Optimizing the Assessment of Co-Morbidities in Psoriatic Disease Using Patient-Reported Outcome Measures

Abstract

Psoriasis is a chronic, immune-mediated, inflammatory skin disease that affects approximately 125 million people globally. Over the last two decades, extensive research has shown that psoriasis is associated with multiple extra-cutaneous co-morbidities including psoriatic arthritis (PsA) and sleep disturbance. Despite the relationship between psoriasis and these co-morbidities having been established, both PsA and sleep disturbance remain largely under-explored, under-diagnosed and, therefore, under-treated in this population. Patient-reported outcome measures (PROMs) are questionnaires designed to collect data derived directly from patients to measure an explicit concept such as quality of life, functioning, symptoms or health status without interpretation by healthcare providers. Currently, there are thousands of PROMs available across disease states and their use is becoming vital in clinical settings to improve health-care delivery as well as in clinical trials to support label claims.However, not all PROMs are equally useful. Selecting the most appropriate measures is critical asa PROM is only as valuable as its ability to accurately and precisely measure what it intends to measure, which starts with the earliest conceptual design elements. A given instrument should be based on a theoretical conceptual framework of what it intends to measure, should include patients in its development process to ensure its relevance to the target population and context of use, and have adequate psychometric properties. The overarching aim of this thesis is to optimize the assessment of highly prevalent but under-recognized comorbidities in psoriatic disease by using standardized PROMs. The aim of first project of this thesis is to select the best PROM to assess PsA symptoms in psoriasis clinical trials. The aim of the second project, is to develop a robust sleep questionnaire to assess sleep disturbance across psoriasis and psoriatic arthritis.