Content Validation of a Modified PozQoL for Assessing HIV Therapies
Author(s)
Karine Dube, DrPH1, Sorana Segal-Maurer, MD2, Martin Duracinsky, PhD, MD3, Martha Gauthier, MA4, Kathy Vong, BA4, Harlow Sharp, BA4, Blaise Cureg, MPH4, Imani Weeks, BA4, Kwanza Price, MPH5, Caroline Burk, PharmD, MS5, James Jarrett, MA, PhD5.
1University of California San Diego, School of Medicine, Division of Infectious Diseases and Global Public Health, San Diego, CA, USA, 2NewYork-Presbyterian Queens, The Dr James J Rahal Jr Division of Infectious Diseases, Flushing, NY, USA, 3Patient-Reported Outcomes Research (PROQOL), Health Economics Clinical Trial Unit (URC-ECO), Hôtel-Dieu Hospital, AP-HP, Paris, France, 4Lumanity, Boston, MA, USA, 5Gilead Sciences Inc., Foster City, CA, USA.
1University of California San Diego, School of Medicine, Division of Infectious Diseases and Global Public Health, San Diego, CA, USA, 2NewYork-Presbyterian Queens, The Dr James J Rahal Jr Division of Infectious Diseases, Flushing, NY, USA, 3Patient-Reported Outcomes Research (PROQOL), Health Economics Clinical Trial Unit (URC-ECO), Hôtel-Dieu Hospital, AP-HP, Paris, France, 4Lumanity, Boston, MA, USA, 5Gilead Sciences Inc., Foster City, CA, USA.
OBJECTIVES: Patient-reported outcome measures (PROMs) are essential tools for capturing patient perspectives on health status and quality of life. The PozQoL is a 13-item questionnaire that assesses psychological, social, health and functional concepts for people with HIV (PWH). This study evaluated a modified version of the PozQoL incorporating revisions from the research team, clinician experts, and a PWH advocate to ensure its suitability and practicality for use in HIV clinical trials that include a complex regimen phase along with analytical treatment interruption (ATI).
METHODS: Researchers conducted hybrid concept elicitation and cognitive debriefing interviews with 14 PWH in the United States currently on antiretroviral therapy to assess the content validity of the PozQoL. The team analyzed interview transcripts for issues with content, language, and structure/format. Based on feedback from PWH, revisions were made and the revised PozQoL is undergoing further cognitive debriefing interviews with an additional 12 PWH to ensure its comprehensibility, clarity, and relevance.
RESULTS: The PozQoL was restructured so that positively worded items were grouped together, and a 4-week recall period was added to the instructions. PWH in the first set of interviews interpreted all items on the PozQoL as intended. Potential clarity issues were identified for 3 items (lack a sense of belonging [item 6]; worn out due to HIV management [item 11]; limits personal relationships [item 12]) by 2 participants for each item. No changes were implemented for items 6 and 11. Item 12 is being tested in its original form and additionally with alternative language including two sub-questions to differentiate friendships and romantic relationships.
CONCLUSIONS: The results support the content validity of the PozQoL and its suitability and practicality in clinical trial settings inclusive of complex regimen and ATI phases. The PozQoL will be implemented in future HIV studies and its psychometric properties will be assessed using trial data.
METHODS: Researchers conducted hybrid concept elicitation and cognitive debriefing interviews with 14 PWH in the United States currently on antiretroviral therapy to assess the content validity of the PozQoL. The team analyzed interview transcripts for issues with content, language, and structure/format. Based on feedback from PWH, revisions were made and the revised PozQoL is undergoing further cognitive debriefing interviews with an additional 12 PWH to ensure its comprehensibility, clarity, and relevance.
RESULTS: The PozQoL was restructured so that positively worded items were grouped together, and a 4-week recall period was added to the instructions. PWH in the first set of interviews interpreted all items on the PozQoL as intended. Potential clarity issues were identified for 3 items (lack a sense of belonging [item 6]; worn out due to HIV management [item 11]; limits personal relationships [item 12]) by 2 participants for each item. No changes were implemented for items 6 and 11. Item 12 is being tested in its original form and additionally with alternative language including two sub-questions to differentiate friendships and romantic relationships.
CONCLUSIONS: The results support the content validity of the PozQoL and its suitability and practicality in clinical trial settings inclusive of complex regimen and ATI phases. The PozQoL will be implemented in future HIV studies and its psychometric properties will be assessed using trial data.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR52
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Infectious Disease (non-vaccine)