Assessment of measurement properties of peak VO<sub>2</sub> in children with pulmonary arterial hypertension
<p>Abstract</p> <p>Background</p> <p>The 6-minute walk test evaluates the effect of pharmacologic intervention in adults with pulmonary arterial hypertension (PAH) but, for reasons of compliance or reliability, may not be appropriate for children at all ages. Thus, peak...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2012-09-01
|
| Series: | BMC Pulmonary Medicine |
| Online Access: | http://www.biomedcentral.com/1471-2466/12/54 |
| _version_ | 1811319861762064384 |
|---|---|
| author | Cappelleri Joseph C Hwang Lie-Ju Mardekian Jack Mychaskiw Marko A |
| author_facet | Cappelleri Joseph C Hwang Lie-Ju Mardekian Jack Mychaskiw Marko A |
| author_sort | Cappelleri Joseph C |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>The 6-minute walk test evaluates the effect of pharmacologic intervention in adults with pulmonary arterial hypertension (PAH) but, for reasons of compliance or reliability, may not be appropriate for children at all ages. Thus, peak oxygen consumption (VO<sub>2</sub>, maximal exercise test) was used instead in a pediatric PAH trial (STARTS-1) to evaluate pharmacologic intervention with sildenafil. This was the first large placebo-controlled trial to use the peak VO<sub>2</sub> endpoint in this population. Our working hypothesis was that, as with other populations, percentage changes in peak VO<sub>2</sub> in pediatric patients with PAH are reliable and are associated with changes in other clinical endpoints.</p> <p>Methods</p> <p>Using data from the subpopulation of 106 patients who were developmentally and physically able to perform exercise testing, all of whom were World Health Organization Functional Class (WHO FC) I, II, or III, reliability was assessed using the intraclass correlation coefficient and Bland-Altman plot on screening and baseline data. Relationships between percentage change in peak VO<sub>2</sub> from baseline to end of treatment and other endpoints were evaluated using correlation coefficients and regression analyses.</p> <p>Results</p> <p>The intraclass correlation was 0.79 between screening and baseline peak VO<sub>2</sub>, an agreement that was supported by the Bland-Altman plot. Percentage change in peak VO<sub>2</sub> correlated well (<it>r</it> ≥0.40) and showed responsiveness to a physician global assessment of change and with change in WHO FC (for baseline classes I and III). Percentage change in peak VO<sub>2</sub> did not correlate with change in the Family Cohesion of the Child Health Questionnaire (<it>r</it> = 0.04) or with a subject global assessment of change (<it>r</it> = 0.12). The latter may have been influenced by child and parental-proxy response and instrument administration.</p> <p>Conclusion</p> <p>In pediatric PAH patients who are developmentally and physically able to perform exercise testing, peak VO<sub>2</sub> measurements exhibited good reliability and improvements that were associated with improvements in certain other clinical endpoints, such as the WHO FC and a physician global assessment.</p> <p>Trial registration</p> <p>ClinicalTrials.gov identifier NCT00159913.</p> |
| first_indexed | 2024-04-13T12:49:46Z |
| format | Article |
| id | doaj.art-efb3be5e887e419eab31c46a0b861ae1 |
| institution | Directory Open Access Journal |
| issn | 1471-2466 |
| language | English |
| last_indexed | 2024-04-13T12:49:46Z |
| publishDate | 2012-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pulmonary Medicine |
| spelling | doaj.art-efb3be5e887e419eab31c46a0b861ae12022-12-22T02:46:16ZengBMCBMC Pulmonary Medicine1471-24662012-09-011215410.1186/1471-2466-12-54Assessment of measurement properties of peak VO<sub>2</sub> in children with pulmonary arterial hypertensionCappelleri Joseph CHwang Lie-JuMardekian JackMychaskiw Marko A<p>Abstract</p> <p>Background</p> <p>The 6-minute walk test evaluates the effect of pharmacologic intervention in adults with pulmonary arterial hypertension (PAH) but, for reasons of compliance or reliability, may not be appropriate for children at all ages. Thus, peak oxygen consumption (VO<sub>2</sub>, maximal exercise test) was used instead in a pediatric PAH trial (STARTS-1) to evaluate pharmacologic intervention with sildenafil. This was the first large placebo-controlled trial to use the peak VO<sub>2</sub> endpoint in this population. Our working hypothesis was that, as with other populations, percentage changes in peak VO<sub>2</sub> in pediatric patients with PAH are reliable and are associated with changes in other clinical endpoints.</p> <p>Methods</p> <p>Using data from the subpopulation of 106 patients who were developmentally and physically able to perform exercise testing, all of whom were World Health Organization Functional Class (WHO FC) I, II, or III, reliability was assessed using the intraclass correlation coefficient and Bland-Altman plot on screening and baseline data. Relationships between percentage change in peak VO<sub>2</sub> from baseline to end of treatment and other endpoints were evaluated using correlation coefficients and regression analyses.</p> <p>Results</p> <p>The intraclass correlation was 0.79 between screening and baseline peak VO<sub>2</sub>, an agreement that was supported by the Bland-Altman plot. Percentage change in peak VO<sub>2</sub> correlated well (<it>r</it> ≥0.40) and showed responsiveness to a physician global assessment of change and with change in WHO FC (for baseline classes I and III). Percentage change in peak VO<sub>2</sub> did not correlate with change in the Family Cohesion of the Child Health Questionnaire (<it>r</it> = 0.04) or with a subject global assessment of change (<it>r</it> = 0.12). The latter may have been influenced by child and parental-proxy response and instrument administration.</p> <p>Conclusion</p> <p>In pediatric PAH patients who are developmentally and physically able to perform exercise testing, peak VO<sub>2</sub> measurements exhibited good reliability and improvements that were associated with improvements in certain other clinical endpoints, such as the WHO FC and a physician global assessment.</p> <p>Trial registration</p> <p>ClinicalTrials.gov identifier NCT00159913.</p>http://www.biomedcentral.com/1471-2466/12/54 |
| spellingShingle | Cappelleri Joseph C Hwang Lie-Ju Mardekian Jack Mychaskiw Marko A Assessment of measurement properties of peak VO<sub>2</sub> in children with pulmonary arterial hypertension BMC Pulmonary Medicine |
| title | Assessment of measurement properties of peak VO<sub>2</sub> in children with pulmonary arterial hypertension |
| title_full | Assessment of measurement properties of peak VO<sub>2</sub> in children with pulmonary arterial hypertension |
| title_fullStr | Assessment of measurement properties of peak VO<sub>2</sub> in children with pulmonary arterial hypertension |
| title_full_unstemmed | Assessment of measurement properties of peak VO<sub>2</sub> in children with pulmonary arterial hypertension |
| title_short | Assessment of measurement properties of peak VO<sub>2</sub> in children with pulmonary arterial hypertension |
| title_sort | assessment of measurement properties of peak vo sub 2 sub in children with pulmonary arterial hypertension |
| url | http://www.biomedcentral.com/1471-2466/12/54 |
| work_keys_str_mv | AT cappellerijosephc assessmentofmeasurementpropertiesofpeakvosub2subinchildrenwithpulmonaryarterialhypertension AT hwanglieju assessmentofmeasurementpropertiesofpeakvosub2subinchildrenwithpulmonaryarterialhypertension AT mardekianjack assessmentofmeasurementpropertiesofpeakvosub2subinchildrenwithpulmonaryarterialhypertension AT mychaskiwmarkoa assessmentofmeasurementpropertiesofpeakvosub2subinchildrenwithpulmonaryarterialhypertension |