Skip to main content
Mijn bibliotheek
Shop
Nieuws Boeken Tijdschriften E-learning Web-tv Video Audio
Tips voor Mijn BSL
UITGEBREID ZOEKEN
Inloggen
Top
Quality of Life Research
Gepubliceerd in: Quality of Life Research 8/2010

01-10-2010

Psychometric evaluation of the functional assessment of HIV Infection (FAHI) questionnaire and its usefulness in clinical trials

Auteurs: Muriel Viala-Danten, Dominique Dubois, Hélène Gilet, Silas Martin, Katrien Peeters, David Cella

Gepubliceerd in: Quality of Life Research | Uitgave 8/2010

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail
    Link delen
publish
Publiceer nu

Abstract

Purpose

To evaluate psychometric properties of the Functional Assessment of Human Immunodeficiency Virus Infection (FAHI) questionnaire, a 47-item disease-specific instrument evaluating Health-Related Quality of Life (HRQL) in human immunodeficiency virus (HIV)-infected patients.

Methods

Treatment-experienced HIV-infected patients from two clinical programmes (N = 565; N = 1,096) completed the FAHI at Baseline and after 24 weeks of treatment. Psychometric properties of the FAHI were assessed in both trial populations, including minimal important differences (MIDs) calculations. Links between HRQL assessed by FAHI Total score, and biological endpoints were explored by regression analysis and mean score comparisons.

Results

Cronbach’s alphas ranged from 0.72 to 0.94. Most items met convergent and discriminant validity criteria. Better FAHI scores were seen for patients in earlier HIV stages. Responsiveness was demonstrated with changes in FAHI scores significantly linked to change in EQ-5D score. Depending on methods used, MIDs ranged from 3.2 to 14 for FAHI Total score. Small association was found between FAHI Total score and CD4 count and viral load (r-square < 3%). Mean changes in FAHI scores were not statistically related to viral response.

