EUR J PHYS REHABIL MED 10;6:73-80 Functional living skills assessment: a standardized measure of high-order activities of daily living in patients with dementia Aim. Performance measures are tools aimed to directly evaluate social function in older adults. The authors present the standardization of a new direct performance measure for patients with dementia, the functional living skills assessment (FLSA). Methods. FLSA was conceived to detect functional impairment in very mild to moderate patients and to pick up functional modification due to intervention. The patient is asked to perform an activity, and the performance is scored according to completeness and level of assistance required. Eight areas of interest are evaluated (Resources, Consumer Skills, Public Transportation, Time Management, Money management, Leisure, Telephone Skills, Self-Care and Health). Subjects included 5 patients with dementia and 36 normal controls. Results. Total and partial FLSA scores significantly differed for the two groups (P<0.0001). Performance on FLSA could divide clinical dementia rating (CDR) 0 from CDR 1, CDR 2 e CDR 3 groups. Both sensitivity and specificity were 9%; inter-rater and test-retest reliability was good (P>0.9). Correction scores for education were calculated, while age influence was only marginally significant. Mini Mental State Examination (MMSE) and CDR highly influenced FLSA score (P< 0.0001); FLSA was highly correlated with another performance measure (the Direct Assessment of Functional Status; P=0.821), and with the Instrumental Activity of Daily Living (IADL) E. FARINA 1, R. FIORAVANTI 1, R. PIGNATTI 2, M. ALBERONI 1, F. MANTOVANI, 1 G. MANZONI 2, L. CHIAVARI 1, E. IMBORNONE 1, F. VILLANELLI 1, R. NEMNI 1 It is possible to receive the material needed to perform the FLSA by writing to the first author. In our center it is also possible to perform a brief practical training on the scoring method. Received on August 1, 08. Accepted for publication on November 2, 09. Epub ahead of print on February 5, 10. Corresponding author: E. Farina, Neurorehabilitation Unit, IRCCS Don Gnocchi Foundation, University of Milan, via Capecelatro 66 18, Milan, Italy. E-mail: efarina@dongnocchi.it. 1 Neurorehabilitation Unit IRCCS Don Gnocchi Foundation University of Milan, Milan, Italy 2Unit of Psychology, Istituto Auxologico di Piancavallo, Piancavallo (VB),Italy, scale (P=-0.612), while no significant correlation was present with the Geriatric Depression Scale. Conclusion. FLSA evidences construct, concurrent and discriminative validity. We suggest that this tool could be possibly useful when a high sensibility to different levels of functional impairment is needed, as evaluation of treatment efficacy (both non-pharmacological and pharmacological) identification of relatively intact functional areas to plan cognitive rehabilitation, and confirmation of dementia in the initial phase when there are doubts about functional decline. KEY WORDS: Task Performance and Analysis - Activities of daily living - Dementia - Rehabilitation - Alzheimer disease. L oss of functioning in complex tasks of everyday life is a hallmark feature of dementing illness: in fact, current clinical diagnostic criteria for dementia 1, 2 require documentation of cognitive decline as well as loss of competence in either social or occupational domains. On the other hand, in the last years, some randomized controlled trials and single case-studies 3-7 have suggested the efficacy of rehabilitation and cognitive stimulation interventions in order to improve cognitive status and quality of life in people affected by dementia. Therefore, assessment of function should be included not only as a part of diagnostic evaluation in dementia, but it would be also essential to evalu- Vol. 6 - No. 1 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 73
FARINA FUNCTIONAL LIVING SKILLS ASSESSMENT ate efficacy in the rehabilitation setting. 8, 9 However, information learnt from functional assessment may vary considerably according to the source of data. The use of informant reports is appealing, because it can allow comprehensive and longitudinal evaluations, but it has potential disadvantages: the source of information is filtered through an observer, and it may contain distortions based on the personal needs and opinions of the informant. 10 The growing recognition of the need for an objective and direct measure of social function in older adults has led to the development of an alternative approach: performance measures are tools in which an individual is asked to perform or simulate an activity and is evaluated in a formal manner on that performance with standardized criteria. They have been used in medical rehabilitation for diagnosis and to demonstrate therapeutic progress, and have shown to predict survival, hospitalization, use of assistance, long-term-care, and nursing home placement. 