Nitrogen dioxide and respiratory illness in children. Part III: Quality assurance in an epidemiologic study

This report describes the quality assurance and quality control program developed for the previously reported epidemiologic study of nitrogen dioxide (NO2) and respiratory illness in children (Health Effects Institute Research Report 58, Parts I and II). The specific aims of the program were to make certain that data were sufficiently accurate, complete, verifiable, and retrievable. The quality assurance and quality control program consisted of: a written protocol, standard operating procedures, written records, a project management system, appropriate data processing, data verification, and data analysis planning, and was staffed by qualified and appropriately trained personnel. Within the activities of the overall program, two focused quality assurance studies were conducted. During the first of these focused studies, parents maintained a calendar-diary of their child's daily respiratory symptoms. Telephone interviews were conducted at intervals of two weeks, and parents used the calendars to report on symptom occurrence since the previous call. To assess the comparability of illness events based on symptom reports from the parents with usual clinical diagnostic methods, nurse practitioners examined children during illness, and office and clinic records of outpatient visits were reviewed. Using the parent reports, respiratory illnesses were defined as symptom episodes of at least two consecutive days; lower respiratory illnesses included at least one day of either wet cough or wheeze. Runny or stuffy nose was reported for 93% of illnesses; and wet cough for 33% and wheeze for 6% of illnesses. In comparison with the diagnoses made by a nurse practitioner, parent reports of wet cough or wheeze were sensitive (93.4%) for detecting lower respiratory illnesses, but nonspecific (with specificity of only 24.2%). The majority of the false-positive lower respiratory illnesses had the symptom of wet cough. The comparison of parent reports with outpatient records provided similar findings. These findings indicate that standardized reporting of respiratory illnesses can be achieved with regular telephone interviews, but the classification of specific illnesses from the observations of parents' information may differ from diagnoses made by clinicians. The second focused quality assurance study evaluated the measurement error associated with the parents' use of passive diffusion samplers for NO2. Midway through the study, technicians conducted home visits to assess compliance with stated procedures, and to make independent measurements of NO2. Based on criteria for placement and use of the samplers, conditions of noncompliance were observed on about 40% of visits.(ABSTRACT TRUNCATED AT 400 WORDS)