Research Methods for Pharmaceutical Practice and Policy

Cover......Page 1
Introduction to the Pharmacy Business Administration Series......Page 3
Title page......Page 4
Copyright......Page 5
Dedication......Page 6
Contents......Page 8
Preface......Page 14
References......Page 17
Acknowledgments......Page 18
About the editor......Page 20
Contributors......Page 22
Introduction......Page 24
Health services research......Page 25
Pharmaceutical practice and policy research......Page 27
Pose a significant scientific question that needs empirical investigation......Page 29
Utilize relevant methodologies that involve direct investigation......Page 30
Replicate and generalize across studies......Page 31
Stages of pharmaceutical practice and policy research......Page 32
Research hypothesis......Page 33
Research report......Page 34
References......Page 36
Online resources......Page 38
Introduction......Page 40
Definition of theory......Page 41
Application of a theory......Page 43
Andersen Behavioral Model......Page 44
Health Belief Model......Page 46
Application of the HBM......Page 47
Application of the TPB......Page 48
The Transtheoretical Model......Page 49
Application of the TTM......Page 51
Importance of using a theoretical framework in pharmaceutical practice and policy research......Page 52
Independent and dependent variables......Page 53
Attribute and active variables......Page 54
Scientific relationships in pharmaceutical practice and policy research......Page 55
Connecting theory and variables in pharmaceutical practice and policy......Page 56
Summary and conclusions......Page 57
References......Page 58
Online resources......Page 59
Introduction......Page 60
Selection and definition of a research problem......Page 61
Sources of research problem......Page 63
Feasible......Page 64
Process of framing research questions......Page 65
Types of research question......Page 66
Causal......Page 67
Definition......Page 68
Simple versus complex hypotheses......Page 69
Associative versus causal hypotheses......Page 70
Abstraction and extensionalization......Page 71
Issues to consider in operationalization......Page 73
Summary and conclusions......Page 74
References......Page 75
Online resources......Page 76
Introduction......Page 78
Acceptable behavioral specimen......Page 79
Assignment of values......Page 80
Measurement issues......Page 82
Measurement errors......Page 83
Measures of stability......Page 84
Measures of equivalence......Page 85
Validity......Page 87
Translational validity......Page 88
Criterion validity......Page 89
Measurement process and practice......Page 90
Summary and conclusions......Page 91
References......Page 92
Online resources......Page 93
Introduction......Page 94
Experimental research......Page 95
Design characteristics of controlled experiments......Page 96
Inclusion and exclusion criteria......Page 97
Field experiments......Page 98
Validity considerations in experimental research......Page 99
History......Page 100
Testing......Page 101
Interactions of internal validity threats......Page 102
Reactive effects of experimental arrangements......Page 103
Types of experimental designs......Page 104
Randomized pre-test–post-test control group design......Page 105
Solomon four-group design......Page 106
Randomized crossover designs......Page 107
Randomized repeated measures designs......Page 108
Resource considerations......Page 109
Summary and conclusions......Page 110
Online resources......Page 111
Introduction......Page 112
Role of nonexperimental research......Page 113
Studying the treatment–outcome relationship......Page 114
Case–control designs......Page 115
Case–crossover designs......Page 116
Ecological designs......Page 117
Interrupted time series designs......Page 118
Bias......Page 119
Confounding by indication for treatment......Page 120
Time-dependent confounding......Page 121
Approaches to mitigate confounding and bias in design......Page 122
Regression......Page 123
Propensity score analysis......Page 124
Strengths and limitations of nonexperimental studies......Page 125
Summary and conclusions......Page 126
References......Page 127
Online resources......Page 128
Sampling terminology......Page 130
Sampling plan......Page 131
Sampling design......Page 132
Probability sampling......Page 133
Nonprobability sampling......Page 136
Randomization and random sampling......Page 137
Sample size......Page 138
Sample size for estimating population mean......Page 139
Sample size for comparison of population mean......Page 140
Sample size for comparison of population proportion......Page 141
Study design considerations......Page 142
Practical considerations......Page 143
Summary and conclusions......Page 144
References......Page 145
Online resources......Page 146
Review terminology......Page 148
Importance of systematic reviews......Page 149
Is a review required?......Page 150
Development of a review protocol......Page 151
Formulating the research question......Page 152
Conducting the literature search......Page 154
Refining the search......Page 156
Data extraction......Page 157
Quality assessment......Page 159
Reporting......Page 160
Identifying and appraising systematic reviews......Page 161
Summary and conclusions......Page 162
