Foundations of Clinical Research : Applications to Practice

by Portney, Leslie Gross; Watkins, Mary P.

• ISBN13: 9780838526958
• ISBN10: 0838526950
• Edition: 2nd
• Format: Hardcover
• Copyright: 2008-01-01
• Publisher: Pearson

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.

Table of Contents

PART I: FOUNDATIONS OF CLINICAL RESEARCH	1	(46)
A Concept of Research	3	(18)
A Definition of Clinical Research	3	(1)
Contemporary Perspectives	4	(3)
Sources of Knowledge	7	(5)
Types of Research	12	(3)
The Research Process	15	(2)
Understanding Method, Content, and Philosophy	17	(1)
Commentary: Research and Clinical Problem Solving	18	(3)
The Role of Theory in Clinical Research	21	(12)
Purposes of Theories	22	(1)
Components of Theories	23	(2)
Types of Theories	25	(1)
Characteristics of Theories	26	(1)
Theory and Research	27	(2)
Theory and Law	29	(1)
Commentary: Applying Theory	29	(4)
Ethical Issues in Clinical Research	33	(14)
Integrity of the Researcher	33	(1)
Protection of Human Rights in Clinical Research	34	(5)
Institutional Review Board	39	(1)
Elements of Informed Consent	40	(5)
Commentary: A Patient Care Perspective	45	(2)
PART II: CONCEPTS OF MEASUREMENT	47	(64)
Principles of Measurement	49	(12)
Quantification and Measurement	50	(1)
The Indirect Nature of Measurement	50	(2)
Rules of Measurement	52	(5)
Commentary: When Is an Ordinal Measure Not an Ordinal Measure?	57	(4)
Reliability	61	(18)
Measurement Error	61	(3)
Reliability Coefficients	64	(2)
Types of Reliability	66	(7)
Generalizability	73	(2)
Pilot Testing	75	(1)
Commentary: What Is the True Score?	75	(4)
Validity of Measurements	79	(32)
Validity and Reliability	79	(1)
Validity of Inferences	80	(2)
Face Validity	82	(1)
Content Validity	83	(1)
Criterion-Related Validity	84	(3)
Construct Validity	87	(5)
Evaluating Diagnostic Procedures	92	(9)
Measuring Change	101	(4)
Criterion Referencing and Norm Referencing	105	(2)
Cross-Validation	107	(1)
Commentary: The Ongoing Pursuit of Validity	107	(4)
PART III: DESIGN	111	(254)
The Research Question	113	(24)
Selecting a Topic	114	(1)
The Research Problem	115	(2)
Importance and Feasibility of the Research Question	117	(2)
Target Population	119	(1)
The Research Rationale	119	(1)
Variables	120	(3)
Research Objectives	123	(4)
Reviewing the Literature	127	(6)
Pilot Testing	133	(1)
Commentary: Putting the Horse before the Cart	133	(4)
Sampling	137	(16)
Populations and Samples	137	(3)
Sampling Techniques	140	(1)
Probability Sampling	141	(5)
Nonprobability Sampling	146	(3)
Recruitment	149	(1)
Commentary: Sampling, Like Life, is a Compromise	150	(3)
Experimental Control	153	(24)
Characteristics of Experiments	154	(3)
The Research Protocol	157	(2)
Blinding	159	(1)
Design Strategies for Controlling Intersubject Differences	159	(4)
Threats to Validity	163	(10)
Commentary: The Realities of Clinical Research	173	(4)
Experimental Design	177	(26)
Selecting a Design	178	(1)
Design Notation	179	(1)
True Experimental Designs	179	(8)
Repeated Measures Designs	187	(6)
Quasi-Experimental Designs	193	(6)
Commentary: The Design Should Fit the Question	199	(4)
Sequential Clinical Trials	203	(20)
The Design of a Sequential Trial	204	(1)
Measuring Preferences	205	(1)
Sequential Plans for Evaluating Preferences	206	(9)
Limitations of Sequential Designs	215	(2)
Commentary: Try It, You'll Like It	217	(6)
Single-Subject Designs	223	(42)
