Cost-effectiveness Analysis of the Dental RECUR Pragmatic Randomized Controlled Trial: Evaluating a Goal-oriented Talking Intervention to Prevent Reoccurrence of Dental Caries in Children

BACKGROUND: The formation of dental caries is the most common chronic disease in children, and is preventable. The oral health-related quality of life has an immense impact on an individual’s daily functioning, well-being or overall quality of life. OBJECTIVES: This study aims to investigate the cost effectiveness of the Dental RECUR Brief Negotiated Interview for Oral Health (DR-BNI). This 30-minute therapeutic “talk” by a dental nurse with a parent/guardian was compared with a placebo-controlled intervention in preventing reoccurrence of dental caries in children who have had a primary tooth extracted. METHODS: An economic model was developed to simulate the clinical progression of dental caries among children who have previously had a primary tooth extracted. The analysis was conducted using the UK NHS perspective. The main outcome was the incremental cost-effectiveness ratio (ICER) based on the quality-adjusted life years (QALYs). Estimates of costs and probabilities were obtained from the DR-BNI multicentre randomised controlled trial (RCT), while QALY values were obtained from published literature. Univariate and probabilistic sensitivity analyses were conducted to assess the uncertainty of the result and robustness of the model. Affordability and risk-aversion of the intervention were investigated to help decision makers make the best possible choices. RESULTS: With an intervention cost of £6.47, the results from the RCT showed the healthcare cost for the DR-BNI intervention was £115.90 per child while the control had a healthcare cost of £119.46 per child. The QALYs gained for the prevention of reoccurrence of dental caries was higher in the DR-BNI intervention arm by 0.023 QALYs; thus, the DR-BNI was the dominant intervention. At willingness to pay threshold of £3500/QALY gained, a maximum probability of being cost effectiveness is achieved at 86%. The secondary analysis showed a cost-savings of £20.94 per participant for the prevention of at least one filling or extraction. Affordability results showed that the DR-BNI programme is affordable to the UK health system at a moderately low budget. CONCLUSIONS: This study shows the proactive talking intervention to have a very moderate cost and to be effective in providing better health related quality-of-life gains. The intervention is cost savings with a dominant ICER even with a 200% increase in the cost of intervention. The NHS will be providing better oral health for children at a better net monetary benefit-to-risk ratio by adopting the DR-BNI intervention in preventing the reoccurrence of dental fillings and extractions for each participant. Trial Registration: This trial was registered prospectively on 27th September 2013 with the trial registration number ISRCTN 24958829. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40258-022-00720-5

Identification of platform-independent gene expression markers of cisplatin nephrotoxicity.

Within the International Life Sciences Institute Committee on Genomics, a working group was formed to focus on the application of microarray technology to preclinical assessments of drug-induced nephrotoxicity. As part of this effort, Sprague-Dawley rats were treated with the nephrotoxicant cisplatin at doses of 0.3-5 mg/kg over a 4- to 144-hr time course. RNA prepared from these animals was run on a variety of microarray formats at multiple sites. A set of 93 differentially expressed genes associated with cisplatin-induced renal injury was identified on the National Institute of Environmental Health Sciences (NIEHS) custom cDNA microarray platform using quadruplicate measurements of pooled animal RNA. The reproducibility of this profile of statistically significant gene changes on other platforms, in pooled and individual animal replicate samples, and in an independent study was investigated. A good correlation in response between platforms was found among the 48 genes in the NIEHS data set that could be matched to probes on the Affymetrix RGU34A array by UniGene identifier or sequence alignment. Similar results were obtained with genes that could be linked between the NIEHS and Incyte or PHASE-1 arrays. The degree of renal damage induced by cisplatin in individual animals was commensurate with the number of differentially expressed genes in this data set. These results suggest that gene profiles linked to specific types of tissue injury or mechanisms of toxicity and identified in well-performed replicated microarray experiments may be extrapolatable across platform technologies, laboratories, and in-life studies

A new primary dental care service compared with standard care for child and family to reduce the re-occurrence of childhood dental caries (Dental RECUR): study protocol for a randomised controlled trial

Background: In England and Scotland, dental extraction is the single highest cause of planned admission to the hospital for children under 11 years. Traditional dental services have had limited success in reducing this disease burden. Interventions based on motivational interviewing have been shown to impact positively dental health behaviours and could facilitate the prevention of re-occurrence of dental caries in this high-risk population. The objective of the study is to evaluate whether a new, dental nurse-led service, delivered using a brief negotiated interview based on motivational interviewing, is a more cost-effective service than treatment as usual, in reducing the re-occurrence of dental decay in young children with previous dental extractions. Methods/Design: This 2-year, two-arm, multicentre, randomised controlled trial will include 224 child participants, initially aged 5 to 7 years, who are scheduled to have one or more primary teeth extracted for dental caries under general anaesthesia (GA), relative analgesia (RA: inhalation sedation) or local anaesthesia (LA). The trial will be conducted in University Dental Hospitals, Secondary Care Centres or other providers of dental extraction services across the United Kingdom. The intervention will include a brief negotiated interview (based on the principles of motivational interviewing) delivered between enrolment and 6 weeks post-extraction, followed by directed prevention in primary dental care. Participants will be followed up for 2 years. The main outcome measure will be the dental caries experienced by 2 years post-enrolment at the level of dentine involvement on any tooth in either dentition, which had been caries-free at the baseline assessment. Discussion: The participants are a hard-to-reach group in which secondary prevention is a challenge. Lack of engagement with dental care makes the children and their families scheduled for extraction particularly difficult to recruit to an RCT. Variations in service delivery between sites have also added to the challenges in implementing the Dental RECUR protocol during the recruitment phase. Trial registration: ISRCTN24958829 (date of registration: 27 September 2013), Current protocol version: 5.0

