The clinical research landscape is increasingly focused on patient well-being, with results going beyond traditional clinical and biological endpoints. Understanding how individuals perceive their health, emotional state, and overall well-being has become essential for generating robust, meaningful, and market-relevant evidence. In this context, patient-reported outcome measures (PROMs) play a critical role in capturing dimensions of health that cannot be fully explained by biomarkers alone, supporting more comprehensive evaluation of interventions across clinical, nutritional, and lifestyle-focused research.
Patient-reported outcome measures (PROMs) are validated, standardized questionnaires that directly capture a patient’s own perspective on their health, quality of life, symptoms, and functional status. They are used to evaluate treatment impact, support value-based care, and improve clinical outcomes by measuring health changes over time, often before and after interventions¹.
The use of validated questionnaires to assess quality of life, anxiety, depression, and related psychosocial outcomes is fundamental in clinical research, as these constructs cannot be fully captured through biological or clinical measures alone. The scientific validity of these questionnaires is well established through rigorous psychometric testing, including assessments of reliability, construct validity, and responsiveness.
Instruments such as the Short Form Health Survey (SF-36)² and the World Health Organization Quality of Life questionnaire (WHOQOL)³ are widely employed to quantify health-related quality of life across diverse clinical populations and cultural contexts, supporting a more patient-centered approach to clinical evaluation. Besides that, questionnaires such as the Hospital Anxiety and Depression Scale (HADS) and the Beck Depression Inventory (BDI)5 have demonstrated strong internal consistency and convergent validity with clinical diagnostic criteria. Additionally, many of these tools have been cross-culturally adapted and validated in multiple languages, which strengthens their applicability in international and multicenter clinical studies.
Practical examples illustrate the relevance of these measures in clinical trials and observational studies since biochemical improvements such as reduced inflammation or oxidative stress may not fully capture patient benefit unless accompanied by improvements in quality of life or mental health scores. For example, interventions involving cocoa or dark chocolate consumption have reported improvements in mood and perceived quality of life using instruments such as the SF-36 and Profile of Mood States (POMS)6,7.
Similarly, supplementation with fruits rich in antioxidants or probiotics has been associated with reductions in anxiety and depression scores measured by the HADS and the BDI, highlighting the relevance of these questionnaires in nutrition and functional food research8.
Baseline identification of anxiety or depressive symptoms can influence dietary adherence, symptom perception, and treatment response.
In summary, incorporating validated questionnaires into clinical research enhances methodological rigor, supports comprehensive interpretation of findings, and strengthens the evidence base for patient-centered and lifestyle-oriented interventions.
Q&A
What does PROMs mean, and why are they different from traditional clinical endpoints?
PROMs (Patient-Reported Outcome Measures) are validated tools that capture health outcomes directly from the patient’s perspective, providing insights into quality of life, symptoms, and well-being that are not fully reflected by biological or clinical measurements alone.
Can PROMs support claims in nutrition and functional food research?
Yes. They provide validated evidence of benefits related to quality of life, mood, and mental well-being—key drivers of consumer relevance.
Are PROMs suitable for global and multicenter studies?
Absolutely. Many instruments are cross-culturally adapted and validated in multiple languages, enabling consistent and scalable international research.
References
1) U.S. Food and Drug Administration. (2009). Guidance for industry: Patient-reported outcome measures: Use in medical product development to support labeling claims. U.S. Department of Health and Human Services.
2) Ware, J. E., & Sherbourne, C. D. (1992). The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Medical Care, 30(6), 473–483.
3) Skevington, S. M., Lotfy, M., & O’Connell, K. A. (2004). The World Health Organization’s WHOQOL-BREF quality of life assessment: Psychometric properties and results of the international field trial. Psychological Medicine, 34(2), 299–310.
4) Zigmond, A. S., & Snaith, R. P. (1983). The Hospital Anxiety and Depression Scale. Acta Psychiatrica Scandinavica, 67(6), 361–370.
5) Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Manual for the Beck Depression Inventory–II. Psychological Corporation.
6) Pase, M. P., Scholey, A. B., Pipingas, A., et al. (2013). Cocoa polyphenols enhance positive mood states but not cognitive performance: A randomized, placebo-controlled trial. Journal of Psychopharmacology, 27(5), 451–458.
7) Grassi, D., Desideri, G., Croce, G., et al. (2008). Flavanol-rich dark chocolate improves endothelial function and quality of life in healthy adults. Journal of Hypertension, 26(8), 1575–1580.
8) Liu, R. T., Walsh, R. F. L., & Sheehan, A. E. (2019). Prebiotics and probiotics for depression and anxiety: A systematic review and meta-analysis. Psychological Medicine, 49(16), 2623–2633.
