Scientific Concept of the National Cohort (status ... - Nationale Kohorte

More documents

Recommendations

Info

A.7 A.7 Ethical aspects The more extensive dental examination could cause slight bleeding of the gum. During the MRI, participants are enclosed and the MRI device will produce some noise, which may be considered uncomfortable/unpleasant. If the participants should become scared or uncomfortable, the imaging procedure will be terminated. MRI will not be conducted in pregnant women or in participants with claustrophobia, with embedded metallic objects, e.g., from surgery or accidents, or with pacemakers. During the DXA measurement, participants are not at all enclosed. The dose of radiation is very low (less than 20µSv). In comparison, the average dose of natural radiation is 2100 µSv per year. DXA will not be conducted in pregnant women. For the OGTT, participants must be in a fasting state, which could cause hypoglycemia. In the study center, participants must drink a solution of sugar. During or after the test, a small risk for short-term hypoglycemia or gastrointestinal problems is present. No other direct risks are associated with the foreseen research program (Table 7.1). Table 7.1: Physical examinations in the National Cohort and their risks and contraindications Examination 1. Level examinations Risks Contraindications Weight and height - - Waist (and hip) circumference - - DXA scan Low dose radiation Pregnancy (ask for known or possible (< 20µSv) pregnancy) Blood pressure - - Arterial stiffness, ankle brachial index (combined device) - - 10-sec ECG - - 33 echocardiography - - Spirometry Dizziness Heart attack Collapsed lung Infection of the upper airways Accelerometry - - Hand grip strength - Swollen, inflamed, or paining hands Operation on the hand within the last 6 months Cognitive function tests - - Tooth count - - Collection of blood Blue marks (hematoma) Local or systemic infection Injury of a nerve Known haemophilia 194
Examination Risks Contraindication 2. Level examinations 195 A.7 Ethical aspects OGTT Hypoglycaemia Fever Gastrointestinal symptoms Gastrointestinal infections/diseases Pregnancy Allergy to currant juice Known diabetes mellitus Carotid sonography, intima media thickness - - 24h-ECG/apnae device - - AGE reader/skin AF - - Step test Chest pain Angina pectoris Dizziness Aortic stenosis (Muscle) fatigue Dysrrhythmias Physical discomfort Pacemaker One-leg-stand test - Analysis of NO in exhaled air - - Audiometry - - Eye-related measurements - - Dental examinations Slight gum bleeding Known Haemophilia Known heart valve problems Smelling test - - Examination of the musculoskeletal system 3. Level examinations - - MRI Incidental findings Claustrophobia Pregnancy Embedded metallic objects from surgery or accidents Pacemaker Indirect risks may present due to findings during the examination visit and the biosample analyses that deserve further medical examination. In the case of an incidental finding, participants will be informed and advised to contact a physician, if they consented to be informed. The strategy for how participants will be informed about incidental findings is described in detail below, in the section “Feedback of incidental findings”. Finally, a minimal risk is associated with the use of personal information, but greatest care will be taken to maintain data protection and confidentiality as described below. A.7.1.5 