NDLI: Modified visual analog scale symptom-intensity and overall-bother measures for the assessment of symptoms in studies of pharmacologic stress agents.

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Modified visual analog scale symptom-intensity and overall-bother measures for the assessment of symptoms in studies of pharmacologic stress agents.

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Modified visual analog scale symptom-intensity and overall-bother measures for the assessment of symptoms in studies of pharmacologic stress agents.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Harding, Gale Coyne, Karin Barrett, Richard J. Pixton, Glenn C.
Description	Country affiliation: United States Author Affiliation: Harding G ( United BioSource Corporation, Bethesda, Maryland 20814, USA. gale.harding@unitedbiosource.com)
Abstract	BACKGROUND: Drugs used to induce stress for cardiac imaging studies often cause discomfort. Patient-reported intensity of discomfort should be considered when comparing such agents. OBJECTIVE: The purpose of this study was to assess the psychometric properties of a modified visual analog scale (VAS) symptom-intensity measure and an overall-bother measure adapted to assess patient-reported intensity of the adverse events (AEs) associated with pharmacologic stress testing with adenosine, a pharmacologic stress myocardial perfusion imaging (PS-MPI) agent. METHODS: Data were based on 2 complementary, open-label, multicenter, naturalistic, observational studies among patients completing a PS-MPI procedure. Content, concurrent, and discriminant validity was examined by correlating modified VAS symptom-intensity scores obtained from patients with investigator-rated intensity at time of event, overall bother, and patient-reported measures obtained during a structured interview. Test-retest reliability of the overall-bother measure was examined using 1- and 2-hour assessments, and concurrent validity was assessed by correlating counts of symptoms and other patient-reported measures. Responsiveness was examined by calculating change scores of the VAS symptom-intensity measures from baseline to 1 hour among patients who reported symptoms during the 1-hour monitoring period after PS infusion. Low to moderate correlation was defined as a coefficient between 0.3 and 0.5. RESULTS: A total of 324 patients enrolled in the 2 studies. Content validity of the VAS symptom-intensity and overall-bother measures was established, with nearly all patients reporting that they were a useful way to rate symptom intensity and overall bother. VAS ratings were moderately to highly correlated with physician-rated AE intensity, and patient-reported assessments of symptom intensity, discomfort, and concern (r(s) = 0.21 r(s) = 0.84). Findings to support discriminant validity were inconclusive because of small sample size. Responsiveness was demonstrated with VAS symptom-intensity change scores ranging from 2.8 for headache to 4.9 for chest pain; effect sizes for these differences were large, ranging from 1.6 to 7.3, respectively. CONCLUSION: Findings support the validity, reliability, and responsiveness of the modified VAS symptom-intensity measure, and the reliability and validity of the overall-bother measure for use in patients completing PS procedures.
File Format	HTM / HTML
ISSN	01492918
Issue Number	4
Volume Number	31
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2009-04-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Adenosine Exercise Test Methods Myocardial Perfusion Imaging Pain Measurement Aged Aged, 80 And Over Clinical Trials As Topic Female Humans Male Middle Aged Reproducibility Of Results Vasodilator Agents Journal Article Research Support, Non-u.s. Gov't Validation Studies
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

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