Related Experiment Video
Updated: Jul 16, 2026

Oral Health Assessment by Lay Personnel for Older Adults
Published on: February 2, 2020
Recommendations for evaluating the validity of quality of life claims for labeling and promotion
N K Leidy1, D A Revicki, B Genesté
1Center for Health Outcomes Research, MEDTAP International, Bethesda, MD 20814, USA. leidy@medtap.com
Abstract:
The pharmaceutical industry, the medical device industry, and national regulatory agencies such as the United States Food and Drug Administration (FDA) are faced with a number of difficult issues related to the development and evaluation of health-related quality of life (HRQL) claims for product labeling and promotion. This paper outlines some of the unique challenges of HRQL research and makes recommendations for assuring that claims are based on the results of rigorous studies designed and conducted according to accepted scientific principles and practices. Standards of evidence for HRQL are discussed in terms of research design and methodology, instrumentation, statistical analysis, and interpretation. Examples are provided to highlight important points. The paper concludes with a brief discussion of future trends in HRQL outcomes evaluation.
More Related Videos
Related Concept Videos
Levels of Health Promotion and Illness Prevention
In primary prevention, actions taken before disease onset prevent the disease from...
Models of Health Promotion and Illness Prevention II
The agent-host-environment model states that disease results from...
Data Validation
Nursing assessment guides are generally based on holistic models rather than medical...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Assessment of the Cardiovascular System I: Subjective Data
Initial Enquiry
Ask the patient about their primary concern and thoroughly explore all reported symptoms.
Medical History
Investigate past illnesses affecting the cardiovascular system, such as angina, anemia, rheumatic fever, congenital heart disease, stroke, thrombophlebitis, dysrhythmias, varicosities
Inquire about symptoms...
Lifestyle Factors and Health
Benefits of Physical Activity
Physical activity, whether through structured exercise or casual activities like walking, biking, or dancing, is a cornerstone of a...