Expense allowance Participants will receive a small expense allowance, including travel costs. This aims to strengthen the idea of donating important information and material for research on the prevention and treatment of serious disease. Samples and data should be seen as public goods. A.7.1.6 Participant insurance Due to the minimal risk of the study, general participation insurance will not be required. For any damage, the public liability insurance of the study centers will be liable. For the partici- A.7
Page 1:
The National Cohort A prospective e
Page 4 and 5:
Applicants Applicants Applicants Cl
Page 6 and 7:
Applicants IV
Page 8 and 9:
Executive Summary 2. The National C
Page 10 and 11:
Executive Summary 3. Scientific aim
Page 12 and 13:
Executive Summary essary to address
Page 14 and 15:
Executive Summary 7. Examples for s
Page 16 and 17:
Contents A.2.4 major areas of expos
Page 18 and 19:
Contents A.3.8.2 Social security da
Page 20 and 21:
Contents A.6.4.2 Minimally detectab
Page 22 and 23:
Abbreviations C.2 mEThOdS fOr STATI
Page 24 and 25:
Abbreviations DXA Dual-energy x-ray
Page 26 and 27:
Abbreviations CHS Cardiovascular He
Page 28 and 29:
A.1 A.1 Introduction and overview a
Page 30 and 31:
A.1 A.1 Introduction and overview s
Page 32 and 33:
A.1 A.1 Introduction and overview T
Page 34 and 35:
A.1 A.1 Introduction and overview m
Page 36 and 37:
A.1 A.1 Introduction and overview
Page 38 and 39:
A.1 A.1 Introduction and overview s
Page 40 and 41:
A.1 A.1 Introduction and overview
Page 42 and 43:
A.1 A.1 Introduction and overview P
Page 44 and 45:
A.1 A.1 Introduction and overview t
Page 46 and 47:
A.1 A.1 Introduction and overview A
Page 48 and 49:
A.2 A.2. Scientific background and
Page 50 and 51:
Page 52 and 53:
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 68 and 69:
Page 70 and 71:
Page 72 and 73:
Page 74 and 75:
Page 76 and 77:
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
A.3 A.3 Study design ment instrumen
Page 84 and 85:
A.3 A.3 Study design Table 3.2: Des
Page 86 and 87:
A.3 A.3 Study design Table 3.3: Dis
Page 88 and 89:
A.3 A.3 Study design the participan
Page 90 and 91:
A.3 A.3 Study design with a prepare
Page 92 and 93:
A.3 A.3 Study design rural areas, t
Page 94 and 95:
A.3 A.3 Study design A.3.2 Baseline
Page 96 and 97:
A.3 A.3 Study design Modules 70 Int
Page 98 and 99:
A.3 A.3 Study design ovarian carcin
Page 100 and 101:
A.3 A.3 Study design Table 3.5: Spe
Page 102 and 103:
A.3 A.3 Study design depression and
Page 104 and 105:
A.3 A.3 Study design to the extent
Page 106 and 107:
A.3 A.3 Study design ers to vaccina
Page 108 and 109:
A.3 A.3 Study design certain foods)
Page 110 and 111:
A.3 A.3 Study design A short instru
Page 112 and 113:
A.3 A.3 Study design ticipants and
Page 114 and 115:
A.3 A.3 Study design a resting time
Page 116 and 117:
A.3 A.3 Study design index, convent
Page 118 and 119:
A.3 A.3 Study design Although the i
Page 120 and 121:
A.3 A.3 Study design air and then t
Page 122 and 123:
A.3 A.3 Study design hemorrhages (0
Page 124 and 125:
A.3 A.3 Study design genetics of BM
Page 126 and 127:
A.3 A.3 Study design hand grip stre
Page 128 and 129:
A.3 A.3 Study design Project title
Page 130 and 131:
A.3 A.3 Study design diseases in va
Page 132 and 133:
A.3 A.3 Study design associations,
Page 134 and 135:
A.3 A.3 Study design Informed Conse
Page 136 and 137:
A.3 A.3 Study design 6. Since being
Page 138 and 139:
