Studies Within A Trial (SWATs) are smaller studies carried out within a larger clinical trial. Large studies often offer the opportunity to investigate important issues around trial design, methodology and trial processes. Examples include whether sending a letter or telephoning potential participants as a method of follow-up improves recruitment to research, or if there is an optimum time and day to send invitation letter for trials.
Response rates to follow-ups are crucial to the success of a trial and therefore it is very important to maximise response rates in participants. The SIFT study, which aimed to recruit 2800 participants and follow them up at around 2 years, provided an excellent opportunity to monitor and assess response rates. The SIFT study team designed and implemented a SWAT which compared two types of incentive to participants in follow-up - an unconditional incentive (a £15 gift voucher enclosed with the follow-up questionnaire), versus the same value voucher sent to the participant on the return of the completed questionnaire. The SIFT SWAT has been registered with the MRC SWAT Repository Store, set up by Queen's University Belfast, in order to increase transparency in trials and share knowledge on trial methodology and design with other researchers.
Results of the SWAT are currently being written up, and will be submitted for publication very soon.
The SIFT protocol was published last year in the journal BMC Pediatrics. It is now open access, meaning you can download the full article either online or as PDF for free.
The link to the full article is here: https://goo.gl/CtQaHp
The SIFT protocol was published in the journal BMC Pediatrics on 28 January 2017.
The protocol explains the background, rationale, methods and design of the trial. SIFT compares two different speeds of milk feed increase, one 'faster' and one 'slower', both within rates currently used in United Kingdom neonatal units. The study aims to find out if either speed of milk feed increase gives better outcomes for the infants. Investigators will measure a variety of outcomes, such as survival without disability, infection, bowel problems, growth and long-term physical and mental development, as well as the impact on families and the National Health Service, including costs. It is led by Dr Jon Dorling in Nottingham and co-ordinated by the NPEU.
The published protocol can be found here: http://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-017-0794-z
The SIFT study has now started its follow-up phase. We will be sending questionnaires directly to parents just before their child's second birthday.
It is imperative that we receive these questionnaire back, as it measures the primary outcome of the trial. So if your baby was a participant on the trial, please help us out by taking part in this important stage of the study.
If you have any questions regarding this follow-up, have any queries regarding the questionnaire or haven't received your questionnaire when you think you should have, please contact the SIFT team via email (firstname.lastname@example.org) or telephone 01865 617919.
There will be an option of completing the questionnaire online available very shortly.