Stroke is a major public health issue. The long-term

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1 Quality of Life Among Stroke Survivors Evaluated 1 Year After Stroke Experience of a Stroke Unit Javier Carod-Artal, MD, PhD; José Antonio Egido, MD; José Luis González, MD; E. Varela de Seijas, MD, PhD Background and Purpose We sought to study overall and domain-specific quality of life in stroke survivors 1 year after stroke and to identify variables that could predict quality of life after stroke. Methods We followed up for 1 year a cohort of 118 patients consecutively admitted to our stroke unit at San Carlos University Hospital in Madrid, Spain. The final series at 1-year follow-up consisted of 90 survivors (41 women and 49 men; mean age, 68 years; range, 32 to 90 years). A cross-sectional, descriptive design was developed. Patients completed a questionnaire that included socioeconomic variables, Hamilton Rating Scale for Depression, Sickness Impact Profile (SIP), Short Form 36, Frenchay Index, Barthel Index, Rankin Scale, and Scandinavian Stroke Scale. Independent variables were sex, age, functional status, motor impairment, and depression. We developed an ANOVA model for statistical analysis. Results We interviewed 79 patients with ischemic and 11 with hemorrhagic stroke. Thirty-eight percent of patients scored in the depressed range. Variables related to depression were status as a housewife, female sex, inability to work because of disability, and diminished social activity (P ). Mean total SIP (24.3), SIP psychosocial dimension (27.5), and SIP physical dimension (21.2) were correlated with disability, female sex, motor impairment, and depression (P ). Conclusions Functional status and depression were identified as predictors of quality of life. Patients independent in their activities of daily living suffered from a deterioration of the psychosocial dimension of the SIP. (Stroke. 2000;31: ) Key Words: disability evaluation quality of life stroke assessment stroke outcome Stroke is a major public health issue. The long-term consequences of stroke have been recognized in recent years. Traditionally, epidemiological stroke studies focused on mortality and recurrence 1,2 but not on quality of life (QOL) issues. The prevalence of stroke survivors with incomplete recovery has been estimated at 460/ First-year mortality has been estimated between 15% and 25%, recurrence between 5% and 14%, and partial or complete disability between 24% and 54%. 4 QOL related to stroke and life satisfaction after stroke are important healthcare outcomes that have not received sufficient attention in the literature. The Barthel Index (BI) and the Rankin Scale have been the most frequent outcome measures used in stroke research, focusing on stroke-related disability and recovery of motor function after stroke. 5 9 However, stroke patients have a broad range of impairments and a wide spectrum of symptom severity and sequelae. Some aspects of QOL considered important by the patients have been studied infrequently. A multidimensional approach is necessary to measure QOL. QOL assessment includes at least 4 dimensions: physical, functional, psychological, and social health. 10 The physical health dimension refers to disease-related symptoms. Functional health comprises self-care, mobility, and the capacity to perform various family and work roles. Psychological dimension includes cognitive and emotional functions (eg, vascular dementia and poststroke depression) and subjective perceptions of health and life satisfaction. Social dimension includes social and familial contacts. The multidimensional approach of perceived health status in stroke patients has received attention only in the last few years Consequences of stroke and health status affect even mild strokes. 13 However, evaluation of QOL data in stroke is complicated by several factors. These include the use of nonstandardized measures, comparison of samples taken from patients with wide variability in their condition since symptom onset, and variability of treatment regimens from centers of contrasting orientation such as rehabilitation centers and general wards versus stroke units. There are few studies of QOL in stroke units. 14 Most published works focused on rehabilitation centers or gen- Received April 28, 2000; final revision received July 12, 2000; accepted August 7, From the Stroke Unit, Department of Neurology, San Carlos University Hospital, Madrid, Spain. Correspondence to Dr Javier Carod-Artal, Servicio de Neurología, Hospital Universitario San Carlos, Calle Profesor Martín Lagos s/n, CP 28040, Madrid, Spain. javier@bsb.sarah.br 2000 American Heart Association, Inc. Stroke is available at

