The economic impact of two diagnostic strategies in the management of restorations in primary teeth: a health economic analysis plan for a trial-based economic evaluation.

BACKGROUND: Different approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. Indeed, using a more interventionist strategy (the World Dental Federation - FDI), more replacements tend to be indicated than using a minimally invasive one (based on the Caries Around Restorations and Sealants-CARS). Since the resources related to the long-term health effects of these strategies have not been explored, the economic impact of using the less-invasive strategy is still uncertain. Thus, this health economic analysis plan aims to describe methodologic approaches for conducting a trial-based economic evaluation that aims to assess whether a minimally invasive strategy is more efficient in allocating resources than the conventional strategy for managing restorations in primary teeth and extrapolating these findings to a longer time horizon. METHODS: A trial-based economic evaluation will be conducted, including three cost-effectiveness analyses (CEA) and one cost-utility analysis (CUA). These analyses will be based on the main trial (CARDEC-03/ NCT03520309 ), in which children aged 3 to 10 were included and randomized to one of the diagnostic strategies (based on FDI or CARS). An examiner will assess children's restorations using the randomized strategy, and treatment will be recommended according to the same criteria. The time horizon for this study is 2 years, and we will adopt the societal perspective. The average costs per child for 24 months will be calculated. Three different cost-effectiveness analyses (CEA) will be performed. For CEAs, the effects will be the number of operative interventions (primary CEA analysis), the time to these new interventions, the percentage of patients who did not need new interventions in the follow-up, and changes in children's oral health-related quality of life (secondary analyses). For CUA, the effect will be tooth-related quality-adjusted life years (QALYs). Intention-to-treat analyses will be conducted. Finally, we will assess the difference when using the minimally invasive strategy for each health effect (∆effect) compared to the conventional strategy (based on FDI) as the reference strategy. The same will be calculated for related costs (∆cost). The discount rate of 5% will be applied for costs and effects. We will perform deterministic and probabilistic sensitivity analyses to handle uncertainties. The net benefit will be calculated, and acceptability curves plotted using different willingness-to-pay thresholds. Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon. DISCUSSION: The main trial is ongoing, and data collection is still not finished. Therefore, economic evaluation has not commenced. We hypothesize that conventional strategy will be associated with more need for replacements of restorations in primary molars. These replacements may lead to more reinterventions, leading to higher costs after 2 years. The health effects will be a crucial aspect to take into account when deciding whether the minimally invasive strategy will be more efficient in allocating resources than the conventional strategy when considering the management of restorations in primary teeth. Finally, patients/parents preferences and consequent utility values may also influence this final conclusion about the economic aspects of implementing the minimally invasive approach for managing restorations in clinical practice. Therefore, these trial-based economic evaluations may bring actual evidence of the economic impact of such interventions. TRIAL REGISTRATION: NCT03520309 . Registered May 9, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment.

O impacto econômico de duas estratégias de diagnóstico no manejo de restaurações em dentes decíduos: avaliação econômica baseada em um ensaio clínico / The economic impact of two diagnostic strategies in the management of restorations in primary teeth: a trial-based economic evaluation

