International Clinical Trials Day 2021

Lucy Culliford, Andrew Shearn and Giovanni Biglino were involved in an outreach activity at Parson Street School. This was organised by Lucy, and the group explained some of their 3D printing research to the Year 6 students. As the visit happened on Clinical Trials Day (21^st May 2021), it was also an opportunity to stimulate the students to think about clinical studies, the idea of randomisation and ‘what is a clinical trial?’, which was further explained by viewing the THERMIC 3 animation video. This was developed as part of the TRECA trials, looking at trials engagement in children and adolescents.

Giovanni gave them an overview of the technology involved in 3D printing and Andrew brought a series of heart models, both adult and paediatric, including examples of babies’ hearts with congenital heart disease, which sparked some very good conversation from the 53 students who attended.

Developing a social media strategy to improve recruitment to the REPROVIDE Trial

Study manager/coordinator: Melissa Cole

Domestic violence and abuse (DVA) is a serious public and clinical health problem. This research plans to improve how healthcare professionals respond to both adult patients who experience or perpetrate DVA, and their children.

The REPROVIDE Trial is testing the effectiveness and cost effectiveness of a group programme for men who are concerned about their abusive behaviour in relationships with women. The trial continued to recruit throughout the COVID-19 lockdowns, however referral numbers – which come mostly through social services with some self-referrals – have diminished despite the team working hard to keep numbers up. It became clear that a broader digital recruitment strategy than the UoB website was required, both targeting professionals (such as social workers, police etc.) and men who might self-refer.

With support from the local Clinical Research Network (CRN), a strategy comprising of a new Twitter platform aimed at professionals, bolstered by Facebook and Google ads campaigns aimed at self-referral by men, was developed. This was recently shown to be effective for a large mental health related trial which we consulted (Online intervention for prevention of major depression in primary care: Moodbuster) and, given we know from pre-assessment and assessment interviews that a high proportion of our participant population use multiple digital platforms, this strategy was felt to be worth testing.

REPROVIDE hired a social marketing company to help develop the ads which took around two months, included consulting our partners (e.g. the DV accreditation agency, RESPECT) to hone the language used in the ads, add in the optimal search terms and place them in a targeted and focused e-recruitment campaign. It is still early days, but the ‘link click rate’ is looking good. Please contact us if you wish to know the outcome in a few months’ time and we will aim to update you in due course

“This research was funded by the National Institute for Health Research (NIHR) (RP-PG-0614-20012 REPROVIDE (Reaching Everyone Programme of Research On Violence in diverse Domestic Environments) project reference) using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR or the UK Department of Health and Social Care.”

Bristol Oxford Surgical Trials Intervention Course (BOSTiC): Registration Open

BOSTiC: Making Trials Stick will take place on 15-17 September 2021, Bristol.

The Bristol and Oxford Surgical Trials Units offer a 3-day surgical research training event on surgical trials for foundation, core and specialist trainees of all surgical specialities. Learn how to design and conduct RCTs in surgery that answer research questions of relevance to surgeons, patients and the NHS. It is necessary to commit to all three days, so we ask for all attendees to provide the course coordinator with evidence of approval for study leave.

The course fee covers all subsistence and one conference dinner. Accommodation, travel and remaining dinner is not covered.

BOSTiC 2021 – register here

Society for Clinical Trials Meeting: PPI in Randomised Controlled Trials

Athene Lane, Professor in Trials Research and Deputy Director of the Bristol Trials Centre, gave a virtual presentation at the Society for Clinical Trials meeting (May 17th -20th) titled ‘Patient and public involvement (PPI) in randomised controlled trials: a mixed methods study of a clinical trials unit to identify good practice, barriers and facilitators.

This research was led by qualitative researchers, with involvement from two PPI members and members of the Bristol Trials Centre. The project/work included a survey of 21 trial managers and qualitative interviews with members of 8 case study trials.

Research found that found that the most common tasks undertaken by public contributors were review of participant-facing materials/study documents and advising on recruitment/retention strategies. Public contributors wanted and valued feedback on changes made due to their input, but it was not always provided.

Barriers to successful PPI included:

recruitment challenges
group dynamics
maintaining professional boundaries
negative attitudes to PPI among some researchers
a lack of continuity of trial staff
the academic environment

Successful PPI required early and explicit planning, sharing of power and ownership of the trial with public contributors, as well as building and maintaining relationships, a joint understanding and clarity about expectations/roles. Clinical Trials Units have an important role to play in supporting recruitment, signposting and coordinating PPI.

While highly valuable, PPI in trials is currently very variable. PPI representatives are recruited informally, may not be provided with any training, and are paid inconsistently across trials. These study findings can help optimise PPI in trials and ensure researchers and public contributors are adequately supported.