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300
Angela Fidler Pfammatter, PhD, MS
Department of Preventive Medicine
Northwestern University Feinberg School of
Medicine
680N.Lake Shore Drive, Suite 1400
Chicago, IL 60611
Celeste Fraser, MA
Senior Editor, Scott Foresman Co. (retired)
Education Specialist, Chicago Children's
Museum (retired)
Estes Park, Colorado 80517
Robert M.Kaplan, PhD
Clinical Excellence Research Center (CERC)
Littleeld Center, Room 337
365 Lasuen Street
Stanford University
Stanford, CA 94305
Michaela Kiernan, PhD
Stanford Prevention Research Center
Stanford University School of Medicine
MSOB 1265 Welch Road X342
Stanford, CA 94305
Emily Kuschner, PhD
Perelman School of Medicine
University of Pennsylvania
Department of Radiology
2716 South St., Rm 5251
Philadelphia, PA 19146
Brittney Lange-Maia, PhD
Department of Preventive Medicine
Rush University Medical Center
1700W.Van Buren St., Suite 470
Chicago, IL 60612
Kim Lavoie, PhD
Montreal Behavioral Medicine Center
Department of Psychology
University of Quebec at Montreal
CP 8888, Succursale Centre-Ville,
Montreal, Quebec, H3C 3P8
Canada
Philip Liebson, MD
Department of Preventive Medicine
Rush University Medical Center
1700W.Van Buren St., Suite 470
Chicago, IL 60612
Jun Ma, MD, PhD
Institute for Health Research and Policy
University of Illinois at Chicago
586 Westside Research Ofce Bldg.
(MC 275)
1747 West Roosevelt Road
Chicago, IL 60608
Kevin S.Masters, PhD
Director, Clinical Health Psychology
Department of Psychology
PO Box 173364
University of Colorado, Denver
Denver, CO 80217
Amanda R.Mathew, PhD
Department of Preventive Medicine
Rush University Medical Center
1700W.Van Buren St., Suite 470
Chicago, IL 60612
Kei Ouchi, MD, MPH
Division of Health Policy Research and
Translation
Department of Emergency Medicine
Brigham and Women’s Hospital/Harvard
Medical School
75 Francis St.
Boston, MA 02115
Ty A.Ridenour, PhD, MPE
Division of Behavioral Health and Criminal
Justice Research
RTI, International
Research Triangle Park
PO Box 1219
3040 Cornwallis Rd
Durham, NC 27709
Catherine M.Stoney, PhD
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive
Bethesda, MD 20892
Appendix: Chapter Reviewers
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301
Christine Vinci, PhD
Tobacco Research & Prevention Program
Moftt Cancer Center
Morsani College of Medicine
University of South Florida
4115 E.Fowler Avenue
Tampa, FL 33617
Rachel Wu, PhD, MS
Department of Psychology
University of California, Riverside
900 University Avenue
Riverside, CA 92521
Appendix: Chapter Reviewers
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303© Springer Nature Switzerland AG 2021
L. H. Powell et al., Behavioral Clinical Trials for Chronic Diseases,
https://doi.org/10.1007/978-3-030-39330-4
A
Absolute risk reduction (ARR), 221
Academic advancement, 9, 52, 57-59, 92-94,
153, 164-165, 272
ACCORD trial, 219
Adaptive interventions (also called: Adaptive
treatments), 46, 48, 50, 268-269
Adherence (see : Non-adherence)
Aging of the population, 1-3
American Statistical Association, 100-103,
119
Anchor-based method for clinical signicance,
222-223
Applied behavioral medicine, 8, 281-283
ASCEND trial, 263
Ascertainment bias, 23, 85, 87, 237, 243-244
Assessment reactivity, 215-216, 228, 232
B
Bacon S, 265, 271-272, 283, 299
Bakan D, 97, 104-105
Basic behavioral and social science, 36-37,
42-43
Barrett-Connor E, 121, 229
Bayesian analysis, 99, 105, 286
Beecher HK, 242
Behavioral economics, 42
Behavioral Medicine Research Council, 271,
272
Behavioral randomized clinical trial (BRCT)
methods
Adherence (see : Non-Adherence)
Analyses, Secondary, 193, 197-199
Analysis, Primary, 201, 216-217
Bias (see : Bias)
Big data (see : Big data)
