Designing Clinical Research (2006)

sampson2010 · 发表于 2013-12-17 10:13:15

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本帖最后由 sampson2010 于 2014-12-26 11:06 编辑

Title: Designing Clinical Research
Author(s): Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady, Thomas B. Newman
Publisher: Lippincott Williams & Wilkins
Year: 2006
Edition: Third
Language: English
Pages: 386
ISBN: 0781782104, 9780781782104
Size: 4 MB (4552156 bytes)
Extension: pdf
Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.
Table of contents :
Designing Clinical Research, THIRD EDITION......Page 1
Title Page......Page 3
Copyright......Page 4
Dedication......Page 5
CONTENTS......Page 7
CONTRIBUTING AUTHORS......Page 13
INTRODUCTION......Page 15
ACKNOWLEDGMENTS......Page 17
SECTION I: Basic Ingredients......Page 19
ANATOMY OF RESEARCH: WHAT IT’S MADE OF......Page 21
PHYSIOLOGY OF RESEARCH: HOW IT WORKS......Page 26
DESIGNING THE STUDY......Page 31
SUMMARY......Page 32
REFERENCE......Page 33
CHAPTER 2: Conceiving The Research Question......Page 35
ORIGINS OF A RESEARCH QUESTION......Page 36
CHARACTERISTICS OF A GOOD RESEARCH QUESTION......Page 37
DEVELOPING THE RESEARCH QUESTION AND STUDY PLAN......Page 40
TRANSLATIONAL RESEARCH......Page 41
REFERENCES......Page 43
CHAPTER 3: Choosing the Study Subjects: Specification, Sampling, and Recruitment......Page 45
BASIC TERMS AND CONCEPTS......Page 46
SELECTION CRITERIA......Page 47
SAMPLING......Page 50
RECRUITMENT......Page 51
SUMMARY......Page 53
REFERENCE......Page 54
CHAPTER 4: Planning the Measurements: Precision and Accuracy......Page 55
MEASUREMENT SCALES......Page 56
PRECISION......Page 57
ACCURACY......Page 59
OTHER FEATURES OF MEASUREMENT APPROACHES......Page 63
MEASUREMENTS ON STORED MATERIALS......Page 64
SUMMARY......Page 65
APPENDIX 4.1: Operations Manual: Operational Definition of a Measurement of Grip Strength......Page 66
REFERENCES......Page 67
HYPOTHESES......Page 69
UNDERLYING STATISTICAL PRINCIPLES......Page 72
ADDITIONAL POINTS......Page 77
SUMMARY......Page 80
REFERENCES......Page 81
SAMPLE SIZE TECHNIQUES FOR ANALYTIC STUDIES AND EXPERIMENTS......Page 83
OTHER CONSIDERATIONS AND SPECIAL ISSUES......Page 89
SAMPLE SIZE TECHNIQUES FOR DESCRIPTIVE STUDIES......Page 91
WHAT TO DO WHEN SAMPLE SIZE IS FIXED......Page 93
STRATEGIES FOR MINIMIZING SAMPLE SIZE AND MAXIMIZING POWER......Page 94
HOW TO ESTIMATE SAMPLE SIZE WHEN THERE IS INSUFFICIENT INFORMATION......Page 99
COMMON ERRORS TO AVOID......Page 100
SUMMARY......Page 101
APPENDIX 6A: Sample Size Required per Group When Using the t Test to Compare Means of Continuous Variables......Page 102
APPENDIX 6B: Sample Size Required per Group When Using the Chi-Squared Statistic or Z Test to Compare Proportions of Dichotomous Variables......Page 104
APPENDIX 6C: Total Sample Size Required When Using the Correlation Coefficient (r)......Page 107
APPENDIX 6D: Sample Size for a Descriptive Study of a Continuous Variable......Page 108
APPENDIX 6E: Sample Size for a Descriptive Study of a Dichotomous Variable......Page 109
APPENDIX 6F: Use and Misuse of t Tests......Page 110
REFERENCES......Page 111
SECTION II: Study Designs......Page 113
PROSPECTIVE COHORT STUDIES......Page 115
RETROSPECTIVE COHORT STUDIES......Page 117
NESTED CASE–CONTROL AND CASE–COHORT STUDIES......Page 118
MULTIPLE-COHORT STUDIES AND EXTERNAL CONTROLS......Page 121
OTHER COHORT STUDY ISSUES......Page 122
REFERENCES......Page 124
CROSS-SECTIONAL STUDIES......Page 127
CASE–CONTROL STUDIES......Page 130
SUMMARY......Page 139
APPENDIX 8A: Calculating Measures of Association......Page 140
APPENDIX 8B: Why the Odds Ratio Can Be Used as an Estimate for Relative Risk in a Case–Control Study......Page 142
REFERENCES......Page 143
SPURIOUS ASSOCIATIONS......Page 145
REAL ASSOCIATIONS OTHER THAN CAUSE–EFFECT......Page 149
COPING WITH CONFOUNDERS IN THE DESIGN PHASE......Page 150
COPING WITH CONFOUNDERS IN THE ANALYSIS PHASE......Page 155
CHOOSING A STRATEGY......Page 159
SUMMARY......Page 161
APPENDIX 9A: Hypothetical Example of Confounding and Interaction......Page 162
APPENDIX 9B: A Simplified Example of Adjustment......Page 163
REFERENCES......Page 164
SELECTING THE INTERVENTION AND CONTROL CONDITIONS......Page 165