11-16 Performance measures allow to take into account a large variability of the ability to perform a task, thus increasing the sensitivity of the tool. 17 Other claimed advantages are good patient s acceptability, and good inter-rater reliability. 1, 18- In the last years, some performance measures of everyday functioning have been proposed to assess patients with dementia, but, to our knowledge, only a few have been adapted and standardized at least in our country. 21, 22 An example is the Direct Assessment of Functional Status (DAFS), 18-22 which represents an interesting tool, but it explores only four IADL skills and does not define the degree of dependence of the patient. One can, therefore, wonder whether it is sensitive enough to mild level of functional impairment, and to moderate improvement induced by drugs or non-pharmacological treatments. We present the Italian standardization of a new performance measure for patients with dementia, the Functional Living Skills Assessment (FLSA). This tool was conceived in order to detect functional impairment in the type of population that is usually seen in outpatient services, that is patients ranging from very mild (Clinical Dementia Rating, CDR 0.5) 23 to moderate level of dementia (CDR 2): therefore, it targets high-order social abilities in everyday-life, and IADL. It was also hypothesized that FLSA could be potentially useful in longitudinal assessment (to monitor progression of functional impairment or change following treatment). TABLE I. Demographical values from patients and controls. Subjects Materials and methods Subjects included 5 patients with dementia and 36 healthy age and education matched normal controls, who gave their consent to perform the test. The protocol was approved by the local Ethic Committee. T- tests (and χ 2 tests when appropriate) were employed to compare demographic data between patients and controls. T-tests and χ 2 analyses yielded no significant difference in demographic aspects between patients with dementia and control subjects (Table I). The patients were consecutively recruited from the outpatient Service for Cognitive Disorders of the Don Carlo Gnocchi Foundation in Milan. Diagnoses were based on currently accepted criteria. 2, 2-26 Forty-six patients had probable or possible Alzheimer s disease (AD), five had vascular dementia (VaD), and three had other types of dementing disorders (frontotemporal dementia: two subjects; Parkinson dementia : one subject). Patients were stratified according to the CDR 23. None of the patients refused the administration of the task. Control subjects were recruited from the same geographical area as the patients. A cut-off of 25 based on the MMSE score was applied and control subjects were, therefore, included in the study. Instrument development Patients Controls Sample size 5 36 Age (years; mean±sd, range) 73.28±6.28, 57-83 71.72±5.93, 61-88 Education (years; mean±sd, range) 8.56±.06, 3-18 9.89±3.72, 5-18 Gender (M/F) 22/32 1/22 MMSE (mean±sd, range) 19.63±5.01, 9-28 28.33±1.01, 26-30 MMSE: Mini Mental Examination State. The FLSA has been developed as a shorter version of a parent measure used at the Boston Braintree Rehabilitation Hospital to evaluate functioning in the community of patients with previous head trauma. The original measure (comprising 8 areas of interest and 1 items) was translated and adapted for Italian head trauma patients; we then realized that a similar tool could be useful for our patients affected by 7 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE March 10
FUNCTIONAL LIVING SKILLS ASSESSMENT FARINA TABLE II. Functional living skills assessment (FLSA), range for FLSA total score and each subscale. Area Tasks Min Max Resources Consumer skills Public transportation Time management Money management Leisure Telephone skills Self-care and Health Total FLSA: Functional living skills assessment. Identifying town utilities Remembering emergency telephone numbers Listing city public transports Selecting TV programs Food categorization Filling a check Comparing prices Consulting a train time-table Consulting a city map Selecting city transports for a given way Leisure scheduling Filling a daily diary Filling a monthly diary Managing a rendezvous planning Profit calculation Consulting a restaurant menu Food price appraising Doing a payment by mail Identifying leisure resources Providing procedure for theatre subscription Calling a restaurant Consulting telephone directories Number