Due 3/28/19 8 p.m est400 words discussion APA format not including min 3 refArticle Attached " Relationships between long-term stroke disability, handicap and health-related quality of life "Data that

Relationships between long-term stroke outcomes 273 23.Jarman B. Identification of underprivileged areas. Br Med J 1983; 286: 1705–08.

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doi:10.1093/ageing/afj074 All rights reserved. For Permissions, please email: [email protected] Relationships between long-term stroke disability, handicap and health-related quality of life M. D. P ATEL2 , K. T ILLING1 , E. L AWRENCE1 , A. G. R UDD1 , C. D. A. W OLFE1 , C. M CKEVITT1 1Department of Public Health Sciences, Guy’s, King’s & St. Thomas’ School of Medicine, King’s College London, UK2Department of Elderly Medicine, University Hospital Lewisham, London, UK Address for correspondence: M. D. Patel. Tel: (+44) 20 8333 3000. Fax: (+44) 20 8333 3381. Email: [email protected] Abstract Objectives: to estimate levels of disability, handicap and health-related quality of life (HRQOL) up to 3 years after stroke and examine the relationships between these domains.

Design: a longitudinal, observational study Setting: population-based register of first-ever strokes Methods: subjects, registered between 1 January 1995 and 31 December 1997, were assessed at 1 year (n = 490) and 3 years (n = 342) post-stroke for disability [Barthel index (BI)], handicap [Frenchay activity index (FAI)] and HRQOL (SF-36). BI was categorised as severe, moderate, mild and independent (0–9, 10–14, 15–19 and 20); FAI was categorised as inactive, moderately active and very active (0–15, 16–30 and 31–45). SF-36 domains include: Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH). Physical (PHSS) and Mental Health (MHSS) Summary Scores were computed.

Results: at 1 and 3 years, 26.1 and 26.3%, respectively, were disabled (BI <15); 55 and 51%, respectively, were handicapped (FAI = 0–15); and survivors had low mean PHSS (37.1 and 37.9), but satisfactory mean MHSS (46.6 and 47.7). There was a graded positive relationship between all SF-36 domains and the categories of BI and FAI. Spearman rank correlations were significant between BI and all SF-36 domains at both time points: strong (r>0.70) with PF, moderate (r = 0.31–0.70) with RP, SF and PHSS, but weak (r<0.30) with other domains. Correlations between FAI and SF-36 domains were strong with PF, weak with BP, RE and MHSS, and moderate with other domains.

Conclusions: disability and handicap remain highly prevalent up to 3 years after stroke. Patients’ perception of physical health is persistently low, but mental health perception is satisfactory up to 3 years. Due to variable correlations between dif- ferent HRQOL domains with disability and handicap, it is suggested that disability, handicap and HRQOL should all be assessed to acquire a broader measure of stroke outcome.

Keywords: stroke, long-term outcomes, disability, handicap, quality of life, elderly Downloaded from https://academic.oup.com/ageing/article-abstract/35/3/273/40353 by guest on 27 March 2019 M. D. Patel et al.

274 Introduction Stroke remains one of the major chronic illnesses worldwide that health care organisations will need to address for the next several decades. This is because stroke can impact on virtually all human functions [1] and, unlike other disabling conditions, the onset of stroke is sudden, leaving the individual and the family ill prepared to deal with its sequelae[1]. Stroke is a chronic disease, yet studies have focused on measuring short- term outcomes mainly in the domain of impairments and disa- bility. The concept of broader outcomes was globally recog- nised in 1980 with the development of the international classification of impairments, disabilities and handicaps by the World Health Organisation (WHO) [2]. The few community- based reports on the long-term prognosis of an unselected cohort have mainly looked at stroke survival, recurrence, impairment and disability [3–5]. A review of stroke outcome measures in 174 acute stroke trials showed that death was recorded in 76%, impairment in 76%, disability in 42% and handicap in only 2% [6]. Another distinct paradigm that is also relevant in assessing the impact of stroke, from a patient’s per- spective, is health-related quality of life (HRQOL) [7]. Meas- urement of HRQOL in stroke patients can potentially provide researchers with a more holistic picture of stroke recovery and assist in the evaluation of medical interventions [8].

Many clinical trials have used scales assessing more than one domain of outcome, yet there is a paucity of long-term stroke studies exploring the relationships between the dif- ferent domains [6]. Exploring the relationships of HRQOL to disability and handicap would enable one to establish whether these ‘objective’ tools of assessment of stroke out- come are also relevant to patients themselves, examine the correlations of outcomes with one another and allow one to focus on specific measures [e.g. the Barthel index (BI)] rather than the numerous measures currently used in the hope of capturing stroke outcomes.

