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Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial

BACKGROUND: Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on millions of patients and an increasing demand for health care use. Digital technologies to improve health care outcomes and efficiency are considered a priority; however, innovations are ra...

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Autores principales: Lowe, Cabella, Hanuman Sing, Harry, Marsh, William, Morrissey, Dylan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8713101/
https://www.ncbi.nlm.nih.gov/pubmed/34898461
http://dx.doi.org/10.2196/31541
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author Lowe, Cabella
Hanuman Sing, Harry
Marsh, William
Morrissey, Dylan
author_facet Lowe, Cabella
Hanuman Sing, Harry
Marsh, William
Morrissey, Dylan
author_sort Lowe, Cabella
collection PubMed
description BACKGROUND: Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on millions of patients and an increasing demand for health care use. Digital technologies to improve health care outcomes and efficiency are considered a priority; however, innovations are rarely tested with sufficient rigor in clinical trials, which is the gold standard for clinical proof of safety and efficacy. We have developed a new musculoskeletal digital assessment routing tool (DART) that allows users to self-assess and be directed to the right care. DART requires validation in a real-world setting before implementation. OBJECTIVE: This pilot study aims to assess the feasibility of a future trial by exploring the key aspects of trial methodology, assessing the procedures, and collecting exploratory data to inform the design of a definitive randomized crossover noninferiority trial to assess DART safety and effectiveness. METHODS: We will collect data from 76 adults with a musculoskeletal condition presenting to general practitioners within a National Health Service (NHS) in England. Participants will complete both a DART assessment and a physiotherapist-led triage, with the order determined by randomization. The primary analysis will involve an absolute agreement intraclass correlation (A,1) estimate with 95% CI between DART and the clinician for assessment outcomes signposting to condition management pathways. Data will be collected to allow the analysis of participant recruitment and retention, randomization, allocation concealment, blinding, data collection process, and bias. In addition, the impact of trial burden and potential barriers to intervention delivery will be considered. The DART user satisfaction will be measured using the system usability scale. RESULTS: A UK NHS ethics submission was done during June 2021 and is pending approval; recruitment will commence in early 2022, with data collection anticipated to last for 3 months. The results will be reported in a follow-up paper in 2022. CONCLUSIONS: This study will inform the design of a randomized controlled crossover noninferiority study that will provide evidence concerning mobile health DART system clinical signposting in an NHS setting before real-world implementation. Success should produce evidence of a safe, effective system with good usability, potentially facilitating quicker and easier patient access to appropriate care while reducing the burden on primary and secondary care musculoskeletal services. This rigorous approach to mobile health system testing could be used as a guide for other developers of similar applications. TRIAL REGISTRATION: ClinicalTrials.gov NCT04904029; http://clinicaltrials.gov/ct2/show/NCT04904029 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31541
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spelling pubmed-87131012022-01-14 Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial Lowe, Cabella Hanuman Sing, Harry Marsh, William Morrissey, Dylan JMIR Res Protoc Protocol BACKGROUND: Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on millions of patients and an increasing demand for health care use. Digital technologies to improve health care outcomes and efficiency are considered a priority; however, innovations are rarely tested with sufficient rigor in clinical trials, which is the gold standard for clinical proof of safety and efficacy. We have developed a new musculoskeletal digital assessment routing tool (DART) that allows users to self-assess and be directed to the right care. DART requires validation in a real-world setting before implementation. OBJECTIVE: This pilot study aims to assess the feasibility of a future trial by exploring the key aspects of trial methodology, assessing the procedures, and collecting exploratory data to inform the design of a definitive randomized crossover noninferiority trial to assess DART safety and effectiveness. METHODS: We will collect data from 76 adults with a musculoskeletal condition presenting to general practitioners within a National Health Service (NHS) in England. Participants will complete both a DART assessment and a physiotherapist-led triage, with the order determined by randomization. The primary analysis will involve an absolute agreement intraclass correlation (A,1) estimate with 95% CI between DART and the clinician for assessment outcomes signposting to condition management pathways. Data will be collected to allow the analysis of participant recruitment and retention, randomization, allocation concealment, blinding, data collection process, and bias. In addition, the impact of trial burden and potential barriers to intervention delivery will be considered. The DART user satisfaction will be measured using the system usability scale. RESULTS: A UK NHS ethics submission was done during June 2021 and is pending approval; recruitment will commence in early 2022, with data collection anticipated to last for 3 months. The results will be reported in a follow-up paper in 2022. CONCLUSIONS: This study will inform the design of a randomized controlled crossover noninferiority study that will provide evidence concerning mobile health DART system clinical signposting in an NHS setting before real-world implementation. Success should produce evidence of a safe, effective system with good usability, potentially facilitating quicker and easier patient access to appropriate care while reducing the burden on primary and secondary care musculoskeletal services. This rigorous approach to mobile health system testing could be used as a guide for other developers of similar applications. TRIAL REGISTRATION: ClinicalTrials.gov NCT04904029; http://clinicaltrials.gov/ct2/show/NCT04904029 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31541 JMIR Publications 2021-12-13 /pmc/articles/PMC8713101/ /pubmed/34898461 http://dx.doi.org/10.2196/31541 Text en ©Cabella Lowe, Harry Hanuman Sing, William Marsh, Dylan Morrissey. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.12.2021. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Lowe, Cabella
Hanuman Sing, Harry
Marsh, William
Morrissey, Dylan
Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial
title Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial
title_full Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial
title_fullStr Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial
title_full_unstemmed Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial
title_short Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial
title_sort validation of a musculoskeletal digital assessment routing tool: protocol for a pilot randomized crossover noninferiority trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8713101/
https://www.ncbi.nlm.nih.gov/pubmed/34898461
http://dx.doi.org/10.2196/31541
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