Biomaterial Database

Validation of scalp coverage scoring methods for scalp hair loss in male pattern hair loss (androgenetic alopecia). 2006

D Van Neste, and E Sandraps, and D Herbaut, and P Lelubre, and T Leroy

Skinterface, Tournai, Belgium. info@skinterface.be

BACKGROUND Global evaluation of hair loss in male subjects affected by androgenetic alopecia has been proposed as a means for monitoring changes over time, including placebo-controlled drug efficacy studies. Because of the potential impact of subjectivity (e.g. placebo effect) of clinical investigators, global photographs (GPs) have been introduced as a more objective record. Examination of paired before and after pictures and rating on a seven-point scale (from greatly decreased -3 to greatly increased +3) have been historically introduced by United States of America (US) experts. METHODS Based on published GPs and original GPs obtained at our clinical research facility, we developed a training set in order to allow European Union (EU) observers to practice and compare with ratings by the US experts. RESULTS After training with the seven-point scale, there was a positive correlation between three US and three EU ratings (n=52 paired images from 35 different subjects, r=0.795). The results of a test-retest evaluation was performed on 18 paired images from the initial image collection by the three EU experts. Correlation r=0.806 and identical scores in 78% of cases documents a reproducibility similar to the single one US expert published data (119 subjects, retest correlation 0.76 with 75% identical duplicate ratings). Seventeen subjects taken from a placebo-controlled trial had GPs at 6 and 12 months. The average difference between an efficacious drug treatment and the placebo were almost similar in the US (0.833) as in the EU (0.689) expert panels. We also trained the EU experts in performing the scalp coverage scoring (SCS), a novel system for the global evaluation of scalp hair in vivo and on GP. SCS was performed on single images (randomised as to time and treatment) taken from the same set of 17 paired GPs. This showed a between-group difference of 0.055 at 6 months and 0.201 at 12 months, i.e. 5% improved coverage in favour of the active group. CONCLUSIONS After completion of our study, US and trained - calibrated EU experts seem equally valuable in comparing before-after GPs. SCS can also be used on GPs and may support the clinical investigator during inclusion of test subjects and for real-time efficacy evaluation during the trial.

UI	MeSH Term	Description	Entries
D007090	Image Interpretation, Computer-Assisted	Methods developed to aid in the interpretation of ultrasound, radiographic images, etc., for diagnosis of disease.	Image Interpretation, Computer Assisted,Computer-Assisted Image Interpretation,Computer-Assisted Image Interpretations,Image Interpretations, Computer-Assisted,Interpretation, Computer-Assisted Image,Interpretations, Computer-Assisted Image
D008297	Male		Males
D010781	Photography	Method of making images on a sensitized surface by exposure to light or other radiant energy.	Photographies
D011379	Prognosis	A prediction of the probable outcome of a disease based on a individual's condition and the usual course of the disease as seen in similar situations.	Prognostic Factor,Prognostic Factors,Factor, Prognostic,Factors, Prognostic,Prognoses
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000505	Alopecia	Absence of hair from areas where it is normally present.	Alopecia, Androgenetic,Baldness,Male Pattern Baldness,Pseudopelade,Alopecia Cicatrisata,Alopecia, Male Pattern,Androgenetic Alopecia,Androgenic Alopecia,Baldness, Male Pattern,Female Pattern Baldness,Hair Loss,Pattern Baldness,Alopecia Cicatrisatas,Alopecia, Androgenic,Alopecias, Androgenic,Androgenic Alopecias,Baldness, Female Pattern,Baldness, Pattern,Hair Losses,Loss, Hair,Losses, Hair,Male Pattern Alopecia
D012536	Scalp Dermatoses	Skin diseases involving the SCALP.	Scalp Dermatosis,Dermatoses, Scalp,Dermatosis, Scalp
D012680	Sensitivity and Specificity	Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)	Specificity,Sensitivity,Specificity and Sensitivity
D015203	Reproducibility of Results	The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.	Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D015588	Observer Variation	The failure by the observer to measure or identify a phenomenon accurately, which results in an error. Sources for this may be due to the observer's missing an abnormality, or to faulty technique resulting in incorrect test measurement, or to misinterpretation of the data. Two varieties are inter-observer variation (the amount observers vary from one another when reporting on the same material) and intra-observer variation (the amount one observer varies between observations when reporting more than once on the same material).	Bias, Observer,Interobserver Variation,Intraobserver Variation,Observer Bias,Inter-Observer Variability,Inter-Observer Variation,Interobserver Variability,Intra-Observer Variability,Intra-Observer Variation,Intraobserver Variability,Inter Observer Variability,Inter Observer Variation,Inter-Observer Variabilities,Inter-Observer Variations,Interobserver Variabilities,Interobserver Variations,Intra Observer Variability,Intra Observer Variation,Intra-Observer Variabilities,Intra-Observer Variations,Intraobserver Variabilities,Intraobserver Variations,Observer Variations,Variabilities, Inter-Observer,Variabilities, Interobserver,Variabilities, Intra-Observer,Variabilities, Intraobserver,Variability, Inter-Observer,Variability, Interobserver,Variability, Intra-Observer,Variability, Intraobserver,Variation, Inter-Observer,Variation, Interobserver,Variation, Intra-Observer,Variation, Intraobserver,Variation, Observer,Variations, Inter-Observer,Variations, Interobserver,Variations, Intra-Observer,Variations, Intraobserver,Variations, Observer