PSYCHOMETRIC PROPERTIES OF THE MODIFIED VIH-47 IN A THERAPEUTIC TRIAL EVALUATING THE IMPACT OF AN EDUCATIONAL PROGRAM IN HIV+ PATIENTS

Author(s)

Arnould B1, Lançon F2, Bernard N3, Prost L1, Delfraissy JF4, Sohier N2, Chwalow J5, 1Mapi Values, Lyon, France; 2Alliance Medica, Marly Le Roi, France; 3Groupe Hospitalier Saint André, Bordeaux, France; 4CHU Bicêtre, LE KREMLIN BICETRE, France; 5Inserm U 341, Paris, France

The VIH-46, a modified version of the VIH-47 developed in French by Gerbaud based on the SF-36 and the MOS-HIV, was used as endpoint in a therapeutic educational program in HIV+. OBJECTIVE: To check the psychometric properties of the VIH-46 in the study population. The VIH-46 covers 11 Quality of Life (QoL) domains: Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), Mental Health (MH), Activities of daily Living (ADL), Psychological Distress (PD), Cognitive Functioning (CF). METHODS: Three hundred twenty-six patients were analysed for cross-sectional analyses at baseline (BL) and 242 patients were analysed over the initial 6-month (M6) period. A Multitrait Analysis Program (MAP) was used to assess convergent and divergent item validity. Cronbach°¦s ƒÑ measured internal consistency reliability. Values d 0.7 were expected. Floor and ceiling effects were calculated. The clinical validity was assessed against Karnofski index, CD4+ count, and virus load. Responsiveness to change over time was assessed by Effect Sizes (ES) calculation in improved and impaired patients according to clinical change at M6. A value of 0.50 measures moderate responsiveness. RESULTS: At BL 89.6% patients had no missing data. All items matched the item-convergent validity criterion, and all items except two matched the item-discriminant validity criterion. Internal consistency reliability was satisfactory. Moderate (20%) to high (50%) ceiling effects were found in PF, RP, RE, SF, BP, ADL dimensions. The differences in QoL scores according to Karnofski Index, CD4+ level, and virus load, were limited. The ES were always less than moderate. CONCLUSION: in the study population, the impact of compliance on QoL might be too complex to be captured by the VIH-46. In addition, the importance of ceiling effects suggests a limitation of the ability of the VIH-46 to detect improvements.

Conference/Value in Health Info

2002-11, ISPOR Europe 2002, Rotterdam, The Netherlands

Value in Health, Vol. 5, No. 6 (November/December 2002)

Code

PIN29

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Infectious Disease (non-vaccine)

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