Neurol Sci (2006) 27:4046 DOI 10.

1007/s10072-006-0563-5 ORIGINAL

I. Aprile D.B. Piazzini C. Bertolini P. Caliandro C. Pazzaglia P. Tonali L. Padua

Predictive variables on disability and quality of life in stroke outpatients undergoing rehabilitation

Received: 28 July 2005 / Accepted in revised form: 16 January 2006

Abstract The purposes of this study were: (1) to evaluate the relationship between disability and Quality of Life (QoL) in stroke outpatients undergoing rehabilitation and (2) to determine whether and how demographic and social features of the patient, duration of disease and concomitant diseases influence the disability and QoL of the stroke outpatients. We performed a prospective study using several conventional disability measurements (Barthel Index, Functional Independence Measure, Modified Rankin Scale and Deambulation Index) and a validated patient-oriented measurement of QoL (SF-36). Sixty-eight outpatients were evaluated consecutively. As expected, all disability measurements were related to Physical Function: patients with higher disability, according to the physicians perspective, complained of higher deterioration of physical performance. Unexpectedly, patients with higher disability from the physicians point of view perceive that they were not able to do some daily activities not only because of physi-

cal problems but also because of emotional problems, and complained of higher deterioration of mental health. Multivariate analysis showed that higher disability is associated with higher age, depression and lower educational level. Physical Composite Score appeared to be deteriorated in patients with lower educational level who lived with family; on the contrary, Mental Composite Score appeared deteriorated in patients with higher educational level who lived alone. The current study provides interesting data about the relationship, not always expected, between disability and QoL for stroke patients and about the influence of patients characteristics on disability and QoL. Our results showed that in a rehabilitation programme we should consider not only disability assessment but also QoL, which is more relevant for the patient. Key words Outcome assessment Rehabilitation Disability Stroke

Quality of Life

Introduction
I. Aprile () Department of Physical Therapy and Rehabilitation L.go F. Vito 1, I-00168 Rome, Italy e-mail: i.aprile@rm.unicatt.it I. Aprile L. Padua Fondazione Don C. Gnocchi Centro Santa Maria della Pace Rome, Italy I. Aprile P. Caliandro C. Pazzaglia P. Tonali L. Padua Department of Neuroscience Universit Cattolica Rome, Italy I. Aprile D.B. Piazzini C. Bertolini Department of Physical Therapy and Rehabilitation Universit Cattolica Rome, Italy

Disability is the most evident and measurable effect of stroke. Many studies have assessed disability after stroke [1, 2]. From the patients point of view, deterioration of healthrelated quality of life (QoL) is the most relevant effect of stroke. Usually physicians hypothesise the existence of a strict relationship between patients QoL and their disability: the higher the disability, the more impaired the QoL. Nevertheless, some studies on spina bifida and multiple sclerosis have shown that there is not an easy and linear inverse correlation between disability and QoL [35]. Few published studies have assessed the relationship between conventional disability measurements and QoL measurements in stroke survivor patients [6, 7]. The aims of the study were: (1) to evaluate the relationship between disability and health-related QoL and (2) to determine

