MObile Technology for Improved Family Planning: update to randomised controlled trial protocol.
MObile Technology for Improved Family Planning: update to randomised controlled trial protocol.
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DOI：
10.1186/1745-6215-15-440
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发表时间：
2014-11-12
期刊：
影响因子：
2.5
通讯作者：
Free C
中科院分区：
文献类型：
--
作者：
Smith C;Ngo TD;Edwards P;Free C
本次更新概述了“改进计划生育的移动技术”研究统计分析计划的变更以及长期随访计划。这些变更源于获得额外资金以及决定将主要分析限定于有随访数据的参与者。这些变更在最终确定统计分析计划和封存数据集之前已达成一致。
主要分析现在将限定于在4个月随访时有主要结局数据的受试者。在敏感性分析中将使用极端情况，即所有失访者都被视为未依从。除了方案中概述的次要结局外，我们还将评估干预措施对长效避孕（植入物、宫内节育器和永久性方法）的影响。
为了评估干预措施的长期效果，我们计划通过电话自我报告对4个月时使用的所有主要和次要结局进行额外的12个月随访。所有参与者在被招募参加试验时都对这次额外随访提供了知情同意。12个月时的结局测量和分析将与4个月随访时相似。该试验的主要结局将是流产后4个月和12个月时使用一种有效的现代避孕方法。次要结局将包括长效避孕方法的使用、自我报告的怀孕情况、重复流产以及流产后12个月期间的避孕方法使用情况。
将主要分析限定于有随访数据的参与者是试验分析的标准方法，这将有助于与其他旨在提高避孕措施采用率或使用率的干预试验进行比较。进行12个月的试验随访将使我们能够评估干预措施的长期效果。
临床试验注册号：ClinicalTrials.gov NCT01823861
This update outlines changes to the MObile Technology for Improved Family Planning study statistical analysis plan and plans for long-term follow-up. These changes result from obtaining additional funding and the decision to restrict the primary analysis to participants with available follow-up data. The changes were agreed prior to finalising the statistical analysis plan and sealing the dataset. The primary analysis will now be restricted to subjects with data on the primary outcome at 4-month follow-up. The extreme-case scenario, where all those lost to follow-up are counted as non-adherent, will be used in a sensitivity analysis. In addition to the secondary outcomes outlined in the protocol, we will assess the effect of the intervention on long-acting contraception (implant, intra-uterine device and permanent methods). To assess the long-term effect of the intervention, we plan to conduct additional 12-month follow-up by telephone self-report for all the primary and secondary outcomes used at 4 months. All participants provided informed consent for this additional follow-up when recruited to the trial. Outcome measures and analysis at 12 months will be similar to those at the 4-month follow-up. The primary outcomes of the trial will be the use of an effective modern contraceptive method at 4 months and at 12 months post-abortion. Secondary outcomes will include long-acting contraception use, self-reported pregnancy, repeat abortion and contraception use over the 12-month post-abortion period. Restricting the primary analysis to those with follow-up data is the standard approach for trial analysis and will facilitate comparison with other trials of interventions designed to increase contraception uptake or use. Undertaking 12-month trial follow-up will allow us to evaluate the long-term effect of the intervention. ClinicalTrials.gov NCT01823861.
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