Foundations of Clinical Research : Applications to Practice

by Leslie G. Portney; Mary P. Watkins

• ISBN13: 9780838510650
• ISBN10: 0838510655
• Format: Hardcover
• Copyright: 1993-01-01
• Publisher: Appleton & Lange

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.

Table of Contents

Foundations of Clinical Research	p. 1
A Concept of Research	p. 3
A Definition of Clinical Research	p. 3
Contemporary Perspectives	p. 4
Sources of Knowledge	p. 7
Types of Research	p. 12
The Research Process	p. 15
Understanding Method, Content, and Philosophy	p. 17
Commentary: Research and Clinical Problem Solving	p. 18
The Role of Theory in Clinical Research	p. 21
Purposes of Theories	p. 22
Components of Theories	p. 23
Types of Theories	p. 25
Characteristics of Theories	p. 26
Theory and Research	p. 27
Theory and Law	p. 29
Commentary: Applying Theory	p. 29
Ethical Issues in Clinical Research	p. 33
Integrity of the Researcher	p. 33
Protection of Human Rights in Clinical Research	p. 34
Institutional Review Board	p. 39
Elements of Informed Consent	p. 40
Commentary: A Patient Care Perspective	p. 45
Concepts of Measurement	p. 47
Principles of Measurement	p. 49
Quantification and Measurement	p. 50
The Indirect Nature of Measurement	p. 50
Rules of Measurement	p. 52
Commentary: When Is an Ordinal Measure Not an Ordinal Measure?	p. 57
Reliability	p. 61
Measurement Error	p. 61
Reliability Coefficients	p. 64
Types of Reliability	p. 66
Generalizability	p. 73
Pilot Testing	p. 75
Commentary: What Is the True Score?	p. 75
Validity of Measurements	p. 79
Validity and Reliability	p. 79
Validity of Inferences	p. 80
Face Validity	p. 82
Content Validity	p. 83
Criterion-Related Validity	p. 84
Construct Validity	p. 87
Evaluating Diagnostic Procedures	p. 92
Measuring Change	p. 101
Criterion Referencing and Norm Referencing	p. 105
Cross-Validation	p. 107
Commentary: The Ongoing Pursuit of Validity	p. 107
Design	p. 111
The Research Question	p. 113
Selecting a Topic	p. 114
The Research Problem	p. 115
Importance and Feasibility of the Research Question	p. 117
Target Population	p. 119
The Research Rationale	p. 119
Variables	p. 120
Research Objectives	p. 123
Reviewing the Literature	p. 127
Pilot Testing	p. 133
Commentary: Putting the Horse before the Cart	p. 133
Sampling	p. 137
Populations and Samples	p. 137
Sampling Techniques	p. 140
Probability Sampling	p. 141
Nonprobability Sampling	p. 146
Recruitment	p. 149
Commentary: Sampling, Like Life, is a Compromise	p. 150
Experimental Control	p. 153
Characteristics of Experiments	p. 154
The Research Protocol	p. 157
Blinding	p. 159
Design Strategies for Controlling Intersubject Differences	p. 159
Threats to Validity	p. 163
Commentary: The Realities of Clinical Research	p. 173
Experimental Design	p. 177
Selecting a Design	p. 178
Design Notation	p. 179
True Experimental Designs	p. 179
Repeated Measures Designs	p. 187
Quasi-Experimental Designs	p. 193
Commentary: The Design Should Fit the Question	p. 199
Sequential Clinical Trials	p. 203
The Design of a Sequential Trial	p. 204
Measuring Preferences	p. 205
Sequential Plans for Evaluating Preferences	p. 206
Limitations of Sequential Designs	p. 215
Commentary: Try It, You'll Like It	p. 217
Single-Subject Designs	p. 223
Structure of Single-Subject Designs	p. 224
Target Behavior	p. 227
Reliability	p. 231
Experimental Control: Limitations of the A-B Design	p. 234
Withdrawal Designs	p. 235
Multiple-Treatment Designs	p. 238
Multiple-Baseline Designs	p. 243
Changing Criterion Design	p. 246
Data Analysis in Single-Subject Research	p. 249
Generalization of Findings	p. 258
Commentary: It's a Start	p. 261
Descriptive and Exploratory Research	p. 265
Retrospective and Prospective Research	p. 266
Descriptive Research	p. 267
Exploratory Research	p. 277
Commentary: First Things First	p. 281
Surveys	p. 285
Interviews and Questionnaires	p. 286
Design of Surveys	p. 287
Constructing Survey Questions	p. 293
Scales	p. 299
Q-Sort	p. 308
Delphi Survey	p. 310
Analysis of Survey Data	p. 311
Informed Consent	p. 312
Commentary: They Have a Thousand and One Uses	p. 312
Epidemiology	p. 317
Descriptive Epidemiology	p. 319
Analytic Designs: Observational Studies	p. 324
Analytic Designs: Clinical Trials	p. 330
Measures of Association	p. 332
Evaluating Causality in Observational Studies	p. 341
Commentary: A New View of Outcomes	p. 341
Other Research Approaches	p. 345
Evaluation Research	p. 346
Methodological Research	p. 351
Secondary Analysis	p. 353
Meta-Analysis	p. 355
Historical Research	p. 358
Commentary: Moving Forward	p. 360
Analysis	p. 365
Descriptive Statistics and Measures of Variability	p. 367
Frequency Distributions	p. 367
Measures of Central Tendency	p. 372
Measures of Variability	p. 374
The Normal Distribution	p. 381
Commentary: Description Only Goes So Far	p. 385
Statistical Inference	p. 387
Probability	p. 387
Sampling Error	p. 389
Confidence Intervals	p. 392
