Strengths and limitations
SUTTON
To our knowledge, no previous RCT concerning induction of labour in a LMIC has included an individualised respondent-driven PREM such as this, although various studies have used health status or specific quality of life instruments. The ‘before-and-after’ aspect allows for direct evaluation of the anticipated and actual impact of the intervention on participants. Using it again very soon after the birth ensured high follow-up rates.Basing the PaGES Form assessments on the areas of life which the mother considers to be those most important to her avoids the pitfalls of a ‘top-down’ instrument which, however well prepared, may not reflect all the woman’s current concerns [A tool that, in addition to a numerical comparison of intervention and control groups, also allows for more nuanced analysis of the issues that are important to participants, adds a valuable additional layer of understanding. This could be used to highlight the contextual factors that might influence the success or failure of an intervention. The PaGES Index, like the MGI, can be administered to a large cohort. This raises the prospect of obtaining high-quality qualitative data from all study participants (rather than only the typically small sub-sample included to provide a qualitative add-on to a trial); this can also happen both before and after the intervention. This could help to open up what Sutton calls the ‘black box’ of the mechanisms of effect in such interventions [Preparing the PaGES Index for use in different populations is not time-consuming. The form and its language are simple; even if translation is required this is not a complex task for competent researchers. We do acknowledge that if it is to be used in large sub-samples, then adequate time and other resources must be factored in to collect, clean, and analyse the data, and translate where necessary. All of these processes require appropriately trained / supervised researchers who may not be inexpensive. Nevertheless, the advantage is that this allows for broader population coverage than is possible in a discrete qualitative alongside study.While the data collected from 68 participants gives us a detailed insight into the participant experience, we cannot say from this pilot dataset what the optimal sampling frame would be for implementing the PaGES Index within other large studies. For example, administering the PaGES Index soon after birth ensured high follow-up rates. It does, however, raise pertinent questions about how time may influence what participants would cite as important and how they might score these issues at different times.Further research is planned to compare the outcomes of the PaGES Index analysis with the classical alongside qualitative study approach. This will be possible within the MOLI study as both assessments have been undertaken. We will also compare the PaGES outcomes from the two arms of the randomised trial to quantify the difference that the intervention had on the study population.