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

Muriel Viala-Danten; Dominique Dubois; Hélène Gilet; Silas Martin; Katrien Peeters; David Cella

doi:10.1007/s11136-010-9674-9

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

Muriel Viala-Danten^*, Dominique Dubois, Hélène Gilet, Silas Martin, Katrien Peeters, David Cella

^*Corresponding author for this work

Medical Social Sciences

Research output: Contribution to journal › Article › peer-review

18 Scopus citations

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.

Original language	English (US)
Pages (from-to)	1215-1227
Number of pages	13
Journal	Quality of Life Research
Volume	19
Issue number	8
DOIs	https://doi.org/10.1007/s11136-010-9674-9
State	Published - Oct 2010

Funding

Acknowledgments The present work was funded by Johnson & Johnson—Tibotec. Hélène Gilet and Muriel Viala-Danten are paid consultants to Johnson & Johnson—Tibotec. Silas Martin, Katrien Peeters and Dominique Dubois are employees of Johnson & Johnson—Tibotec. David Cella has no conflict of interest. The manuscript has been reviewed for its English by Angela Read-Meshil from Adelphi whom we would like to include in our acknowledgments.

Keywords

FAHI questionnaire
HIV/AIDS
Health-Related Quality of Life
Psychometric properties

ASJC Scopus subject areas

Public Health, Environmental and Occupational Health

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s11136-010-9674-9

Cite this

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title = "Psychometric evaluation of the Functional Assessment of HIV Infection (FAHI) questionnaire and its usefulness in clinical trials",

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.",

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author = "Muriel Viala-Danten and Dominique Dubois and H{\'e}l{\`e}ne Gilet and Silas Martin and Katrien Peeters and David Cella",

note = "Funding Information: Acknowledgments The present work was funded by Johnson & Johnson—Tibotec. H{\'e}l{\`e}ne Gilet and Muriel Viala-Danten are paid consultants to Johnson & Johnson—Tibotec. Silas Martin, Katrien Peeters and Dominique Dubois are employees of Johnson & Johnson—Tibotec. David Cella has no conflict of interest. The manuscript has been reviewed for its English by Angela Read-Meshil from Adelphi whom we would like to include in our acknowledgments.",

year = "2010",

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doi = "10.1007/s11136-010-9674-9",

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AU - Viala-Danten, Muriel

AU - Dubois, Dominique

AU - Gilet, Hélène

AU - Martin, Silas

AU - Peeters, Katrien

AU - Cella, David

N1 - Funding Information: Acknowledgments The present work was funded by Johnson & Johnson—Tibotec. Hélène Gilet and Muriel Viala-Danten are paid consultants to Johnson & Johnson—Tibotec. Silas Martin, Katrien Peeters and Dominique Dubois are employees of Johnson & Johnson—Tibotec. David Cella has no conflict of interest. The manuscript has been reviewed for its English by Angela Read-Meshil from Adelphi whom we would like to include in our acknowledgments.

PY - 2010/10

Y1 - 2010/10

N2 - 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.

AB - 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.

KW - FAHI questionnaire

KW - HIV/AIDS

KW - Health-Related Quality of Life

KW - Psychometric properties

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

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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