Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire: feasibility of utilizing one-day versus seven-day symptom reporting
Patient-reported outcomes are important measures to include in pulmonary arterial hypertension clinical trials but are not widely utilized in clinical practice. Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire (PAH-SYMPACT) is the only pulmonary arterial hypertension-specific patien...
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Online Access: | https://doi.org/10.1177/2045894020923957 |
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doaj-5a9489d392a74c17a5933126d1ba14522020-11-25T03:26:26ZengSAGE PublishingPulmonary Circulation2045-89402020-05-011010.1177/2045894020923957Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire: feasibility of utilizing one-day versus seven-day symptom reportingRobert P. Frantz0Kelly M. Chin1Carol Zhao2Megan Flynn3David Badesch4Department of Cardiovascular Disease, Mayo Clinic College of Medicine, Rochester, MN, USAInternal Medicine, Pulmonary Hypertension Program, University of Texas Southwestern Medical Center, Dallas, TX, USAActelion Pharmaceuticals US, Inc., South San Francisco, CA, USAActelion Pharmaceuticals US, Inc., South San Francisco, CA, USADivision of Pulmonary Sciences and Critical Care Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USAPatient-reported outcomes are important measures to include in pulmonary arterial hypertension clinical trials but are not widely utilized in clinical practice. Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire (PAH-SYMPACT) is the only pulmonary arterial hypertension-specific patient-reported outcomes instrument developed and validated in accordance with the US Food and Drug Administration guidance on patient-reported outcomes development. The PAH-SYMPACT tool measures pulmonary arterial hypertension-related symptoms and impact of pulmonary arterial hypertension on daily life. Symptoms are reported each day for seven consecutive days, and the impact of pulmonary arterial hypertension over one week is recalled and reported on day 7; however, daily symptom reporting may overburden patients and healthcare resources, limiting the practicality of PAH-SYMPACT outside of clinical trials. To determine the practicability of an abridged version of PAH-SYMPACT for which all reporting is completed on one day, symptom data from the SYMPHONY trial (NCT01841762; PAH-SYMPACT validation study) were retrospectively analyzed to assess whether symptoms reported on each day correlated with the weekly average and whether one-day symptom scores were sensitive to disease severity. Correlation coefficients comparing the weekly average and individual day symptom scores were mostly high or very high regardless of the day they were measured. Findings were similar when using either Spearman's rank correlation or weighted kappa method. One-day symptom scores differentiated well between World Health Organization functional classes II and III/IV pulmonary arterial hypertension and were sensitive to change in disease severity as measured by the Patient Global Assessment of Disease Severity. These data suggest that the one-day PAH-SYMPACT is feasible and appropriate for routine implementation in clinical practice.https://doi.org/10.1177/2045894020923957 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Robert P. Frantz Kelly M. Chin Carol Zhao Megan Flynn David Badesch |
spellingShingle |
Robert P. Frantz Kelly M. Chin Carol Zhao Megan Flynn David Badesch Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire: feasibility of utilizing one-day versus seven-day symptom reporting Pulmonary Circulation |
author_facet |
Robert P. Frantz Kelly M. Chin Carol Zhao Megan Flynn David Badesch |
author_sort |
Robert P. Frantz |
title |
Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire: feasibility of utilizing one-day versus seven-day symptom reporting |
title_short |
Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire: feasibility of utilizing one-day versus seven-day symptom reporting |
title_full |
Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire: feasibility of utilizing one-day versus seven-day symptom reporting |
title_fullStr |
Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire: feasibility of utilizing one-day versus seven-day symptom reporting |
title_full_unstemmed |
Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire: feasibility of utilizing one-day versus seven-day symptom reporting |
title_sort |
pulmonary arterial hypertension—symptoms and impact questionnaire: feasibility of utilizing one-day versus seven-day symptom reporting |
publisher |
SAGE Publishing |
series |
Pulmonary Circulation |
issn |
2045-8940 |
publishDate |
2020-05-01 |
description |
Patient-reported outcomes are important measures to include in pulmonary arterial hypertension clinical trials but are not widely utilized in clinical practice. Pulmonary Arterial Hypertension—Symptoms and Impact Questionnaire (PAH-SYMPACT) is the only pulmonary arterial hypertension-specific patient-reported outcomes instrument developed and validated in accordance with the US Food and Drug Administration guidance on patient-reported outcomes development. The PAH-SYMPACT tool measures pulmonary arterial hypertension-related symptoms and impact of pulmonary arterial hypertension on daily life. Symptoms are reported each day for seven consecutive days, and the impact of pulmonary arterial hypertension over one week is recalled and reported on day 7; however, daily symptom reporting may overburden patients and healthcare resources, limiting the practicality of PAH-SYMPACT outside of clinical trials. To determine the practicability of an abridged version of PAH-SYMPACT for which all reporting is completed on one day, symptom data from the SYMPHONY trial (NCT01841762; PAH-SYMPACT validation study) were retrospectively analyzed to assess whether symptoms reported on each day correlated with the weekly average and whether one-day symptom scores were sensitive to disease severity. Correlation coefficients comparing the weekly average and individual day symptom scores were mostly high or very high regardless of the day they were measured. Findings were similar when using either Spearman's rank correlation or weighted kappa method. One-day symptom scores differentiated well between World Health Organization functional classes II and III/IV pulmonary arterial hypertension and were sensitive to change in disease severity as measured by the Patient Global Assessment of Disease Severity. These data suggest that the one-day PAH-SYMPACT is feasible and appropriate for routine implementation in clinical practice. |
url |
https://doi.org/10.1177/2045894020923957 |
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