Oct 25, 2024

Public workspaceVersion reporting of wearables in clinical trials

DOI
dx.doi.org/10.17504/protocols.io.rm7vzkmo4vx1/v1
  • 1Keele University;
  • 2Manchester Metropolitan University
Khalid Ahmad Khattak
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DOI: dx.doi.org/10.17504/protocols.io.rm7vzkmo4vx1/v1
Protocol Citation: Khalid Ahmad Khattak, Sandra Woolley, Tim Collins 2024. Version reporting of wearables in clinical trials. protocols.io https://dx.doi.org/10.17504/protocols.io.rm7vzkmo4vx1/v1
Manuscript citation:
Cite 1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License,  which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: October 25, 2024
Last Modified: October 25, 2024
Protocol Integer ID: 110902
Keywords: wearables, health trackers, clinical trials, Internet-of-medical-things, version reporting
Abstract
This study involved the extraction and analysis of version reporting information from completed and reported ClinicalTrials.gov entries for wrist-worn wearable intervention studies.

Guidelines
N/A
Materials
Safety warnings
N/A
Ethics statement
N/A
Before start
N/A
Search string
Search string
The ClinicalTrials.gov database was used to search for trial “Interventions/treatment” fields matching the search string:

“tracker OR fitbit OR fit bit OR wearable OR smartwatch OR smart watch OR Apple watch”

The results were assessed according to inclusion and exclusion criteria (below) and findings from inspections of the wearable intervention material information.
Inclusion criteria
Inclusion criteria
  • Results first reported prior to 1st May 2024
  • Interventions using non-specialised, non-prototypical wrist-worn wearable devices.

ClinicalTrials.gov filters:
  • Status: completed
  • Study: with results
  • Participant age: 18+
  • Study type: Interventional clinical trial
Exclusion Criteria
Exclusion Criteria
  • Trials exclusively recruiting minors
  • Trials using specialised or laboratory prototype devices
  • Trials using devices designed primarily for wrist use but not worn on wrist
Information sought
Information sought
Study records, documents and linked publications were searched for wearable intervention details to determine:
  • Manufacturer
  • Family
  • Model
  • Software/firmware version numbers
Information inspected
Information inspected
  • ClinicalTrials.gov study records
  • Study Protocol and Statistical Analysis Plan documents
  • Linked Publications
Preliminary analysis (first and last 10%)
Preliminary analysis (first and last 10%)
Two researchers independently applied the inclusion and exclusion criteria and a third researcher assessed instances where there were differences or uncertainties, and a consensus agreed.

The resulting trials were listed chronologically by “Results first reported”. In order to test and refine the inclusion and exclusion criteria, a sample of the earliest completed 10% and most recently completed 10% of studies was analysed. Selecting the earliest and latest of the wearable intervention trials also provided an opportunity to identify changes in reporting practice over time.
Protocol references
Khattak K.A., Woolley S. I. and Collins T., Wearables, Healthcare-Computer Interaction and the Internet of Obscure Medical Things, 37th International BCS Human-Computer Interaction Conference, Preston, 15-17 July 2024