Evidence map›Paper›PMID 30355360›Full record

Trial reportTrials2018

Feasibility of weekly participant-reported data collection in a pragmatic randomised controlled trial in primary care: experiences from the BATHE trial (Bath Additives for the Treatment of cHildhood Eczema).

Beth Stuart, Kate Rumsby, Miriam Santer, Matthew J Ridd, Nick A Francis, Maria Chorozoglou, Carla Spreadbury, Mary Steele, Claire Nollett, Lyn Liddiard and 7 more

Open access · goldAbstract readMulticenter StudyPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 30% of its field
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

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. 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

17 authors at 4 institutions in 1 country.

Beth StuartDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK. bls1@soton.ac.uk.ORCID http://orcid.org/0000-0001-5432-7437
Kate RumsbyDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
Miriam SanterDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
Matthew J RiddSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Nick A FrancisWales School of Primary Care Research, Cardiff University, Cardiff, UK.
Maria ChorozoglouSouthampton Health Technology Assessment Centre (SHTAC), University of Southampton, Southampton, UK.
Carla SpreadburyDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
Mary SteeleCentre for Clinical and Community Applications of Health Psychology, Psychology, Faculty of Social and Human Sciences, University of Southampton, Southampton, UK.
Claire NollettWales School of Primary Care Research, Cardiff University, Cardiff, UK.
Lyn LiddiardSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Martina PrudeDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
Julie HooperDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
Emma Thomas-JonesWales School of Primary Care Research, Cardiff University, Cardiff, UK.
Amanda RobertsCentre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.
Kim S ThomasCentre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.
Hywel C WilliamsCentre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.
Paul LittleDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
University of Southampton · GBCardiff University · GBUniversity of Nottingham · GBUniversity of Bristol · GB

Funding

Department of Health 11/153/01Health Technology Assessment Programme 11/153/01
6 · The paper itself

Abstract

backgroundPatient-reported outcomes measures in clinical trials ensure that evaluations of effectiveness focus on outcomes that are important to patients. In relapsing-remitting conditions, such as eczema, repeated measurements may allow a more accurate reflection of disease burden and treatment effect than less frequent measurements. We asked parents/carers of children with eczema taking part in a trial of bath emollients to complete weekly questionnaires for 16 weeks.

methodsThe objective of this study was to determine the acceptability and practicality of collecting weekly measures of eczema severity online for 16 weeks in children aged 1 to 11 years as part of the BATHE study. BATHE randomised patients to bath emollients plus standard eczema care or standard eczema care only. The primary outcome was eczema severity, measured by the seven-item Patient-Oriented Eczema Measure (POEM) repeated weekly for 16 weeks. Acceptability was explored through qualitative interviews with 10 participants. Interviews were audio-recorded, transcribed and analysed thematically. Practicality was assessed by exploring the completeness of the data and keeping a log of any problems.

resultsFour hundred and eighty-two participants were recruited to the trial and 429 opted to complete measures online (89.0%). Data were collected online for 83% of time points over the 16-week period and there was no association between socio-demographic characteristics and data completeness. Two hundred and six (48%) completed their weekly data every week for 16 weeks and 341 (79%) completed it at least 80% of the time. The mean number of weeks completed was 13.3 out of 16 (SD 4.2). Interviewees said that they understood the rationale behind weekly collection and some welcomed this as it helped them realise how their child's eczema changed weekly. Whilst some interviewees spoke of weekly questionnaires as onerous, others said that they found them quick and easy. Reminders were welcomed. Parents/carers seemed happy to receive telephone reminders and it was sometimes useful for eliciting problems relating to obtaining trial medication or password problems for online data collection.

conclusionsAmongst this population, high levels of data completeness suggests that weekly completion of the online questionnaire appears to be acceptable and feasible over a 16-week period.

trial registrationISRCTN84102309 . Registered on 9 December 2013.

Indexed as

Data CollectionPatient Reported Outcome MeasuresPrimary Health CareBathsCaregiversChildChild, PreschoolEczemaEmollientsFeasibility StudiesFemaleHumansInfantMaleParentsRecurrenceEmollientsAtopic dermatitisEczemaFeasibilityPOEMPROMsRepeated measuresTrial methodology

Identifiers

PMID30355360
PMCPMC6201535
OpenAlexW2898295580

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.