Procedural Variation May Contribute to 6-Minute Walk Distance Variability in Real-World Pediatric Pulmonary Arterial Hypertension Study.

IF 3.7 3区 医学 Q1 PHARMACOLOGY & PHARMACY
Cynthia Kleppinger, Dunbar Ivy, Norman Stockbridge, Angela Bates, Stephanie Handler, Usha S Krishnan, Mary P Mullen, Delphine Yung, Rachel K Hopper, Nidhy P Varghese, Jeff Fineman, Eric D Austin, Catherine M Avitabile, Grace Freire, Jennifer Clark, Haihao Sun
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Abstract

The six-minute walk test (6MWT) is a common method to assess submaximal exercise capacity in children and adults with pulmonary arterial hypertension (PAH) and other chronic diseases. There is no guideline specifically for 6MWT in children. In this observational pilot study, we evaluated the impact of procedural variations on the outcome of the 6MWT in the real-world clinical setting at pediatric PAH programs. We collected 6MWT data from 33 children with PAH participating in a multicenter, prospective, non-interventional study. Data range/quantiles and standard deviation (SD) were used to describe distribution of the six-minute walk distance (6MWD) and data variability. Levene's test was used to test for heterogeneity of variance with the two sites of similar altitude and their age/height/weight-matched Panama Function Class II participants. We analyzed all 33 eligible participants and their qualified first walks at five centers (A-E) with 6MWD ranges of 420-570, 357-683, 418-481, 400-700, 377-549 m, respectively. Site D performed the 6MWT in a busy hallway and allowed parental/caregiver's cheering, while Site E performed the 6MWT in a secluded area with no parental/caregiver involvement. Mean 6MWD and SD for Sites D and E were 547 (125) and 432 (67.5) meters, respectively (p = 0.03). In conclusion, procedural variations seem to associate with 6MWD data variability. Although interpretation of our results is limited by the small sample size, our findings suggest that standardizing pediatric 6MWT procedures are needed.

在真实世界儿童肺动脉高压研究中,程序变异可能导致6分钟步行距离的变异。
6分钟步行试验(6MWT)是评估患有肺动脉高压(PAH)和其他慢性疾病的儿童和成人亚极限运动能力的常用方法。没有针对儿童6MWT的专门指南。在这项观察性试点研究中,我们评估了在现实世界的临床环境中,在儿童PAH项目中,程序变化对6MWT结果的影响。我们收集了33名参与多中心、前瞻性、非干预性研究的多环芳烃患儿的6MWT数据。数据范围/分位数和标准差(SD)用于描述6分钟步行距离(6MWD)的分布和数据变异性。采用Levene检验检验海拔相近的两个地点及其年龄/身高/体重匹配的巴拿马函数II类参与者的方差异质性。我们分析了所有33名符合条件的参与者及其在5个中心(A-E)的首次步行,6MWD范围分别为420-570、357- 683,418 - 481,400 -700、377-549 m。站点D在一个繁忙的走廊进行6MWT,允许父母/照顾者欢呼,而站点E在一个僻静的区域进行6MWT,没有父母/照顾者参与。D点和E点的平均6MWD和SD分别为547(125)和432(67.5)米(p = 0.03)。总之,程序变化似乎与6MWD数据变异性有关。尽管我们的研究结果受到样本量小的限制,但我们的研究结果表明,需要标准化儿童6MWT手术。
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来源期刊
AAPS Journal
AAPS Journal 医学-药学
CiteScore
7.80
自引率
4.40%
发文量
109
审稿时长
1 months
期刊介绍: The AAPS Journal, an official journal of the American Association of Pharmaceutical Scientists (AAPS), publishes novel and significant findings in the various areas of pharmaceutical sciences impacting human and veterinary therapeutics, including: · Drug Design and Discovery · Pharmaceutical Biotechnology · Biopharmaceutics, Formulation, and Drug Delivery · Metabolism and Transport · Pharmacokinetics, Pharmacodynamics, and Pharmacometrics · Translational Research · Clinical Evaluations and Therapeutic Outcomes · Regulatory Science We invite submissions under the following article types: · Original Research Articles · Reviews and Mini-reviews · White Papers, Commentaries, and Editorials · Meeting Reports · Brief/Technical Reports and Rapid Communications · Regulatory Notes · Tutorials · Protocols in the Pharmaceutical Sciences In addition, The AAPS Journal publishes themes, organized by guest editors, which are focused on particular areas of current interest to our field.
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