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 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.
Highlights
Variable adherence to standardized case definitions, clinical procedures, specimen collection techniques, and laboratory methods has complicated the interpretation of previous multicenter pneumonia etiology studies
Satisfactory clinical standardization was achieved within and across all Pneumonia Etiology Research for Child Health (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
Standardization of the clinical [8], radiological [9], laboratory [10], and data management methods [11] at all PERCH sites has been prioritized since inception, as we wished to ensure that any observed variation in pneumonia etiology between sites was not attributable to methodological differences
Summary
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. At all sites (Table 1), clinical assessment and enrollment of PERCH cases and controls were carried out by doctors, nurses, and clinical officers (health workers with at least 3 years of formal clinical training). Nurses and field workers or research assistants took anthropometric measurements, assisted clinical staff with procedures, and identified and located PERCH community controls. Through a series of teleconferences and 2 face-to-face meetings between all PERCH principal investigators (PIs), consensus was achieved on how to elicit, recognize, and interpret each of the signs and symptoms comprising the PERCH clinical case definition (Table 2), and on the choice of methods and equipment for obtaining key clinical measurements (pulse oximetry, anthropometry, respiratory rate) and clinical samples (nasopharyngeal [NP] and oropharyngeal [OP] swabs, induced sputum [IS], lung aspirates, blood, urine)
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