Development of a core outcome set for orthodontic trials using a mixed-methods approach: Protocol for a multicentre study

© 2017 The Author(s). Background: Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people. Methods/design: This is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16 years to determine what outcomes are important to them. The outcomes elicited from these two stages will inform the third stage of the study in which a long-list of outcomes will be ranked in terms of importance using electronic Delphi surveys involving clinicians and patients. The final stage of the study will involve face-to-face consensus meetings with all stakeholders to discuss and agree on the outcome measures that should be included in the final core outcome set. Discussion: This research will help to inform patients, parents, clinicians and commissioners about outcomes that are important to young people undergoing orthodontic treatment. Adoption of the core outcome set in future clinical trials of orthodontic treatment will make it easier for results to be compared, contrasted and combined. This should translate into improved decision-making by all stakeholders involved. Trial registration: The project has been registered on the Core Outcome Measures in Effectiveness Trials (COMET) website, January 2016

Organizational Barriers to Oral Health Conversations Between Health Visitors and Parents of Children Aged 9–12 Months Old

Background: Dental caries is the most prevalent preventable childhood disease and a major public health priority. Local authorities in England have a statutory responsibility to improve child health, including oral health, through the “Healthy Child Programme.” The “Healthy Child Programme,” which includes the provision of oral health advice is delivered by health visitors to parents of young children. To date, research has mainly concentrated on individual interactions between health visitors and parents, with less attention given to the broader context in which these oral health conversations between health visitor and parents take place. Objective: Our study explored the organizational factors that obstruct health visitors from engaging in meaningful conversations with parents about young children's oral health. Methods: Qualitative interviews and focus groups were held with health visiting teams (n = 18) conducting home visits with parents of 9–12-month olds in a deprived, urban area in England. Results: The study revealed the wide variation in what and how oral health advice is delivered to parents at home visits. Several barriers were identified and grouped into four key themes: (1) Priority of topics discussed in the home visits; (2) Finance cuts and limited resources; (3) Oral health knowledge and skills; and (4) Collaborative working with other professionals. It was evident that organizational factors in current public health policy and service provision play an important role in shaping oral health practices and opportunities for behavior change. Conclusion: Organizational practices and procedures play an important role in creating interaction patterns between health visiting teams and parents of young children. They often limit effective engagement with and positive change in oral health. For future oral health interventions to be effective, awareness of these barriers is essential alongside them being founded on evidence-based advice and underpinned by appropriate theory

Development of a secondary school-based digital behaviour change intervention to improve tooth brushing

Background Dental caries in adolescents remains a significant public health problem with few oral health promotion interventions aimed at reducing dental caries in secondary school-aged students. Previous oral health and mobile health (mHealth) research has suggested the need for the development of a school-based behaviour change intervention incorporating a digital component. This study aimed to describe the development process of a behaviour change intervention to improve the oral health of students aged 11–16 years attending secondary schools in the UK. Methods A six-step process was used to develop the complex intervention informed by behaviour change theory and involving students, young people, parents and teachers in the process. The steps were: (1) identifying the target behaviours, namely tooth brushing with a fluoride toothpaste (2) identifying the theoretical basis and developing the causal model (3) reviewing the relevant literature and developing the logic model (4) designing the intervention with young people, parents and school staff (5) specifying the intervention content and (6) translating this content into features of the intervention and piloting. Results The resultant intervention included a quality-assured classroom-based session (CBS) (guided by a lesson plan and teaching resources), delivered by school teachers which was embedded within the school curriculum. This CBS was followed by a series of (Short Message Service) SMS texts delivered twice daily to student’s mobile telephones with the content, duration and timing of the messages informed by involvement of students and young people. Conclusions An intervention to improve the oral health of secondary school students through improved tooth brushing was rigorously developed based on behaviour change theory and work with young people, parents and school staff. Further research is needed to evaluate the outcomes and processes involved following the delivery of this intervention

Brushing RemInder 4 Good oral HealTh (BRIGHT) trial: does an SMS behaviour change programme with a classroom-based session improve the oral health of young people living in deprived areas? A study protocol of a randomised controlled trial

