Introduction to health research methods

3.1 Informal Sources3.2 Statistical Reports3.3 Abstract Databases3.4 Full-Text Articles3.5 Critical Reading3.6 Annotated Bibliographies3.7 What Makes ResearchOriginal?Chapter 4 Focusing

INTRODUCTION TO HEALTH RESEARCH METHODS

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Names: Jacobsen, Kathryn H., author

Title: Introduction to health research methods : apractical guide / Kathryn

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Preface About the Author What’s New in the Second Edition

Chapter 1 The Health Research

2.1 Practical Questions2.2 Brainstorming and ConceptMapping

2.3 Keywords2.4 Exposure, Disease,Population (EDP)2.5 PICOT

Chapter 3 Reviewing the Literature

3.1 Informal Sources3.2 Statistical Reports3.3 Abstract Databases3.4 Full-Text Articles3.5 Critical Reading3.6 Annotated Bibliographies3.7 What Makes ResearchOriginal?

Chapter 4 Focusing the Research

Question

4.1 Study Approach4.2 Conceptual and TheoreticalFrameworks

4.3 Study Goal and SpecificObjectives

4.4 Checklist for Success

Chapter 5 Collaboration and

Mentorship

5.1 Collaborators andConsultants

5.2 Finding Research Mentors5.3 The Mentor–Mentee

Relationship5.4 Professional Development

Chapter 6 Coauthoring

6.1 Coauthorship

6.2 Authorship Criteria6.3 Authorship Order6.4 Decisions About Authorship

STEP 2: SELECTING A STUDY

APPROACH Chapter 7 Overview of Study Designs

7.1 Types of Study Approaches7.2 Primary, Secondary, andTertiary Studies

7.3 Study Duration7.4 Primary Focus: Exposure,Disease, or Population?

Chapter 8 Case Series

8.1 Overview8.2 Case Definitions8.3 Special Considerations8.4 Analysis

Chapter 9 Cross-Sectional Surveys

9.1 Overview9.2 Representative Populations9.3 KAP Surveys

9.4 Repeated Cross-SectionalSurveys

9.5 Analysis: Prevalence

Chapter 10 Case-Control Studies

10.1 Overview10.2 Finding Cases and Controls10.3 Matching

10.4 Special Considerations10.5 Analysis: Odds Ratios (ORs)10.6 Matched Case-Control

Studies

Chapter 11 Cohort Studies

11.1 Overview11.2 Types of Cohort Studies11.3 Special Considerations11.4 Analysis: Incidence RateRatios (RRs)

Chapter 12 Experimental Studies

12.1 Overview12.2 Describing the Intervention12.3 Defining Outcomes

12.4 Selecting Controls12.5 Blinding

12.6 Randomization12.7 Ethical Considerations12.8 Analysis

12.9 Screening and DiagnosticTests

Chapter 13 Qualitative Studies

13.1 Qualitative ResearchTheories

13.2 Qualitative ResearchTechniques

13.3 Qualitative InterviewingMethods

13.4 Focus Group Discussions13.5 Coding Qualitative Data13.6 Mixed Methods Research13.7 Monitoring and Evaluation13.8 Consensus Methods

Chapter 14 Correlational Studies

14.1 Overview14.2 Aggregate Data14.3 Analysis: Correlation14.4 Age Adjustment

14.5 Avoiding the EcologicalFallacy

STEP 3: DESIGNING THE STUDY AND

COLLECTING DATA Chapter 15 Research Protocols

15.1 Overview of Research Plans

by Study Approach15.2 Research Timelines15.3 Researcher Responsibilities

15.4 Writing a Research Protocol15.5 Preparing for Data

Collection

Chapter 16 Population Sampling

16.1 Types of ResearchPopulations

16.2 Target and SourcePopulations

16.3 Sample Populations16.4 Study Populations16.5 Populations for Cross-Sectional Surveys

16.6 Populations for Control Studies

Case-16.7 Populations for CohortStudies

16.8 Populations forExperimental Studies16.9 Vulnerable Populations16.10 Community Involvement

Chapter 17 Sample Size Estimation

17.1 Importance of Sample Size17.2 Sample Size and CertaintyLevels

17.3 Sample Size Estimation17.4 Power Estimation

17.5 Refining the StudyApproach

Chapter 18 Questionnaire Development

18.1 Questionnaire DesignOverview

18.2 Questionnaire Content18.3 Types of Questions18.4 Anonymity

18.5 Types of Responses18.6 Wording of Questions18.7 Order of Questions18.8 Layout and Formatting18.9 Reliability and Validity18.10 Commercial ResearchTools

