Assessment of chronic disease self-management in patients with chronic heart failure based on the MCID of patient-reported outcomes by the multilevel model

Abstract

Purpose: The minimal clinically important difference (MCID) of a patient-reported outcome (PRO) represents the threshold value of the change in the score for that PRO. It is deemed to have an important implication in clinical management. This study was performed to evaluate the clinical significance of chronic disease self-management (CDSM) for patients with chronic heart failure based on the MCID of the chronic heart failure-PRO measure (CHF-PROM).

Methods: A multicenter, prospective cohort study of 555 patients with heart failure were enrolled from July 2018. Advice of CDSM was provided in written form at discharge to all patients. Information regarding CHF-PROM and CDSM were collected during follow-up. Multilevel models were applied to dynamically evaluate the effects of CDSM for CHF-PROM scores, as well as its physical and psychological domains. MCID changes of the PRO were introduced and compared with β values of CDSM obtained from the multi-level models to further evaluate the clinical significance. The STROBE checklist is shown in Additional file 1.

Results: Scores for CHF-PROM improved significantly after discharge. The multilevel models showed that a regular schedule, avoidance of over-eating, a low-sodium diet and exercise increased scores on CHF-PROM. Compared with the MCID, avoidance of over-eating (12.39 vs. 9.75) and maintenance of a regular schedule often (10.98 vs. 9.75), and exercise almost every day (11.36 vs. 9.75) reached clinical significance for the overall summary. Avoidance of over-eating (5.88 vs. 4.79) and a regular schedule almost every day (4.96 vs. 4.79) reached clinical significance for the physical scores. Avoidance of over-eating half of the time (5.26 vs. 4.87) and a regular schedule almost every day (5.84 vs. 4.87) demonstrated clinical significance for the psychological scores.

Conclusions: This study observed an association of avoidance of over-eating and maintenance of a regular schedule with the improvement of CHF-PROM. It provides further evidence for management of heart failure.

Trial registration: Current Prospective Trials NCT02878811; registered August 25, 2016; https://ichgcp.net/clinical-trials-registry/NCT02878811?term=NCT02878811&draw=2&rank=1 .

Keywords: Chronic disease self-management; Chronic heart failure; Minimal clinically important difference; Multilevel model; Patient-reported outcome.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig.1

Residual normality test diagram of OS (a, b) are the residual normality test graphs of OS at the different time points level and the individual level, respectively. The ordinates of the diagrams represent the standardized residuals of each level, and the abscissas are their normal fractions. The curve of each figure represents the residual normality test of each level. The residual is normally distributed when the curve performs as a straight line

Fig. 2

Residual normality test diagram of PHYS and PSYS (a, b) represent the residual normality tests of PHY at the timepoint level and the individual level, respectively. c, d Represent the residual normality test of PSY at the time-point level and the individual level, respectively

Fig. 3

Comparation of MCID to the cumulative β for variables each point represents the value that the correspond β of strategy multiplied by (grade-1). MCID is shown as a dotted black line. The strategy is of the clinical significance when the its value is larger than MCID. a Represents the influence of management strategies on OS. b, c represent the influence of management strategies on PHY and PSY, respectively