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A

abbreviations, 118, 173, 197

absolute measures

absolute risk reduction/increase, 93, 94

defined, 92

number needed to harm (NNH), 95

number needed to treat (NNT), 94

absolute risk increase (ARI), 94, 95

absolute risk reduction (ARR), 94

absolute risk reduction/increase, 93, 94

abstract

of manuscript, 190, 202, 203

preparation, 171, 174

authorship, 172

background/purpose, 172

conclusions, 173

formatting, 172

methods, 172

results, 173

style, 173

tips for writing, 173, 174

title, 172, 173

sample of, 185

of study protocol, 19

submitting to conference/professional meeting, 174

Academy of Managed Care Pharmacy (AMCP), 164

acknowledgments

in manuscript, 193, 204

in platform presentations, 179

acronyms, 173

adaptive randomization, 28

administrative data, 62

Adverse Events Reporting System Public Dashboard (FDA), 40

Agency for Healthcare Research and Quality, 161

alpha (α), 87

alternative hypothesis, 12, 13

ambispective studies, 25, 31, 35

American Society of Health Economists (ASHEcon), 164

American Society of Health-System Pharmacists (ASHP), 164

analysis of covariance (ANCOVA/ANACOVA), 85

analysis of variance (ANOVA), 83, 84

analytical plan, in study protocol, 19

analytic study design, 22, 24, 27, 29

quasi-experimental designs, 22, 23, 28, 29

randomized/interventional studies, 22, 23, 25, 27, 28

anonymity in surveys, 137

appendixes, in study protocol, 19

associative hypothesis, 12, 13

ATLAS.ti, 124

attributable risk, 93, 94

attrition bias, 34

audience, engaging, 176, 177

audit trail, 125

authorship

in abstract preparation, 172

criteria, 195, 197

roles, 196, 197

autobiography, 106

average wholesale price (AWP), 161

B

background/purpose

in abstract, 172

in manuscript, 190

in study protocol, 19

bar graphs, 180

base case scenario, 153, 157

Belmont Report, 41

beta (ß), 87

bias

confounding, 32, 34, 35

history, 29

maturation, 29

nonresponse, 134, 140, 141

reporting, 33

response, 141

in survey research, 141, 142

types of, 33, 34

in validity, 32, 35

wish, 33

BibMe, 9

biographical study, 106

biostatistician, when to consult, 88

biostatistics, 75, 90

defined, 76

descriptive statistics, 78, 81

inferential statistics, 81, 86

sample size, estimation of, 87, 88

statistical software, 86

study statistics, recommendations for, 88

variable types, 76, 77

bivariate comparisons, 140

block randomization, 27

bounding the case, 108

Box, 112

budget impact analysis (BIA), 148, 149, 151, 152, 160

C

case analysis, 108

case-control studies, 22, 24, 30, 31

case report or case series, 22, 25, 26

case studies, 105, 107, 108

categorical variables, 76

category, 124

causal hypothesis, 12, 13

causality, 27, 30

causal research questions, 3

Centers for Medicare & Medicaid Services (CMS), 161

central tendency, measures of, 77, 78, 79

charges, 162

checkboxes, 138

chi-square (χ2) test, 82, 83

Cite This For Me, 9

Clinical Laboratory Fee Schedule, 161

clinical significance, statistical versus, 99

Cloud storage, 112

cluster randomized trials, 28

co-authors, 195, 197

authorship criteria, 195, 197

feedback, 197

Cochran, Mantel, Haenszel test, 82, 83

codebook, 122, 123

code data, 123, 124

Code of Federal Regulations, 40

coding frame, 65, 67, 122, 123

coercion, 50

cognitive interviewing, 139

cohort, defined, 31

cohort studies, 22, 24, 25, 31, 32

prospective, 25, 31

retrospective, 25, 31, 32

collaborating with research team, 13, 14

items for discussion, 14

successful collaborations, 14

Collaborative Institutional Training Initiative Program, 42

Common Procedural Terminology (CPT) codes, 161

Common Rule, 40, 41, 44

Revised, 41, 43, 44

compensation, 162

complex vocabulary questions, 136

conceptual framework, 114

conclusions

in abstract, 173

in manuscript, 193, 203

confidence intervals, 98, 99

confidentiality, in surveys, 137

confirmability, of qualitative research, 125

