初级医疗干预治疗男性下尿路症状的成本效益：TRIUMPH 集群随机对照试验。

Cost-effectiveness of a primary healthcare intervention to treat male lower urinary tract symptoms: the TRIUMPH cluster randomised controlled trial.

机构信息

Population Health Sciences, University of Bristol, Bristol, UK

Department of Surgery & Cancer, Imperial College London, London, UK.

出版信息

BMJ Open. 2024 Jan 30;14(1):e075704. doi: 10.1136/bmjopen-2023-075704.

DOI:10.1136/bmjopen-2023-075704

PMID:38296301

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10828877/

Abstract

OBJECTIVES

To estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care.

DESIGN

Economic evaluation alongside a cluster randomised controlled trial from a UK National Health Service (NHS) perspective with a 12-month time horizon.

SETTING

Thirty NHS general practice sites in England.

PARTICIPANTS

1077 men aged 18 or older identified in primary care with bothersome LUTS.

INTERVENTIONS

A standardised and manualised intervention for the treatment of bothersome LUTS was compared with usual care. The intervention group (n=524) received a standardised information booklet with guidance on conservative treatment for LUTS, urinary symptom assessment and follow-up contacts for 12 weeks. The usual care group (n=553) followed local guidelines between general practice sites.

MEASURES

Resource use was obtained from electronic health records, trial staff and participants, and valued using UK reference costs. Quality-adjusted life-years (QALYs) were calculated from the EQ-5D-5L questionnaire. Adjusted mean differences in costs and QALYs and incremental net monetary benefit were estimated.

RESULTS

866 of 1077 (80.4%) participants had complete data and were included in the base-case analysis. Over the 12-month follow-up period, intervention and usual care arms had similar mean adjusted costs and QALYs. Mean differences were lower in the intervention arm for adjusted costs -£29.99 (95% CI -£109.84 to £22.63) while higher in the intervention arm for adjusted QALYs 0.001 (95% CI -0.011 to 0.014). The incremental net monetary benefit statistic was £48.01 (95% CI -£225.83 to £321.85) at the National Institute for Health and Care Excellence UK threshold of £20 000 per QALY. The cost-effectiveness acceptability curve showed a 63% probability of the intervention arm being cost-effective at this threshold.

CONCLUSIONS

Costs and QALYs were similar between the two arms at 12 months follow-up. This indicates that the intervention can be implemented in general practice at neutral cost.

TRIAL REGISTRATION NUMBER

ISRCTN11669964.

摘要

目的

从英国国家医疗服务体系（NHS）的角度，对初级保健干预治疗男性下尿路症状（LUTS）与常规护理的成本效益进行评估。

设计

从 NHS 的角度，对一项初级保健干预治疗男性下尿路症状（LUTS）的随机对照试验进行经济评估，时间范围为 12 个月。

地点

英格兰 30 个 NHS 基层医疗点。

参与者

在基层医疗中被确诊为患有烦扰性 LUTS 的 1077 名年龄在 18 岁及以上的男性。

干预措施

对烦扰性 LUTS 进行标准化和手动干预，与常规护理进行比较。干预组（n=524）接受标准化信息手册，其中包括 LUTS 保守治疗、尿症状评估和 12 周随访的指导。常规护理组（n=553）遵循基层医疗点之间的当地指南。

措施

资源使用情况从电子健康记录、试验工作人员和参与者处获得，并根据英国参考成本进行估值。使用 EQ-5D-5L 问卷计算质量调整生命年（QALY）。估计了成本和 QALY 的调整平均值差异以及增量净货币收益。

结果

1077 名参与者中的 866 名（80.4%）完成了数据并纳入了基础案例分析。在 12 个月的随访期间，干预组和常规护理组的平均调整成本和 QALY 相似。干预组的调整成本低£29.99（95%CI -£109.84 至 £22.63），而干预组的调整 QALY 高 0.001（95%CI -0.011 至 0.014）。在英国国民保健制度的£20000 每 QALY 阈值下，增量净货币收益统计数据为£48.01（95%CI -£225.83 至 £321.85）。成本效益接受性曲线显示，在该阈值下，干预组的成本效益有 63%的可能性。