Highlights
- •More than 1 in 10 trials reported outcomes inconsistent with those prespecified.
- •The majority of the inconsistencies favored statistically significant findings.
- •Single-center recruitment was associated with inconsistent outcome reporting.
ABSTRACT
Background
Randomized controlled trials (RCTs) may report outcomes different from those prespecified
on trial-registration websites, protocols and statistical analysis plans (SAPs). This
study sought to investigate the prevalence and characteristics of heart failure (HF)
RCTs that report outcomes different from those prespecified.
Methods and Results
MEDLINE via PubMed was searched to include phase II–IV HF RCTs in 9 high-impact journals
from 2010 to 2020. Outcomes reported in trial publications were compared with prespecified
outcomes in protocols, registration websites and SAPs. We used the χ2 or Fisher exact test to analyze correlations between trial characteristics and inconsistencies.
Among 216 trials, 32 inconsistencies were observed in 28 trials (13.0%). Among 32
inconsistencies, 2 (6.3%) pertained to omission of prespecified primary outcomes,
4 (12.5%) to omission of prespecified secondary outcomes, 2 (6.3%) to changing prespecified
primary outcomes to secondary outcomes, and 2 (6.3%) to changing prespecified secondary
outcomes to primary outcomes. Of the inconsistencies, 3 (9.4%) pertained to addition
of new primary outcomes, 17 (53.1%) to addition of new secondary outcomes, and 2 (6.3%,)
to changes in the timing of assessment of primary outcomes. The majority of the inconsistencies
favored statistically significant findings; 78 (36.1%) were registered retrospectively.
Single-center recruitment was associated with outcome inconsistencies (β = -0.14;
95% CI, -0.22 – -0.01; P = 0.035).
Conclusions
More than 1 in 10 trials reported outcomes inconsistent with those specified in trial
registration websites, SAPs and protocols. An action plan is warranted to minimize
selective reporting and improve transparency.
Graphical abstract
Graphical Abstract
Key Words
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Article info
Publication history
Published online: December 10, 2022
Accepted:
November 8,
2022
Received in revised form:
October 18,
2022
Received:
March 16,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2022 Elsevier Inc. All rights reserved.