I. Aprile et al.: Disability and QoL in stroke patients

41 Disability evaluation To assess disability we used the Barthel Index (BI), Functional Independence Measure (FIM), Modified Rankin Scale (MRS) and Deambulation Index (DI). The BI was developed to assess the change in functional status in individuals with neurologic or musculoskeletal disorders who undergo rehabilitation. The BI measures what an individual can do, providing a measure of ability. The BI assesses 10 activities of daily life, 8 of which can be described as self-care activities (feeding, transfer from chair to bed and back, grooming, toileting, bathing, dressing, bowel continence and bladder continence), and 2 as mobility-related activities (walking or propelling a wheelchair on a level surface 50 yards with or without devices or prostheses, ascending and descending stairs). We used the BI classical form; it is scored on a 3- or 4-point scale, from totally dependent in a given activity to totally independent. An intermediate score is assigned when some help is needed to perform the activity. Items are given arbitrary weightings and item scores are totalled to give a range of scores from 0 (total dependence) to 100 (total independence) [13]. The BI is among the most widely used measurements of functional status, providing great validity, reliability and sensitivity. Because it was the first measurement developed to assess the rehabilitation process, it has been a benchmark with which to judge other measurements. The FIM is the most widely accepted functional assessment measurement in the rehabilitation community. It is a functional assessment scale that evaluates the patients abilities in self-care, sphincter control, mobility, locomotion, communication and social cognition [14]. FIM consists of 18 scales scored from 1 to 7; higher numbers mean greater ability. We used the total score (sum of all the scales) [15]. The MRS is primarily used in patients with stroke [16]; it describes the severity level of stroke according to the degree of resulting disability (observed after symptoms stabilised in the weeks following stroke occurrence). The five Rankin categories are: (1) no significant disability: able to carry out all usual activities of daily living; (2) slight disability: unable to carry out some previous activities but able to look after own affairs without assistance; (3) moderate disability: requiring some help but able to walk without assistance; (4) moderately severe disability: unable to walk or attend to own bodily needs without assistance; (5) severe disability: bedridden, incontinent and requiring constant nursing care and attention. The DI is an adapted form (8-point scale) of the physical therapy portion of the Patient Evaluation Conference System. The 8-point scale is: 0, not assessed; 1, needs maximal assistance from 2 people or an assistive device + 1 person; 2, requires minimal assistance from another person with or without an assistive device; 3, requires supervision and an assistive device; 4, requires supervision for safety, no assistive device needed; 5, independent but cannot walk at a reasonable rate and/or has poor endurance (i.e., 10 m or less with or without an assistive device), difficulty ambulating outdoors; 6, independent with assistive device, no supervision required, person can ambulate indoors and outdoors under different conditions (i.e., ramp, carpet, curb, uneven surface, any season); 7, within normal limits, functionally independent [17].

whether and how demographic and social features of the patient, duration of disease and concomitant diseases influence the disability and QoL of stroke outpatients. We performed this study using several conventional disability measurements as well as a validated patient-oriented measurement of QoL. During the period from January 2002 to December 2003, 68 consecutive outpatients were evaluated.

Materials and methods

This was a prospective study on consecutive stroke survivors, outpatients admitted to the Don Gnocchi Centre for rehabilitation from January 2002 to December 2003. As self-administered questionnaires require normal cognitive function, we performed a screening of the patients through the Mini Mental State Examination (MMSE) [8] in order to exclude those patients who were unable to fill in the questionnaire appropriately. An MMSE score of 24 was the only exclusion criterion for enrolment in the study. All patients were thoroughly informed about the study, and gave their permission.

Personal data and patients history Before examination, we acquired personal data for each patient: name of patient (immediately replaced with an identification code), age, sex, educational level, job, if the patient lived alone or with family, duration of disease and concomitant diseases (diabetes, cardiovascular disease). Moreover in each patient the depression picture was evaluated using the Beck Depression Scale [9].

Health-related quality of life evaluation To assess QoL in our patients we used the Medical Outcome Study 36-item Short Form (SF-36), the most widely used generic health tool [10]. The Official SF-36 Italian version [11] was administered to the patients in agreement with standardised methodologies [12]. SF-36 consists of 36 questions that inquire about the general health status of patients. This questionnaire provides eight specific categories of physical and emotional scores (Physical Function PF, Role Physical RP, Bodily Pain BP, General Health GH, Vitality VT, Social Functioning SF, Role Emotional RE, Mental Health MH), which are summed up in two main scores: Physical Composite Score (PCS) and Mental Composite Score (MCS). A very low PCS indicates severe physical dysfunction, distressful bodily pain, frequent tiredness and unfavourable evaluation of health status. Very low MCS indicates frequent psychological distress, and severe social and role disability due to emotional problems [10].

42 Statistical analysis Statistical analysis was performed using the STAT-SOFT (OK, USA) package. Because ordinal measurement (such as SF-36) was used, non-parametric analysis of the correlation was assessed by Spearmans rank correlation coefficient. Multivariate analysis was used in order to find which variables have a significant influence on the following dependent variables: DI, FIM, BI, Rankin Scale, SF36 scores (PF, RP, BP, GH, VT, SF, RE, MH, PCS, MCS). Age, sex, educational level, duration of disease, if the patient lived alone or with family, concomitant diseases (diabetes or cardiovascular disease) and Beck score were considered independent variables. In this analysis, age of the patient, Beck score and duration of the disease were considered as continuous independent variables. Statistical significance was set at p<0.05.

