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

Health and Quality of Life Outcomes

Albert W Wu⁶  Chris L Pashos³  Alexandra Khachatryan⁴  Margaret Tawadrous⁵  Seema Haider⁵  Gale Harding¹  Kristin A Hanson⁷  Kit N Simpson² 

[1] Evidera, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD 20814, USA;Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC 29425, USA;UBC: An Express Scripts Company, 430 Bedford Street, Lexington, MA 02420, USA;Pharmerit, 4350 East West Highway, Suite 430, Bethesda, MD 20814, USA;Pfizer Inc., 558 Eastern Point Road, Groton, CT 06340, USA;Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD 21205, USA;UBC: An Express Scripts Company, 185 Dorval Ave, Suite 500, Dorval, QC H9S 5J9, Canada

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

Others  :  822391
DOI  :  10.1186/1477-7525-11-164

 received in 2012-11-08, accepted in 2013-09-05,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Simpson et al.; licensee BioMed Central Ltd.

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