Validity and utility of the questionnaire-based FRAIL scale in elderly patients with heart failure: findings from the FRAGILE-HF

Nozaki, K; Kamiya, K; Hamazaki, N; Saitou, H; Saitou, K; Ogasawara, Y; Maekawa, E; Konishi, M; Kitai, T; Iwata, K; Jujo, K; Kagiyama, N; Matsue, Y

INTRODUCTION: The coexistence of heart failure (HF) and frailty leads to a worse prognosis. Frailty is generally diagnosed using the Fried criteria. To assess whether patients are frail according to the Fried scale, face-to-face physical examinations are required. However, with the COVID-19 pandemic, to avoid the spread of the virus in hospitals, it is important to screen hospitalized patients for frailty without contact. Therefore, non-contact measurement methods, such as questionnaires, should be used to screen for frailty in clinical practice. The FRAIL scale is a questionnaire used to screen for frailty. There are no studies regarding the consistency of the FRAIL scale with the Fried criteria, the impact on mortality, and physical dysfunction in elderly patients with HF. PURPOSE: We investigated whether the FRAIL scale questionnaire is consistent with the Fried criteria, predicts all-cause mortality, and reflects physical dysfunction in patients with HF. METHODS: The present study was secondary analysis of FRAGILE-HF, a cohort study that enrolled participants from 2016 to 2018 and followed up for 1-year of discharge. A prospective multicenter cohort study in which 15 hospitals in Japan (8 university hospitals and 7 non-university teaching hospitals) participated. We prospectively enrolled 1332 consecutive hospitalized patients with HF ≥65 years old and analyzed 1028 patients after excluding 304 patients with missing data on the FRAIL scale. The FRAIL scale, the Fried model, and physical function were measured before discharge. The endpoint was all-cause mortality. RESULTS: According to the FRAIL scale, 459 (44.6%) and 491 (47.8%) were classified as frail and pre-frail, respectively. The Kappa coefficient between the FRAIL scale and the Fried criteria were 0.39 (95% confidence interval [CI]: 0.34–0.44; P value: <0.001). The area under the receiver-operating characteristic curves for frailty diagnosed by the Fried criteria of the FRAIL scale was 0.74 (95% CI: 0.71–0.76; P value: <0.001). A total of 118 deaths occurred during 1 year of follow-up. After adjusting for the MAGGIC score and log-BNP, The FRAIL scale predicted all-cause mortality (hazard ratio: 1.17; 95% CI: 1.01–1.36; P value = 0.035). The FRAIL scale was also associated with various physical dysfunction that correlated with poor prognosis. CONCLUSIONS: The FRAIL scale had moderate consistency with the Fried criteria, predicted all-cause mortality, and reflected clinically important physical dysfunction. FUNDUNDING ACKNOWLEDGEMENT: Type of funding sources: Public grant(s) – National budget only. Main funding source(s): the Japan Society for the Promotion of Science Grant-in-Aid (JSPS KAKENHI, Grant Number 19K19884)