Feasibility of an internet-based study of time-to-pregnancy in the United States

描述（由研究者提供）：大约10-15%的夫妇患有不孕症，其患病率在美国正在增加。不孕不育服务的使用构成了主要的经济负担，治疗成功率相对较低。我们建议对延迟怀孕时间（TTP）的风险因素进行基于互联网的可行性研究，TTP是夫妇生育能力的敏感指标。通过在FACEBOOK（流行社交网站）和其他社交和健康相关网站上投放有针对性的互联网广告，我们将招募2，500名年龄在21-44岁之间的马萨诸塞州计划怀孕的女性居民。为了增加少数族裔的入学率，我们将对非裔美国人（20%）和西班牙裔（15%）妇女进行过度抽样。经过一个短暂的磨合期，以验证参与者的身份和参加为期一年的研究的意愿，参与者将使用基于网络的问卷调查，每8周进行一次，持续12个月，或直到临床公认的怀孕发生，以先发生者为准。女性参与者的男性伴侣将被要求完成一份关于生活方式和病史的基于网络的基线问卷。一半的入组女性将在基线时随机接受免费访问基于网络的月经图表软件（Fertility.com），可通过计算机和智能手机获得。本研究的主要目的是评估使用互联网进行招募、随访和数据收集的可行性、有效性和效率。其次，它将评估延迟TTP的几个潜在风险因素，包括咖啡因，人体测量因素，体力活动和抗抑郁药的使用。第三，它将评估使用基于网络的月经图表软件是否会增加队列保留并缩短TTP。在研究的前12个月内怀孕和分娩的一部分妇女中，我们将调查问卷数据与来自马萨诸塞州公共卫生部生命记录登记处的出生登记数据联系起来。登记数据将用于验证自我报告的TTP和其他问卷数据（例如，怀孕前体重指数）。我们优先考虑常见的危险因素，现有的研究，他们与TTP的关系是不确定的。所提出的前瞻性设计是新颖的，因为大多数关于生育能力的研究都对怀孕妇女的TTP进行了回顾性评估，这种方法容易产生选择和回忆偏倚。此外，以前没有TTP研究评估将基于网络的月经图表软件纳入其协议的影响。互联网将使我们能够识别计划怀孕的妇女，这是一个具有挑战性的人群，使用传统的流行病学方法。最近，我们的研究团队在丹麦的TTP前瞻性队列研究中证明，基于互联网的方法是一种有效且具有成本效益的招募和随访方法。不过，这些方法的可行性还有待于在美国进行测试。这样的设计可能对流行病学的实践产生深远的影响。

DESCRIPTION (provided by investigator): About 10-15% of couples suffer from infertility and its prevalence is increasing in the United States. Use of infertility services constitutes a major economic burden, and success rates of treatment are relatively low. We propose to conduct an internet-based feasibility study of risk factors for delayed time-to-pregnancy (TTP), a sensitive indicator of a couple's fertility. With targeted internet advertisements on FACEBOOK (popular social- networking website) and other social- and health-related websites, we will recruit a cohort of 2,500 female residents of Massachusetts aged 21-44 years who are planning a pregnancy. To increase minority enrollment, we will oversample African American (20%) and Hispanic (15%) women. After a short run-in period to verify a participant's identity and willingness to participate in a year-long study, participants will be followed using web-based questionnaires every 8 weeks for 12 months or until clinically-recognized pregnancy occurs, whichever comes first. The male partners of female participants will be asked to complete a web- based baseline questionnaire on lifestyle and medical history. Half of enrolled women will be randomized at baseline to receive free access to web-based menstrual charting software (FertilityFriend.com), available to them via both computer and smartphone. The primary aim of the study will be to assess the feasibility, validity, and efficiency of using the internet for recruitment, follow-up, and data collection. Secondarily, it will evaluate several potential risk factors for delayed TTP, including caffeine, anthropometric factors, physical activity, and antidepressant use. Thirdly, it will assess whether use of the web-based menstrual charting software increases cohort retention and shortens TTP. In a subset of women who conceive and deliver births during the first 12 months of the study, we will link questionnaire data with birth registry data from the Massachusetts Department of Public Health Registry of Vital Records. Registry data will be used to validate self-reported TTP and other questionnaire data (e.g., prepregnancy body mass index). We have given priority to common risk factors for which existing studies of their relation to TTP are inconclusive. The proposed prospective design is novel because most studies of fecundability have evaluated the TTP retrospectively among women who become pregnant, a method prone to selection and recall biases. Moreover, no previous TTP study has evaluated the impact of incorporating web-based menstrual charting software into its protocol. The internet will allow us to identify women planning a pregnancy, a challenging population to target using traditional epidemiologic methods. Recently, our research team demonstrated that internet-based methods are an efficient and cost-effective means of recruitment and follow-up in a prospective cohort study of TTP in Denmark. However, the feasibility of these methods remains to be tested in the United States. Such a design could have far-ranging implications for the practice of epidemiology.