There are limitations to studies that have examined stroke outcomes beyond a year, including restriction to a selective groups such as hospital admissions [9–13], stroke units [14,15], specific age groups [5,13,15] or specific subtypes of stroke [9,11]. The design of the studies was predominantly cross-sectional so subjects were assessed at variable times after their stroke, and thus were at differing stages of the nat- ural recovery from stroke. Earlier studies [9,14] used non- standardised instruments to assess HRQOL, which made it difficult to interpret their results. Finally, associations between disability, handicap and HRQOL are not at all well established, even in short-term stroke studies [13].

The aims of this longitudinal study were to describe long-term disability, handicap and HRQOL up to 3 years after stroke, and to examine the relationships between these domains of stroke outcomes in an unbiased community- based sample of stroke subjects.

Methodology Stroke subjects were recruited from the South London Stroke Register (SLSR) which is a longitudinal, population- based register of first-ever strokes in subjects of all agegroups covering a multiethnic, inner-city population of 234,533. Detailed methodology of the compilation of this register has been reported earlier [16]. Consent was obtained from Guy’s & St Thomas’ Ethics Committee according to the revised Declaration of Helsinki of 1983. Stroke was defined according to the WHO criteria [17]. ‘Hot pursuit’ of cases and multiple sources of notification were used to achieve a high level of case ascertainment. Data collected on initial assessment included patient demography, risk factors, and pre-morbid disability using the BI. The Oxfordshire Community Stroke Project Classification (OCSP) was used to distinguish between total and partial anterior, lacunar and posterior circulatory infarctions [18].

Subjects were followed up at 1 and 3 years after stroke.

For this study, subjects who sustained their strokes between 1 January 1995 and 31 December 1997 were included.

Their 3-year follow-up was completed by 31 December 2000. Follow-up data were collected by personal inter- views with the subjects and/or their carers. The outcome measures collected were survival rates, disability using the BI [19], handicap using the Frenchay activities index (FAI) [20], and HRQOL which was evaluated by the UK version of the Medical Outcomes Study 36 item Short-Form Health Survey (SF-36) [21]. The HRQOL assessments were done mainly by asking the subjects themselves, except in those who were too confused or dysphasic to undergo these assessments themselves. This ensured that the SF-36 represented the subjects’ own subjective views on their health.

The BI was used because it is simple, and has a well- established validity, communicability and efficiency [19].

The BI was interpreted as follows [22]: 0–9, severely disa- bled; 10–14, moderately disabled; 15–19, mildly disabled; and 20, functionally independent. Defined specifically for stroke subjects, the FAI was used as a measure of social function and of handicap as it is simple, has good validity and is widely used [20]. The FAI was interpreted as follows:

0–15, inactive; 16–30, moderately active; and 31–45, very active [23]. The SF-36 was selected to measure HRQOL because of its strong psychometric properties, wide use, reli- ability, validity and responsiveness [21,24]. It assesses eight domains of health status: Physical Functioning (PF); Role Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Emotional (RE); and Mental Health (MH). Each domain is scored between 0 and 100. Absence of problems is indicated by scores of 100 for PF, RP, BP, SF and RE, and scores of 50 in GH, VT and MH. These domains were then computed to produce two summary scales representing physical and mental health [25]. Domains for the physical health sum- mary scale (PHSS) include PF, RP, BP and GH. The mental health summary scale (MHSS) includes VT, SF, RE and MH. The summary scales are based on norms with a mean of 50 and an SD of 10.

Due to unavoidable practical problems with the register, SF-36 assessments at the 3-year follow-up were adminis- tered only for subjects registered between 1 January 1995 and 29 February 1996. Thereafter, for subjects registered between 1 January 1997 and 31 December 1997, HRQOL Downloaded from https://academic.oup.com/ageing/article-abstract/35/3/273/40353 by guest on 27 March 2019 Relationships between long-term stroke outcomes 275 was assessed using the shorter version of SF-36, SF-12 [26].

Thus, there were fewer SF-36 assessments (n = 99) done at 3 years. As the 12 items in the SF-12 have been adopted from the SF-36 verbatim, and SF-12 and SF-36 summary scores are replicable and reproducible [8], the responses given to the specific 12 items in the SF-36 version, by the earlier group of subjects (n = 99), were combined with those obtained from the SF-12 in the later group (n = 51) to obtain a larger cohort with SF-12 assessments at 3 years after stroke (n = 150 out of 294 survivors, 51%). This cohort was used to calculate the mean PHSS and MHSS at 3 years.

