Foundations of clinical research : applications to practice / Leslie Gross Portney, Mary P. Watkins.

Format:

Book

Author/Creator:

Portney, Leslie Gross.

Contributor:

Watkins, Mary P.

Language:

English

Subjects (All):

Medicine--Research--Methodology.

Medicine.

Research Design.

Medical Subjects:

Research Design.

Physical Description:

xiv, 752 pages : illustrations ; 25 cm

Edition:

Second edition.

Place of Publication:

Upper Saddle River, N.J. : Prentice Hall Health, [2000]

Summary:

This book serves as a comprehensive reference for a variety of research situations. This edition reflects the popular approaches to analysis and design, and addresses the focus of health-care related research through the 1990s and into the 21st century. Expanded or added topics include outcomes research and the disablement model, validity and diagnostic screening, meta-analysis, scales used in survey and outcomes research, logistic regression, measures of reliability, and data management to prepare for computer analysis. For those in the health professions, including physical therapy, occupational therapy, speech therapy, nursing, and exercise physiology.

Contents:

Part I Foundations of Clinical Research 1

Chapter 1 A Concept of Research 3

Contemporary Perspectives 4

Sources of Knowledge 7

Types of Research 12

The Research Process 15

Understanding Method, Content, and Philosophy 17

Commentary: Research and Clinical Problem Solving 18

Chapter 2 The Role of Theory in Clinical Research 21

Purposes of Theories 22

Components of Theories 23

Types of Theories 25

Characteristics of Theories 26

Theory and Research 27

Theory and Law 29

Commentary: Applying Theory 29

Chapter 3 Ethical Issues in Clinical Research 33

Integrity of the Researcher 33

Protection of Human Rights in Clinical Research 34

Institutional Review Board 39

Elements of Informed Consent 40

Commentary: A Patient Care Perspective 45

Part II Concepts of Measurement 47

Chapter 4 Principles of Measurement 49

Quantification and Measurement 50

The Indirect Nature of Measurement 50

Rules of Measurement 52

Commentary: When Is an Ordinal Measure Not an Ordinal Measure? 57

Chapter 5 Reliability 61

Measurement Error 61

Reliability Coefficients 64

Types of Reliability 66

Generalizability 73

Pilot Testing 75

Commentary: What Is the True Score? 75

Chapter 6 Validity of Measurements 79

Validity and Reliability 79

Validity of Inferences 80

Face Validity 82

Content Validity 83

Criterion-Related Validity 84

Construct Validity 87

Evaluating Diagnostic Procedures 92

Measuring Change 101

Criterion Referencing and Norm Referencing 105

Cross-Validation 107

Commentary: The Ongoing Pursuit of Validity 107

Part III Design 111

Chapter 7 The Research Question 113

Selecting a Topic 114

The Research Problem 115

Importance and Feasibility of the Research Question 117

Target Population 119

The Research Rationale 119

Variables 120

Research Objectives 123

Reviewing the Literature 127

Pilot Testing 133

Commentary: Putting the Horse before the Cart 133

Chapter 8 Sampling 137

Populations and Samples 137

Sampling Techniques 140

Probability Sampling 141

Nonprobability Sampling 146

Recruitment 149

Commentary: Sampling, Like Life, is a Compromise 150

Chapter 9 Experimental Control 153

Characteristics of Experiments 154

The Research Protocol 157

Blinding 159

Design Strategies for Controlling Intersubject Differences 159

Threats to Validity 163

Commentary: The Realities of Clinical Research 173

Chapter 10 Experimental Design 177

Selecting a Design 178

Design Notation 179

True Experimental Designs 179

Repeated Measures Designs 187

Quasi-Experimental Designs 193

Commentary: The Design Should Fit the Question 199

Chapter 11 Sequential Clinical Trials 203

The Design of a Sequential Trial 204

Measuring Preferences 205

Sequential Plans for Evaluating Preferences 206

Limitations of Sequential Designs 215

Commentary: Try It, You'll Like It 217

Chapter 12 Single-Subject Designs 223

Structure of Single-Subject Designs 224

Target Behavior 227

Reliability 231

Experimental Control: Limitations of the A-B Design 234

Withdrawal Designs 235

Multiple-Treatment Designs 238

Multiple-Baseline Designs 243

Changing Criterion Design 246

Data Analysis in Single-Subject Research 249

Generalization of Findings 258

Commentary: It's a Start 261

Chapter 13 Descriptive and Exploratory Research 265

Retrospective and Prospective Research 266

Descriptive Research 267

Exploratory Research 277

Commentary: First Things First 281

Chapter 14 Surveys 285

Interviews and Questionnaires 286

Design of Surveys 287

Constructing Survey Questions 293

Scales 299

Q-Sort 308

Delphi Survey 310

Analysis of Survey Data 311

Informed Consent 312

Commentary: They Have a Thousand and One Uses 312

Chapter 15 Epidemiology 317

Descriptive Epidemiology 319

Analytic Designs: Observational Studies 324

Analytic Designs: Clinical Trials 330

Measures of Association 332

Evaluating Causality in Observational Studies 341

Commentary: A New View of Outcomes 341

Chapter 16 Other Research Approaches 345

Evaluation Research 346

