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

Simpson, Kit N; Hanson, Kristin A; Harding, Gale; Haider, Seema; Tawadrous, Margaret; Khachatryan, Alexandra; Pashos, Chris L; Wu, Albert W

doi:10.1186/1477-7525-11-164

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)
Name	Instrument type	Items (N)	Domains/scales/concepts	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 symptoms^2,3,4	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 symptoms^2,3	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

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.
¹Physical health and mental health summary scores; ²Depression; ³Anxiety; ⁴Stress; ⁵Daytime sleepiness; ⁶Sleep quality; ⁷Symptom count and symptom bother count.

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ISSN: 1477-7525

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