dialing Consulting yellow pages Understanding a recipe Identifying health resources dementia. A team composed of neurologists, psychologists, and physical therapists with expertise in assessment, treatment, and rehabilitation of dementia was formed to this aim. The expert team first excluded items which were not adequate to the culture or the age of our patients such as locating a shop in a shopping centre and to calculate the ticket price to get a train by a family with children. The tool was then administered to a pilot group of ten normal elderly and ten patients with dementia. The pilot study was conducted in the same setting and by the same people than the final study. Thanks to this pilot study, we realised that the instrument was still taking too much time to be used with patients affected by dementia: we, therefore, decided to delete some items exploring similar abilities in the original tool because of redundancy (e.g., providing procedure for theatre subscription and providing procedure to book a train ticket ), and to select the remaining items according to their relevance for ambulatory patients with dementia, and their familiarity to the large majority of elderly people. Other criteria that were taken into consideration for the item selection were practicality of implementing the task in the laboratory setting (ease of setting up individual task, and time for each task), acceptability for patients, and gradation of task difficulty (we deleted some items due to ceiling effect). All the original eight areas of interest (Resources, Consumer Skills, Public Transportation, Time Management, Money Management, Leisure, Telephone Skills, Self-Care and Health) were maintained because our task force considered that they were all fully relevant to assess the independence of patients in every day life. 3 2 2 27 15 10 10 135 Vol. 6 - No. 1 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 75
FARINA FUNCTIONAL LIVING SKILLS ASSESSMENT According to selection criteria, for each area a minimum of two, and a maximum of four items were identified, giving a total of 27 (Table II). After identification, functional behaviors were quantified and refined through extensive pilot work with cognitively impaired patients. The selected items explore functional abilities by practical tasks or by verbal simulation. Cognitive functions compromised in dementia that are explored by FLSA tasks include semantic (e.g., remembering emergency telephone numbers and identifying health resources) and on-going memory (almost all tasks), executive functions (e.g., managing rendez-vous planning, consulting yellow pages and telephone directories), verbal comprehension (almost all tasks - patient must understand complex verbal instructions) and production (e.g., calling a restaurant, submitting the procedure for subscription theatre), written comprehension (e.g., understanding a recipe) and writing (e.g., writing on a daily diary, writing a cheque), calculation (e.g., consulting a restaurant menu, profit calculation), and visuospatial functions (e.g., consulting a city map, selecting city transports for a given way). The FLSA was administered to each patient in a well-lighted comfortable room containing all material needed for testing by a physical therapist or by a psychologist. We standardized material to be used, directions to give to the subject, as well as possible verbal, visual, and physical prompting for each task. An example of verbal prompting is giving a general explanation of the menu structure and an example of bill calculation in the item Consulting a restaurant menu (area Money Management); an example of visual prompting is pointing out the right place where the patient must write the amount of the cheque to be filled (area Consumer Skills). Directions and prompting could be repeated when requested. For each item, the performance score derives from the level of assistance needed by the subject to carry out the task and from the completeness of the task: it ranges from 5 (subject completes the task independently) to 1 (he/she does not perform the task even with assistance): we chose 1 as minimum score following the example of the Functional Independence Measure (FIM). 