Study design
The full study protocol has previously been published6. In brief, this cohort of survivors were recruited between the period of August 2018 and October 2019 from 19 hospital sites with acute and hyper-acute patient facilities in the UK. Baseline data was assessed within 14 days of post-stroke event (herein defined as the baseline period post-stroke), with a 3 and 6 month follow up.
The COVID-19 pandemic impacted on the study follow up and herein report baseline data in the acute stroke setting. Data collection was conducted by trained and experienced research staff.
Ethical approval
All participates provided the informed consent to participate for the study. All methods were conducted in accordance with relevant guidelines and regulations. Ethical approval was granted by the NHS Research Ethics Committee – Wales REC 3 - 18/WA/0299 - Health and Care Research Wales Support and Delivery Centre for all the sites
Measures
Demographic, lifestyle and clinical measures
During the baseline assessment the following were assessed: age; sex; stroke type; pre stroke smoking; alcohol consumption; level of care: clinical characteristics which included past medical history (hypertension, diabetes; transient ischemic attacks and prior stroke).
Patient-Reported Outcome Measures (PROM)
A Stroke Specific PROM, developed by Salinas et al4 was used. It contains 10 questions from the Patient-Reported Outcomes Measurement Information System Global Health Short Form-10 (PROMIS-10), which has two domains of physical health (PH) and mental health (MH). This is a validated and established patient-reported outcome measure4, 7-8. Salinas et al added an additional 5 stroke specific questions.
Short-Form Montreal Cognitive Assessment (SF-MoCA)
The SF-MoCA is an adapted shorter 10-point version of the 30 item Montreal Cognitive
Assessment. This contains three sections, comprising of clock drawing, abstraction and 5-word recall This tool may act as an indicator of post-stroke cognitive impairment, utilising a threshold score of 7 or below9.
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-910 is a primary care screening tool for depression and has previously been recommended in stroke with strong psychometric properties11.The recommended cut off used in stroke, and the one utilised in this study in terms of morbidity is above or equal to 811.
Generalised Anxiety Disorder-7 (GAD-7)
Whilst the GAD-712 has not been validated within stroke use, it is a wildy used screening tool for generalised anxiety in primary care, a stroke specific a threshold of above or equal to 5 was determined13,14.
Modified Rankin Scale (mRS)
The mRS 15 is delineated using the Rankin Focussed Assessment (RFA), a questionnaire that allows global consideration of disability after the occurrence of stroke. Questions from the RFA are scored on the Modified Rankin scale from 0-5, with 0 being the lowest level of disability and 5 being the highest16.
Data Analysis
All data analysis were undertaken in Stata version 16.0. The measures were scored using the validated methods and missing item missingness (e.g. no more than 30%) within each measure (or domain) within participant were pro-rata mean imputed17. Participants with over 30% of missing items were scored as missing.
Prevalence of morbidity within PROM measures
In order to quantify morbidity within the PROMIS 10, morbidity was defined across each domain as a supra-threshold response to the clinical threshold set for the total PROMIS 10 response (a score of 85 and below to indicate morbidity5-8,18). This was at the acute baseline period. 95% confidence intervals (95% CI) were reported. Domain specific analysis was conducted for the cognitive and physical domains of the PROMIS 10.
Outcomes
The co-primary outcomes were the MH and PH domains. Secondary outcomes included the GAD-7; PHQ-9; mRS, SF-MoCA and the additional 5 stroke specific questions (walking, toileting, dressing, tube feeding and communication).
Covariates
The following were fitted to assess any association with the outcomes: pre-stroke hypertension, previous TIA, previous stroke, pre-stroke diabetes, male sex, and age.
Statistical Analysis
The association between exposures and outcomes were fitted using a crude and multivariable multilevel linear model, where hospital site was fitted as a random effect. The multivariable model was adjusted for: age, sex, pre-stroke hypertension, previous stroke event, previous TIA and pre-stroke diabetes diagnosis. The analysis presented the mean difference (MD) and adjusted mean difference (aMD) reported with associated 95% CI and P-values.