Handbook for clinical research : design, statistics, and implementation / editors Flora M. Hammond, [and others].

Format:

Book

Contributor:

ebrary, Inc.

Dr. D. Sergeant Pepper Memorial Fund.

Language:

English

Subjects (All):

Clinical trials.

Biomedical Research.

Clinical Trials as Topic.

Epidemiologic Research Design.

Statistics as Topic.

Medical Subjects:

Biomedical Research.

Clinical Trials as Topic.

Epidemiologic Research Design.

Statistics as Topic.

Physical Description:

1 online resource (348 pages)

polychrome

Place of Publication:

New York, New York : Demos Medical Publishing, LLC, 2015.

System Details:

text file

Summary:

With over 80 information-packed chaffers, Handbook for Clinical Research delivers the-practical insights and expert tips necessary for successful research design, analysis, and implementation. Using clear language and an accessible bullet point format, the authors present the knowledge and expertise developed over time and traditionally shared from mentor to mentee and colleague to colleague. Organized for quick access to key topics and replete with practical examples, the book describes a variety of research designs and statistical methods and explains how to choose the best design for a particular project. Research implementation, including regulatory issues and grant writing, is also covered. The book opens with a section on the basics of research design, discussing the many ways in which studies can be organized, executed, and evaluated. The second section is devoted to statistics; it explains how to choose the correct statistical approach and reviews the varieties of data types, descriptive and inferential statistics, methods for demonstrating associations, hypothesis testing and prediction, specialized methods, and considerations in epidemiological studies and measure construction. The third section covers implementation, including how to develop a grant application step by step, the project budget, and the nuts and bolts of the timely and successful completion of a research project and documentation of findings: procedural manuals and case report forms; collecting, managing and securing data; operational structure and ongoing monitoring and evaluation; and ethical and regulatory concerns in research with human subjects. With a concise presentation of the essentials for successful research, the Handbook for Clinical Research is a valuable addition to the library of any student, researcher, professional, or clinician interested in expanding the knowledge base of his or her field. Key Features: Delivers the essential elements, practical insights, and trade secrets for ensuring successful research design, analysis, and implementation, Presents the nuts and bolts of statistical analysis, Organized for quick access to a wealth of information, Replete with practical examples of successful research designs-from single case designs to meta-analysis-and how to achieve them, Addresses research implementation including regulatory issues and grant writing Book jacket.

Contents:

Part I Design

1 Development and Testing of Treatments / Eric Lenze Lenze, Eric, John Whyte Whyte, John 3

2 Qualitative Research / Elena Gillespie Gillespie, Elena 9

3 Single-Case Experimental Designs / Robyn L. Tate Tate, Robyn L., Michael Perdices Perdices, Michael 13

4 Studies of Associations / Michael Schönberger Schönberger, Michael 18

5 Observational Studies: Retrospective Versus Prospective / Brian Keogh, Jr Jr, Brian Keogh,, Katherine W. Stenson Stenson, Katherine W. 23

6 Historical Controls / Whitney Pratt Pratt, Whitney, Katherine W. Stenson Stenson, Katherine W. 27

7 Subject as Own Control / Lisa A. Lombard Lombard, Lisa A. 30

8 Longitudinal Cohort Versus Cross-Sectional Cohort Studies / Zachary Timothy Glynn Siegel Siegel, Zachary Timothy Glynn, Katherine W. Stenson Stenson, Katherine W. 32

9 Survey Research / Amanda Leigh Harrington Harrington, Amanda Leigh 34

10 Choice of Control Groups in Treatment Studies / Sureyya S. Dikmen Dikmen, Sureyya S. 37

11 Randomization / Emilia Bagiella Bagiella, Emilia 40

12 Special Issues in Randomized Controlled Trials / Grace Handler Handler, Grace, Michael L. Boninger Boninger, Michael L. 43

13 Secondary Data Analysis / Kenneth J. Ottenbacher Ottenbacher, Kenneth J., James E. Graham Graham, James E., Amol Karmarkar Karmarkar, Amol 46

