| | HANFORD THYROID DISEASE STUDY FINAL REPORT |
| | 14,1 | | MB |
| | 614 | | stron |
| | 5426 | | ID | Centers for Disease Control and Prevention |
| | 2002 | | rok |
| | TABLE OF CONTENTS |
| | EXECUTIVE SUMMARY |
| | I. INTRODUCTION .....1 |
| | II. BACKGROUND ....4 |
| | A. Historical Perspective ....4 |
| | B. Ionizing Radiation and Thyroid Disease ....9 |
| | B.1. Thyroid Neoplasia: Exposure to External Photon Radiation ....9 |
| | B.2. Thyroid Neoplasia: Exposure to Radioactive Iodine ...10 |
| | B.2.a. Medical Exposures to Radioiodine ..10 |
| | B.2.b. Environmental Exposures to Radioiodine ...11 |
| | B.2.b.1. Utah .11 |
| | B.2.b.2. Marshall Islands ....11 |
| | B.2.b.3 Chernobyl ..12 |
| | B.2.c. Relative Biological Effectiveness of I-131 in the Induction of |
| | Thyroid Cancer .13 |
| | B.3. Hypothyroidism ...14 |
| | B.4. Autoimmune Thyroiditis ..14 |
| | C. Ionizing Radiation and Parathyroid Disease ...16 |
| | C.1. Hyperparathyroidism: Exposure to External Photon Radiation .....16 |
| | C.2. Hyperparathyroidism: Exposure to Radioactive Iodine ..17 |
| | D. Ultrasound-Detected Abnormalities of the Thyroid (Thyroid UDAs) .....18 |
| | D.1. Prevalence of Thyroid UDAs .18 |
| | D.2. Specificity of Thyroid Ultrasonography in Predicting Thyroid Cancer ...19 |
| | D.3. Ionizing Radiation and Thyroid UDAs .20 |
| | III. STUDY OBJECTIVES ...21 |
| | IV. STUDY DESIGN .....22 |
| | A. Eligibility Criteria ....22 |
| | A.1. Mother's Residence at the Time of the Particpant's Birth ....22 |
| | A.2. Year of Birth .....30 |
| | A.3. Other Possible Criteria ....33 |
| | B. Definition of Evaluable Participant ..34 |
| | C. Outcome Criteria ..35 |
| | C.1. Thyroid Cancer ....35 |
| | C.2. Benign Thyroid Nodule .....35 |
| | C.3. Any Thyroid Nodule .36 |
| | C.4. Hypothyroidism ...36 |
| | C.5. Autoimmune (Hashimoto’s) Thyroiditis ..36 |
| | C.6. Graves Disease ....37 |
| | C.7. Autoimmune Thyroid Disease ..37 |
| | C.8. Hyperthyroidism ..37 |
| | C.9. Multinodular Thyroid Gland ....38 |
| | C.10. Simple Goiter ....38 |
| | C.11. Other Thyroid Disease .....38 |
| | C.12. Ultrasound-Detected Abnormalities of the Thyroid (Thyroid UDAs) ..39 |
| | C.13. Hyperparathyroidism ...39 |
| | V. FIELD PROCEDURES AND METHODS, RESULTS OF DATA COLLECTION PROCESS ....40 |
| | A. Cohort Definition, Subject Identification and Selection ..40 |
| | A.1. Background ..40 |
| | A.1.a. Objectives .....40 |
| | A.1.b. Definition of the Cohort ...40 |
| | A.2. Plan ..41 |
| | A.2.a. Protocol Plan ...41 |
| | A.2.a.1. Rationale ...41 |
| | A.2.a.2. Completeness Required for Success ....43 |
| | A.2.b. Plans for Assessing the Need for Change in the Full Study ....43 |
| | A.3. Revisions .44 |
| | A.3.a. Rationale for Revisions made in the Transition Sample ..44 |
| | A.3.b. Rationale for Revisions made in the Full Study ..44 |
| | A.4. Outcome and Final Results .45 |
| | A.5. Summary of Full Study Power Calculations, as Presented in HTDS Pilot Study Report 47 |
| | B. Tracing Potential Participants ..52 |
| | B.1. Background .52 |
| | B.1.a. Objectives of Tracing ..52 |
| | B.1.b. History of Tracing Efforts Around Hanford 52 |
| | B.1.c. Overview of Tracing Efforts 53 |
| | B.1.d. Staffing and Logistics ..55 |
| | B.2. Revisions to the Original Protocol Plan ..55 |
| | B.2.a. Deletion of Ineffective Sources of Information and Addition of New Sources .55 |
| | B.2.b. Addition of Computer On-line Database Information .56 |
| | B.3. Final Tracing Process ..56 |
| | B.3.a. Linkages with Publicly Available Data Sources ..56 |
| | B.3.b. Manual Tracing Resources ..58 |
