Abstract：
This study aimed to develop a core set of patient reported outcome quality indicators (QIs) for the treatment of patients with intermittent claudication (IC), that allow a broad international implementation across different vascular registries and within trials.
A rigorous modified two stage Delphi technique was used to promote consensus building on patient reported outcome QIs among an expert panel consisting of international vascular specialists, patient representatives, and registry members of the VASCUNET and the International Consortium of Vascular Registries. Potential QIs identified through an extensive literature search or additionally proposed by the panel were validated by the experts in a preliminary survey and included for evaluation. Consensus was reached if ≥ 80% of participants agreed that an item was both clinically relevant and practical.
Participation rates in two Delphi rounds were 66% (31 participants of 47 invited) and 90% (54 of 60), respectively. Initially, 145 patient reported outcome QIs were documented. Following the two Delphi rounds, 18 quality indicators remained, all of which reached consensus regarding clinical relevance. The VascuQoL questionnaire (VascuQoL-6), currently the most common patient reported outcome measurement (PROM) used within vascular registries, includes a total of six items. Five of these six items also matched with high rated indicators identified in the Delphi study. Consequently, the panel recommends the use of the VascuQoL-6 survey as a preferred core PROM QI set as well as an optional extension of 12 additional patient reported QIs that were also identified in this study.
The current recommendation based on the Delphi consensus building approach, strengthens the international harmonisation of registry data collection in relation to patient reported outcome quality. Continuous and standardised quality assurance will ensure that registry data may be used for future quality benchmarking studies and, ultimately, positively impact the overall quality of care provided to patients with peripheral arterial occlusive disease.
A rigorous modified two stage Delphi technique was used to promote consensus building on patient reported outcome QIs among an expert panel consisting of international vascular specialists, patient representatives, and registry members of the VASCUNET and the International Consortium of Vascular Registries. Potential QIs identified through an extensive literature search or additionally proposed by the panel were validated by the experts in a preliminary survey and included for evaluation. Consensus was reached if ≥ 80% of participants agreed that an item was both clinically relevant and practical.
Participation rates in two Delphi rounds were 66% (31 participants of 47 invited) and 90% (54 of 60), respectively. Initially, 145 patient reported outcome QIs were documented. Following the two Delphi rounds, 18 quality indicators remained, all of which reached consensus regarding clinical relevance. The VascuQoL questionnaire (VascuQoL-6), currently the most common patient reported outcome measurement (PROM) used within vascular registries, includes a total of six items. Five of these six items also matched with high rated indicators identified in the Delphi study. Consequently, the panel recommends the use of the VascuQoL-6 survey as a preferred core PROM QI set as well as an optional extension of 12 additional patient reported QIs that were also identified in this study.
The current recommendation based on the Delphi consensus building approach, strengthens the international harmonisation of registry data collection in relation to patient reported outcome quality. Continuous and standardised quality assurance will ensure that registry data may be used for future quality benchmarking studies and, ultimately, positively impact the overall quality of care provided to patients with peripheral arterial occlusive disease.
摘要：
本研究旨在开发一套用于治疗间歇性跛行（IC）患者的核心患者报告结果质量指标（QI）。这允许在不同的血管登记处和试验内进行广泛的国际实施。
在由国际血管专家组成的专家小组中，采用了严格的改良的两阶段Delphi技术，以促进对患者报告的结果QIs达成共识。患者代表,VASCUNET和国际血管注册协会的注册成员。专家在初步调查中验证了通过广泛的文献检索或小组提出的潜在质量指标，并将其纳入评估范围。如果≥80％的参与者同意该项目既具有临床相关性又具有实用性，则达成共识。
两轮Delphi的参与率分别为66％（邀请47名参与者中的31名）和90％（60名参与者中的54名），分别。最初，记录了145例患者报告的结果QI。在两次德尔福回合之后，剩下18项质量指标,所有这些都在临床相关性方面达成了共识.VascuQoL问卷（VascuQoL-6），目前最常见的患者报告在血管登记处使用的结果测量（PROM），共包括六个项目。这六个项目中的五个也与Delphi研究中确定的高评级指标相匹配。因此,小组建议使用VascuQoL-6调查作为首选的核心PROMQI组,并任选扩展本研究中也确定的另外12例患者报告的QI.
当前基于Delphi共识构建方法的建议，加强与患者报告结果质量相关的注册数据收集的国际协调。持续和标准化的质量保证将确保登记册数据可用于未来的质量基准研究，最终,对外周动脉闭塞性疾病患者的整体护理质量产生积极影响.
在由国际血管专家组成的专家小组中，采用了严格的改良的两阶段Delphi技术，以促进对患者报告的结果QIs达成共识。患者代表,VASCUNET和国际血管注册协会的注册成员。专家在初步调查中验证了通过广泛的文献检索或小组提出的潜在质量指标，并将其纳入评估范围。如果≥80％的参与者同意该项目既具有临床相关性又具有实用性，则达成共识。
两轮Delphi的参与率分别为66％（邀请47名参与者中的31名）和90％（60名参与者中的54名），分别。最初，记录了145例患者报告的结果QI。在两次德尔福回合之后，剩下18项质量指标,所有这些都在临床相关性方面达成了共识.VascuQoL问卷（VascuQoL-6），目前最常见的患者报告在血管登记处使用的结果测量（PROM），共包括六个项目。这六个项目中的五个也与Delphi研究中确定的高评级指标相匹配。因此,小组建议使用VascuQoL-6调查作为首选的核心PROMQI组,并任选扩展本研究中也确定的另外12例患者报告的QI.
当前基于Delphi共识构建方法的建议，加强与患者报告结果质量相关的注册数据收集的国际协调。持续和标准化的质量保证将确保登记册数据可用于未来的质量基准研究，最终,对外周动脉闭塞性疾病患者的整体护理质量产生积极影响.
