Methodological decisions influence the identification of potential core outcomes in studies related to pre-eclampsia: an analysis informing the development of recommendations for future core outcome set developers

Methodological decisions influence the identification of potential core outcomes in studies related to pre-eclampsia: an analysis informing the development of recommendations for future core outcome set developers
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DOI:
10.1111/1471-0528.15892
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发表时间:
2019-11-01
影响因子:
5.8
通讯作者:
McManus, Richard J.
McManus, Richard J.
中科院分区:
医学1区
文献类型:
--
作者:
Duffy, J. M. N.;Hirsch, M.;McManus, Richard J.

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目的量化不同方法学决策对确定潜在核心结果的影响,为未来核心结果集开发者提供建议。设计混合方法研究。设置先兆子痫的核心结果集被用作范例。样本通过对先兆子痫试验进行系统回顾和对深入的患者访谈进行主题分析,开发了一长串潜在核心结局。方法用于生成潜在核心结果的长列表的具体方法进行了评估。结果不同的方法学决策对潜在核心结果的识别产生了重大影响。从已发表的先兆子痫试验中提取结果是识别48例母体、8例胎儿、25例新生儿结果和8例患者报告结果的有效方法。将结局的提取限制在主要结局或先兆子痫试验中通常报告的结局,减少了确定的潜在核心结局的数量和多样性。深入的患者访谈的主题分析确保了额外的五个患者报告的结果和六个结果与未来的儿童健康被确定。结论未来的核心成果集开发者在开发一长串潜在核心成果时应使用定量和定性方法。发表在@BJOGtweets上的可发推文摘要@ pathalNIHR研究为未来的@ coreguitsdevelopers提供了新的建议。
Objective To quantify the effect of different methodological decisions on the identification of potential core outcomes to inform the development of recommendations for future core coutcome set developers. Design Mixed methods study. Setting A core outcome set for pre-eclampsia was used as an exemplar. Sample A long list of potential core outcomes was developed by undertaking a systematic review of pre-eclampsia trials and performing a thematic analysis of in-depth patient interviews. Methods Specific methods used to generate long lists of potential core outcomes were evaluated. Results Different methodological decisions had a substantial impact on the identification of potential core outcomes. Extracting outcomes from published pre-eclampsia trials was an effective way of identifying 48 maternal, eight fetal, 25 neonatal outcomes, and eight patient-reported outcomes. Limiting the extraction of outcomes to primary outcomes or outcomes commonly reported in pre-eclampsia trials reduced the number and diversity of potential core outcomes identified. Thematic analysis of in-depth patient interviews ensured an additional five patient reported outcomes and six outcomes related to future child health were identified. Conclusions Future core outcome set developers should use quantitative and qualitative methods when developing a long list of potential core outcomes. Tweetable abstract @OfficialNIHR research published in @BJOGtweets informs new recommendations for future @coreoutcomes developers.