conflicts of interest, in manuscript, 193, 204

confounder, 85

confounding bias, 32, 34

consent form, 48. See also informed consent

Consolidated Criteria for Reporting Qualitative Research (COREQ), 126, 191

Consolidated Health Economic Evaluation Reporting Standards (CHEERS), 165

contingency table, 92

continuous data, statistical tests for, 83, 84

continuous variables, 76, 77

contractions, 173

control group, 27

controls, 29, 30

convenience sample, 114, 132, 133

copyright permissions, in manuscript, 193

correlation, 83

cost-benefit analysis (CBA), 148, 150

cost data, 161, 162

costs versus charges, 162

direct medical costs, 161

direct non-medical costs, 161, 162

discounting, 156, 157

in economic model, 156, 157

estimating, 161

indirect costs, 162

inpatient costs, 161

institution-specific costs, 161, 162

outpatient costs, 161

cost-effectiveness acceptability curve, 159

cost-effectiveness analysis (CEA), 148, 150, 151, 164, 165

cost-effectiveness planes, 159, 160, 164

cost-effectiveness quadrant diagram, 160

cost-minimization analysis (CMA), 148, 150

cost-of-illness (COI) analysis, 149, 150

cost-utility analysis, 150, 151

Council for International Organization of Medical Sciences Guidelines, 41

coverage bias, 141

cover letter, for manuscript, 188, 202

Cox proportional hazards regression, 86, 97

credibility, of qualitative research, 125

criterion sampling, 115

critical case sampling, 114

critical sampling, 114

Cronbach‘s alpha values, 140

cross-sectional studies, 22, 23, 26, 27

cross-sectional surveys, 26

cross-tabulation, 82

D

data. See also study data

distribution of, normal versus non-normal, 80, 81

outcomes and quality-of-life, 162, 163

in pharmacoeconomic analyses

cost, 161, 162

outcomes and quality-of-life data, 162, 163

presentation of, 164, 165, 169

privacy, 111

problems and limitations of, 70, 72

data quality, 71

duplicate data, 71

missing data, 70

outliers, 71

recording, 112

scaling, 140

security, 139

sources, 62

storage, 112, 113, 139

summarized, in table using descriptive statistics, 78

variability, measures of, 79, 80

data collection

defined, 61

format, 109, 110

inclusion and exclusion criteria, 36

location of, 112

study population, 36

timeframe, 35

data collection methods, 108, 121

focus groups

defined, 109, 110

ground rules for, 111

individual interviews versus, 110

length of, 116

location of, 116

moderating, 117

probing during, 118, 119

recruitment of participants and sampling strategies, 114, 115

sample size in, 115, 116

interviews

asking questions, 118

conducting, 116, 117

ground rules for, 111

individual versus focus groups, 110

interview guide, creating, 119, 121

length of, 116

location of, 116

overview of, 113

planning, 114, 121

probing during, 118, 119

recruitment of participants and sampling strategies, 114, 115

sample size in, 115, 116

types of, advantages and disadvantages of, 120, 121

IRB considerations in, 111, 113

informed consent, 111

location of data collection, 112

number of participants, 111, 112

recording data, 112

storing data, 112, 113

use of incentives, 112

overview of, 109

seven key steps, 108, 111

access to participants, 108, 109

data collection format, 109, 110

data privacy, 111

field issues, 110, 111

identify sample size, 109

population of focus, 108

process for documenting information, 110

data collection platforms, 68, 70

electronic data capture tools, 70

Microsoft Excel or similar spreadsheet tool, 68, 69

statistical software, 68, 69

data collection tool, 64, 69

coding frame, 65, 67

data collection platforms, 68, 70

data dictionary, 65, 68

list of variables, 64, 65

real-world example, 67, 68

tips for creating and using, 69

data dictionary, 65, 68

data extraction errors, 71

data source triangulation, 125

data transcription, 121, 122

debriefing, 125

decision tree, 148, 153, 154

Declaration of Helsinki, 41

