A qualitative phase I study protocol on developing patient-reported outcome measure for hair, scalp, eyebrows, eyelashes, and beard-related skin disorders

Introduction Hair disorders can have both physical and psychosocial effects significantly impacting patients’ quality of life. Well-designed patient-reported outcome measures (PROMs) are vital to determine meaningful patient-centered management. Currently available PROMs for individual hair disorders are available, however, making it difficult to use across diseases. This phase I protocol aims to create a clinically meaningful hair assessment across multiple hair disorders that evaluate the patients’ reported assessment of their disease, its symptoms, and impact on their quality of life, as well as defining characteristics of their desired outcome. Methods and analysis This phase I study, we will use thematic analysis of qualitative semi-structured interviews. Participants aged 18 years and older, a sampling of patients diagnosed with alopecia areata, androgenic alopecia, lichen planopilaris, central centrifugal cicatricial alopecia, and sebopsoriasis will be invited to take part in qualitative interviews. Participants recruitment and interviews will continue iteratively until thematic saturation is reached, with a focus on interview quality and patient diversity in gender, race and ethnicity, age, and hair-related disorder. The open-ended interview questions will allow participants to reflect on their physical appearance, disease journey, and treatment goals, as well as define the associated physical symptoms and psychosocial impact. These predominant domains will be used to form the basis for a hair-related PROM that can be applied to a multitude of hair-related disorders. Ethics and dissemination The Brigham and Women’s Hospital Institutional Review Board (2022P001033) approved this study. Following the description of the study protocol, we obtained verbal consent from all the study participants. All personal information, interview responses, and medical records are confidential and are stored in an encrypted database. Findings from this study will be published in peer-reviewed journals and presented at dermatology conferences. This is an open access article with Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, that permits others to distribute, remix, and build upon the licensed work non-commercially, and require attribution to the original authors. See https://creativecommons.org/licenses/by-nc/4.0/ for details. Strengths and limitations of this study Recruitment of participants with common scarring and non-scarring hair-related disorders will make it possible to establish patients’ perspectives on physical appearance, definitions of treatment success, physical signs and symptoms, psychological and social impact across multiple disease states involving hair, scalp, eyebrows, eyelashes, and beard. Inclusion of patients from a wide range of demographics such as age, gender, race, and ethnicity will enable identification of domains common across these differing backgrounds. We adhere to published guidelines for determining validity of scales. We aim to use modern psychometric approach to ensure this study are clinically meaningful.