The Brod Group, Mill Valley, CA 94941, USA.
Health Qual Life Outcomes. 2013 Jul 31;11:130. doi: 10.1186/1477-7525-11-130.
Controlled Ovarian Stimulation (COS) is the first step for in vitro fertilization (IVF) treatment, a treatment often described and experienced as stressful to patients and their partners. COS also requires concerted efforts by the patients in administering medication and general compliance to treatment protocols. Little is known about the impacts on patients that may be specific to this important first step in treatment. The absence of a conceptually sound and well-validated measure assessing patient experience and functioning during ovarian stimulation has been an obstacle to understanding the impacts of ovarian stimulation on women pursuing IVF. To address this gap, the Controlled Ovarian Stimulation Impact Measure (COSI) was developed based upon accepted methods for designing patient reported outcome (PRO) measures. The purpose of this study was to psychometrically validate the COSI.
267 patients from three countries (Ireland, United Kingdom, United States) were administered the COSI. Psychometric validation was conducted according to an a priori statistical analysis plan.
The final 28-item COSI was found to have robust scale structure with four domains: Interference in Daily Life (Work and Home), Injection Burden, Psychological Health and Compliance Worry. Internal consistency of all domains was adequate (between 0.80 to 0.87) as was test-retest reliability (between 0.72-0.87). All a-priori hypotheses for convergent and known-groups validity tests were met.
There is a measurable impact of COS on patient functioning and well-being. The COSI is a well-developed and validated PRO measure of this impact. Future work should include examination of responsiveness and confirmation of concepts in non-western countries.
控制性卵巢刺激（COS）是体外受精（IVF）治疗的第一步，这一治疗过程常常被描述为对患者及其伴侣造成压力。COS 还需要患者共同努力，自行给药并严格遵守治疗方案。对于治疗过程中这一重要的第一步可能对患者产生的影响，我们知之甚少。缺乏一种概念合理且经过良好验证的评估卵巢刺激期间患者体验和功能的衡量标准，这一直是阻碍我们理解卵巢刺激对接受 IVF 治疗的女性产生影响的障碍。为了解决这一差距，根据设计患者报告结果（PRO）衡量标准的公认方法，开发了控制性卵巢刺激影响衡量标准（COSI）。本研究的目的是对 COSI 进行心理测量学验证。
来自三个国家（爱尔兰、英国、美国）的 267 名患者接受了 COSI 评估。根据预先设定的统计分析计划进行了心理测量学验证。
最终的 28 项 COSI 具有稳健的量表结构，分为四个领域：日常生活干扰（工作和家庭）、注射负担、心理健康和遵医嘱担忧。所有领域的内部一致性均足够（在 0.80 到 0.87 之间），重测信度也足够（在 0.72 到 0.87 之间）。所有关于聚合和已知组有效性测试的先验假设均得到满足。
COS 对患者的功能和幸福感有可衡量的影响。COSI 是一种经过充分开发和验证的该影响的 PRO 衡量标准。未来的工作应包括对反应性的检查和在非西方国家的概念确认。