| | B.3.c. Unlocated Potential Participants .63 |
| | B.4. Outcome and Final Results ..68 |
| | B.4.a. Results from the Pilot Study Sample .68 |
| | B.4.a.1. Results by Strata .68 |
| | B.4.b. Results from Transition Sample 68 |
| | B.4.b.1. Results by Strata .68 |
| | B.4.c. Results for the Full Study Sample 75 |
| | B.4.c.1. Results by Strata .76 |
| | B.4.d. Overall Results for the Full Study 78 |
| | B.4.d.1. Success in Locating Study Potential Participants ..78 |
| | B.4.d.2. Current Residence of Living Potential Participants 81 |
| | B.4.d.3. Death Certificates Obtained for Deceased Potential Participants .82 |
| | C. Recruiting .84 |
| | C.1. Background ..84 |
| | C.1.a. Objectives of Recruiting ..84 |
| | C.2. Recruiting Procedures 84 |
| | C.2.a. Initial Written Contact and Attempt to Contact by Phone ..84 |
| | C.2.b. Telephone Contact with the Potential Participant ..85 |
| | C.2.c. Confirmation of Agreement to Participate and Six Month Letter 86 |
| | C.2.d. Refusals and Second Attempts .86 |
| | C.2.e. Second Request for Participation 86 |
| | C.3. Outcome and Results 87 |
| | C.3.a. Results for the Pilot Study Sample ..87 |
| | C.3.b. Results from the Transition Sample .91 |
| | C.3.c. Results for the Full Study Sample 95 |
| | C.3.d. Results for the Entire Study .98 |
| | C.3.d.1. Agreement on First Attempt vs. Second Attempt (conversions) 102 |
| | C.3.d.2. Refusal 103 |
| | C.3.d.3. Success in Converting Refusals/Withdrawals by Reason for Refusal .104 |
| | C.3.d.4. Success in Converting Refusals/Withdrawals by “Strength” of Refusal 105 |
| | C.3.e. Conclusions ...106 |
| | D. Computer Assisted Telephone Interview ..107 |
| | D.1. Background ...107 |
| | D.1.a. Objectives of the Interview 107 |
| | D.1.b. Historical Perspective and Special Challenges .107 |
| | D.2. Content and Design of the CATI ...108 |
| | D.2.a. Development of a Cognitive Approach to Enhance Long-term Recall ....108 |
| | D.2.b. Development and Testing of the CATI ..109 |
| | D.2.c. Final Process and Procedures ..110 |
| | D.2.c.1. Conducting the Interview ..110 |
| | D.2.c.2. Quality Control ....111 |
| | D.3. Outcome and Results .112 |
| | D.3.a. Pilot Study Results ....112 |
| | D.3.b. Transition Sample Results .112 |
| | D.3.c. Results for the Full Study Sample .112 |
| | D.3.d. Overall Results for the Entire Study 112 |
| | D.3.e. Conclusions ..112 |
| | D.3.e.1. Quality of the Data 113 |
| | D.4. Attempts to Administer the CATI to Respondents for Deceased Potential Participants ..115 |
| | D.4.a. Development of a Revised CATI for Deceased Potential Participants ..115 |
| | D.4.b. Conducting a CATI for Deceased Potential Participants .116 |
| | D.5. Success of the CATI Component ...116 |
| | E. Scheduling 118 |
| | E.1. Background 118 |
| | E.2. Objectives of Scheduling 118 |
| | E.3. Final Process and Procedures 119 |
| | E.4. Outcome .120 |
| | E.4.a. Results for the Pilot Study Sample .120 |
| | E.4.b. Results for the Transition Sample ..120 |
| | E.4.c. Results for the Full Study Sample ..121 |
| | E.4.d. Overall Results for the Entire Study121 |
| | E.4.e. Conclusions 124 |
| | F. Clinical Evaluation 125 |
| | F.1. Background ...125 |
| | F.1.a. Objectives for Clinical Evaluations ..125 |
| | F.1.b. Rationale ...125 |
| | F.2. Clinic Procedures ..125 |
| | F.2.a. Clinic Locations and Schedules .125 |
| | F.2.b. Clinical Evaluation Process ..125 |
| | F.2.c. Clinic Staffing 126 |
| | F.2.d. Efforts to Reduce Physician and Ultrasonographer Bias .126 |
| | F.3. Serum Sample 127 |
| | F.3.a. Laboratory Studies ..127 |
| | F.3.b. Changes in Laboratory Assays ..127 |