I. Aprile et al.: Disability and QoL in stroke patients

Results Between January 2002 and December 2003, 75 consecutive stroke survivor outpatients were considered for the study. Five patients were excluded due to low MMSE score (24), and 2 patients refused to participate. A total of 68 patients (52.9% male, 47.1% female; mean duration of disease 4 years, SD 3.3, range: 3.5 months to 11 years) completed the study. Age distribution was normal (mean 66.3, SD 11.7, range 3888, Kolmogorov-Smirnov p<0.10, Lilliefors p<0.01). With regard to the duration of disease, note that our sample was enrolled in an outpatient rehabilitation service and includes post-acute and chronic stroke patients; in our country this kind of patient can undergo a rehabilitation programme in an outpatient service. Table 1 shows the disability and QoL findings for the sample studied. The correlation between the conventional disability measurements used (BI, FIM, MRS and DI) and SF-36 showed interesting results.
Table 1 Disability and QoL findings of the sample Index measurements Disability Barthel Index FIM Modified Rankin Scale Deambulation Index PF (physical function) RP (role physical) BP (bodily pain) GH (general health) VT (vitality) SF (social functioning) RE (role emotional) MH (mental health) PCS (physical composite score) MCS (mental composite score)

With regard to the BI, we observed a close relationship between BI score and PF (p=0.000001, r=0.6, Fig. 1), RE (p=0.000007, r=0.6) and MH (p=0.03, r=0.3). This means that patients with greater disability complained of greater deterioration in their physical performance; similarly, patients with greater disability perceived that they have greater deterioration in their daily activity due to emotional problems, and they complain of lower mental health. The FIM score, similarly to the BI, was related to PF (p=0.0001, r=0.5) and RP (p=0.01, r=0.3): patients with higher disability according to the physicians perspective complained of higher deterioration of physical performance. In the same way, FIM score was mildly related with MH (p=0.04, r=0.3) and RE (p<0.0000001, r=0.7): the greater the disability assessed by physician through FIM score, the more the patient complained of difficulty in daily activity due to emotional problems. Finally, FIM appeared to be related to the main SF-36 mental and physical scores (PCS p=0.01; r=0.3; MCS p=0.02 r=0.3). FIM score is the only disability score related to main score QoL measurements (PCS and MCS). With regard to the disability assessment through MRS, we observed similar relationships: Rankin score was closely related to PF (p=0.000001, r=0.6) and RE (p=0.0005, r=0.5). Like the other disability scores, the Rankin score was also related to MH (p=0.02, r=0.3). In this case, relationships were negative because a higher Rankin score means higher disability. With regard to the specific disability measurement focused on walking ability (DI), we observed again that this disability measurement was related to PF (p=0.0004, r=0.4) and RE (p=0.001, r=0.4). Finally, the very highly positive correlation observed among all conventional disability measurements used in our sample is noteworthy (p<0.0000001).

MeanSD 74.121.6 100.819.9 2.81.1 4.02.3 36.128.3 12.124.4 61.7430.6 41.921.4 47.226.8 56.533.0 25.033.2 57.329.3 34.07.3 42.915.8

QoL

I. Aprile et al.: Disability and QoL in stroke patients

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Physical Functioning (PF)

Barthel Index (BI)

Fig. 1 Correlationship between Barthel Index and Physical Functioning

Influence of patient features on QoL and disability Statistical multiple regression analysis was performed to identify the variables that cause deterioration of QoL and disability. All variables were associated with at least one outcome measure in a statistically significant manner. With regard to the disability (Table 2), age, sex, educational level and the Beck score were associated with almost

all disability measures (older patients with lower educational level and higher depression are associated with higher disability, the women are associated with higher disability than men). Moreover, diabetes was associated with higher disability (measured using BI and Rankin Scale) while a longer duration disease was associated with lower disability (measured using DI). As expected, the patients living alone were associated with a lower disability (measured using FIM).