Use of a mixed tissue RNA design for performance assessments on multiple microarray formats

The comparability and reliability of data generated using microarray technology would be enhanced by use of a common set of standards that allow accuracy, reproducibility and dynamic range assessments on multiple formats. We designed and tested a complex biological reagent for performance measurements on three commercial oligonucleotide array formats that differ in probe design and signal measurement methodology. The reagent is a set of two mixtures with different proportions of RNA for each of four rat tissues (brain, liver, kidney and testes). The design provides four known ratio measurements of >200 reference probes, which were chosen for their tissue-selectivity, dynamic range coverage and alignment to the same exemplar transcript sequence across all three platforms. The data generated from testing three biological replicates of the reagent at eight laboratories on three array formats provides a benchmark set for both laboratory and data processing performance assessments. Close agreement with target ratios adjusted for sample complexity was achieved on all platforms and low variance was observed among platforms, replicates and sites. The mixed tissue design produces a reagent with known gene expression changes within a complex sample and can serve as a paradigm for performance standards for microarrays that target other species

Cost-effectiveness Analysis of the Dental RECUR Pragmatic Randomized Controlled Trial: Evaluating a Goal-oriented Talking Intervention to Prevent Reoccurrence of Dental Caries in Children

Abstract: Background: The formation of dental caries is the most common chronic disease in children, and is preventable. The oral health-related quality of life has an immense impact on an individual’s daily functioning, well-being or overall quality of life. Objectives: This study aims to investigate the cost effectiveness of the Dental RECUR Brief Negotiated Interview for Oral Health (DR-BNI). This 30-minute therapeutic “talk” by a dental nurse with a parent/guardian was compared with a placebo-controlled intervention in preventing reoccurrence of dental caries in children who have had a primary tooth extracted. Methods: An economic model was developed to simulate the clinical progression of dental caries among children who have previously had a primary tooth extracted. The analysis was conducted using the UK NHS perspective. The main outcome was the incremental cost-effectiveness ratio (ICER) based on the quality-adjusted life years (QALYs). Estimates of costs and probabilities were obtained from the DR-BNI multicentre randomised controlled trial (RCT), while QALY values were obtained from published literature. Univariate and probabilistic sensitivity analyses were conducted to assess the uncertainty of the result and robustness of the model. Affordability and risk-aversion of the intervention were investigated to help decision makers make the best possible choices. Results: With an intervention cost of £6.47, the results from the RCT showed the healthcare cost for the DR-BNI intervention was £115.90 per child while the control had a healthcare cost of £119.46 per child. The QALYs gained for the prevention of reoccurrence of dental caries was higher in the DR-BNI intervention arm by 0.023 QALYs; thus, the DR-BNI was the dominant intervention. At willingness to pay threshold of £3500/QALY gained, a maximum probability of being cost effectiveness is achieved at 86%. The secondary analysis showed a cost-savings of £20.94 per participant for the prevention of at least one filling or extraction. Affordability results showed that the DR-BNI programme is affordable to the UK health system at a moderately low budget. Conclusions: This study shows the proactive talking intervention to have a very moderate cost and to be effective in providing better health related quality-of-life gains. The intervention is cost savings with a dominant ICER even with a 200% increase in the cost of intervention. The NHS will be providing better oral health for children at a better net monetary benefit-to-risk ratio by adopting the DR-BNI intervention in preventing the reoccurrence of dental fillings and extractions for each participant. Trial Registration: This trial was registered prospectively on 27th September 2013 with the trial registration number ISRCTN 24958829

Health-promoting schools: an opportunity for oral health promotion.

Schools provide an important setting for promoting health, as they reach over 1 billion children worldwide and, through them, the school staff, families and the community as a whole. Health promotion messages can be reinforced throughout the most influential stages of children's lives, enabling them to develop lifelong sustainable attitudes and skills. Poor oral health can have a detrimental effect on children's quality of life, their performance at school and their success in later life. This paper examines the global need for promoting oral health through schools. The WHO Global School Health Initiative and the potential for setting up oral health programmes in schools using the health-promoting school framework are discussed. The challenges faced in promoting oral health in schools in both developed and developing countries are highlighted. The importance of using a validated framework and appropriate methodologies for the evaluation of school oral health projects is emphasized

The promotion of oral health within the Healthy School context in England: a qualitative research study

Background Healthy Schools programmes may assist schools in improving the oral health of children through advocating a common risk factor approach to health promotion and by more explicit consideration of oral health. The objectives of this study were to gain a broad contextual understanding of issues around the delivery of oral health promotion as part of Healthy Schools programmes and to investigate the barriers and drivers to the incorporation of oral health promoting activities in schools taking this holistic approach to health promotion. Methods Semi-structured telephone interviews were carried out with coordinators of Healthy Schools programmes in the Northwest of England. Interview transcripts were coded using a framework derived from themes in the interview schedule. Results All 22 Healthy Schools coordinators participated and all reported some engagement of their Healthy Schools scheme with oral health promotion. The degree of this engagement depended on factors such as historical patterns of working, partnerships, resources and priorities. Primary schools were reported to have engaged more fully with both Healthy Schools programmes and aspects of oral health promotion than secondary schools. Participants identified healthy eating interventions as the most appropriate means to promote oral health in schools. Partners with expertise in oral health were key in supporting Healthy Schools programmes to promote oral health. Conclusion Healthy Schools programmes are supporting the promotion of oral health although the extent to which this is happening is variable. Structures should be put in place to ensure that the engagement of Healthy Schools with oral health is fully supported

Primary school-based behavioural interventions for preventing caries

To assess the clinical effectiveness of school-based interventions aimed at changing behaviour relating to tooth brushing habits and the frequency of consumption of cariogenic food and drink in children (4 to 12 year olds)