United States Environmental Protection Agency Health Effects Research Laboratory Research Triangle Park NC 27711 Research and Development EPA-600/S1-81 -065 August 1982 Project Summary Effects of Short-Term Intermittent Air Pollutants on Incidence and Severity of Acute Respiratory Disease: Data Collection and Quality Assurance R. David Flesh, Margaret L. Riha, and Michelle F. Miller The purpose of this study was to measure the acute response of respi- ratory disease from peak hourly and daily average exposures to nitrogen dioxide alone and in combination with other pollutants. The study population was made up of families with children attending public elementary schools and living in four California South Coast Air Basin study areas: West Los Angeles/Santa Monica, Garden Grove/Westminster, Glendora/Covina, and Upland/Ontario. The role and responsibility of the contractor were to collect all back- ground and health data, to process and assure the quality of the data, and to prepare the report. The contractor was assisted by the Statewide Air Pol- lution Research Center at the Univer- sity of California, Riverside (UCR), in the data collection tasks. Families were recruited for partici- pation during the spring and summer months of 1978. Recruitment included face-to-face interviews for the pur- pose of collecting family background data. Over 3,000 families were inter- viewed. From these, 1,402 families (about 350 per study area) were selected. Participation required that families record daily the disease symptoms that they experienced. According to instructions mailed to them, the symp- toms were to be recorded on a spe- cially prepared calendar. Each week, the symptoms recorded the previous week were given by telephone to a staff of trained interviewers employed by the contractor. Symptom surveil- lance began in September 1978 and ended in March 1979. The background and symptom data were reviewed and edited in the field and in the contractor's main offices prior to data entry. Computer files of the background and symptom data were prepared in three steps. First, the data were transferred from the back- ground and symptom questionnaires to magnetic tapes through the use of an optical reader. Second, supple- mentary information including up- dates to the background data and doc- tors' diagnoses of illnesses reported during symptom surveillance were key- taped into a separate computer file. Third, quality assurance procedures were used to minimize error in the computer files. Maximum allowable error was set at 2%. The computer ------- files and all questionnaires were then sent to the EPA for analysis. This Project Summary was deve- loped by EPA's Health Effects Re- search Laboratory, Research Triangle Park. NC, to announce key findings of the research project that is fully doc- umented in a separate report of the same title (see Project Report order- ing information at back). Introduction This report covers the health data collection phase of the project. Delineating the Study Areas Four study areas had been tentatively chosen by the EPA for this study in 1976. In December 1977, the EPA decided to place a second air monitoring station in each of the study areas. The purpose of installing a second station was to permit better characterization of air pollution exposure of families enrolled in the study. An added benefit of having a second station was to expand the portion of each area in which families could be interviewed. The criterion placed on the locations of the second stations was that they be located no more than two miles from the existing EPA air monitoring stations. An additional criterion stated that the 2-mile area around the new station must be socio-economically comparable to the 2-mile area around the existing station. The final shape of each of the study areas was a rectangle, measuring two miles by four miles. This was done to improve estimates of human exposure over what would have been obtained if only one air monitoring station had been located in each of the areas andto increase the number of households from which families could be recruited. The study areas were divided into inter- viewing zones so that the addresses of elementary school families residing in the areas could be plotted on the maps and an orderly schedule of interviewing could be established. Background Survey Intervie wing Lists of student and/or family names and addresses were obtained by the contractor. Using EPA-supplied maps, the contractor's clerical staff listed the streets and street number limits which fell into each zone, making proper zone assignment of each address an easy task. For a given interviewing zone, the study area with the lowest number of multiple family units determined the number of multiple family dwellings to be interviewed in all four areas. For example, if a particular zone in West Los Angeles had the least number of multi- ple family dwellings of the four areas, then that number of multiple family addresses would be randomly chosen from the corresponding zones in each of the other three study areas. The same procedure was used for single family dwellings. The zone sample size was, therefore, the sum of the lowest number of multiple family dwellings and the lowest number of remaining addresses making the zone sample size the same for all four study areas. This technique resulted in an initial sample size of 1,294 homes in each study area. A training session for interviewers was held on May 18 and 19. It began with a presentation given by the con- tractor on the proper techniques of interviewing in studies of scientific concern. Following this, the inter- viewers were given copies of the ARD Study Background Questionnaire and interviewers' instructions, which con- tained information on the background and purpose of the study, a sheet of questions and answers about the study that the interviewers were to use when they contacted the school families for interviews, an interviewing schedules, and maps of the study areas. After the formal presentations were completed the interviewers practiced administering the questionnaire to each other. Sample interviews were presented and critiqued, and then actual interviews were practiced in