Evidence map›Paper›PMID 39333196›Full record

ArticleScientific reports2024

Key considerations for digital decentralised clinical trials from a feasibility study assessing pacing interventions for long COVID.

Christel McMullan, Shamil Haroon, Grace Turner, Olalekan Lee Aiyegbusi, Anuradhaa Subramanian, Sarah E Hughes, Sarah Flanagan, Krishnarajah Nirantharakumar, Elin Haf Davies, Chris Frost and 8 more

Abstract read
In one paragraph

Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
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

18 authors.

Christel McMullanCentre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK. c.mcmullan@bham.ac.uk.
Shamil HaroonInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Grace TurnerCentre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.
Olalekan Lee AiyegbusiCentre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.
Anuradhaa SubramanianInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Sarah E HughesCentre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.
Sarah FlanaganInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Krishnarajah NirantharakumarInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Elin Haf DaviesAparito Ltd, Wrexham, UK.
Chris FrostAparito Ltd, Wrexham, UK.
Louise JacksonInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Naijie GuanInstitute of Applied Health Research, University of Birmingham, Birmingham, UK.
Yvonne AlderCentre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.
Amy ChongCentre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.
Lewis BucklandCentre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.
Felicity JeyesCentre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.
David StantonCentre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.
Melanie CalvertCentre for Patient Reported Outcomes Research, University of Birmingham, Birmingham, UK.

Funding

NIHR COV-LT-0013
6 · The paper itself

Abstract

Post COVID-19 condition or long COVID is highly prevalent and often debilitating, with key symptoms including fatigue, breathlessness, and brain fog. There is currently a lack of evidence-based treatments for this highly complex syndrome. There is a need for clinical trial platforms to rapidly evaluate nonpharmacological treatments to support affected individuals with symptom management. We co-produced a mixed methods feasibility study to evaluate a multi-arm digital decentralised clinical trial (DCT) platform to assess non-pharmacological interventions for Long COVID, using pacing interventions as an exemplar. The study demonstrated that the platform was able to successfully e-consent participants, randomise them into one of four intervention arms, capture baseline data, and capture outcomes relevant to a health economic evaluation. The study also highlighted several challenges, including difficulties with recruitment, imposter participants, and high attrition rates. We highlight how these challenges can potentially be mitigated to make a fully powered DCT more feasible.

Indexed as

COVID-19Feasibility StudiesAdultAgedClinical Trials as TopicFemaleHumansMaleMiddle AgedPatient SelectionPost-Acute COVID-19 SyndromeSARS-CoV-2Decentralised trialsFeasibility studyLong COVIDPacing interventionPROMs

Identifiers

PMID39333196
PMCPMC11436957

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.