Abstract：
BACKGROUND: Venous leg ulceration (VLU) is a chronic, recurring condition with associated pain, malodour, impaired mobility and susceptibility to infection which in turn significantly impacts an individual\'s health-related quality of life. Randomised controlled trials (RCTs) aim to determine the efficacy of interventions to improve outcomes. To be useful, these outcomes should be consistently and fully reported across RCTs. A core outcome set (COS) is an agreed-upon standardised set of outcomes which should be, at a minimum, reported in all RCTs for a given indication including that of VLU.
OBJECTIVE: To gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment.
METHODS: Two sequential, two round e-Delphi surveys were completed. The first gained consensus on core outcome domains and the second on core outcomes within those domains. Participants included: people with direct experience of having VLUs and their carers, healthcare professionals whose practice included VLU care and researchers within wound care (clinical, academic, industry).
RESULTS: Five outcome domains; healing, pain, quality of life, resource use and adverse events, and 11 outcomes were rated as core by participants. The patient and not the limb or ulcer was the preferred unit of analysis for reporting.
CONCLUSIONS: We recommend investigators report on all five outcome domains, regardless of the type of intervention being evaluated. Future research is needed to identify measurement methods for the 11 identified outcomes. We also recommend investigators follow the CONSORT guidelines (http://www.consort-statement.org/).
OBJECTIVE: To gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment.
METHODS: Two sequential, two round e-Delphi surveys were completed. The first gained consensus on core outcome domains and the second on core outcomes within those domains. Participants included: people with direct experience of having VLUs and their carers, healthcare professionals whose practice included VLU care and researchers within wound care (clinical, academic, industry).
RESULTS: Five outcome domains; healing, pain, quality of life, resource use and adverse events, and 11 outcomes were rated as core by participants. The patient and not the limb or ulcer was the preferred unit of analysis for reporting.
CONCLUSIONS: We recommend investigators report on all five outcome domains, regardless of the type of intervention being evaluated. Future research is needed to identify measurement methods for the 11 identified outcomes. We also recommend investigators follow the CONSORT guidelines (http://www.consort-statement.org/).
摘要：
背景：下肢静脉性溃疡（VLU）是一种慢性，与相关的疼痛复发，恶臭,行动不便和对感染的易感性，进而显着影响个人的健康相关生活质量。随机对照试验（RCT）旨在确定干预措施改善预后的有效性。为了有用，这些结果应在RCT中一致且充分地报告.核心成果集(COS)是一套商定的标准化成果集，至少,在所有随机对照试验中报告了给定的适应症，包括VLU的适应症。
目的：就哪些结局域和结局应被视为核心，因此应被纳入VLU治疗的所有干预RCT中，达成共识。
方法：两个顺序，完成了两轮e-Delphi调查。第一次就核心成果领域达成共识，第二次就这些领域内的核心成果达成共识。参与者包括：直接拥有VLU及其看护人的人，医疗保健专业人员的实践包括VLU护理和伤口护理中的研究人员(临床，学术,行业)。
结果：五个结果域；愈合，疼痛,生活质量,资源使用和不良事件，参与者将11项结果评为核心。患者而不是肢体或溃疡是报告的首选分析单位。
结论：我们建议研究者报告所有五个结果领域，无论评估的干预类型如何。需要未来的研究来确定11个已确定结果的测量方法。我们还建议调查人员遵循CONSORT指南(http://www.consort-statement.org/)。
目的：就哪些结局域和结局应被视为核心，因此应被纳入VLU治疗的所有干预RCT中，达成共识。
方法：两个顺序，完成了两轮e-Delphi调查。第一次就核心成果领域达成共识，第二次就这些领域内的核心成果达成共识。参与者包括：直接拥有VLU及其看护人的人，医疗保健专业人员的实践包括VLU护理和伤口护理中的研究人员(临床，学术,行业)。
结果：五个结果域；愈合，疼痛,生活质量,资源使用和不良事件，参与者将11项结果评为核心。患者而不是肢体或溃疡是报告的首选分析单位。
结论：我们建议研究者报告所有五个结果领域，无论评估的干预类型如何。需要未来的研究来确定11个已确定结果的测量方法。我们还建议调查人员遵循CONSORT指南(http://www.consort-statement.org/)。
