Development of the Pruritus-Associated Stress Scale: A Cross-Sectional Pilot Study in Adults with Atopic Dermatitis, Chronic Prurigo and Chronic Pruritus on Non-Lesional Skin

Background A significant relationship exists between perceived stress and the exacerbation and perpetuation of chronic pruritic dermatoses. Despite this, there is a notable absence of validated tools to specifically measure pruritus-associated stress.

To develop and pilot the Pruritus-Associated Stress Scale (PASS), a patient-reported outcome measure (PROM) for assessing pruritus-associated stress. Patients and Methods Patients with chronic prurigo (CPG), atopic dermatitis (AD), and chronic pruritus on non-lesional skin (CPNL) were recruited at a German university centre. They were interviewed on pruritus-associated stress, and perceived stress using the PSS-10 and PSQ-30 questionnaires, to compile the first PASS version in accordance with the guidelines for PROM development. Subsequently, a second patient cohort was interviewed to refine the items of the PASS instrument based on impact analysis, interitem and item-total correlation, and internal consistency reliability.

Of 55 patients (15 with AD, 20 with CPG, and 20 with CPNL; 61.8% female; mean age 61.0 ± 15.4 years), who participated in the item selection phase, 94.5% reported pruritus-associated stress in the previous two weeks. The preliminary PASS demonstrated excellent internal consistency (Cronbach’s alpha = 0.91). The twelve items that showed strong impact scores addressed nervousness, therapeutic strategies for managing pruritus-associated stress, fatigue, and urges to scratch more frequently or intensely due to pruritus.

This pilot study yielded a preliminary PASS, identified poorly performing items, and collected information for further refinement. As a next step, retaining the full item pool, an exploratory factor analysis will be conducted in a larger sample. SIGNIFICANCE This study addresses a critical gap in dermatological research by developing and piloting the first questionnaire specifically designed to assess pruritus-associated stress in patients with chronic pruritus of diverse aetiologies. Competing Interest Statement Svenja Royeck was an advisor, speaker, or investigator for Incyte Inc., Eli Lilly, LEO Pharma, and Sanofi/Regeneron outside the submitted work. Claudia Zeidler is an investigator for Novartis, Janssen, Pfizer, UCB, Lilly, Abbvie, Boehringer Ingelheim, Sanofi, Regeneron, Leo, Galderma and has received speaker honoraria/travel fees from Dermasence, Beiersdorf, Leo, Sanofi, Novartis, Unna Akademie, Almirall and AbbVie outside the submitted work. Bernd Loewe reports research funding (no personal honoraria) from the German Research Foundation, the German Federal Ministry of Education and Research, the German Innovation Committee at the Joint Federal Committee, the European Commission's Horizon 2020 Framework Programme, the European Joint Programme for Rare Diseases (EJP), the Ministry of Science, Research and Equality of the Free and Hanseatic City of Hamburg, Germany, and the Foundation Psychosomatics of Spinal Diseases, Stuttgart, Germany. He received remunerations for several scientific book articles from various book publishers, from the Norddeutscher Rundfunk (NDR) for interviews in medical knowledge programmes on public television, and as a committee member from Aarhus University, Denmark. He received travel expenses from the European Association of Psychosomatic Medicine (EAPM), and accommodation and meals from the Societatea de Medicina Biopsyhosociala, Romania, for a presentation at the EAPM Academy at the Conferința Națională de Psihosomatică, Cluj-Napoca, Romania, October 2023. He received a travel grant for a lecture on the occasion of the presentation of the Alison Creed Award at the EAPM Conference in Lausanne, 12-15 June 2024. He received remuneration and travel expenses for lecture at the Lindauer Psychotherapiewochen, April 2024. He is President of the German College of Psychosomatic Medicine (DKPM) (unpaid) since March 2024 and was a member of the Board of the European Association of Psychosomatic Medicine (EAPM) (unpaid) until 2022. He is member of the EIFFEL Study Oversight Committee (unpaid). Angelika Weigel reports research funding (no personal honoraria) from the Werner Otto Foundation. She has received remunerations for a lecture at the Lindauer Psychotherapietage and she has been treasurer of the EAPM (unpaid) until 2023. Volker Huck has received research funding from LEO Pharma GmbH in terms of an investigator-initiated trial outside the submitted work. Stefan W. Schneider was speaker and/or consultant funding from Almirall S. A., GSK R&D Ltd., Incyte Corporation, LEO Pharma GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, Sanofi-Aventis Deutschland GmbH, Pfizer Pharma GmbH. Christoph Schramm was consultant for Pliant Therapeutics, Chemomab, Agomab, Amgen and Moonlake and received honoraria for lectures from Falk Foundation. Sonja Staender was speaker and/or consultant and/or Investigator and/or has received research funding from Amgen Inc., Almirall S. A., Celldex Therapeutics Inc., Clexio Biosciences Ltd., Focus-Insight Healthtech Group Co. Ltd., Galderma Laboratorium GmbH, Galderma R & D, LLC., Galderma SA, Klirna Biotech Inc., GSK R&D Ltd., Incyte Corporation, LEO Pharma GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, P. G. Unna Academy, Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis R& D, Sanofi Genzyme Corporation, TouchIME, Vifor Pharma Deutschland GmbH. The other authors have no conflict of interest to declare. Clinical Protocols https://bmjopen.bmj.com/content/12/1/e057596 Funding Statement We thank the German Research Foundation for funding the research unit 5211 (RU5211) SOMACROSS (DFG project number 445297796; STA 1159/7-1,SCHN 657/5-1; SCHN 474/9-1) and for funding the research unit PRUSEARCH (FOR 2690; STA 1159/4-2). The funding sources did not participate in study design and conduct, nor in the data collection, management, analysis, and interpretation, nor in the preparation, review, or approval of the manuscript, nor in the decision to submit the article for publication. We thank Helena Karajiannis, PhD, HK Scientific Consulting, for the writing assistance. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics Committee of the State Medical Association of Westfalen-Lippe, Muenster, Germany gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data produced in the present work are contained in the manuscript.