分析导致女性参与（或不参与）新生儿队列研究的动机。
Analysis of motivations that lead women to participate (or not) in a newborn cohort study.
机构信息
Institute for Maternal and Child Health, IRCCS Burlo Garofolo, via dell'Istria, 65/1, 34137, Trieste, Italy.
出版信息
BMC Pediatr. 2013 Apr 11;13:53. doi: 10.1186/1471-2431-13-53.
BACKGROUND
Little is known about reasons that influence parents' decision to participate in studies enrolling healthy children. The aim of this observational study was to verify the reasons that lead pregnant women to give their consent or to refuse participation to a newborn cohort study with a long follow up time.
METHODS
To prospectively investigate the reasons that lead women to participate, to refuse the participation or to withdraw from a newborn cohort study, three different questionnaires were administered to pregnant women contacted or enrolled in the Phime cohort study, carried out in an Italian Hospital from 2007 to 2010.
RESULTS
Phime study participation was refused by 304 women and 145 withdrew their consent during the follow up. All these women filled in the related questionnaires. Within 632 mothers in follow up at 18 months, 430 filled in the questionnaire on motivation to participate: 97% stated that the main reason was to contribute to research; 96% and 90% stated that they wanted to benefit future babies' and mothers' health. Ninety-six percent of women would appreciate to know the results of analysis carried out on biological samples collected and of the overall study results. One third of the mothers (37%) wanted to be involved in the definition of future similar studies, bringing their experience and their views. Within the 304 women who refused participation, 56% stated that the study was too demanding, 26% was not interested in participating and 18% was concerned about the need to collect biological samples and to be submitted to neurocognitive tests. Fifty-two percent of 145 women who withdrew after enrollment stated that the study was too demanding (52%), and 6% was concerned about the biological samples collection.
CONCLUSIONS
The altruistic reason appears to be the main reported by women to decide to participate in a newborn cohort study. The fact that the study was too demanding and the need to collect biological samples are important reasons that lead women to refuse participation or to withdraw from the study. An adequate communication on these aspects should minimize difficulties in enrolment and losses to follow up.
背景
对于影响父母决定参与招募健康儿童的研究的原因知之甚少。本观察性研究的目的是验证导致孕妇同意或拒绝参与随访时间长的新生儿队列研究的原因。
方法
为了前瞻性地调查导致女性参与、拒绝参与或退出新生儿队列研究的原因，在 2007 年至 2010 年期间，在意大利一家医院开展的 Phime 队列研究中，向接触或入组的孕妇分别使用三种不同的问卷进行调查。
结果
304 名孕妇拒绝参与研究，145 名孕妇在随访期间撤回同意。所有这些女性都填写了相关问卷。在 18 个月时进行随访的 632 名母亲中，有 430 名填写了参与动机问卷：97%的母亲表示主要原因是为研究做出贡献；96%和 90%的母亲表示希望有益于未来婴儿和母亲的健康。96%的女性希望了解收集的生物样本和整个研究结果的分析结果。三分之一的母亲（37%）希望参与未来类似研究的定义，将自己的经验和观点带入其中。在 304 名拒绝参与的母亲中，56%的母亲表示研究要求太高，26%的母亲不感兴趣，18%的母亲担心需要收集生物样本并接受神经认知测试。在入组后退出的 145 名女性中，52%的母亲表示研究要求太高（52%），6%的母亲担心生物样本采集。
结论
利他主义原因似乎是女性决定参与新生儿队列研究的主要原因。研究要求太高和需要收集生物样本是导致女性拒绝参与或退出研究的重要原因。在这些方面进行充分的沟通应最大限度地减少入组困难和随访损失。
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