Evidence map›Paper›PMID 28764800›Full record

Trial reportTrials2017

'We knew it was a totally at random thing': parents' experiences of being part of a neonatal trial.

Merryl Harvey, Phumza Nongena, David Edwards, Maggie Redshaw

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01049594 (Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT01049594 unknown statusnot on this map

Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants

TypeobservationalSponsorImperial College LondonRan2010 to 2015Enrolled625ConditionsCerebral Palsy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. 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

4 authors.

Merryl HarveyCentre for the Developing Brain, Division of Imaging and Biomedical Engineering, King's College, London, UK.
Phumza NongenaCentre for the Developing Brain, Division of Imaging and Biomedical Engineering, King's College, London, UK.
David EdwardsCentre for the Developing Brain, Division of Imaging and Biomedical Engineering, King's College, London, UK.
Maggie RedshawNational Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Old Road, Oxford, OX3 7LF, UK. maggie.redshaw@npeu.ox.ac.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStudies exploring parents' trial experiences generally relate to their understanding of the consent process and the development of researcher strategies to facilitate recruitment and retention. The aim was to better understand parents' experience of being part of a trial at the time and their perceptions of trial participation in retrospect.

methodsData were collected in a number of ways: from recorded discussions between parents and clinicians about the MRI or ultrasound, in open-text responses to questionnaires and in qualitative interviews at 1 and 2 years after participation. Thematic analysis was undertaken using NVivo10.

resultsKey themes identified were 'deciding to take part', with subthemes associated with 'benefitting self', 'benefitting others' and 'being prepared'; 'the randomisation process' with subthemes relating to 'acceptance' and 'understanding' and 'actual engagement' with subthemes of 'practicalities' and 'care from responsive staff'.

conclusionParents' perspectives on the trial and the processes and information received reflect their understanding and experience of the trial and the value of parent-friendly information-giving about participation, randomisation and follow-up. The practical and logistical points raised confirm the key issues and parents' need for sensitive care and support in the course of a trial. Looking back, almost all parents were positive about their experience and felt that the family had benefitted from participation in the trial and follow-up studies, even when the developmental outcomes were poor.

trial registrationClinicalTrials.gov, ID: NCT01049594. https://clinicaltrials.gov/ct2/show/NCT01049594 . Registered on 13 January 2010. EudraCT: EudraCT: 2009-011602-42. https://www.clinicaltrialsregister.eu/ .

Indexed as

Magnetic Resonance ImagingResearch DesignUltrasonographyAltruismAttitude of Health PersonnelBirth WeightBrainClinical ProtocolsCommunicationComprehensionFemaleGestational AgeHealth Knowledge, Attitudes, PracticeHumansInfant, Low Birth WeightInfant, NewbornMRINeonatal trialParentsPretermTrial recruitmentUltrasound scan

Identifiers

PMID28764800
PMCPMC5539623

What OpenQuestion holds

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Registered trials

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.