Table 2 Relationships between disability measurements and analysed factors (statistical results of multiple linear regression) Disability measurements (dependent variable) Deambulation Index Predictive factors (independent variable) Age Sex (ref. men) Educational level Duration of disease Sex (ref. men) Educational level Beck Depression Scale Living alone Age Sex (ref. men) Educational level Diabetes Beck Depression Scale Age Sex (ref. men) Diabetes Beck Depression Scale 0.68 0.50 0.22 0.24 0.54 0.30 0.36 0.28 0.46 0.56 0.36 0.27 0.48 0.62 0.53 0.24 0.51 p

FIM

Barthel Index

Rankin

<0.00001 <0.00001 0.02 0.02 <0.00001 0.005 <0.01 0.03 0.002 <0.000001 0.0003 <0.01 <0.0005 0.0001 <0.000001 0.002 0.0001

*Age: 1-year increment; #Duration of disease: 1-year increment Sex (men=1, women=2), educational level (illiterate=0, elementary school=1, middle school=2, high school=3, university degree=4), living alone (=1) or with family (=2), concomitant diseases, diabetes and cardiovascular disease (=1 or 0 if the disease was present or absent respectively)

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I. Aprile et al.: Disability and QoL in stroke patients

Table 3 Relationships between QoL measurements and analysed factors (statistical results of multiple linear regression) QoL measurements (dependent variable) Physical Composite Score Predictive factors (independent variable) Sex (ref. men) Educational level Living alone Educational level Diabetes Living alone Sex (ref. men) Educational level Diabetes Beck Depression Scale Living alone Sex (ref. men) Sex (ref. men) Duration of disease Diabetes Beck Depression Scale Living alone Age Diabetes Sex (ref. men) Educational level Diabetes Cardiovascular disease Educational level Diabetes Living alone Sex (ref. men) Educational level Diabetes Beck Depression Scale Living alone p

Mental Composite Score

Physical Function

Role Physical Bodily Pain

General Health Vitality

Social Functioning

Mental Health

0.38 0.40 0.60 0.45 0.46 0.46 0.70 0.32 0.23 0.64 0.34 0.35 0.29 0.35 0.44 0.34 0.30 0.46 0.30 0.22 0.27 0.65 0.54 0.53 0.51 0.54 0.25 0.34 0.39 0.33 0.33

0.002 0.001 <0.00003 0.002 <0.001 0.001 <0.00001 <0.03 <0.02 <0.000001 0.003 0.01 0.01 0.01 0.0002 <0.01 <0.03 0.03 0.03 0.02 0.005 <0.000001 <0.0001 <0.000001 <0.000001 <0.00003 0.04 0.01 0.002 <0.01 <0.01

*Age: 1-year increment; #Duration of disease: 1-year increment Sex (men=1, women=2); Educational level (illiterate=0, elementary school=1, middle school=2, high school=3, university degree=4); Living alone (=1) or with family (=2); Concomitant diseases, diabetes and cardiovascular disease (=1 or 0 if the disease was present or absent respectively)

With regard to the QoL (Table 3), the main measure of physical aspect of QoL (PCS) appeared to be deteriorated in patients with lower educational level living with family; moreover men usually had better physical QoL. On the contrary, the main measure of the mental aspect of QoL (MCS) appeared to be deteriorated in patients with higher educational level living alone. With regard to the QoL domains, women presented a higher deterioration of physical function, role physical, vitality and mental health but referred less bodily pain than men. The patients living with family showed a higher social function and mental health but lower physical function and pain tolerance. As expected, patients with higher depression referred lower physical function and mental health but

higher pain tolerance. Diabetes was associated with higher QoL in almost all mental domains but with lower QoL in physical function. Finally, patients with cardiovascular disease presented lower vitality.

