Open Access Research

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

Kit N Simpson1, Kristin A Hanson2*, Gale Harding3, Seema Haider4, Margaret Tawadrous4, Alexandra Khachatryan5, Chris L Pashos6 and Albert W Wu7

Author Affiliations

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

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Health and Quality of Life Outcomes 2013, 11:164  doi:10.1186/1477-7525-11-164

Published: 3 October 2013

Abstract

Background

Patient-reported outcomes (PROs) may provide valuable information to clinicians and patients when choosing initial antiretroviral therapy.

Objective

To identify and classify PRO instruments used to measure treatment effects in clinical trials evaluating NNRTIs.

Methods

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.

Results

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).

Conclusions

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.

Keywords:
HIV; Patient-reported outcome (PRO); Instrument; NNRTI