18.11 Translation18.12 Pilot Testing

Chapter 19 Surveys and Interviews

19.1 Interviews Versus Administered Surveys19.2 Recruiting Methods19.3 Data Recording Methods19.4 Training Interviewers

Self-Chapter 20 Additional Assessments

20.1 Supplementing Reported Information20.2 Anthropometric Measures20.3 Vital Signs

Self-20.4 Clinical Examination20.5 Tests of PhysiologicalFunction

20.6 Laboratory Analysis ofBiological Specimens20.7 Medical Imaging20.8 Tests of Physical Fitness20.9 Environmental Assessment20.10 GIS (Geographic

Information Systems)20.11 Inter-Rater Reliability

Chapter 21 Secondary Analyses

21.1 Overview of SecondaryAnalysis

21.2 Publicly Available Data Sets21.3 Private Data Sets

21.4 Clinical Records21.5 Health Informatics, BigData, and Data Mining21.6 Ethics Committee Review

Chapter 22 Systematic Reviews and

Meta-Analyses

22.1 Overview22.2 Selecting a Topic22.3 Library Access22.4 Narrative Reviews22.5 Systematic Reviews22.6 Search Strings

22.7 Search Limiters22.8 Eligibility Criteria22.9 Data Extraction22.10 Systematic ReviewResults

22.11 Meta-Analysis22.12 Pooled Analysis22.13 Forest Plots and FunnelPlots

Chapter 23 Ethical Considerations

23.1 Foundations of ResearchEthics

23.2 Respect, Beneficence, andJustice

23.3 Incentives and Coercion23.4 Informed Consent

Statements23.5 Informed Consent Process23.6 Informed Consent

Documentation

23.7 Confidentiality and Privacy23.8 Sensitive Issues

23.9 Cultural Considerations23.10 Vulnerable Populations23.11 Ethics Training andCertification

Chapter 24 Ethical Review and

Approval

24.1 Ethics CommitteeResponsibilities24.2 Ethics CommitteeComposition

24.3 Application Materials24.4 Review Process

24.5 Review by MultipleCommittees

24.6 Ongoing Review24.7 Conflicts of Interest24.8 Is Ethics Review Required?

Chapter 25 Writing Grant Proposals

25.1 Identifying Funding Sources25.2 Selecting Grant

Opportunities25.3 Writing a ResearchProposal

25.4 Budgets

25.5 Grant Management

STEP 4: ANALYZING DATA

Chapter 26 Data Management

26.1 Data Management26.2 Codebooks

26.3 Data Entry26.4 Data Cleaning26.5 Data Recoding26.6 Data Security

Chapter 27 Descriptive Statistics

27.1 Analytic Plan by StudyApproach

27.2 Types of Variables27.3 Measures of CentralTendency

27.4 Range and Quartiles27.5 Displaying Distributions27.6 Normal Curves, Variance,and Standard Deviation27.7 Reporting DescriptiveStatistics

27.8 Confidence Intervals27.9 Statistical Honesty27.10 Consultation andCollaboration

Chapter 28 Comparative Statistics

28.1 Comparative Analysis byStudy Approach

28.2 Hypotheses for StatisticalTests

28.3 Rejecting the NullHypothesis

28.4 Interpreting p-Values28.5 Measures of Association28.6 Interpreting ConfidenceIntervals

28.7 Selecting an AppropriateTest

28.8 Comparing a Population to

a Set Value28.9 Comparing IndependentPopulations

28.10 Comparing Paired Data

Chapter 29 Regression Analysis

29.1 Regression Modeling29.2 Simple Linear Regression29.3 Simple Logistic Regression29.4 Confounding and EffectModification

