Qualitative and Mixed Methods Service Tips

October 2026 

Topic: Validity – Are You Measuring the Right Construct?

Patient-reported outcome measures (PROMs) are only useful if they accurately measure the concept of interest.

Validity refers to the degree to which a measure captures what it claims to measure. For example, a fatigue scale should assess fatigue rather than depression, pain, or sleep disturbances.

When evaluating validity, look for evidence of construct validity, which examines whether scores behave as expected. A fatigue measure should correlate strongly with other fatigue instruments and distinguish between patients with different symptom burdens. For instance, patients receiving intensive chemotherapy would be expected to report higher fatigue scores than healthy controls.

Researchers may report correlation coefficients as evidence of validity. Moderate to strong correlations (e.g., r ≥ 0.50) with measures assessing similar concepts support construct validity. Equally important, the measure should show weaker correlations with unrelated constructs.

Before selecting a PROM, review studies conducted in populations similar to your own. A scale validated in healthy adults may not perform similarly in patients with chronic illness. Strong validity evidence improves confidence that observed differences or treatment effects reflect true changes rather than measurement artifacts.

Thoughtful review of validity helps ensure that patient-reported data contribute meaningful evidence for both research and clinical decision-making.

September 2026 

Topic: Using Patient-Reported Outcomes in Clinical Research and Healthcare

Patient-reported outcome measures (PROs or PROMs) are health status and related assessments collected directly from patients without interpretation of the patient’s response by a clinician or anyone else. The use of PROs/PROMs in clinical research is well established in helping evaluate the risks and benefits of treatments. This includes (1) measuring research study endpoints, (2) monitoring adverse events, and (3) monitoring symptoms, patient satisfaction, and healthcare performance.

To date, PROs have been used mainly for research and occasionally for monitoring the health of a given population, mostly as part of population surveys. However, a key goal of collecting PRO/PROM data in more pragmatic (or real-world) clinical research and in healthcare more generally is to improve clinical decision-making within the context of data-driven care. The successful integration of PRO measures within this context requires continuous collection of accurate, valid, accessible, and reusable data in real time to support patient care, clinical research, quality improvement, and comparative effectiveness research. Over the next several newsletters, we’ll focus on tips that can help clinical researchers better evaluate and adopt PROs/PROMs in their work.

For comprehensive overviews of PRO/PROM use, see:

FDA Guidance Document. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. (2009 with verified content current as of 10/17/19)

NIH Collaboratory Guidance on Patient Reported Outcomes in Living (Online) Textbook