Introduction
The World Health Organisation (WHO) estimates 15 million people suffer from stroke each year, with more than 5 million living with permanent disability [
1‐
3]. Neurological deficits that persist secondary to stroke are heterogeneous and vary across the patient population.
The use of patient reported outcomes measures (PROMs), defined as questionnaires measuring views on health status from the perspective of the patient rather than the clinician, have grown in importance and significance. PROMs offer a way to measure specific functional domains in a way which is meaningful to the patient, encapsulating the patient’s own perspective of their health [
4,
5]. To improve the use of PROMs within the stroke community, a consensus Stroke Standard Set of outcome data has been developed which promotes the use of patient reported outcomes as part of a value-based assessment of care [
4].
The PROMIS-10 is a patient reported outcome measure which allows components of both physical and mental health to be accessed from the patient perspective [
6,
7]. Utilised in stroke, the PROMIS-10, allows consideration of functional and cognitive status post-stroke. It has previously been estimated that around 50% of survivors are chronically disabled [
3]. Physically, survivors of stroke have been seen to suffer from impairments in language and speech, swallowing, vision, weakness, and paralysis. Mentally, survivors of stroke have been reported to experience higher levels of anxiety and depression as well as greater levels of cognitive impairment [
8‐
15]. However, the understanding of the impact of symptoms across mental and physical health domains, especially from the patient perspective, is lacking.
Aims
The primary aim of this study was to assess the quality of life for stroke survivors throughout England and Wales. The primary objective was to determine the prevalence of mental and physical health outcome for stroke survivors, and secondarily, to report if there was any association with clinical and demographic risk factors.
Methods
Study design
The study protocol has previously been published [
16]. The cohort was recruited between August 2018, and October 2019 from 19 hospital sites with acute and hyper-acute patient facilities in the UK. Data was assessed within 14 days of the index stroke event (the baseline period post-stroke). Data collection was conducted by trained and experienced research staff.
Ethical approval
All participants provided 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)
The PROM is a combination of the PROMIS-10 and additional five stroke specific questions. The PROMIS-10 was developed by Cella et. al [
7] and has been validated in previous stroke population [
4]. The instrument has two domains of physical health (PH) and mental health (MH) and consists of 10 items. Raw domain scores are converted to T-Scores which are normed to the US population. The PROMIS-10 is a well validated and established patient-reported outcome measure [
3,
4,
6,
7,
17,
18]. The additional five stroke specific questions were added to include assessment of patient function, which included items on: walking; eating; toileting; dressing; and communication [
4,
8,
9,
18]. These additional questions were developed in order to add stroke specific reporting as well as improve functional-capacity reporting within the PROMIS-10. Further, the PROMIS-10 in combination with the five additional questions has been shown to hold value within other common neurological conditions, such as Multiple sclerosis, Parkinson’s disease and Acquired brain injury [
18].
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. It is a clinician delivered tool which acts as an indicator of post-stroke cognitive impairment [
10].
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 [
11] is a widely used self-reported primary care screening tool for depression and has previously been recommended in stroke, the instrument has strong psychometric properties [
12].
Generalised Anxiety Disorder-7 (GAD-7)
Whilst the GAD-7 [
13] has not been validated within stroke use, it is a widely used self reported screening tool for generalised anxiety in primary care [
14,
15].
Modified Rankin Scale (mRS)
The mRS [
19] is clinician recorded and delineated using the Rankin Focussed Assessment (RFA), a questionnaire that allows global consideration of disability after the occurrence of stroke [
20].
Data analysis
All data analysis were undertaken in Stata version 16.0. The measures were scored using the validated methods. Item missingness (e.g. no more than 30%) within each measure (or domain) were pro-rata mean imputed [
21]. Participants with over 30% of missing items were marked as missing.
Outcomes
The co-primary outcomes were the MH and PH domains of the PROMIS-10. 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. This utilised PH and MH domain T-scores. The multivariable model was adjusted for: age, sex, pre-stroke hypertension, previous stroke event, previous TIA and pre-stroke diabetes diagnosis. Residuals were used to visually inspect the distributional assumptions from each linear model. The analysis presented the mean difference (MD) and adjusted mean difference (aMD) reported with associated 95% CI and P-values. We have reported significant differences of 2 (or more) as both statistically and clinically important differences to patients.
Discussion
We included 549 stroke survivors and found almost half reported poor physical health. Poorer mental health (MH) outcomes were associated with age, female sex, previous stroke and pre-stroke diabetes and worse physical health (PH) outcomes with female sex and age. The stroke specific questions [
4] suggested that stroke survivors had a high degree of stroke specific comorbidity.
The PROMIS-10 has been shown as a feasible instrument in stroke survivors [
22‐
27] and exhibited the components of patient reported morbidity. Particularly when considering the high post-stroke prevalence of PROMIS-10 poor outcomes immediately after stroke. The PROMIS-10 represents an outcome measure that is real and accessible to the stroke survivor. Work by Phillipp et al. also demonstrates the instrument across stroke survivor populations, suggesting it was a valid and reliable instrument in German stroke surviors [
28]. Previously, measures accessing quality of life, such as the HRQOL, in stroke, has demonstrated that physical domains are adversely impacted by stroke in diverse communities [
29,
30,
31]. Further assessment of the PROMIS-10 in broader populations is needed to integrate the tool to wider clinical populations.
