SMART Approach to Spine Clinical Research

Title Page

Copyright

Contributors

Preface

Foreword/Acknowledgments

Table of Contents

1 SMART-B: overview of study conceptualization and planning

1.1 Introduction

1.2 Study question

1.3 Searching the literature

1.4 Study design

1.5 Measurement

1.6 Analysis

1.7 Resources and funding

1.8 Timing

1.9 Bias reduction

1.10 Summary

2 Constructing a SMART study question

2.1 Introduction

2.2 Initial refinement of your study question

2.3 Conceptualizing your study in terms of PICO or PPO

2.4 Summary

3 Constructing a SMART literature search

3.1 Introduction

3.2 Databases and search engines

3.3 A quick search

3.4 Structuring a formal search—the basics

3.5 The language of searches in PubMed

3.6 Combining search terms and wild cards

3.7 Filters (Limits)

3.8 Putting it all together—an example and considerations for study design

3.9 Summary

3.10 References

4 Importance and implications of study design selection

4.1 Introduction

4.2 Descriptive studies

4.3 Analytic studies

4.4 Summary

4.5 References

5 Measurements: the backbone of the study

5.1 Introduction

5.2 Categories of measurement

5.3 Selecting outcomes

5.4 Minimizing bias in outcomes measurements

5.5 Sample size considerations in outcome selection

5.6 Why are you collecting the measurements?

5.7 Case example

5.8 Summary

5.9 References

6 Analysis: basic statistical methods and principles

6.1 Introduction

6.2 Understanding your measurement variables

6.3 Power and sample size calculations

6.4 Developing your data collection forms and database

6.5 Analysis plan

6.6 SMART analysis plan checklist

6.7 Summary

6.8 References

7 Resources and Timing

7.1 Introduction

7.2 Building your team and a network of collaborators

7.3 Can you proceed without funding? What funding options do you have?

7.4 Possible funding sources

7.5 What is the cost of data collection and study operations?

7.6 Timing

7.7 Summary

8 Bias reduction: how to avoid spurious conclusions

8.1 Introduction

8.2 Selection bias

8.3 Attrition bias

8.4 Performance bias

8.5 Measurement or detection bias

8.6 Reporting bias

8.7 Summary

8.8 References

9 Special topics

9.1 Manuscript preparation: being SMART about getting published

9.2 Heterogeneity of treatment effects

9.3 Planning a SMART Registry

9.4 Systematic reviews, comparative effectiveness, and health technology assessments

9.5 The SMART use of meta-analyses

9.6 Healthcare policy: evolution, evidence, and appraisal

Glossary of terms and abbreviations