2 2996 Stroke December 2000 eral neurology wards. European QOL studies have been centered for some time in Scandinavian 12,15 17 but not in Mediterranean countries. These studies reported diminished global, leisure, sexual, and work-related satisfaction The purposes of this study were to examine global and domain-specific QOL in individuals treated with a standardized approach to treatment and outcome measurement in a stroke unit located in Madrid, Spain. Subjects and Methods We followed up for 1 year (1996 to 1997) a cohort of 118 patients consecutively admitted to our stroke unit at San Carlos University Hospital in Madrid, Spain. The stroke unit takes care of all stroke patients admitted to our Neurology Department. We studied all patients admitted to the stroke unit between July 1 and December 31, Patients with advanced age or coma at stroke onset were admitted to the stroke unit; patients with severe comorbidity were not. Patients affected by a subarachnoid hemorrhage or transient ischemic attack and those who died during the acute stage were excluded from the study. Diagnosis of stroke was confirmed by clinical and/or radiological findings. 18 The Oxfordshire classification 19 was used to define stroke subtype. A cross-sectional, descriptive analysis design was developed. All interviews were conducted 1 year after stroke and were administered by the main author (J.C-A.). When cognition and language function were not adequate, QOL questionnaires were administered as a proxy and recognized as such during statistical analysis. Three patients were rated by proxy (main caregiver) for the Sickness Impact Profile (SIP) because of aphasia. We did not include proxy ratings in the Short Form 36 (SF-36) subscales vitality and mental health. Data were collected on age, sex, marital status, education, location of brain lesion, diagnostic stroke subtype, and stroke laterality. Independent variables included age, sex, comorbid conditions, functional status, motor impairment, and depression. Neurological impairment was measured with the Scandinavian Stroke Scale (SSS) 20 and handicap with the Rankin Scale. 21 Information about falls was recorded from interviews with patients and main caregivers 1 year after stroke. Activities of daily living (ADL) were measured with the BI. 22 We defined severe disability as BI score 60; moderate disability, 65 to 90; mild disability, 95; and independent in ADL, 100. Instrumental ADL were measured with the Frenchay Activities Index (FAI). 23 The FAI measures lifestyle in terms of more complex physical activities and social functioning. The FAI rates the frequency with which respondents perform 15 activities (eg, gardening, washing dishes) that have been content-validated for application to the stroke population. 23 It can be measured as a total score (total FAI) or divided into 3 subscales (domestic activities, work/pleasure, and social activities). QOL was measured by the SIP 24 and the SF The SIP is a well-evaluated 136-item measure organized into 12 subscales and 2 main dimensions, psychosocial and physical. The physical dimension contains items measuring a broad range of ADL, mobility, and complex physical activities. Because of its breadth, the SIP is chiefly used for cross-sectional studies. Its reliability is enhanced by using aggregated category scores for description and analysis 10 rather than analyzing specific item responses. Health status measures included the SF-36, the 8 subscales of which assess general health, mental health, emotional role, physical role, social function, vitality, bodily pain, and physical function. Depression was evaluated with the Hamilton Rating Scale for Depression. 26 QOL scales were validated in Spanish by other authors Informed consent was obtained from all participants in the study at the time of data collection and interview. All but 2 interviews were conducted in our stroke unit; the remaining 2 patients were interviewed in a nursing home. A multifactorial ANOVA was performed to examine relations among qualitative variables and a quantitative variable. A Bonferroni correction was applied for multiple significance tests. A 2-tailed probability value 0.05 was considered TABLE 1. Demographics of Study Population Mean age (SD), y (10.82) Male (11.40) Female (8.88) Sex, % Male Female Education, % Read and write Primary school Secondary school 7.78 Bachelor s degree Living arrangement, % Alone 7.78 Spouse, relatives Nursing home 4.44 Employment, % Retired Housewife Disability Employed 7.78 statistically significant. A regression model was used to correlate quantitative variables. Results One hundred eighteen patients met the inclusion criteria of the study. Seventeen patients could not be located for final follow-up at 12 months, 10 died, and 1 refused to participate. Marital status, age, and sex were not significantly different among participants and nonparticipants. Ninety survivors were available at 1-year follow-up, consisting of 41 women and 49 men with a mean age of 68 years, ranging from 32 to 90 years. They included 79 patients affected by ischemic stroke and 11 with hemorrhagic stroke. Table 1 describes the sociodemographic characteristics of the patients 12 months after stroke. In this group 64.44% of patients were older than 65 years. All individuals were white, and slightly more than one half were male. Family support seemed to be strong since, on average, 1.6 family members were living with the stroke patient. Table 2 describes stroke characteristics and the distribution of other comorbid diseases. Fifty-one percent of patients had 3 vascular risk factors. Hypertension was the most frequent vascular risk factor; 52.2 patients had osteoarthritis. Mean comorbid conditions in patients numbered 2.93; when we included vascular risk factors, the mean comorbid index increased to 5.6. Seventeen patients (18.89%) had moved temporarily or permanently to a relative s house or nursing home, for a mean time of 7.29 months; 13.3% of patients had to make modifications in the bathroom or lounge; and 31% of patients needed walking assistance, cane, or wheelchair to move 12 months after stroke. Thirty-six patients (40%) had falls after stroke at home, in the bathroom, or in the street. We measured 70 falls during the first year after stroke, with a mean fall