Methodological Research 351

Secondary Analysis 353

Meta-Analysis 355

Historical Research 358

Commentary: Moving Forward 360

Part IV Analysis 365

Chapter 17 Descriptive Statistics and Measures of Variability 367

Frequency Distributions 367

Measures of Central Tendency 372

Measures of Variability 374

The Normal Distribution 381

Commentary: Description Only Goes So Far 385

Chapter 18 Statistical Inference 387

Probability 387

Sampling Error 389

Confidence Intervals 392

Hypothesis Testing 397

Errors in Hypothesis Testing 399

Type I Error: Level of Significance 400

Type II Error: Statistical Power 402

Concepts of Statistical Testing 404

Parametric versus Nonparametric Statistics 409

Commentary: Statistical versus Clinical Significance 410

Chapter 19 The t-Test 413

The Conceptual Basis for Comparing Group Means 413

The t-Test for Independent Samples 416

The t-Test for Paired Samples 422

Inappropriate Use of Multiple t-Tests 423

Use of Confidence Intervals to Test Differences between Means 425

Commentary: The Significance of Significance 426

Chapter 20 Analysis of Variance 427

Analysis of Variance for Independent Samples: One-Way Classification 427

Analysis of Variance: Two-Way Classification 432

Analysis of Variance: Three-Way Classification 441

Repeated Measures Analysis of Variance 442

Commentary: Beyond Analysis of Variance 450

Chapter 21 Multiple Comparison Tests 453

Type I Error Rate: Per Comparison versus Family 454

Statistical Ratios for Multiple Comparison Tests 455

Tukey's Honestly Significant Difference 456

Newman-Keuls Method 457

Scheffe's Comparison 460

Bonferroni t-Test 461

Simple and Complex Contrasts 462

Presentation of Results of Multiple Comparisons 463

Multiple Comparison Procedures for Factorial Designs 463

Multiple Comparison Procedures for Repeated Measures 466

Trend Analysis 467

Commentary: Choices, Choices, Choices 471

Chapter 22 Nonparametric Tests for Group Comparisons 473

Criteria for Choosing Nonparametric Tests 473

Procedure for Ranking Scores 475

Test for Two Independent Samples: Mann-Whitney U-Test 475

Test for More than Two Independent Samples: Kruskal-Wallis One-Way Analysis of Variance by Ranks 478

Tests for Two Correlated Samples: Sign Test and Wilcoxon Signed-Ranks Test 482

Test for More than Two Correlated Samples: Friedman Two-Way Analysis of Variance by Ranks 486

Commentary: Decisions, Decisions, Decisions 489

Chapter 23 Correlation 491

Scatter Plots 492

Correlation Coefficients 493

Linear versus Curvilinear Relationships 493

Criteria for Evaluating Correlation Coefficients 494

Pearson Product-Moment Correlation Coefficient 496

Correlation of Ranks: Spearman Rank Correlation Coefficient 497

Correlation of Dichotomies 500

Interpreting Correlation Coefficients 505

Commentary: The Stork Was Busy 507

Chapter 24 Regression 509

Linear Regression 509

Assumptions for Regression Analysis 515

Outliers 517

Accuracy of Prediction 519

Analysis of Variance of Regression 521

Restrictions on the Interpretation of Linear Regression Analysis 523

Nonlinear Regression 523

Analysis of Covariance 527

Commentary: It's Not That Simple 534

Chapter 25 Analysis of Frequencies: Chi-square 537

The Chi-square Statistic 538

Goodness of Fit 539

Interpreting Significant Effects: Standardized Residuals 543

Tests of Independence 544

McNemar Test for Correlated Samples 551

Coefficients of Association 552

Commentary: Uses of Chi-square 554

Chapter 26 Statistical Measures of Reliability 557

Reliability Theory and Measurement Error 557

Intraclass Correlation Coefficient 560

Agreement 568

Internal Consistency: Cronbach's Alpha 575

Response Stability 577

Alternate Forms: Limits of Agreement 581

Commentary: Know Your Reliability Coefficient 584

Chapter 27 Multivariate Analysis 587

Partial Correlation 587

Multiple Regression 589

Logistic Regression 597

Discriminant Analysis 603

Factor Analysis 607

Multivariate Analysis of Variance 615

Commentary: Can We Keep It Simple? 618

Chapter 28 Data Management 621

Recording Data 621

Data Coding 622

Data Entry 623

Data Modification 626

Data Management 628

Commentary: "Anyone can analyze data, but to really mess things up takes a computer." 629

Part V Communication 631

Chapter 29 Writing a Research Proposal 633

Components of the Research Plan 635

Plan for Administrative Support 639

Presentation of the Proposal 642

Commentary: Review, Revise, Edit, Revise, Review 642

Chapter 30 Reporting the Results of Clinical Research 645

The Journal Article 645

The Poster Presentation 656

The Oral Presentation 658

Commentary: Taking the Final Step 661

Chapter 31 Evaluating Research Reports 663

Analyzing Content of an Article 663

Commentary: The Reader's View 671

Appendix A Statistical Tables 673

Appendix B Summary of Statistical Procedures 699

Appendix C Power and Sample Size 705

The Effect Size Index 705

Power Analysis for the t-Test 707

Power Analysis for the Analysis of Variance 710

Power Analysis for Correlation 714

Power Analysis for Regression 715

Power Analysis for Chi-square 717.

Notes:

Includes bibliographical references.

ISBN:

0838526950

OCLC:

187482288