Dedoose, 124

deductive approach, 123

de-identification of study data, 48

delivering presentation, 181, 183

key tips for, 181, 182

questions, responding to, 182

Department of Defense, 40

dependability, of qualitative research, 125

dependent variable

confounding bias and, 32, 34

defined, 32

descriptive research questions, 3

descriptive statistics, 78, 81

data summarized in table using, example of, 78

defined, 78

distribution of data, normal versus non-normal, 80, 81

measures of central tendency, 78, 79

measures of data variability, 79, 80

in sample responses, 139

descriptive study designs, 22, 25, 27. See also ­qualitative research

case report or case series, 22, 25, 26

cross-sectional studies, 22, 23, 26, 27

deviant case selection, 115

dichotomous questions, 118

dichotomous variables, 76, 77

difference-in-difference (DID) analysis, 86

directional hypothesis, 12, 13

direct medical costs, 161

direct non-medical costs, 161, 162

direct quotes, 125

discounting, 148, 156, 157

discrete variables, 76, 77

discussion, in manuscript, 192, 193, 203

dispersion, measures of, 77

documenting information, process for, 110

double-barreled questions, 136

double-negative questions, 136

Dropbox, 112

drug interactions involving direct oral anticoagulants (DOACs), 25

duplicate data, 71

E

economic model

building, step-by-step guide, 152, 160

checklist for, 165, 166

costs and discounting, 156, 157

model perspective, 155

model structure, determine, 153, 155

summary of, 160

target population, 155

time horizon, 155, 156

key features of, 153

presentation, elements of, 164, 165, 169

software for running, 163

structure of, 153, 155

base case scenario, 153, 157

decision tree, 153, 154

Markov model, 153, 155

uncertainty analysis, 157, 160

electronic data capture tools, 70, 71

electronic data storage, 112

electronic/web-based surveys, 134

encoding key, 112

encore presentation, 174

EndNote, 10, 194

endpoint, 13

Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ), 126, 191

ethical codes and laws, 41

ethnography, 105, 107

Excel spreadsheets, 9, 68, 69

exclusion criteria, 36

exempt research categories, 45, 46

exempt review, 44, 46

expedited research categories, 55, 56

expedited review, 44, 46

expert reviewers, 197

exploratory perspective, 123

external audits, 125

external validity, 32, 35

of quantitative research, 125

extreme or deviant case selection, 115

F

face-to-face interviews, 113, 116, 133, 142

false negative, 87

false positive, 87

false sense of security, 124

Family Educational Rights and Privacy Act, 40

Federal Policy for the Protection of Human Subjects, 40

feedback, from co-authors, 197

field issues, 110, 111

FINER criteria, 6, 7

ethical, 7

feasibility, 6, 7

interesting, 7

novel, 7

relevant, 7

first right of refusal, 174

Fisher‘s exact test, 82, 83

fixed-response questions, 135, 136

flowcharts, 180

focus groups

in conjunction with professional meeting, 113

defined, 109, 110

ground rules for, 111

individual interviews versus, 110

interviews compared to, 110, 111

length of focus group, 116

location of, 116

moderating, 117

planning, 114, 121

probing during, 118, 119

recruitment of participants and sampling strategies, 114, 115

sample size in, 115, 116

Food and Drug Administration (FDA), 40

formatting

abstract, 172

IMRaD format, 190

journal, 188

poster presentations, 175, 176

Friedman ANOVA, 85

full board review, 44, 46

funnel method, 120, 121

G

Gantt chart, 15, 16

generalizable knowledge, 40

general reviewers, 197

Google Drive, 112

Google forms, 139

Google Voice, 112

GoToMeeting, 112

GraphPad, 86

grounded theory, 105, 106, 107

H

halo effect questions, 136

hazard ratios (HRs), 97, 98

Healthcare Common Procedure Coding System (HCPCS), 161

Healthcare Cost and Utilization Project (HCUP), 161

Health Insurance Portability and Accountability Act (HIPAA), 40, 41, 43, 48, 112, 134

