@article{d31a0f811da04527a98cf25872f52805,
title = "Standardization of clinical assessment and sample collection across all PERCH study sites",
abstract = "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 201and August 2013, standardized training on the PERCH case definition, clinical procedures, and collection of laboratory specimens was delivered to 33clinical staff at study sites in countries (The Gambia, Kenya, Mali, South Africa, Zambia, Thailand, and Bangladesh), through 3on-site courses and a training website. Staff competency was assessed throughout 2months of enrollment with multiple-choice question (MCQ) examinations, a video quiz, and checklist evaluations of practical skills. Results. MCQ evaluation was confined to 15clinical 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 1percentage 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 (ACstatistic, 0.62-0.82) for of 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.",
keywords = "Childhood, Hospital, Pneumonia, Standardization, Training",
author = "{PERCH Study Groupa} and Jane Crawley and Christine Prosperi and Baggett, {Henry C.} and Brooks, {W. Abdullah} and Knoll, {Maria Deloria} and Hammitt, {Laura L.} and Howie, {Stephen R.C.} and Kotloff, {Karen L.} and Levine, {Orin S.} and Madhi, {Shabir A.} and Murdoch, {David R.} and O'Brien, {Katherine L.} and Thea, {Donald M.} and Awori, {Juliet O.} and Charatdao Bunthi and DeLuca, {Andrea N.} and Driscoll, {Amanda J.} and Ebruke, {Bernard E.} and Doli Goswami and Hidgon, {Melissa M.} and Karron, {Ruth A.} and Sidi Kazungu and Nana Kourouma and Grant Mackenzie and Moore, {David P.} and Azwifari Mudau and Magdalene Mwale and Kamrun Nahar and Park, {Daniel E.} and Barameht Piralam and Phil Seidenberg and Mamadou Sylla and Feikin, {Daniel R.} and Scott, {J. Anthony G.} and Nicholas Fancourt and Wei Fu and Higdon, {Melissa M.} and Kagucia, {E. Wangeci} and Mengying Li and Zhenke Wu and Zeger, {Scott L.} and Watson, {Nora L.} and Endtz, {Hubert P.} and Khalequ Zaman and Lokman Hossain and Yasmin Jahan and Hasan Ashraf and Martin Antonio and Jessica McLellan and Eunice Machuka",
note = "Funding Information: Supplement sponsorship. This article appears as part of the supplement “Pneumonia Etiology Research for Child Health (PERCH): Foundational Basis for the Primary Etiology Results,” sponsored by a grant from the Bill & Melinda Gates Foundation to the PERCH study of Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland. Funding Information: Potential conflicts of interest. M. D. K. has received funding for consultancies from Merck, Pfizer, and Novartis, and grant funding from Merck. L. L. H. has received grant funding from Pfizer and GlaxoSmithKline. K. L. K. has received grant funding from Merck Sharp & Dohme. S. A. M. has received honoraria for advisory board membership from the Bill & Melinda Gates Foundation, Pfizer, Medimmune, and Novartis; has received institutional grants from GSK, Novartis, Pfizer, Minervax, and the Bill & Melinda Gates Foundation; and has served on speaker{\textquoteright}s bureaus for Sanofi Pasteur and GSK. K. L. O. has received grant funding from GSK and Pfizer and participates on technical advisory boards for Merck, Sanofi Pasteur, PATH, Affinivax, and ClearPath. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Funding Information: Financial support. PERCH was supported by the Bill & Melinda Gates Foundation (grant number 48968 to the International Vaccine Access Center, Department of International Health, Johns Hopkins Bloomberg School of Public Health). J. A. G. S. was supported by a clinical fellowship from The Wellcome Trust of Great Britain (award number 098532). Publisher Copyright: {\textcopyright} The Author 2017.",
year = "2017",
doi = "10.1093/cid/cix077",
language = "English (US)",
volume = "64",
pages = "S228--S237",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
}