Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy

A 10-year review

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

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article number164
JournalHealth and Quality of Life Outcomes
Volume11
Issue number1
DOIs
StatePublished - Oct 3 2013

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antineoplaston A10
Clinical Trials
HIV
Therapeutics
Quality of Life
HIV-2
Health Surveys
PubMed
Psychiatry
Patient Reported Outcome Measures
Consensus
Sleep
Anxiety
Outcome Assessment (Health Care)
Depression

Keywords

  • HIV
  • Instrument
  • NNRTI
  • Patient-reported outcome (PRO)

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy : A 10-year review. / Simpson, Kit N.; Hanson, Kristin A.; Harding, Gale; Haider, Seema; Tawadrous, Margaret; Khachatryan, Alexandra; Pashos, Chris L.; Wu, Albert W.

In: Health and Quality of Life Outcomes, Vol. 11, No. 1, 164, 03.10.2013.

Research output: Contribution to journalArticle

Simpson, Kit N. ; Hanson, Kristin A. ; Harding, Gale ; Haider, Seema ; Tawadrous, Margaret ; Khachatryan, Alexandra ; Pashos, Chris L. ; Wu, Albert W. / Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy : A 10-year review. In: Health and Quality of Life Outcomes. 2013 ; Vol. 11, No. 1.
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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.",
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