Having an implantable cardioverter-defibrillator or cardiac resynchronization therapy was consistently associated with lower lost to follow-up in two pragmatic heart failure trials (aOR 0.56 and 0.59).
Observational (n=7,105)
Yes
What patient- and site-level factors are associated with loss to follow-up in pragmatic heart failure trials using remote follow-up?
In pragmatic heart failure trials using remote follow-up, younger patients, those without an ICD/CRT, and those at smaller hospitals are at higher risk for loss to follow-up.
Odds Ratio: 0.56 (95% CI 0.43–0.75)
Background Pragmatic trials commonly use remote follow‐up to reduce participant burden and costs. However, these approaches may increase the risk of lost to follow‐up (LTFU). We identified patient‐ and site‐level factors associated with LTFU in 2 large, pragmatic heart failure (HF) trials. Methods We analyzed data from 2 pragmatic US trials (CONNECT‐HF Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure, TRANSFORM‐HF Torsemide Comparison With Furosemide for Management of Heart Failure) following HF hospitalization. Both trials employed centralized call center–based follow‐up with supplemental data sources. For this analysis, LTFU was defined as the absence of both a completed 6‐month assessment and any subsequent clinical follow‐up throughout the study (confirmation of vital status alone was insufficient). Multivariable logistic regression models were used to identify factors associated with LTFU in each trial. Results The LTFU rates were 7.6% (362/4771) in CONNECT‐HF and 10.5% (245/2334) in TRANSFORM‐HF. In multivariable analyses of both trials, younger age was consistently associated with increased LTFU. Conversely, implantable cardioverter‐defibrillator/cardiac resynchronization therapy was consistently associated with lower LTFU (CONNECT‐HF: adjusted odds ratio aOR, 0.56 95% CI, 0.43–0.75; TRANSFORM‐HF: aOR, 0.59 95% CI, 0.39–0.89). In CONNECT‐HF, smaller hospital size (aOR per 100 beds, 0.90 95% CI, 0.83–0.97) was also associated with higher LTFU. Socioeconomic factors were not significantly associated with LTFU. Conclusions In analyses of 2 pragmatic trials of patients hospitalized for HF in the United States, younger patients, those without implantable cardioverter‐defibrillator/cardiac resynchronization therapy, and smaller hospital size were associated with higher LTFU. Tailoring retention strategies to both patient and site characteristics should be explored in future work to help mitigate LTFU in pragmatic trials.
Shoji et al. (Sat,) conducted a observational in Heart failure (n=7,105). Implantable cardioverter-defibrillator/cardiac resynchronization therapy vs. No implantable cardioverter-defibrillator/cardiac resynchronization therapy was evaluated on Lost to follow-up (absence of both a completed 6-month assessment and any subsequent clinical follow-up) (aOR 0.56, 95% CI 0.43-0.75). Having an implantable cardioverter-defibrillator or cardiac resynchronization therapy was consistently associated with lower lost to follow-up in two pragmatic heart failure trials (aOR 0.56 and 0.59).