Evaluating midwifery units (EMU): Lessons from the pilot study
Evaluating midwifery units (EMU): Lessons from the pilot study
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DOI：
10.1016/j.midw.2012.08.012
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发表时间：
2013-08-01
期刊：
影响因子：
2.7
通讯作者：
Tracy, Mark
中科院分区：
文献类型：
--
作者：
Monk, Amy R.;Tracy, Sally K.;Tracy, Mark
目的：本文描述了澳大利亚新南威尔士州两个独立助产单位的试点研究，该研究旨在测试招募计划的可行性，该计划旨在招募预约分娩的妇女。试点之前的完整的前瞻性队列研究，评估助产单位（EMU），其目的是检查产前，出生和产后的妇女计划在独立的助产单位相比，那些预定在高等妇产科单位在澳大利亚和新西兰的结果。设计：一个前瞻性队列研究与两个相互排斥的队列。设置：新南威尔士州的两个独立助产单位及其相应的三级转诊医院。参与者：在2009年9月13日至2010年3月31日期间，共招募了146名妇女，这些妇女的计划出生地点是独立的助产单位或第三妇产单位，几乎没有确定的风险因素。和调查结果：试点研究确定了依靠预约助产士从几个产前预约诊所招募合格妇女参加研究的可行性。符合条件的妇女被邀请的比率低，导致同意率低于预期。此外，虽然大多数情况下只有低风险的妇女被邀请参加，但一些在预订时需要医疗咨询的妇女被无意中招募到研究中。这项试点研究的结果使我们修改了研究方案，以找到包括所有在该地区的独立助产单位或三级转诊医院预订的没有确定风险因素的妇女的结局的方法。本文介绍了对研究计划的修订。主要结论：从试点研究中吸取了五个教训。我们发现，队列研究采用的招募方案过于复杂，需要简化以最大限度地发挥研究的潜力。主研究的研究方案需要变更，以确保样本量更大，并确保每个队列的风险特征尽可能相似。数据来源需要扩大，以产生一个完整的数据集。对实践的影响：试点研究是非常有用的工具，在测试方法，以告知研究协议。我们发现，进行试点研究的头几个月确保了更强大的设计，有可能显示出更有意义的结果。皇冠版权所有（C）2012由爱思唯尔有限公司出版。保留所有权利。
Objective: this paper describes the pilot study that was undertaken to test the feasibility of the recruitment plan designed to recruit women who booked to give birth in two freestanding midwifery units in NSW, Australia. The pilot preceded the full prospective cohort study, Evaluating Midwifery Units (EMU), which aimed to examine the antenatal, birth and postnatal outcomes of women planning to give birth in freestanding midwifery units compared to those booked to give birth in tertiary level maternity units in Australia and New Zealand.Design: a prospective cohort study with two mutually-exclusive cohorts.Setting: two freestanding midwifery units in NSW and their corresponding tertiary referral hospitals.Participants: a total of 146 women with few identified risk factors recruited between 13 September 2009 and 31 March 2010 whose planned place of birth was either a freestanding midwifery unit or tertiary maternity unit.Measurements and findings: the pilot study identified the feasibility of relying on the booking midwife to recruit eligible women from several antenatal booking clinics to the study. Low rates of eligible women were invited resulting in a lower than expected consent rate. In addition, although mostly only low-risk women were invited to participate, some women requiring medical consultation at the time of booking were inadvertently recruited into the study. The results of this pilot study led us to revise the study protocol to find ways of including the outcomes of all women without identified risk factors who booked at either the freestanding midwifery units or the tertiary referral hospital in that area. This paper describes the revisions that were made to the study plan.Key conclusions: five lessons were learned from the pilot study. We found that recruitment protocols employed for the cohort study were too complicated and required simplification to maximise the potential of the study. The study protocol needed to be changed for the main study to ensure a larger sample size and to ensure the risk profile of each cohort was as similar as possible. Sources of data needed to be expanded to produce a complete data set.Implications for practice: pilot studies are extremely useful tools in testing methods to inform research protocols. We found that the first months spent undertaking a pilot study ensured a stronger design with the potential to show more meaningful results. Crown Copyright (C) 2012 Published by Elsevier Ltd. All rights reserved.