Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Aug;137(8):1784-1786.
doi: 10.1016/j.jid.2017.04.017. Epub 2017 Apr 27.

Identifying What to Measure in Acne Clinical Trials: First Steps towards Development of a Core Outcome Set

Collaborators, Affiliations

Identifying What to Measure in Acne Clinical Trials: First Steps towards Development of a Core Outcome Set

Alison M Layton et al. J Invest Dermatol. 2017 Aug.
No abstract available

PubMed Disclaimer

Conflict of interest statement

CONFLICTS OF INTEREST

The authors have no conflicts of interest.

Figures

Figure 1
Figure 1. International participation in defining core outcome domains in acne clinical trials
(a) Demographics of the 500 participants in Round 1 (Respondent type adds up to >500 as some participants selected more than one option). (b) Demographics of the 116 participants in Round 3. There were 164 participants in Round 2: 112 professionals (including 9 editors and 10 industry personnel) and 52 patients (data not shown) (c) Responses to ranking importance of the initial 24 items in Round 1. The top 12 items are shown in black. Two items in red were taken forward into Round 2 following consultation with the Outcomes Identification group. (d) Seven core outcome domains were identified after all three rounds had been completed. Domains in gray and green were decided by consensus in Rounds 2 and 3, respectively. Adverse Events (in red) was chosen prior to the exercise based on recommendations in the literature (see text). HCP, health care practitioner.

References

    1. Alexis A, Daniels SR, Johnson N, Pompilus F, Burgess SM, Harper JC. Development of a new patient-reported outcome measure for facial acne: the Acne Symptom and Impact Scale (ASIS) J Drugs Dermatol. 2014;13:333–40. - PubMed
    1. Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d’Agostino MA, et al. Developing core outcome measurement sets for clinical trials: OMERACT filter 2.0. J Clin Epidemiol. 2014;67:745–53. - PubMed
    1. Food and Drug Administration (FDA) Center for Drug Evaluation and Research. Guidance for Industry. Acne vulgaris: developing drugs for treatment. 2005 Sep;
    1. Girman CJ, Hartmaier S, Thiboutot D, Johnson J, Barber B, DeMuro-Mercon C, et al. Evaluating health-related quality of life in patients with facial acne: development of a self-administered questionnaire for clinical trials. Qual Life Res. 1996;5:481–90. - PubMed
    1. Gupta MA, Johnson AM, Gupta AK. The development of an Acne Quality of Life scale: reliability, validity, and relation to subjective acne severity in mild to moderate acne vulgaris. Acta Derm Venereol. 1998;78:451–6. - PubMed

Publication types