We thank the participants of the study.
This study was sponsored by Pfizer Inc., New York, NY, USA. Pfizer Inc. additionally funded the Rapid Service Fees.
Medical Writing Support
Medical writing support under the guidance of the authors was provided by Marianna Johnson, PhD, and Jennifer C. Jaworski, MS, at ApotheCom, San Francisco, CA, USA, and was funded by Pfizer Inc., New York, NY, USA, in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med. 2015;163:461-464).
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
RH, MGL, AGB, AG, JRW, JCC, MH, JP, EP, AMT, WZ, and LC contributed to the conceptualization of the study. RH, AGB, AW, AG, JRW, JCC, MH, EP, WZ, and LC performed or supported the formal analysis. All authors (RH, MGL, AGB, ELS, MJG, AW, AG, JRW, JCC, MH, JP, EP,AMT, WZ, and LC) contributed to the data interpretation, critically reviewed the manuscript and approved the submitted version.
Rebecca Hall, Adam Gater, and Jane R. Wells are employees of Adelphi Values, which has received payment from Pfizer Inc. for conducting the instrument development research activities described in this paper. Mark G. Lebwohl is an employee of Mount Sinai, which receives research funds from Pfizer Inc., AbbVie, Bausch Health (Valeant), Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Janssen/Johnson & Johnson, LEO Pharma, Medimmune/AstraZeneca, Novartis, SCIderm, UCB, and Vidac Pharma. He is also a consultant for Allergan, Almirall (Aqua Pharmaceuticals), Boehringer Ingelheim, Dr. Reddy’s Laboratory (Promius), LEO Pharma, Menlo Therapeutics, and Verrica. He is also a member of the journal’s Editorial Board. Andrew G. Bushmakin Joseph C. Cappelleri, Ming-Ann Hsu, and Elena Peeva are employees and stockholders of Pfizer Inc. Eric L. Simpson has received grants, personal fees, and/or nonfinancial support from Pfizer Inc., AbbVie, Celgene, Eli Lilly, Galderma, GSK, LEO Pharma, Menlo Therapeutics, Novartis, Regeneron, Tioga Pharmaceuticals, and Vanda Pharmaceuticals. Melinda J. Gooderham has received grants, personal fees, and/or nonfinancial support from Pfizer Inc., AbbVie, Akros Pharma, Amgen, Arcutis, Bausch Health (Valeant), Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Coherus, Dermira, Eli Lilly, Galderma, Incyte, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Merck, Novartis, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, and UCB. Andreas Wollenberg has received grants, personal fees, and/or nonfinancial support from Pfizer Inc., Almirall, Anacor, Astellas, Beiersdorf, Bioderma, Celgene, Chugai, Galderma, Hans Karrer, L'Oréal, LEO Pharma, Meda, MedImmune, Merck, Novartis, Pierre Fabre, Regeneron, and Sanofi. Jocelyn Papacharalambous, Anna M. Tallman, Weidong Zhang and Linda Chen were employees and stockholders of Pfizer Inc. at the time of this research.
Compliance with Ethics Guidelines
The PSAAD development was reviewed and approved by a centralized review board for conduct in the USA (Copernicus Group Independent Review Board; tracking number: ADE2-15-310). The data used for psychometric validation of the PSAAD was from a phase 2b study (NCT027801670), which was also approved by institutional review boards at each study site . All patients provided written informed consent and all research was conducted in accordance with the Helsinki Declaration of 1964 and its later amendments.
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. Upon request, and subject to certain criteria, conditions and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (ie development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.