Designing Clinical Research (2006)

$ i& `9 t8 g, ^9 [+ \# ?" Y3 r9 M
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       
+ d' S/ W2 ]; i1 X! O6 e: {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.
1 J! V* |; u$ t3 r! r' W8 {Table of contents :
Designing Clinical Research, THIRD EDITION......Page 1
) `& U% V/ }) i8 e/ qTitle Page......Page 3
) ]( |' r, ~" T$ U6 s  l8 iCopyright......Page 4
9 ~( }8 M; T2 O2 a( {: pDedication......Page 5
' b6 F, T' ~, ]6 Z2 E8 r1 ]& TCONTENTS......Page 7
! O6 Y/ i+ O- U4 vCONTRIBUTING AUTHORS......Page 13
( s. N% w' j$ V- |INTRODUCTION......Page 15
ACKNOWLEDGMENTS......Page 17
8 H5 Q" A: x, E! M# Q) U  qSECTION I: Basic Ingredients......Page 19
ANATOMY OF RESEARCH: WHAT IT’S MADE OF......Page 21
2 T* Q! L( Y) `7 PPHYSIOLOGY 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
1 r' t) k7 y0 jCHARACTERISTICS OF A GOOD RESEARCH QUESTION......Page 37
6 n* X1 l" g0 q. `! I, WDEVELOPING THE RESEARCH QUESTION AND STUDY PLAN......Page 40
) _9 d' d( ~5 [: L2 T! }: j8 ^* iTRANSLATIONAL RESEARCH......Page 41
/ C. m* I3 F) m& K: V2 xREFERENCES......Page 43
. `" ?* W6 [) N2 N3 L1 ?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
6 |2 F0 m; P: W, qSUMMARY......Page 53
REFERENCE......Page 54
) @  S2 e( _! h4 V8 B) `( ZCHAPTER 4: Planning the Measurements: Precision and Accuracy......Page 55
MEASUREMENT SCALES......Page 56
4 G, `- y, Q% ~. e' n& Z' DPRECISION......Page 57
ACCURACY......Page 59
OTHER FEATURES OF MEASUREMENT APPROACHES......Page 63
% Y7 l' a  {" ~& u( u2 Y+ ?2 P! Q* `; h2 }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
) O7 Q' {/ A7 y/ g4 U  A& BSUMMARY......Page 80
( g9 w3 J+ ^( J) U! LREFERENCES......Page 81
6 D) P4 j. {- C" USAMPLE SIZE TECHNIQUES FOR ANALYTIC STUDIES AND EXPERIMENTS......Page 83
4 {# o0 M" m2 O1 `OTHER CONSIDERATIONS AND SPECIAL ISSUES......Page 89
$ E0 N% n, M, b6 @3 {4 DSAMPLE SIZE TECHNIQUES FOR DESCRIPTIVE STUDIES......Page 91
WHAT TO DO WHEN SAMPLE SIZE IS FIXED......Page 93
6 u( @! r( _$ j! ?9 OSTRATEGIES FOR MINIMIZING SAMPLE SIZE AND MAXIMIZING POWER......Page 94
; h: N+ u- M8 i% e( d2 P2 a) Q- U1 t# ~HOW TO ESTIMATE SAMPLE SIZE WHEN THERE IS INSUFFICIENT INFORMATION......Page 99
- n! U9 L3 G" W/ G9 zCOMMON ERRORS TO AVOID......Page 100
. U& f: N+ `3 M, Q9 d: `/ {0 ASUMMARY......Page 101
* w6 G' o. U* K/ s/ yAPPENDIX 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
. O8 ?9 S* J! kAPPENDIX 6E: Sample Size for a Descriptive Study of a Dichotomous Variable......Page 109
APPENDIX 6F: Use and Misuse of t Tests......Page 110
' h7 H6 H. l( b% X: f4 bREFERENCES......Page 111
SECTION II: Study Designs......Page 113
