No difference in health-related quality of life, after a food challenge with cashew nut in children participating in a clinical trial

J.P.M. van der Valk, R. Gerth van Wijk, B.M.J. Flokstra-de Blok, J.L. van der Velde, H. de Groot, H.J. Wichers, A.E.J. Dubois, N.W. de Jong

Research output: Contribution to journalArticleAcademicpeer-review

6 Citations (Scopus)

Abstract

Background: Previous studies showed that health-related quality of life (HRQL) significantly improved after the food challenge, with greater improvements in HRQL after a negative outcome than after a positive outcome. It is currently unknown whether this also occurs in patients undergoing DBPCFCs with cashew nut in the context of a clinical trial. Methods: Quality of life was studied in children enrolled in a cashew nut study using Food Allergy Quality of Life Questionnaires (FAQLQs). Children, teenagers and parents of the children completed the questionnaires before the challenge test and 6 months after the DBPCFC with cashew nut. The difference in the change in HRQL between the children with a positive and negative DBPCFC outcome was studied by Mann-Whitney U-test. Results: In total, 112 children (67 boys, median age of 9 years) were included. The children, teenagers and parents of the children completed 143 sets of questionnaires in total. There were no significant differences in baseline total and domain scores compared to the follow-up scores in the FAQLQ-CF, FAQLQ-TF and FAQLQ-PF. In children, the delta FAIM score in the negative DBPCFC tested group was significantly better than the delta FAIM score in the positive challenged group (p = 0.026). There were no significant differences in the changes in the scores of the FAQLQ-CF and FAQLQ-PF in the children with a positive challenge outcome, compared to the children with a negative challenge result. However, there was a significant difference in the change in score between the latter groups in the domain 'accidental exposure' of the FAQLQ-TF (p = 0.049). Conclusion: This study showed no difference in the change in HRQL scores after a DBPCFC with cashew nut in children participating in a clinical trial. The utility of HRQL as an outcome for clinical trials in food allergy may be limited if participant baseline HRQL is relatively unimpaired.

Original languageEnglish
Pages (from-to)812-817
JournalPediatric Allergy and Immunology
Volume27
Issue number8
DOIs
Publication statusPublished - 2016

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Anacardium
Nuts
Quality of Life
Clinical Trials
Food Hypersensitivity
Food
Food Quality
Parents
Surveys and Questionnaires

Keywords

  • Anaphylaxis
  • Cashew nut allergy
  • Double-blind placebo-controlled food challenge
  • Food Allergy Quality of Life Questionnaire

Cite this

van der Valk, J.P.M. ; Gerth van Wijk, R. ; Flokstra-de Blok, B.M.J. ; van der Velde, J.L. ; de Groot, H. ; Wichers, H.J. ; Dubois, A.E.J. ; de Jong, N.W. / No difference in health-related quality of life, after a food challenge with cashew nut in children participating in a clinical trial. In: Pediatric Allergy and Immunology. 2016 ; Vol. 27, No. 8. pp. 812-817.
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title = "No difference in health-related quality of life, after a food challenge with cashew nut in children participating in a clinical trial",
abstract = "Background: Previous studies showed that health-related quality of life (HRQL) significantly improved after the food challenge, with greater improvements in HRQL after a negative outcome than after a positive outcome. It is currently unknown whether this also occurs in patients undergoing DBPCFCs with cashew nut in the context of a clinical trial. Methods: Quality of life was studied in children enrolled in a cashew nut study using Food Allergy Quality of Life Questionnaires (FAQLQs). Children, teenagers and parents of the children completed the questionnaires before the challenge test and 6 months after the DBPCFC with cashew nut. The difference in the change in HRQL between the children with a positive and negative DBPCFC outcome was studied by Mann-Whitney U-test. Results: In total, 112 children (67 boys, median age of 9 years) were included. The children, teenagers and parents of the children completed 143 sets of questionnaires in total. There were no significant differences in baseline total and domain scores compared to the follow-up scores in the FAQLQ-CF, FAQLQ-TF and FAQLQ-PF. In children, the delta FAIM score in the negative DBPCFC tested group was significantly better than the delta FAIM score in the positive challenged group (p = 0.026). There were no significant differences in the changes in the scores of the FAQLQ-CF and FAQLQ-PF in the children with a positive challenge outcome, compared to the children with a negative challenge result. However, there was a significant difference in the change in score between the latter groups in the domain 'accidental exposure' of the FAQLQ-TF (p = 0.049). Conclusion: This study showed no difference in the change in HRQL scores after a DBPCFC with cashew nut in children participating in a clinical trial. The utility of HRQL as an outcome for clinical trials in food allergy may be limited if participant baseline HRQL is relatively unimpaired.",
keywords = "Anaphylaxis, Cashew nut allergy, Double-blind placebo-controlled food challenge, Food Allergy Quality of Life Questionnaire",
author = "{van der Valk}, J.P.M. and {Gerth van Wijk}, R. and {Flokstra-de Blok}, B.M.J. and {van der Velde}, J.L. and {de Groot}, H. and H.J. Wichers and A.E.J. Dubois and {de Jong}, N.W.",
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No difference in health-related quality of life, after a food challenge with cashew nut in children participating in a clinical trial. / van der Valk, J.P.M.; Gerth van Wijk, R.; Flokstra-de Blok, B.M.J.; van der Velde, J.L.; de Groot, H.; Wichers, H.J.; Dubois, A.E.J.; de Jong, N.W.