health-system perspective, 155

heterogeneous group, 113

high facilitator involvement, 117

highly structured interview, 120

history bias, 29

homogenous group, 113

human subjects research, 40, 41

hypothesis, 12, 13

statements, 12, 13

testing, inferential statistics and, 81

I

IBM Micromedex RED BOOK, 161

identifiable private information, 40

illustrations, 180

impact factor, 188

IMRaD format, 190

incentives, 112

in surveys, 138

incidence, 26, 30

inclusion criteria, 36

incremental budget impact, 152

incremental cost-effectiveness ratio (ICER), 149, 159, 160, 164, 169

independent variables

confounding bias and, 32, 34

defined, 32

in-depth interviews (IDIs), 106, 110, 113, 116. See also interviews

indexing tool, 197

indirect costs, 162

inductive approach, 114, 123

inferential statistics, 81, 86

difference-in-difference analysis, 86

hypothesis testing, 81

multivariable regression analysis, 85, 86

statistical tests, 82, 85

for continuous data, 83, 84

for nominal data, 82, 83

for ordinal or skewed data, 84, 85

information bias, 33

informed consent

IRB considerations, 111, 137

study participants, 48, 49

creating, 48, 49

elements of, 48

verbal, 49, 56

waiving requirement for, 48, 111

written, 49, 57, 59, 111

inpatient costs, 161

Institutional Review Board (IRB), 39, 55

approval process, 41, 43

questions about, 42, 43

considerations for surveys, 137, 138

anonymity and confidentiality, 137

incentives, 138

informed consent, 137

introductory statement, 137, 145

protocol modifications, 138

data collection methods, 111, 113

informed consent, 111

location of data collection, 112

number of participants, 111, 112

recording data, 112

storing data, 112, 113

use of incentives, 112

ethical codes and laws, 41

expedited research categories, 55, 56

human subjects research, 40, 41

protocol modifications, 50, 51

complaints, 51

noncompliance, 51

unanticipated problems, 51

review, categories of, 44, 46

exempt review, 44, 46

expedited review, 44, 46

full board review, 44, 46

overview of, 44

role of, 41, 47

study participants

confidentiality, 47, 50

incentives to encourage participation, 50

informed consent, 48, 49

responsibility to, 46, 47

telephone screening script for recruitment, 49, 60

submission, preparation for, 50

training requirements, 42

institution-specific costs, 161, 162

integer variables, 77

internal consistency, 71

internal validity, 32, 35

of quantitative research, 125

International Classification of Diseases (ICD), 65, 66, 67, 161

International Committee of Medical Journal Editors (ICMJE) criteria, 195, 196

international normalized ratios (INRs), 28, 104

International Society for Pharmacoeconomics and Outcomes Research (ISPOR), 164, 165

interquartile range (IQR), 76, 79

interrupted time series designs, 24, 29

interval data, 77

interval variables, 77

interventional studies, 22, 23, 25, 27, 28

intervention group, 27

interviewer bias, 34

interview guide, creating, 119, 121

interviews

asking questions, 118

conducting, 116, 117

focus groups compared to, 110, 111

ground rules for, 111

in-depth (IDIs), 106, 110, 113, 116

individual versus focus groups, 110

interview guide, creating, 119, 121

length of, 116

location of, 116

overview of, 113

planning, 114, 121

probing during, 118, 119

recruitment of participants and sampling strategies, 114, 115

sample size in, 115, 116

types of, advantages and disadvantages of, 120, 121

introduction, in manuscript, 190, 203

An Introduction to Codes and Coding (Saldana), 122

introductory statement

for electronic/web-based survey, 137, 145

for in-person survey, 137, 145

investigator bias, 34

investigator triangulation, 125

iterative process, 115

J

jargon, 118, 136

JMP Statistical Discovery, 86

journal for submission, selecting, 188, 189

K

key informant interviews (KII), 113

keywords, in manuscript, 197, 203

Kruskal, Wallis test, 85

L

leading questions, 118

less structured interview, 120

Likert scales, 135, 140

line graphs, 180

linking file, 48

list-based sample frame, 133

literature review, 8, 10

Excel spreadsheet with study description, 9

purpose of, 8

reference management resource, 9, 10

search results, 8, 9

search strategy, 8

loaded question, 136

logistic regression, 82, 83, 85

low facilitator involvement, 117

M

mail-based surveys, 133, 134

Manitoba Centre for Health Policy, 71

Mann, Whitney U test, 85

manuscript, writing, 189, 195

abstract, 190, 202, 203

acknowledgments, 193, 204

background information, 190

conclusions, 193, 203

conflicts of interest, 193, 204

copyright permissions, 193

cover letter, 188, 202

discussion, 192, 193, 203

introduction, 190, 203

keywords, 197, 203

methods section, 190, 191, 203

outline, sample of, 202, 204

purpose, 190

references, 194, 204

reporting guidelines, 191

results, 192, 203

tables and figures, 194, 195, 204

title of, 190

title page, 190, 202

manuscript preparation and submission, 187, 204

co-authors, 195, 197

authorship criteria, 195, 197

feedback, 197

journal for submission, selecting, 188, 189

keywords for manuscript, 197, 203

peer review, 197, 198

reviewer comments, 198, 199

writing your manuscript, 189, 195 (See also manuscript, writing)

