials. Establishing a high level of agreement between SLE disease activity measures obtained with videoconference TM and F2F at the same time point, will allow for improved assessment of disease activity when F2F data cannot be acquired. This information may guide both medical decision-making and provide reliable outcome measures for clinical research. BMJ Publishing Group 2023-07-10 /pmc/articles/PMC10335468/ /pubmed/37429672 http://dx.doi.org/10.1136/lupus-2023-000952 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Epidemiology and Outcomes Askanase, Anca D Aranow, Cynthia Kim, Mimi Y Kamen, Diane L Arriens, Cristina Khalili, Leila Tang, Wei Barasch, Julia Dall'Era, Maria Mackay, Meggan Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE |
title | Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE |
title_full | Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE |
title_fullStr | Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE |
title_full_unstemmed | Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE |
title_short | Protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in SLE |
title_sort | protocol for virtual physical examination in an observational, longitudinal study evaluating virtual outcome measures in sle |
topic | Epidemiology and Outcomes |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10335468/ https://www.ncbi.nlm.nih.gov/pubmed/37429672 http://dx.doi.org/10.1136/lupus-2023-000952 |
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