the field. The survey began in West Los Angeles on May 22,1978, the first work day following the training session. The interviewers met with their team lead- ers late in the afternoon, giving them the questionnaires they completed that day. During this meeting the interview- ers received a new supply of blank ques- tionnaires and address sheets for the study area and zone where interviews were to be conducted the next day. Families who could not be contacted on a previous visit were reassigned to the interviewers. Every day, the inter- viewers would first attempt to make callbacks in previous zones before mak- ing contacts with families in newly assigned zones. Interviewing was rotated from study area to study area to avoid day of the week effects and to maximize the chances of finding the families at home. A "round" of interviewing was said to have been completed after each four days of the survey. The final round (Round 12) of interviewing ended on August 1. The total numbers of inter- views completed in each of the study areas during the 12 rounds of interview- ing were as follows: 740 in West Los Angeles/Santa Monica, 754 in Garden Grove/Westminster, 824 in Glendora/- Covina, and 842 in Upland/Ontario. Telephone validation of 10 percent of the interviews completed by each inter- viewer was conducted through Round 12 by non-interviewing personnel. No significant differences were found be- tween the initial interviews and the val- idation interviews. Selecting Families for Participation As the face-to-face interviews of fam- ilies progressed through the 12 rounds, the questionnaires were edited for completeness and inconsistencies. The answers given were checked to deter- mine eligibility, also. Five criteria, deve- loped by the EPA, had to be met for families to qualify for participation. 1. Have access to working telephone. 2. Have lived in the study area for one or more years. 3. Do not plan to move within 12 months. 4. Agree to participate in the weekly telephone surveillance. 5. Have one or more elementary school children living in the home. Initially, priority for selection was to take the following factors into consider- ation: 1. Presence of the pre-school children in the family. 2. Length of residence in the study area: a. Three or more years b. One to three years 3. Parents livng the home: a. Both parents b. Female parent c. Male parent 4. Type of fuel used for cooking: a. Gas b. Electricity ------- 5. Type of air conditioning in the home: a. Central b. Room c. None 6. Type of dwelling unit: a. Single Family b. Multi-family 7. Presence of older family members (e.g., grandparents) living in the home. It was planned that the study areas would be matched in terms of these fac- tors as well as in terms of the socioeco- nomic characteristics. However, as the responses to the Background Question- naires were being coded, it quickly became clear that the study area could not be completely matched and that all of the factors could not be accommo- dated if the selection process was to yield the quota of at least 350families in each study area. Therefore, a decision was made by the EPA to use 80% of the families who cook with gas and 20% of the families who cook with electricity in each study area where this combination was possible (in West Los Angeles, Garden Grove, and Glendora) and a 50%: 50% ratio of gas to electricity where the 80%:20% ratio was not possible (in Upland). The EPA also decided that 2- parent families with no pre-schoolers, living in single family dwellings, should be given lowest selection priority and should be randomly sampled to complete the quota of 350 panel families in each study area. Other factors, including the type of air conditioning and the pres- ence of older family members living in the home, had to be dropped completely as selection criteria, since too few homes in the West Los Angeles study area had air conditioning and too few school fam- ilies contained older people. A total of 1,400 families (4 study areas x 350 families per study area) were selected and randomly distributed into 14 groups in preparation for weekly telephone surveillance. Each group was assigned to a different telephone interviewer. Weekly Telephone Interviewing In August 1978, the contractor and subcontractor each recruited seven telephone interviewers and two alter- nates in preparation for weekly symptom surveillance. All interviewers had pre- viously been members of the background survey teams. A training session was held on September 6 and 7 with the interviewers, alternates, and supervi- sors in attendance. An EPA instruction manual on how to complete the ARD Study Symptom Questionnaire was dis- tributed to each of the interviewers prior to the briefing. A review of the instructions was followed by a demon- stration on conducting the weekly symp- tom surveillance calls. After a period of questions and answers, the interview- ers practiced conducting weekly inter- views. Pre-surveillance telephone calls were conducted during the week of Septem- ber 11. During the presurveillance calls, an interviewer ascertained, without directly asking, whether or not the re- pondent still wished to participate in the panel. Respondents were asked if they had received their calendars and if they had any questions relating to the use of the calendar. Next, a day and time for the weekly telephone calls was estab- lished with each respondent. Finally, all information on the background of the respondent's family was updated. Families which stated, during the pre- surveillance call, that they were no longer interested in participating in the study, were replaced by eligible families which were selected as alternates. A withdrawn family that cooked with gas was replaced with another family from the same study area that also cooked with gas. This was done to maintain the existing balance of selection factors and the quota of 350 panel families in each study area. The families began to keep records of symptoms on their calendars on Sep- tember 10. The first week of symptom surveillance telephoning took place dur- ing the week of September 18. Each interviewer was provided with 100 pre- printed ARD Study Symptom Question- naires, one for each of the