Statistical analyses were carried out using χ 2 tests and t-tests as appropriate. The SF-36 scores were presented according to accepted guidelines [21], and non-parametric tests were used for analyses involving SF-36: Wilcoxon signed-rank tests for analyses between continuous variables, Kruskal–Wallis rank tests between categorical and continu- ous variables, and Spearman rank correlation coefficients for correlations with other outcomes. Results There were 946 subjects who had strokes between 1 January 1995 and 31 December 1997. At 1 and 3 years respectively, case fatality rates were 42% (397) and 54% (507), and data were unavailable for 6.2% (59) and 10.2% (97) of subjects because they were either lost to follow-up or refused to be assessed. Data were thus available for 490 subjects at 1 yearand 342 at 3 years after stroke. Appendix 1 in the supplementary data on the journal website (www.ageing.oxfordjournals.

org) describes their demographic characteristics. Potential selection biases Univariate analyses showed no differences between subjects included (n = 490) and excluded (n = 59) from the 1-year analyses. This is discussed in the supplementary data on the journal website (Appendix 2, available on the journal web- site: www.ageing.oxfordjournals.org).

Long-term disability, handicap and HRQOL (Table 1 and Appendix 3) At 1 and 3 years after stroke, 40 and 34% of subjects, respectively, were independent (BI = 20). Twenty-six per cent of subjects were moderately or severely disabled (BI 0–14) at 1 and 3 years after stroke. In terms of FAI, 16% were very active at 1 year and 14% at 3 years. At both time points, more than half the survivors were inactive. SF-36 summary scales revealed low mean PHSS scores but satisfactory MHSS scores. There were no significant changes observed in any domains between 1 and 3 years, except for a small improvement in RE. The Spearman correlation between BI and FAI was strong at 0.83 and 0.79 at 1 and 3 years, respec- tively. It is important to note that analyses for Table 1 were conducted for only those subjects with data available at both time points. Hence, BI was compared in 342 subjects, FAI in 294, HRQOL summary scales in 150, and individual HRQOL domains in 90.

Table 1. Disability, handicap and health-related quality of life (HRQOL) at 1 and 3 years after stroke aStatistical analyses were only conducted in subjects with data available at both times.bSubjects registered between 1 March and 31 December 1996 did not have their HRQOL assessed at 3 years after their stroke. See text for further details. Subjects, n (%) at 1 year Subjects, n (%) at 3 years Mean change a (95% CI) .................................................................................................................................................................................Case fatality rates 397 (42%) 507 (54%) – Alive and followed-up 490 342 – Institutionalisation 76 (15.5%) 51 (15.0%) – Barthel index Severe (0–9) 60 (12.2%) 49 (14.3%) – Moderate (10–14) 68 (13.9%) 41 (12.0%) Mild (15–19) 168 (34.3%) 136 (39.8%) Independent (20) 194 (39.6%) 116 (33.9%) Mean 16.3 15.9 Median (range) 19.0 (0–20) 18.0 (0–20) –0.83 (–1.20 to 0.46) Frenchay activity indexn = 462n = 323 Inactive (0–15) 254 (55.0%) 166 (51.4%) – Moderately active (16–30) 133 (28.8%) 111 (34.4%) Very active (31–45) 75 (16.2%) 46 (14.2%) Mean 15.4 15.8 Median (range) 13.0 (0–45) 15.0 (0–44) –1.05 (–2.07 to 0.04) SF-36 scalesn = 397n = 150 b Physical health summary scales Mean, SD 37.1 (12.4) 37.9 (11.5) –0.46 (–2.39 to 1.48) Range 11.7–65.4 19.0–59.8 Mental health summary scales Mean, SD 46.6 (12.1) 47.7 (10.2) –0.95 (–3.04 to 1.15) Range 15.4–71.9 20.3–68.0 Downloaded from https://academic.oup.com/ageing/article-abstract/35/3/273/40353 by guest on 27 March 2019 M. D. Patel et al.

276 Relationships between disability and HRQOL Correlations between disability and all HRQOL domains were significant at both 1 and 3 years after stroke, but there was variation in the strength of these correlations; it was strong [26] (r>0.70) with PF, moderate (r = 0.31–0.70) with RP, SF and PHSS, and weak (r< 0.30) with the other domains (Table 2). One year after stroke, there was a graded positive relationship between all the domains of HRQOL and categorical levels of disability (Figure 1). At 3 years, sim- ilar analyses showed that this graded relationship was evi- dent only for PF, RP and SF. However, caution must be exercised when interpreting the 3-year results as only 14 subjects had severe disability.

