Background:
An outcome is a measured effect a treatment has on an individual, but in other fields problems have been identified with how outcomes are selected, collected, reported and interpreted. Core outcomes sets (a minimum set of essential outcomes reported by all related research) have been developed using consensus methods to address these problems. There has been no systematic evaluation of the importance of outcomes in neonatal research.
Aims:
Improve understanding of the importance of outcomes to neonatal research.
Methods:
Two systematic reviews identifying outcomes from neonatal trials and qualitative research were completed. The results of these reviews informed a consensus process, which included a Delphi survey, to identify a core outcomes set. The Delphi results were also used to analyse how groups prioritise outcomes and how methodological approaches affect core outcomes set development. Finally, the core outcomes set and population-level data were used to explore how early parenteral nutrition use affects outcomes in very preterm neonates in a retrospective cohort study using propensity score matching.
Results:
In 76 neonatal trials, 216 outcomes were reported using 889 measures; 146 outcomes were identified in 62 qualitative studies. These outcomes were scored by importance by 414 former patients, parents, healthcare professionals and researchers: the final core outcomes set included 12 outcomes. Delphi results showed stakeholder groups prioritise different outcomes. Data from 16, 292 matched very premature neonates showed that those given PN in the first postnatal week had higher rates of survival (absolute increase 0.91%; confidence interval 0.53, 1.30), but increased morbidity.
Conclusions:
Outcomes are inconsistently reported in neonatal trials: different outcomes are discussed in qualitative research. The core outcomes set will ensure research outcomes meet the priorities of different groups: I have demonstrated its utility in observational research.
Keywords: Outcomes, systematic review, Delphi survey, core outcomes setOpen Acces