A.3 A.3 Study design the possible d
Page 140 and 141:
A.3 A.3 Study design A.3.5 Collecti
Page 142 and 143:
A.3 A.3 Study design Blood In addit
Page 144 and 145:
A.3 A.3 Study design the anterior n
Page 146 and 147:
A.3 A.3 Study design study. For exa
Page 148 and 149:
A.3 A.3 Study design large-size sto
Page 150 and 151:
A.3 A.3 Study design routinely prep
Page 152 and 153:
A.3 A.3 Study design Subjects who m
Page 154 and 155:
A.3 A.3 Study design A.3.6.3 reliab
Page 156 and 157:
A.3 A.3 Study design In addition, a
Page 158 and 159:
A.3 A.3 Study design Disease Questi
Page 160 and 161:
A.3 A.3 Study design Data routinely
Page 162 and 163:
A.3 A.3 Study design tial misclassi
Page 164 and 165:
A.3 A.3 Study design � The KORA c
Page 166 and 167:
A.3 A.3 Study design Table 3.16: Co
Page 168 and 169:
A.3 A.3 Study design Table 3.17: Co
Page 170 and 171: A.4 A.4 Integrated Data Management
Page 182 and 183: A.5 A.5 Methods for quality assuran
Page 196 and 197: A.6 A.6 Planned statistical analyse
Page 204 and 205: A.6 A.6 Table Planned 6.4: Expected
Page 208 and 209: A.6 Planned statistical analyses an
Page 218 and 219: A.7 A.7 Ethical aspects logical/gen
Page 222 and 223: A.7 A.7 Ethical aspects pants, trav
Page 224 and 225: A.7 A.7 Ethical aspects Data handli
Page 226 and 227: A.7 Table 7.2 Availability of ident
Page 228 and 229: A.7 A.7 Ethical aspects Should bios
Page 230 and 231: A.7 A.7 Ethical aspects ing finding
Page 232 and 233: A.7 A.7 Ethical aspects 206
Page 234 and 235: C.1 C.1 Annex: Description of the s
Page 258 and 259: C.1 C.1 Table Annex: 1: Cluster Des
Page 270 and 271:
C.1 C.1 Annex: Description of the s
Page 272 and 273:
Page 274 and 275:
Page 276 and 277:
Page 278 and 279:
Page 280 and 281:
Page 282 and 283:
C.2 C.2 Annex: Methods for Statisti
Page 284 and 285:
Page 286 and 287:
C.2 Table S6.5: Sample size needed
Page 288 and 289:
Page 290 and 291:
Page 292 and 293:
Page 294 and 295:
Page 296 and 297:
C.3 References 17. Keil, U., et al.
Page 298 and 299:
C.3 References 50. Benjamin, E.J.,
Page 300 and 301:
C.3 References 85. Calle, E.E. and
Page 302 and 303:
C.3 References 121. Walter, R., D.J
Page 304 and 305:
C.3 References 155. Ross, R., Ather
Page 306 and 307:
C.3 References 189. Ghiotto, F., et
Page 308 and 309:
C.3 References 225. Schmidt, C.O.,
Page 310 and 311:
C.3 References 260. Eussen, S., et
Page 312 and 313:
C.3 References 294. McCrae, R.R. an
Page 314 and 315:
C.3 References 327. Lynch, J.W., G.
Page 316 and 317:
C.3 References 360. Mair, C., A.V.
Page 318 and 319:
C.3 References 395. Lesourd, B., Nu
Page 320 and 321:
C.3 References 431. Statistisches B
Page 322 and 323:
C.3 References 462. Bundeszentrale
Page 324 and 325:
C.3 References 494. Rammstedt, B. a
Page 326 and 327:
C.3 References 526. Mack, F., et al
Page 328 and 329:
C.3 References 560. Palatini, P., A
Page 330 and 331:
C.3 References 590. Greenland, P.,
Page 332 and 333:
C.3 References 623. Olin, A.C., et
Page 334 and 335:
C.3 References 658. Pate, R.R., J.R
Page 336 and 337:
C.3 References 691. Zenge, M.O., et
Page 338 and 339:
C.3 References 727. Ryu, O.H., et a
Page 340 and 341:
C.3 References 757. BSI-Standard 10
Page 342 and 343:
C.3 References 790. Davis, C.E., et
Page 344:
C.3 References 822. Hegenscheid, K.
show all

Scientific Concept of the National Cohort (status ... - Nationale Kohorte

Create successful ePaper yourself

Delete template?

Save as template?