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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2013

Open Access 01-12-2013 | Research

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

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

Published in: Health and Quality of Life Outcomes | Issue 1/2013

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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.
Appendix
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Metadata
Title
Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy: a 10-year review
Authors
Kit N Simpson
Kristin A Hanson
Gale Harding
Seema Haider
Margaret Tawadrous
Alexandra Khachatryan
Chris L Pashos
Albert W Wu
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2013
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-11-164

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