PROSPECTIVE COHORT STUDIES......Page 115
RETROSPECTIVE COHORT STUDIES......Page 117
5 Z9 p: W: M  @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
& s$ o9 y' k- i8 F7 J8 PCASE–CONTROL STUDIES......Page 130
SUMMARY......Page 139
+ S. m6 a0 }4 o9 }$ K, t9 FAPPENDIX 8A: Calculating Measures of Association......Page 140
- E+ g" O0 j& jAPPENDIX 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
% k; [- w& O; {3 h" {2 nREAL ASSOCIATIONS OTHER THAN CAUSE–EFFECT......Page 149
COPING WITH CONFOUNDERS IN THE DESIGN PHASE......Page 150
. ~& y6 W9 x5 L5 d  W1 d& y0 M* aCOPING WITH CONFOUNDERS IN THE ANALYSIS PHASE......Page 155
CHOOSING A STRATEGY......Page 159
' o" m# ]# k4 c: b# R3 _- uSUMMARY......Page 161
# H$ L+ m2 z: G* S: AAPPENDIX 9A: Hypothetical Example of Confounding and Interaction......Page 162
APPENDIX 9B: A Simplified Example of Adjustment......Page 163
4 W2 P8 S( t! l/ g! ^REFERENCES......Page 164
) l" q, {/ [& J) ESELECTING THE INTERVENTION AND CONTROL CONDITIONS......Page 165
CHOOSING OUTCOME MEASUREMENTS......Page 168
% Y# g9 s& C8 _% y6 ^& [SELECTING THE PARTICIPANTS......Page 170
/ Y- W! @5 L0 p1 V/ O- cMEASURING BASELINE VARIABLES......Page 172
: }* B" o- o2 X2 NRANDOMIZING AND BLINDING......Page 173
3 n& N7 O4 @1 _7 USUMMARY......Page 177
( ?+ c, d: S) I& MREFERENCES......Page 178
ALTERNATIVE CLINICAL TRIAL DESIGNS......Page 181
* q) P( ]4 j! g- E% TCONDUCTING A CLINICAL TRIAL......Page 188
SUMMARY......Page 197
APPENDIX 11.1: Interim Monitoring of Trial Outcomes......Page 198
REFERENCES......Page 199
& N' Z) i- h! ^DETERMINING WHETHER A TEST IS USEFUL......Page 201
STUDIES OF TEST REPRODUCIBILITY......Page 204
6 q, P7 m& ]+ C5 I4 q9 M0 oSTUDIES OF THE ACCURACY OF TESTS......Page 206
( ]8 V, H: K. mSTUDIES OF THE EFFECT OF TEST RESULTS ON CLINICAL DECISIONS......Page 210
0 F1 Q! C. k6 _( M3 r4 {STUDIES OF FEASIBILITY, COSTS, AND RISKS OF TESTS......Page 211
9 v7 N) A- L2 q* ]( CSTUDIES OF THE EFFECT OF TESTING ON OUTCOMES......Page 212
* V+ ~8 O2 t2 y; }PITFALLS IN THE DESIGN OR ANALYSIS OF DIAGNOSTIC TEST STUDIES......Page 214
7 G. m) r) Y' HSUMMARY......Page 217
( h, [; F. P: e3 Y8 KAPPENDIX 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
" C( C+ q% k: F$ VSECONDARY DATA ANALYSIS......Page 226
ANCILLARY STUDIES......Page 229
SYSTEMATIC REVIEWS......Page 231
* J' y9 l3 ^3 ]$ n; tSUMMARY......Page 236
SUMMARY EFFECTS AND CONFIDENCE INTERVALS......Page 237
' o+ H: W3 y; Y; P% s. I' NREFERENCES......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
2 e; Q* p4 z6 h* bRESPONSIBILITIES OF INVESTIGATORS......Page 250
