Validating the Reliability and Clinical Relevance of a Nasolabial Fold Photonumeric Scale.

BACKGROUND: The use of tissue fillers to treat age-related deepening of the nasolabial fold (NLF) has increased and become the standard clinical approach, creating a need for evidence-based, objective evaluation for pre- and post-procedure assessment of the NLF. METHODS: A 5-point rating scale was developed to assess the NLF, specifically the presence of depression and shadowing. Live validation of the scale was performed with a total of 73 participants representing the full range of NLF severities. Physicians board-certified in a core aesthetic specialty (3 trained raters) performed the scale validation over 2 rounds, 2 weeks apart. Training was carried out, and test-retest reliability was quantitated through the determination of intra- and inter-rater reliability by percentage of agreement, weighted kappa statistic with 95% confidence interval (CI), and intraclass correlation coefficient with 95% CI. To evaluate the clinical relevance of a 1-grade difference, rater assessments of 90 photo pairs were compared with previous designations of clinically different or not clinically different. RESULTS: The NLF scale achieved near-perfect intra- and inter-rater reliability when utilized by trained raters to assess a diverse group of live participants. Furthermore, clinically relevant differences between grades were established, and a 1-point difference was detectable by trained evaluators using the NLF scale. CONCLUSION: The clinically relevant and highly reliable validated NLF scale provides a standardized grading system with a user-friendly design for objectively assessing NLF in clinical practice and as a research tool for clinical approval studies of new aesthetic products and technologies. J Drugs Dermatol. 2024;23(1):1284-1291.   doi:10.36849/JDD.7316.

Validating the Reliability and Clinical Relevance of an Infraorbital Hollow Photonumeric Scale.

Background: Infraorbital hollowing is a facial aesthetic issue for which a broad age range of patients seek treatment. Expanding treatment options for this region warrants the development of validated tools to objectively assess infraorbital hollow (IOH) severity before and after treatment. Objectives: To validate a 4-point rating scale to assess depression of IOH, depression relative to the mid-pupillary line, and visibility of the lateral orbital rim. Methods: The IOH scale described herein was developed and subjected to live validation with a total of 73 patients representing the full range of IOH severities. Scale validation was performed by board-certified plastic surgeons and dermatologists (3 raters) over 2 rounds, 2 weeks apart. Intrarater and interrater reliabilities were used to demonstrate test-retest reliability as quantitated with percentage of agreement, weighted kappa statistic with 95% confidence interval (CI), and intraclass correlation coefficient with 95% CI. The clinical relevance of a 1-grade difference was evaluated by comparing rater assessments of 77 photo pairs with their previously determined designation as "clinically different" or "not clinically different." Results: The IOH scale demonstrated substantial to near-perfect intrarater and interrater reliabilities when utilized by trained raters to assess a diverse group of live patients. Furthermore, clinically relevant differences between grades were established, and detection of a 1-point difference could be achieved by trained evaluators using the IOH scale. Conclusions: This highly reliable, clinically relevant, and validated IOH scale provides a user-friendly, standardized grading system to objectively evaluate and track changes in infraorbital hollowing in clinical practice and research.