Blinding (see : Blinding)
Causality (see : Causal inference)
Ceiling effects, 215, 229-230
Comparator choice (see : Comparator)
Conclusive result (see : Conclusive trial
result)
Conrmatory trial (also called: Denitive
trials) (see : Conrmatory trials)
Confounding (see : Confounding)
Covariate adjustment, 177-178
Designs, 295
Differential treatment demands, 184
Ecologic validity (see : Ecologic validity)
Effectiveness trials (see : Phase IV
behavioral effectiveness trials)
Efcacy trials (see : Phase II behavioral
efcacy trials; Phase III behavioral
efcacy trials)
Efcacy vs. effectiveness, 20, 33, 181-182,
200, 210-212
Eligibility (see : Eligibility)
Ethics, 180, 245-246, 250, 288
Evidence-based, 12, 17-18, 32, 34, 57
Expect the unexpected, 153, 160, 165
Exploratory studies (see : Exploratory
studies)
External validity (see : External validity)
Feasibility studies (see : Feasibility
studies)
Fidelity assessment, 295, 296
Independent monitoring (see : Data and
Safety Monitoring Board)
Intent-to-treat analyses (see : Intent-to-treat
analyses)
Interim reports, 248
Index
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304
Behavioral randomized clinical trial (BRCT)
methods (cont.)
Internal validity (see : Internal validity)
Justication for, 165
Mechanisms (see : Mechanisms)
Metascience, 8, 261, 265-266
Miniature efcacy trials (see : Miniature
efcacy trials)
Multi-site trials, 215, 271-272, 287
Networks, 261, 270-272
Non-adherence (see : Non-Adherence)
Null trial (see also : Null trials, examples),
33, 34, 81-82, 89-92, 116-118, 156,
197, 198, 215, 219, 220, 225,
229-230, 245, 251-252, 254)
“One fell swoop” trials (see : “One fell
swoop” trials)
“One size t-all” methods (see : “One size
ts all” methods)
Operations, 149-154, 178, 292
Outcomes (see : Outcomes)
Per-protocol analyses (also called:
Responder-only; On-treatment)
(see : Per-protocol analyses)
Phase I studies (see : Phase I behavioral
studies)
Phase II efcacy trials (see : Phase II
behavioral efcacy trials)
Phase III efcacy trials (see : Phase III
behavioral efcacy trials)
Phase IV effectiveness trials (see : Phase
IV effectiveness trials)
Pilot studies (see : Pilot studies)
Post-randomization exclusions, 178-179
Pre-specied outcomes, 217
Progression (see : Behavioral treatment
development: Progression;
Progressive translational science)
Psychotherapy, 295, 296, 297
Purposes of, 17-18, 136-138, 212
Quality, 11-25
Randomization (see : Random assignment)
Rationale, 157-160, 262-264
Recruitment (see : Recruitment)
Remote trials (see : Remote clinical trials)
Replication (see : Replication)
Retention (see : Retention)
Reviewers (see : Reviewers)
Run-in period, 52, 187, 189, 192, 194
Sample size, 110-113, 115-117, 287
Single blind design, 8, 9, 213-214, 240
Single primary outcome, 216-217
Status quo (see : Status quo)
Target population (see : Target population)
Team science (see : Team science)
Translational research (see : Progressive
translational science)
Types of randomized studies, 17-18, 53-54,
136-138, 212
Virtual trials (see : Remote clinical trials)
Behavioral risk factors
Clinically signicant treatment target,
106-108
Denition, 9
Evidence: Intervention studies, 4-5, 16
Evidence: Observational studies, 3-4
Behavioral treatments
Credibility, 157-158
Critique, 34-35
Denition, 8, 9
Feasibility, 159-160
Multi-component, 42, 44-47, 137
Plausibility, 158-159
Precision lifestyle medicine, 266-269
Strength of, 22-23, 42, 97, 98, 106,
266-270
Tailored, 268-269
Targeted, 266-268
Behavioral treatment development (see also :
ORBIT model)
Basic behavioral and social science, 42-43
Clinician-Scientist Training Model, 31, 58
Cross-disciplinary methods (see :
Cross-disciplinary science)
Culture-specic models, 33