Conclusions

The FAHI demonstrated acceptable psychometric properties in two independent populations. HRQL assessment enabled detection of changes in patients’ health status not revealed by traditional efficacy endpoints.
vorige artikel Development of the Healthy Pathways Child-Report Scales
volgende artikel Psychometric properties of the Chinese version of the Pediatric Quality of Life Inventory™ 4.0 generic core scales
Literatuur
1.
Detels, R., Munoz, A., McFarlane, G., Kingsley, L. A., Margolick, J. B., Giorgi, J., et al. (1998). Effectiveness of potent antiretroviral therapy on time to AIDS and death in men with known HIV infection duration. Multicenter AIDS Cohort Study Investigators. The Journal of American Medical Association, 280(17), 1497–1503.CrossRef
2.
Palella, F. J., Jr., Delaney, K. M., Moorman, A. C., Loveless, M. O., Fuhrer, J., Satten, G. A., et al. (1998). Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. The New England Journal of Medicine, 338(13), 853–860.CrossRefPubMed
3.
Walensky, R. P., Paltiel, A. D., Losina, E., Mercincavage, L. M., Schackman, B. R., Sax, P. E., et al. (2006). The survival benefits of AIDS treatment in the United States. Journal of Infectious Diseases, 194(1), 11–19.CrossRefPubMed
4.
Mrus, J. M., Williams, P. L., Tsevat, J., Cohn, S. E., & Wu, A. W. (2005). Gender differences in health-related quality of life in patients with HIV/AIDS. Quality of Life Research, 14(2), 479–491.CrossRefPubMed
5.
van Sighem, A. I., van de Wiel, M. A., Ghani, A. C., Jambroes, M., Reiss, P., Gyssens, I. C., et al. (2003). Mortality and progression to AIDS after starting highly active antiretroviral therapy. AIDS, 17(15), 2227–2236.CrossRefPubMed
6.
Agrawal, L., Lu, X., Jin, Q., & Alkhatib, G. (2006). Anti-HIV therapy: Current and future directions. Current Pharmaceutical Design, 12(16), 2031–2055.CrossRefPubMed
7.
Montessori, V., Press, N., Harris, M., Akagi, L., & Montaner, J. S. (2004). Adverse effects of antiretroviral therapy for HIV infection. Canadian Medical Association Journal, 170(2), 229–238.PubMed
8.
Carr, A., Samaras, K., Burton, S., Law, M., Freund, J., Chisholm, D. J., et al. (1998). A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS, 12(7), F51–F58.CrossRefPubMed
9.
Miller, J., Carr, A., Emery, S., Law, M., Mallal, S., Baker, D., et al. (2003). HIV lipodystrophy: prevalence, severity and correlates of risk in Australia. HIV Medicine, 4(3), 293–301.CrossRefPubMed
10.
Gulick, R. M. (1997). Current antiretroviral therapy: An overview. Quality of Life Research, 6(6), 471–474.CrossRefPubMed
11.
Leplege, A., Rude, N., Ecosse, E., Ceinos, R., Dohin, E., & Pouchot, J. (1997). Measuring quality of life from the point of view of HIV-positive subjects: The HIV-QL31. Quality of Life Research, 6(6), 585–594.CrossRefPubMed
12.
Reynolds, N. R. (2004). Adherence to antiretroviral therapies: state of the science. Current HIV Research, 2(3), 207–214.CrossRefPubMed
13.
Chassany, O., Sagnier, P., Marquis, P., Fullerton, S., Aaronson, N., & ERIQA Group. (2002). Patient-reported outcomes: The example of health-related quality of life—A European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Information Journal, 36, 209–238.
14.
Lin, M. K., Wu, A. W., & Revicki, D. A. (2002). Incorporating quality of life measures in HIV clinical trials. HIC Clinical Trials, 3(3), 202–218.CrossRef
15.
Lohr, K. N., Aaronson, N. K., Alonso, J., Burnam, M. A., Patrick, D. L., Perrin, E. B., et al. (1996). Evaluating quality-of-life and health status instruments: Development of scientific review criteria. Clinical Therapeutics, 18(5), 979–992.CrossRefPubMed
16.
17.
Clayson, D. J., Wild, D. J., Quarterman, P., Duprat-Lomon, I., Kubin, M., & Coons, S. J. (2006). A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials. PharmacoEconomics, 24(8), 751–765.CrossRefPubMed
18.
Cella, D. F., McCain, N. L., Peterman, A. H., Mo, F., & Wolen, D. (1996). Development and validation of the functional assessment of human immunodeficiency virus infection (FAHI) quality of life instrument. Quality of Life Research, 5(4), 450–463.CrossRefPubMed
19.
Cella, D. F., Tulsky, D. S., Gray, G., et al. (1993). The functional assessment of cancer therapy scale: Development and validation of the general measure. Journal of Clinical Oncology, 11(3), 570–579.PubMed
20.
Peterman, A. H., Cella, D., Mo, F., & McCain, N. (1997). Psychometric validation of the revised functional assessment of human immunodeficiency virus infection (FAHI) quality of life instrument. Quality of Life Research, 6, 572–584.CrossRefPubMed
21.
Wu, A. W., Rubin, H. R., Mathews, W. C., Ware, J. E., Jr., Brysk, L. T., Hardy, W. D., et al. (1991). A health status questionnaire using 30 items from the medical outcomes study. Preliminary validation in persons with early HIV infection. Medical Care, 29(8), 786–798.CrossRefPubMed
22.
Berzon, R. A., & Lenderking, W. R. (1998). Evaluating the outcomes of HIV disease: Focus on health status measurement. A publication for members of medical outcomes trust, 3(4).
23.
Davis, E. A., & Pathak, D. S. (2001). Psychometric evaluation of four HIV disease-specific quality-of-life instruments. Annals of Pharmacotherapy, 35(5), 546–552.CrossRefPubMed
24.
Grossman, H. A., Sullivan, P. S., & Wu, A. W. (2003). Quality of life and HIV: Current assessment tools and future directions for clinical practice. AIDS Read, 13(12), 583–587.PubMed
25.
Haubrich, R., Berger, D., Chiliade, P., Colson, A., Conant, M., Gallant, J., et al. (2007). Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients. AIDS, 21(6), F11–F18.CrossRefPubMed
26.
Katlama, C., Esposito, R., Gatell, J. M., Goffard, J. C., Grinsztejn, B., Pozniak, A., et al. (2007). Efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients: 24-week results of POWER 1. AIDS, 21(4), 395–402.CrossRefPubMed
27.
Lazzarin, A., Campbell, T., Clotet, B., Johnson, M., Katlama, C., Moll, A., et al. (2007). Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet, 370(9581), 39–48.CrossRefPubMed
28.
Madruga, J. V., Cahn, P., Grinsztejn, B., Haubrich, R., Lalezari, J., Mills, A., et al. (2007). Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet, 370(9581), 29–38.CrossRefPubMed