References......Page 163
Online resources......Page 164
Qualitative data collection methods......Page 166
Personal interviews......Page 167
Focus groups......Page 169
Unstructured observation methods......Page 170
Structured observation......Page 172
Sel-reports......Page 173
Content analysis......Page 175
Clinical/biophysiological data......Page 176
Mixed methods research designs......Page 177
Summary and conclusions......Page 179
References......Page 180
Online resources......Page 182
Introduction......Page 184
Writing survey questions......Page 185
Additional question writing tips......Page 186
Likert scale......Page 187
Rank order scale......Page 188
Ordering of survey questions......Page 189
Visual appearance of the survey......Page 190
Self-administration......Page 191
Considerations for selecting modes of administration......Page 192
Review by an expert panel, pre-testing, pilot testing......Page 193
Mail survey implementation......Page 194
Coverage error......Page 195
Preparing data for analysis......Page 196
Summary and conclusions......Page 198
References......Page 199
Other resources......Page 200
The purpose and function of statistics in research......Page 202
Types of research studies......Page 203
Classification of variables......Page 204
Description of statistical techniques using the classification criteria......Page 206
Regression......Page 207
Poisson regression......Page 209
Analysis of covariance......Page 210
Discriminant function analysis......Page 211
Conjoint analysis......Page 212
Path analysis......Page 213
Survival analysis......Page 214
Time-series analysis......Page 215
Factor analysis......Page 216
Latent class analysis......Page 217
Modeling correlated data......Page 219
Selecting an appropriate statistical technique......Page 221
Summary and conclusions......Page 222
References......Page 223
Online resources......Page 225
Defining administrative data......Page 226
Uses of administrative claims data......Page 227
Medicaid recipients......Page 228
Medicare claims data......Page 230
Medicare covered services......Page 231
Acquiring Medicaid and Medicare claims data......Page 232
Administrative claims files......Page 235
Professional services and physician claims......Page 237
Outpatient prescription claims......Page 239
Coding for morbidity......Page 241
Typical research issues of ICD-9-CM and DRG codes......Page 242
Coding for services, procedures, and products......Page 243
Acknowledgments......Page 245
References......Page 246
Online resources......Page 247
Introduction......Page 250
Insurance claims, open databases......Page 252
Insurance claims, closed population databases......Page 255
Hospital databases, administrative......Page 256
Electronic health records databases, hospital......Page 257
EHR databases, physician......Page 258
EHR databases, integrated delivery network......Page 260
Therapeutic area-specific (or disease-specific) clinical databases......Page 261
Considerations in choosing among commercial data sources......Page 262
Summary and conclusions......Page 264
References......Page 265
Online resources......Page 266
Introduction......Page 268
National Health Interview Survey......Page 269
National Health and Nutrition Examination Survey......Page 270
National Ambulatory Medical Care Survey......Page 271
National Nursing Home Survey......Page 272
Medical Expenditure Panel Survey......Page 273
Medicare Current Beneficiary Survey......Page 274
Sampling design......Page 275
Sampling error estimations......Page 276
Statistical software packages......Page 277
Research question and design......Page 279
Data extraction and analysis......Page 280
Strengths and weaknesses of national surveys......Page 281
Summary and conclusions......Page 282
Online resources......Page 283
Introduction......Page 284
Step 1: consider goals-based, process-based, and outcomes-based evaluations......Page 285
Step 3: formulate problem......Page 286
Step 5: design data collection and forms......Page 288
Step 7: analyze and interpret data......Page 289
Case mix......Page 290
Standards for effective program evaluation......Page 291
Feasibility......Page 292
Accuracy......Page 293
Some people believe evaluation is a useless activity that generates a lot of boring data with useless conclusions (McNamara 2006)......Page 294
Summary and conclusions......Page 295
Online resources......Page 296
Future direction for pharmaceutical policy research......Page 298
Methods and metrics......Page 299
Data sources......Page 300
Measuring quality......Page 302
Policy issues......Page 303
Evidence-based practice......Page 304
Pharmacist practice limits......Page 305
Medicare Part D......Page 306
Pharmacy practice......Page 307
Money......Page 308
Summary and conclusions......Page 309
Online resources......Page 310
Clinical Therapeutics......Page 312
Journal of Evaluation in Clinical Practice......Page 313
Medical Care......Page 314
Statistics in Medicine......Page 315
Value in Health......Page 316
American Society of Health-System Pharmacists (ASHP) Foundation......Page 318
Pharmaceutical Research and Manufacturers of America (PhRMA) Foundation......Page 319
Veterans Administration (VA)......Page 320
Index......Page 322