CONTENT
Preface
About the Author
New to This Edition
CHAPTER 1 The Health Research Process
1.1 Clinical and Population Health Research1
1.2 The Research Process
1.3 Text Overview
STEP 1 Identifying a Study Question
CHAPTER 2 Selecting a Research Question
2.1 Practical Research
2.2 Brainstorming and Concept Mapping
2.3 Keywords
2.4 Exposures, Diseases, and Populations (EDPs)
2.5 PICOT
2.6 From Inquiry to Research
2.7 Testable Questions
2.8 Framing for Generalizability
CHAPTER 3 Reviewing the Literature
3.1 Informal Sources
3.2 Statistical Reports
3.3 Abstract Databases
3.4 Full-Text Articles
3.5 Critical Reading
3.6 Annotated Bibliographies
3.7 What Makes Research Original?
CHAPTER 4 Defining Specific Aims
4.1 Refining the Study Question
4.2 One Study Goal
4.3 Several Specific Aims
4.4 Conceptual and Theoretical Frameworks
4.5 Feasibility
CHAPTER 5 Professional Development
5.1 Research Teams
5.2 Finding Research Mentors
5.3 The Mentor–Mentee Relationship
5.4 Professional Development
5.5 Social Media and Impact Metrics
5.6 Responsible Conduct of Research
CHAPTER 6 Coauthoring
6.1 Coauthorship
6.2 Authorship Criteria
6.3 Authorship Order
6.4 Decisions About Authorship
STEP 2 Selecting a Study Approach
CHAPTER 7 Overview of Study Designs
7.1 Types of Study Approaches
7.2 Primary, Secondary, and Tertiary Studies
7.3 Observational and Experimental Studies
7.4 Exposure, Disease, or Population?
7.5 Study Duration
CHAPTER 8 Case Series
8.1 Overview
8.2 Case Definitions
8.3 Data Collection
8.4 Ethical Considerations
8.5 Analysis
CHAPTER 9 Cross-Sectional Studies
9.1 Overview
9.2 Representative Populations
9.3 KAP Surveys
9.4 Repeated Cross-Sectional Surveys
9.5 Prevalence
CHAPTER 10 Case–Control Studies
10.1 Overview
10.2 Finding Cases and Controls
10.3 Matching
10.4 Minimizing Bias
10.5 Odds Ratios
10.6 Matched Case–Control Studies
CHAPTER 11 Cohort Studies
11.1 Overview
11.2 Prospective Cohort Studies
11.3 Retrospective Cohort Studies
11.4 Longitudinal Cohort Studies
11.5 Data Collection
11.6 Ratios, Rates, and Risk
11.7 Incidence Rates
11.8 Incidence Rate Ratios
11.9 Attributable Risk
11.10 Person–Time Analysis
CHAPTER 12 Experimental Studies
12.1 Overview
12.2 Describing the Intervention
12.3 Defining Outcomes
12.4 Selecting Controls
12.5 Blinding
12.6 Randomization
12.7 Ethical Considerations
12.8 Efficacy
12.9 Screening and Diagnostic Tests
CHAPTER 13 Qualitative Studies
13.1 Overview
13.2 Ontology, Epistemology, and Axiology
13.3 Theoretical Paradigms
13.4 Qualitative Methodologies
13.5 Mixed Methods Research
CHAPTER 14 Correlational Studies
14.1 Overview
14.2 Aggregate Data
14.3 Avoiding the Ecological Fallacy
14.4 Correlation
14.5 Age Standardization
CHAPTER 15 Synthesis Research
15.1 Overview
15.2 Selecting a Topic
15.3 Library Access
15.4 Narrative Reviews
15.5 Systematic Reviews
15.6 Meta-analysis
15.7 Meta-synthesis
STEP 3 Designing the Study and Collecting Data
CHAPTER 16 Research Protocols
16.1 Overview of Research Plans by Study
Approach
16.2 Writing a Research Protocol
16.3 Rigor and Reproducibility
16.4 Research Timelines
16.5 Roles and Responsibilities
16.6 Preparing for Data Collection
CHAPTER 17 Ethical Considerations
17.1 Foundations of Research Ethics
17.2 Respect, Beneficence, and Justice
17.3 Incentives and Coercion
17.4 Informed Consent Statements
17.5 Informed Consent Process
17.6 Informed Consent Documentation