14 Scoping Study / Xinsheng Cai Cai, Xinsheng 50

15 Systematic Reviews / Naomi Lynn Gerber Gerber, Naomi Lynn, Xinsheng Cai Cai, Xinsheng 53

16 Meta-Analysis / Xinsheng Cai Cai, Xinsheng 57

17 Recommendations for Reporting Research Studies / Ronald T. Seel Seel, Ronald T. 62

18 Developing and Evaluating Systematic Reviews and Practice Guidelines / Ronald T. Seel Seel, Ronald T. 68

Part II Statistics

19 Introduction / Todd G. Nick Nick, Todd G., Christopher J. Swearingen Swearingen, Christopher J. 77

20 Types of Data / Maria S. Melguizo Melguizo, Maria S., Marcus Wellen Wellen, Marcus 79

21 Descriptive Statistics / Todd G. Nick Nick, Todd G. 84

22 Data Distributions / Maria S. Melguizo Melguizo, Maria S., Marcus Wellen Wellen, Marcus 87

23 Samples and Populations / Maria S. Melguizo Melguizo, Maria S., Marcus Wellen Wellen, Marcus 91

24 Visual Display of Data / Maria S. Melguizo Melguizo, Maria S., Marcus Wellen Wellen, Marcus 93

25 Data Cleaning / Jingyun Li Li, Jingyun 101

26 Missing Data and Imputation / Christopher J. Swearingen Swearingen, Christopher J. 105

27 Estimation / Mallikarjuna Rettiganti Rettiganti, Mallikarjuna 108

28 Hypothesis Testing / Mallikarjuna Rettiganti Rettiganti, Mallikarjuna 112

29 Sample Size and Power / Mallikarjuna Rettiganti Rettiganti, Mallikarjuna 115

30 Comparing Matched Samples With Continuous-Type Outcomes: Two Groups / Ming Li Li, Ming 119

31 Comparing Independent Samples With Continuous-Type Outcomes: Two Groups / Ming Li Li, Ming 124

32 Comparing Independent Samples for Continuous-Type Outcomes: Three Groups or More / Ming Li Li, Ming 129

33 Correlation / Christopher J. Swearingen Swearingen, Christopher J. 133

34 Simple Linear Regression / Christopher J. Swearingen Swearingen, Christopher J. 137

35 Multiple Linear Regression / Christopher J. Swearingen Swearingen, Christopher J. 142

36 Longitudinal and Clustered Data / Mallikarjuna Rettiganti Rettiganti, Mallikarjuna 147

37 Significance Tests: Categorical Data / Xinyu Tang Tang, Xinyu 152

38 Measures of Effect Sizes for Categorical Outcomes / Todd G. Nick Nick, Todd G. 155

39 Logistic Regression / Todd G. Nick Nick, Todd G., Chunqiao Luo Luo, Chunqiao 158

40 Kaplan-Meier Estimator / Xinyu Tang Tang, Xinyu 164

41 Log-Rank Test / Xinyu Tang Tang, Xinyu 167

42 Proportional Hazards Model / Xinyu Tang Tang, Xinyu 169

43 Sources of Error: Selection Bias, Information Bias, and Confounding / Jareen Meinzen-Derr Meinzen-Derr, Jareen, Laura Smith Smith, Laura 171

44 Mediation Analyses / Bin Huang Huang, Bin, Todd G. Nick Nick, Todd G. 174

45 Epidemiology Study: Incidence and Prevalence / Jareen Meinzen-Derr Meinzen-Derr, Jareen, Laura Smith Smith, Laura 178

46 Validity and Performance of Screening: Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value / Jareen Meinzen-Derr Meinzen-Derr, Jareen, Laura Smith Smith, Laura 182