7 N- X& @  i5 w) \( WETHICAL ISSUES SPECIFIC TO CERTAIN TYPES OF RESEARCH......Page 253
OTHER ISSUES......Page 254
REFERENCES......Page 255
DESIGNING GOOD INSTRUMENTS......Page 259
8 ^; G' {4 a( n' Q) K& t* W. GSTEPS IN ASSEMBLING THE INSTRUMENTS FOR THE STUDY......Page 268
1 j! t5 i. b3 g; S/ U( u5 d/ cADMINISTERING THE INSTRUMENTS......Page 270
6 M* E' O! m$ ASUMMARY......Page 271
9 t  h0 U# X, c+ S% L/ BAPPENDIX 15.1: An Example of a Questionnaire about Smoking......Page 272
: C1 c  z* [9 h4 m' pREFERENCES......Page 273
: U& _9 k9 c2 }& u8 f$ ]DATA TABLES......Page 275
( X6 [+ r4 [5 I: A, ~: ^DATA ENTRY......Page 279
EXTRACTING DATA (QUERIES)......Page 284
+ v9 n6 u3 d9 K* PIDENTIFYING AND CORRECTING ERRORS IN THE DATA......Page 285
9 f! O5 }' Z, A- G: S. h, G: DCONFIDENTIALITY AND SECURITY......Page 286
REFERENCES......Page 287
CHAPTER 17: Implementing the Study and Quality Control......Page 289
9 a( u5 j0 |- u8 ~ASSEMBLING RESOURCES......Page 290
FINALIZING THE PROTOCOL......Page 294
" c/ H4 C3 M7 ^2 S  YQUALITY CONTROL DURING THE STUDY......Page 296
" W; n3 q# F% S) ]1 J; D3 C1 `, E1 C- tSUMMARY......Page 303
: h4 x" i, M8 z, ^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
/ @- f9 v5 O6 U4 A: jREFERENCES......Page 317
WRITING PROPOSALS......Page 319
ELEMENTS OF A PROPOSAL......Page 321
4 ~3 T6 X/ E# K8 d7 r! z7 XCHARACTERISTICS OF GOOD PROPOSALS......Page 327
FINDING SUPPORT FOR RESEARCH......Page 328
SUMMARY......Page 333
5 S1 V1 n! f: ?$ N- }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
, `% ^- A* S) o! [1 \7 J" \; GCHAPTER 10. DESIGNING A RANDOMIZED BLINDED TRIAL......Page 340
CHAPTER 12. DESIGNING STUDIES OF MEDICAL TESTS......Page 341
& U# ^' E/ N. m/ FCHAPTER 13. UTILIZING EXISTING DATABASES......Page 342
$ e) _; q. e( _0 L9 CCHAPTER 14. ADDRESSING ETHICAL ISSUES......Page 343
CHAPTER 16. DATA MANAGEMENT......Page 344
) N9 Z. @0 }4 x( r1 O% `2 N, fCHAPTER 17. IMPLEMENTING THE STUDY AND QUALITY CONTROL......Page 347
CHAPTER 19. WRITING AND FUNDING A RESEARCH PROPOSAL......Page 348
CHAPTER 2......Page 349
& D9 y8 G& |: L1 w' E: ECHAPTER 3......Page 350
' ]! L9 @. {) P7 v) ]! XCHAPTER 4......Page 351
CHAPTER 6......Page 352
3 v, V3 U+ i+ A# s( |9 zCHAPTER 8......Page 355
CHAPTER 9......Page 357
' G4 g3 E5 ^$ r5 e7 A$ w) g9 eCHAPTER 10......Page 359
( J% F( a+ R% ^- H7 D. uCHAPTER 12......Page 360
7 W# g; F" e/ z" W; ACHAPTER 13......Page 362
CHAPTER 14......Page 363
CHAPTER 15......Page 365
CHAPTER 16......Page 366
7 g& R$ n# `# U7 QCHAPTER 18......Page 368
! d+ h# l5 u! Y) y- R6 I8 t7 _CHAPTER 19......Page 369
SUBJECT INDEX......Page 371
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