Structure of Single-Subject Designs	224	(3)
Target Behavior	227	(4)
Reliability	231	(3)
Experimental Control: Limitations of the A-B Design	234	(1)
Withdrawal Designs	235	(3)
Multiple-Treatment Designs	238	(5)
Multiple-Baseline Designs	243	(3)
Changing Criterion Design	246	(3)
Data Analysis in Single-Subject Research	249	(9)
Generalization of Findings	258	(3)
Commentary: It's a Start	261	(4)
Descriptive and Exploratory Research	265	(20)
Retrospective and Prospective Research	266	(1)
Descriptive Research	267	(10)
Exploratory Research	277	(4)
Commentary: First Things First	281	(4)
Surveys	285	(32)
Interviews and Questionnaires	286	(1)
Design of Surveys	287	(6)
Constructing Survey Questions	293	(6)
Scales	299	(9)
Q-Sort	308	(2)
Delphi Survey	310	(1)
Analysis of Survey Data	311	(1)
Informed Consent	312	(1)
Commentary: They Have a Thousand and One Uses	312	(5)
Epidemiology	317	(28)
Descriptive Epidemiology	319	(5)
Analytic Designs: Observational Studies	324	(6)
Analytic Designs: Clinical Trials	330	(2)
Measures of Association	332	(9)
Evaluating Causality in Observational Studies	341	(1)
Commentary: A New View of Outcomes	341	(4)
Other Research Approaches	345	(20)
Evaluation Research	346	(5)
Methodological Research	351	(2)
Secondary Analysis	353	(2)
Meta-Analysis	355	(3)
Historical Research	358	(2)
Commentary: Moving Forward	360	(5)
Part IV: ANALYSIS	365	(266)
Descriptive Statistics and Measures of Variability	367	(20)
Frequency Distributions	367	(5)
Measures of Central Tendency	372	(2)
Measures of Variability	374	(7)
The Normal Distribution	381	(4)
Commentary: Description Only Goes So Far	385	(2)
Statistical Inference	387	(26)
Probability	387	(2)
Sampling Error	389	(3)
Confidence Intervals	392	(5)
Hypothesis Testing	397	(2)
Errors in Hypothesis Testing	399	(1)
Type I Error: Level of Significance	400	(2)
Type II Error: Statistical Power	402	(2)
Concepts of Statistical Testing	404	(5)
Parametric versus Nonparametric Statistics	409	(1)
Commentary: Statistical versus Clinical Significance	410	(3)
The t-Test	413	(14)
The Conceptual Basis for Comparing Group Means	413	(3)
The t-Test for Independent Samples	416	(6)
The t-Test for Paired Samples	422	(1)
Inappropriate Use of Multiple t-Tests	423	(2)
Use of Confidence Intervals to Test Differences between Means	425	(1)
Commentary: The Significance of Significance	426	(1)
Analysis of Variance	427	(26)
Analysis of Variance for Independent Samples: One-Way Classification	427	(5)
Analysis of Variance: Two-Way Classification	432	(9)
Analysis of Variance: Three-Way Classification	441	(1)
Repeated Measures Analysis of Variance	442	(8)
Commentary: Beyond Analysis of Variance	450	(3)
Multiple Comparison Tests	453	(20)
Type I Error Rate: Per Comparison versus Family	454	(1)
Statistical Ratios for Multiple Comparison Tests	455	(1)
Tukey's Honestly Significant Difference	456	(1)
Newman-Keuls Method	457	(3)
Scheffee's Comparison	460	(1)
Bonferroni t-Test	461	(1)
Simple and Complex Contrasts	462	(1)
Presentation of Results of Multiple Comparisons	463	(1)
Multiple Comparison Procedures for Factorial Designs	463	(3)
Multiple Comparison Procedures for Repeated Measures	466	(1)
Trend Analysis	467	(4)
Commentary: Choices, Choices, Choices	471	(2)
Nonparametric Tests for Group Comparisons	473	(18)
Criteria for Choosing Nonparametric Tests	473	(2)
Procedure for Ranking Scores	475	(1)