Discussion We performed a prospective study on stroke survivor outpatients in which several disability measurements were related to the commonly used generic health tool, SF-36. It is very interesting to note that all general disability measurements used were closely related to some domains of

I. Aprile et al.: Disability and QoL in stroke patients

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QoL. As expected, the disability measurements were related to PF; in fact, this specific SF-36 domain is mainly a disability measurement as perceived by the patient: patients with higher disability according to the physicians perspective (FIM, BI, Modified Rankin Scale and DI) complained of higher deterioration of physical performance (PF). Unexpectedly, another QoL domain, Role Emotional, which measures difficulty in daily activity due to emotional problems, was always related to general disability scores. This particular relationship may mean that patients with higher disability from the physicians point of view perceive themselves as unable to carry out various daily activities not only because of physical problems but also because of emotional problems. Moreover, another mental domain, Mental Health, was always related to general disability measurements, although less significantly than for PF and RE: patients with higher disability according to the physicians perspective complained of higher deterioration of mental health. The constancy of these correlations underlines the important role of the Physical Function, Role Emotional and Mental Health SF-36 domains in assessing QoL in patients after stroke. With regard to Physical Function, a low score on this item indicates limitations in performing all physical activities, including bathing and dressing; a low Role Emotional subscore indicates problems with work or other daily activities as a result of emotional problems; and a low Mental Health subscore indicates continuous feelings of nervousness and depression. Although the results of the different disability measurements appeared to be uniformly related to QoL domains, it must be noted that FIM was the only measurement related to a thorough QoL measurement; in fact, FIM was the only general disability measurement related to the main QoL scores, i.e., PCS and MCS. DI was closely related, like the general disability measurements used, to PF and RE; however, it was not related to MH. This last result may suggest that deambulation is not so important for the mental aspect of the QoL. The relationship observed between deambulation and QoL is interesting, but the current results must be assessed more extensively in focused studies. It must be noted that we observed a similar finding in spina bifida patients where walking ability was not strictly related to the mental aspect of QoL [5]. As expected, all disability measurements gave very similar results, which again prove their high reliability. With regard to the role of patient features on disability, the study showed that older patients with lower educational level, higher depression and living with family presented higher disability. With regard to the influence of variables on QoL, physical aspects appeared to be deteriorated in patients with lower educational level living with family while the mental aspects appeared to be deteriorated in patients with higher educational level living alone. One hypothesis is that the

patients living alone adapt and better exploit their remaining physical ability out of necessity, but they have a deterioration of social function and perceive themselves to have low mental health. More likely, the other hypothesis, is that patients with lower disability are able to live alone although they do not have possibilities for social activity. An association between depression and QoL has been reported [1820]. Our data confirm this observations and show that depression is a negative predictive factor on disability and QoL many years after stroke. Women presented a higher disability and deterioration of physical function, role physical, vitality and mental health but lower bodily pain than men. Diabetes was associated with higher disability but the QoL evaluation showed that the diabetic patients even if they have a lower QoL in the physical aspects, presented higher QoL in almost all mental domains. Finally, patients with a long duration of disease are better at walking and tolerating bodily pain. The explanation of this result could be that patients with a long duration of disease are the ones who had a better evolution of disease. In conclusion, the current study provides interesting data about the relationship, not always expected, between disability and QoL in stroke patients. In particular, some domains of the most used QoL measurement, SF-36, which assesses physical and mental limitation in daily activities, were closely related to all of the disability measurements used. Moreover, the current study provides useful information about the significance of disability measurements as the primary outcome in stroke trials and the influence of patient features on disability and QoL. Considering the negative and stronger influence of depression on disability and QoL, our data suggest the need for follow-up programmes to include assessment and interventions to treat depression. Further multidimensional studies including a complete screening for depression should be performed in order to assess the role of deambulation in the QoL, the usefulness of depression assessment and treatment on disability and QoL. Results from these studies may be relevant for the rehabilitation approach and, particularly, for targeting the main goals of rehabilitation, which should take into account not only disability assessment, but also QoL, which is more relevant for the patient.

Sommario Questo studio si propone di valutare la correlazione tra disabilit e qualit della vita (QoL) e linfluenza delle caratteristiche del paziente sulla disabilit e sulla QoL in pazienti affetti da stroke afferenti al Centro di Riabilitazione della Fondazione Don Gnocchi. Si tratta di uno studio prospettico in cui abbiamo utilizzato misure validate di disabilit (Barthel Index, Functional Independence Measure, Modified Rankin Scale and Deambulation Index) e di QoL (SF-36).

