Why and how to choose patient-reported outcome measures in dermatology?

Abstract

I read with great interest the article by Pereira et al.¹ on the acceptability from the patients' perspective and perceived benefits from physicians' perspective of the patient-reported outcome measures (PROMs) to assess pruritus. As the number of PROMs has increased in recent years, this question is of great interest. The authors showed that PROMs are welcomed by patients, with high levels of acceptability and relevance, which is important for the relational and ethical aspects. For physicians, the usefulness and feasibility depended on the questionnaire. Measuring pruritus with the numerical rating scale (NRS) and the impairment of quality of life with the Dermatology Life Quality Index (DLQI) were considered the most beneficial in clinical routine.

PROMs are tools used to capture patients' reports of their experiences. It is still debated whether they should be used in everyday life and become an indispensable tool in the future, or whether their use should be reserved for clinical research, where their interest seems obvious and their use essential.

A systematic review identified many benefits for PROMs: promoting active patient involvement, improving the focus of consultations, improving the quality of care, enabling standardized monitoring of patient outcomes and improving the patient-clinician relationship.² Perceived limitations included the ability of PROMs to shift the focus of consultations, create unrealistic expectations of care, inhibit patient-clinician interaction, lack clinically meaningful information and not be suitable for all patients. The main disadvantage in daily practice is the time required to complete various questionnaires, but different tools can help clinicians, such as the use of mobile phones, tablets or computers, with possible completion before the consultation.

Pereira's study¹ evaluated five PROMs, related to pruritus intensity (NRS), symptom control (Itch-Controlled Days, ItchCD), quality of life (DLQI; 5-Pruritus Life Quality, 5PLQ) and general health status (EuroQol, EQ-VAS). There are a large number of PROMs available today, which can be divided into different categories: (1) generic, that is an instrument that can be used across therapeutic areas, such as the EQ-VAS, (2) dermatology-specific, that is an instrument that is specific to dermatology and can be used across skin conditions, such as the DLQI and (3) disease-specific, that is an instrument that can only be used for a particular skin condition such as the Prurigo Control Test (PCT).³ First, clinicians need to select the most appropriate PROM, for their clinical practice or a clinical trial, and for the disease. Second, they have to consider the measurement properties (such as reliability, validity and responsiveness) and keep in mind that there is no ideal dermatology-specific PROM.^{3, 4} The PROM should be valid, reliable and responsive, but also short, interpretable and accessible.⁵ If the questionnaire has been validated in another language, a process of translation and validation is required.

In dermatology, PROMs are of particular interest in the assessment of pruritus when the symptom is isolated and there are no visible lesions, such as chronic pruritus without skin disease. For many pruritic skin conditions, the use of disease-specific PROMs can be considered, such as the Urticaria Control Test (UCT) for urticaria, the PCT for prurigo or the Patient-Oriented Eczema Measure (POEM) for atopic dermatitis. The rhythm of completion can be variable, regularly at each consultation, or only when the disease is not fully controlled and a change in treatment option is being discussed.

In conclusion, PROMs have many advantages but also some limitations and need to be integrated intelligently into research and daily practice. Good acceptance by patients is a positive finding.¹

None.

EB is on the advisory board or speaker for Lilly, UCB, Jannsen, Leo Pharma, Boehringer Ingelheim, Abbvie, Gilead, Almirall, Amgen and Pfizer, investigator for Galderma, Sanofi, Trevi, Incyte, Abbvie, Lilly, AstraZeneca, Almirall, Galderma and Dermira and has received travel support from Novartis and Lilly.