28 Scores from to 2 represent growing levels of assistance and/or incompleteness of the task despite the prompts. For each domain, the total area score is derived by adding the rating obtained on each item of that area. The minimum score for Resources is, and the maximum ; for Consumer Skills the range is 3-15; for Public Transportation -; for Time Management -; for Money Management -; for Leisure 2-10; for Telephone Skills -; for Self-Care and Health 2-10. The Total FLSA Score (range 27-135) is calculated by adding the area scores. It is possible to obtain a percentage score for each area, and for Total FLSA Score, by using the following formula: (raw score - minimum score) x 100 (maximum score - minimum score). A high percentage corresponds to a better or more independent performance. Study protocol FLSA administration took up about 5 minutes for controls, and about 60 minutes for patients. In order to assess concurrent validity, for all patients with dementia, a different psychologist, blinded to the patient s FLSA score, asked the main caregiver (the patient s spouse when available, or his/her son/daughter) to complete subsequently the Katz ADL scale 29 and the Lawton IADL scale. 30 These additional scales were completed by the caregiver in the meantime the patient was completing the FLSA, in a separate room, in a fixed order. Not all the main caregivers were living with the patient at the moment of scale administration, but all of them were actively involved into the patient s assistance. For a subgroup of 32 patients, affected by probable or possible AD (mean age: 72.9±7.17, mean education: 8.81±3.97, M/F ratio: 0.60), the main caregiver also completed the NOSGER, 31 after ADL and IADL. After completing the FLSA, to the same subgroup of patients was also given the Geriatric Depression Scale (GDS), 32 in order to study a possible correlation between depression and performance at FLSA and then it was also asked to perform the DAFS, 22 again with the aim to assess construct and concurrent validity. Inter-rater reliability was determined by having two raters scored 10 patients with dementia (mean age: 73.80, mean education: 6.30, M/F: ratio 0.67); the two raters (a physical therapist and a psychologist) were present during the same interview, which was conducted by one of the raters. Each rater was blind to the rating chosen by the other, but not to clinical diagnosis. Eight patients (mean age: 76.38, mean education: 5.88, M/F ratio: 0.33), were reassessed by FLSA within the same week of their initial evaluation to determine test-retest reliability. 76 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE March 10
FUNCTIONAL LIVING SKILLS ASSESSMENT FARINA TABLE III. Descriptive statistics on functional living skills assessment (FLSA) total score for the whole group and the separate groups. Percentiles Results We applied Spearman s P correlation in order to evaluate interrater reliability. Spearman s correlation was significant (P=0.995, P<0.0001). Results showed a perfect agreement in 60% of cases, a disagreement of ± 1 in % of cases, and a disagreement between ± 2 and ± 3 in the remaining %. The Kendall W coefficient of concordance between two raters was utilized 33 and showed significant results: W (9)=0.992, χ 2 =17.8632, P=.0368. Test-retest reliability was evaluated via the Spearman s P correlation and showed significant results (P=0.976, P<0.0001). The Kendall W coefficient of concordance between the two testing was marginally significant: W(7)=0.9881, χ 2 =13.8333, P=0.052. Analysis of inter-item reliability revealed a standardized Cronbach s α coefficient of 0.97, with Spearman s P correlations among item ranging from 0.27 and 0.78 (mean 0.57). The standardized Cronbach s α coefficient for intersubscale reliability analysis was 0.97, with Spearman s P correlations among subscales ranging from 0.62 and 0.83 (mean 0.69). We performed a Mann-Whitney non-parametrical analysis on total FLSA score, in order to compare the two groups (patients vs. controls). Results showed high significant results (U=21.00, P<0.0001). The whole N. Mean SD Minimum Maximum 25 th 50 th (Median) 75 th FLSA total score (all subjects) 90 106.3 27.9 39 135 88.25 116.50 131.00 FLSA total score (controls) 36 131.00 3.225 122 135 129.00 132.00 133.00 FLSA total score (patients) 5 90.06 2.921 39 129 72.75 95.00 109.25 FLSA: Functional living skills assessment. TABLE IV. Mann-Whitney non-parametrical analyses on each functional living skills assessment (FLSA) subscale comparing the two groups. Resources Consumer Public Time Money Telephone Self-Care Skills Transportation Management Management Leisure Skills and Health Mann-Whitney U 62.00 223.50 130.00 88.50 57.00 128.00 58.00 96.00 Wilcoxon W 157.00 1708.50 1615.00 1573.50 152.00 1613.00 153.00 1981.00 Z -7.571-6.337-7.016-7.352-7.667-7.056-7.635 -.512 Asymp. Sig. (2-tailed) <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 FLSA: Functional living skills assessment. group and separate groups mean, SD and Quartiles are indicated in Table III. Therefore, we carried out a series of Mann-Whitney non-parametrical analysis on each FLSA subscale comparing the two groups. Results were all highly significant (P<0.0001) (Table IV). Moreover, we performed a Kruskal-Wallis Test with total FLSA score as dependent variable and five CDR groups of subjects as independent variables: CDR groups were composed as follows, according to the subjects CDR scores: four groups of patients (CDR 0.5, CDR 1, CDR 2 and CDR 3) and one group of controls (to whom a CDR value of 0 was assigned). In order to investigate if FLSA total score could operate some distinction inside CDR groups, a multiple comparison among each couple of group was carried out following a different method. 