This study describes the development of a new questionnaire to measure health-related quality of life (HRQoL) in patients with type 1 diabetes (the ViDa1 questionnaire) and provides information on its psychometric properties. For its development, open interviews with patients took place and topics relevant to patients' HRQoL were identified and items were generated. Qualitative analysis of items, expert review, and refinement of the questionnaire followed. A pilot study (N = 150) was conducted to explore the underlying structure of the 40-item ViDa1 questionnaire. A Principal Component Analysis (PCA) was performed and six of the items that did not load on any of the factors were eliminated. The results supported a four-dimensional structure for ViDa1, the dimensions being Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease. Subsequently, the PCA was repeated in a larger sample (N = 578) with the reduced 34-item version of the questionnaire, and a Confirmatory Factor Analysis (CFA) was performed (N = 428). Overall fit indices obtained presented adequate values which supported the four-factor model initially proposed [(χ(df=554)2= 2601.93) (p < 0.001); Root Mean Square Error of Approximation = 0.060 (CI = 0.056 −0.064)]. As regards reliability, the four dimensions of the ViDa1 demonstrated good internal consistency, with Cronbach's alphas ranging between 0.71 and 0.86. Evidence of convergent-discriminant validity in the form of high correlations with another specific HRQoL questionnaire for diabetes and low correlations with other constructs such as self-efficacy, anxiety, and depression were presented. The ViDa1 also discriminated between different aspects of clinical interest such as type of insulin treatment, presence of chronic complications, and glycemic control, temporal stability, and sensitivity to change after an intervention. In conclusion, the ViDa1 questionnaire presents adequate psychometric properties and may represent a good alternative for the evaluation of HRQoL in type 1 diabetes.

BackgroundThe Health Assessment Questionnaire (HAQ) is an instrument administered to patients to self-report functional status originally in rheumatoid arthritis (RA). In Argentina, it has been translated and validated for RA in 2004. For diffuse SSc, HAQ has been associated to morbidity and mortality.ObjectivesTo adapt S-HAQ into Spanish and to assess its validity in SSc patients in Argentina.MethodsS-HAQ was translated following a forward-backward translation procedure of the original English version, and transcultural adaptation was performed by a comprehension test reaching the final Spanish version. SSc patients that fulfilled ACR 80 criteria and early Systemic Sclerosis according to Le Roy and Medsger criteria were included. Patients with overlap were excluded. Cronbach's alpha and item-item item-total correlations were used to assess internal consistency. Construction validity was analyzed through factor analysis with Varimax rotation. Continuous variables were compared by t-test, Mann-Whitney or Kruskal-Wallis test, and categorical variables by chi-square or Fisher's test. A value of p<0.05 was considered significant.Resultsl9An adapted Argentine-Spanish version of S-HAQ was developed. One hundred patients were surveyed; 84% were female, mean age 54±12.8 years and disease duration 8.8±9.1 years. Limited SSc was more frequent (63%), followed by diffuse SSc (36%). Serologically, 89% were ANA positive, 27% had anti Scl 70 and 41% had anti centromere antibodies. Median Rodnan score (mRSS) was 9.8 (0–40.5) and median activity measured by EUSTAR was 1.25 (0–6). Median S-HAQ was 0.62 (0–2.5), Cronbach's alpha 0.89, and when removing questions one by one the coefficient decreased. Median VAS (visual analogue scale) was 0.57 (0–2.8). Factor analysis identified two factors for the S-HAQ: factor 1: dressing (0.61), arising (0.68), reach (0.63), and personal hygiene (0.70); factor 2: eating (0.68), grip (0.72), walking (0.49), usual activities (0.62). For questions, three factors were identified through VAS: factor 1: overall disease severity (0.63) and gastro-intestinal symptoms (0.57); factor 2: Raynaud's (0.66), digital ulcers (0.56); factor 3: respiratory symptoms (0.43). There was a statistically significant association between higher values of S-HAQ and higher values of mRSS (1.1±0.74 vs. 0.64±0.5 p=0.002) and also with seropositivity for anti-Scl 70 (p=0.003). Higher values of total VAS were associated to female gender (0.75±0.5 vs. 0.49±0.71, p=0.01). There was a significant association between S-HAQ and MEDSGER (p=0.04) and EUSTAR (p=0.03) scores; likewise, between VAS and MEDSGER (p=0.00) and EUSTAR (p=0.00) scores.ConclusionsA Spanish version of S-HAQ was developed, showing an acceptable reliability and validity.Disclosure of InterestNone declared

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