Further, the PROMIS-10 aligns with clinical risk factors of stroke. A pre-stroke diagnosis of diabetes is significantly associated with worse MH PROMIS-10 outcome scores following a stroke. This is mirrored within the association with other outcome measures; pre-stroke diabetes and a worse MoCA and PHQ9 scores across the cohort at the baseline period (Supplementary Table
4 and
6). A diagnosis of diabetes is considered a high-risk factor for stroke and confers worse outcomes in terms of overall morbidity, functional outcomes and readmission or recurrence [
32]. Diabetes, as a comorbidity, has been accepted as being highly related to overall outcome [
27,
33] and the reflection within the PROMIS-10 measures is not surprising.
The study demonstrated that sex was associated with different outcomes. When using the PROMIS-10 as an outcome measure, male sex was associated with better cognitive and physical domain scores post-stroke (Tables
2 and
3). This was comparable with the modified Rankin scale, (Supplementary Table
3), where male sex was shown to be associated with better physical functioning. This is consistent with the literature; worse post-stroke outcomes have been previously reported across female patients [
34‐
36]. One large scale study of post stroke outcomes including > 19,000 people reported that 3–6 months after stroke women are more likely to experience disability and worse quality of life [
37].
Table 3
Association of hypertension, TIA, previous stroke, diabetes, sex and age on PRO physical health domain. Both crude and adjusted results are reported with associated p-values and intervals. Statistically significant p-values are reported in bold. As a negative score is associated with worse outcome – a negative value indicates a factor resulting in worse outcome
Pre-Stroke Hypertension | −0.22 | 0.774 | (−1.72, 1.28) | 0.19 | 0.808 | (− 1.34, 1.72) |
Previous TIA | −1.65 | 0.111 | (−3.67, 0.38) | − 1.25 | 0.234 | (− 3.31, 0.81) |
Previous stroke | −3.17 | 0.003 | (−5.27,-1.08) | −3.05 | 0.005 | (− 5.17, −0.93) |
Pre-Stroke Diabetes | −1.64 | 0.071 | (−3.44, 0.134) | −1.48 | 0.107 | (−3.27, 0.32) |
Sex (Male) | 2.02 | 0.009 | (0.50, 3.54) | 2.09 | 0.008 | (0.54, 3.65) |
Age | 0.01 | 0.724 | (−0.05, 0.07) | 0.02 | 0.472 | (−0.04, 0.09) |
This study offers a novel insight to the use of a PROMIS-10 to assess post-stroke quality of life. We demonstrate the patient outcomes of MH and PH and highlight association with clinical and demographic risk factors. While it must be noted that the PROMIS-10 is not a direct measure of morbidity, adverse scores in this instrument globally is likely to correlate strongly with high morbidity, thus this adds value for the use of PROMs in clinical practice for the feasible measurement of patient-reported outcomes. This is important to consider in the clinical context and may allow a way to understand physical and mental outcomes, that are significant to a patient, in a global manner. By using the PROMIS-10 clinicians may potentially enact a more sensitive measure to indicate morbidity, especially as perceived by the stroke survivor. In turn, this is likely to add understanding of individual patient needs and improve quality of care in conjunction with improvement in quality of life.
This was a large UK wide prospective multicentre study that assessed patient reported outcomes. The limitations to our study are that PROMIS-10 may only be useful in patients with mild to moderate impairment [
28,
38]. While 146 of our subjects (26.9%) reported post-stroke aphasia, the degree and severity of impairment was not noted. Therfore, it is unclear if the functional impairment in communication may hinder the completion of the PROMIS-10. The use of patient reported tools in patients that struggle with communication is a current limitation of all self-reporting measures and should continue to be considered. Further, validation and standardisation of the 15-question measure, the PROMIS-10 and five additional reported questions, would be beneficial and allow a more specific measure of physical health, metal health and functional-capacity that is specific to a stroke population.
Conclusions
PROMs such as the PROMIS-10 offer a feasible way to measure patient reported quality of life.
Future research is needed to compare a wider set of PROMs. Future clinical practice should investigate comorbidity of mental health in stroke survivors.
Acknowledgements
We would like to acknowledgements the More Precise study team – consisting of Amber Corrigan, Alexander Smith, Anna Pennington, Ben Carter and Jonathan Hewitt.
We would further like to acknowledge the lead site investigations at each hospital site; Louise Coombe, Sarah Jones, Jayne Thomas, Sharon Storton, Richard Dewar, Lindsay Tarasconi, Benjamin Jelly, Walee Sayeed, Maureen Bartley, Kerry Smith, Sarah Dunne, Sarah Board, Katherine Ahlquist, Angela Kulendran, Ravneeta Singh, Asis Kumar, Deborah Ward, Rachel Teal, Ken Fotherby and Radim Licenik.
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