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Studies Within a Trial (SWATS)

York Trials Unit are actively involved in a range of work relating to Studies within a Trial (SWAT). A number of our associated sessions and presentations across the conference therefore focussed on this work.

David Torgerson along with Adwoa Parker and Catherine Arundel ran a well-attended pre-conference workshop on the role of Studies Within A Trial (SWATs) and helped with the pre-conference Trial Forge meeting on improving the efficiency and conduct of RCTs. York Trials Unit is part of the Trial Forge initiative and hosts the York Trial Forge SWATs Centre. At the conference, the Trial Forge Initiative - including York - was awarded the Cochrane-REWARD prize in recognition for innovation in reducing waste in research. This included prize money of £1,500 to support the goals of the initiative.

Catherine Arundel and David Togerson at ITCMC

Catherine Arundel presented findings from the PROMETHEUS programme in relation to the complexities we have experienced in delivering studies within a trial (SWATs). The presentation also offered some solutions to dealing with these complexities, which included resource provision and educating the wide range of research stakeholders involved in RCTs

The use of SMS reminders are a simple, inexpensive and easy to implement strategy to encourage trial participant completion of questionnaires. Stephen Brealey’s embedded trial found that timing of an SMS reminder did not have an effect on the response rates to a postal questionnaire. There is also no conclusive evidence from a meta-analysis of over 2,000 trial participants that electronic reminders are more effective than no reminders for the return of postal questionnaires.

Adwoa Parker presented initial feasibility findings from a PROMETHEUS SWAT investigating the effectiveness of a training intervention aimed at recruiters. This work has shown it is feasible to test a recruitment training intervention across multiple trials simultaneously, that training is acceptable and can increase confidence in recruiting staff for up to 3 months post training.  

Learning from trials conducted at YTU 

Liz Cook presented lessons learned from AVURT, a phase II feasibility trial to determine whether 300mg of daily oral Aspirin, in addition to standard care, is effective for healing chronic Venous Leg Ulcers and to establish feasibility and safety of Aspirin in this patient population. The value of assessing feasibility before going to full trial was shown when sites identified fewer patients than they originally estimated. Reasons patients did not meet the eligibility criteria included: they were already taking aspirin or other prohibited medication; ulcer was too small; or wrong ulcer type. The study team were able to made recommendations to address these issues in a future trial.

Izzy Coleman and Liz Cook presented PRESTO, a feasibility trial, qualitative interviews with patients and surgeons and the survey of health professionals were undertaken in an area lacking in evidence: the treatment of stable thorocolumbar fractures. Their results show that a trial using the current study design would not be feasible but they have provided important information for future research in this area. 

The rewards and challenges of undertaking trials in the police setting were presented by Alison Booth. Her talk highlighted the differences in legal and regulatory requirements, processes and IT systems encountered in the Connect and Gateway trials. The rewards she highlighted were working in a multidisciplinary team to find solutions to problems and proving trials are possible in this complex environment.

Adowa Parker with poster at ITCMC

Catriona McDaid and Adwoa Parker presented the findings of an examination of data from a systematic review that showed a lack of consistency in the outcome measures used in studies assessing the effectiveness of interventions to manage non-respiratory sleep disturbances in children with neurodisabilities. Establishing an international consensus on a minimum core outcome set that involves parents, children and young people, and those involved in supporting families is the next phase in this important work.

Statistical methods

Three YTU trainee statisticians presented posters on methodological issues they had been involved in studying. Charlie Welch presented on incorporating estimated correlation between repeat measurements of continuous outcomes into the sample size calculations of parallel group trials. He felt this went well and he was able to engage in a number of fruitful discussions with statisticians from other institutions, which in turn has helped formulate a number of ideas for inclusion in a paper he and colleagues are currently writing. Alex Mitchell presented two posters; the first was on the use of baseline testing in cluster RCTs, and the second was on the association between poor allocation concealment and measures of bias in trials. Both posters attracted a number of researchers and led to some interesting discussions. Alex, “particularly enjoyed trying to convince them of the merits of the ideas presented in my posters”. The results of a methodological review of evidence of risk of bias in cluster trials was presented by Jenny Roche. The review showed some evidence of bias in trials conducted over the past five years but also a clear improvement in reporting compared to a similar review conducted 16 years previously. 

Learning from attending

Michelle Watson attended the conference as part of her NIHR Pre Doctoral Fellowship. She used the opportunity to learn more about the latest advances in research and gather information to inform components of work to support her future Doctoral Fellowship application. Sessions relating to recruitment and retention challenges and strategies, were particularly useful as this is Michelle’s area of interest. 

Reflecting on the conference, we all felt the event was well organised and really showcased the wide range of methodological work being undertaken. The enthusiasm of attendees to engage and learn from each other was great and confirmed this is certainly an exciting time in the world of trial methodology. We all came away having our existing knowledge and experience at least confirmed and frequently expanded and with ideas about how we might do things differently, from issues of recruitment and retention to presentation of statistical analyses.

We all clearly acknowledged the team members we work with; both colleagues in the Unit and in the wider collaborations necessary for delivering high quality trials. Following the conference YTU Director Professor David Torgerson said “It was really great to see so many from YTU showcasing the high quality methodological work being carried out across the unit. Sharing advances in trial methods is essential for reducing research waste and improving outcomes for all. YTU showed it continues to make an important contribution in this area.