Prestroke physical activity and outcomes after intracerebral haemorrhage in comparison to ischaemic stroke: protocol for a matched cohort study (part of PAPSIGOT).

Abstract

Piling evidence suggests that a higher level of prestroke physical activity can decrease stroke severity, and reduce the risk of poststroke mortality. However, prior studies have only included ischaemic stroke cases, or a majority of such. We aim to investigate how premorbid physical activity influences admission stroke severity and poststroke mortality in patients with intracerebral haemorrhage, compared with ischaemic stroke. A prespecified analysis plan counteract some inherent biases in observational studies, and promotes transparency. This is a statistical analysis protocol for a matched cohort study, including all adult patients with intracerebral haemorrhage, and matched ischaemic stroke controls, treated at Sahlgrenska University Hospital in Sweden between 1 November 2014 and 30 June 2019. All patients have been identified in the Väststroke register, and the data file has been sent for merging with national registries. The follow-up of time for survival will be approximately 2-7 years. The sample size calculation indicates that a minimum of 628 patients with intracerebral haemorrhage is needed for power of 80% at an alpha level of 0.01. Multiple imputation by chained equations will be used to handle missing data. The entire cohort of patients with intracerebral haemorrhage will be matched with consecutive ischaemic stroke controls (1:3 ratio) using nearest neighbour propensity score matching. The association between prestroke physical activity and admission stroke severity will be evaluated using multivariable ordinal regression models, and risk for all-cause mortality will be analysed using multivariable Cox proportional-hazards models. Potential confounders include age, ethnicity, income, educational level, comorbidity, medical treatments, alcohol-related disorders, drug abuse and smoking. Data collection for the Physical Activity Pre-Stroke In GOThenburg project was approved by the Regional Ethical Board on 4 May 2016. An additional application was approved by the National Ethical Review Authority on 7 July 2021.