3 Carod-Artal et al Quality of Life Among Stroke Survivors 2997 TABLE 2. Stroke Characteristics and Comorbid Diseases in Study Population Variable No. % Side of brain lesion Right Left Stroke syndrome TACI PACI LACI POCI 9 10 Hemorrhage Communication impairment None Motor/sensitive aphasia 9 10 Transcortical aphasia Vacular risk factors Hypertension Hyperlipidemia Cardiopathy Diabetes Smoking Previous stroke/tia Comorbid conditions Osteoarthritis Cataracts/retinopathy Cardiac dysrhythmia (AF) Ischemic heart disease Valvular heart disease Heart failure COPD Hepatic disease Peripheral vascular disease TACI indicates total anterior circulation infarct; PACI, partial anterior circulation infarct; LACI, lacunar infarct; POCI, posterior circulation infarct; TIA, transient ischemic attack; AF, atrial fibrillation; and COPD, chronic obstructive pulmonary disease. index of 0.78 per patient year. No significant correlations were observed between falls and dimensions of SIP. After stroke, 28.89% of patients modified their habits and ceased tobacco or alcohol consumption. Barthel Index Mean BI score at onset was 65.8 and 1 year later was 88.5 (scoring moderate to mild disability; P ). At 1-year follow-up, 52% of patients were independent in their ADL, while only 32.2% of patients were independent at stroke onset. Forty percent of patients presented total or severe disability (defined by BI score 60) at discharge and only 11.1% at 1-year follow-up. Twenty percent of patients were incontinent or had problems with vesical control, 32% were dependent when bathing, and 7% were completely dependent for personal hygiene 1 year after stroke. BI scores in women were significantly lower than those in men (mean BI score, 80 TABLE 3. ADL Assessed by BI at Stroke Onset and BI 1 Year After Stroke BI at Onset BI 1 Year After Stroke Total dependence (BI 0 20) 15 (16.6) 1 (1.1) Severe dependence (BI 25 60) 21 (23.3) 9 (10) Moderate dependence (BI 65 90) 25 (27.7) 20 (22.2) Mild dependence (BI 95) 10 (11.1) 13 (8.4) Independence (BI 100) 19 (21.1) 47 (52.2) Values are number (percent). versus 95.7; P ) at 1 year follow-up and also at onset (mean BI score, 55.6 versus 74.3). BI scores were not significantly modified by age. Patients with lacunar infarction had a higher BI score 1 year after stroke than those with cortical infarctions (P ). Table 3 shows the comparison between BI score at stroke onset and BI score 1 year after stroke. Scandinavian Stroke Scale The SSS total score at 1 year was Patients with lacunar and atherothrombotic stroke subtypes had significantly lower SSS scores. Women had lower total SSS scores than men (mean SSS score, 47.9 versus 53.4; P ). The mean Rankin Scale score was 1 point lower at 1 year of follow-up than at hospital discharge. According to the modified Rankin Scale, 55 patients (62.33%) had either no symptoms or symptoms that did not interfere with their capacity to look after themselves (scores of 0 to 2). Frenchay Activities Index We used the original scoring system for FAI, with scores between 0 and 60. Mean FAI score 12 months after stroke was 36 (SD, 11); 74.5% of patients scored 30. We found no statistically significant differences by sex or age in the global FAI score. Men scored better in the subscales hobby/work and social activities (P 0.001); there were no differences by sex in the domestic work category. The 3 FAI subscales were diminished 50% in patients with severe disability (BI score 60); social activities were significantly decreased in patients with severe disability (P ). Patients independent in ADL scored 42.2, patients with BI 60 scored 20, and patients with BI between 65 and 100 scored 38.3 in total FAI. Domains on FAI according to level of disability and FAI overall scores are shown in Tables 4 and 5. Hamilton Rating Scale for Depression Depression was estimated by use of the Hamilton Rating Scale for Depression. The mean score 12 months after stroke was A third of patients showed depressive symptoms at TABLE 4. Domains on FAI According to Level of Disability FAI Domains BI 60 BI 60 P Domestic activities Pleasure/work Social activities

4 2998 Stroke December 2000 TABLE 5. Instrumental ADL 12 Months After Stroke Measured by FAI (n 90 Subjects) Overall Score Men Women Total FAI Domestic activities Pleasure/work P Social activities P discharge; 67% of patients scored in the range of depression at the end of the year of follow-up, with 37.7% in the range of major depression. Twelve months after stroke, 13.3% of patients were receiving antidepressive treatment, and 24.4% were receiving sedatives. Prevalence of depression was significantly higher in women than in men (78% versus 57%; P 0.014), as was the severity and mean time of illness. Neither stroke laterality, stroke subtype diagnosis, marital status, nor educational level was correlated with depression. Two social variables, status as a housewife and inability to work because of a poststroke handicap, were significantly correlated with depression (P ). Thus, poststroke depression