Use of PROs in clinical trials

In the final instalment of this three-part series, Dr Martin discusses the use of patient reported outcomes (PROs) in HIV research and the importance of using adequately validated tools.

In recent years the number of generic and disease-specific tools available to capture PROs has increased dramatically. While the information obtained from PROs can help improve communication between healthcare professionals (HCPs) and patients1-4 and allow HCPs to manage patients more effectively and efficiently,5 good clinical research demands that any measurement tool must first be clinically validated; preferably within the specific cohort for whom it is intended.

“The tool that is best validated for use in PLHIV is the HIV Symptom Index”

– Dr Hal Martin

The importance of well conducted validation studies on PRO questionnaires is essential; not only for guiding the types of questions that people living with HIV (PLHIV) should be asked in relation to specific issues, but also for making better sense of what insights such questions might convey. The use of unvalidated questionnaires in practice should be avoided. Unvalidated questionnaires introduce a potential source of bias that can detract from the reliability and generalisability of the findings.

In reference to Gilead clinical trials performed to-date, Dr Martin emphasised that the company had “chosen PRO tools [to use] that have been well validated in a number of different populations and [they’ve been] published in scientific journals. The tool that is best validated for use in PLHIV is the HIV Symptom Index (HIV-SI)6” he said.

The HIV-SI was first developed in 2001 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 for individuals to complete. A copy of the HIV-SI can be accessed via the link below.

Although formal validation of tools such as the HIV-SI is essential, the validation process means that new instruments take considerable time to develop.

As Dr Martin explained, “…treatments have progressed so far since 2001. We would love to have new instruments and, in fact, Gilead has been working with behavioralists to develop new tools…”

View the interview with Hal Martin


Access a copy of the HIV Symptom Index

Click here

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