Relationships between handicap and HRQOL Correlations between handicap and HRQOL domains were also all significant, but their strength was variable (Table 2); cor- relation was strong with PF, weak with BP, RE and MHSS, and moderate with the other domains. There was a graded positive relationship between all the domains of HRQOL and categori- cal levels of handicap at 1 year after stroke (Figure 1). This relationship was also observed at 3 years after stroke.

Discussion This large, population-based longitudinal study of first-ever strokes has shown that the long-term impact of stroke is considerable. Three years after stroke, 26% of subjects were moderately or severely disabled (BI <15), 51% were handi- capped (inactive, FAI <15), mean scores for physical HRQOL (PHSS) were poor, but the mean scores for mental HRQOL (MHSS) were satisfactory.

Disability remains prevalent for years following a stroke, with studies reporting 13–66% of their sample hav- ing some disability [5,14,15]. The prevalence of handicap in previous stroke studies ranges from 12 to 64% [15,27] (fur- ther discussed in Appendix 4 on the journal website:

www.ageing.oxfordjournals.org). Apart from individual domains of HRQOL, PHSS and MHSS were also com- puted in this study. These scales were particularly useful as they allowed meaningful and simple comparisons to bemade between subjects’ perceived physical and mental health and objective measures used in research and clinical practice. Subjects perceived their physical health to be low up to 3 years after a stroke, whereas their perception of their mental health was satisfactory. The acceptable MHSS found in this study could be due to higher initial mortality in stroke, meaning this ‘natural selection’ resulted in assess- ments being undertaken in a ‘survivor cohort’ who were in better spirits, younger and living at home [29]. The physical scores were also low in subjects with minimal or no disabil- ity, which confirms earlier reports that in many instances low HRQOL is reported, yet the individual is independent in activities of daily living [13]. In contrast, Hackett [29] meas- ured HRQOL using the SF-36 in 639 subjects from a popu- lation-based study at 6 years after stroke, and concluded that HRQOL was acceptable for most stroke survivors com- pared with controls, despite ongoing physical limitations.

This study showed that most domains of HRQOL had a graded relationship with the categorical levels of disability and handicap. As previously recommended [6], categorical analysis was done as it is more appropriate than continuous analysis in terms of clinical relevance that can usually be applied to different categories, such as describing disability as mild, moderate or severe. The graded relationship was more consistent with FAI than with BI at both time points, which may be either due to the small number of subjects with severe disability at 3 years or due to the slightly stronger correlation between most domains of HRQOL and FAI (Table 2). These results are comparable with previ- ous studies. Wilkinson [5] examined 106 subjects in a cross- sectional study, and reported a high correlation between BI and FAI (r = 0.83) at a mean follow-up of 5 years. Another hospital-based study of 81 patients with lacunar infarctions reported a strong correlation between disability (Katz activ- ities of daily living) and handicap (Oxford Handicap Scale) [27]. Duncan [30] indicated that standardised assessment of stroke subjects must evaluate across the entire continuum of health-related functions, and recommended that mea- sures such as SF-36 be used in addition to the BI, which has a ceiling effect and captures only physical functions.

Roberts [6] also concluded that as there is no simple Table 2. Relationship between disability (Barthel index), handicap (Frenchay activities index) and HRQOL (SF-36) at 1 and 3 years after stroke, using Spearman’s rank correlation coefficient ..................................................................Disability ..................................................................Handicap ..............................One year, n = 401 ..............................Three years, n = 99 ..............................One year, n = 379 ..............................Three years, n = 90 Domain of SF-36 Correlation, rP-value Correlation, rP-value Correlation, rP-value Correlation, rP-value .................................................................................................................................................................................