was highly prevalent 1 year after stroke (37.7%) and was chiefly associated with female sex, status as a housewife, handicap that affected ability to work, and diminished social activity (P ). Short Form 36 Mean scores in the 8 SF-36 subscales were decreased 40% from theoretical values of reference (100). Figure 1 expresses values corrected by sex. QOL perceived by SF-36 was significantly much lower in women (P ); the main differences were observed in the subscales physical functioning, mental health, emotional role, and vitality. Bodily pain was the only subscale that significantly decreased with age. Neither educational level nor marital status influenced scoring. Low QOL measured by SF-36 was significantly correlated with presence of depression and severe disability. SF-36 subscale values according to level of ADL are shown in Table 6. SF-36 social function was affected more in disabled than in depressed patients (22.7 versus 40), while SF-36 vitality Figure 1. Mean scores on SF-36 in men and women. decreased slightly more in patients with poststroke depression (35.2 versus 41). Women perceived a lower QOL according to SF-36 score in all dimensions of this questionnaire (P ). SF-36 social function was correlated with the FAI social activities category (r ). Sickness Impact Profile The mean total SIP score 1 year after stroke was 24.3; mean physical dimension score was 21.2 and psychosocial dimension The categories of home management (42.6), emotional activity (31.2), and recreation (32.1) were the most altered (Figure 2). Variables related to deterioration of QOL evaluated with SIP were female sex (P ), cerebral anterior circulation infarction, cardioembolic or atherothrombotic stroke subtype, depression, disability, and sociodemographic variables such as work-related disability and status as a housewife. Physical and psychosocial dimension and total score of SIP showed significantly greater deterioration in women and in subjects with severe disability and depression (Table 6). Patients independent in ADL 12 months after stroke also were affected on the psychosocial dimension of SIP (score of 21.24) even though they were clinically recovered in terms of ADL. The most sensitive measure of depression by SIP was the category of emotional role, with a mean value of 31. Stroke patients who were not depressed (as measured by the Hamilton scale) scored 14 in this category, while depressed patients scored 50.1 (P ). We have shown that SIP and SF-36 are 2 valid instruments to study QOL. A strong correlation was observed between SF-36 physical functioning and SIP body movement (r ), SIP transfers (r ), SIP home management (r ), SIP physical dimension (r ), and total SIP (r ) and also between SF-36 mental health and SIP emotional role (r ), psychosocial dimension (r ), and total SIP (r ). Discussion The aim of our study was to provide information regarding the variables that had the greatest impact on the QOL of patients treated in a stroke unit 1 year after stroke. Additionally, we wished to determine the utility of the various outcome measures developed in other cultural environments as applied to our Spanish population. The mortality rate of 8.47% during follow-up and the 15% of patients lost to follow-up are within the expected range, and thus we believe that they do not invalidate our results. Almost 50% of patients recovered as measured by BI, which is similar to the findings of Wade and Langton-Hewer. 30 This good recovery was confirmed in ADL, social activities, and return to work. However, significant deleterious effects persisted in the QOL of patients independent in ADL but not achieving the level of function they enjoyed before the stroke. This latter effect is shown in the results of the psychosocial dimension of SIP and all subscales of the SF-36. These results agree with previous descriptions in the literature. 12,13,31 This apparent divergence may be due to 2 factors. The first is the presence of a ceiling effect in the BI. The BI is insensitive to subjective dysfunction in patients with high performance in ADL. The second is the presence of anomalous perceptions and dissatisfaction in patients with minor disability levels that were incompletely re-

5 Carod-Artal et al Quality of Life Among Stroke Survivors 2999 TABLE 6. Health Status of Individuals According to ADL and Depression Rating BI Hamilton Rating Scale for Depression Subscales P P SF-36 Physical functioning Physical role Bodily pain General health Vitality Social functioning Emotional role Mental health SIP Physical dimension Psychosocial dimension Total SIP stored after the stroke. Thus, the consequences of mild to moderate stroke can affect all dimensions of QOL despite the patient achieving full independence in ADL. 13 Isolated measures of the physical domains of health such as the BI are not adequate to study the full impact of the long-term disability that stroke produces. QOL measurement, when added to measures of the person s state of health, assesses the patient more completely. The additional subjective component shows the effect of survivor attitudes, health beliefs, and their interaction on activity levels. The focus of the SF-36 is on this subjective perception of health. The SIP emphasizes behavior as a valid and reliable generic instrument of QOL. Unfortunately, the SIP takes a long time