Evaluating "Bother" As A Component Of Patient-Reported Outcomes In Clinical Studies

Patient-reported outcome (PRO) instruments include various scales and questionnaires designed to gather patients’ feedback on their experiences during a clinical trial. These validated tools can be broadly applied across diverse populations or tailored to specific diseases and conditions.

Depending on the research objectives, patient-reported outcome measures (PROMs) can serve as primary, secondary, or exploratory endpoints. PROMs are increasingly vital to clinicians, regulators, and payors for capturing patient-centered data on disease symptoms, side effects, functional outcomes, and health-related quality of life.

In clinical trials, "bother" is closely related to PROMs. It refers to the adverse subjective experiences, from mild discomfort to significant distress, caused by side effects or trial procedures. Including bother questions in PROMs helps researchers understand the impact of the condition or treatment on patients' daily lives. This information is crucial for evaluating treatment effectiveness, making informed clinical decisions, and improving patient care and quality of life.

For example, the FACT-G questionnaire includes the item GP5: “I am bothered by side effects of treatment.” This item serves as an indicator of treatment-related toxicity and is significantly correlated with overall quality of life, specifically the patient’s ability to enjoy life. Additionally, bother as a PROM helps regulatory agencies and healthcare providers assess the overall benefit of a treatment from the patient’s perspective.

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