Zaat T R, de Bruin J P, Mol F, van Wely M
Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Department of Obstetrics and Gynaecology, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, the Netherlands.
Hum Reprod Open. 2022 May 30;2022(3):hoac021. doi: 10.1093/hropen/hoac021. eCollection 2022.
What are the facilitators and barriers concerning the implementation of home-based monitoring for natural cycle frozen embryo transfer (NC-FET) from the perspectives of patients and healthcare providers in the Netherlands?
The most important facilitator was optimal pregnancy chance for both the patients and healthcare providers, and the most important barriers were the risk of missing an ovulation for the patients and laboratory capacity for the healthcare providers.
The share of FET cycles in IVF treatments is increasing and, therefore, it is important to optimize protocols for FET. Monitoring of ovulation, which is used in NC-FET, can be hospital-based (ultrasounds and ovulation triggering) or home-based (LH urine tests). Home-based monitoring has the advantage of being the most natural protocol for FET and provides the feeling of empowerment and discretion for patients. A systematic approach for the implementation of home-based monitoring has to start with an exploration of the perspectives of all stakeholders.
Stakeholders (patients and healthcare providers) involved in the implementation process in the Netherlands participated in the present study. Patients were represented by the Dutch Patient Organisation for Couples with Fertility Problems (FREYA) and healthcare providers were represented by gynaecologists and their society (The Netherlands Society of Obstetrics and Gynaecology), embryologists and their society (The Dutch Federation of Clinical Embryology) as well as fertility doctors. A panel of experts hypothesized on barriers and facilitators for the implementation of home-based monitoring during the proposal phase of the Antarctica-2 randomized controlled trial (RCT).
PARTICIPANTS/MATERIALS SETTING METHODS: All stakeholders were represented during the study. Two different questionnaires were developed in order to investigate facilitators and barriers for the patients and for healthcare providers. The facilitators and barriers were ranked on a scale of 1-10 with 10 being the most important. Based on our power analysis, we aimed for a minimum of 300 completed questionnaires for the patients and a minimum of 90 completed questionnaires for the healthcare providers. Facilitators and barriers were analysed using frequencies, mean (SD) and ranking.
A total of 311 patients filled out the questionnaire of whom 86.8% underwent FET previously. The most important facilitator for the patients was to implement the strategy with the highest chance of pregnancy (mean 9.7; 95% CI 9.6-9.7) and the most important barrier was risk of missing ovulation (mean 8.4; 95% CI 8.2-8.6). A total of 96 healthcare providers filled out the questionnaire. According to healthcare providers, patients would accept the strategy when it causes less interference with their work and private life (mean 7.5; 95% CI 7.1-8.0) and has a low risk of missing the ovulation (mean 7.6; 95% CI 7.1-8.0). The most important facilitator for the implementation of home-based monitoring for healthcare providers was optimizing cumulative pregnancy rates (mean 8.1; 95% CI 7.7-8.4) and the most important barrier was the lack of laboratory capacity and flexibility (mean 6.4; 95% CI 5.8-7.0).
Facilitators and barriers were selected based on expert opinion. Currently, there are no validated questionnaires that aim to assess facilitators and barriers for the implementation of treatments in fertility care.
During our study, we gained insight into barriers and facilitators for the implementation of home-based monitoring of NC-FET at an early phase. Early sharing and discussion of the results of this study with all stakeholders involved should stimulate a fast incorporation in guidelines, especially as key professionals in guideline development took part in this study. Also, based on our results, we can advise guideline developers to add tools to the guideline that may help overcome the implementation barriers.
STUDY FUNDING/COMPETING INTERESTS: The Antarctica-2 RCT is supported by a grant from the Netherlands Organisation for Health Research and Development (ZonMw 843002807). No authors have any competing interests to declare.
Trial NL6414 (NTR6590).
从荷兰患者和医疗服务提供者的角度来看，实施自然周期冷冻胚胎移植（NC-FET）的家庭监测的促进因素和障碍有哪些？
最重要的促进因素是对患者和医疗服务提供者而言都有最佳的怀孕几率，而最重要的障碍是患者错过排卵的风险以及医疗服务提供者的实验室能力。
体外受精治疗中冷冻胚胎移植周期的占比正在增加，因此，优化冷冻胚胎移植方案很重要。自然周期冷冻胚胎移植中使用的排卵监测可以是基于医院的（超声检查和排卵触发）或基于家庭的（促黄体生成素尿液检测）。家庭监测的优势在于它是冷冻胚胎移植最自然的方案，并且能为患者提供自主感和决定权。实施家庭监测的系统方法必须从探索所有利益相关者的观点开始。
参与荷兰实施过程的利益相关者（患者和医疗服务提供者）参与了本研究。患者由荷兰生育问题夫妇患者组织（FREYA）代表，医疗服务提供者由妇科医生及其协会（荷兰妇产科学会）、胚胎学家及其协会（荷兰临床胚胎学联合会）以及生育医生代表。在南极洲-2随机对照试验（RCT）的提案阶段，一个专家小组对实施家庭监测的障碍和促进因素进行了假设。
参与者/材料设置方法：研究期间所有利益相关者都有代表参与。为了调查患者和医疗服务提供者的促进因素和障碍，开发了两种不同的问卷。促进因素和障碍按1至10分进行排名，10分为最重要。根据我们的功效分析，我们的目标是患者至少完成300份问卷，医疗服务提供者至少完成90份问卷。使用频率、均值（标准差）和排名对促进因素和障碍进行分析。
共有311名患者填写了问卷，其中86.8%之前接受过冷冻胚胎移植。对患者来说最重要的促进因素是实施怀孕几率最高的策略（均值9.7；95%置信区间9.6 - 9.7），最重要的障碍是错过排卵的风险（均值8.4；95%置信区间8.2 - 8.6）。共有96名医疗服务提供者填写了问卷。据医疗服务提供者称，当策略对患者的工作和私人生活干扰较小时（均值7.5；95%置信区间7.1 - 8.0）且错过排卵的风险较低时（均值7.6；95%置信区间7.1 - 8.0），患者会接受该策略。对医疗服务提供者实施家庭监测来说最重要的促进因素是优化累积妊娠率（均值8.1；95%置信区间7.7 - 8.4），最重要的障碍是缺乏实验室能力和灵活性（均值6.4；95%置信区间5.8 - 7.0）。
促进因素和障碍是基于专家意见选择的。目前，没有经过验证的问卷旨在评估生育护理中实施治疗的促进因素和障碍。
在我们的研究中，我们在早期阶段深入了解了实施自然周期冷冻胚胎移植家庭监测的障碍和促进因素。尽早与所有相关利益者分享和讨论本研究结果应能促进其快速纳入指南，特别是因为指南制定的关键专业人员参与了本研究。此外，根据我们的结果，我们可以建议指南制定者在指南中添加可能有助于克服实施障碍的工具。
研究资金/利益冲突：南极洲-2随机对照试验由荷兰卫生研究与发展组织（ZonMw 843002807）的一项拨款支持。没有作者有任何利益冲突需要声明。
试验NL6414（NTR6590）
