Evaluation of the Bear Hill Camp Pilot Study and Recommendations for Implementation in a School Setting

1. Evaluation of the Bear Hill Camp Pilot Study and Recommendations for Implementation in a School Setting Richard G. Rumba UNH Master of Public Health Program Field Study (PHP- 990) 10 March 2004

2. Background INHALE Goal #1: investigate relationship between AQ & pulmonary health in New England Proposal: examine short-term changes in local air pollutant levels and pulmonary function among a cohort of elementary school children in 3 northern NE communities. Pilot project conducted at the Bear Hill 4-H Camp, summer 2003 to collect preliminary data and assess feasibility & required level of effort.

3. UNH MPH Field Study Purpose - to assist INHALE project by: Facilitating and supervising logistics & implementation during the pilot project process; Evaluating the processes, materials and methods used to conduct the pilot project; and Making recommendations for successful transfer to the school-based study.

4. Evaluation and Recommendations for: Pulmonary Function Measurements: Measurement techniques Measurement devices Study Design Supplementary Information: Informed consent Medical/environmental/behavioral background info. Daily health assessment Data Management Program Costs and Level of Effort

5. Pulmonary Function Measurements Spirometry is the most widely used test Primarily used as a diagnostic tool, but increasingly used in research to measure respiratory function in relation to other variables Two types of respiratory problems can be observed: airway obstruction and airway restriction.

6. Airway Obstruction vs Airway Restriction Obstruction: impediment to normal air flow Restriction: reduction in lung volume Asthma and other reversible inflammatory lung diseases are characterized by air flow obstruction in the lower airways, thus this study will focus on measurements of airway obstruction

7. Spirometry Measurement Techniques peak expiratory flow rate (PEFR), forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC ratio (FEV1%), and forced expiratory volume in six seconds (FEV6) and FEV1/FEV6 ratio.

8. Peak Expiratory Flow Rate (PEFR) Advantages: Measurement devices are safe, cheap, portable, simple to use Routinely and universally used by individuals with asthma and other obstructive respiratory diseases to objectively assess lung function. Disadvantages: Highly effort dependent Only moderately accurate and precise Large inter-subject and intra-subject variability Significant diurnal variations within individuals Poor correlation with other spirometry measurements

10. Forced Expiratory Volume in One Second (FEV1) Advantages: Evaluates large & mid- airways Measures obstruction (narrowed airways = air expelled more slowly) ATS recommends FEV1 for diagnosis of airway obstruction severity: (60-75% = mild, 40-59% = moderate, <40% = severe) New screening instruments are safe, cheap, portable, simple to use

11. FEV1/FVC ratio (FEV1%) Advantages: Same advantages as FEV1 Provides its own standardized measure of obstruction (FEV1 measures airflow rate & FVC measures volume) ATS recommends FEV1% as the primary standard for diagnosing, assessing and quantifying airway obstruction (< 70-75%)

15. Summary of Pulmonary Function Measurements Spirometry measurements for the continuation of this study should at a minimum include FEV1 Preferably also measure FEV1/FVC ratio and/or FEV1/FEV6 ratio due to measurement self-standardization. Consider using eNO and FOT techniques to supplement spirometry

16. Pulmonary Function Measurement Devices Evaluated ~20 portable spirometric measurement devices for cost, availability, performance, ease of use, ATS acceptability,measurement parameters, data collection and storage capability, etc. Recommend single-user devices due to issues of mucosal cross-contamination and data acquisition. Ferraris Medical makes several low-cost devices (similar to those used in pilot study) that best meet study needs. Primary choice: KoKo Peak Pro 6 (measures PEFR, FEV1, FEV1/FEV6 ratio, self-assessment questions) Secondary Choice: PiKo-1 PiKo-1 is less costly, but has limited measurement/data storage & handing capabilities One manufacturer of eNO devices, but limited information available

21. Pulmonary Function Study Design Measurement Subject Selection children age 8 or older supervised by trained technician representative of local gender and ethnic background mix equal proportion of those with and without existing respiratory disease study population size = 20-30 individuals Measurement Parameters Outdoor air pollutants (continuous O3, PM) Indoor air pollutants (continuous) Pulmonary function (FEV1, FEV1/FEV6 ratio, PEFR)

23. Supplemental Pulmonary Function Health Information  Informed Consent: IRB-approved parental consent/child assent IRB-approved continuing review process Medical/Environmental/Behavioral Background Info: health background – (health history, respiratory health status, medication use, body mass index, gender, and ethnicity) environment – (exposure to respiratory irritants and/or allergens in the home, neighborhood, etc.) behavior – (activities, diet, exercise, etc.) Daily Health Assessment: activity, medication use, symptoms twice daily during spirometry measurements use of automated rather than manual data collection system

24. Data Management Pilot project – data collected and input into database (spreadsheet) manually KoKo Peak Pro 6: collects and stores pulmonary function data and self-assessment questions. data downloaded once/month KAMP professional software: stores and analyzes data for unlimited number of individuals. allows data transfer and communication via the internet PiKo-1: stores pulmonary function test results for 45 days data downloaded to a professional software program for storing and analyzing data for multiple individuals no capacity for self-assessment questions Confidentiality???

25. Program Costs and Level of Effort

26. Program Costs and Level of Effort When evaluating project costs, there is a trade-off between equipment costs and level of effort (labor) The total equipment costs for the KoKo Peak Pro 6 and KAMP software are 2 times greater than for the PiKo-1 and PiKo Trend software. However, the labor costs using the KoKo Peak equipment are 1/3 less than if using the PiKo-1 equipment. Since the labor costs are far more than the equipment costs in this program, the overall program costs using the KoKo Peak equipment are only 75%-80% of those using the PiKo-1 equipment.

27. Summary Recommendations: Pulmonary Function Measurement Techniques: FEV1, and FEV1/FEV6 ratio Pulmonary Function Measurement Device: Ferraris Medical, Inc. KoKo Peak Pro 6 Study Design: Panel study, 20-30 subjects each using individual measurement device Schedule, Frequency, Duration: 1 school year per school, 2 consistent measurements periods per day (am and pm) each school day

29. Summary (cont.) The success of the proposed school-based study of the relationship between air quality and respiratory health will be dependent both on its scientific validity and practical feasibility. As such, a balance between assuring the study’s technical and statistical strength while at the same time maintaining a reasonable, attainable and affordable approach must be achieved.