Markov model, 149, 153, 155

matching, 30

MATLAB, 163

maturation bias, 29

maximum variation case selection, 115

MAXQDA, 124

McNemar‘s test, 82, 83

mean, 78, 79, 83

measures of association, 92, 98

absolute measures

absolute risk reduction/increase, 93, 94

defined, 92

number needed to harm (NNH), 95

number needed to treat (NNT), 94

contingency table, 92

relative measures

defined, 92

hazard ratios (HRs), 97, 98

odds ratio (OR), 95, 97

relative risk (RR), 92, 93

measures of central tendency, 77, 78, 79

measures of data variability, 79, 80

measures of dispersion, 77

median, 76, 78, 79

MedWatch reports, 40

member check, 126

memoing, 107

Mendeley, 10, 194

Methods of Economic Evaluation of Health Care Programmes, 165

methods section

in abstract, 172

in manuscript, 190, 191, 203

in study protocol, 19

method triangulation, 125

Microsoft Excel, 9, 63, 67, 68, 69, 71, 86, 163

Microsoft Word, 63, 64, 135

Minitab, 86

mirroring, 119

misclassification bias, 34

missing at random, 70

missing completely at random, 70

missing data, 70

missing not at random, 70

mixed methods research, 104

mixed-mode surveys, 134

mode, 78, 79

mode effects, 134

model cycle length, 156

Monte Carlo simulations, 159

multiple choice research questions, 135, 138

multiple comparison procedures, 83

multiple linear regression, 86

multivariable procedures, 85, 86

multivariable regression analysis, 84, 85, 86

multivariate sensitivity analysis, 158

N

narrative research, 105, 106

National Inpatient Sample (NIS), 161

National Institute for Health and Care Excellence (NICE), 164

National Institutes of Health, 42

National Research Act, 41

net monetary benefit (NMB), 149, 164, 169

net present value, 156

no comparator questions, 136

nominal data, statistical tests for, 82, 83

nominal variables, 76, 77

nondirectional hypothesis, 12, 13

non-normal distribution of data, 78, 80, 81

nonparametric methods, 81

nonresponse bias, 134, 140, 141

nonresponse errors, 141

nonverbal probe, 119

normal distribution of data, 80, 81

normally distributed data, 78

null hypothesis, 12, 13, 81

number needed to harm (NNH), 95

number needed to treat (NNT), 94

Nuremburg Code, 41

NVivo, 124

O

objectives, writing, 11, 12

objectivity, of quantitative research, 125

observational study designs, 24, 30, 32

case-control studies, 22, 24, 30, 31

cohort studies, 22, 24, 25, 31, 32

odds ratio (OR), 30, 95, 97

Office for Human Research Protections (OHRP), 42, 43, 50, 51

one-way sensitivity analysis, 157, 158

open access journals, 188

open-ended questions, 116, 117, 118, 135

open source content, 188

oral history, 106

ORCID iD, 196

ordering bias, 142

ordinal data, statistical tests for, 84, 85

ordinal variables, 76, 77

outcome frequency, measures of, 91, 98

measures of association, 92, 98

rate, 92

risk, 91, 92

outcomes and quality-of-life data, 162, 163

outcome variable, 87

outliers, 71, 78

outpatient costs, 161

oversampling, 133

P

paired t-test, 83

Paperpile, 10

paradigmatic case selection, 115

parametric tests, 81

participants. See study participants

payer perspective, 155

PDF files, 176

peer review, 197, 198

process, 174

of qualitative data, 125

reviewer comments, 198, 199

peer-reviewed journal, 189

percentiles/quartiles, 79, 80

performance improvement (PI), 43

personally identifiable information (PII), 40

perspective, 149, 155

pharmacoeconomic analyses, 147, 169. See also economic model

considerations for, 165, 166

data

cost, 161, 162

outcomes and quality-of-life data, 162, 163

presentation of, 164, 165, 169

interpretation of, 163, 164

results, application of, 165

software for running, 163

types of, 149, 152

budget impact analysis (BIA), 151, 152

cost-benefit analysis (CBA), 150

cost-effectiveness analysis (CEA), 150, 151

cost-minimization analysis (CMA), 150

cost-of-illness (COI) analysis, 149, 150

pharmacoeconomics

defined, 147

role of, 147, 148

terminology in, 148, 149

phenomenology, 105, 106

