NETS(1HD) study: development of a Hirschsprung's disease core outcome set.

NETS(1HD) study: development of a Hirschsprung's disease core outcome set.
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DOI:
10.1136/archdischild-2017-312901
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发表时间:
2017-12
影响因子:
5.2
通讯作者:
NETS1HD Collaboration
NETS1HD Collaboration
中科院分区:
医学2区
文献类型:
--
作者:
Allin BSR;Bradnock T;Kenny S;Kurinczuk JJ;Walker G;Knight M;NETS1HD Collaboration

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本研究的目的是建立一个先天性巨结肠(HD)核心结局集(COS)。候选结果是从系统性审查和利益相关者提名中确定的。一个三阶段的德尔菲过程和共识会议被用来优先考虑候选结果的基础上分配的分数由利益相关者参与者使用九点量表。在第二阶段和第三阶段,参与者被展示了他们小组的分数和所有小组的分数分别为前一阶段的每个结果的图形表示。在第三阶段之后,由两个或三个小组优先考虑的成果将提交共识会议。COS由符合入选阈值的10个最高评分结局组成(≥70% 7-9和<15% 1-3)。89个利益攸关方(82%)完成了德尔菲进程的所有三个阶段。在德尔菲过程的第一阶段评估了74项成果,其中以下10项符合纳入COS的标准:(1)特定原因的死亡,(2)长期大便失禁,(3)长期自主排便,无需灌肠或直肠或结肠冲洗,(4)先天性巨结肠患者长期心理压力,(5)长期尿失禁,(6)生活质量客观评分,(7)肠功能客观评分,(8)计划外再次手术,(9)>需要永久性造口,(10)小肠结肠炎。这一高级别核心业务由关键利益攸关方认为重要的10项成果组成。在研究中使用该COS将减少结果报告的异质性,并提高我们识别HD金标准治疗方法的能力。
The objective of this study was to develop a Hirschsprung’s disease (HD) core outcome set (COS). Candidate outcomes were identified from a systematic review and stakeholder nomination. A three-phase Delphi process and consensus meeting were used to prioritise candidate outcomes based on scores assigned by stakeholder participants using a nine-point scale. In phases two and three, participants were shown graphical representations of their panel’s scores and all panels’ scores respectively for each outcome from the previous phase. After the third phase, outcomes prioritised by two or three panels were taken forward to the consensus meeting. The COS was formed from the 10 highest scoring outcomes meeting the threshold for inclusion (≥70% 7–9 and <15% 1–3). Eighty-nine stakeholders (82%) completed all three phases of the Delphi process. Seventy-four outcomes were assessed in phase one of the Delphi process, the following 10 of which met criteria for inclusion in the COS: (1) death with cause specified, (2) long-term faecal incontinence, (3) long-term voluntary bowel movements without need for enemas, or rectal or colonic irrigation, (4) long-term psychological stress for the individual with Hirschsprung’s disease, (5) long-term urinary incontinence, (6) objective score of quality of life, (7) objective score of bowel function, (8) unplanned reoperation, (9) >need for a permanent stoma, (10) enterocolitis. This HD COS is formed of 10 outcomes deemed important by key stakeholders. Use of this COS in research will reduce outcome reporting heterogeneity and increase our ability to identify gold standard treatments for HD.
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