Aletta Boerkoel, Maresa Buchholz, Luisa Tischler, Niklas Weber, Wolfgang Hoffmann, Jan de Laffolie, Neeltje van den Berg
{"title":"儿童炎症性肠病患者的健康相关生活质量：德国IMPACT-III验证","authors":"Aletta Boerkoel, Maresa Buchholz, Luisa Tischler, Niklas Weber, Wolfgang Hoffmann, Jan de Laffolie, Neeltje van den Berg","doi":"10.1186/s12955-025-02437-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Health related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) is typically measured using the patient reported outcome measure IMPACT-III. This measure has not yet been validated for German patients using the new 4-domain structure. As Germany has a comparatively high prevalence of paediatric IBD and as the IMPACT-III is the main HRQoL outcome measure in use, a validation in the German population is overdue.</p><p><strong>Objective: </strong>To validate the main patient reported outcome measure of health-related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) IMPACT-III in a German patient sample.</p><p><strong>Methods: </strong>Clinical and HRQoL data was gathered in the CEDATA-GPGE registry. To determine the psychometric performance of the IMPACT-III in a German sample, distribution properties, reliability (Cronbach's alpha) and validity (correlations with clinical values; known-groups validity by age, sex, and self-rated health) were calculated. In addition, a confirmatory factor analysis was performed to determine the appropriateness of the factor structure.</p><p><strong>Results: </strong>The IMPACT-III was filled out by 221 patients (Female 46%; M<sub>age</sub>=14.05; Morbus Crohn n = 126; Ulcerative Colitis n = 79; unclassified IBD n = 18). The total score ranged from 19.29 to 95.00, without the occurrence of ceiling or floor effects. Internal consistency using Cronbach's alpha was excellent (α = 0.91) for the total scale. The total score correlated strongly with the subscales of wellbeing (r = 0.90) and social functioning (r = 0.80). Concerning validity, the subscale of wellbeing correlated with self-reported health and clinical assessments. Younger patients (< 14) reported a significantly better HRQoL than older patients (14-17). The 4-domain structure of IMPACT-III could not be confirmed through factor analysis.</p><p><strong>Conclusions: </strong>The German version of the IMPACT-III is a valid and reliable instrument to measure HRQoL in paediatric patients with IBD. The subscales of well-being and social functioning explain most of the total score. To interpret the subdomains of the IMPACT-III further research in a longitudinal design needs to be done, especially with age-related phrasing of the items.</p><p><strong>Trial registration: </strong>German Clinical Trials Register DRKS00015505. Registered on 22.01.2019 Inclusion of patients 01.03.2019; https://drks.de/search/en/trial/DRKS00015505 .</p>","PeriodicalId":12980,"journal":{"name":"Health and Quality of Life Outcomes","volume":"23 1","pages":"94"},"PeriodicalIF":3.4000,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12492618/pdf/","citationCount":"0","resultStr":"{\"title\":\"Health-related quality of life in patients with paediatric inflammatory bowel disease: IMPACT-III validation in Germany.\",\"authors\":\"Aletta Boerkoel, Maresa Buchholz, Luisa Tischler, Niklas Weber, Wolfgang Hoffmann, Jan de Laffolie, Neeltje van den Berg\",\"doi\":\"10.1186/s12955-025-02437-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Health related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) is typically measured using the patient reported outcome measure IMPACT-III. This measure has not yet been validated for German patients using the new 4-domain structure. As Germany has a comparatively high prevalence of paediatric IBD and as the IMPACT-III is the main HRQoL outcome measure in use, a validation in the German population is overdue.</p><p><strong>Objective: </strong>To validate the main patient reported outcome measure of health-related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) IMPACT-III in a German patient sample.</p><p><strong>Methods: </strong>Clinical and HRQoL data was gathered in the CEDATA-GPGE registry. To determine the psychometric performance of the IMPACT-III in a German sample, distribution properties, reliability (Cronbach's alpha) and validity (correlations with clinical values; known-groups validity by age, sex, and self-rated health) were calculated. In addition, a confirmatory factor analysis was performed to determine the appropriateness of the factor structure.</p><p><strong>Results: </strong>The IMPACT-III was filled out by 221 patients (Female 46%; M<sub>age</sub>=14.05; Morbus Crohn n = 126; Ulcerative Colitis n = 79; unclassified IBD n = 18). The total score ranged from 19.29 to 95.00, without the occurrence of ceiling or floor effects. Internal consistency using Cronbach's alpha was excellent (α = 0.91) for the total scale. The total score correlated strongly with the subscales of wellbeing (r = 0.90) and social functioning (r = 0.80). Concerning validity, the subscale of wellbeing correlated with self-reported health and clinical assessments. Younger patients (< 14) reported a significantly better HRQoL than older patients (14-17). 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Health-related quality of life in patients with paediatric inflammatory bowel disease: IMPACT-III validation in Germany.
Background: Health related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) is typically measured using the patient reported outcome measure IMPACT-III. This measure has not yet been validated for German patients using the new 4-domain structure. As Germany has a comparatively high prevalence of paediatric IBD and as the IMPACT-III is the main HRQoL outcome measure in use, a validation in the German population is overdue.
Objective: To validate the main patient reported outcome measure of health-related quality of life (HRQoL) in paediatric patients with inflammatory bowel disease (IBD) IMPACT-III in a German patient sample.
Methods: Clinical and HRQoL data was gathered in the CEDATA-GPGE registry. To determine the psychometric performance of the IMPACT-III in a German sample, distribution properties, reliability (Cronbach's alpha) and validity (correlations with clinical values; known-groups validity by age, sex, and self-rated health) were calculated. In addition, a confirmatory factor analysis was performed to determine the appropriateness of the factor structure.
Results: The IMPACT-III was filled out by 221 patients (Female 46%; Mage=14.05; Morbus Crohn n = 126; Ulcerative Colitis n = 79; unclassified IBD n = 18). The total score ranged from 19.29 to 95.00, without the occurrence of ceiling or floor effects. Internal consistency using Cronbach's alpha was excellent (α = 0.91) for the total scale. The total score correlated strongly with the subscales of wellbeing (r = 0.90) and social functioning (r = 0.80). Concerning validity, the subscale of wellbeing correlated with self-reported health and clinical assessments. Younger patients (< 14) reported a significantly better HRQoL than older patients (14-17). The 4-domain structure of IMPACT-III could not be confirmed through factor analysis.
Conclusions: The German version of the IMPACT-III is a valid and reliable instrument to measure HRQoL in paediatric patients with IBD. The subscales of well-being and social functioning explain most of the total score. To interpret the subdomains of the IMPACT-III further research in a longitudinal design needs to be done, especially with age-related phrasing of the items.
Trial registration: German Clinical Trials Register DRKS00015505. Registered on 22.01.2019 Inclusion of patients 01.03.2019; https://drks.de/search/en/trial/DRKS00015505 .
期刊介绍：
Health and Quality of Life Outcomes is an open access, peer-reviewed, journal offering high quality articles, rapid publication and wide diffusion in the public domain.
Health and Quality of Life Outcomes considers original manuscripts on the Health-Related Quality of Life (HRQOL) assessment for evaluation of medical and psychosocial interventions. It also considers approaches and studies on psychometric properties of HRQOL and patient reported outcome measures, including cultural validation of instruments if they provide information about the impact of interventions. The journal publishes study protocols and reviews summarising the present state of knowledge concerning a particular aspect of HRQOL and patient reported outcome measures. Reviews should generally follow systematic review methodology. Comments on articles and letters to the editor are welcome.
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