After considerable debate and review of the likely effects of the service it was agreed that a delayed intervention randomised controlled trial was the best option because it provided a randomised control trial method.
It is possible that a delayed intervention directed at children receiving a lower (or absent) proportion of breast milk in their diet, and, hence, likely to be deficient in all PUFAs (81), would have shown a greater benefit.
Since current clinical services provided little or no EOL intervention for such patients, a final consensus, mainly driven by comments from patients and carers, was made to offer a delayed intervention to the control group given that the intervention addressed a clear need which was patient-centred and which could provide an apparent benefit to those who participated.
Ethically, a delayed intervention is considered appropriate since it is not known at this stage, whether or not the intervention is effective.
Our report, together with these two previous reports [17], [18], supported that a delayed intervention might be more efficacious than immediate one.
It was generally agreed that it would be unethical not to provide an intervention of some sort to all patients who agreed to take part and so a delayed intervention group design was finally agreed (see figure 1).
This is a non-randomised, delayed intervention study design.
4 6 10 The major reasons for the decreased effect of interventions in clinical practice are delayed intervention for prodromal depressive and manic episodes 11 12 as well as decreased medical adherence.
As women in the intensive arm already experienced greater anxiety than women receiving standard care, it could be speculated that delaying intervention after highlighting an increased risk of morbidity would raise maternal anxiety to unacceptable levels.
To evaluate this initiative, a prospective delayed intervention design has been selected.
