The effect of frailty in pleural disease using the SAIL Databank: a study protocol.

Abstract Background Frailty can impact on patient care and its assessment may improve patient management and clinical outcomes. Pleural disease is common and associated with increased mortality and symptoms, but prediction of outcomes is limited and there is currently no evidence available on the relationship between frailty and outcomes in these patients. This protocol describes an observational study which sets out to assess whether frailty correlates with survival and morbidity in patients with malignant or non-malignant pleural disease. Methods Participants with a first episode of pleural disease after 1st January 2005 will be identified from the SAIL Databank using ICD-10 read codes. The electronic frailty index (eFI), included within the databank and measured at the time of first diagnosis of pleural disease, will provide stratification of patients by frailty status. Baseline data collection will also include: patient demographics, presence of comorbidities, smoking status, date of death. The eFI will be correlated with clinical outcomes, including survival, index hospitalisation, length of stay, readmissions, total number of hospitalisations. Our primary analysis will be all-cause mortality by eFI, adjusted for age (≤ 64, 65–74, 75–84, and ≥ 85), sex, ethnicity, deprivation score, smoking status, Charlson Comorbidity Index. The secondary analyses will be pleural disease-specific mortality, time to first hospital admission (all-cause and disease-specific), total length of stay, and readmissions. All analyses will be presented as crude and adjusted HR and OR with associated 95% CIs and p values. Discussion The aim of this study is to collect targeted data from a large dataset of subjects with a wide range of pleural disease and provide first data of size reviewing the link between frailty and pleural disease. The eFI can be a potential tool to guide clinical decision making in pleural disease. Trial registration Retrospectively registered.