17.7 Confidentiality and Privacy
17.8 Sensitive Issues
17.9 Cultural Considerations
17.10 Vulnerable Populations
17.11 Ethics Training and Certification
CHAPTER 18 Ethical Review and Approval
18.1 Ethics Committee Responsibilities
18.2 Ethics Committee Composition
18.3 Application Materials
18.4 Exemption from Review
18.5 Review Process
18.6 Review by Multiple Committees
18.7 Ongoing Review
18.8 Conflicts of Interest
18.9 Is Ethics Review Required?
CHAPTER 19 Population Sampling
19.1 Types of Research Populations
19.2 Target and Source Populations
19.3 Sample Populations
19.4 Study Populations
19.5 Populations for Cross-Sectional Studies
19.6 Populations for Case–Control Studies
19.7 Populations for Cohort Studies
19.8 Populations for Experimental Studies
19.9 Sampling for Qualitative Studies
19.10 Vulnerable Populations
19.11 Community Involvement
CHAPTER 20 Sample Size and Power
20.1 Importance of Sample Size
20.2 Sample Size and Certainty Levels
20.3 Sample Size Estimation
20.4 Type 1 and Type 2 Errors
20.5 Power Estimation
20.6 Refining the Study Approach
CHAPTER 21 Questionnaire Development
21.1 Questionnaire Design Overview
21.2 Questionnaire Content
21.3 Types of Questions
21.4 Types of Responses
21.5 Anonymity
21.6 Wording of Questions
21.7 Order of Questions
21.8 Layout and Formatting
21.9 Reliability and Validity
21.10 Commercial Research Tools
21.11 Translation
21.12 Pilot Testing
CHAPTER 22 Collecting Quantitative Data
22.1 Interviews Versus Self-Administered Surveys
22.2 Recruiting Methods
22.3 Encouraging Participation
22.4 Data Recording Methods
22.5 Training Interviewers
CHAPTER 23 Collecting Qualitative Data
23.1 Overview
23.2 In-Depth Interviews
23.3 Focus Group Discussions
23.4 Observational Methods
23.5 Other Qualitative Research Techniques
23.6 Community-Based Participatory Research
23.7 Consensus Methods
CHAPTER 24 Additional Assessments
24.1 Supplementing Self-Reported Data
24.2 Anthropometric Measures
24.3 Vital Signs
24.4 Clinical Examination
24.5 Tests of Physiological Function
24.6 Laboratory Analysis of Biological Specimens
24.7 Medical Imaging
24.8 Tests of Physical Fitness
24.9 Environmental Assessment
24.10 Geographic Information Systems
24.11 Monitoring and Evaluation
CHAPTER 25 Secondary Analyses
25.1 Overview of Secondary Analysis
25.2 Accessing Secondary Data
25.3 Publicly Available Data Sets
25.4 Private Data Sets
25.5 Challenges of Secondary Research
25.6 Clinical Records
25.7 Health Informatics, Big Data, and Data Mining
25.8 Ethics Committee Review
CHAPTER 26 Systematic Reviews and Metaanalyses
26.1 Overview of Tertiary Analysis
26.2 Search Strings
26.3 Search Limiters
26.4 Supplemental Searches
26.5 Eligibility Criteria
26.6 Quality Assessment
26.7 Data Extraction
26.8 Systematic Review Results
26.9 Pooled Analysis
26.10 Forest Plots and Funnel Plots
CHAPTER 27 Writing Grant Proposals
27.1 Preparing to Write a Proposal
27.2 Identifying Grant Opportunities
27.3 Requests for Proposals
27.4 Research Proposal Components
27.5 Writing a Research Narrative
27.6 Funding Criteria
27.7 Budgeting
27.8 Financial Accounting
27.9 Grant Management
27.10 Unfunded Research
STEP 4 Analyzing Data
CHAPTER 28 Data Management
28.1 Data Management
28.2 Codebooks
28.3 Data Entry
28.4 Data Cleaning
28.5 Data Recoding
28.6 Statistical Software Programs
28.7 Data Security
CHAPTER 29 Descriptive Statistics
