title: Validation of a fentanyl transdermal adhesion scoring tool for use in clinical practice.
abstract: BACKGROUND
  The therapeutic efficacy of a transdermal system (TDS) is directly related to the adhesion of TDS, with partial adhesion resulting in lower plasma concentration. Currently there is no TDS adhesion scoring tool available for use in the clinical setting.
  
  
  OBJECTIVE
  To validate a U.S. Food and Drug Administration (FDA) scoring system for the adhesion of the fentanyl TDS in cancer patients.
  
  
  METHODS
  A library of images was created from photographs of fentanyl/placebo TDS placed on patients/volunteers. Thirty photographs, reflecting varying degrees of adhesion, were selected for each of series A and B, with 10 photographs common to both series. Each series was shown to 30 health professionals asked to score the photographs using the FDA scoring system. Validity was assessed using Spearman's rank correlation and reliability by Cohen's kappa (k). Photo editing software was used to assign control scores to each photograph.
  
  
  RESULTS
  Validity was high for both series (≥ 0.954). Inter-reliability (k) ranged from 0.327 to 0.858 (average, 0.547) and 0.433-0.910 (average, 0.620) in series A and B, respectively. The combined agreement across both series was 0.585. Intra-rater agreement (k) of the 10 common images was 0.605. No significant difference was observed between the scoring patterns for those with more than 10 years of working experience.
  
  
  CONCLUSIONS
  Overall, the TDS adhesion score determined by the participants visually in this study corresponded well to those generated by photo editing software, thus rendering the scoring system highly valid. The FDA scoring system is an adequate tool for assessing fentanyl TDS adhesion in clinical practice.
authors.affiliation: School of Pharmacy, Griffith Health Institute, Griffith University, Gold Coast, Southport, Queensland, Australia. Electronic address: s.bista@griffith.edu.au.
authors.forename: Sudeep Raj
authors.initials: SR
authors.lastname: Bista
authors.affiliation: Mater Health Services, South Brisbane, Queensland, Australia; Mater Medical Research Institute, South Brisbane, Queensland, Australia.
authors.forename: Janet
authors.initials: J
authors.lastname: Hardy
authors.affiliation: Mater Health Services, South Brisbane, Queensland, Australia; Mater Medical Research Institute, South Brisbane, Queensland, Australia.
authors.forename: Angela
authors.initials: A
authors.lastname: Tapuni
authors.affiliation: Mater Medical Research Institute, South Brisbane, Queensland, Australia.
authors.forename: Jinlin
authors.initials: J
authors.lastname: Fu
authors.affiliation: Mater Medical Research Institute, South Brisbane, Queensland, Australia.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Gibbons
authors.affiliation: Mater Health Services, South Brisbane, Queensland, Australia; Mater Medical Research Institute, South Brisbane, Queensland, Australia; St. Vincent's Private Hospital, Brisbane, Queensland, Australia.
authors.forename: Phillip
authors.initials: P
authors.lastname: Good
authors.affiliation: Mater Health Services, South Brisbane, Queensland, Australia.
authors.forename: Ross
authors.initials: R
authors.lastname: Norris
authors.affiliation: School of Pharmacy, Griffith Health Institute, Griffith University, Gold Coast, Southport, Queensland, Australia; Mater Medical Research Institute, South Brisbane, Queensland, Australia.
authors.forename: Alison
authors.initials: A
authors.lastname: Haywood
mesh_terms: D000268:Adhesiveness; D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage*; D006801:Humans; D007090:Image Interpretation, Computer-Assisted / Q000379:methods*; D008297:Male; D010349:Patient Compliance; D010781:Photography / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012867:Skin / Q000033:anatomy & histology; D057968:Transdermal Patch; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl
keywords: FDA; TDS adhesion; Transdermal; fentanyl; scoring tool; validation