Background: Almost one-half of 12–15 year olds living in deprived areas of the UK have dental caries (tooth decay) with few oral health promotion programmes aimed at children of this age. Mobile phone-based interventions such as short messaging service (SMS) interventions have been found effective at changing certain behaviours and improving health outcomes. This protocol describes the BRIGHT Trial, investigating the clinical and cost-effectiveness of a behaviour change intervention—classroom-based session (CBS) embedded in the curriculum and a series of SMS delivered to participants twice daily to remind them to brush their teeth, compared to usual curriculum and no SMS—to reduce the prevalence of dental caries in young people from deprived areas. Objectives: To investigate the clinical and cost-effectiveness of a complex intervention to improve the oral health of young people living in deprived areas. Methods/design: This is a school-based, assessor-blinded, two-arm cluster-randomised controlled trial with an internal pilot trial. Overall, the trial will involve approximately 5040 11–13 year olds in 42 schools with a 3-year follow-up. The trial will take place in secondary schools in England, Scotland and Wales. The primary outcome is the presence of carious lesions in permanent teeth at 3 years. Secondary outcomes are: number of carious teeth, frequency of twice-daily toothbrushing, plaque levels, gingivitis, child health-related quality of life and oral health-related quality of life. A cost-utility analysis will be conducted. Discussion: The findings of the trial have implications for embedding oral health interventions into school curricula guidance produced by national bodies, including departments for education and dental public health and guideline-development organisations. Trial registration: ISRCTN registry, ISRCTN12139369. Registered on 10 May 2017

HABIT: Health visitors delivering Advice in Britain on Infant Toothbrushing - an early-phase feasibility study of a complex oral health intervention

Objectives To conduct an early-phase feasibility study of an oral health intervention, Health visitors delivering Advice on Britain on Infant Toothbrushing (HABIT), delivered by Health Visitors to parents of children aged 9–12 months old. Design A mixed-methods, early-phase, non-controlled, feasibility study. Participants Recruitment consisted of Group A—HABIT-trained Health Visitors (n=11) and Group B—parents of children aged 9–12 months old about to receive their universal health check (n=35). Setting Bradford, West Yorkshire, UK. Intervention A multidisciplinary team co-developed digital and paper-based training resources with health visitors and parents of young children. The intervention comprised of two components: (A) training for health visitors to deliver the HABIT intervention and (B) HABIT resources for parents, including a website, videos, toothbrushing demonstration and a paper-based leaflet with an oral health action plan. Primary and secondary outcome measures Recruitment, retention and intervention delivery were analysed as key process outcomes for Groups A and B. Group B demographics, self-reported toothbrushing behaviours, dietary habits and three objective measures of toothbrushing including plaque scores were collected at baseline, 2 weeks and 3 months post intervention. Results HABIT intervention delivery was feasible. Although the intended sample size was recruited (Group A=11 and Group B=35) it was more challenging than anticipated. Retention of Group B participants to final data collection was satisfactory (n=26). Total compliance with toothbrushing guidelines at baseline was low (30%), but significantly improved and was maintained 3 months after the intervention (68%). Plaque scores improved post intervention and participants found video recording of toothbrushing acceptable. Dietary habits remained largely unchanged. Conclusion This feasibility study has demonstrated that HABIT is an appropriate oral health intervention. Adaptions to the study design are recommended to maximise recruitment and data collection in a definitive study. These quantitative findings have demonstrated an early signal of impact for improved oral health behaviours for young children at high risk of decay

Co-design of an oral health intervention (HABIT) delivered by health visitors for parents of children aged 9–12 months

Background Dental caries (tooth decay) in children is a national public health problem with impacts on the child, their family and wider society. Toothbrushing should commence from the eruption of the first primary tooth. Health visitors are a key provider of advice for parents in infancy and are ideally placed to support families to adopt optimal oral health habits. HABIT is a co-designed complex behaviour change intervention to support health visitors’ oral health conversations with parents during the 9–12-month universal developmental home visit. Methods A seven stage co-design process was undertaken: (1) Preparatory meetings with healthcare professionals and collation of examples of good practice, (2) Co-design workshops with parents and health visitors, (3) Resource development and expert/peer review, (4) Development of an intervention protocol for health visitors, (5) Early-phase testing of the resources to explore acceptability, feasibility, impact and mechanism of action, (6) Engagement with wider stakeholders and refinement of the HABIT intervention for wider use, (7) Verification, Review and Reflection of Resources. Results Following preparatory meetings with stakeholders, interviews and co-design workshops with parents and health visitors, topic areas and messages were developed covering six key themes. The topic areas provided a structure for the oral health conversation and supportive resources in paper-based and digital formats. A five-step protocol was developed with health visitors to guide the oral health conversation during the 9–12 month visit. Following training of health visitors, an early-phase feasibility study was undertaken with preliminary results presented at a dissemination event where feedback for further refinement of the resources and training was gathered. The findings, feedback and verification have led to further refinements to optimise quality, accessibility, fidelity and behaviour change theory. Conclusion The co-design methods ensured the oral health conversation and supporting resources used during the 9–12 month visit incorporated the opinions of families and Health Visitors as well as other key stakeholders throughout the development process. This paper provides key learning and a framework that can be applied to other healthcare settings. The structured pragmatic approach ensured that the intervention was evidence-based, acceptable and feasible for the required context

