ASSESSING CELLULITE SEVERITY- METHOD FOR ASSESSING RELIABILITY OF A NEW CLINICIAN-REPORTED AND A NEW PATIENT-REPORTED PHOTONUMERIC SCALE

Author(s)

Kirby MT1, McLane MP1, Lenderking WR2, Bender R2, Chen J2, Hurley D1, Knoble N2, Liu G1, Davidson JA1
1Endo Pharmaceuticals Inc., Malvern, PA, USA, 2Evidera, Bethesda, MD, USA

OBJECTIVES: To develop and validate scales for use by clinicians and patients to measure cellulite severity.

METHODS: The Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS) are 5-point photonumeric scales that include 5 photographs ranked in increasing order of cellulite severity according to the number and depth of dimples on the left or right buttocks and left or right posterolateral thighs, with corresponding labels and text descriptors. Test-retest reliability of the CR-PCSS was evaluated at baseline and Day 2 to minimize clinician reliance on memory (ie, blinded). Patients rated by clinicians also self-rated their cellulite severity by the PR-PCSS, using either photos or mirrors at baseline and the opposite method at Week 2, a duration considered sufficient to minimize reliance on memory; method order was randomly assigned at baseline. Intra- and inter-rater reliability for the CR-PCSS was determined by calculating intraclass correlation coefficients (ICCs) and corresponding 95% confidence intervals (CI). Concordance between the CR-PCSS and PR-PCSS was determined by comparing CR-PCSS ratings from each clinician with pooled (baseline and Week 2) self-ratings of photos or mirrors for each patient (PR-PCSS). Content validity of both scales was established through concept elicitation and cognitive interviews.

RESULTS: Mean intra-rater ICCs (95% CI) for the CR-PCSS (n=6) were 0.78 (0.67-0.90) and 0.79 (0.67-0.90) for the left and right thighs, and 0.81 (left, 0.73-0.90; right, 0.72-0.90) both for the left and right buttocks. Mean intra-rater ICCs (95% CI) for the PR-PCSS (n=75) were 0.57 (0.40-0.70) and 0.60 (0.43-0.72) for the left and right thighs, and 0.74 (0.62-0.83) and 0.64 (0.49-0.76) for the left and right buttocks.

CONCLUSIONS: The CR-PCSS was considered reliable for live assessment and the PR-PCSS (2 different methods) was comparable for the evaluation of cellulite severity of buttocks and thighs.

Conference/Value in Health Info

2018-05, ISPOR 2018, Baltimore, MD, USA

Value in Health, Vol. 21, S1 (May 2018)

Code

PRM121

Topic

Study Approaches

Disease

Reproductive and Sexual Health

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