Quantifying the natural variation in lesion counts over time in untreated hidradenitis suppurativa: Implications for outcome measures and trial design
| Autor: | Roger D. Vaughan, James G. Krueger, Caroline S. Jiang, John W. Frew, Kristina Navrazhina, Neha Singh |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
HS hidradenitis suppurativa HiSCR hidradenitis suppurativa clinical response Placebo Lesion Interquartile range Internal medicine lcsh:Dermatology medicine Hidradenitis suppurativa Family history Stage (cooking) Abscess CVm median absolute deviation divided by the median IQR interquartile range clinical trials AN abscess and nodule variability business.industry hidradenitis suppurativa lcsh:RL1-803 medicine.disease Clinical trial natural history CVq interquartile range divided by the median acne inversa Original Article MAD median absolute deviation medicine.symptom business |
| Zdroj: | JAAD International, Vol 1, Iss 2, Pp 208-221 (2020) JAAD International |
| ISSN: | 2666-3287 |
| Popis: | Background Hidradenitis suppurativa (HS) demonstrates high placebo response rates in clinical trials, possibly due to the natural variability of the disease. No quantification of variability in lesion counts of untreated disease has been undertaken. Objective To quantify the variability of untreated HS. Methods Deidentified individual patient data from the placebo arms of PIONEER studies were analyzed, and measurements of within-subject coefficients of variation were examined. Variability was stratified by disease-associated variables (Hurley stage, BMI, sex, smoking, family history) and body site. Results Analysis of within-subject coefficients of variation demonstrated that half of the participants had a middle spread [difference between 75th and 25th percentiles of the subject's abscess and nodule counts] greater than 33% and 40% of their median abscess and nodule counts, and 25% of the subjects had a middle spread greater than 70% and 78% of their median abscess and nodule counts in PIONEER I and II, respectively. Hurley stage 2 participants had significantly greater within-subject variation than Hurley stage 3 patients. Variation was greater in the axillary and groin regions than in other anatomical locations. Limitations Limitations include the use of precollected clinical trial data. Conclusion The within-subject variability of the lesion counts in untreated HS was greater than previously appreciated. This has profound effects on outcome measures and the conduct of future clinical trials of HS. |
| Databáze: | OpenAIRE |
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