Dene basic elements, 37, 44-47, 56
Discipline-specic models, 33
Discovery, 36-37, 39-43, 56, 282
eHealth, 273
Failure (see : Failure)
Feasibility studies (see : Feasibility
studies)
Funding, 55, 57, 59, 164
Harmonization of treatment development
models, 33
Hypothesized pathway, 37, 43-50
Implementation of treatment (also called:
Enactment), 45, 46-47
Mechanisms (see : Mechanisms)
Milestone for success, 36, 43, 45, 46,
47-48, 50, 51, 53, 54, 78, 106-108,
113-115
Multiple perspectives, 32-33
“One size ts all” methods (see : “One
size ts all methods)
Optimization (see : Renement studies)
Index
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Behavioral treatment development (cont.)
Outcomes (see : Outcomes)
Phase I studies (see : Phase I behavioral
studies)
Phase II efcacy trials (see : Phase II
behavioral efcacy trials)
Phase III efcacy trials (see : Phase III
behavioral efcacy trials)
Pilot studies (see : Pilot studies)
Preferences, 246, 268
Preliminary Testing, 28, 36-37, 50-54
Progression (see also : Progressive
translational science), 7-8, 11, 19,
21-22, 27, 34, 36-38, 44, 47, 50, 53,
54, 55, 59, 69, 76, 78, 92, 118, 125,
143, 144, 165, 231, 265-266)
Proof of concept (see : Proof of concept)
Publishing, 58, 93, 94, 164
Purpose of the trial, 135-137
Renement (see : Renement studies)
Regulatory approval, 32
Reverse translation, 58, 274-275
Signal vs. noise, 19, 20, 32, 34
Tinkering, 27, 36, 43-44
Treatment target, 45, 106-108, 113-115
Berra Y, 261
Bias
Ascertainment (see : Ascertainment bias)
Assessment reactivity (see : Assessment
reactivity)
Ceiling effects (see : Ceiling effects)
“Cherry picking” (see : “Cherry picking”)
Co-interventions, 85, 237, 243, 250
Common factors, 131-132
Conict of interest (see : Conict of interest)
vs. Confounding, 173
Cross-disciplinary synthesis (see :
Cross-disciplinary science)
Differential ascertainment (see :
Differential ascertainment)
Differential dropout (see : Differential
dropout)
Dissimilar treatments, 83, 184
Early unblinding, 86
Expectancy (see : Expectancy bias)
“Faking good”, 87, 214
Fishing/Data snooping (see : “Cherry
picking”)
Hawthorne effect, 86, 215, 228
Inconclusive trial, 74-75, 184, 196
Independent monitoring, 250
Investigator, 265
“John Henry”, 85, 243
Lack of equipoise, 251-254
Non-specic attention, 256-257
Passage of time, 83, 84
Placebo (see : Placebo)
Preferences (see : Preferences)
Treatment crossover/contamination, 82, 85,
237, 243, 250, 253
“True believer”, 86, 253-254, 255
Risk of Bias scale, 128, 251
Scientic hypothesis testing, 73
Social desirability (see : Social
desirability)
Subjective/reactive self-reports, 87,
213-214, 241
Types of, 83-87
Underdog, 85, 243
Unintended treatments, 83, 86-87, 242-244
Violation of statistical assumptions, 83,
84-85
Bible, 169
Big data, 30, 249, 261, 262, 272-273
Blinding (also called: Masking)
Bias, 293, 298
Blinding plan, 248-249
Double-blind designs, 214, 239, 240, 250
Extend the blind, 247-248, 254-255, 256
Preferences and equipoise, 237-259
Single-blind designs, 213-214, 240-241
Quality of trial, 15, 16, 23
Bohr N, 5
Book rationale, 6-8, 9, 12, 20
Books
Behavioral randomized clinical trials,
295-298
Randomized clinical trials, 285-293
Boutron I, 247, 296
Brody B, 190-191
C
Campbell D, 19, 72, 79, 83, 138, 175, 181,
182, 225, 263-264, 283
Carroll L, 131
Causal inference, 172, 175, 180, 262-264, 275
Ceiling effects, 85, 215, 229-230
Chalmers TC, 241, 256
“Cherry picking”, 85, 213, 217, 228
Clinical Antipsychotic Trials of Intervention
Effectiveness Schizophrenia Trial, 223
Clinical practice guidelines, 17, 106, 197, 199
Clinical signicance
Adherence to drug therapy, 109
Anchor-based method, 223
Index
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306
Clinical signicance (cont.)