29.5 Multivariable Comparisons

of Means

29.6 Dummy Variables29.7 Multiple Regression29.8 Causal Analysis29.9 Survival Analysis29.10 Cautions

Chapter 30 Additional Analysis Tools

30.1 GIS and Spatial Analysis30.2 Mathematical Modeling30.3 Agent-Based Modeling30.4 Machine Learning

30.5 Cost-EffectivenessAnalysis, QALYs, and DALYs

STEP 5: REPORTING FINDINGS

Chapter 31 Posters and Presentations

31.1 Purpose of Conferences31.2 Structure of Conferences31.3 Submitting an Abstract31.4 Preparing a Poster31.5 Presenting a Poster31.6 Preparing for an OralPresentation

31.7 Giving an Oral Presentation

Chapter 32 Article Structure

32.1 Writing Checklists32.2 Abstract

32.3 Introduction32.4 Methods32.5 Results32.6 Discussion32.7 Endmatter32.8 Tables and Figures

33.4 Avoiding Plagiarism33.5 Citation Styles

Chapter 34 Critically Revising

34.1 Organization34.2 Structure and Content34.3 Style and Clarity

Chapter 35 Writing Success Strategies

35.1 The Writing Process35.2 Getting Started

35.3 Staying Motivated35.4 Conquering Writer’s Block

Chapter 36 Reasons to Publish

36.1 Scientific Dialogue

36.2 Critical Feedback36.3 Respect for Participantsand Collaborators

36.4 Personal Benefits

Chapter 37 Selecting Target Journals

37.1 Choosing a Target Journal37.2 Aim, Scope, and Audience37.3 Impact Factors and

Indexing37.4 Journal Characteristics37.5 Publication Fees and OpenAccess

37.6 Predatory Journals

Chapter 38 Manuscript Submission

38.1 Submission Timing38.2 Journal Selection38.3 Manuscript Formatting38.4 Cover Letter

38.5 Online Submission

Chapter 39 Review, Resubmission, and

Publication

39.1 Initial Review39.2 External Review Results39.3 Rejection

39.4 Revision and Resubmission

39.5 After Acceptance

Glossary

Index

P REFACE

The goal of this book is to make the health researchprocess accessible, manageable, and perhaps evenenjoyable for new investigators One of the reasonsthat engaging in health research is satisfying is thatresearch is the necessary foundation for meaningfulimprovements in clinical and public health practice.Research helps us learn how to be healthier andhow to help our families, friends, and communitiesimprove and maintain their health Without the

building blocks provided by health research, wewould not be able to identify and map areas thathave a high rate of various diseases We would notknow about the risk factors for various disorders

We would not know which interventions are mosteffective for improving individual and communityhealth

But it is not just the outcomes that make researchrewarding The research process itself—the

process of exploring the unknown and discoveringanswers to previously unanswered questions—can

be exciting This book is a practical, step-by-stepguide to the research process

All research projects follow the same steps:

identifying a focused research question, choosing astudy design, collecting data that will answer thequestion, analyzing the accumulated evidence, anddisseminating the findings The investigation

proceeds through these same basic steps

regardless of whether it involves conducting a

clinical trial, organizing a neighborhood survey,

analyzing an existing data set, or synthesizing theexisting literature through meta-analysis The samesteps are followed whether the researcher is trained

in medicine, nursing, public health, dentistry,

physical therapy, occupational therapy, language therapy, respiratory therapy, radiationtechnology, pharmacy, podiatry, dietetics and

speech-nutrition, athletic training, health policy, psychology,sociology, counseling, optometry, audiology, or anyother clinical or social science discipline And thesteps are the same regardless of whether the

investigator is an undergraduate student, a

master’s or doctoral candidate, or a seasoned

professional

Health research is an intentional process that

requires fastidiousness and perseverance, but it isnot complicated Anyone who is willing to follow thesteps outlined in this guidebook can conceptualize

a research project and see it through to completion

This process can generate many personal benefits:the acquisition of new skills, the fulfillment of

degree or work requirements, the satisfaction ofpersonal curiosity, and even the opportunity to

become a published author And every project, nomatter how modest, has the potential to contribute

to expanding the knowledge base for the healthsciences That means that all researchers may

eventually see their results translated into improvedpatient care, enriched organizational effectiveness,and enhanced community health An increase in thenumber of active investigators who can conductconscientious research and accurately

communicate their findings to others will benefit usall

This book is an invitation to make your own

contribution to the evidence that will inform futuredecisions about preventing and treating disease,allocating health resources, and promoting health