Test for Two Independent Samples: Mann-Whitney U-Test	475	(3)
Test for More than Two Independent Samples: Kruskal-Wallis One-Way Analysis of Variance by Ranks	478	(4)
Tests for Two Correlated Samples: Sign Test and Wilcoxon Signed-Ranks Test	482	(4)
Test for More than Two Correlated Samples: Friedman Two-Way Analysis of Variance by Ranks	486	(3)
Commentary: Decisions, Decisions, Decisions	489	(2)
Correlation	491	(18)
Scatter Plots	492	(1)
Correlation Coefficients	493	(1)
Linear versus Curvilinear Relationships	493	(1)
Criteria for Evaluating Correlation Coefficients	494	(2)
Pearson Product--Moment Correlation Coefficient	496	(1)
Correlation of Ranks: Spearman Rank Correlation Coefficient	497	(3)
Correlation of Dichotomies	500	(5)
Interpreting Correlation Coefficients	505	(2)
Commentary: The Stork Was Busy	507	(2)
Regression	509	(28)
Linear Regression	509	(6)
Assumptions for Regression Analysis	515	(2)
Outliers	517	(2)
Accuracy of Prediction	519	(2)
Analysis of Variance of Regression	521	(2)
Restrictions on the Interpretation of Linear Regression Analysis	523	(1)
Nonlinear Regression	523	(4)
Analysis of Covariance	527	(7)
Commentary: It's Not That Simple	534	(3)
Analysis of Frequencies: Chi-square	537	(20)
The Chi-square Statistic	538	(1)
Goodness of Fit	539	(4)
Interpreting Significant Effects: Standardized Residuals	543	(1)
Tests of Independence	544	(7)
McNemar Test for Correlated Samples	551	(1)
Coefficients of Association	552	(2)
Commentary: Uses of Chi-square	554	(3)
Statistical Measures of Reliability	557	(30)
Reliability Theory and Measurement Error	557	(3)
Intraclass Correlation Coefficient	560	(8)
Agreement	568	(7)
Internal Consistency: Cronbach's Alpha	575	(2)
Response Stability	577	(4)
Alternate Forms: Limits of Agreement	581	(3)
Commentary: Know Your Reliability Coefficient	584	(3)
Multivariate Analysis	587	(34)
Partial Correlation	587	(2)
Multiple Regression	589	(8)
Logistic Regression	597	(6)
Discriminant Analysis	603	(4)
Factor Analysis	607	(8)
Multivariate Analysis of Variance	615	(3)
Commentary: Can We Keep It Simple?	618	(3)
Data Management	621	(10)
Recording Data	621	(1)
Data Coding	622	(1)
Data Entry	623	(3)
Data Modification	626	(2)
Data Management	628	(1)
Commentary: ``Anyone can analyze data, but to really mess things up takes a computer.''	629	(2)
PART V: COMMUNICATION	631	(108)
Writing a Research Proposal	633	(12)
Components of the Research Plan	635	(4)
Plan for Administrative Support	639	(3)
Presentation of the Proposal	642	(1)
Commentary: Review, Revise, Edit, Revise, Review	642	(3)
Reporting the Results of Clinical Research	645	(18)
The Journal Article	645	(11)
The Poster Presentation	656	(2)
The Oral Presentation	658	(3)
Commentary: Taking the Final Step	661	(2)
Evaluating Research Reports	663	(76)
Analyzing Content of an Article	663	(8)
Commentary: The Reader's View	671	(2)
APPENDICES
Appendix A Statistical Tables	673	(26)
Appendix B Summary of Statistical Procedures	699	(6)
Appendix C Power and Sample Size	705	(26)
The Effect Size Index	705	(2)
Power Analysis for the t-Test	707	(3)
Power Analysis for the Analysis of Variance	710	(4)
Power Analysis for Correlation	714	(1)
Power Analysis for Regression	715	(2)
Power Analysis for Chi-square	717	(14)
Appendix D Transformation of Data	731	(4)
Appendix E Sample Informed Consent Form	735	(4)
Glossary of Statistical Symbols and Abbreviations	739	(4)
Index	743