DEPARTMENT OF HEALTH SCIENCES Northern Finland Birth Cohort 1966 46-year follow-up study Protocol 300312 / JA 2 Contents 1 BACKGROUND ....................................................................................................................................................... 6 2 SUBJECTS AND AREAS OF RESEARCH .......................................................................................................... 6 3 TIMETABLE ............................................................................................................................................................ 6 4 STUDY COMPONENTS ......................................................................................................................................... 7 4.1 QUESTIONNAIRES ................................................................................................................................................ 7 4.2 CLINICAL EXAMINATIONS .................................................................................................................................... 8 4.3 EXAMINATION FACILITIES ........................................................................................................................... 9 4.4 APPOINTMENT SCHEDULING ................................................................................................................................. 9 4.5 STAFF, RESPONSIBILITIES AND CONTACT DETAILS ........................................................................................... 10 4.5.1 Staff ........................................................................................................................................................... 10 4.5.2 Substitute arrangements............................................................................................................................ 12 4.6 EXECUTION ................................................................................................................................................... 13 4.6.1 INVITATIONS ........................................................................................................................................... 13 4.6.2 FIELDWORK ............................................................................................................................................ 14 4.6.2.1 SAMPLES AND ANALYSES ............................................................................................................................... 14 4.6.2.1.1 Questionnaires ................................................................................................................................................... 14 4.6.2.1.2 Health examinations in Oulu ............................................................................................................................. 14 4.6.2.1.3 Health examinations in Oulainen and Kemi ...................................................................................................... 14 4.6.2.1.4 Eye examinations .............................................................................................................................................. 14 4.6.2.1.5 Glucose tolerance tests ...................................................................................................................................... 15 4.6.2.1.6 White blood cell isolation .................................................................................................................................. 15 4.6.2.1.7 Saliva samples ................................................................................................................................................... 15 4.6.2.2 CLINICAL EXAMINATIONS, SUBJECTS’ ROUTE BETWEEN EXAMINATION STATIONS AND FIELD STAFF’S RESPONSIBILITIES............................................................................................................................................... 15 4.6.2.2.1 Oulu examination stations, Day 1 (Appendix 21) ............................................................................................. 15 4.6.2.2.2 Oulu examination stations, Day 2 (Appendix 21) ............................................................................................. 26 4.6.2.2.3 Oulainen and Kemi with the same equipment and staff as Oulu (flow chart in Appendix 22) .......................... 28 4.6.2.2.4 Northern Finland and Southern Finland teams (flow chart in Appendix 23) ..................................................... 28 4.6.2.3 CLINICAL EXAMINATION PROTOCOLS ........................................................................................................ 35 4.6.2.3.1 Registration, identity checks and consent for the use of data ............................................................................ 35 4.6.2.3.2 Biological samples ............................................................................................................................................ 35 4.6.2.3.3 Upper arm blood pressure and heart rate measurements ................................................................................... 41 4.6.2.3.4 Central blood pressure measurements ............................................................................................................... 42 4.6.2.3.5 Waist and hip measurements ............................................................................................................................. 43 4.6.2.3.6 Height and weight measurements ...................................................................................................................... 43 4.6.2.3.7 Bioimpedance measurements ............................................................................................................................ 44 4.6.2.3.8 Measures the subject’s hand grip strength ......................................................................................................... 45 4.6.2.3.9 Back strength tests ............................................................................................................................................. 46 4.6.2.3.10 Skin analyses ................................................................................................................................................... 46 4.6.2.3.11 Spirometry ....................................................................................................................................................... 47 4.6.2.3.12 Activity tracker and sleep tracker data ............................................................................................................ 50 4.6.2.3.13 Panoramic radiography and X-ray images of ankles, feet and knees ............................................................... 50 4.6.2.3.14 Dental and oral examination, photography and 3D imaging ........................................................................... 54 4.6.2.3.15 Physiotherapy examinations ............................................................................................................................ 54 4.6.2.3.16 Step tests and autonomic nervous system measurements ................................................................................ 54 4.6.2.3.17 Skin prick testing ............................................................................................................................................. 59 4.6.2.3.18 Pressure pain sensitivity, thermal sensitivity and heat pain threshold tests ..................................................... 63 4.6.2.3.19 Carotid ultrasonography and echocardiography .............................................................................................. 65 4.6.2.3.20 Eye examinations ............................................................................................................................................ 65 5 DATA STORAGE, TRANSMISSION AND MANAGEMENT ......................................................................... 66 5.1 DATA STORAGE AND TRANSMISSION ................................................................................................................. 66 5.2 DATA PROCESSING, CLEANING AND MANAGEMENT ........................................................................................... 66 5.3 COMMUNICATION OF RESULTS TO SUBJECTS .......................................................................................... 67 5.3.1 Results to be communicated on the day .................................................................................................... 67 5.3.2 Results to be sent by post .......................................................................................................................... 67 5.3.3 Procedure in the event of abnormalities ................................................................................................... 68 5.3.3.1 Blood pressure ........................................................................................................................................................ 68 5.3.3.2 ECG ........................................................................................................................................................................ 68 5.3.3.3 Blood tests .............................................................................................................................................................. 68 3 5.3.3.4 Skin health .............................................................................................................................................................