33 The Kruskal-Wallis Test yielded significant results: χ 2 ()=71.896, P<0.0001. After that, ten multiple comparisons among all possible combinations of CDR groups were carried out, showing that performance on FLSA (total score) could divide CDR 0 from CDR 1, CDR 2 e CDR 3 groups and CDR 0,5 from CDR 3; no other significant differences emerged. Spearman s P correlations were also performed on FLSA score and the other measures utilized in the study (CDR, MMSE, Katz ADL, Lawton IADL, NOS- GER total score and its IADL subscale score, DAFS, Vol. 6 - No. 1 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 77
FARINA FUNCTIONAL LIVING SKILLS ASSESSMENT TABLE V. Correlations of the total functional living skills assessment (FLSA) score with other measures. Age -0.2 <0.037 Education -0.329 <0.002 MMSE -0.912 <0.0001 CDR -0.892 <0.0001 Katz ADL (preserved functions) -0.82 <0.0001 Lawton IADL -0.612 <0.0001 NOSGER (total score) -0.007 <0.972 NOSGER (IADL score) -0.28 <0.015 DAFS -0.821 <0.0001 GDS -0.069 <0.619 FLSA: Functional Living Skill Assessment; MMSE: Mini Mental State Examination; CDR: Clinical Dementia Rating; ADL: Activities of Daily Living; IADL: Instrumental Activities of Daily Living; NOSGER: Nurses Observation Scale for Geriatric Patients; DAFS: Direct Assessment of Functional Status; GDS: Geriatric Depression Scale. GDS), including demographic data (age and education). As far as correlation coefficients of the total FLSA score with other evaluation tools are concerned (Table V), they showed high level of significance (P<0.0001) for MMSE, CDR, DAFS, Katz ADL and Lawton IADL, and a lower level (P=0.015) for NOSGER IADL score and education (P=0.002). The correlation between age and total FLSA score was marginally significant (P=0.037). No significant correlation was found between FLSA, GDS and the total NOSGER score. In order to minimize differences due to educational level, we would correct FLSA scores. As we can consider the subjects in the central range of education (8-10 years) as the mean performers, we can obtain corrected scores for education by applying this formula: (Mean scores of other ranges Mean score of central range)/sd of central range. This formula yielded a correction factor of + 0.2 for the lower educated group (0-7 years) and of -0.39 for the higher educated group ( 11 years); corrected scores from the central group (8-10 years) will obviously correspond tout court to raw scores. We suggest a cut-off score of 125 (the last normal score), that is the best fitting score to distinguish between the patient and normal; this score is approximately corresponding to 2 SD under the mean score of normal controls (131-2x3.22 = 12.56). By using this cut-off the sensitivity of the test is 9% (only three patients with a CDR score of 0.5 were missed), and, again, the specificity is 9% (only two false-positive cases). In other words, we can state P P that no patient with dementia obtained a corrected score higher than 128.61, while no normal control scored less than 122.2: the corrected score range between these two values can be considered as borderline. Discussion The objective of the present study was the development of a new instrument for direct assessment of functional status of subjects with dementia in outpatient setting. This tool was developed with a focus on the adequacy and needs of this target population, being conceived to provide an in-depth analysis of discrete high-order functional abilities. Our data indicates that the FLSA has good interrater and sufficient test-retest reliability: in large part this can be considered a consequence of the strict criteria for administration and scoring that were adopted for standardization. The internal consistency item reliability is elevated. In addition, the FLSA evidences construct, concurrent and discriminative validity. In fact, FLSA tasks are be conceived in order to explore the main cognitive domains involved in dementia. Our tool is highly correlated with cognitive impairment measures (MMSE and CDR): this result suggests that is sensitive to declining cognitive abilities. It is also