ATHEROSCLEROSIS RISK IN COMMUNDTIES STUDY Manual 3 Surveillance Component Procedures The National Heart, Lung, and Blood institute of the National Institutes of Health ARIC Protocol Manual3 Surveillance Component Procedures For copies, please contact: ARIC Coordinating Center Department of Biostatistics CB# 8030, Suite 203, NCNB Plaza The University of North Carolina Chapel Hill, NC 27514 Version 1.0: February, 1988 ARIC PROTOCOL3. Surveillance Component Procedures VERSION 1.0, 214188 At the time Manual 3 was approved by the ARIC Steering Committee for release to the public, the following data collection forms have not been evaluated. Upon the completion of the revisions uhich resulted from pilot testing, these forms and their instructions will be added to the Appendices. 1. Coroner/Medical Examiner Form 2. Hospital Record Abstraction Form 3. Stroke Form ARIC PROTOCOL3. Surveillance Component Procedures VERSION 1.0, 2/4/88 This manual entitled, Surveillance Component Procedures, is one of a series of protocols and manuals of operation for the Atherosclerosis Risk in Communities iARIC) Study. The complexity of the ARIC Study requires that a sizeable number of procedures be described, thus this rather extensive set of materials has been organized into the set of manuals listed below. Manual 1 provides the background, organization, and general objectives of the ARIC Study. Manuals 2 and 3 describe the operation of the Cohort and Surveillance Components of the study. Detailed Manuals of Operation for specific procedures, including reading centers and central laboratories, make up Manuals 4 through 11. Manual 12 on Quality Assurance contains a general description of the study's approach t.o quality assurance as well as the details for quality assurance for the different study procedures. The version status of each manual is printed on the title sheet. The first edition of each manual is Version 1.0. Subsequent modifications of Version 1 (pages updated, pages added, or pages deleted) are indicated as Versions 1.1, 1.2, and so on, and are described in detail in the Revision Log located immediately after the title page. When revisions are substantial enough to require a new printing of the manual, the version number will be updated (e.g., Version 2.0) on the title page. ARIC Study Protocols and Manuals of Operation TITLE 1 General Description and Study Management 2 Cohort Component Procedures 3 Surveillance Component Procedures 4 Pulmonary Function Assessment 5 Electrocardiography 6 Ultrasound Assessment a. Ultrasound Scanning b. Ultrasound B-mode Image Reading Protocol 7 Blood Collection and Processing 8 Lipid and Lipoprotein Determinations 9 Hemostasis Determinations 10 Clinical Chemistry Determinations 11 Sitting Blood Pressure and Postural Changes in Blood Pressure and Heart Rate 12 Quality Assurance and Quality Control ARIC PROTOCOL3. Surveillance Component Procedures VERSION 1.0, 214188 Hanual3. Surveillance Component Procedures TABLE OF CONTENTS 1. Introduction . ..*.................................... 1 2. Identification of Events . 2 2.1 Introduction ......................................................... 2 2.2 Identification of Hospitalized MI .................................... 3 2.3 Identification of CHD Deaths ......................................... 7 3. Event Investigation . 9 3.1 Procedures for Fatal CHD............................................. 9 3.2 Procedures for Hospitalized MI ....................................... 12 3.3 Summary of CKD Event Investigations .................................. 13 3.4 Correction of Erroneous Event Investigation Procedures ............... 14 4. Diagnostic Criteria .................................................. 15 4.1 Fatal Coronary Heart Disease ........................................ 15 4.2 Hospitalized Myocardial Infarction (MI) ............................. 16 5. Event Determination .................................................. 23 6. Medical Care Assessment .............................................. 24 7. Linkage of Multiple Events ........................................... 25 8. Reliability and Validity of Co-ity Surveillance Procedures ........ 26 8.1 Reliability ......................................................... 26 8.2 Validity ............................................................ 27 9. References ........................................................... 28 10. Appendices ........................................................... 29 I ICD9 Codes for Identifying Surveillance Events 1. ICD9 Codes for Identifying CHD Deaths ............................ A-i 2. ICD9 Codes for Identifying Hospitalized MI ....................... A-ii II Forms and Instructions 1. ARIC Surveillance Event Investigation Summary Form (SEI).........A - 1 2. ARIC Surveillance Event Investigation Summary Form Instructions..A - 3 3. Surveillance Event Eligibility Form .............................. A- 5 4. Surveillance Eligibility Form Instructions.......................A - 9 5. Cohort Event Eligibility Form .................................... A-13 6. Cohort Event Eligibility Form Instructions ..................... ..A-1 9 7. Death Certificate Form ........................................... A-25 8. Death Certificate Form Instructions .............................. A-31 9. Informant Interview Form ......................................... A-35 10. Informant Interview Form Instructions ............................ A-47 II Forms and Instructions (continued) 11. Physician Questionnaire .......................................... A-55 .12. Coroner/Medical Examiner Form .................................... A-59 13. Coroner/Medical Examiner Form Instructions ..................... ..A-6 9 14. Washington County Medical Examiners Questions....................A-7 4 15. MMCCFinal Diagnosis Form ...................................... ..A-7 5 16. Hospital Record Abstraction Form ................................ A-79 17. Hospital Record Abstraction Form Instructions ................. ..A-10 0 18. ARIC Cohort Event Investigation Summary Form.....................A-13 8 19. ARIC Cohort Event Investigation Summary Form Instructions........A-14 0 20. Stroke Form - not available ..................................... A-142 III Form Letters 1. Format 1: Sample Letter to Informant: Known Telephone Number....A-144 2. Format 2: Sample Letter to Informant: Unknown Telephone Number..A-145 3. Format 3: Reply Postcard from Informant with Telephone Number...A-146 4. Format 4: Letter to Neighbor re: Location of Informant..........A-147 5. Format 5: Reply Postcard on Location of Informant...............A-148 6. Format 6: Informant Release of Information Form - Nursing Home..A-149 7, Format'7: Letter to Physician Signing Death Certificate.........A-150 8. Format 8: Letter to Attending Physician of Decedent.............A-151 9. Format 9: Informant Release of Information - Physician..........A-152 10. Format 10: Informant Release of Information - Out-of-Area Hospital . A-153 Page 1 1. INlmDwmoN Through community surveillance, the ARIC study enumerates and validates cases (events) of hospitalized myocardial infarction (MI) and coronary heart disease (CHD) deaths occurring during a specific time period in 35 through 74 year old male and female residents of the four ARIC study communities: Forsyth County, North Carolina; Jackson, Mississippi; suburbs of Minneapolis, Minnesota; and Washington County, Maryland. This manual details the procedures for ARIC community surveillance. Section 2 describes the procedures by which potential events in the community are identified (i.e., death registries, hospital discharge indexes). Section 3 details procedures for collecting the additional information needed once an event has been identified. Diagnostic criteria are documented in Section 4, and review and classification procedures are described in Section 5. The procedures for obtaining information on certain indicators of medical care are described in Section 6. Procedures for linkage of multiple events are described in Section 7. CHD events occurring among ARIC cohort participants are ascertained through cohort follow-up as well as through the routine community wide surveillance. Cohort follow-up provides a limited validation of routine surveillance. Methods for coordinating cohort and surveillance procedures are described in Section 8. ARIC PROTOCOL3. Surveillance Component Procedures VERSION 1.0, 2/4/88 Page 2 2. lDR4TIFICATIW w BVWTS 2.1 Introduction The basic features of the community surveillance design are summarized in Table 1. Events surveyed in each of the four communities include fatal CHD and hospitalized MI (see Appendix I), beginning January. 1987. Table 1. ARIC Community Surveillance Eligibility Criteria Criteria Eligibility Age Between 35 and 74, inclusive Race All races Place of residence Within the defined boundaries of the ARIC communities Date of discharge or death January 1, 1987 - December 31, 1992 ICD9 Codes for identification 250, 401, 402, 410-414, 427-429, 440, of CHD death 518.4, 798, 799 ICD9 Codes for identification 402, 410-414, 427, 428, 518.4 of hospitalized MI Events meeting the eligibility criteria given in Table 1 are investigated for conformity with ARIC surveillance diagnostic criteria. Identification of hospitalized events is limited to acute care hospitals in the catchment area (Section 2.2.3); no systematic attempt is made to obtain events from records of nursing homes, mental hospitals, private physicians, or hospitals out of the catchment area. Hospitalized MIS are documented