O objetivo desta tese foi avaliar o impacto econômico de utilizar a estratégia Caries Around Restorations and Sealants (CARS) em substituição à estratégia da Federação Dentária Internacional (FDI) para avaliação e manejo de restaurações em dentes decíduos. Este volume apresenta dois capítulos relacionados ao objetivo da tese, sendo o primeiro um plano de avaliação econômica e o segundo uma avaliação econômica com diferentes Análises de Custo-Efetividade (CEAs). O plano de análise econômica propõe uma série de análises baseadas em um ensaio clínico randomizado. O ensaio clínico Caries Detection in Children 3 (CARDEC-03) incluiu participantes de 3 a 10 anos com pelo menos uma restauração em dente decíduo que foram aleatoriamente alocadas para um dos grupos, de acordo com a estratégia de diagnóstico (FDI ou CARS) a ser utilizada nas restaurações. Os participantes foram acompanhados por 2 anos. Para todas as avaliações, será utilizada a perspectiva da sociedade. Serão realizadas CEAs e Análise de Custo-Utilidade considerando o FDI como estratégia referência. Será realizada análise por intenção de tratar e as diferenças em custos e efeitos entre a estratégia CARS e a FDI serão avaliadas. Análises de sensibilidade determinísticas e probabilísticas serão realizadas e curvas de aceitabilidade serão construídas utilizando diferentes valores de disposição a pagar. Adicionalmente, um modelo de Markov será construído para avaliar um horizonte temporal maior. Além do plano de análises, esta tese também avaliou a custo-efetividade em utilizar a estratégia CARS em substituição à estratégia FDI para avaliação de restaurações em dentes decíduos. Para compreender melhor esta relação, foram avaliados 4 efeitos: número de novas intervenções operatórias, tempo até a necessidade de uma nova intervenção operatória, necessidade de novas intervenções operatórias e o número de novas substituições. Custos e efeitos foram comparados entre os grupos por medidas relativas, conforme a quantidade de restaurações incluídas por grupo. Simulações de Monte-Carlo avaliaram as incertezas ao redor dos parâmetros e curvas de aceitabilidades foram construídas. Dados de 163 pacientes e 650 restaurações foram utilizados para a avaliação econômica. Não houve diferença estatisticamente significante entre o custo e o número de novas intervenções operatórias das duas estratégias após 2 anos de acompanhamento. Através da análise dos dados simulados, o CARS demonstrou-se custo-efetivo nas quatro CEAs. Considerando um limiar de disposição a pagar de 100 dólares, esta estratégia apresentou Net Monetary Benefits (NMB) positivos para os efeitos número de novas intervenções operatórias, tempo até a necessidade de uma nova intervenção operatória e número de novas substituições. As simulações demonstraram que, considerando um limiar de disposição a pagar de 100 doláres, o CARS tem uma probabilidade de aproximadamente 90% de ser custo-efetivo considerando o efeito tempo até a necessidade de uma nova intervenção operatória. O pior cenário foi para o efeito necessidade de novas intervenções operatórias, no qual o CARS apresentou NMB negativo e uma probabilidade de aproximadamente 50% de ser custo-efetivo, considerando um limiar de disposição a pagar de 100 dólares. Em conclusão, o CARS é uma alternativa custo-efetiva ao FDI, sobretudo considerando o adiamento de novas intervenções operatórias em dentes decíduos.

The effect of two clinical criteria in the assessment of caries lesions around restorations in children (CARDEC-03): study protocol for a diagnostic randomized clinical trial.

Introduction: The detection of caries lesions around restoration can be challenging. Therefore, the use of some criteria has been proposed in order to give more objectivity to the diagnosis process. Two of them are the International Dental Federation (FDI) and the Caries Associated with Restorations and Sealants (CARS) criteria. Both methods have a different approach to caries, and it is not possible to know which one of them is the best to use in clinical practice to assess restorations in children. Thus, the present protocol aims to evaluate the effect of the use of the FDI and CARS criteria in the assessment of caries lesions around restorations in primary teeth on outcomes related to oral health in children and costs resulting from the assessments. Methods and analysis: A total of 626 restorations of children from three to 10 years were randomly assessed and are being treated following the FDI criteria (FDI group) or CARS criteria (CARS group). Participants will be followed-up after six, 12, 18, and 24 months. The primary outcome will be the need for a new intervention in the evaluated restorations. This outcome consists of several components, and each of these events will be analyzed separately as secondary outcomes. The changes in children's oral health-related quality of life and the cost of the restoration dental treatments will also be analyzed as secondary outcomes. The methods will be compared using the Cox regression model with shared frailty. A significance level of 5% will be adopted for all statistical analyses. Discussion: This will be the first randomized clinical study carried out regarding the detection of caries lesions around restorations in primary teeth. Trial registration: The study underwent registration in Clinicaltrials.gov ( NCT03520309) on 9 May 2018.

Economic evaluations in paediatric dentistry clinical trials.

Economic evaluations play an important role in identifying the cost-effectiveness of alternative healthcare programmes, informing decisions surrounding funding and the allocation of resources. This paper outlines the basic principles of economic evaluation and how it can be conducted alongside a clinical trial. Furthermore, it considers the ways in which evidence from these studies can be used, and the challenges researchers are faced with when conducting economic evaluations in the field of children's oral health.