Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development Research Institute, University of Amsterdam, Amsterdam, The Netherlands.
BMJ Open. 2024 May 1;14(5):e075016. doi: 10.1136/bmjopen-2023-075016.
To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.
Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.
21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.
1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.
Pessary therapy and surgery.
The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of -10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.
For the PGI-I, the mean difference between pessary therapy and surgery was -0.05 (95% CI -0.14; 0.03) and -0.03 (95% CI -0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=-€1807, 95% CI -€2172; -€1446 and mean difference=-€1850, 95% CI -€2349; -€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives.
Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.
NTR4883.
从医疗保健和社会角度评估子宫脱垂（POP）中度至重度症状的女性中，使用子宫托治疗与手术相比作为初始治疗选择的成本效益。
伴随 24 个月随访的多中心随机对照非劣效性试验的经济评估。
荷兰 21 家医院，2015 年至 2022 年期间进行招募。
1605 名因脱垂症状≥2 期就诊于二级医疗机构的女性被邀请参加。其中，440 名女性知情同意并按 1:1 比例按医院分层随机分配至子宫托治疗（n=218）或手术（n=222）。
子宫托治疗和手术。
患者整体改善印象（PGI-I），7 分制，分为成功和不成功，非劣效性边界为-10%；通过 EQ-5D-3L 测量的质量调整生命年（QALYs）；医疗保健和社会成本基于病历和医疗技术评估研究所的问卷。
对于 PGI-I，子宫托治疗与手术之间的平均差异为-0.05（95% CI -0.14；0.03）和-0.03（95% CI -0.07；0.002）对于 QALYs。共有 54.1%随机分配至子宫托治疗的女性交叉至手术组，3.6%再次手术。子宫托治疗的医疗保健和社会成本显著较低（平均差值=-€1807，95% CI -€2172；-€1446 和平均差值=-€1850，95% CI -€2349；-€1341）。从两个角度来看，与手术相比，在€0 至€20000/QALY 获益的意愿支付阈值下，子宫托治疗具有成本效益的概率为 1。
在 PGI-I 方面，子宫托治疗不能显示非劣效性，并且干预措施之间 QALYs 没有统计学上的显著差异。由于成本显著降低，与手术相比，子宫托治疗作为二级保健中患有症状性 POP 的女性的初始治疗选择可能具有成本效益。
NTR4883。
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