PICOTS criteria, 3, 6

comparison group, 4, 5

intervention, 4, 5

outcomes, 4, 5

population, 4, 5

setting, 5, 6

timeline, 5

pie charts, 180

piloting of questions, 138, 139

platform presentations, 177, 181

components of, 177, 181

acknowledgments, 179

background, 177, 178

discussion, 179

methods, 178

results, 178, 179

delivering, 181, 182

slides for, developing and presenting, 177, 181

text versus tables and figures, 180, 181

population. See study population

poster presentations, 175, 177

checklist for creating effective poster, 175

engaging your audience, 176, 177

formatting, 175, 176

key tips for, 176

power, 87

power calculations, 87

pre-post study design, 23, 28, 29

pre-testing questions, 138, 139

prevalence, 26, 30

primary data, 62

primary objective, 12

principal investigator (PI), 112

probabilistic sensitivity analyses, 159

probing, 118, 119

ProQuest RefWorks, 10

prospective cohort studies, 25, 31

protected health information (PHI), 40, 41, 48

protocol modifications, in surveys, 138

PubMed, 10

purpose, of manuscript, 190

purposive sampling, 114

p values, 98

Q

QR code, 176

qualitative data

analyzing, 121, 124

code data, 123, 124

coding frame/codebook, 122, 123

emerging themes, 124

software packages for analysis, 124

transcription, 121, 122

reliability and validity of, 124, 126

principles of, 125, 126

validity strategies, 125, 126

trustworthiness of, 125, 126

extensive quotes, 125

external audits, 125

member check, 126

peer review or debriefing, 125

thick, rich description, 125

triangulation, 125

Qualitative Inquiry and Research Design (Creswell), 106

qualitative research, 103, 129

approaches to, 105, 108

case studies, 105, 107, 108

ethnography, 105, 107

grounded theory, 105, 106, 107

narrative research, 105, 106

overview of, 105, 106

phenomenology, 105, 106

appropriate use of, 104, 105

data collection methods, 108, 121

focus groups

IRB considerations in, 111, 113

overview of, 109

seven key steps, 108, 111

defined, 104

IRB considerations in, 111, 113

informed consent, 111

location of data collection, 112

number of participants, 111, 112

recording data, 112

storing data, 112, 113

use of incentives, 112

publishing, 126

quantitative research compared to, 104

strategies, 118, 135

validity and reliability terms in, 125

quality-adjusted life year (QALY), 149, 150, 151, 164, 165, 166

quality assurance (QA), 43

quality improvement (QI), 43

quality-of-life (QOL), 150, 151, 162, 163

Qualtrics, 134, 139, 142

quantitative data, 75, 90. See also biostatistics

quantitative research, 3

primary data in, 62

qualitative research compared to, 104

sample size in, 115

strategies, 135

validity and reliability terms in, 125

quasi-experimental designs, 22, 23, 28, 29

questionnaires, 135

questions. See research questions

QuickVoice Recorder, 112

quota sampling, 114

quotes, direct, 125

R

R (software), 71, 86

randomized controlled trial (RCT), 27, 28

randomized studies

experimental, 23, 25

interventional, 22, 23, 25, 27, 28

random sampling, 114, 133

range, 79, 80

ranking, 136

rate, 92

rating scale, 135

ratio variables, 77

recall bias, 33, 142

recording applications, 112

recording data, 112

REDCap, 71, 134, 139, 142

redundant data, 115

reference management resource, 9, 10

Reference Manager, 194

references

in manuscript, 194, 204

in study protocol, 19

reflecting, 119

regression, 83, 84

regression to the mean, 29

relational research questions, 3

relative measures

defined, 92

hazard ratios (HRs), 97, 98

odds ratio (OR), 95, 96

relative risk (RR), 92, 93

relative risk (RR), 92, 93

relative risk reduction, 93

reliability, of quantitative research, 125

repeated-measures ANOVA, 83

reporting bias, 33

reporting guidelines, in manuscript, 191

research

categories, expedited, 55, 56

defined, 40

noncompliance, 51

secondary, 44, 46

research findings

presenting (See abstract preparation)

publishing (See manuscript preparation and ­submission)