29.
Bonomi, A. E., Cella, D. F., Hahn, E. A., Bjordal, K., Sperner-Unterweger, B., Gangeri, L., et al. (1996). Multilingual translation of the functional assessment of cancer therapy (FACT) quality of life measurement system. Quality of Life Research, 5(3), 309–320.CrossRefPubMed
30.
Eremenco, S. L., Cella, D., & Arnold, B. J. (2005). A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & The Health Professions, 28(2), 212–232.CrossRef
31.
Cronbach, L. J. (1951). Coefficient alpha and the internal structure of tests. Psychometrika, 16(3), 297–334.CrossRef
32.
Nunnally, J. C., & Bernstein, I. H. (1994). Psychometric theory. New York: McGraw-Hill Inc.
33.
Hays, R. D., Anderson, R. T., & Revicki, D. A. (1998). Assessing reliability and validity of measurement in clinical trials. In M. J. Staquet, R. D. Hays, & P. M. Fayers (Eds.), Quality of life assessment in clinical trials: methods and practice (pp. 169–182). New-York, Tokyo: Oxford.
34.
Hays, R. D., & Hayashi, T. (1990). Beyond internal consistency reliability: rationale and user’s guide for Multitrait analysis program on the microcomputer. Behavior Research, Methods, Instruments and Computers, 22, 167–175.
35.
Rabin, R., & de Charro, F. (2001). EQ-5D: A measure of health status from the EuroQol group. Annals of Medicine, 33(5), 337–343.CrossRefPubMed
36.
Dolan, P. (1997). Modeling valuations for EuroQol health states. Medical Care, 35(11), 1095–1108.CrossRefPubMed
37.
Cohen, J. (1977). Statistical power analysis for the behavioral sciences. New York: Academic Press.
38.
Jaeschke, R., Singer, J., & Guyatt, G. H. (1989). Measurement of health status. Ascertaining the minimal clinically important difference. Controlled Clinical Trials, 10(4), 407–415.CrossRefPubMed
39.
Guyatt, G. H., Osoba, D., Wu, A. W., Wyrwich, K. W., Norman, G. R., & Clinical Significance Consensus Meeting Group. (2002). Methods to explain the clinical significance of health status measures. Mayo Clinic Proceedings, 77, 371–383.CrossRefPubMed
40.
Sloan, J. A., Symonds, T., Vargas-Chanes, D., & Fridley, B. (2003). Practical guidelines for assessing the clinical significance of health related quality of life changes within clinical trials. Drug Information Journal, 37, 23–31.
41.
Wyrwich, K. W., Nienaber, N. A., Tierney, W. M., & Wolinsky, F. D. (1999). Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Medical Care, 37(5), 469–478.CrossRefPubMed
42.
Walters, S. J., & Brazier, J. E. (2005). Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Quality of Life Research, 14(6), 1523–1532.CrossRefPubMed
43.
Shikiar, R., Willian, M. K., Okun, M. M., Thompson, C. S., & Revicki, D. A. (2006). The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study. Health and quality of life outcomes, 4, 71.CrossRefPubMed
44.
Yost, K. J., Sorensen, M. V., Hahn, E. A., Glendenning, G. A., Gnanasakthy, A., & Cella, D. (2005). Using multiple anchor- and distribution-based estimates to evaluate clinically meaningful change on the functional assessment of cancer therapy-biologic response modifiers (FACT-BRM) instrument. Value in Health, 8(2), 117–127.CrossRefPubMed
45.
46.
Rao, D., Hahn, E. A., Cella, D., & Hernandez, L. (2007). The health related quality of life outcomes of English and Spanish speaking persons living with HIV/AIDS from the continental United States and Puerto Rico. AIDS Patient Care STDS, 21(5), 339–346.CrossRefPubMed
47.
Revicki, D. A., Wu, A. W., & Murray, M. I. (1995). Change in clinical status, health status, and health utility outcomes in HIV-infected patients. Medical Care, 33(4 Suppl), AS173–AS182.PubMed
48.
Schag, C. A., Ganz, P. A., Kahn, B., & Petersen, L. (1992). Assessing the needs and quality of life of patients with HIV infection: Development of the HIV overview of problems-evaluation system (HOPES). Quality of Life Research, 1(6), 397–413.CrossRefPubMed
49.
Call, S. A., Klapow, J. C., Stewart, K. E., Westfall, A. O., Mallinger, A. P., DeMasi, R. A., et al. (2000). Health-related quality of life and virologic outcomes in an HIV clinic. Quality of Life Research, 9(9), 977–985.CrossRefPubMed
50.
Murri, R., Fantoni, M., Del Borgo, C., Visona, R., Barracco, A., Zambelli, A., et al. (2003). Determinants of health-related quality of life in HIV-infected patients. AIDS Care, 15(4), 581–590.CrossRefPubMed
51.
Weinfurt, K. P., Willke, R. J., Glick, H. A., Freimuth, W. W., & Schulman, K. A. (2000). Relationship between CD4 count, viral burden, and quality of life over time in HIV-1-infected patients. Medical Care, 38(4), 404–410.CrossRefPubMed
52.
Vidrine, D. J., Amick, B. C., I. I. I., Gritz, E. R., & Arduino, R. C. (2005). Assessing a conceptual framework of health-related quality of life in a HIV/AIDS population. Quality of Life Research, 14(4), 923–933.CrossRefPubMed
Metagegevens
Titel
Psychometric evaluation of the functional assessment of HIV Infection (FAHI) questionnaire and its usefulness in clinical trials
Auteurs
Muriel Viala-Danten
Dominique Dubois
Hélène Gilet
Silas Martin
Katrien Peeters
David Cella
Publicatiedatum
01-10-2010
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 8/2010
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-010-9674-9

Andere artikelen Uitgave 8/2010

Quality of Life Research 8/2010 Naar de uitgave

OriginalPaper

Validation of a Spanish version of the airways questionnaire 20: a short and simple instrument

Erratum

Erratum to: Effectiveness of a Tai chi Qigong program in promoting health-related quality of life and perceived social support in chronic obstructive pulmonary disease clients

OriginalPaper

Measuring community integration after spinal cord injury: validation of the Sydney psychosocial reintegration scale and community integration measure

OriginalPaper

PRO development: rigorous qualitative research as the crucial foundation

BriefCommunication

Psychometric properties of the Chinese version of the Pediatric Quality of Life Inventory™ 4.0 generic core scales

OriginalPaper

Using the Short Form-36 mental summary score as an indicator of depressive symptoms in patients with coronary heart disease