Prevalence and correlates of self-reported state of teeth among schoolchildren in Kerala, India

BACKGROUND: Oral health status in India is traditionally evaluated using clinical indices. There is growing interest to know how subjective measures relate to outcomes of oral health. The aims of the study were to assess the prevalence and correlates of self-reported state of teeth in 12-year-old schoolchildren in Kerala, India. METHODS: Cross-sectional survey data were used. The sample consisted of 838 12-year-old schoolchildren. Data was collected using clinical examination and questionnaire. The clinical oral health status was recorded using Decayed, Missing and Filled Teeth (DMFT) and Oral Hygiene Index – Simplified (OHI-S). The questionnaire included questions on sociodemographics, self reports of behaviour, knowledge and oral problems and a single-item measuring self-reported state and satisfaction with appearance of teeth. The Kappa values for test-retest of the questionnaire ranged from 0.55 to 0.97. RESULTS: Twenty-three per cent of the schoolchildren reported the state of teeth as bad. Multivariate logistic regression showed significant associations between schoolchildren who reported to have bad teeth and poor school performance (Odds Ratio (OR) = 2.5), having bad breath (OR = 2.4), food impaction (OR = 1.7) dental visits (OR = 1.6), being dissatisfied with appearance of teeth (OR = 4.2) and caries experience (OR = 1.7). The explained variance was highest when the variables dental visits, bleeding gums, bad breath, food impaction and satisfaction with appearance were introduced into the model (19%). CONCLUSION: A quarter of 12-year-olds reported having bad teeth. The self-reported bad state of teeth was associated with poor school performance, having bad breath and food impaction, having visited a dentist, being dissatisfied with teeth appearance and having caries experience. Information from self-reports of children might help in planning effective strategies to promote oral health

Stem cells and repair of lung injuries

Fueled by the promise of regenerative medicine, currently there is unprecedented interest in stem cells. Furthermore, there have been revolutionary, but somewhat controversial, advances in our understanding of stem cell biology. Stem cells likely play key roles in the repair of diverse lung injuries. However, due to very low rates of cellular proliferation in vivo in the normal steady state, cellular and architectural complexity of the respiratory tract, and the lack of an intensive research effort, lung stem cells remain poorly understood compared to those in other major organ systems. In the present review, we concisely explore the conceptual framework of stem cell biology and recent advances pertinent to the lungs. We illustrate lung diseases in which manipulation of stem cells may be physiologically significant and highlight the challenges facing stem cell-related therapy in the lung

Skp2B Overexpression Alters a Prohibitin-p53 Axis and the Transcription of PAPP-A, the Protease of Insulin-Like Growth Factor Binding Protein 4

We previously reported that the degradation of prohibitin by the SCF(Skp2B) ubiquitin ligase results in a defect in the activity of p53. We also reported that MMTV-Skp2B transgenic mice develop mammary gland tumors that are characterized by an increased proteolytic cleavage of the insulin-like growth factor binding protein 4 (IGFBP-4), an inhibitor of IGF signaling. However, whether a link exists between a defect in p53 activity and proteolysis of IGFBP-4 was not established.We analyzed the levels of pregnancy-associated plasma protein A (PAPP-A), the protease of IGFBP-4, in MMTV-Skp2B transgenic mice and found that PAPP-A levels are elevated. Further, we found a p53 binding site in intron 1 of the PAPP-A gene and that both wild type and mutant p53 bind to this site. However, binding of wild type p53 results in the transcriptional repression of PAPP-A, while binding of mutant p53 results in the transcriptional activation of PAPP-A. Since MMTV-Skp2B mice express wild type p53 and yet show elevated levels of PAPP-A, at first, these observations appeared contradictory. However, further analysis revealed that the defect in p53 activity in Skp2B overexpressing cells does not only abolish the activity of wild type of p53 but actually mimics that of mutant p53. Our results suggest that in absence of prohibitin, the half-life of p53 is increased and like mutant p53, the conformation of p53 is denatured.These observations revealed a novel function of prohibitin as a chaperone of p53. Further, they suggest that binding of denatured p53 in intron 1 causes an enhancer effect and increases the transcription of PAPP-A. Therefore, these findings indicate that the defect in p53 function and the increased proteolysis of IGFBP-4, we had observed, represent two components of the same pathway, which contributes to the oncogenic function of Skp2B