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【Abstract】 Background Spirometry is the most common and extensively used pulmonary function test method,
whose quality control is the cornerstone for its promotion and application. The report format is a key factor associated with the
quality control of spirometry,but it is generally various in China,which is not conducive to the popularization and application of
spirometry. Objective To assess the current status of report formats for spirometry in Chinese mainland. Methods The reports
of spirometry were collected from some hospitals in China between April 2016 and December 2018,which are composed of four
parts,including the general demographic information,test indicators,graphs,and results evaluation. The key and/or essential
information for each part is as follows:(1)the general demographicinformation part:sex,height,BMI,age and the reference
source;(2)test indicators part:forced vital capacity(FVC),forced expiratory volume in 1 second(FEV 1 ),the ratio
of FEV 1 /FVC or FEV 1 /VCmax,maximal mid-expiratory flow〔FEF 25%-75% ,forced expiratory flow at 50%(FEF 50% ),forced
expiratory flow at 75%(FEF 75% )〕,peak inspiratory flow(PIF)and forced expiratory time(FET);(3)graphs part:
flow-volume curve(F-V curve)and volume-time curve(V-T curve);(4)results evaluation part: subjects cooperation,
test quality control level,and physician interpretation. The differences in the report format of spirometry were compared by region
and hospital level in this study. Results In total,1 562 spirometry reports from 1 562 hospitals(one from each hospital)
across China were enrolled,but only 0.4% provided all key indicators.(1)For the general demographic information part,only
27.7% reports provided complete key indicators,which differed significantly by regions and the level of hospitals(P<0.05).
Moreover,the part showed the reference source only accounted for 28.2%.(2)Furthermore,in the test indicators part,
91.9% of the total reports provided all key indicators. More than 90.0% reports listed FEF 25%-75% ,FEF 50% and/or FEF 75% ,while
the PIF and FET was reported in 36.4%,46.0%,respectively.(3)In terms of the graphs part,73.4% reports provided key
indicators,but 26.6% did not report the important information like V-T curve.(4)Finally,in the results evaluation part,the
report without lacking key indicators were only accounted for 1.6%,and there were great differences between hospitals of different
levels(P<0.05). What's more,only 14.9% clearly showed the quality control of spirometry. Conclusion There were great
differences of the report formats for spirometry analyzed and the 2019 Standard for pulmonary function examination report. Lack of
the key information such as the reference resource,inspiratory phase indicators,the indicators about quality control and quality
control of test would seriously affect the clinical value of spirometry. Therefore,it is suggested to add the program of report format
standards during the standardized trainings of pulmonary function testing,and strengthen the understanding and application of
various indicators of spirometry among pulmonary function practitioners.
【Key words】 Spirometry;Breath tests;Spirometry report;Format;Standardization
肺量计检查是临床上最常用的肺功能检查手段,已广泛 本研究价值:
应用于呼吸系统疾病的诊疗和管理中 [1-2] ,质量控制(以下
(1)本研究进行的肺量计检查报告单格式研究在国内
简称质控)是肺功能检查的生命线,关系着检查结果的准确
外鲜有,填补了这方面的空白;(2)本研究是多中心研究,
性及可用性。以往肺量计检查指南仅关注对肺功能检查的质
囊括全国 31 个省市 1 562 家医院,且数据资料均由医院从
量控制,而忽视了对肺量计检查报告单(以下简称报告单) 事肺功能检查的医务人员提供,研究结果具代表性;(3)
格式规范的要求 [3-5] 。规范的缺失导致不同医疗机构之间的
本研究揭示了我国肺量计检查报告单格式的严峻现状,警
报告单格式大多不同,给医疗人员解读肺功能检查结果和比
示肺功能检查相关医务工作者应重视肺量计检查报告单格
较不同医疗机构数据增添了困难,因此规范报告单格式越发 式在肺功能检查中的重要地位;(4)对进一步推广及规范
受到重视,国内外也发布了有关报告单格式的指南性文件 [6-7] ,
我国肺功检查项目具有较强的指导作用。
但目前有关国内医院报告单格式现状的报道较少。本研究为
本研究不足:
多中心横断面调查,旨在分析我国不同医院的报告单格式,
(1)肺量计检查报告单来源于国内不同地区和不同等
了解我国报告单格式现状,从而推进全国报告单格式规范化
级医院,分布不均衡,本研究未分析其原因,结果可能存
进程。
在偏差;(2)本研究属于横断面研究,缺少纵向对比分析,
1 资料与方法
后续应进行纵向研究,重新整理数据,进一步研究肺量计
1.1 资料收集 收集 2016 年 4 月至 2018 年 12 月上传于肺功
检查报告单格式规范化情况。
能报告在线质控评审系统(www.pftqc.cn)中的报告单,其由
参加了中国肺功能检查临床应用与质量控制规范化培训(肺 中记录的医院名称不一致;(3)非肺量计检查(如支气管舒
功能检查规范化培训) [8] 的各受访医院中从事肺功能检查工 张试验和支气管激发试验)的报告单;(4)同一医院格式相
作的学员拍照上传。排除标准:(1)因照片模糊等导致信息 同的报告单。
不完全的报告单;(2)报告单上医院名称与肺功能评审系统 1.2 研究方法