families to which the interviewer was assigned. All weekly calls to families were made on Mondays and Tuesdays whenever possible. The records of contacts with all families were reviewed at regular intervals by the field supervisors to ascertain how many of the families' surveillance calls had to be made on days other than Monday or Tuesday, how many weeks information was taken from an alternate respondent, and how many weeks the family was unable to be contacted. If a family reported on an alternate day, used an alternate respondent, and/or failed to give a report entirely, for more than eight weeks, the family was withdrawn from the study. Onlyduring the Week 1 were families which withdrew from the study replaced by alternates. After Week 1, no further replacements were made. Any changes in background informa- tion previously supplied by families were recorded as they occurred during the 12 of surveillance. A special form was used for this purpose. After every six weeks of symptom surveillance, i.e., after Weeks 6,12, and 18, the 14 groups of families were ran- domly reassigned to the interviewers. In accordance with the instructions of the EPA Project Officer, no interviewer was assigned the same group of families she had interviewed previously. During Weeks 12 and 24 random samples of 10% of the completed inter- views from each interviewer's group of families was selected for validation. The selected families who had been interviewed on Monday or Tuesday of Weeks 12 and 24 were reinterviewed on Wednesday or Thursday of the same week by the field supervisors. The integrity of the validation procedure was enhanced by the exchange of assignments between the field supervisors, i.e., the prime contractor's field supervisor vali- dated the interviews conducted by the subcontractor's interviewers and vice versa. Once again, no significant differ- ences were found between the initial interviews and the validation interviews. The final session (Week 26) of symp- tom surveillance telephone calls was conducted on March 12 and 13. The numbers of families who participated through the 26 weeks of the study were as follows: 316 (90.3%) in West Los Angeles, 290 (82.9%) in Garden Grove/ Westminister, 300(85.7%) in Glendora/ Covina, and 310 (88.6%) in Upland/ Ontario. Assuring the Accuracy of the Data Files As a preliminary step in testing the accuracy of the data files, computer range checks were performed for all questions in order to verify that all answers were within a valid range. Invalid responses were checked, receded, and corrected on the data tapes. The quality assurance testing proce- dure employed sampling inspection tabjes based on a Poisson distribution, which sets the probability at 90% that less than 2.0% of the forms have one or I US.GOVERNMENTPRINTINa OFFICE. IMi-559-017/0781 ------- more errors. For a quantity of between 3,001 and 4,000 Background Ques- tionnaires, 510 questionnaires had to be drawn at random, and checked against the data from those questionnaires that exist inthe computer files. According to this sampling plan, the maximum number of acceptable errors was six. For the purpose of counting errors, an error was considered to exist if one or more responses in the computer file of a particular questionnaire differed from the corresponding responses on the actual questionnaire. A 100% check on the Background Questionnaires was conducted as a penalty for failing the sample test. Cor- rections to the background data files were made and a new random sample of 510 questionnaires was selected and compared to the computer files twice before the computer file passed the test. The background data files, after passing the quality assurance test, were sub- mitted to EPA on two magnetic tapes. For a quantity of between 1,001 and 2,000 Symptom Questionnaires a ran- dom sample of 380 family records had to be selected. This was done for each of the 26 weeks of data. The computer files corresponding to the random sam- ple of 380 questionnaires were allowed to have a maximum of four errors in order to be within the acceptable levels of the sampling plan. An error existed when a family record in the computer files did not exactly correspond to the actual questionnaire for that family. The first three weeks sampled failed with a great many errors and the deci- sion was made to perform a 100% check of all 26 weeks of symptom data before doing any further random sampling. All 26 weeks were 100% checked by com- paring the computer files to the original written forms. Near the end of the contractor's au- thorized level of effort, random samples were drawn from each week of surveil- lance. Weeks 1, 4, 6, 13, 20, 21, 22, 23, 25, and 26 passed the test, since they had four or less errors per sample. The remaining weeks were again sub- jected to 100% error checks and correc- tions were again made to the computer files to eliminate the errors encoun- tered. The symptom data files were submitted to the EPA on 26 magnetic tapes, one for each week of symptom ij surveillance. EPA continued processing ;i|: |.: the weekly surveillance forms that hadg :jfailed the quality assurance test until*: jthey also passed. 8 This contract was for collection of health data only. HERL, RTP, USEPA is in the process of analyses and interpre- tation of this data set. R. David Flesh, Margaret L. Riha, and Michelle F. Miller are will Del Green Associates, Inc., San Diego, CA 92131. Wilson B. Riggan is the EPA Project Officer (see below}. The complete report, entitled "Effects of Short- Term Intermittent A ir Pollutants on Incidence and Severity of Acute Respiratory Disease: Data Collection and Quality Assurance," (Order No. PB 82-129 479; Cost: $21.00, subject to change) will be available only from: National Technical Information Service 5285 Port Royal Road Springfield, VA22161 Telephone: 703-487-4650 The EPA Project Officer can be contacted at: Health Effects Research Laboratory U.S. Environmental Protection Agency Research Triangle Park, NC 27711 United States Environmental Protection Agency Center for Environmental Research Information Cincinnati OH 45268 Postage and Fees Paid Environmental Protection Agency EPA 335 Official Business Penalty for Private Use $300 ------- |