A BOUT THE A UTHOR

Kathryn H Jacobsen, PhD, MPH, is a professor

of epidemiology and global health at George MasonUniversity in Fairfax, Virginia She has written morethan 100 peer-reviewed articles and is also the

author of Introduction to Global Health (Jones &Bartlett Learning)

W HAT’S N EW IN THE

S ECOND E DITION

In this second edition of Introduction to Health

Research Methods, every chapter from the 1st

edition has been updated to improve content andclarity, and several new chapters and subsectionshave been added to provide more comprehensivecoverage of health research methods Step 1

(“Identifying a Study Question”) presents additionalstrategies for deriving research ideas from

theoretical frameworks and clinical practice

experiences, and it includes new chapters on

collaborating and mentorship Step 2 (“Selecting aStudy Approach”) provides more examples andillustrations of the analytic strategies for each studydesign and features an expanded chapter on

qualitative research theories and methods Step 3

(“Designing the Study and Collecting Data”)

includes new subsections on reliability, validity, andresearch ethics plus a new chapter on writing grantproposals Step 4 (“Analyzing Data”) contains

additional illustrations of how to calculate and

interpret health statistics along with new chapters

on regression analysis and other advanced analysis

tools Step 5 (“Reporting Findings”) highlightsmany more strategies for writing success.

CHAPTER 1: THE

HEALTH RESEARCH

PROCESS

Health research is the process of

systematically investigating a single,

well-defined aspect of physical,

mental, or social well-being

1.1 The Research Process

Research is the process of systematically and

carefully investigating a subject in order to discovernew insights about the world No matter what thegoals of a research project are or what methods areused to achieve those goals, the five steps of theresearch process are the same (Figure 1-1) Thefirst two steps are to identify a study question and

to select a general study approach These two

steps are often completed concurrently, becausethe approach selected may require the refinement

of the study question Once the objectives and the

approach are set, the last three steps are to designthe study and collect data, to analyze the data, and

to write and share a report about the findings

These steps apply to nearly every research project

A research project is not finished until all five stepshave been completed

1.2 Health Research

Health research examines a broad spectrum ofbiological, socioeconomic, environmental, and

other factors that contribute to the presence or

absence of physical, mental, and social health andwell-being Population health research involveshumans as the unit of investigation, rather than

focusing on molecules, genes, cells, or other

smaller biological components Population healthresearch ranges from clinical case studies with just

a few individuals to global public health studies thatmay include many thousands of participants Healthresearch studies apply the tools from a diversity offields Some draw on the tools of the laboratorysciences, such as molecular biology, microbiology,immunology, nutrition, and genetics Many use thetools of demography (the study of populations andpopulation dynamics, such as birth and death

rates), epidemiology, and various social sciences,including psychology, sociology, anthropology, andeconomics

FIGURE 1-1 The Research Process

A distinction is made between routine practice

activities and health research It is not researchwhen an epidemiologist working for a health

department tracks down the source of an outbreak

of gastroenteritis However, that investigation maybecome a research project when the outbreak

investigation team identifies an unusual food item

as the cause of the outbreak, does additional

survey and laboratory work to confirm their

hypothesis, and then shares that discovery by

writing a formal report describing their methods andresults It is not research when a clinician readsseveral articles about an unusual disease or

completes other continuing education activities It

is research when a clinician conducts a systematicsearch of the literature, completes a novel synthesis

of the compiled articles, and then writes and

disseminates that summary It is not research when

an organization asks its clients to complete a

customer satisfaction survey so that opportunitiesfor quality improvement can be identified However,

it is research when a client survey uses a validatedquestionnaire and sampling methods, is approved

by an ethics committee, answers a question thatbuilds on the evidence base provided by previouslypublished articles, and has its results shared

through presentation or publication

Some studies that are very specific to one

population at one place and in one point in time arenot particularly helpful for identifying broader

patterns However, most health researchers hopethat their findings will reveal trends, relationships,and theories that are generalizable to other

populations, places, and times When these

researchers complete the health research process

by sharing their findings with others, they are

contributing to the evidence base used for healthpolicy and practice

1.3 Health Research Purposes

Research in the population health sciences oftenseeks to answer questions about community healthprofiles, risk factors for disease, clinical

effectiveness, and the impact of interventions

Some of the common reasons for initiating a healthresearch study include:

