Development of a core outcome set for clinical trials of interventions to improve sleep in people with cognitive impairment‐the Sleep in Cognitive Impairment Core Outcome Set (SCICOS)

Abstract INTRODUCTION Sleep disturbances are common in older people with cognitive impairment, potentially contributing to negative outcomes. A core outcome set (COS) is required to reduce heterogeneity in clinical trials and promote the development of high‐quality evidence to support clinical management. METHODS A multi‐stage mixed methods study was conducted in accordance with The Core Outcome Set Standards for Development. RESULTS A systematic review identified 287 sleep outcomes from previous clinical trials. Qualitative interviews ensured the COS was informed by what matters most to people with cognitive impairment and their caregivers. A modified Delphi process identified nine outcomes for the COS: total sleep time, sleep onset latency, wakefulness after sleep onset, number of night‐time awakenings, sleep efficiency, and measures of sleep quality, daytime sleepiness, cognition, and mood. DISCUSSION This COS will support researchers to produce more reliable and coherent trial data to guide the management of sleep disturbances in people with neurodegenerative cognitive impairment. Highlights Evidence is lacking regarding the treatment of sleep disturbances in people with cognitive impairment. Heterogeneity of reported outcomes in clinical trials limits data synthesis. A qualitative analysis established what matters most to people with cognitive impairment and their caregivers when determining treatment effectiveness. A Delphi panel of experts agreed upon a core outcome set. This core outcome set will improve the reliability and comparability of data from future trials.