TY - JOUR
T1 - Development and validation of a self-completed HIV symptom index
AU - Justice, A. C.
AU - Holmes, W.
AU - Gifford, A. L.
AU - Rabeneck, L.
AU - Zackin, R.
AU - Sinclair, G.
AU - Weissman, S.
AU - Neidig, J.
AU - Marcus, C.
AU - Chesney, M.
AU - Cohn, S. E.
AU - Wu, A. W.
N1 - Funding Information:
Financial support was supplied by the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases (Cooperative Agreement # U01 AI38858). Dr. Zackin is directly supported by ACTG Cooperative Agreement #U01 AI38855. Dr. Justice is a staff physician at the VA Pittsburgh Healthcare System, a Robert Wood Johnson Generalist Faculty Scholar, and holds a career development award from the National Institute on Aging (Grant #K23 AG 00826-03). Dr. Rabeneck is a recipient of a Department of Veterans Affairs Health Services Research and Development Advanced Research Career Development Award. Dr. Gifford is supported by the U.S. Department of Veteran Affairs Advanced Research Career Development Award, and the Generalist Physician Faculty Scholar Award of the Robert Wood Johnson Foundation. We would like to acknowledge the members of the Adult AIDS Clinical Trials Outcomes and Forms Committees who provided invaluable review of multiple drafts of the symptom index.
PY - 2001
Y1 - 2001
N2 - Traditional, open-ended provider questions regarding patient symptoms are insensitive. Better methods are needed to measure symptoms for clinical management, patient-oriented research, and adverse drug-event reporting. Our objective was to develop and initially validate a brief, self-reported HIV symptom index tailored to patients exposed to multidrug antiretroviral therapies and protease inhibitors, and to compare the new index to existing symptom measures. The research design was a multistage design including quantitative review of existing literature, qualitative and quantitative analyses of pilot data, and quantitative analyses of a prospective sample. Statistical analyses include frequencies, chi-square tests for significance, linear and logistic regression. The subjects were from a multisite convenience sample (n = 73) within the AIDS Clinical Trials Group and a prospective sample from the Cleveland Veterans Affairs Medical Center (n = 115). Measures were patient-reported symptoms and health-related quality of life, physician-assessed disease severity, CD4 cell count, and HIV-1 RNA viral quantification. A 20-item, self-completed HIV symptom index was developed based upon prior reports of symptom frequency and bother and expert opinion. When compared with prior measures the index included more frequent and bothersome symptoms, yet was easier to use (self-report rather than provider interview). The index required less than 5 minutes to complete, achieved excellent completion rates, and was thought comprehensive and comprehensible in a convenience sample. It was further tested in a prospective sample of patients and demonstrated strong associations with physical and mental health summary scores and with disease severity. These associations were independent of CD4 cell count and HIV-1 RNA viral quantification. This 20-item HIV symptom index has demonstrated construct validity, and offers a simple and rational approach to measuring HIV symptoms for clinical management, patient-oriented research, and adverse drug reporting.
AB - Traditional, open-ended provider questions regarding patient symptoms are insensitive. Better methods are needed to measure symptoms for clinical management, patient-oriented research, and adverse drug-event reporting. Our objective was to develop and initially validate a brief, self-reported HIV symptom index tailored to patients exposed to multidrug antiretroviral therapies and protease inhibitors, and to compare the new index to existing symptom measures. The research design was a multistage design including quantitative review of existing literature, qualitative and quantitative analyses of pilot data, and quantitative analyses of a prospective sample. Statistical analyses include frequencies, chi-square tests for significance, linear and logistic regression. The subjects were from a multisite convenience sample (n = 73) within the AIDS Clinical Trials Group and a prospective sample from the Cleveland Veterans Affairs Medical Center (n = 115). Measures were patient-reported symptoms and health-related quality of life, physician-assessed disease severity, CD4 cell count, and HIV-1 RNA viral quantification. A 20-item, self-completed HIV symptom index was developed based upon prior reports of symptom frequency and bother and expert opinion. When compared with prior measures the index included more frequent and bothersome symptoms, yet was easier to use (self-report rather than provider interview). The index required less than 5 minutes to complete, achieved excellent completion rates, and was thought comprehensive and comprehensible in a convenience sample. It was further tested in a prospective sample of patients and demonstrated strong associations with physical and mental health summary scores and with disease severity. These associations were independent of CD4 cell count and HIV-1 RNA viral quantification. This 20-item HIV symptom index has demonstrated construct validity, and offers a simple and rational approach to measuring HIV symptoms for clinical management, patient-oriented research, and adverse drug reporting.
KW - Adverse drug-event reporting
KW - Clinical management
KW - Self-completed HIV symptom index
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U2 - 10.1016/S0895-4356(01)00449-8
DO - 10.1016/S0895-4356(01)00449-8
M3 - Article
C2 - 11750213
AN - SCOPUS:0035659003
SN - 0895-4356
VL - 54
SP - S77-S90
JO - Journal of Chronic Diseases
JF - Journal of Chronic Diseases
IS - 12 SUPPL. 1
ER -