Evidence map›Paper›PMID 35466954›Full record

Trial reportJournal of Parkinson's disease2022

Challenges of Incorporating Digital Health Technology Outcomes in a Clinical Trial: Experiences from PD STAT.

Jacob O Day, Stephen Smith, Alastair J Noyce, Jane Alty, Alison Jeffery, Rebecca Chapman, Camille Carroll

Abstract readLetterRandomized Controlled Trial
In one paragraph

Trial report in Journal of Parkinson's disease, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Jacob O DayFaculty of Health, University of Plymouth, Plymouth, UK.
Stephen SmithDepartment of Electronic Engineering, University of York, York, UK.
Alastair J NoycePreventive Neurology Unit, Wolfson Institute of Population Health, Queen Mary University of London, UK.
Jane AltyWicking Dementia Research and Education Centre, College of Health and Medicine, University of Tasmania, Hobart, Australia.
Alison JefferyPeninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, Plymouth, UK.
Rebecca ChapmanPeninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, Plymouth, UK.
Camille CarrollFaculty of Health, University of Plymouth, Plymouth, UK.

Funding

Parkinson's UK G-1606
6 · The paper itself

Abstract

Digital health technologies (DHTs) have great potential for use as clinical trial outcomes; however, practical issues need to be addressed in order to maximise their benefit. We describe our experience of incorporating two DHTs as secondary/exploratory outcome measures in PD STAT, a randomised clinical trial of simvastatin in people with Parkinson's disease. We found much higher rates of missing data in the DHTs than the traditional outcome measures, in particular due to technical and software difficulties. We discuss methods to address these obstacles in terms of protocol design, workforce training and data management.

Indexed as

Parkinson DiseaseBiomedical TechnologyHumansOutcome Assessment, Health Careclinical trialsdata managementdigital outcomesParkinson’s diseasesensors

Identifiers

PMID35466954
PMCPMC9398088

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.