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

描述(由调查人员提供)：大约10%-15%的夫妇患有不孕症，而且在美国，不孕不育的发病率正在上升。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。我们建议对怀孕延迟时间(TTP)的风险因素进行一项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(流行的社交网站)和其他社交和健康相关网站上发布有针对性的互联网广告，我们将招募2500名年龄在21-44岁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人数，我们将对非裔美国人(20%)和西班牙裔(15%)女性进行过抽样。在经过一段短时间的试探期以验证参与者的身份和参与为期一年的研究的意愿后，参与者将在12个月内每8周使用基于网络的问卷进行跟踪，或者直到发生临床公认的怀孕，以先发生的为准。女性参与者的男性伴侣将被要求完成一份基于网络的关于生活方式和病史的基线问卷。一半登记的女性将在基线上随机接受基于网络的月经图表软件(FertilityFriend.com)的免费访问，该软件可通过电脑和智能手机获得。这项研究的主要目的将是评估使用互联网进行招聘、跟踪和数据收集的可行性、有效性和效率。其次，它将评估延迟TTP的几个潜在危险因素，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，它将评估基于网络的月经图表软件的使用是否增加了队列保留率并缩短了TTP。在研究的前12个月怀孕和分娩的女性中，我们将把问卷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。登记数据将用于验证自我报告的TTP和其他问卷数据(例如孕前体重指数)。我们优先考虑了常见的危险因素，现有的关于它们与TTP关系的研究尚不确定。拟议的前瞻性设计是新颖的，因为大多数关于受孕能力的研究都对怀孕妇女的TTP进行了回溯性评估，这一方法容易出现选择和回忆偏差。此外，之前没有一项TTP研究评估过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女性，这是一个使用传统流行病学方法进行攻击的具有挑战性的人群。最近，我们的研究团队在丹麦TTP的一项前瞻性队列研究中证明，基于互联网的方法是一种高效且成本效益高的招募和跟进手段。不过，这些方法的可行性仍有待美国方面的检验。这样的设计可能会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.