Physical Functioning 0.810 <0.001 0.816 <0.001 0.799 <0.001 0.796 <0.001 Role Physical 0.510 <0.001 0.520 <0.001 0.548 <0.001 0.474 <0.001 Bodily Pain 0.184 <0.001 0.109 0.283 0.223 <0.001 0.187 0.077 General Health 0.249 <0.001 0.314 0.002 0.318 <0.001 0.380 <0.001 Vitality 0.261 <0.001 0.328 0.001 0.315 <0.001 0.368 <0.001 Social functioning 0.543 <0.001 0.502 <0.001 0.572 <0.001 0.554 <0.001 Role Emotional 0.224 <0.001 0.199 0.048 0.182 <0.001 0.241 0.022 Mental Health 0.289 <0.001 0.209 0.040 0.341 <0.001 0.253 0.017 Physical health summary scale 0.608 <0.001 0.562 <0.001 0.633 <0.001 0.594 <0.001 Mental health summary scale 0.183 <0.001 0.229 0.005 0.216 <0.001 0.273 <0.001 Downloaded from https://academic.oup.com/ageing/article-abstract/35/3/273/40353 by guest on 27 March 2019 Relationships between long-term stroke outcomes 277 Figure 1. Comparison of SF- 36 according to disability (Barthel index) and handicap (Frenchay activities index) 1 year after stroke using Kruskal–Wallis rank tests. 0 10 20 30 40 50 60 70 80 90 100 Physical Functioning p<0.001Role Physical p<0.001Bodily Pain p=0.002General Health p<0.001Vitality p<0.001 Social functioning p<0.001Role Emotional p<0.001Mental Health p<0.001Physical health summary scale p<0.001Mental health summary scale p<0.001 domains of HRQOL mean percentage scores bi 0-14, n=73 bi 15-19, n=145 bi 20, n=183 SF-36 & Barthel Index 0 10 20 30 40 50 60 70 80 90 100 Physical Functioning p<0.001Role Physical p<0.001Bodily Pain p<0.001Gener al He al t h p<0.001Vitality p<0.001 Social functioning p<0.001Role Emotional p=0.031Ment al Health p<0.001Physical health summary scale p<0.001Mental health summary scale p<0.001 domains of HRQOL mean percentage scores fai 0-15, n=179 fai 16-30, n=129 fai 31-45, n=71 SF-36 & Frenchay Activity Index Downloaded from https://academic.oup.com/ageing/article-abstract/35/3/273/40353 by guest on 27 March 2019 M. D. Patel et al.

278 relationship between disability, handicap and HRQOL, out- come measures should include items relating only to a single level because a mixture of levels is conceptually confusing and difficult to interpret clinically. In view of the variable correlations of disability and handicap with different domains of HRQOL observed in this study, we suggest that a multitude of standardised assessments should be con- ducted to obtain a more holistic measure of stroke out- come. This would provide useful information for planners of rehabilitation services and long-term care, and scope for new interventions to improve these outcomes.

There are some limitations to this study. First, it is acknowledged that although it is widely used, SF-36 is not a stroke-specific measure, but instead a generic measure that was first developed to assess HRQOL outcomes that are closely affected by disease and treatment. Thus, it may not be sensitive or specific enough to detect the psychological domains of mental health that are relevant to stroke [29].

Secondly, data were missing for several subjects, particularly for subjects who were very dysphasic or confused and they had no carers to act as proxies, and for subjects registered during part of the study period due to reasons already men- tioned. These ‘missing’ data may have introduced a bias into the study so that the frequency of poor outcomes may actu- ally have been underestimated. Thirdly, SF-12 was used for some subjects instead of SF-36, though the summary scores produced by either of them have been shown to be replica- ble [8]. Fourthly, this study did not consider the effects that stroke recurrence or other major co-morbidities such as vascular cognitive impairment may have had on the sub- jects’ disability or handicap during the 3 years after stroke.

Finally, the strong correlation between BI and FAI with the physical domains of SF-36, particularly PF, may be due to common factors being assessed, i.e. questions relating to this domain assess mobility and physical activities which are also assessed by similar questions in BI and FAI.

We conclude that the prevalence of disability and handi- cap following stroke remains high up to 3 years after a stroke. By embracing a wider perspective than merely sur- vival, this study provides a broader and more representative description of long-term stroke outcome than has been pre- viously reported. Patients’ perception of physical HRQOL is persistently low, while their perception of mental HRQOL is satisfactory up to 3 years post-stroke. There is a graded relationship of HRQOL to disability and handicap.

The correlation of disability and handicap is variable with different domains of HRQOL (SF-36); it is strong with PHSS, but weak with MHSS. In view of these variable cor- relations, it is suggested that future studies should assess disability, handicap and HRQOL, using standardised assess- ments, as primary outcome measures in order to acquire a broader measure of stroke outcome.

Key points •This report provides a broader and more representative description of long-term stroke outcome than has been previously reported.•It provides population-based estimates of impact of stroke in terms of disability, handicap and HRQOL up to 3 years after stroke.

•The correlation of disability and handicap is variable with different domains of HRQOL (SF-36); it is strong with PHSS, but weak with MHSS.

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