Focusing on positive outcomes in frailty research: development of a short well-being instrument for older adults (SWIO)

Objective: Studies of frailty have tended to focus on adverse outcomes. This study aims to develop a short instrument that identifies a positive outcome, namely, the level of well-being in older adults at risk of frailty. Method: 871 older adults (49.4% women; mean age 75.72 years; SD = 8.05) with a frailty risk profile participated in the first wave of the D-SCOPE study. The possible domains of well-being were identified using a bottom-up approach. Exploratory Structural Equation Modeling (ESEM) and multidimensional Item Response Theory (IRT) analysis of 17 items in 4 domains measuring well-being was performed on a calibration sample (n = 435) to develop the instrument. The instrument was subsequently corroborated by confirmatory factor analysis and convergent/divergent relations with relevant external measures in a validation sample (n = 436). Results: The ESEM three-factor solution, with the subdimensions of sense of mastery, meaning in life, and life satisfaction, displayed good fit to the data (RMSEA = 0.070). For each dimension, the three best discriminating items were retained for the instrument following IRT analysis. Internal consistency of these dimensions was good in the validation sample (sense of mastery alpha = 0.864, meaning in life alpha = 0.715, and life satisfaction alpha = 0.782). The confirmatory factor analysis (CFA) three-factor model also showed good fit to the data (RMSEA = 0.064). Small to large zero-order correlations with the external measures were as expected. Conclusions: Using a bottom-up approach, this study developed a short instrument to identify levels of well-being in vulnerable or frail older adults. The instrument can be applied in primary care and prevention programs

Focusing on positive outcomes in frailty research: development of a short well-being instrument for older adults (SWIO)

Objective: Studies of frailty have tended to focus on adverse outcomes. This study aims to develop a short instrument that identifies a positive outcome, namely, the level of well-being in older adults at risk of frailty. Method: 871 older adults (49.4% women; mean age 75.72 years; SD = 8.05) with a frailty risk profile participated in the first wave of the D-SCOPE study. The possible domains of well-being were identified using a bottom-up approach. Exploratory Structural Equation Modeling (ESEM) and multidimensional Item Response Theory (IRT) analysis of 17 items in 4 domains measuring well-being was performed on a calibration sample (n = 435) to develop the instrument. The instrument was subsequently corroborated by confirmatory factor analysis and convergent/divergent relations with relevant external measures in a validation sample (n = 436). Results: The ESEM three-factor solution, with the subdimensions of sense of mastery, meaning in life, and life satisfaction, displayed good fit to the data (RMSEA = 0.070). For each dimension, the three best discriminating items were retained for the instrument following IRT analysis. Internal consistency of these dimensions was good in the validation sample (sense of mastery alpha = 0.864, meaning in life alpha = 0.715, and life satisfaction alpha = 0.782). The confirmatory factor analysis (CFA) three-factor model also showed good fit to the data (RMSEA = 0.064). Small to large zero-order correlations with the external measures were as expected. Conclusions: Using a bottom-up approach, this study developed a short instrument to identify levels of well-being in vulnerable or frail older adults. The instrument can be applied in primary care and prevention programs

Concordances and differences between a unidimensional and multidimensional assessment of frailty: a cross-sectional study

Background: Many instruments to identify frail older people have been developed. One of the consequences is that the prevalence rates of frailty vary widely dependent on the instrument selected. The aims of this study were 1) to examine the concordances and differences between a unidimensional and multidimensional assessment of frailty, 2) to assess to what extent the characteristics of a 'frail sample' differ depending on the selected frailty measurement because 'being frail' is used in many studies as an inclusion criterion.Method: A cross-sectional study was conducted among 196 community-dwelling older adults (&gt;= 60 years), which were selected from the census records. Unidimensional frailty was operationalized according to the Fried Phenotype (FP) and multidimensional frailty was measured with the Comprehensive Frailty Assessment Instrument (CFAI). The concordances and differences were examined by prevalence, correlations, observed agreement and Kappa values. Differences between sample characteristics (e.g., age, physical activity, life satisfaction) were investigated with ANOVA and Kruskall-Wallis test.Results: The mean age was 72.74 (SD 8.04) and 48.98% was male. According to the FP 23.59% was not-frail, 56.92% pre-frail and 19.49% frail. According to the CFAI, 44.33% was no-to-low frail, 37.63% was mild frail and 18.04% was high frail. The correlation between FP and the CFAI was r = 0.46 and the observed agreement was 52.85%. The Kappa value was kappa = 0.35 (quadratic kappa = 0.45). In total, 11.92% of the participants were frail according to both measurements, 7.77% was solely frail according to the FP and 6.21% was solely frail according to the CFAI. The 'frail sample respondents' according to the FP had higher levels of life satisfaction and net income, but performed less physical activities in comparison to high frail people according to the CFAI.Conclusion: The present study shows that the FP and CFAI partly measure the same 'frailty-construct', although differences were found for instance in the prevalence of frailty and the composition of the 'frail participants'. Since 'being frail' is an inclusion criterion in many studies, researchers must be aware that the choice of the frailty measurement has an impact on both the estimates of frailty prevalence and the characteristics of the selected sample.</p

‘Minimal symptom expression’ in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab

Background: The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension. Methods: Attainment of ‘minimal symptom expression’ was evaluated using patient-reported outcome measures of gMG symptoms [MG activities of daily living scale (MG-ADL), 15-item MG quality of life questionnaire (MG-QOL15)] at the completion of REGAIN and during the open-label extension. ‘Minimal symptom expression’ was defined as MG-ADL total score of 0–1 or MG-QOL15 total score of 0–3. Results: At REGAIN week 26, more eculizumab-treated patients achieved ‘minimal symptom expression’ versus placebo [MG-ADL: 21.4% vs 1.7%; difference 19.8%; 95% confidence interval (CI) 8.5, 31.0; p = 0.0007; MG-QOL15: 16.1% vs 1.7%; difference 14.4%; 95% CI 4.3, 24.6; p = 0.0069]. During the open-label extension, the proportion of patients in the placebo/eculizumab group who achieved ‘minimal symptom expression’ increased after initiating eculizumab treatment and was sustained through 130 weeks of open-label eculizumab (MG-ADL: 1.7 to 27.8%; MG-QOL15: 1.7 to 19.4%). At extension study week 130, similar proportions of patients in the eculizumab/eculizumab and placebo/eculizumab groups achieved ‘minimal symptom expression’ (MG-ADL: 22.9% and 27.8%, respectively, p = 0.7861; MG-QOL15: 14.3% and 19.4%, respectively, p = 0.7531). The long-term tolerability of eculizumab was consistent with previous reports. Conclusions: Patients with AChR+ refractory gMG who receive eculizumab can achieve sustained ‘minimal symptom expression’ based on patient-reported outcomes. ‘Minimal symptom expression’ may be a useful tool in measuring therapy effectiveness in gMG. Trial registration: ClinicalTrials.gov NCT01997229, NCT02301624