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Agile research to complement agile development: a proposal for an mHealth research lifecycle.

作者信息

Wilson Kumanan, Bell Cameron, Wilson Lindsay, Witteman Holly

机构信息

1Faculty of Medicine, University of Ottawa, Ottawa, Canada.

2Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.

出版信息

NPJ Digit Med. 2018 Sep 13;1:46. doi: 10.1038/s41746-018-0053-1. eCollection 2018.


DOI:10.1038/s41746-018-0053-1
PMID:31304326
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6550198/
Abstract

Mobile health (mHealth) technology is increasingly being used, but academic evaluations supporting its use are not keeping pace. This is partly due to the disconnect between the traditional pharmaceutical approach to product evaluation, with its incremental approach, and the flexible way in which mHealth products are developed. An important step to addressing these problems lies in establishing agile research methods that complement the agile development methodologies used to create modern digital health applications. We describe an mHealth research model that mirrors traditional clinical research methods in its attention to safety and efficacy, while also accommodating the rapid and iterative development and evaluation required to produce effective, evidence-based, and sustainable digital products. This approach consists of a project identification stage followed by four phases of clinical evaluation: Phase 1: User Experience Design, Development, & Alpha Testing; Phase 2: Beta testing; Phase 3: Clinical Trial Evaluation; and Phase 4: Post-Market Surveillance. These phases include sample gating questions and are adapted to accommodate the unique nature of digital product development.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5826/6550198/dc120f8f47ae/41746_2018_53_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5826/6550198/6e0c7a5ef79e/41746_2018_53_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5826/6550198/30496bbe1bd4/41746_2018_53_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5826/6550198/dc120f8f47ae/41746_2018_53_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5826/6550198/6e0c7a5ef79e/41746_2018_53_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5826/6550198/30496bbe1bd4/41746_2018_53_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5826/6550198/dc120f8f47ae/41746_2018_53_Fig3_HTML.jpg

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本文引用的文献

[1]
Prescribable mHealth apps identified from an overview of systematic reviews.

NPJ Digit Med. 2018-5-9

[2]
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JAMA. 2018-7-24

[3]
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BMC Med. 2018-2-28

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JMIR Mhealth Uhealth. 2017-12-19

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JMIR Med Inform. 2017-12-8

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The Promise, Growth, and Reality of Mobile Health - Another Data-free Zone.

N Engl J Med. 2017-11-23

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JMIR Mhealth Uhealth. 2017-5-2

[8]
Who Uses Mobile Phone Health Apps and Does Use Matter? A Secondary Data Analytics Approach.

J Med Internet Res. 2017-4-19

[9]
IDEAS (Integrate, Design, Assess, and Share): A Framework and Toolkit of Strategies for the Development of More Effective Digital Interventions to Change Health Behavior.

J Med Internet Res. 2016-12-16

[10]
Adaptive Designs for Clinical Trials.

N Engl J Med. 2016-7-7

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