Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy: a 10-year review
1 Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29425, USA
2 UBC: An Express Scripts Company, 185 Dorval Ave, Suite 500, Dorval, QC H9S 5J9, Canada
3 Evidera, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USA
4 Pfizer Inc., 558 Eastern Point Road, Groton, CT 06340, USA
5 Pharmerit, 4350 East West Highway, Suite 430, Bethesda, MD 20814, USA
6 UBC: An Express Scripts Company, 430 Bedford Street, Lexington, MA 02420, USA
7 Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, USA
Health and Quality of Life Outcomes 2013, 11:164 doi:10.1186/1477-7525-11-164Published: 3 October 2013
Patient-reported outcomes (PROs) may provide valuable information to clinicians and patients when choosing initial antiretroviral therapy.
To identify and classify PRO instruments used to measure treatment effects in clinical trials evaluating NNRTIs.
We conducted a structured literature review using PubMed to identify NNRTI trials published from March 2003 to February 2013. Studies identified--based on disease, instrument, PRO, and NNRTI medication terms were reviewed--to identify PRO instruments. Domains measured within each instrument were recorded to understand key areas of interest in NNRTIs.
Of 189 articles reviewed, 27 validated instruments were administered in 26 unique trials, with a mean of 1.9 instruments (median: 1; range: 1–7) per trial. The Medical Outcomes Study HIV Health Survey (MOS-HIV) was the most commonly used instrument (n = 8 trials). Seventeen trials (65%) included at least one multidimensional health-related quality of life (HRQL) instrument (HIV-targeted, n = 11; general, n = 8). Other validated instruments measured sleep (n = 5), depression (n = 5), anxiety (n = 4), psychiatric symptoms (n = 2), beliefs about HIV medications (n = 2), HIV symptoms (n = 1), and stress (n = 1).
Although review of recent NNRTI trials suggests a lack of consensus on the optimal PRO instruments, a typical battery is comprised of a multidimensional HRQL measure coupled with one or more symptom measures. Further work is needed to clarify advantages and disadvantages of using specific PRO instruments to measure relevant constructs and to identify the most useful batteries of instruments for NNRTI trials.