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)
Abstract Background Patient-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 tre...
Main Authors: | , , , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2018-10-01
|
Series: | Trials |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s13063-018-2962-3 |
id |
doaj-2c0548fefce94cc2a892b25edf2f5dd4 |
---|---|
record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Beth Stuart Kate Rumsby Miriam Santer Matthew J. Ridd Nick A. Francis Maria Chorozoglou Carla Spreadbury Mary Steele Claire Nollett Lyn Liddiard Martina Prude Julie Hooper Emma Thomas-Jones Amanda Roberts Kim S. Thomas Hywel C. Williams Paul Little |
spellingShingle |
Beth Stuart Kate Rumsby Miriam Santer Matthew J. Ridd Nick A. Francis Maria Chorozoglou Carla Spreadbury Mary Steele Claire Nollett Lyn Liddiard Martina Prude Julie Hooper Emma Thomas-Jones Amanda Roberts Kim S. Thomas Hywel C. Williams Paul Little 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) Trials Feasibility Repeated measures Trial methodology Eczema Atopic dermatitis POEM |
author_facet |
Beth Stuart Kate Rumsby Miriam Santer Matthew J. Ridd Nick A. Francis Maria Chorozoglou Carla Spreadbury Mary Steele Claire Nollett Lyn Liddiard Martina Prude Julie Hooper Emma Thomas-Jones Amanda Roberts Kim S. Thomas Hywel C. Williams Paul Little |
author_sort |
Beth Stuart |
title |
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) |
title_short |
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) |
title_full |
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) |
title_fullStr |
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) |
title_full_unstemmed |
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) |
title_sort |
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) |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2018-10-01 |
description |
Abstract Background Patient-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. Methods The 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. Results Four 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. Conclusions Amongst 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 registration ISRCTN84102309. Registered on 9 December 2013. |
topic |
Feasibility Repeated measures Trial methodology Eczema Atopic dermatitis POEM |
url |
http://link.springer.com/article/10.1186/s13063-018-2962-3 |
work_keys_str_mv |
AT bethstuart feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT katerumsby feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT miriamsanter feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT matthewjridd feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT nickafrancis feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT mariachorozoglou feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT carlaspreadbury feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT marysteele feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT clairenollett feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT lynliddiard feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT martinaprude feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT juliehooper feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT emmathomasjones feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT amandaroberts feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT kimsthomas feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT hywelcwilliams feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema AT paullittle feasibilityofweeklyparticipantreporteddatacollectioninapragmaticrandomisedcontrolledtrialinprimarycareexperiencesfromthebathetrialbathadditivesforthetreatmentofchildhoodeczema |
_version_ |
1725478560953532416 |
spelling |
doaj-2c0548fefce94cc2a892b25edf2f5dd42020-11-24T23:50:54ZengBMCTrials1745-62152018-10-011911910.1186/s13063-018-2962-3Feasibility 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 Stuart0Kate Rumsby1Miriam Santer2Matthew J. Ridd3Nick A. Francis4Maria Chorozoglou5Carla Spreadbury6Mary Steele7Claire Nollett8Lyn Liddiard9Martina Prude10Julie Hooper11Emma Thomas-Jones12Amanda Roberts13Kim S. Thomas14Hywel C. Williams15Paul Little16Department of Primary Care and Population Sciences, University of Southampton, Aldermoor Health CentreDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health CentreDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health CentreSchool of Social and Community Medicine, University of BristolWales School of Primary Care Research, Cardiff UniversitySouthampton Health Technology Assessment Centre (SHTAC), University of SouthamptonDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health CentreCentre for Clinical and Community Applications of Health Psychology, Psychology, Faculty of Social and Human Sciences, University of SouthamptonWales School of Primary Care Research, Cardiff UniversitySchool of Social and Community Medicine, University of BristolDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health CentreDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health CentreWales School of Primary Care Research, Cardiff UniversityCentre of Evidence-Based Dermatology, University of NottinghamCentre of Evidence-Based Dermatology, University of NottinghamCentre of Evidence-Based Dermatology, University of NottinghamDepartment of Primary Care and Population Sciences, University of Southampton, Aldermoor Health CentreAbstract Background Patient-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. Methods The 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. Results Four 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. Conclusions Amongst 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 registration ISRCTN84102309. Registered on 9 December 2013.http://link.springer.com/article/10.1186/s13063-018-2962-3FeasibilityRepeated measuresTrial methodologyEczemaAtopic dermatitisPOEM |