research idea, 1, 19

collaborating with research team, 13, 14

items for discussion, 14

successful collaborations, 14

conceiving, 2, 7

hypothesis, formulating, 12, 13

literature review, 8, 10

Excel spreadsheet with study description, 9

purpose of, 8

reference management resource, 9, 10

search results, 8, 9

search strategy, 8

objectives, writing, 11, 12

research question, developing

FINER criteria for, 6, 7

PICOTS criteria for, 3, 6

study outcomes, specifying, 13

study protocol

background, writing, 11

methods, determining, 11

outline, 19

study timeline, 14, 16

Gantt chart, 15, 16

sample timeline, 15

in study protocol, 19

research-in-progress, 172

research note, 188

research questions

about IRB approval process, 42, 43

causal, 3

descriptive, 3

developing

FINER criteria for, 6, 7

PICOTS criteria for, 3, 6

fixed-response, 135, 136

interview, 118

multiple choice, 135

open-ended, 116, 117, 118, 135

piloting of, 138, 139

poorly designed, 136

in presentation delivery, 182

pre-testing, 138, 139

questionnaires, 135

relational, 3

types of, 135, 136

yes/no, 135

respondents, 131. See also study participants

response bias, 141

response rates, 132, 133

re-storying, 106

results

in abstract, 173

in manuscript, 192, 203

retrospective cohort studies, 25, 31, 32

Rev, 122

reviewer comments, 198, 199

Revised Common Rule, 40, 41, 43, 44

risk, 91, 92

R Studio, 163

S

sample size

estimation of, 87, 88

in focus groups, 115, 116

identifying, 109

in interviews, 115, 116

in survey planning, 132, 133

sampling

defined, 114

methods, 132, 133, 139

strategies, 114, 115

sampling frame, 132, 133

SAS, 71

saturation, 115

scatter plot, 83, 84, 159, 160

Scribie, 122

seasonal variances, 29

secondary data, 62, 63

secondary objectives, 12

secondary research, 44, 46

security, 124

selection bias, 33

sensitivity analysis, 149, 157, 159

multivariate, 158

one-way, 157, 158

probabilistic, 159

univariate, 157, 158

sharedness, 140

simple linear regression, 83, 84

simple randomization, 27

skewed data, statistical tests for, 84, 85

slides, for platform presentations, 177, 181

snowball sampling, 114, 115

Social Cognitive Theory, 123

social desirability bias, 141

societal perspective, 155

software

for analyzing qualitative data, 124

to assist with data analysis, 86

to assist with data collection, 69

reference management packages, 194

for running pharmacoeconomic analyses, 163

SoundCloud, 112

SoundNote, 112

Spearman‘s Rho, 85

spreadsheet tools, 9, 63, 67, 68, 69, 71, 86, 163

standard deviation, 79, 80

Standards for Reporting Qualitative Research (SRQR), 126, 191

Stata, 71, 86

Statistical Analysis Software (SAS), 86

statistical inference, 81. See also inferential statistics

Statistical Package for the Social Sciences (SPSS), 86

statistical packages, 86

statistical tests, 82, 85

for continuous data, 83, 84

for nominal data, 82, 83

for ordinal or skewed data, 84, 85

statistical versus clinical significance, 99

stratified randomization, 28

stratified sampling, 114

Students t-test, 83

study data, 61, 73

data problems and limitations, 70, 72

data quality, 71

duplicate data, 71

missing data, 70

outliers, 71

organization of, 63, 70

data collection platforms, 68, 70

data collection tool, 64, 69

protocol changes, tracking, 63, 70

sources, 61, 63

primary data, 62

secondary data, 62, 63

study design, 21, 38

ambispective studies, 25, 31, 35

analytic, 22, 24, 27, 29

quasi-experimental designs, 22, 23, 28, 29

randomized/interventional studies, 22, 23, 25, 27, 28

data collection, considerations for, 35, 36

inclusion and exclusion criteria, 36

study population, 36

timeframe, 35

descriptive, 22, 25, 27 (See also qualitative research)

