所有PERCH研究地点临床评估和样本采集的标准化
Standardization of Clinical Assessment and Sample Collection Across All PERCH Study Sites.
作者信息
Crawley Jane, Prosperi Christine, Baggett Henry C, Brooks W Abdullah, Deloria Knoll Maria, Hammitt Laura L, Howie Stephen R C, Kotloff Karen L, Levine Orin S, Madhi Shabir A, Murdoch David R, O'Brien Katherine L, Thea Donald M, Awori Juliet O, Bunthi Charatdao, DeLuca Andrea N, Driscoll Amanda J, Ebruke Bernard E, Goswami Doli, Hidgon Melissa M, Karron Ruth A, Kazungu Sidi, Kourouma Nana, Mackenzie Grant, Moore David P, Mudau Azwifari, Mwale Magdalene, Nahar Kamrun, Park Daniel E, Piralam Barameht, Seidenberg Phil, Sylla Mamadou, Feikin Daniel R, Scott J Anthony G
机构信息
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, United Kingdom.
Department of International Health, International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
出版信息
Clin Infect Dis. 2017 Jun 15;64(suppl_3):S228-S237. doi: 10.1093/cid/cix077.
BACKGROUND.: Variable adherence to standardized case definitions, clinical procedures, specimen collection techniques, and laboratory methods has complicated the interpretation of previous multicenter pneumonia etiology studies. To circumvent these problems, a program of clinical standardization was embedded in the Pneumonia Etiology Research for Child Health (PERCH) study.
METHODS.: Between March 2011 and August 2013, standardized training on the PERCH case definition, clinical procedures, and collection of laboratory specimens was delivered to 331 clinical staff at 9 study sites in 7 countries (The Gambia, Kenya, Mali, South Africa, Zambia, Thailand, and Bangladesh), through 32 on-site courses and a training website. Staff competency was assessed throughout 24 months of enrollment with multiple-choice question (MCQ) examinations, a video quiz, and checklist evaluations of practical skills.
RESULTS.: MCQ evaluation was confined to 158 clinical staff members who enrolled PERCH cases and controls, with scores obtained for >86% of eligible staff at each time-point. Median scores after baseline training were ≥80%, and improved by 10 percentage points with refresher training, with no significant intersite differences. Percentage agreement with the clinical trainer on the presence or absence of clinical signs on video clips was high (≥89%), with interobserver concordance being substantial to high (AC1 statistic, 0.62-0.82) for 5 of 6 signs assessed. Staff attained median scores of >90% in checklist evaluations of practical skills.
CONCLUSIONS.: Satisfactory clinical standardization was achieved within and across all PERCH sites, providing reassurance that any etiological or clinical differences observed across the study sites are true differences, and not attributable to differences in application of the clinical case definition, interpretation of clinical signs, or in techniques used for clinical measurements or specimen collection.
背景
对标准化病例定义、临床程序、标本采集技术和实验室方法的依从性各异，这使得以往多中心肺炎病因学研究的结果解读变得复杂。为规避这些问题，儿童健康肺炎病因学研究（PERCH）项目中纳入了临床标准化方案。
方法
在2011年3月至2013年8月期间，通过32次现场课程和一个培训网站，为7个国家（冈比亚、肯尼亚、马里、南非、赞比亚、泰国和孟加拉国）9个研究地点的331名临床工作人员提供了关于PERCH病例定义、临床程序和实验室标本采集的标准化培训。在入组的24个月内，通过多项选择题（MCQ）考试、视频测验和实践技能清单评估对工作人员的能力进行了评估。
结果
MCQ评估仅限于158名纳入PERCH病例和对照的临床工作人员，每个时间点>86%的合格工作人员获得了分数。基线培训后的中位数分数≥80%，复习培训后提高了10个百分点，各地点之间无显著差异。在视频片段上与临床培训师就临床体征是否存在的百分比一致性很高（≥89%），在评估的6项体征中的5项中，观察者间的一致性为中度到高度（AC1统计量，0.62 - 0.82）。工作人员在实践技能清单评估中的中位数分数>90%。
结论
在所有PERCH研究地点内部和之间都实现了令人满意的临床标准化，这让人放心，即研究地点之间观察到的任何病因或临床差异都是真实差异，而不是由于临床病例定义的应用、临床体征的解释或临床测量或标本采集所使用的技术差异所致。
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