Study within a Trial (SWAT)
Objective of this SWAT
To determine the key motivators and challenges that influence informal caregivers who are deciding whether to participate in a randomised trial, and to prioritise these to inform future trial design and conduct.
Specific objectives are;
• To engage with patients with upper gastrointestinal (UGI) cancer, namely oesophageal/gastric/
pancreatic/liver cancer and their family members to develop participant information for ReStOre II.
• To examine the impact of the patient and family co-developed participant information on ReStORe II recruitment rates.
• To determine the impact of the patient and family co-developed participant information on ReStOre II retention rates.
• To explore the impact of the patient and family co-developed participant information on patient’s understanding of the ReStORe II trial.
development of an intervention to improve uptake of retinopathy screening.
To evaluate the effects on recruitment and retention of the timing of invitations to pregnant women to participate in a randomised trial.
Dissemination of the results from randomised trials has traditionally been limited to three channels: scientific meetings and journals, lay media and groups with a particular health interest. To ensure that the dissemination report is clear, simple and tailored for TRUST participants, a qualitative focus group study is to be conducted with participants to elicit their perspectives, preferences and knowledge requirements.
To evaluate the effects of a telephone reminder to enhance the adherence of participants to interventions in randomised trials.
To examine the effects of a (patient) PPI-designed-and-informed participant information sheet
(PIS) in comparison with a standard, researcher-designed information sheet on recruitment to the
trial, rate of consent and relationship with participant retention, and understanding regarding the two PIS.
1) To compare Multiple Imputation (MI) with Maximum Likelihood (ML) modelling methods to compensate for loss to follow-up over time in a longitudinal, cluster-randomised trial.
2) To investigate the relative power and type I error rate of MI versus ML methods to compensate for missing data in a simulated longitudinal, cluster-randomised trial.
Two previous studies by our research group showed there was disparity in recommendation uptake rates between physicians and pharmacists. The objective of this SWAT is, if in a medication optimistion trial, there is a difference in recommendation uptake rates between a pharmacist delivered intervention and a physician delivered intervention. There will be a qualitative aspect to the study at then end to attempt to explain any differences observed if any.
To compare the effects of same-day versus delayed consent on recruitment and retention rates in a randomised trial.
To use a mixed-methods sequential explanatory design to develop and test a novel approach of using a programmable multimedia animation to improve the success of pre-screening and enhance recruitment to randomised trial.