29.1 Analytic Plan by Study Approach
29.2 Types of Variables
29.3 Measures of Central Tendency
29.4 Range and Quartiles
29.5 Displaying Distributions
29.6 Normal Curves, Variance, and Standard Deviation
29.7 Reporting Descriptive Statistics
29.8 Confidence Intervals
29.9 Statistical Honesty
29.10 Statistical Consultants
CHAPTER 30 Comparative Statistics
30.1 Comparative Analysis by Study Approach
30.2 Hypotheses for Statistical Tests
30.3 Rejecting the Null Hypothesis
30.4 Interpreting p Values
30.5 Measures of Association
30.6 Interpreting Confidence Intervals
30.7 Selecting an Appropriate Test
30.8 Parametric and Nonparametric Tests
30.9 Comparing a Population Statistic to a Set Value
30.10 Comparing Independent Populations
30.11 Multivariable Comparisons of Means
30.12 Correlation Analysis
30.13 Comparing Paired Data
CHAPTER 31 Regression Analysis
31.1 Regression Modeling
31.2 Simple Linear Regression
31.3 Simple Logistic Regression
31.4 Dummy Variables
31.5 Confounding and Effect Modification
31.6 Multiple Regression
31.7 Causal Analysis
31.8 Survival Analysis
31.9 Cautions
CHAPTER 32 Qualitative Analysis
32.1 Overview
32.2 Analytic and Interpretive Frameworks
32.3 Codes, Categories, and Themes
32.4 Manual and Electronic Coding
32.5 Quality Assurance
CHAPTER 33 Additional Analysis Tools
33.1 Spatial Analysis
33.2 Bayesian Statistics
33.3 Mathematical Modeling
33.4 Agent-Based Modeling
33.5 Machine Learning
33.6 Cost-Effectiveness Analysis
33.7 Burden of Disease Metrics
STEP 5 Reporting Findings
CHAPTER 34 Posters and Presentations
34.1 Purpose of Conferences
34.2 Structure of Conferences
34.3 Writing an Abstract
34.4 Submitting an Abstract
34.5 Preparing a Poster
34.6 Using Images
34.7 Presenting a Poster
34.8 Preparing for an Oral Presentation
34.9 Giving an Oral Presentation
CHAPTER 35 Article Structure
35.1 Outlining a Manuscript
35.2 Abstract
35.3 Introduction
35.4 Methods
35.5 Results
35.6 Discussion
35.7 Writing Checklists
35.8 End Matter
35.9 Tables and Figures
CHAPTER 36 Citing
36.1 Referring to the Scientific Literature
36.2 Formal and Informal Sources
36.3 Writing in One’s Own Words
36.4 Common Knowledge and Specific Knowledge
36.5 Avoiding Plagiarism
36.6 Citation Styles
CHAPTER 37 Critically Revising
37.1 Clarifying the Storyline
37.2 One Paper, One Story
37.3 Structure and Content
37.4 Style, Clarity, and Consistency
CHAPTER 38 Writing Success Strategies
38.1 The Writing Process
38.2 Getting Started
38.3 Staying Motivated
38.4 Conquering Writer’s Block
38.5 Finishing a Manuscript
CHAPTER 39 Reasons to Publish
39.1 Scientific Dialogue
39.2 Critical Feedback
39.3 Respect for Participants and
Collaborators
39.4 Personal Benefits
CHAPTER 40 Selecting Target Journals
40.1 Choosing a Target Journal
40.2 Aim, Scope, and Audience
40.3 Impact Factors
40.4 Other Journal Characteristics
40.5 Open Access and Copyright
40.6 Publication Fees
40.7 Predatory Journals
CHAPTER 41 Manuscript Submission
41.1 Submission Timing
41.2 Journal Selection
41.3 Manuscript Formatting
41.4 Cover Letter
41.5 Online Submission
CHAPTER 42 Peer Review and Publication
42.1 Initial Review
42.2 External Review Results
42.3 Rejection
42.4 Revision and Resubmission
42.5 After Acceptance
Glossary Index
CHAPTER
1
The Health Research Process
Health research is the process of systematically investigating a single, welldefined aspect of physical, mental, or social well-being.
