Kersten F A M, Hermens R P G M, Braat D D M, Hoek A, Mol B W J, Goddijn M, Nelen W L D M
Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, Nijmegen 6500 HB, The Netherlands.
Scientific Institute for Quality of Healthcare, Radboud University Medical Center, PO Box 9101, Nijmegen 6500 HB, The Netherlands.
Hum Reprod. 2015 Jan;30(1):71-80. doi: 10.1093/humrep/deu262. Epub 2014 Oct 21.
What is the percentage of overtreatment, i.e. fertility treatment started too early, in couples with unexplained infertility who were eligible for tailored expectant management?
Overtreatment occurred in 36% of couples with unexplained infertility who were eligible for an expectant management of at least 6 months.
Prognostic models in reproductive medicine can help to identify infertile couples that would benefit from fertility treatment. In couples with unexplained infertility with a good chance of natural conception within 1 year, based on the Hunault prediction model, an expectant management of 6-12 months, as recommended in international fertility guidelines, prevents unnecessary treatment.
STUDY DESIGN, SIZE, DURATION: A retrospective cohort study in 25 participating clinics, with follow-up of all couples who were seen for infertility in 2011-2012.
PARTICIPANTS/MATERIALS, SETTING, METHODS: In all, 9818 couples were seen for infertility in the participating clinics. Couples were eligible to participate if they were diagnosed with unexplained infertility and had a good prognosis of natural conception (>30%) within 1 year based on the Hunault prediction model. Data to assess overtreatment were collected from medical records. Multilevel regression analyses were performed to investigate associations of overtreatment with patient and clinic characteristics.
Five hundred and forty-four couples eligible for expectant management were included in this study. Among these, overtreatment, i.e. starting medically assisted reproduction within 6 months, occurred in 36%. The underlying quality indicators showed that in 34% no prognosis was calculated and that in 42% expectant management was not recommended. Finally, 16% of the couples for whom a correct recommendation of expectant management for at least 6 months was made, started treatment within 6 months anyway. Overtreatment was associated with childlessness, higher female age and a longer duration of infertility. No associations between overtreatment and clinic characteristics were found.
LIMITATIONS, REASONS FOR CAUTION: The response rate was low compared with other fertility studies. Evaluation of possible selection bias showed that responders had a higher socio-economic status than non-responders.
Our findings show that developing and publishing guideline recommendations on tailored expectant management (TEM) is not enough and that overtreatment still occurs frequently. Future research should focus on tailored efforts to implement guideline recommendations on TEM.
STUDY FUNDING/COMPETING INTERESTS: Supported by Netherlands Organisation for Health Research and Development (ZonMW). ZonMW had no role in designing the study, data collection, analysis and interpretation of data or writing of the report. Competing interests: none.
www.trialregister.nl NTR3405.
对于符合个性化期待管理条件的不明原因不孕夫妇,过度治疗(即生育治疗开始得过早)的比例是多少?
在符合至少6个月期待管理条件的不明原因不孕夫妇中,36%发生了过度治疗。
生殖医学中的预后模型有助于识别能从生育治疗中获益的不孕夫妇。根据Hunault预测模型,对于自然受孕几率较大(一年内超过30%)的不明原因不孕夫妇,国际生育指南推荐进行6 - 12个月的期待管理,以避免不必要的治疗。
研究设计、规模、持续时间:一项在25家参与诊所进行的回顾性队列研究,对2011 - 2012年因不孕前来就诊的所有夫妇进行随访。
参与者/材料、环境、方法:共有9818对夫妇在参与诊所因不孕前来就诊。如果夫妇被诊断为不明原因不孕,且根据Hunault预测模型在1年内自然受孕预后良好(>30%),则有资格参与研究。从病历中收集评估过度治疗的数据。进行多水平回归分析以研究过度治疗与患者及诊所特征之间的关联。
本研究纳入了544对符合期待管理条件的夫妇。其中,36%发生了过度治疗,即在6个月内开始医学辅助生殖。潜在质量指标显示,34%未计算预后,42%未推荐期待管理。最后,对于那些被正确推荐至少进行6个月期待管理的夫妇,仍有16%在6个月内开始了治疗。过度治疗与无子女、女性年龄较大以及不孕时间较长有关。未发现过度治疗与诊所特征之间的关联。
局限性、谨慎理由:与其他生育研究相比,本研究的回应率较低。对可能的选择偏倚进行评估表明,回应者的社会经济地位高于未回应者。
我们的研究结果表明,仅制定和发布关于个性化期待管理(TEM)的指南建议是不够的,过度治疗仍然频繁发生。未来的研究应专注于为实施TEM指南建议而进行的针对性努力。
研究资金/利益冲突:由荷兰卫生研究与发展组织(ZonMW)资助。ZonMW在研究设计、数据收集、数据分析与解释或报告撰写方面没有参与。利益冲突:无。
www.trialregister.nl NTR3405