University of Groningen, University Medical Center Groningen, Department of General Practice and Elderly Care Medicine, Groningen, The Netherlands.
Pelvicum kinderbekkenfysiotherapie, Paediatric Pelvic Physiotherapy, Groningen, The Netherlands.
Fam Pract. 2022 Jul 19;39(4):662-668. doi: 10.1093/fampra/cmab147.
Health care expenditures for children with functional constipation (FC) are high, while conservative management is successful in only 50% of the children. The aim is to evaluate whether adding physiotherapy to conventional treatment (CT) is a cost-effective strategy in the management of children with FC aged 4-18 years in primary care.
A cost-effectiveness analysis was performed alongside a randomized controlled trial (RCT) with 8-month follow-up. Costs were assessed from a societal perspective, effectiveness included both the primary outcome (treatment success defined as the absence of FC and no laxative use) and the secondary outcome (absence of FC irrespective of laxative use). Uncertainty was assessed by bootstrapping and cost-effectiveness acceptability curves (CEACs) were displayed.
One hundred and thirty-four children were randomized. The incremental cost-effectiveness ratio (ICER) for one additional successfully treated child in the physiotherapy group compared with the CT group was €24,060 (95% confidence interval [CI] €-16,275 to €31,390) and for the secondary outcome €1,221 (95% CI €-12,905 to €10,956). Subgroup analyses showed that for children with chronic laxative use the ICER was €2,134 (95% CI -24,975 to 17,192) and €571 (95% CI 11 to 3,566), respectively. At a value of €1,000, the CEAC showed a probability of 0.53 of cost-effectiveness for the primary outcome, and 0.90 for the secondary outcome.
Physiotherapy added to CT as first-line treatment for all children with FC is not cost-effective compared with CT alone. Future studies should consider the cost-effectiveness of physiotherapy added to CT in children with chronic laxative use.
The RCT is registered in the Netherlands Trial Register (NTR4797), on the 8th of September 2014. The first child was enrolled on the 2nd of December 2014. https://www.trialregister.nl/trial/4654.
患有功能性便秘（FC）的儿童医疗支出较高，而保守治疗仅对 50%的儿童有效。本研究旨在评估在初级保健中对 4-18 岁 FC 患儿采用添加物理疗法与常规治疗（CT）的对比，是否为一种具有成本效益的策略。
在一项 8 个月随访的随机对照试验（RCT）中进行成本效果分析。从社会角度评估成本，效果包括主要结局（定义为无 FC 且无泻药使用的治疗成功）和次要结局（无论是否使用泻药，均无 FC）。采用 bootstrap 进行不确定性评估，并展示成本效果可接受性曲线（CEAC）。
共有 134 名患儿被随机分组。与 CT 组相比，物理治疗组每多成功治疗一名患儿的增量成本效果比（ICER）为 24,060 欧元（95%置信区间 [CI] -16,275 至 31,390 欧元），次要结局为 1,221 欧元（95% CI -12,905 至 10,956 欧元）。亚组分析显示，对于慢性泻药使用者，ICER 分别为 2,134 欧元（95% CI -24,975 至 17,192 欧元）和 571 欧元（95% CI 11 至 3,566 欧元）。在 1,000 欧元的阈值下，CEAC 显示主要结局的成本效果概率为 0.53，次要结局为 0.90。
与 CT 单独治疗相比，将物理治疗作为所有 FC 患儿的一线治疗方法添加到 CT 中并不具有成本效益。未来的研究应考虑在慢性泻药使用者中添加物理治疗的成本效果。
RCT 于 2014 年 9 月 8 日在荷兰临床试验注册中心（NTR4797）注册，首位患儿于 2014 年 12 月 2 日入组。https://www.trialregister.nl/trial/4654。
