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在囊性纤维化患儿和青少年中,非监督家庭肺量计检测与监督临床肺量计检测并不等效:来自 CLIMB-CF 研究的结果。

Unsupervised home spirometry is not equivalent to supervised clinic spirometry in children and young people with cystic fibrosis: Results from the CLIMB-CF study.

机构信息

NHLI, Imperial College, London, UK.

Royal Brompton Hospital, Part of Guy's & St Thomas' NHS Trust, London, UK.

出版信息

Pediatr Pulmonol. 2023 Oct;58(10):2871-2880. doi: 10.1002/ppul.26602. Epub 2023 Jul 28.

DOI:10.1002/ppul.26602
PMID:37503909
Abstract

BACKGROUND

Handheld spirometry allows monitoring of lung function at home, of particular importance during the COVID-19 pandemic. Pediatric studies are unclear on whether values are interchangeable with traditional, clinic-based spirometry. We aimed to assess differences between contemporaneous, home (unsupervised) and clinic (supervised) spirometry and the variability of the former. The accuracy of the commercially available spirometer used in the study was also tested.

METHODS

Data from participants in the Clinical Monitoring and Biomarkers to stratify severity and predict outcomes in children with cystic fibrosisc (CLIMB-CF) Study aged ≥ 6 years who had paired (±1 day) clinic and home forced expiratory volume in 1 s (FEV ) readings were analyzed. Variability during clinical stability over 6-months was assessed. Four devices from Vitalograph were tested using 1 and 3 L calibration syringes.

RESULTS

Sixty-seven participants (median [interquartile range] age 10.7 [7.6-13.9] years) provided home and clinic FEV data pairs. The mean (SD) FEV % bias was 6.5% [±8.2%]) with wide limits of agreement (-9.6% to +22.7%); 76.2% of participants recorded lower results at home. Coefficient of variation of home FEV % during stable periods was 9.9%. Data from the testing of the handheld device used in CLIMB-CF showed a potential underread.

CONCLUSION

In children and adolescents, home spirometry using hand-held equipment cannot be used interchangeably with clinic spirometry. Home spirometry is moderately variable during clinical stability. New handheld devices underread, particularly at lower volumes of potential clinical significance for smaller patients; this suggests that supervision does not account fully for the discrepancy. Opportunities should be taken to obtain dual device measurements in clinic, so that trend data from home can be utilized more accurately.

摘要

背景

手持式肺活量计可在家中监测肺功能,在 COVID-19 大流行期间尤为重要。儿科研究尚不清楚其数值是否与传统的基于诊所的肺活量计互换。我们旨在评估同期家庭(非监督)和诊所(监督)肺活量计之间的差异以及前者的变异性。还测试了研究中使用的商业上可用的肺活量计的准确性。

方法

对年龄≥6 岁的囊性纤维化临床监测和生物标志物分层严重程度和预测结局研究(CLIMB-CF)中符合条件的参与者进行分析,这些参与者有配对(±1 天)的诊所和家庭 1 秒用力呼气量(FEV )读数。评估了 6 个月期间临床稳定期间的变异性。使用 Vitalograph 的 4 种设备,使用 1 和 3 L 校准注射器进行测试。

结果

67 名参与者(中位数[四分位间距]年龄 10.7 [7.6-13.9]岁)提供了家庭和诊所 FEV 数据对。FEV %的平均(SD)偏差为 6.5%[±8.2%]),一致性界限较宽(-9.6%至+22.7%);76.2%的参与者在家中记录的结果较低。在稳定期内,家庭 FEV %的变异系数为 9.9%。CLIMB-CF 中使用的手持式设备测试数据显示潜在的读数不足。

结论

在儿童和青少年中,使用手持式设备进行家庭肺活量计检查不能与诊所肺活量计互换使用。在临床稳定性期间,家庭肺活量计的变异性中等。新型手持式设备读数不足,尤其是在较小患者具有潜在临床意义的较低容量下;这表明监督并不能完全解释差异。应抓住机会在诊所获得双设备测量,以便更准确地利用家庭的趋势数据。

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