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
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
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
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
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
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
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
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
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
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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