Neurological Sciences Volume 27 Issue 1 2006 [Doi 10.1007_s10072-006-0563-5] I. Aprile; D. B....

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    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 out-

    patients. 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 mea-

    surements were related to Physical Function: patients with

    higher disability, according to the physicians perspective,complained of higher deterioration of physical perfor-

    mance. 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 asso-

    ciated with higher age, depression and lower educational

    level. Physical Composite Score appeared to be deteriorat-

    ed 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 dis-

    ability 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, whichis more relevant for the patient.

    Key words Outcome assessment Quality of Life

    Rehabilitation Disability Stroke

    Introduction

    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 health-related 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 disabili-

    ty: 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

    Neurol Sci (2006) 27:4046

    DOI 10.1007/s10072-006-0563-5

    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

    O R I G I N A L

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

    I. Aprile ()Department of Physical Therapy and Rehabilitation

    L.go F. Vito 1, I-00168 Rome, Italy

    e-mail: [email protected]

    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

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    I. Aprile et al.: Disability and QoL in stroke patients 41

    whether and how demographic and social features of the

    patient, duration of disease and concomitant diseases influ-

    ence the disability and QoL of stroke outpatients.

    We performed this study using several conventional

    disability measurements as well as a validated patient-ori-

    ented measurement of QoL. During the period fromJanuary 2002 to December 2003, 68 consecutive outpa-

    tients 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 excludethose patients who were unable to fill in the questionnaire appro-

    priately. An MMSE score of 24 was the only exclusion criterionfor 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 (dia-betes, cardiovascular disease).

    Moreover in each patient the depression picture was evaluat-

    ed 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 gener-

    ic 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 spe-

    cific 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 phys-

    ical dysfunction, distressful bodily pain, frequent tiredness and

    unfavourable evaluation of health status. Very low MCS indicates

    frequent psychological distress, and severe social and role dis-

    ability due to emotional problems [10].

    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 sta-

    tus in individuals with neurologic or musculoskeletal disorderswho 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, groom-

    ing, toileting, bathing, dressing, bowel continence and bladder

    continence), and 2 as mobility-related activities (walking or pro-

    pelling 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, pro-

    viding 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 mea-

    surements.

    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]; itdescribes 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 dis-

    ability: 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 assis-

    tance from 2 people or an assistive device + 1 person; 2,

    requires minimal assistance from another person with or with-

    out 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 nor-

    mal limits, functionally independent [17].

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

    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 dis-

    eases (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 atp

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    I. Aprile et al.: Disability and QoL in stroke patients 43

    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, educa-tional level and the Beck score were associated with almost

    all disability measures (older patients with lower education-

    al level and higher depression are associated with higher dis-

    ability, the women are associated with higher disability than

    men). Moreover, diabetes was associated with higher dis-

    ability (measured using BI and Rankin Scale) while a longer

    duration disease was associated with lower disability (mea-

    sured using DI). As expected, the patients living alone wereassociated with a lower disability (measured using FIM).

    Fig. 1 Correlationship between

    Barthel Index and Physical

    Functioning

    Table 2 Relationships between disability measurements and analysed factors (statistical results of multiple linear regression)

    Disability measurements Predictive factors p(dependent variable) (independent variable)

    Deambulation Index Age 0.68

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

    With regard to the QoL (Table 3), the main measure of

    physical aspect of QoL (PCS) appeared to be deterioratedin 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 depres-

    sion 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 inphysical function. Finally, patients with cardiovascular dis-

    ease presented lower vitality.

    Discussion

    We performed a prospective study on stroke survivor out-

    patients 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

    Table 3 Relationships between QoL measurements and analysed factors (statistical results of multiple linear regression)

    QoL measurements Predictive factors p(dependent variable) (independent variable)

    Physical Composite Score Sex (ref. men) 0.38 0.002

    Educational level 0.40 0.001

    Living alone 0.60

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    QoL. As expected, the disability measurements were related

    to PF; in fact, this specific SF-36 domain is mainly a dis-

    ability measurement as perceived by the patient: patients

    with higher disability according to the physicians perspec-

    tive (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 emotion-

    al problems, was always related to general disability scores.

    This particular relationship may mean that patients with

    higher disability from the physicians point of view per-

    ceive themselves as unable to carry out various daily activ-

    ities 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 perspec-

    tive 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 measure-

    ments appeared to be uniformly related to QoL domains, itmust 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 mea-

    surements 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 relation-

    ship 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 wasnot strictly related to the mental aspect of QoL [5].

    As expected, all disability measurements gave very sim-

    ilar 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 education-

    al level, higher depression and living with family presented

    higher disability.

    With regard to the influence of variables on QoL, phys-

    ical 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

    I. Aprile et al.: Disability and QoL in stroke patients 45

    patients living alone adapt and better exploit their remain-

    ing physical ability out of necessity, but they have a deteri-

    oration 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 dis-

    ability 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 disabil-

    ity 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 close-

    ly 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 thenegative and stronger influence of depression on disability

    and QoL, our data suggest the need for follow-up pro-

    grammes 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 correlazio-ne tra disabilit e qualit della vita (QoL) e linfluenza dellecaratteristiche del paziente sulla disabilit e sulla QoL inpazienti affetti da stroke afferenti al Centro di Riabilitazionedella Fondazione Don Gnocchi. Si tratta di uno studio pro-spettico in cui abbiamo utilizzato misure validate di disabilit(Barthel Index, Functional Independence Measure, ModifiedRankin Scale and Deambulation Index) e di QoL (SF-36).

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

    Sessantotto pazienti ambulatoriali sono stati valutati consecu-tivamente. Come ci aspettavamo, tutte le misura di disabilitsono risultate correlate alla funzione fisica (physical function PF): in altre parole i pazienti con grave disabilit presenta-no, anche per quanto riguarda la prospettiva del paziente, una

    maggiore compromissione degli aspetti fisici della loro qualitdella vita. I nostri dati mostrano anche che i pazienti congrave disabilit lamentano anche una incapacit nellesegui-re le attivit di tutti i giorni a causa non solo di problemi fisi-ci ma anche emotivi ed emozionali e lamentano un deteriora-mento della loro salute mentale. Inoltre lanalisi multivariataha mostrato che pazienti pi anziani, con pi bassa scolarit,con maggiore depressione e che vivono con i familiari presen-tano una maggiore disabilit. interessante notare riguardoalla valutazione della Qol che pazienti con pi elevata scola-rit e che vivono da soli mostrano un minore coinvolgimentodegli aspetti fisici della QoL ma una maggiore compromissio-

    ne degli aspetti emotivi della QoL. Questo studio mostra inte-ressanti risultati circa la relazione tra disabilit e qualit dellavita e linfluenza delle caratteristiche del paziente sulla disa-bilit e sulla QoL nei pazienti affetti da stroke, risultati chedovrebbero essere considerati nel programma riabilitativo incui attenzione deve essere posta al riduzione del grado di disa-bilit ma anche, a ci che ancora pi importante per ilpaziente, al miglioramento della qualit della vita.

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