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Gulf STUDY Version 3.0 (03/01/11) National Institute of Environmental Health Sciences (NIEHS) GuLF STUDY Version 3.0 (03/01/11) GuLF STUDY: Gulf Long-Term Follow-Up Study Dale P. Sandler, Ph.D. Principal Investigator Chief, Epidemiology Branch Division of Intramural Research National Institute of Environmental Health Sciences Richard K. Kwok, Ph.D. Lead Associate Investigator Epidemiology Branch Division of Intramural Research National Institute of Environmental Health Sciences Lawrence S. Engel, Ph.D. Associate Investigator Department of Epidemiology Gillings School of Global Public Health University of North Carolina at Chapel Hill and Epidemiology Branch Division of Intramural Research National Institute of Environmental Health Sciences Christine Parks, Ph.D. Associate Investigator Epidemiology Branch Division of Intramural Research National Institute of Environmental Health Sciences Stephanie J. London, M.D., Dr.P.H. Associate Investigator Epidemiology Branch Division of Intramural Research National Institute of Environmental Health Sciences Aubrey K. Miller, M.D., M.P.H. Associate Investigator Office of the Director National Institute of Environmental Health Sciences Page 1 of 96 National Institute of Environmental Health Sciences (NIEHS) GuLF STUDY Version 3.0 (03/01/11) Aaron Blair, Ph.D. Consultant Occupational and Environmental Epidemiology Branch National Cancer Institute John Hankinson, Ph.D. Consultant Hankinson Consulting, Inc. Mark Stenzel Consultant Exposure Assessment Applications, LLC. Patricia A. Stewart, Ph.D. Consultant Stewart Exposure Assessments, LLC. Page 2 of 96 National Institute of Environmental Health Sciences (NIEHS) GuLF STUDY Version 3.0 (03/01/11) Table of Contents Table of Contents ................................................................................................ 3 List of Acronyms ................................................................................................. 7 Protocol Summary .............................................................................................. 9 Précis ................................................................................................................. 10 Schematic of Study Design .............................................................................. 12 Background Information and Scientific Rationale ......................................... 13 1 Study Objectives .................................................................................... 15 1.1 Primary Objective ................................................................................. 16 1.2 Secondary Objectives ........................................................................... 16 1.3 Sub-study Objectives ............................................................................ 16 2 Study Design .......................................................................................... 17 2.1 Description of the Study Design ........................................................... 17 2.1.1 Study Population ........................................................................... 17 2.1.2 Study Cohort and Sub-cohorts ...................................................... 18 2.1.3 Exposure Reconstruction .............................................................. 20 2.2 Eligibility Criteria ................................................................................... 23 2.2.1 Rationale for including only workers or those who were trained .... 23 2.2.2 Rationale for Exclusions ................................................................ 24 2.3 Recruitment .......................................................................................... 25 2.3.1 Recruitment Database ................................................................... 25 2.4 Community and Scientific Outreach ..................................................... 26 2.4.1 Meetings with potentially affected groups ...................................... 26 2.4.2 Community Advisory Group ........................................................... 29 2.4.3 Communicating the Study to the Community ................................ 29 2.4.4 Scientific Outreach ........................................................................ 31 2.5 Enrollment Procedures and Enrollment Questionnaire ......................... 31 2.6 Tracing .................................................................................................. 32 2.7 Procedures for Enrolling Cohort Members ............................................ 33 2.7.1 Recruitment and Retention ............................................................ 33 2.7.2 Recruitment/Retention Strategies and Approach .......................... 34 2.8 Recruitment of Special Populations ...................................................... 35 2.8.1 Special Issues in Recruiting Vietnamese Participants ................... 35 2.8.2 Special Issues in Recruiting Creole-Speaking Persons ................. 36 2.8.3 Special Issues in Recruiting Women ............................................. 36 2.8.4 Special Issues in Persons with Reactive Airways Disease ............ 37 2.8.5 Other Special Populations ............................................................. 37 2.9 Home Visit ............................................................................................ 37 Page 3 of 96 National Institute of Environmental Health Sciences (NIEHS) GuLF STUDY Version 3.0 (03/01/11) 2.9.1 Advance Study Packet .................................................................. 38 2.9.2 In-Home Visit ................................................................................. 38 2.9.3 Baseline Questionnaire ................................................................. 40 2.9.4 Anthropometric/Physiological Measures ........................................ 41 2.9.5 Collection of Biological Samples ................................................... 43 2.9.6 Home Environment Sampling ........................................................ 44 2.9.7 In-Home Biospecimen Processing and Shipment ......................... 45 2.10 Reports to Participants, Health Care Referrals and Incident Reports ... 45 2.10.1 Overview ....................................................................................... 45 2.10.2 Home Visits or Participant Evaluations at other Locations ............ 46 2.10.3 Home Visit/Evaluation Measurements & Testing ........................... 48 2.10.4 Follow-up Actions for Abnormal Findings ...................................... 49 2.10.5 Abnormal Findings Form ............................................................... 54 2.10.6 Follow-up Reports & Information ................................................... 54 2.11 Laboratory Biospecimen Processing and Storage ................................ 55 2.11.1 Central Laboratory Processing ...................................................... 55 2.11.2 Study Sample Long-Term Storage at the NIEHS Repository ........ 56 2.11.3 Analyses (including future studies) ................................................ 56 2.12 Follow-Up of Cohorts ............................................................................ 57 2.12.1 Telephone Questionnaires (Year 2 and 4) ..................................... 57 2.12.2 Biomedical Surveillance Sub-cohort Follow-up (Year 1 and 3) ...... 57 2.12.3 Annual Morbidity and Mortality Outcomes (Year 2 and later) ........ 58 2.12.4 Follow-up in Years 6-10 ................................................................. 58 2.13 Retention Strategies ............................................................................. 58 2.13.1 Annual Update of Contact Information ........................................... 58 2.13.2 Newsletters and Other Mailings ..................................................... 59 2.13.3 Study Website ............................................................................... 59 2.13.4 Social Media .................................................................................. 59 2.13.5 Community Partnerships and Outreach ......................................... 60 2.14 Remuneration ....................................................................................... 60 2.15 Study Timeline ...................................................................................... 61 3 Evaluation of Benefits and Risks .......................................................... 63 3.1 Potential Benefits .................................................................................. 63 3.2 Potential Risks ...................................................................................... 63 4 Adverse Event Reporting ...................................................................... 64 5 Study Oversight ..................................................................................... 65 6 Statistical Analysis Methods ................................................................. 66 6.1 Treatment of Exposure Status and Health Outcomes .......................... 66 6.2 Statistical Methods to Address Study Objectives .................................. 67 6.3 Interim and Safety Analyses ................................................................. 68 6.4 Laboratory QA/QC Analyses ................................................................ 69 6.5 Sample Size Considerations and Power............................................... 69 Page 4 of 96 National Institute of Environmental Health Sciences (NIEHS) GuLF STUDY Version 3.0 (03/01/11) 6.5.1 Estimated sizes of worker (exposed) and non-worker
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