1.1 Clinical and Population Health Research
Health is defined by the World Health Organization as “a state of complete physical, mental, and social well-being, and not merely the absence of disease or infirmity.” Determinants of health are the biological, behavioral, social, environmental, political, and other factors that influence the health status of individuals and populations. Health research is the investigation of health and disease or any of the factors that contribute to the presence or absence of physical, mental, and social health among individuals, families, communities, nations, or the
world population as a whole. Health research encompasses both clinical research and population health research.
Medicine is the practice of preventing, diagnosing, and treating health problems in individuals and families. A clinician is a medical professional who provides direct care to patients or clients. Clinicians include physicians, surgeons, nurses, psychiatrists, physician assistants, midwives, registered dietitians, and other skilled professionals who work in medical settings as well as practitioners in dentistry, clinical psychology, podiatry, physical therapy, occupational therapy, pharmacy, optometry, kinesiology, rehabilitation, and other health-related fields. Clinical practice is contrasted with laboratory work and research that do not involve direct interaction with patients or clients.
Clinical research evaluates the best ways to prevent, diagnose, and treat adverse health issues that adversely affect individuals and families. For example, clinical research projects may examine the progression of a disease over time, compare the effectiveness of various therapeutic regimens, or test the safety and utility of new diagnostic tests, medications, or medical devices.
Clinical research generally uses humans as the unit of investigation, whereas basic medical research (also called basic science) studies molecules, genes, cells, and other smaller biological components related to human function and health.
Translational research bridges basic research and clinical research by applying scientific discoveries to the improvement of clinical outcomes. The aim of translational medicine is to move research from the bench (the laboratory) to the bedside (clinical care settings).
Population health focuses on the health outcomes and the determinants of health in groups of humans. Population health is a function of many factors, including human behaviors, the social and economic environment, the physical environment, access to healthcare services, and many other exposures. Public health consists of the actions taken to promote health and prevent illnesses, injuries, and early deaths at the population level. Public health practitioners monitor health status in communities, mitigate environmental hazards, provide health education, support community health partnerships, develop public health policies, enforce safety regulations, and ensure access to essential health services.
Population health research examines health outcomes at the community, regional, national, and worldwide levels. For example, public health researchers assess population needs and capacities; design, implement, and test population-based health interventions; and evaluate population-based health programs, projects, and policies. Both clinical and population health research studies apply the tools from a diversity of academic disciplines. Clinical research often draws on the tools of the laboratory sciences, such as molecular biology, microbiology, immunology, nutrition, and genetics. Population health research often uses tools from demography, the study of the size and composition of populations and of population dynamics, such as birth and death rates. Many clinical and population health research studies use the methods of social science fields such as psychology, sociology, anthropology, and economics.
1.2 The Research Process
Research is the process of systematically and carefully investigating a topic in order to discover new insights about the world. No matter what the
goals of a research project are or what methods are used to achieve those goals, the five steps of the research process are the same (Figure 1-1). The first two steps are identifying a study question and selecting a general study approach. These two steps are often completed concurrently, because the approach selected may require the refinement of the study question. After the objectives and the approach are set, the last three steps are designing the study and collecting data, analyzing the data, and reporting the findings. These steps apply to nearly every research project. A research project is not finished until all five steps have been completed.
FIGURE 1-1 The Research Process
1.3 Text Overview
This text is a handbook for clinical and population health researchers. The chapters are organized according to the five steps of the research process. The first section provides suggestions for selecting an appropriately focused research question and establishing good relationships with collaborators and mentors early in a project. The second section presents an overview of each of the main study designs used in the clinical and population health
sciences. The third section describes research ethics and the data collection process. The fourth section summarizes common strategies for quantitative and qualitative data analysis. The fifth section presents tips for writing success and a step-by-step guide for preparing a manuscript for review and publication. If the goal is to publish the findings of a study, it may be helpful to write throughout the research process. Thus, some readers may find it helpful to read some of the chapters from the fifth section of the text prior to finalizing their research plans. The best way to learn about health research is to do actual research and to learn firsthand how the research process works. This guidebook provides a comprehensive overview of the entire research process and details about the most common methods used in clinical and population health research. It is not intended to be a compendium of everything that health researchers know about study design, data collection, and statistical analysis. As a research project unfolds, most researchers will benefit from consulting specialized references. Many excellent books, journal articles, technical reports, and online and library resources contain the advanced information required for complex study
designs and analytic techniques. It is also essential for the consulted resources to include human experts professors, supervisors, colleagues, librarians, statistical consultants, and others—who can provide insights gained from personal research experience and can direct new investigators to the background readings and other information that will be most helpful as they explore their selected research questions.