CHOOSING OUTCOME MEASUREMENTS......Page 168
SELECTING THE PARTICIPANTS......Page 170
MEASURING BASELINE VARIABLES......Page 172
RANDOMIZING AND BLINDING......Page 173
SUMMARY......Page 177
REFERENCES......Page 178
ALTERNATIVE CLINICAL TRIAL DESIGNS......Page 181
CONDUCTING A CLINICAL TRIAL......Page 188
SUMMARY......Page 197
APPENDIX 11.1: Interim Monitoring of Trial Outcomes......Page 198
REFERENCES......Page 199
DETERMINING WHETHER A TEST IS USEFUL......Page 201
STUDIES OF TEST REPRODUCIBILITY......Page 204
STUDIES OF THE ACCURACY OF TESTS......Page 206
STUDIES OF THE EFFECT OF TEST RESULTS ON CLINICAL DECISIONS......Page 210
STUDIES OF FEASIBILITY, COSTS, AND RISKS OF TESTS......Page 211
STUDIES OF THE EFFECT OF TESTING ON OUTCOMES......Page 212
PITFALLS IN THE DESIGN OR ANALYSIS OF DIAGNOSTIC TEST STUDIES......Page 214
SUMMARY......Page 217
APPENDIX 12A: Calculation of Kappa to Measure Interobserver Agreement......Page 218
APPENDIX 12B: Numerical Example of Verification Bias: 1......Page 220
APPENDIX 12C: Numerical Example of Verification Bias: 2......Page 221
REFERENCES......Page 222
ADVANTAGES AND DISADVANTAGES......Page 225
SECONDARY DATA ANALYSIS......Page 226
ANCILLARY STUDIES......Page 229
SYSTEMATIC REVIEWS......Page 231
SUMMARY......Page 236
SUMMARY EFFECTS AND CONFIDENCE INTERVALS......Page 237
REFERENCES......Page 238
SECTION III: Implementation......Page 241
ETHICAL PRINCIPLES......Page 243
FEDERAL REGULATIONS FOR RESEARCH ON HUMAN SUBJECTS......Page 244
RESEARCH PARTICIPANTS WHO REQUIRE ADDITIONAL PROTECTIONS......Page 249
RESPONSIBILITIES OF INVESTIGATORS......Page 250
ETHICAL ISSUES SPECIFIC TO CERTAIN TYPES OF RESEARCH......Page 253
OTHER ISSUES......Page 254
REFERENCES......Page 255
DESIGNING GOOD INSTRUMENTS......Page 259
STEPS IN ASSEMBLING THE INSTRUMENTS FOR THE STUDY......Page 268
ADMINISTERING THE INSTRUMENTS......Page 270
SUMMARY......Page 271
APPENDIX 15.1: An Example of a Questionnaire about Smoking......Page 272
REFERENCES......Page 273
DATA TABLES......Page 275
DATA ENTRY......Page 279
EXTRACTING DATA (QUERIES)......Page 284
IDENTIFYING AND CORRECTING ERRORS IN THE DATA......Page 285
CONFIDENTIALITY AND SECURITY......Page 286
REFERENCES......Page 287
CHAPTER 17: Implementing the Study and Quality Control......Page 289
ASSEMBLING RESOURCES......Page 290
FINALIZING THE PROTOCOL......Page 294
QUALITY CONTROL DURING THE STUDY......Page 296
SUMMARY......Page 303
APPENDIX 17.1......Page 305
APPENDIX 17.2......Page 306
REFERENCES......Page 307
WHY COMMUNITY AND INTERNATIONAL RESEARCH?......Page 309
COMMUNITY RESEARCH......Page 311
INTERNATIONAL RESEARCH......Page 312
REFERENCES......Page 317
WRITING PROPOSALS......Page 319
ELEMENTS OF A PROPOSAL......Page 321
CHARACTERISTICS OF GOOD PROPOSALS......Page 327
FINDING SUPPORT FOR RESEARCH......Page 328
SUMMARY......Page 333
REFERENCES......Page 334
CHAPTER 1. GETTING STARTED: THE ANATOMY AND PHYSIOLOGY OF CLINICAL RESEARCH......Page 335
CHAPTER 3. CHOOSING THE STUDY SUBJECTS: SPECIFICATION, SAMPLING, AND RECRUITMENT......Page 336
CHAPTER 5. GETTING READY TO ESTIMATE SAMPLE SIZE: HYPOTHESES AND UNDERLYING PRINCIPLES......Page 337
CHAPTER 6. ESTIMATING SAMPLE SIZE AND POWER: APPLICATIONS AND EXAMPLES......Page 338
CHAPTER 8. DESIGNING CROSS-SECTIONAL AND CASE–CONTROL STUDIES......Page 339
CHAPTER 10. DESIGNING A RANDOMIZED BLINDED TRIAL......Page 340
CHAPTER 12. DESIGNING STUDIES OF MEDICAL TESTS......Page 341
CHAPTER 13. UTILIZING EXISTING DATABASES......Page 342
CHAPTER 14. ADDRESSING ETHICAL ISSUES......Page 343
CHAPTER 16. DATA MANAGEMENT......Page 344
CHAPTER 17. IMPLEMENTING THE STUDY AND QUALITY CONTROL......Page 347
CHAPTER 19. WRITING AND FUNDING A RESEARCH PROPOSAL......Page 348
CHAPTER 2......Page 349
CHAPTER 3......Page 350
CHAPTER 4......Page 351
CHAPTER 6......Page 352
CHAPTER 8......Page 355
CHAPTER 9......Page 357
CHAPTER 10......Page 359
CHAPTER 12......Page 360
CHAPTER 13......Page 362
CHAPTER 14......Page 363
CHAPTER 15......Page 365
CHAPTER 16......Page 366
CHAPTER 18......Page 368
CHAPTER 19......Page 369
SUBJECT INDEX......Page 371

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lfray · 发表于 2014-1-9 11:40:32

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