highly correlated with another direct performance measure (the DAFS), and with traditional measures of functioning in IADL and ADL. The lower correlation with the IADL subscale of the NOSGER can be explained when considering the different domains explored and the different procedures of evaluation and scoring. Discriminative validity is indicated by the fact that the performance of patients with dementia is significantly worse than that of controls in all FLSA sub-domains, and that sensitivity and specificity are elevated. Statistics showed highly significant values and let us consider our results as reliable predictors of the whole demented population, even we recognize that a limited number of subjects was involved in the study. Depression self-rating score on the GDS and FLSA score were not significantly correlated, suggesting that depressive features were not a significant factor in patient performance. Direct assessment of daily living skills, as with the FLSA, might provide objective information enhancing the quality of clinical decision-making. Direct 78 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE March 10
FUNCTIONAL LIVING SKILLS ASSESSMENT FARINA observation may allow the examiner to pinpoint specific areas of decline as dementia develops (as well as preserved functional domains), and to discern the nature of the impairment that is hindering performance: this may have implication for caregiving and rehabilitation strategy. Our tool in particular could be further evaluated in order to establish its usefulness to monitor the response of patients with dementia to non-pharmacological and pharmacological treatments: in fact, very recently, a Consensus Statement of the international Psychogeriatric Association underlined the need for including outcome measures evaluating functional and executive capacity in treatment trials. 3 The need of using functional measures to assess efficacy of rehabilitation interventions is well known. In two studies about cognitive rehabilitation in dementia, we found that the FLSA was the most sensitive instrument to detect functional changes in AD patients after performing a cognitive training of a five-week duration. 35, 36 In fact, FLSA assesses a large range of functions, allowing to follow the patient evolution in an analytical manner (but it also provides a total score, that it easy to be calculated and followed serially). On the contrary, the functional areas covered by traditional ADL and IADL scales are limited, and they do not reflect adequately the kind and the amount of help that is needed for cognitively impaired persons to plan and perform an action, a variable that can be modified by treatment. On the other hand, we agree that the potential usefulness of our tool in the rehabilitation setting needs to be confirmed in further studies. On the other hand, direct performance measures, as our own, must not be thought as a replacement for scales and questionnaires based on caregiver report. FLSA might be viewed as an adjunctive measure for all situations in which a high sensibility to different levels of functional impairment is needed: as an example, it could potentially add useful information to confirm the presence of dementia in the initial phase when there are doubts about functional decline or when there is a gap between clinical history and results of traditional neuropsychological tests; it might possibly assist evaluation of treatment efficacy (as already mentioned); another potential use could be the identification of relatively intact functional areas to plan cognitive rehabilitation, particularly when a disagreement is present between clinical evaluation and caregiver report. Some caution points deserve mention: FLSA could show some limitation in term of applicability, if administered out of Italy (particularly, out of Western countries) because of different socio-cultural background. Moreover, some tasks could suffer some temporal bias, due to change of ecological procedures (e.g., old manual procedures could be bypassed by technological ones, as via Internet access). There is also the need to further test the FLSA on larger populations of patients affected by different types of dementia: this work is actually in progress in our center. Conclusions We have developed a new functional measure, based on direct observation of patients with dementia, that we suggest to be potentially useful in diagnostic settings and in planning rehabilitation. References 1. American Psychiatric Association. Diagnostic and Statistical Manual of mental Disorders, fourth edition. Washington, DC: American Psychiatric Association; 199. 2. 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