A programme of five linked studies will overhaul how the NHS treats children born with cleft lip and palate and adults with head and neck cancer, from surgical techniques to the organisation of care itself. Both conditions cause facial disfigurement and functional problems, require expensive, multi-disciplinary surgery, and have a weak evidence base for many routine decisions. Centralising services into fewer, larger centres—already underway for cleft care and now happening for head and neck cancer—raises urgent questions about whether this reorganisation actually improves outcomes and how to make it cost-effective. The programme will fill these gaps by systematically reviewing existing evidence, evaluating the results of centralisation, and conducting qualitative research with patients and clinicians. If successful, the work will produce formal evidence-based practice guidelines for the NHS, directly informing how surgical teams close wounds, use antibiotics, and provide speech therapy. A large UK-wide trial of skin closure techniques in 500 children with cleft lip and palate will generate definitive data on which method works best. The programme will also establish a clinical cohort of 5,000 head and neck cancer patients followed for two years, creating a resource for future research. The ultimate change is that patients receive care proven to be both clinically effective and efficient, rather than care based on tradition or opinion.
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Aims - The overall aim of this programme is to improve the quality of care for children born with cleft lip and palate (CLP) and those suffering from head and neck cancer (H&N). Our proposal will integrate research evidence, clinical expertise and patient values into a coherent programme of applied research. The specific aims are to:1.Identify key research questions in partnership with users and clinicians and incorporate these into formal research strategies for appropriate national bodies2.Systematically review and synthesise quantitative and qualitative evidence and translate this into evidence-based practice guidelines 3.Evaluate and disseminate the outcome of centralisation in CLP and H&N 4.Conduct qualitative and patient-centred research to investigate centralisation, multi-disciplinary working, psychological adaptation and barriers to research 5.Develop and conduct randomised controlled trials Background - CLP and H&N are important causes of ill health. They share features that justify and add value to a combined applied research programme. Both conditions often result in facial disfigurement and functional deficits and both require surgery. Treatment for both conditions is resource intensive and multi-disciplinary. Care for CLP has been centralised and services for H&N are being centralised. Such multi-disciplinary working tends to further increase health service costs as teams require time and resources to function effectively. Furthermore the centralisation of care in a smaller number of larger centres has important resource and logistic implications for both users and service providers. The evidence base to inform the treatment of both conditions is limited. Practice within these cost intensive services needs to be both clinically and cost effective to ensure that patients are receiving the best quality care and that NHS resources are being used efficiently. There is therefore a need for observational research to evaluate multi-disciplinary centralised services and multi-centre randomised trials of interventions to provide and implement best evidence that will improve patient care and outcome. We have developed the multi-disciplinary partnerships required to evaluate centralised multi-disciplinary models of care, produce best evidence and disseminate evidence based practice.Research plans - Our proposed research programme consists of five linked work packages that match on to the five aims. The results of activities in one work package will feed into work in others. The work packages comprise:1.An annual programme of CLP and H&N workshops attended by clinicians; managers; users and members of the research team. These workshops will identify key questions and result in formal research strategies.2.A series of systematic reviews in CLP on skin closure techniques, peri-operative antibiotics and early speech therapy; an extension and update of Cochrane reviews of oral cancer to include all H&N and reviews on psychosocial interventions in CLP and H&N. We will also identify all ongoing and completed qualitative studies in CLP and H&N.3.An evaluation of the outcome of centralisation in CLP and H&N using questionnaire surveys of clinical teams by collecting detailed data on the treatment and outcomes of around 250 five year old children with complete unilateral CLP and by establishing a clinical cohort of 5,000 people with H&N and following them up for two years.4.Qualitative studies as part of the evaluation of centralisation and multi-disciplinary working and qualitative studies to inform the design and conduct of randomised trials.5.Development of proposals for feasible adequately powered randomised trials and the conduct of a large UK wide multi-centre trial of skin closure techniques in 500 CLP children.Research team - The research team includes clinicians from a range of relevant disciplines including Oncology; Ear Nose and Throat and Maxillofacial surgery; Orthodontics and Public Health. The team brings together appl
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