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# Foundations of Clinical Research : Applications to Practice

**by**Leslie G. Portney; Mary P. Watkins

### 9780838510650

0838510655

Hardcover

1/1/1993

Appleton & Lange

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## 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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