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

描述（由研究者提供）：在美国，大约10-15%的夫妇患有不孕症，其患病率正在上升。使用不孕症服务是一个主要的经济负担，治疗成功率相对较低。我们建议对延迟怀孕（TTP）的风险因素进行基于互联网的可行性研究，TTP是一对夫妇生育能力的敏感指标。通过在FACEBOOK（流行的社交网站）和其他社交与健康相关的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、计划怀孕的马萨诸塞州女性居民。为了增加少数族裔的入学率，我们将对非裔美国女性（20%）和西班牙裔女性（15%）进行抽样调查。在验证参与者的身份和参与为期一年的研究的意愿后，参与者将每8周接受一次基于网络的问卷调查，持续12个月，或者直到临床确认怀孕，以先到者为准。女性参与者的男性伴侣将被要求完成一份基于网络的生活方式和病史基线问卷。一半的入选女性将在基线时随机分配，免费获得基于网络的月经图表软件（ferilityfriend.com），可通过电脑和智能手机使用。本研究的主要目的是评估利用互联网进行招聘、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、身体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率并缩短TTP。在研究的前12个月内怀孕并分娩的妇女的一个子集中，我们将把问卷调查数据与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。注册数据将用于验证自我报告的TTP和其他问卷数据（如孕前体重指数）。我们优先考虑了常见的危险因素，现有的研究表明它们与TTP的关系尚无定论。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是对怀孕妇女的TTP进行回顾性评估，这种方法容易产生选择和回忆偏差。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方案的影响。互联网将使我们能够识别计划怀孕的妇女，这是一个使用传统流行病学方法难以定位的人群。最近，我们的研究小组在丹麦的一项TTP前瞻性队列研究中证明，基于互联网的方法是一种高效且经济的招募和随访手段。然而，这些方法在美国的可行性仍有待检验。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.