Hypothesis Testing	p. 397
Errors in Hypothesis Testing	p. 399
Type I Error: Level of Significance	p. 400
Type II Error: Statistical Power	p. 402
Concepts of Statistical Testing	p. 404
Parametric versus Nonparametric Statistics	p. 409
Commentary: Statistical versus Clinical Significance	p. 410
The t-Test	p. 413
The Conceptual Basis for Comparing Group Means	p. 413
The t-Test for Independent Samples	p. 416
The t-Test for Paired Samples	p. 422
Inappropriate Use of Multiple t-Tests	p. 423
Use of Confidence Intervals to Test Differences between Means	p. 425
Commentary: The Significance of Significance	p. 426
Analysis of Variance	p. 427
Analysis of Variance for Independent Samples: One-Way Classification	p. 427
Analysis of Variance: Two-Way Classification	p. 432
Analysis of Variance: Three-Way Classification	p. 441
Repeated Measures Analysis of Variance	p. 442
Commentary: Beyond Analysis of Variance	p. 450
Multiple Comparison Tests	p. 453
Type I Error Rate: Per Comparison versus Family	p. 454
Statistical Ratios for Multiple Comparison Tests	p. 455
Tukey's Honestly Significant Difference	p. 456
Newman-Keuls Method	p. 457
Scheffe's Comparison	p. 460
Bonferroni t-Test	p. 461
Simple and Complex Contrasts	p. 462
Presentation of Results of Multiple Comparisons	p. 463
Multiple Comparison Procedures for Factorial Designs	p. 463
Multiple Comparison Procedures for Repeated Measures	p. 466
Trend Analysis	p. 467
Commentary: Choices, Choices, Choices	p. 471
Nonparametric Tests for Group Comparisons	p. 473
Criteria for Choosing Nonparametric Tests	p. 473
Procedure for Ranking Scores	p. 475
Test for Two Independent Samples: Mann-Whitney U-Test	p. 475
Test for More than Two Independent Samples: Kruskal-Wallis One-Way Analysis of Variance by Ranks	p. 478
Tests for Two Correlated Samples: Sign Test and Wilcoxon Signed-Ranks Test	p. 482
Test for More than Two Correlated Samples: Friedman Two-Way Analysis of Variance by Ranks	p. 486
Commentary: Decisions, Decisions, Decisions	p. 489
Correlation	p. 491
Scatter Plots	p. 492
Correlation Coefficients	p. 493
Linear versus Curvilinear Relationships	p. 493
Criteria for Evaluating Correlation Coefficients	p. 494
Pearson Product-Moment Correlation Coefficient	p. 496
Correlation of Ranks: Spearman Rank Correlation Coefficient	p. 497
Correlation of Dichotomies	p. 500
Interpreting Correlation Coefficients	p. 505
Commentary: The Stork Was Busy	p. 507
Regression	p. 509
Linear Regression	p. 509
Assumptions for Regression Analysis	p. 515
Outliers	p. 517
Accuracy of Prediction	p. 519
Analysis of Variance of Regression	p. 521
Restrictions on the Interpretation of Linear Regression Analysis	p. 523
Nonlinear Regression	p. 523
Analysis of Covariance	p. 527
Commentary: It's Not That Simple	p. 534
Analysis of Frequencies: Chi-square	p. 537
The Chi-square Statistic	p. 538
Goodness of Fit	p. 539
Interpreting Significant Effects: Standardized Residuals	p. 543
Tests of Independence	p. 544
McNemar Test for Correlated Samples	p. 551
Coefficients of Association	p. 552
Commentary: Uses of Chi-square	p. 554
Statistical Measures of Reliability	p. 557
Reliability Theory and Measurement Error	p. 557
Intraclass Correlation Coefficient	p. 560
Agreement	p. 568
Internal Consistency: Cronbach's Alpha	p. 575
Response Stability	p. 577
Alternate Forms: Limits of Agreement	p. 581
Commentary: Know Your Reliability Coefficient	p. 584
Multivariate Analysis	p. 587
Partial Correlation	p. 587
Multiple Regression	p. 589
Logistic Regression	p. 597
Discriminant Analysis	p. 603
Factor Analysis	p. 607
Multivariate Analysis of Variance	p. 615
Commentary: Can We Keep It Simple?	p. 618
Data Management	p. 621
Recording Data	p. 621
Data Coding	p. 622
Data Entry	p. 623
Data Modification	p. 626
Data Management	p. 628
Commentary: "Anyone can analyze data, but to really mess things up takes a computer."	p. 629
Communication	p. 631
Writing a Research Proposal	p. 633
Components of the Research Plan	p. 635
Plan for Administrative Support	p. 639
Presentation of the Proposal	p. 642
Commentary: Review, Revise, Edit, Revise, Review	p. 642
Reporting the Results of Clinical Research	p. 645
The Journal Article	p. 645
The Poster Presentation	p. 656
The Oral Presentation	p. 658
Commentary: Taking the Final Step	p. 661
Evaluating Research Reports	p. 663
Analyzing Content of an Article	p. 663
Commentary: The Reader's View	p. 671
Appendices
Statistical Tables	p. 673
Summary of Statistical Procedures	p. 699
Power and Sample Size	p. 705
The Effect Size Index	p. 705
Power Analysis for the t-Test	p. 707
Power Analysis for the Analysis of Variance	p. 710
Power Analysis for Correlation	p. 714
Power Analysis for Regression	p. 715
Power Analysis for Chi-square	p. 717
Transformation of Data	p. 731
Sample Informed Consent Form	p. 735
Glossary of Statistical Symbols and Abbreviations	p. 739
Index	p. 743
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