Patient-reported outcomes have adjusted with the needs of PLHIV

This is the first in a three-part series on patient reported outcomes (PROs) and how they can be incorporated into the clinical management of people living with HIV (PLHIV). The series includes expert insights from Dr Hal Martin, Director of Clinical Research at Gilead Sciences, San Francisco, California, and includes a link to the HIV Symptom Index – the most commonly used instrument to measure PROs in PLHIV.

“These are tools that really try to probe and prompt the patient about any symptoms that he or she is having”

– Dr Hal Martin

PROs are reflections that are generated from questionnaires that PLHIV complete. They ask for the individual’s assessment of how interventions have, over time, affected their quality of life, daily functioning, symptom severity, and other dimensions of health, which only the individual can know.1  They are particularly important as many clinicians remain unaware of symptoms and may discount those of which they are aware.2,3 Furthermore, clinicians may be unaware of symptoms because they forget to ask or because individuals want to give “socially desirable” responses and omit symptoms when interviewed.4

As Dr Martin explained, “These are tools that really try to probe and prompt the patient about any symptoms that he or she is having,” he said.

In the early stages of the HIV epidemic, PROs focused on symptoms related to the disease itself (e.g., fever, weight loss, swollen glands etc.). However, now that HIV survival can be extended with antiretroviral therapy (ART),5 the focus of PROs has shifted to treatment-related symptoms, the impact of medication on an individual’s overall health, including their sense of wellbeing.

Indeed, as the success of ART largely depends on adherence to and persistence with that therapy,6 PROs are becoming an important consideration for clinicians when prescribing HIV treatment.

Old tools put to good use

The HIV Symptom Index (HIV-SI) was first developed in 20014 and, despite its age, is still considered to be the gold standard in clinical research owing to its validation in several studies.7 The instrument assesses the burden of 20 common symptoms associated with HIV treatment and takes less than 5 minutes to complete.

“Those 20 questions ask everything from headaches to memory problems to nausea, vomiting, diarrhoea, difficulty sleeping, feeling nervous, anxious,” said Dr Martin.

Individuals are asked about their experience with each of 20 symptoms during the past 4 weeks using a 5-point, Likert-type scale. Response options and scores are as follows:4

(0) “I don’t have this symptom;”

(1) “I have this symptom and it doesn’t bother me;”

(2) “I have this symptom and it bothers me a little;”

(3) “I have this symptom and it bothers me;” and

(4) “I have this symptom and it bothers me a lot.”

This 20-item HIV-SI offers a simple and rational approach to measuring treatment-related symptoms as part of routine clinical practice. A copy of the HIV-SI can be accessed via the link below.

View the interview with Dr Hal Martin


Access a copy of the HIV Symptom Index

Click here

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