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I. Aprile et al.: Disability and QoL in stroke patients MS. Impact of quality of life. Neurology 57:18701875 5. Benito-Leon J, Morales JM, Rivera Navarro J (2002) Healthrelated quality of life and its relationship to cognitive and emotional functioning in multiple sclerosis patients. Eur J Neurol 9:497502 6. Suenkeler IN, Nowak M, Misselwitz B et al (2002) Timecourse of health-related quality of life as determined 3, 6 and 12 months after stroke. Relationship to neurological deficit, disability and depression. J Neurol 249:11601167 7. Weimar C, Kurth T, Kraywinkel K et al (2002) Assessment of functioning and disability after ischemic stroke. Stroke 33:20532059 8. Folstein MF, Folstein SE, McHugh PR (1975) Mini-mental state. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12:189198 9. Beck AT, Ward CH, Mendelson M et al (1961) An inventory for measuring depression. Arch Gen Psychiatry 4:561571 10. Ware JE, Sherborn CD (1992) The MOS 36-item short form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30:473483 11. Apolone G, Mosconi P, Ware JE (1997) Questionario sullo stato di salute SF-36. Guerini e associati, Milan 12. Ware JE (1994) SF-36 Physical and Mental Health Summary Scales: a users manual. New England Medical Centre, Boston 13. Mahoney FI, Barthel DW (1965) Functional evaluation: The Barthel Index. Md State Med J 14:6165 14. Cohen ME, Marino RJ (2000) The tools of disability outcomes research functional status measures. Arch Phys Med Rehabil 81[Suppl]:2129 15. Guide for the Uniform Data Set for Medical Rehabilitation (Adult FIM) (1993) State University of New York at Buffalo, Buffalo, NY 16. van Swieten JC, Koudstaal PJ, Visser MC et al (1988) Interobserver agreement for the assessment of handicap in stroke patients. Stroke 19:604607 17. Korner-Bitensky N, Mayo N, Cabot R, Becker R, Coopersmith H (1989) Motor and functional recovery after stroke: accuracy of physical therapists predictions. Arch Phys Med Rehab 70:9599 18. King RB (1996) Quality of life after stroke. Stroke 27:14671472 19. Kim P, Warren S, Madill H, Hadley M (1999) Quality of life of stroke survivors. Qual Life Res 8:293301 20. Jnsson AC, Lindgren I, Hallstrm B et al (2005) Determinants of quality of life in stroke survivors and their informal caregivers. Stroke 36:803808

Sessantotto pazienti ambulatoriali sono stati valutati consecutivamente. Come ci aspettavamo, tutte le misura di disabilit sono risultate correlate alla funzione fisica (physical function PF): in altre parole i pazienti con grave disabilit presentano, anche per quanto riguarda la prospettiva del paziente, una maggiore compromissione degli aspetti fisici della loro qualit della vita. I nostri dati mostrano anche che i pazienti con grave disabilit lamentano anche una incapacit nelleseguire le attivit di tutti i giorni a causa non solo di problemi fisici ma anche emotivi ed emozionali e lamentano un deterioramento della loro salute mentale. Inoltre lanalisi multivariata ha mostrato che pazienti pi anziani, con pi bassa scolarit, con maggiore depressione e che vivono con i familiari presentano una maggiore disabilit. interessante notare riguardo alla valutazione della Qol che pazienti con pi elevata scolarit e che vivono da soli mostrano un minore coinvolgimento degli aspetti fisici della QoL ma una maggiore compromissione degli aspetti emotivi della QoL. Questo studio mostra interessanti risultati circa la relazione tra disabilit e qualit della vita e linfluenza delle caratteristiche del paziente sulla disabilit e sulla QoL nei pazienti affetti da stroke, risultati che dovrebbero essere considerati nel programma riabilitativo in cui attenzione deve essere posta al riduzione del grado di disabilit ma anche, a ci che ancora pi importante per il paziente, al miglioramento della qualit della vita.

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