How was the study set up?
This research programme has been established over a number of years. The studies would not be possible without the support of a number of different groups and organisations.
The Clinical Standards Advisory Group (CSAG)
In 1998, the CSAG commissioned a research team to evaluate the care of children with cleft lip/palate. Standards were disappointing, and as a result services were centralised in the UK. This process reduced the number of centres from 57 to 18 and ensured that all of the Health Professionals working in cleft lip/palate were specialists.
This process established the UK as one of the only countries in the world with centralised cleft lip/palate services. This has provided us with the unique opportunity to conduct large research studies across different cleft teams and disciplines. Through this national research strategy, the UK is now well placed to make important contributions to our understanding of cleft lip/palate, and to investigate what the best treatments are for children born with a cleft.
The Craniofacial Society of Great Britain and Ireland (CFSGBI)
Although centralisation allowed for more research activity, the CFSGBI recognised that the amount of research taking place in the UK was still limited, and that there were no agreed research priorities for cleft lip/palate. Between 2005 and 2007, the CFSGBI funded a series of workshops for clinicians and researchers to discuss how to move cleft research forward.
It was suggested that a ‘gene bank’ be established in order to find out more about the causes of cleft. A number of pilot studies were subsequently carried out with parents of children with cleft, to discuss the feasibility of collecting genetic information from affected families. These pilot studies helped us to begin designing a large genetic study.
The James Lind Alliance (JLA)
The JLA is an organisation which brings patients, clinicians and researchers together to identify the most important ‘unanswered questions’ in a particular area of health care. In 2012, a list of the ‘Top 12 Research Priorities in cleft lip/palate’ was published. These priorities included questions on the causes of cleft, the best treatments for cleft, and the long-term personal and social outcomes for people affected by cleft and their families. The JLA priority setting process confirmed these three ‘unanswered questions’ as key to The Cleft Collective research programme.
The Scar Free Foundation
The Scar Free Foundation (previously known as the Healing Foundation) is a national charity which raises funds to support research in the areas of disfigurement and visible loss of function. The charity was formed in 1999 by founder members of six societies, including the CFSGBI. The charity has raised millions to support pioneering research in this area, and to enhance the physical, psychological and practical support available to people affected by conditions such as cleft lip/palate.
The Scar Free Foundation has contributed £2.4 million over 5 years to the University of Bristol, to set up The Cleft Collective Cohort Studies. To find out more about The Scar Free Foundation, visit their website and follow them on Twitter: @scarfreeworld.
The Vocational Training Charitable Trust (VTCT)
VTCT is a charitable organisation specialising in providing high quality education and qualifications in the field of health and beauty and related disciplines. In addition, VTCT aim to advance research and public knowledge in these fields, as well as the impact and treatment of physical disfigurement.
VTCT has provided significant financial support to the establishment of The Cleft Collective Cohort Studies. Find out more about VTCT.
The Centre for Appearance Research (CAR)
CAR is a research centre based at the University of the West of England in Bristol. Members of CAR carry out psychological and interdisciplinary research in appearance, disfigurement, body image and related studies, in order to make a real difference to the lives of the many hundreds of thousands of people with appearance-related concerns both in the UK and across the world. Nichola Rumsey (Co-Director of CAR) and Nicola Stock (Research Fellow) from CAR are both part of The Cleft Collective team.
The Cleft Lip and Palate Association (CLAPA)
CLAPA is the only UK-wide voluntary organisation dedicated solely to supporting the many individuals and families affected by cleft lip/palate. Set up in 1979 as a partnership between parents and health professionals, CLAPA offers support from infancy through to adulthood.
CLAPA has been involved in many research endeavours and has been extremely supportive of The Cleft Collective research programme. Not only can CLAPA help to steer our research in the right direction, but CLAPA is ideally placed to help us carry out our research, and to implement our research findings to ensure the research leads to positive changes for patients and their families.
Avon Longitudinal Study of Parents and Children (ALSPAC; also known as Children of the 90s)
The Avon Longitudinal Study of Parents and Children (ALSPAC) - which is also known as Children of the 90s - is a long-term health research cohort study also based at the University of Bristol. More than 14,000 mothers enrolled during pregnancy in 1991 and 1992, and the health and development of their children has been followed in great detail ever since. The ALSPAC families have provided a vast amount of genetic and environmental information over the years. This resource is assisting scientists all over the world with research into a wide range of health problems.
The biological samples that we receive from participants in The Cleft Collective are stored at ALSPAC’s laboratory based at the University of Bristol. They have many years of experience in storing and processing these kinds of samples. We hope that our cohort studies will also be going strong after 20+ years! You can find out more about ALSPAC by visiting their website and by following them on Twitter: @CO90s.
Working with the experts
In September 2012, The Cleft Collective received financial support from CCUK to host a one day workshop for researchers, cleft teams and other experts with a background in cleft lip/palate. The aim of this workshop was to discuss the proposed research plans and collect feedback from experts in the areas of genetics, 3D imaging, psychology, and speech and language. A PPI representative also attended this workshop, and made a fantastic contribution on the day, and in a written report. Please see below for more information about PPI.
The Cleft Collective team has since had regular contact with members of every cleft team in the UK, as part of our strategy for ongoing communication and collaboration. The cleft nurses, psychologists, speech and language therapists, surgeons, orthodontists and other members of the cleft teams have all inputted significantly in the design and conduct of The Cleft Collective Cohort Studies.
Patient and Public Involvement (PPI)
In 2012-2013, The Cleft Collective also ran a series of one day workshops for parents of children affected by cleft lip/palate, with the aim of informing them about the research process, and gathering their feedback on the proposed research plans. As a result, parents were able to contribute significantly to the design of the cohort studies, as well as all of our materials, including our leaflets, information packs and questionnaires. Learn more about the research protocol, and to see examples of our materials. View more information about PPI and how you can get involved in The Cleft Collective Cohort Studies.
The Cleft Collective Cohort Studies is sponsored by the University of Bristol and has been ethically approved by the NRES Committee South West – Central Bristol; an independent group who look at all research involving NHS patients and who are there to protect your safety, rights, well-being and dignity.
The main aim of the feasibility study was to test the collection, processing and storage of biological samples (blood, tissue, saliva) taken from babies (born with a cleft) and their parents. We worked in collaboration with the Bristol Cleft team who recruited our target of ten families during the summer of 2013. The study was extremely successful and showed that it was possible to collect high quality biological samples from both babies and parents. The results meant that we could go ahead and carry out the collection of biological samples on a larger scale.
Training the cleft teams
To take part in the Cohort Studies, a cleft team requires approval and financial support from their local NHS Trust. Once a cleft team has these approvals in place, The Cleft Collective team travel to the hospital which the cleft team is based at and deliver a half-day training session on how to carry out the study. Each cleft team works differently, so the process is tailored to each cleft team. The Cleft Collective provides the cleft teams with everything they will need to help us carry out the study in your local area. The cleft team is then ready to start recruiting families into the Cohort Studies!
As the process of gaining approval and financial support takes time, each cleft team may start recruiting families at a different time. If your cleft team is not yet recruiting, please contact them, or The Cleft Collective, to find out what is happening in your area.