Current status and prospects of usefulness of research in preterm birth
The multidimensional assessment of usefulness can map the strengths and weaknesses of a large field. The remarkable absence of reference to patient centeredness in our assessment could be the first ‘low hanging fruit’ to improve usefulness in future trials. Luckily, an extensive patient/parents and clinicians research priority list of 15 research questions related to PTB has already been developed through the James Lind Alliance.(24) Participants have also been involved in a ‘core outcome set’ for PTB prevention studies.(25) The essential step is implementing these two tools in future PTB trials.
Different studies may require very different levels of financial investment and may differ substantially in how much we can learn from them.(5) An assessment of value of information through formal modelling (13) can help reduce the conduct of studies that do not convincingly change practice. Hopefully, this will help decrease the use of surrogate and composite outcomes and the conduct of underpowered studies.(26) Proper power calculations require clinicians’ and women’s input to define the minimal clinically important difference. For PTB research, this is a remarkable knowledge gap. We found only one study investigating the minimal clinically important difference for preventive PTB strategies (cerclage, progesterone).(27)
The very low number of pragmatic trials may also be a missed opportunity. Traditional trials recruit highly selected participants, seen in specialist environments and meet rigorous inclusion/exclusion criteria such as being free of comorbidities, which might influence generalizability of the results. In contrast, pragmatic trials support the generation of evidence relevant to real-world decision making.(28)