Needs assessment: What is the health status ofthis population? What are the major health

concerns of members of this population? Whathealth-related needs in this population are notbeing addressed? A population can be defined

as any well-defined group of individuals, such

as the patients of a particular hos pital, the

clients of a particular organization, the residentsliving in a particular town, the students attending

a particular school, or some other set of people.Risk assessment: What are the threats to health

in this population? What are the risk factors for

morbidity (illness), mortality (death), disability,and other health issues?

Applied practice: How well are we preventing,diagnosing, and treating health concerns in thepopulations we serve? Similar questions can beasked by health professionals in a diversity offields, including medicine, nursing, public health,physical therapy, occupational therapy,

pharmacy, dentistry, optometry, clinical

psychology, kinesiology, health policy, healthadministration and management, and others.Outcomes evaluation: Was this intervention

successful at improving health status in thispopulation? Alternative versions of this questionmight ask about the effectiveness of a

procedure, process, project, program, policy, orother activity.

The goal of any single health research project isusually modest: to answer one well-defined

question When many researchers add their

findings to the scientific literature, the cumulativeinformation provides an evidentiary foundation forimproving the health of individuals and

communities

1.4 Book Overview

Anyone who is committed to seeing a new and

valid project through to completion can contribute

to advancing health science Health research doesnot 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 iscertainly 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 theability to criticize and revise one’s own work andwriting These are personal character traits thateveryone can cultivate and develop

This book is intended to serve as a handbook forpopulation health researchers The chapters areorganized according to the five steps of the

research process The first section provides

suggestions for selecting an appropriately focusedresearch question and establishing good

relationships with collaborators and mentors early

in a project The second section opens with a

chapter that summarizes the various approaches togathering data and then presents an overview ofeach of the main study designs used in the

population health sciences The third section

describes the data collection process, and it

emphasizes research ethics along with the methodsfor collecting new data The fourth section

summarizes common strategies for data analysis.The fifth section presents tips for writing successand 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 ofthe chapters from the fifth section of the book prior

to finalizing their research plans

This guidebook is not meant to be a compendium

of everything that health researchers know aboutstudy design, data collection, and statistical

analysis Instead, it provides a comprehensive

overview of the entire process The best way tolearn about health research is to do actual researchand to learn firsthand how the research processworks As a research project unfolds, most

researchers will benefit from consulting specializedreferences Many excellent books, journal articles,technical reports, and other online and library

resources contain the advanced information

required for complex study designs and analytictechniques It is also essential for the consultedresources to include human experts—professors,supervisors, colleagues, coauthors, librarians,

statistical consultants, and others—who can

provide insights gained from personal researchexperience and can direct new investigators to thebackground readings and other information that will

be most helpful as they explore their selected

research questions

STEP 1: IDENTIFYING A STUDY QUESTION

The first step in the research process is selectingthe focus of the study This section describes how

to select a general topic, review the literature, refinethe scope of the project, and work with

collaborators

Selecting a general topic

Reviewing the literature

Focusing the research question

Collaboration and mentorship

Coauthoring

CHAPTER 2: SELECTING

A GENERAL TOPIC

Selecting one workable study topic is

the first step toward a successful

research project Many approaches

can be used to identify potential

research questions

2.1 Practical Questions

Many research questions in the health sciencesarise from observations made during applied

practice Consider the types of questions that

different health practitioners might raise abouttrampoline injuries:

An emergency room physician: “The trampolineinjuries we’ve been seeing include a mix of limbfractures and head/neck trauma Are the kidswho present with trampoline-related arm

fractures being screened for concussions? Are