47 Statistical Tools for Agreement and Reliability Studies / Shasha Bai Bai, Shasha 185

48 Classical Test Theory / Jacob Kean Kean, Jacob, Jamie Reilly Reilly, Jamie 192

49 Item Response Theory / Jacob Kean Kean, Jacob, Jamie Reilly Reilly, Jamie 195

Part III Implementation

Grant Proposals

50 Successful Grant Applications / Flora M. Hammond Hammond, Flora M. 201

51 Sources of Research Funding / James F. Malec Malec, James F. 204

52 Planning Grants / Eric Lenze Lenze, Eric 208

53 Developing the Idea With Stakeholder Input / John D. Corrigan Corrigan, John D. 211

54 Research Questions, Hypotheses, Aims, and Abstract / Flora M. Hammond Hammond, Flora M. 214

55 Reviewing the Literature / Dawn Neumann Neumann, Dawn, Edward Garay Garay, Edward 218

56 Background and Significance / Flora M. Hammond Hammond, Flora M. 222

57 Preliminary Studies and Experience / Flora M. Hammond Hammond, Flora M. 224

58 Methods and Design / Kathleen R. Bell Bell, Kathleen R. 226

59 Types of Measures / James F. Malec Malec, James F. 231

60 Letters of Support / James F. Malec Malec, James F. 234

61 Budget and Budget Justification / LaMoria Patterson Patterson, LaMoria, Rob Dimmitt Dimmitt, Rob 236

62 Preaward Management / LaMoria Patterson Patterson, LaMoria, Rob Dimmitt Dimmitt, Rob 241

Conducting the Research

63 Post-Award Management / Rob Dimmitt Dimmitt, Rob, LaMoria Patterson Patterson, LaMoria 245

64 Good Clinical Practices / Shawn Axe Axe, Shawn, John R. Baumann Baumann, John R. 249

65 Research Misconduct / John R. Baumann Baumann, John R., Shelley Bizila Bizila, Shelley, Rebecca Hopson Hopson, Rebecca 252

66 Study Protocol / Flora M. Hammond Hammond, Flora M. 256

67 Manual of Procedures / Flora M. Hammond Hammond, Flora M. 260

68 Treatment Manuals / Kathleen R. Bell Bell, Kathleen R. 263

69 Participant Recruitment and Enrollment / Flora M. Hammond Hammond, Flora M. 266

70 Participant Retention / Flora M. Hammond Hammond, Flora M. 271

71 Data Collection / Elena Gillespie Gillespie, Elena, Flora M. Hammond Hammond, Flora M. 276

72 Case Report Forms / Marybeth Whitney Whitney, Marybeth, Flora M. Hammond Hammond, Flora M. 280

73 Database Development / Emilia Bagiella Bagiella, Emilia 283

74 Data Dictionary / Emilia Bagiella Bagiella, Emilia 286

75 Data Management / Emilia Bagiella Bagiella, Emilia 288

76 Plan of Operation / Angelle M. Sander Sander, Angelle M. 291

77 Evaluation / Angelle M. Sander Sander, Angelle M. 295

78 Regulatory Binder and Essential Documents / Marybeth Whitney Whitney, Marybeth, Flora M. Hammond Hammond, Flora M. 298

79 Adverse Events / Marybeth Whitney Whitney, Marybeth, Flora M. Hammond Hammond, Flora M. 302

80 Protocol Deviations and Violations / Marybeth WhitneyN WhitneyN, Marybeth, Flora M. Hammond Hammond, Flora M. 307

81 Data and Safety Monitoring / Emilia Bagiella Bagiella, Emilia 310

82 Multicenter Trials / Flora M. Hammond Hammond, Flora M. 315

83 Site Monitoring and Oversight / Marybeth Whitney Whitney, Marybeth, Flora M. Hammond Hammond, Flora M. 318.

Notes:

Includes bibliographical references and index.

Electronic reproduction. Palo Alto, Calif. Available via World Wide Web.

Description based on print version record.

Local Notes:

Acquired for the Penn Libraries with assistance from the Dr. D. Sergeant Pepper Memorial Fund.

Other Format:

Print version: Handbook for clinical research : design, statistics, and implementation.

ISBN:

9781617050992

1617050997

Publisher Number:

99969810108

Access Restriction:

Restricted for use by site license.