Anyone who completes a novel, valid research project can contribute to advancing clinical and population health. Health research does not require a license. It does not require a doctorate or a master’s degree. It does not even require coursework in research methods, although that is certainly helpful. What research demands is perseverance and patience, honesty and integrity, carefulness and attention to detail, the willingness to learn new knowledge and develop new skills, openness to expert advice and feedback, and the ability to criticize and revise one’s own work and writing. These are personal character traits that everyone can cultivate and develop along with the technical skills required for research excellence. STEP 1
Identifying a Study Question
The first step in the research process is selecting the focus of the study. This section describes how to select a research question, review the literature, refine the scope of the project, and work with mentors and collaborators.
Selecting a research question
Reviewing the literature
Defining specific aims
Professional development
Coauthoring
© DmitriyRazinkov/Shutterstock
CHAPTER 2
Selecting a Research Question
Selecting one focused study topic is the first step toward completing a successful research project.
2.1 Practical Research
Many research questions in the health sciences arise from observations made during applied practice.
Consider the types of questions that different health practitioners might raise about trampoline injuries:
An emergency room physician: “The trampoline injuries we’ve been seeing include a mix of limb fractures and head/neck trauma. Are the kids who present with trampoline-related arm fractures being screened for concussions? Are they being adequately treated for multiple injuries?”
A physical therapist: “It seems like a lot more of the patients coming in for therapy this year are recovering from trampoline-related injuries. Has the rate of injuries really increased, or am I just noticing them more? Should I be telling my patients not to use home trampolines?”
A health educator: “I’m working at a fitness center that offers trampoline workouts. Is this an effective way to improve cardiovascular fitness? What can we do to ensure the safety of our clients?”
Any of these questions might be worth exploring in a new research project, assuming that a review of the literature shows that there is not yet consensus about the answers to these questions. A good first step toward selecting a research topic is to think about the various questions about
health that have arisen from personal experiences, coursework, clinical or public health practice, and informal reading about subjects of interest (Figure 21). Practical questions about who, where, when, what, why, and how often point toward unmet demand for descriptive studies, needs assessments, program evaluations, clinical effectiveness studies, and other types of health-related research.
FIGURE 2-1 Brainstorming Questions
Area Questions
Interests What are my interests? What health-related conditions have significantly affected me, my family, my friends, my patients or clients, my community, and/or other populations that I care about?
Aptitudes What knowledge and skills do I already have? What topics am I prepared to study in depth? What methods am I prepared to apply? What methods am I eager to learn?
Applications What studies would help improve health-related practices or policies? What are the gaps in the literature
that I can fill?
Mentors What are the areas of expertise of my supervisors, professors, and/or other mentors? What source populations and/or data sources might be available to me through professors, supervisors, colleagues, and other personal and professional contacts?
2.2 Brainstorming and Concept Mapping
After thinking about the types of questions that have arisen from personal and professional experiences, the researcher can use a brainstorming session to convert those areas of interest into potential research themes. In this context, brainstorming is the process of generating long lists of spontaneous ideas about possible research questions. This is not the stage for eliminating ideas because they do not appear feasible. The ideas do not yet need to be well formed. The goal of brainstorming is to generate a lengthy list of possible topics. In addition to compiling one’s own ideas, it can be valuable to check with colleagues, practitioners, and friends about their thoughts. Internet searches, journals, and books
might reveal gaps in knowledge that are worth exploring. For example, many research articles end with a call for further research on a particular topic.
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