Study within a Trial (SWAT)

SWAT 1: Site visits by the principal investigator to improve recruitment in a multicentre randomized trial
Objective of this SWAT To assess the effects on recruitment of site visits by the principal investigator in a multicentre randomized trial.

SWAT 11: Monitoring consent forms by Skype video-conferences
Randomised trial of Skype-based tele-monitoring versus standard monitoring This research will evaluate Skype-based monitoring versus traditional site visit monitoring within a large international clinical trial which aims to prevent stroke and coronary events.
SWAT 38: Cost implications of conducting a risk assessment prior to developing a monitoring plan for a multicentre clinical trial
Assess the cost implications of conducting a risk assessment prior to developing a monitoring plan for a multi-centre clinical trial, and examine if sites that conducted a risk assessment prior to developing their monitoring plan have less protocol violations compared to the sites that did not conduct a prior risk assessment.
SWAT 55: Prioritising key motivators and challenges influencing informal caregivers to participate in randomised trials
HRB-TMRN FUNDED 2016
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.
SWAT 78: Examining the influence of an informational video on participant retention in a randomised controlled trial
Common strategies increasing retention of participants, such as monetary incentives, participant led scheduling, and customised reminders can be costly, both as a direct cost in the case of monetary incentives, and in researcher and/or clinician time (Brueton et al., 2014; Khadjesari et al., 2011). Many studies incorporating patient public involvement in research development and data collection have shown a shift away from these strategies towards ones focused on increasing participant knowledge and decreasing complexity (Brett et al., 2014).
SWAT 100: Patient and family co-developed participant information to improve recruitment rates, retention, and patient understanding of a randomised trial
To examine if participant information co-developed by patients and their families can lead to greater recruitment rates, retention, and participant understanding of the study in comparison to standard participation information leaflets in the Rehabilitation Strategies following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) trial.
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.
SWAT 123: Seldom heard: Listening to patients and the public during intervention development
The aim of this SWAT is to examine the impact of involving patients and the public in the
development of an intervention to improve uptake of retinopathy screening.
SWAT 128: Timing of recruitment of pregnant women to participate in a trial
Objective of this SWAT
To evaluate the effects on recruitment and retention of the timing of invitations to pregnant women to participate in a randomised trial.
SWAT 6: Using a limited number of practitioners to recruit participants to a multicentre randomized trial
A key challenge in doing multicentre trials is that there is significant uncertainty about the best way to ensure good recruitment rates at different sites. Maintaining the interest of those responsible for recruiting participants can be a significant challenge and can slow the recruitment of new participants.
SWAT 14: A web-based multimedia information resource on recruitment and retention of general practitioners
Recruitment in Primary Care Recruiting clinicians and patient participants to trials is recognised as a significant challenge. It is estimated that less than 50% of trials meet their target or do so with an extension to the trial length.
SWAT 46: Participants' perspectives and preferences on clinical trial result dissemination
HRB-TMRN FUNDED 2016
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.
SWAT 57: Provision of information about a core outcome set and trial questionnaire completion
Lack of standardised trial outcomes significantly impacts examination of intervention effects and synthesis of trial findings. The use of core outcome sets (COS) enhances outcome evaluation and evidence syntheses, by reducing outcome heterogeneity and reporting bias risk…
SWAT 81: A Telephone Reminder to Enhance Adherence to Interventions in Randomised Trials
Objective of this SWAT
To evaluate the effects of a telephone reminder to enhance the adherence of participants to interventions in randomised trials.
SWAT 105: Effects of a patient-designed-and-informed participant information sheet versus a standard, researcher-designed information sheet on recruitment to a randomised trial
Objective of this SWAT
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.
SWAT 124: Exploring the impact of ineligibility on individuals expressing interest in a trial aimed at improving daily functioning regarding perceptions of self, research and likelihood of future participation.
For the read more part: In the analysis of clinical trials, maximum likelihood offers certain pragmatic advantages over multiple imputation[1] although both methods are expected to give similar results…
SWAT 133: Branded gift and letter from PPI group to enhance questionnaire response rate in a randomised trial
To evaluate the effects of providing a branded gift and letter from the study’s PPI group one month before the end of the trial on the response rate to the final questionnaire
SWAT 10: Skype videoconferences to improve site engagement in multicentre randomised trials
To compare trial quality metrics (recruitment, retention and data quality) for centres receiving Skype-based ‘visits’ from the central trial team versus those receiving traditional site visits.
SWAT 15: Video presentation of trial information to potential patient participants in a randomized trial
To evaluate the effectiveness of hand-held video presentation of trial information to potential patient participants on recruitment and retention to a randomised trial.
SWAT 52: Statistical methods for compensating for missing longitudinal data in a cluster-randomised trial
HRB-TMRN FUNDED 2016: The objectives of the study are:
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.
SWAT 62: The influence of different healthcare professionals delivering an intervention in a medication optimisation trial.
HRB-TMRN FUNDED 2016
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.
SWAT 84: Objective of this SWAT To evaluate the effects of a telephone reminder to enhance the adherence of participants to interventions in randomised trials.
Objective of this SWAT
To compare the effects of same-day versus delayed consent on recruitment and retention rates in a randomised trial.
SWAT 107: Effects of a multi-trial programmable animation platform on the efficiency and success of pre-screening and subsequent recruitment to a randomised trial
Objective of this SWAT
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.
SWAT 127: Qualitative exploration of occupational therapists’ perspectives on barriers and enablers to helping conduct research
The primary objectives are to collect and analyse qualitative data from occupational therapists (OTs) who expressed interest in delivering a Cognitive-Occupation-based program for people with multiple sclerosis [excluding OTs participating in the treatment group; see program details (1)], to ascertain: (i) Reasons behind the decision to participate or not participate, in order to improve the conduct of future trials; and (ii) Potential barriers and enablers for healthcare professionals in helping to conduct research, particularly randomised trials.

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