The development of the DISCO-RC for measuring children's discomfort during research procedures

Mira S. Staphorst, Reinier Timman, Jan Passchier, Jan J.V. Busschbach, Johannes B. van Goudoever, Joke A.M. Hunfeld

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: There is a need for data on children's self-reported discomfort in clinical research, helping ethics committees to make their evaluation of discomfort described in study protocols evidence-based. Since there is no appropriate instrument to measure children's discomfort during medical research procedures, we aimed to develop a generic, short and child-friendly instrument: the DISCO-RC questionnaire (DISCOmfort in Research with Children). Methods: This article describes the six steps of the development of the DISCO-RC. First, we updated a literature search on children's self-reported discomfort in clinical research to get insight in what words are used to measure discomfort (step 1). Subsequently, we interviewed 46 children (6-18years) participating in research to get insight into important forms of discomfort for children (step 2), and asked them about their preferred response option for measuring discomfort (step 3). Next, we consulted nine paediatric research professionals from various backgrounds for input on the content and feasibility of the DISCO-RC (step 4). Based on the previous steps, we developed a draft version of the DISCO-RC, which we discussed with the professionals. The DISCO-RC was then pretested in 25 children to ensure face-validity from the child's perspective and feasibility (step 5). Finally, validity, reliability and internal consistency were tested (step 6). Results: The search-update revealed several words used for measuring discomfort in research (e.g. 'worries', 'unpleasantness'). The interviews gave insight into important forms of discomfort for children in research (e.g. 'pain', 'boredom'). Children preferred a 5-point Likert scale as response option for the DISCO-RC. The experts recommended a short, digital instrument involving different forms of discomfort, and measuring discomfort of individual research procedures. Pretesting of the DISCO-RC resulted in a few layout changes, and feedback from the children confirmed the feasibility of the DISCO-RC. Convergent validity and test-retest reliability were acceptable. Internal consistency based on item-rest correlations and Cronbach's alpha were low, as expected. Conclusions: The DISCO-RC is a generic, practical and psychometrically sound instrument for measuring children's discomfort during research procedures. It contributes to make the evaluation of discomfort in paediatric research evidence-based. Therefore, we recommend including the DISCO-RC as standard component of paediatric research studies.

Original languageEnglish
Article number199
JournalBMC Pediatrics
Volume17
Issue number1
DOIs
Publication statusPublished - 29 Nov 2017

Cite this

Staphorst, Mira S. ; Timman, Reinier ; Passchier, Jan ; Busschbach, Jan J.V. ; van Goudoever, Johannes B. ; Hunfeld, Joke A.M. / The development of the DISCO-RC for measuring children's discomfort during research procedures. In: BMC Pediatrics. 2017 ; Vol. 17, No. 1.
@article{ddc1a5085c574797a975d3c969fe1b60,
title = "The development of the DISCO-RC for measuring children's discomfort during research procedures",
abstract = "Background: There is a need for data on children's self-reported discomfort in clinical research, helping ethics committees to make their evaluation of discomfort described in study protocols evidence-based. Since there is no appropriate instrument to measure children's discomfort during medical research procedures, we aimed to develop a generic, short and child-friendly instrument: the DISCO-RC questionnaire (DISCOmfort in Research with Children). Methods: This article describes the six steps of the development of the DISCO-RC. First, we updated a literature search on children's self-reported discomfort in clinical research to get insight in what words are used to measure discomfort (step 1). Subsequently, we interviewed 46 children (6-18years) participating in research to get insight into important forms of discomfort for children (step 2), and asked them about their preferred response option for measuring discomfort (step 3). Next, we consulted nine paediatric research professionals from various backgrounds for input on the content and feasibility of the DISCO-RC (step 4). Based on the previous steps, we developed a draft version of the DISCO-RC, which we discussed with the professionals. The DISCO-RC was then pretested in 25 children to ensure face-validity from the child's perspective and feasibility (step 5). Finally, validity, reliability and internal consistency were tested (step 6). Results: The search-update revealed several words used for measuring discomfort in research (e.g. 'worries', 'unpleasantness'). The interviews gave insight into important forms of discomfort for children in research (e.g. 'pain', 'boredom'). Children preferred a 5-point Likert scale as response option for the DISCO-RC. The experts recommended a short, digital instrument involving different forms of discomfort, and measuring discomfort of individual research procedures. Pretesting of the DISCO-RC resulted in a few layout changes, and feedback from the children confirmed the feasibility of the DISCO-RC. Convergent validity and test-retest reliability were acceptable. Internal consistency based on item-rest correlations and Cronbach's alpha were low, as expected. Conclusions: The DISCO-RC is a generic, practical and psychometrically sound instrument for measuring children's discomfort during research procedures. It contributes to make the evaluation of discomfort in paediatric research evidence-based. Therefore, we recommend including the DISCO-RC as standard component of paediatric research studies.",
keywords = "Adolescent, Child, Discomfort, Ethics committees, Questionnaire development, Research participation, Self report",
author = "Staphorst, {Mira S.} and Reinier Timman and Jan Passchier and Busschbach, {Jan J.V.} and {van Goudoever}, {Johannes B.} and Hunfeld, {Joke A.M.}",
year = "2017",
month = "11",
day = "29",
doi = "10.1186/s12887-017-0949-y",
language = "English",
volume = "17",
journal = "BMC Pediatrics",
issn = "1471-2431",
publisher = "BioMed Central",
number = "1",

}

The development of the DISCO-RC for measuring children's discomfort during research procedures. / Staphorst, Mira S.; Timman, Reinier; Passchier, Jan; Busschbach, Jan J.V.; van Goudoever, Johannes B.; Hunfeld, Joke A.M.