case report or case series, 22, 25, 26

cross-sectional studies, 22, 23, 26, 27

internal and external validity, 32, 35

observational, 24, 30, 32

case-control studies, 22, 24, 30, 31

cohort studies, 22, 24, 25, 31, 32

overview of, 22, 25

randomized experimental studies, 23, 25

selection of, 22, 25

study findings, 91, 101

confidence intervals, 98, 99

outcome frequency, measures of, 91, 98

measures of association, 92, 98

rate, 92

risk, 91, 92

p values, 98

statistical versus clinical significance, 99

study hypothesis, 12, 13

study objectives/hypothesis, in study protocol, 19

study outcome, 13

study participants

access to, 108, 109

anonymity of, 112

confidentiality, 47, 50

incentives to encourage participation, 50

informed consent, 48, 49

creating, 48, 49

elements of, 48

verbal, 49, 56

waiving requirement for, 48, 111

written, 57, 59, 111

number of, 111, 112

participant complaint, 51

in randomized controlled trial (RCT), 27, 28

recruitment of, 114, 115

responsibility to, 46, 47

telephone screening script for recruitment, 49, 60

study population, 36

of focus, 108

target, 113, 155

study protocol

background, writing, 11

methods, determining, 11

outline, 19

sample of, 19

study timeline, 14, 16

Gantt chart, 15, 16

sample timeline, 15

in study protocol, 19

surveillance bias, 33

survey

data analysis and validity, 139, 141

objectives, 132

overview of, 131, 132

survey delivery, mode of, 133, 134

electronic/web-based surveys, 134

face-to-face methods, 113, 116, 133, 142

mail-based surveys, 133, 134

mixed-mode surveys, 134

telephone-based surveys, 133

survey design, 131, 145

data storage and security, 139

dissemination and publication, 142

limitations and biases of survey research, 141, 142

survey data analysis and validity, 139, 141

survey planning, 132, 138

tips, 136, 137

survey instruments, 134, 138

preparation and construction of, 138

survey design tips, 136, 137

survey questions, 135, 136

fixed-response, 135, 136

open-ended, 116, 117, 118, 135

pre-testing and piloting of, 138, 139

SurveyMonkey, 134, 139, 142

survey planning, 132, 138

IRB considerations for surveys, 137, 138

anonymity and confidentiality, 137

incentives, 138

informed consent, 137

introductory statement, 137, 145

protocol modifications, 138

sample size and response rates, 132, 133

survey delivery, mode of, 133, 134

survey instruments, 134, 138

preparation and construction of, 138

survey design tips, 136, 137

survey questions, 135, 136

survey objectives, 132

survey research

data storage and security, 139

defined, 131

dissemination and publication, 142

limitations and biases of, 141, 142

pre-testing and piloting of questions, 138, 139

survey data analysis and validity, 139, 141

survey instruments, 134, 138

survey planning, 132, 138

systematic investigation, 40

T

tables and figures

in manuscript, 194, 195, 204

text versus, 180, 181

table shells, 189

telephone-based surveys, 133

telephone screening script for recruitment, 49, 60

telephonic survey administration, 138

text versus tables and figures, 180, 181

themes, 124

theoretical sampling, 107, 115

theoretical saturation, 106

Theory of Planned Behavior, 123

theory triangulation, 125

time horizon, 149, 155, 156

time series designs, 23, 29

title

of abstract, 172, 173

of manuscript, 190

title page

in manuscript, 190, 202

in study protocol, 19

traditional journals, 188

Transcribe (application), 122

transcription, 121, 122

applications, 122

errors, 71

transferability, of qualitative research, 125

Transtheoretical model, 123

TreeAge, 163

trends, 29

triangulation, 125

Trint, 122

trustworthiness of qualitative data, 125, 126

extensive quotes, 125

external audits, 125

member check, 126

peer review or debriefing, 125

thick, rich description, 125

triangulation, 125

t-test, 83, 84

Tufts CEA Registry, 162

two-sample t-test, 83

2018 Requirements, 40

two-way ANOVA, 83

Type I error, 87

Type II error, 87

U

uncertainty analysis, 157, 160

multivariate sensitivity analysis, 158

one-way sensitivity analysis, 157, 158

probabilistic sensitivity analyses, 159

undue influence, 50

univariate sensitivity analysis, 157, 158

utility, 149, 150, 151

V

validity

bias in, 32, 35

defined, 32

internal and external, 32, 35

survey data analysis and, 139, 141

value of a statistical life, 150

variables, 76, 77

confounding, 32, 34

continuous variables, 76, 77

dependent, 32, 34

discrete, 76, 77

list of, 64, 65

verbal consent script

elements of, 49

example of, 56

verbal informed consent, 49, 56

Veterans Affairs Federal Supply Schedule (VA FSS), 161

visual analog scale, 135, 138

Visual Basic, 163

Voice Record Pro, 112

W

web-based surveys, 134

wholesale acquisition cost (WAC), 161

Wilcoxon Signed Rank test, 85

willingness-to-pay (WTP), 149, 159, 164

wish bias, 33

within-case analysis, 108

word processing program, 63, 64

written informed consent, 57, 59, 111

X

zig-zag process, 107

Zotero, 10

Y

yes/no research questions, 135, 138

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