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ORAL PRESENTATION Open Access What parents think about being approached about childrens trials, how this differs from what practitioners expect, and what this tells us about enhancing recruitment Bridget Young 1* , Valerie Shilling 2 , Helen Hickey 3 , Emma Sowden 1 , Rosalind L Smyth 4 , Paula R Williamson 3 From Clinical Trials Methodology Conference 2011 Bristol, UK. 4-5 October 2011 Objectives Recruiting to clinical trials that involve vulnerable patient groups such as children is regarded as challen- ging. We compared how parents and practitioners described their experiences of recruitment to clinical trials of medicines for children in order to identify stra- tegies to optimise recruitment and its conduct. Methods Qualitative study of recruitment within four randomised controlled trials at 11 research sites in the UK. We com- pared i) audio-recording of practitioner-family dialogue during trial recruitment discussions with ii) audio- recordings of interviews that we subsequently conducted with parents and practitioners. Analyses of transcribed audio-recordings were informed by the principles of the constant comparative method. Results Parents from 59 families were interviewed, 41 of whom had participated in audio-recorded recruitment discus- sions. Thirty one practitioners (doctors and nurses) were interviewed. While parents said little in the recruit- ment discussions and asked few questions, they reported a positive experience of the trial approach describing a sense of comfort and safety. Parents wanted to be told about a trial if their child was eligible - they did not want practitioners to exclude their child without dis- cussing it. Even if parents declined or if the discussion took place at a difficult time, they understood the need to approach them and spoke of the value of research. Some parents viewed research participation as an excit- ingopportunity. By contrast, practitioners often worried about approaching families about research in case it burdened them. Some practitioners were particularly apprehensive about approaching families and implied that recruiting to clinical trials was something which they found aversive. Many were also concerned about the amount of information they had to provide and believed this overwhelmed families. Conclusions The concerns of some practitioners, that parents would be overburdened, stood in sharp contrast to the per- spectives of parents. Contrary to what practitioners often expected, parents were positive about being approached to enter their child into a clinical trial. Helping practitioners to understand how families per- ceive clinical trials and providing them with moralsup- port in approaching families may enhance recruitment to childrens clinical trials. This strategy may also poten- tially benefit recruitment in trials with other vulnerable patient groups [1]. Author details 1 Mental and Behavioural Health Science, University of Liverpool, Liverpool, L69 3GB, UK. 2 Child Health Research Group, Peninsula Medical School, University of Exeter, PL6 8BU, UK. 3 Biostatistics, University of Liverpool, Liverpool, L69 3GS, UK. 4 Reproductive and Developmental Medicine, University of Liverpool, Liverpool, L12 2AP, UK. Published: 13 December 2011 * Correspondence: [email protected] 1 Mental and Behavioural Health Science, University of Liverpool, Liverpool, L69 3GB, UK Full list of author information is available at the end of the article Young et al. Trials 2011, 12(Suppl 1):A116 http://www.trialsjournal.com/content/12/S1/A116 TRIALS © 2011 Young et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

What parents think about being approached about children’s trials, how this differs from what practitioners expect, and what this tells us about enhancing recruitment

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Page 1: What parents think about being approached about children’s trials, how this differs from what practitioners expect, and what this tells us about enhancing recruitment

ORAL PRESENTATION Open Access

What parents think about being approachedabout children’s trials, how this differs from whatpractitioners expect, and what this tells us aboutenhancing recruitmentBridget Young1*, Valerie Shilling2, Helen Hickey3, Emma Sowden1, Rosalind L Smyth4, Paula R Williamson3

From Clinical Trials Methodology Conference 2011Bristol, UK. 4-5 October 2011

ObjectivesRecruiting to clinical trials that involve vulnerablepatient groups such as children is regarded as challen-ging. We compared how parents and practitionersdescribed their experiences of recruitment to clinicaltrials of medicines for children in order to identify stra-tegies to optimise recruitment and its conduct.

MethodsQualitative study of recruitment within four randomisedcontrolled trials at 11 research sites in the UK. We com-pared i) audio-recording of practitioner-family dialogueduring trial recruitment discussions with ii) audio-recordings of interviews that we subsequently conductedwith parents and practitioners. Analyses of transcribedaudio-recordings were informed by the principles of theconstant comparative method.

ResultsParents from 59 families were interviewed, 41 of whomhad participated in audio-recorded recruitment discus-sions. Thirty one practitioners (doctors and nurses)were interviewed. While parents said little in the recruit-ment discussions and asked few questions, they reporteda positive experience of the trial approach describing asense of comfort and safety. Parents wanted to be toldabout a trial if their child was eligible - they did notwant practitioners to exclude their child without dis-cussing it. Even if parents declined or if the discussion

took place at a difficult time, they understood the needto approach them and spoke of the value of research.Some parents viewed research participation as an ‘excit-ing’ opportunity. By contrast, practitioners often worriedabout approaching families about research in case itburdened them. Some practitioners were particularlyapprehensive about approaching families and impliedthat recruiting to clinical trials was something whichthey found aversive. Many were also concerned aboutthe amount of information they had to provide andbelieved this overwhelmed families.

ConclusionsThe concerns of some practitioners, that parents wouldbe overburdened, stood in sharp contrast to the per-spectives of parents. Contrary to what practitionersoften expected, parents were positive about beingapproached to enter their child into a clinical trial.Helping practitioners to understand how families per-ceive clinical trials and providing them with ‘moral’ sup-port in approaching families may enhance recruitmentto children’s clinical trials. This strategy may also poten-tially benefit recruitment in trials with other vulnerablepatient groups [1].

Author details1Mental and Behavioural Health Science, University of Liverpool, Liverpool,L69 3GB, UK. 2Child Health Research Group, Peninsula Medical School,University of Exeter, PL6 8BU, UK. 3Biostatistics, University of Liverpool,Liverpool, L69 3GS, UK. 4Reproductive and Developmental Medicine,University of Liverpool, Liverpool, L12 2AP, UK.

Published: 13 December 2011* Correspondence: [email protected] and Behavioural Health Science, University of Liverpool, Liverpool,L69 3GB, UKFull list of author information is available at the end of the article

Young et al. Trials 2011, 12(Suppl 1):A116http://www.trialsjournal.com/content/12/S1/A116 TRIALS

© 2011 Young et al; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.

Page 2: What parents think about being approached about children’s trials, how this differs from what practitioners expect, and what this tells us about enhancing recruitment

Reference1. Shilling V, Williamson PR, Hickey H, Sowden E, Beresford MW, Smyth RL,

Young B: Communication about Children’s Clinical Trials as observedand experienced: qualitative study of parents and practitioners. PLoSONE 2011, 6(7):e21604, doi:10.1371/journal.pone.0021604.

doi:10.1186/1745-6215-12-S1-A116Cite this article as: Young et al.: What parents think about beingapproached about children’s trials, how this differs from whatpractitioners expect, and what this tells us about enhancingrecruitment. Trials 2011 12(Suppl 1):A116.

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Young et al. Trials 2011, 12(Suppl 1):A116http://www.trialsjournal.com/content/12/S1/A116

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