In: BMC Pediatrics, Vol. 17, No. 1, 199, 29.11.2017.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - The development of the DISCO-RC for measuring children's discomfort during research procedures

AU - Staphorst, Mira S.

AU - Timman, Reinier

AU - Passchier, Jan

AU - Busschbach, Jan J.V.

AU - van Goudoever, Johannes B.

AU - Hunfeld, Joke A.M.

PY - 2017/11/29

Y1 - 2017/11/29

N2 - Background: There is a need for data on children's self-reported discomfort in clinical research, helping ethics committees to make their evaluation of discomfort described in study protocols evidence-based. Since there is no appropriate instrument to measure children's discomfort during medical research procedures, we aimed to develop a generic, short and child-friendly instrument: the DISCO-RC questionnaire (DISCOmfort in Research with Children). Methods: This article describes the six steps of the development of the DISCO-RC. First, we updated a literature search on children's self-reported discomfort in clinical research to get insight in what words are used to measure discomfort (step 1). Subsequently, we interviewed 46 children (6-18years) participating in research to get insight into important forms of discomfort for children (step 2), and asked them about their preferred response option for measuring discomfort (step 3). Next, we consulted nine paediatric research professionals from various backgrounds for input on the content and feasibility of the DISCO-RC (step 4). Based on the previous steps, we developed a draft version of the DISCO-RC, which we discussed with the professionals. The DISCO-RC was then pretested in 25 children to ensure face-validity from the child's perspective and feasibility (step 5). Finally, validity, reliability and internal consistency were tested (step 6). Results: The search-update revealed several words used for measuring discomfort in research (e.g. 'worries', 'unpleasantness'). The interviews gave insight into important forms of discomfort for children in research (e.g. 'pain', 'boredom'). Children preferred a 5-point Likert scale as response option for the DISCO-RC. The experts recommended a short, digital instrument involving different forms of discomfort, and measuring discomfort of individual research procedures. Pretesting of the DISCO-RC resulted in a few layout changes, and feedback from the children confirmed the feasibility of the DISCO-RC. Convergent validity and test-retest reliability were acceptable. Internal consistency based on item-rest correlations and Cronbach's alpha were low, as expected. Conclusions: The DISCO-RC is a generic, practical and psychometrically sound instrument for measuring children's discomfort during research procedures. It contributes to make the evaluation of discomfort in paediatric research evidence-based. Therefore, we recommend including the DISCO-RC as standard component of paediatric research studies.

AB - Background: There is a need for data on children's self-reported discomfort in clinical research, helping ethics committees to make their evaluation of discomfort described in study protocols evidence-based. Since there is no appropriate instrument to measure children's discomfort during medical research procedures, we aimed to develop a generic, short and child-friendly instrument: the DISCO-RC questionnaire (DISCOmfort in Research with Children). Methods: This article describes the six steps of the development of the DISCO-RC. First, we updated a literature search on children's self-reported discomfort in clinical research to get insight in what words are used to measure discomfort (step 1). Subsequently, we interviewed 46 children (6-18years) participating in research to get insight into important forms of discomfort for children (step 2), and asked them about their preferred response option for measuring discomfort (step 3). Next, we consulted nine paediatric research professionals from various backgrounds for input on the content and feasibility of the DISCO-RC (step 4). Based on the previous steps, we developed a draft version of the DISCO-RC, which we discussed with the professionals. The DISCO-RC was then pretested in 25 children to ensure face-validity from the child's perspective and feasibility (step 5). Finally, validity, reliability and internal consistency were tested (step 6). Results: The search-update revealed several words used for measuring discomfort in research (e.g. 'worries', 'unpleasantness'). The interviews gave insight into important forms of discomfort for children in research (e.g. 'pain', 'boredom'). Children preferred a 5-point Likert scale as response option for the DISCO-RC. The experts recommended a short, digital instrument involving different forms of discomfort, and measuring discomfort of individual research procedures. Pretesting of the DISCO-RC resulted in a few layout changes, and feedback from the children confirmed the feasibility of the DISCO-RC. Convergent validity and test-retest reliability were acceptable. Internal consistency based on item-rest correlations and Cronbach's alpha were low, as expected. Conclusions: The DISCO-RC is a generic, practical and psychometrically sound instrument for measuring children's discomfort during research procedures. It contributes to make the evaluation of discomfort in paediatric research evidence-based. Therefore, we recommend including the DISCO-RC as standard component of paediatric research studies.

KW - Adolescent

KW - Child

KW - Discomfort

KW - Ethics committees

KW - Questionnaire development

KW - Research participation

KW - Self report

UR - http://www.scopus.com/inward/record.url?scp=85035321792&partnerID=8YFLogxK

U2 - 10.1186/s12887-017-0949-y

DO - 10.1186/s12887-017-0949-y

M3 - Article

VL - 17

JO - BMC Pediatrics

JF - BMC Pediatrics

SN - 1471-2431

IS - 1

M1 - 199

ER -