Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, Lineu Prestes Avenue, 2227, São Paulo, SP, 05508000, Brazil.
School of Clinical Dentistry, University of Sheffield, Sheffield, UK.
Trials. 2021 Nov 12;22(1):794. doi: 10.1186/s13063-021-05722-7.
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.
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.
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.
NCT03520309 . Registered May 9, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment.
牙医在做出决策时采用了不同的方法。其中，可能存在导致更具干预性方法的审美问题。事实上，使用更具干预性的策略（世界牙科联合会-FDI）比使用微创策略（基于龋齿周围修复和密封剂-CARS）更倾向于进行更多的修复。由于尚未探讨这些策略的长期健康效果相关资源，因此使用微创策略的经济影响仍不确定。因此，本健康经济分析计划旨在描述进行基于试验的经济评估的方法学方法，该评估旨在评估微创策略在分配资源方面是否比传统策略更有效，用于管理乳牙的修复，并将这些发现推断到更长的时间范围。
将进行基于试验的经济评估，包括三项成本效益分析（CEA）和一项成本效用分析（CUA）。这些分析将基于主要试验（CARDEC-03/NCT03520309），其中纳入了年龄在 3 至 10 岁的儿童，并随机分配到两种诊断策略之一（基于 FDI 或 CARS）。评估员将根据随机策略评估儿童的修复情况，并根据相同的标准推荐治疗。本研究的时间范围为 2 年，我们将采用社会视角。将计算每个孩子在 24 个月内的平均成本。将进行三项不同的成本效益分析（CEA）。对于 CEA，效果将是手术干预的数量（主要 CEA 分析），这些新干预的时间，不需要在随访中进行新干预的患者的百分比，以及儿童口腔健康相关生活质量的变化（次要分析）。对于 CUA，效果将是牙齿相关的质量调整生命年（QALYs）。将进行意向治疗分析。最后，我们将评估与传统策略（基于 FDI）相比，使用微创策略对每种健康效果（∆效果）的差异，作为参考策略。对于相关成本（∆成本）也将进行相同的计算。将对成本和效果应用 5%的折扣率。我们将进行确定性和概率敏感性分析以处理不确定性。将计算净效益，并使用不同的支付意愿阈值绘制可接受性曲线。使用马尔可夫模型，将根据主要磨牙的寿命延长试验结果进行长期经济评估。
主要试验正在进行中，数据收集尚未完成。因此，经济评估尚未开始。我们假设传统策略与更多需要更换乳牙修复物的情况相关。这些更换可能会导致更多的再干预，导致 2 年后的成本更高。健康效果将是决定微创策略在分配资源方面是否比传统策略更有效的关键方面，当考虑在临床实践中管理乳牙修复物时。最后，患者/家长的偏好和相应的效用值也可能影响关于在临床实践中实施微创方法管理修复物的经济方面的最终结论。因此，这些基于试验的经济评估可能会带来这些干预措施的经济影响的实际证据。
NCT03520309。于 2018 年 5 月 9 日注册。目前尚未启动经济评估（本计划的重点）。
