Abstract
BackgroundPatient-reported outcomes (PROs) may provide valuable information to clinicians and patients when choosing initial antiretroviral therapy.ObjectiveTo identify and classify PRO instruments used to measure treatment effects in clinical trials evaluating NNRTIs.MethodsWe 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.ResultsOf 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).ConclusionsAlthough 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.
Highlights
Patient-reported outcomes (PROs) may provide valuable information to clinicians and patients when choosing initial antiretroviral therapy
Conclusions: review of recent nucleoside reverse transcriptase inhibitor (NNRTI) trials suggests a lack of consensus on the optimal PRO instruments, a typical battery is comprised of a multidimensional health-related quality of life (HRQL) measure coupled with one or more symptom measures
Our search strategy included a combination of Medical Subject Headings (MeSH) terms for HIV [HIV OR HIV infections], MeSH terms associated with PROs/instruments [questionnaires OR interviews as topic OR quality of life OR patient satisfaction OR self-evaluation programs], Substance Names of NNRTIs [efavirenz OR nevirapine OR delavirdine OR etravirine OR rilpivirine OR efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination], and clinical trial Publication Types [clinical trial OR clinical trial, phase IV OR clinical trial, phase III OR clinical trial, phase II OR controlled clinical trial OR randomized controlled trial]
Summary
Patient-reported outcomes (PROs) may provide valuable information to clinicians and patients when choosing initial antiretroviral therapy. The majority of published comparative treatment studies that include PROs are limited to comparing differences between protease inhibitor (PI) and non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens. This may be due in part to the fact that for several years, treatment guidelines have recommended initiating HAART with two NRTIs plus either an NNRTI or a boosted PI [5,6]. This broad comparison may miss important distinctions among regimens that are related to within-class PRO differences
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