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Table 2 Characteristics of identified PRO measures

From: Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy: a 10-year review

Name Instrument type Items (N) Domains/scales/concepts Score type(s)
Dimension Summary1 Total
BDI-II Psychiatric symptoms2 21 Severity of depression    X
BMQ-ART Medication beliefs (HIV-targeted) 19 HAART necessity scale (beliefs about personal need for HAART for controlling HIV, maintaining their health, preventing illness), HAART concerns scale (potential adverse effects, dependence, embarrassment about treatment, etc.) X   
Body Image Impact Psychiatric symptoms 3 Belly size, belly image distress, belly profile X   
CES-D Psychiatric symptoms2 20 Frequency and severity of depression symptoms    X
DASS21 Psychiatric symptoms2,3,4 21 Depression, anxiety, stress X   
EORTC QLQ-30 HRQL (general) 30 6 functioning scales (physical, role, cognitive, emotional, social, global QOL), 9 symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact) X   
ESS Sleep5 8 Rates chances of dozing during the daytime in 8 situations    X
FAHI HRQL (HIV-targeted) 47 Physical well-being, functional and global well-being, emotional well-being/living with HIV, social well-being, cognitive functioning X   X
GSQS Sleep6 15 Questions about quality of previous night’s sleep    X
HAART Intrusiveness Scale Medication beliefs (HIV-targeted) 12 Degree to which ART is perceived to interfere with aspects of daily life (e.g., social life, ability to work, relationships)    X
HADS Psychiatric symptoms2,3 14 Anxiety, depression X   
HAM-A Psychiatric symptoms3 14 Severity of anxiety    X
HAM-D Psychiatric symptoms2 17 Severity of depression    X
HIV-SI / SDM HIV symptoms 20 HIV- or treatment-related symptoms (e.g., fatigue, dizziness, nausea, depression, anxiety)   X7 X
IIRS HRQL (general) 13 Relationships and personal development, intimacy, instrumental X   X
ISSQoL HRQL (HIV-targeted) 62 QOL core (satisfaction with QOL, physical well-being, role well-being, social functioning, depression/anxiety, energy/vitality, health distress, cognitive functioning, sexual life), Additional important areas (social support, interaction with medical staff, treatment impact, body changes, life planning, motherhood/fatherhood) X   
MOS-HIV HRQL (HIV-targeted) 35 General health perceptions, physical functioning, role functioning, social functioning, pain, energy/fatigue, health distress, mental health, cognitive functioning, and quality of life X X1 X
OSQ Sleep6 13 Subjective sleep quality, somnolence, insomnia, nightmares    X
PANSI Psychiatric symptoms 14 Positive suicidal ideation, negative suicidal ideation X   
PANSS Psychiatric symptoms 30 Positive items (e.g., delusions, hallucinations), Negative items (e.g., blunted affect, emotional withdrawal), General Psychopathology (e.g., anxiety, depression, disorientation) X   X
PSQI Sleep6 19 Subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction    X
SCL-90 Somatization subscale Psychiatric symptoms 12 Distress arising from perceptions of bodily dysfunction, such as cardiovascular, gastrointestinal, respiratory, and autonomic symptoms X   
SF-12 HRQL (general) 12 Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health X X1  
SF-36 HRQL (general) 36 Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health, reported health transition X X1  
SSS Sleep5 1 Subjects select 1 statement to best describe typical sleepiness at work during the prior week    X
STAI Psychiatric symptoms3 40 State anxiety, trait anxiety    X
WHOQOL-HIV BREF HRQL (HIV-targeted) 31 Physical, psychological, level of independence, social relationships, environment, spirituality X   
  1. Abbreviations: BDI-II Beck Depression Inventory, second edition, BMQ-ART Beliefs about Medicines Questionnaire, adapted for antiretroviral therapy, CES-D Centers for Epidemiological Studies-Depression, DASS21 Depression Anxiety and Stress Scale, short version, EORTC QLQ-30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, ESS Epworth Sleep Score, FAHI Functional Assessment of HIV Infection, GSQS Groningen Sleep Quality Score, HAART Highly Active Antiretroviral Therapy, HADS Hospital Anxiety and Depression Scale, HAM-A Hamilton Anxiety Rating Scale, HAM-D Hamilton Depression Rating Scale, HIV-SI HIV Symptom Index, HRQL health-related quality of life, IIRS Illness Intrusiveness Rating Scale, ISSQoL Istituto Superiore di Sanità Quality of Life, MOS-HIV Medical Outcomes Study-HIV, OSQ Oviedo Sleep Questionnaire, PANSI Positive and Negative Syndrome Scale, PANSS Positive and Negative Suicide Ideation, PSQI Pittsburgh Sleep Quality Index, SCL-90 Symptom Checklist-90, SDM Symptom Distress Module, SF-12 MOS 12-item short-form health survey, SF-36 MOS 36-item short-form health survey, SSS Stanford Sleepiness Scale, STAI State-Trait Anxiety Index, WHOQOL-HIV BREF World Health Organization Quality of Life-HIV, short version.
  2. 1Physical health and mental health summary scores; 2Depression; 3Anxiety; 4Stress; 5Daytime sleepiness; 6Sleep quality; 7Symptom count and symptom bother count.