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

Abstract 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 i...

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Autores principales:	Raíza Dias Freitas, Bruna Lorena Pereira Moro, Laura Regina Antunes Pontes, Haline Cunha Medeiros Maia, Ana Laura Passaro, Rodolfo Carvalho Oliveira, Jonathan Rafael Garbim, Maria Eduarda Franco Vigano, Tamara Kerber Tedesco, Christopher Deery, Daniela Prócida Raggio, Maximiliano Sergio Cenci, Fausto Medeiros Mendes, Mariana Minatel Braga, CARDEC collaborative group - CARDEC-03 trial
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Cost-effectiveness analysis Cost-utility analysis Dental caries Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/9f419c14b3eb47119a78fc1473a1417d
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id	oai:doaj.org-article:9f419c14b3eb47119a78fc1473a1417d
record_format	dspace
institution	DOAJ
collection	DOAJ
language	EN
topic	Cost-effectiveness analysis Cost-utility analysis Dental caries Medicine (General) R5-920
spellingShingle	Cost-effectiveness analysis Cost-utility analysis Dental caries Medicine (General) R5-920 Raíza Dias Freitas Bruna Lorena Pereira Moro Laura Regina Antunes Pontes Haline Cunha Medeiros Maia Ana Laura Passaro Rodolfo Carvalho Oliveira Jonathan Rafael Garbim Maria Eduarda Franco Vigano Tamara Kerber Tedesco Christopher Deery Daniela Prócida Raggio Maximiliano Sergio Cenci Fausto Medeiros Mendes Mariana Minatel Braga CARDEC collaborative group - CARDEC-03 trial 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
description	Abstract 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.
format	article
author	Raíza Dias Freitas Bruna Lorena Pereira Moro Laura Regina Antunes Pontes Haline Cunha Medeiros Maia Ana Laura Passaro Rodolfo Carvalho Oliveira Jonathan Rafael Garbim Maria Eduarda Franco Vigano Tamara Kerber Tedesco Christopher Deery Daniela Prócida Raggio Maximiliano Sergio Cenci Fausto Medeiros Mendes Mariana Minatel Braga CARDEC collaborative group - CARDEC-03 trial
author_facet	Raíza Dias Freitas Bruna Lorena Pereira Moro Laura Regina Antunes Pontes Haline Cunha Medeiros Maia Ana Laura Passaro Rodolfo Carvalho Oliveira Jonathan Rafael Garbim Maria Eduarda Franco Vigano Tamara Kerber Tedesco Christopher Deery Daniela Prócida Raggio Maximiliano Sergio Cenci Fausto Medeiros Mendes Mariana Minatel Braga CARDEC collaborative group - CARDEC-03 trial
author_sort	Raíza Dias Freitas
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMC
publishDate	2021
url	https://doaj.org/article/9f419c14b3eb47119a78fc1473a1417d
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spelling	oai:doaj.org-article:9f419c14b3eb47119a78fc1473a1417d2021-11-14T12:31:00ZThe economic impact of two diagnostic strategies in the management of restorations in primary teeth: a health economic analysis plan for a trial-based economic evaluation10.1186/s13063-021-05722-71745-6215https://doaj.org/article/9f419c14b3eb47119a78fc1473a1417d2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05722-7https://doaj.org/toc/1745-6215Abstract 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.Raíza Dias FreitasBruna Lorena Pereira MoroLaura Regina Antunes PontesHaline Cunha Medeiros MaiaAna Laura PassaroRodolfo Carvalho OliveiraJonathan Rafael GarbimMaria Eduarda Franco ViganoTamara Kerber TedescoChristopher DeeryDaniela Prócida RaggioMaximiliano Sergio CenciFausto Medeiros MendesMariana Minatel BragaCARDEC collaborative group - CARDEC-03 trialBMCarticleCost-effectiveness analysisCost-utility analysisDental cariesMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-11 (2021)

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

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