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血管紧张素转换酶抑制剂(ACEI)诱发血管性水肿研究者评定量表的开发与验证及拟议的出院标准

Development and validation of the angiotensin-converting enzyme inhibitor (ACEI) induced angioedema investigator rating scale and proposed discharge criteria.

作者信息

Bonner Nicola, Panter Charlotte, Kimura Alan, Sinert Rich, Moellman Joseph, Bernstein Jonathan A

机构信息

Adelphi Values, Adelphi Mill, Grimshaw Lane, Bollington, Cheshire, SK10 5JB, UK.

Shire, 300 Shire Way, Lexington, MA, 02421, USA.

出版信息

BMC Health Serv Res. 2017 May 22;17(1):366. doi: 10.1186/s12913-017-2274-4.

DOI:10.1186/s12913-017-2274-4
PMID:28532495
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5440910/
Abstract

BACKGROUND

The use of angiotensin-converting enzyme inhibitors (ACEI) has been associated with the development of bradykinin-mediated angioedema. With ever-widening indications for ACEI in diseases including hypertension, congestive heart failure and diabetic nephropathy, a concomitant increase in ACEI-Angioedema (ACEI-A) has been reported. At present there is no validated severity scoring or discharge criteria for ACEI-A. We sought to develop and validate an investigator rating scale with corresponding discharge criteria using clinicians experienced in treating ACEI-A.

METHODS

In-depth, 60-min qualitative telephone interviews were conducted with 12 US-based emergency physicians. Beforehand, clinicians were sent four case studies describing patients experiencing different severities of angioedema attacks. Clinicians were initially asked open-ended questions about their experience of patients' symptoms, treatment and discharge decisions. Clinicians then rated each patient case study and discussed patient diagnoses, ratings of symptom severity and discharge evaluation. The ratings were used to assess inter-rater reliability of the scale using the intra-class correlation coefficient (ICC) using IBM SPSS analysis Version 19 software.

RESULTS

The findings provide support focusing on four key symptoms of airway compromise scored on a 0-4 scale: 1) Difficulty Breathing, 2) Difficulty Swallowing, 3) Voice Changes and 4) Tongue Swelling and the corresponding discharge criteria of a score of 0 or 'No symptoms' for Difficulty Breathing and Difficulty Swallowing and a score of 0 or 1 indicating mild or absence of symptoms for Voice Change and Tongue Swelling. Eleven clinicians agreed the absence of standardized discharge criteria supported the use of this scale. All physicians concurred with the recommended discharge criteria. The clinician ratings provided evidence of strong inter-rater reliability for the rating scale (ICC > 0.80).

CONCLUSION

The investigator rating scale and discharge criteria are clinically valid, relevant and reliable. Moreover, both address the current unmet need for standardized ED discharge criteria.

摘要

背景

血管紧张素转换酶抑制剂(ACEI)的使用与缓激肽介导的血管性水肿的发生有关。随着ACEI在包括高血压、充血性心力衰竭和糖尿病肾病等疾病中的适应证不断扩大,据报道ACEI相关性血管性水肿(ACEI-A)也随之增加。目前,尚无针对ACEI-A的有效严重程度评分或出院标准。我们试图开发并验证一种由治疗ACEI-A经验丰富的临床医生使用的调查员评定量表及相应的出院标准。

方法

对12名美国急诊医生进行了时长60分钟的深入定性电话访谈。在此之前,向临床医生发送了4个病例研究,描述经历不同严重程度血管性水肿发作的患者。临床医生首先被问及关于患者症状、治疗和出院决定的开放式问题。然后临床医生对每个患者病例研究进行评分,并讨论患者诊断、症状严重程度评分和出院评估。使用IBM SPSS分析第19版软件,通过组内相关系数(ICC)来评估量表的评分者间信度。

结果

研究结果支持聚焦于按0-4分评分的气道受损的四个关键症状:1)呼吸困难,2)吞咽困难,3)声音改变,4)舌肿胀,以及相应的出院标准,即呼吸困难和吞咽困难评分为0或“无症状”,声音改变和舌肿胀评分为0或1表示症状轻微或无症状。11名临床医生一致认为缺乏标准化出院标准支持使用该量表。所有医生均认可推荐的出院标准。临床医生的评分证明了该评定量表具有很强的评分者间信度(ICC>0.80)。

结论

调查员评定量表和出院标准在临床上是有效的、相关的和可靠的。此外,两者都满足了目前对标准化急诊科出院标准的未满足需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5478/5440910/6553df55e8eb/12913_2017_2274_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5478/5440910/81bf18b781ca/12913_2017_2274_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5478/5440910/fd14422a16b9/12913_2017_2274_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5478/5440910/0c2a9a1f146b/12913_2017_2274_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5478/5440910/6553df55e8eb/12913_2017_2274_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5478/5440910/81bf18b781ca/12913_2017_2274_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5478/5440910/fd14422a16b9/12913_2017_2274_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5478/5440910/0c2a9a1f146b/12913_2017_2274_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5478/5440910/6553df55e8eb/12913_2017_2274_Fig4_HTML.jpg

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