Pilot study to develop and validate a questionnaire based on HIV symptoms index

• Main Authors: Olatz Ibarra-Barrueta, Oihana Mora-Atorrasagasti, María José Legarreta, Aitziber Illaro-Uranga, Ramón Morillo-Verdugo
• Format: Article
• Language: English
• Published: Grupo Aula Médica 2019-05-01
• Series: Farmacia Hospitalaria
• Subjects: Adverse effects; Antiretroviral agents; HIV; Questionnaire validation; Patient reported outcomes
• Online Access: http://www.aulamedica.es/fh/pdf/11127.pdf

Objective: The primary endpoint is to validate the HIV Symptoms Index Questionnaire in a Spanish population, in terms of comprehension and acceptability. The secondary endpoints are to describe symptoms reported by patients, tolerance, and quality of life. Method: The pilot trial of an observational and multicenter non-comparative study, for the validation of the HIV Symptoms Index Questionnaire in a Spanish population. Patients over the age of 18 diagnosed with HIV infection and receiving treatment were included. The symptoms index, treatment adherence based on pharmacy dispensing records, and quality of life with MOS-HIV questionnaire were calculated. Statistical analyses were conducted with the SAP System V9.2. Results:Between 2013 and 2014, the HIV Symptoms Index Questionnaire was applied to 75 patients; 95% of these patients considered the questionnaire was easy to apply and understand. The total median score of the questionnaire was nine symptoms (IQR 1-18); and the most frequent symptoms were nerves or anxiety (45%), stomach swelling, pain or gas (40%), sleep problems (39%), and fatigue or lack of energy (37%). Presence of symptoms was associated with a worse outcome in the MOS-HIV questionnaire. According to the Visual Analogue Scale, the higher the score in the questionnaire, the lower the tolerance level (R = –0.51; p < 0.0001), and the higher number of days with symptoms (R = 0.51; p < 0.0001). Conclusions: The questionnaire was easy to apply. A high tolerance level was confirmed, as well as a consistent and significant correlation with the MOS-HIV and the Visual Analogue Scale.