In: Pediatric Allergy and Immunology, Vol. 27, No. 8, 2016, p. 812-817.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - No difference in health-related quality of life, after a food challenge with cashew nut in children participating in a clinical trial

AU - van der Valk, J.P.M.

AU - Gerth van Wijk, R.

AU - Flokstra-de Blok, B.M.J.

AU - van der Velde, J.L.

AU - de Groot, H.

AU - Wichers, H.J.

AU - Dubois, A.E.J.

AU - de Jong, N.W.

PY - 2016

Y1 - 2016

N2 - Background: Previous studies showed that health-related quality of life (HRQL) significantly improved after the food challenge, with greater improvements in HRQL after a negative outcome than after a positive outcome. It is currently unknown whether this also occurs in patients undergoing DBPCFCs with cashew nut in the context of a clinical trial. Methods: Quality of life was studied in children enrolled in a cashew nut study using Food Allergy Quality of Life Questionnaires (FAQLQs). Children, teenagers and parents of the children completed the questionnaires before the challenge test and 6 months after the DBPCFC with cashew nut. The difference in the change in HRQL between the children with a positive and negative DBPCFC outcome was studied by Mann-Whitney U-test. Results: In total, 112 children (67 boys, median age of 9 years) were included. The children, teenagers and parents of the children completed 143 sets of questionnaires in total. There were no significant differences in baseline total and domain scores compared to the follow-up scores in the FAQLQ-CF, FAQLQ-TF and FAQLQ-PF. In children, the delta FAIM score in the negative DBPCFC tested group was significantly better than the delta FAIM score in the positive challenged group (p = 0.026). There were no significant differences in the changes in the scores of the FAQLQ-CF and FAQLQ-PF in the children with a positive challenge outcome, compared to the children with a negative challenge result. However, there was a significant difference in the change in score between the latter groups in the domain 'accidental exposure' of the FAQLQ-TF (p = 0.049). Conclusion: This study showed no difference in the change in HRQL scores after a DBPCFC with cashew nut in children participating in a clinical trial. The utility of HRQL as an outcome for clinical trials in food allergy may be limited if participant baseline HRQL is relatively unimpaired.

AB - Background: Previous studies showed that health-related quality of life (HRQL) significantly improved after the food challenge, with greater improvements in HRQL after a negative outcome than after a positive outcome. It is currently unknown whether this also occurs in patients undergoing DBPCFCs with cashew nut in the context of a clinical trial. Methods: Quality of life was studied in children enrolled in a cashew nut study using Food Allergy Quality of Life Questionnaires (FAQLQs). Children, teenagers and parents of the children completed the questionnaires before the challenge test and 6 months after the DBPCFC with cashew nut. The difference in the change in HRQL between the children with a positive and negative DBPCFC outcome was studied by Mann-Whitney U-test. Results: In total, 112 children (67 boys, median age of 9 years) were included. The children, teenagers and parents of the children completed 143 sets of questionnaires in total. There were no significant differences in baseline total and domain scores compared to the follow-up scores in the FAQLQ-CF, FAQLQ-TF and FAQLQ-PF. In children, the delta FAIM score in the negative DBPCFC tested group was significantly better than the delta FAIM score in the positive challenged group (p = 0.026). There were no significant differences in the changes in the scores of the FAQLQ-CF and FAQLQ-PF in the children with a positive challenge outcome, compared to the children with a negative challenge result. However, there was a significant difference in the change in score between the latter groups in the domain 'accidental exposure' of the FAQLQ-TF (p = 0.049). Conclusion: This study showed no difference in the change in HRQL scores after a DBPCFC with cashew nut in children participating in a clinical trial. The utility of HRQL as an outcome for clinical trials in food allergy may be limited if participant baseline HRQL is relatively unimpaired.

KW - Anaphylaxis

KW - Cashew nut allergy

KW - Double-blind placebo-controlled food challenge

KW - Food Allergy Quality of Life Questionnaire

U2 - 10.1111/pai.12621

DO - 10.1111/pai.12621

M3 - Article

VL - 27

SP - 812

EP - 817

JO - Pediatric Allergy and Immunology

JF - Pediatric Allergy and Immunology

SN - 0905-6157

IS - 8

ER -