Predictors of quality of life among patients with multiple sclerosis: An Italian cross-sectional study
Introduction
The consensus definition for quality of life (QoL) is that it is a multidimensional concept that detects at least four health-related domains: physical, social, psychological/emotional functions, and physical/emotional role [1].
The impact of multiple sclerosis (MS) on QoL is usually quite dramatic. Rudick et al. reported that the somatic symptoms of MS affect family life, economic condition and social interaction. Furthermore, patients with MS have the lowest QoL compared with, for example, those affected by inflammatory bowel disease or rheumatoid arthritis [2].
There are two different models for the assessment of QoL: the generic and the disease-specific models [3]. The generic models assess universal health dimensions thought to be important for both the disease and its therapy; the Medical Outcome Study (MOS), 36-item, short-form health survey questionnaire (SF-36) is a widely used generic measure of health status [4], [5], [6]. In contrast, the disease-specific models evaluate factors thought to be relevant to a specific disease. A disease-specific measure for MS, the 54-item, 12-scale, Multiple Sclerosis Quality of Life (MSQoL-54) instrument, was developed in 1995 [7]. This has been adapted from the SF-36 measure by the addition of five unchanged SF-36 scales, three altered SF-36 scales (one item added to each scale), and five new scales incorporating 15 additional items [8]. However, modifying existing measures by simply adding MS-specific, clinically chosen items was not found to be as useful as anticipated in improving the measurement properties of the SF-36 questionnaire. Therefore, both the generic and the disease-specific measures are necessary to investigate the QoL of patients with MS [6].
Another QoL measure that has been available for patients with MS since 1996 is the Functional Assessment of Multiple Sclerosis (FAMS) [9]. FAMS is a disease-specific, self-report questionnaire that demonstrates good psychometric properties. It was validated initially in both a mail survey cohort (n = 377, 74% completing) and a clinical cohort (n = 56, 100% completing) [9]. Internal consistency, test-retest reliability, and content, concurrent and construct validity were all demonstrated in both cohorts.
The aims of this study were to evaluate the psychometric properties of the FAMS questionnaire for Italian-speaking patients with MS and to compare these results with those from the original FAMS validation survey.
Section snippets
Study design
The design of this study was cross-sectional. On the basis of a pre-scheduled visit, all patients presenting with MS during a pre-defined, 6-month time window were included. Eighteen centers in Italy participated in the study: six located in the north, seven located in the center, and five located in the south of Italy; 14 centers were public hospitals and four were university hospitals.
Patients with unconfirmed MS were excluded according to the diagnostic criteria proposed by McDonald et al.
Results
The demographic and socioeconomic features of the study cohort according to disease course are shown in Table 1. Patients with progressive forms of MS were older than those patients with benign MS or RRMS (p < 0.001 for both). There were also significant differences in the levels of education between groups (p = 0.012); patients with benign MS and RRMS obtained higher levels of education than patients with either PPMS or SPMS. No significant differences were found in the other demographic features
Discussion
FAMS is a QoL instrument for use with people affected by MS. As shown in Table 3, the Italian cohort provided evidence for internal consistency and test-retest reliability.
Cronbach's α value was about 0.80 in all subgroups tested (see Table 5), except when the cohort was stratified according to depression. In this case, Cronbach's α values were marginally below 0.8, especially in the FAMS subscale of General Contentment, and among patients with moderate-to-severe depression.
Significant
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FAMS study group: Bartalini Sabina (Dipartimento di Neuroscienze, Policlinico Le Scotte, Siena), Bellantonio Paolo (Istituto Mediterraneo di Neuroscienze, NEUROMED, Divisione di Neurologia, Pozzilli, Isernia), Brescia Morra Vincenzo (Università Federico II, Clinica Neurologica, Napoli), Costantino Gianfranco (Ospedale Riuniti di Foggia, Divisione di Neurologia, Foggia), Enrico Millefiorini (Policlinico Umberto I, Roma), Fiè Alessandro (Ospedale Regionale di Torrette, Divisione di Neurologia, Ancona), Florio Ciro (Azienda Ospedaliera Cardarelli, Divisione di Neurologia, Napoli), Gasperini Claudio (Ospedale San Camillo, Divisione di Neurologia, Roma), Lombardi Emilio (Ospedale Civile di Caserta, Divisione di Neurologia, Caserta), Lucci Bruno (Ospedale Civile Santa Maria degli Angeli, Divisione di Neurologia, Pordenone), Moretto Giuseppe (Ospedale Borgo Trento, Divisione di Neurologia, Verona), Morino Ugo (Ospedale Martini, Divisione di Neurologia, Torino), Motti Luisa (Arcispedale Santa Maria Nuova, Divisione di Neurologia, Reggio Emilia), Pasinato Enrico (Ospedale Civile, Divisione di Neurologia, Bassano del Grappa, Vicenza), Pucci Eugenio (Ospedale di Macerata, UO di Neurologia, Macerata), Reggio Ester (Policlinico Universitario, Clinica Neurologica, Catania), Sgolastra Monica (Ospedale Regionale di Torrette, Divisione di Neurologia, Ancona), Vivo Pasquale (Azienda Ospedaliera Cardarelli, Divisione di Neurologia, Napoli), Zorzon Marino (Ospedale di Cattinara, Università di Trieste, Clinica Neurologica, Trieste).