to administer, thus limiting its use in the older patient population. Another objective was to identify selected variables with major effects on QOL. Depression and disability were the strongest predictors of overall, psychosocial, and physical QOL Figure 2. Mean scores on SIP by categories 1 year after stroke. measured with SF-36 and SIP. Poststroke disability was a stronger predictor of low QOL than poststroke depression 1 year after stroke. Patients with severe/moderate disability had lower QOL than depressed patients. Isolation and diminished social activities were the result of physical disability more than poststroke depression. Poststroke depression is a treatable condition; early diagnosis is of paramount importance to prevent progression to a chronic depressive disorder. Depression slows down the process of rehabilitation, exerting a negative influence on all aspects of the process of recovery. All variables related to depression 1 year after stroke were of sociodemographic origin but not related to stroke subtype or stroke etiology. The depression prevalence rate in the present study, measured by Hamilton Rating Scale for Depression, SF-36 vitality and mental health subscales, and psychosocial dimension of SIP, showed a high prevalence of mood disturbances, slightly higher than other studies. 32,33 Older age or lower educational level was not correlated with low QOL. Increasing educational level showed only a weak relationship with better QOL. Comorbid conditions, diabetes, hypertension, or other vascular risk factors did not decrease global QOL. Social support was an important predictor of depression. Social activities measured by SF-36 were lower in women. Women had a lower BI score both on admission and at 1-year follow-up. Similarly, women had a lower SSS score at 1 year than men and a lower QOL assessed by SIP and SF-36. Several hypotheses may explain these results. The mean age of women at stroke onset was 71 years, which is 6 years later than men. Mean Rankin Scale score at discharge was 2.3 in men and 3 in women. Thus, advanced age at stroke onset and more severe impairment at discharge could affect recovery, functional status, and QOL 1 year after stroke in women. Failure to recover the ability to work is a major source of low QOL for the subsample of people aged 65 years. 11 Women in general and housewives in particular are affected with low scores in all instruments of QOL and in the Hamilton Rating Scale for Depression as well. In our study

6 3000 Stroke December % of women were housewives before stroke. Wyller et al, 34 however, found better subjective well-being in women according to measurements in their cultural area. This may be a sociocultural effect specific to Spain, since in Spain elderly women are valued and routinely take responsibility for household management until they reach an advanced age. This social factor may also influence the low QOL in women surviving a stroke. The absence of patients with dementia or aphasia is a bias in most of studies of QOL and stroke, including ours. Methodology for measuring QOL in those patients is difficult and may be better analyzed by caregivers or proxy. Another limitation was the lack of a comparison group of healthy adults. However, it is possible to compare findings with the same QOL instruments in a normal population in whom scales were validated. 27,28 The mean SIP score found (24.3) is coincident with results by Nydevik and Hulter-Åsberg 16 9 months after stroke. These authors used a score of 10 as a cutoff because 70% of patients had a SIP mean score 10, and the mean SIP score in the aged control group was De Haan et al, 35 in a case-control study 6 months after stroke, found the following scores: psychosocial SIP, 19.5 (controls, 3.4); physical SIP, 24.6 (controls, 5); and total SIP, (controls, 5). An important difficulty in the analysis of QOL results in stroke patients is that few studies use the same measurement tools and there is poor agreement about which QOL measures generic or specific are adequate to use in stroke patients. Most of the stroke trials and reports have used generic QOL stroke scales that have the advantage of allowing comparisons among patients with different diseases, but they are less sensitive for exploring the effects of particular impairments on QOL in stroke patients. Recently, SS-QOL, 36 a new stroke-specific QOL measure, has been developed and has been used to predict poststroke QOL in patients with mild and moderate stroke. Thus, we believe that it is necessary to study QOL and patient-centered outcomes in longitudinal studies in patients after stroke with normal and standardized instruments that are accepted as standard in all stroke units. Only in this way will it be possible to accurately quantify the impact and effects of stroke management on the patients. Acknowledgment The authors express gratitude to Dr Thomas A. Horan for helpful suggestions and review of English usage in the manuscript. References 1. Jaap Kapelle L, Adams HP, Heffner ML, Torner JC, Gomez F, Biller J. Prognosis of young adults with ischemic stroke: a long-term follow-up study assessing recurrent vascular events and functional outcome in the Iowa Registry of Stroke in Young Adults. Stroke. 1994;25: Min Lai S, Alter M, Friday G, Sobel E. 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