Cohen’s standards, 220
Consensus method, 222
Continuous vs. categorical milestones, 78,
104, 107
Data ination, 220
Distribution method, 222, 223
Hypothesized pathway, 79-81
Minimal clinically important difference
(MCID), 220-223, 231
Number needed to treat (NNT), 221
Phase II efcacy trial, 106-108, 111-113,
115-116
Phase III efcacy trial, 106-108, 113,
116-118, 156
Pilot studies, 155-156
Proof-of-concept studies (see : Proof of
concept)
Sample size calculations, 110-113, 115-116
Signicant clinical problem, 40-42
Standards in other treatments, 221
Standard in weight loss studies, 109, 221
vs. Statistical signicance, 23, 103,
108-110, 116-118, 264
Treatment benet, 102, 103, 108-110, 119
Treatment target, 106-108, 113-115, 119,
231
Threshold for clinical signicance, 156
Clinician-scientist training model, 31, 58
ClinicalTrials.gov, 231
Cochrane Collaboration, 15, 128, 251
Cohen J, 97
Collins L, 33, 48
Common factors (see : Non-specic attention)
Comparator
Barriers, 134
Context-guided decisions, 130
Control group, 138, 170-172
Decision-making frameworks, 126-130, 144
Evidence-based decisions, 130
Explicit rules, 127-128, 139
Food and Drug Administration guidelines,
127-128
History, 170-172
Implicit rules, 126-127, 139-140, 144
Limitations, 135
Optimal comparator, 134
Phase-guided decisions, 21, 128-129,
142-143
Placebo, 88, 137, 158, 242-243
Pragmatic Model for Comparator Selection
In Health-Related Behavioral Trials,
133-135, 144
Proof-of-concept study, 50-51, 52
Purpose-guided decisions, 129-130,
135-138, 140-142
Purpose-Guided Trial Design Framework,
135-138, 141-142
Purpose of comparator
Compare, 138
Control, 138
Purpose of trial, 136-138
Quality-guided decisions, 128
Quasi-experiment, 51
Treatment development framework, 134
Usual care (also called: Treatment as usual;
Standard of care), 38, 53, 89,
90-91, 116, 129, 130, 135, 137,
138, 141-142, 143, 197, 216,
227-228, 251
Wait list, 128-129, 130, 134, 136, 138
Competing risk, 178
Composite outcomes (see : Outcomes)
Conceptual model (also called: Explanatory
model), 76-78
Conclusion from a trial (see : Scientic
conclusion)
Conclusive trial result, 14, 184, 193, 197, 199
Condence interval (see : Statistical
hypothesis testing)
Conrmatory trials (also called: Denitive
trials), 7, 8, 9, 76-78, 93, 147, 183,
188, 211-212, 217, 224, 226, 229,
232, 246, 263, 264, 272, 285
Conict of interest, 250, 298
Confounding, 23, 54, 74, 136, 137, 169-170,
173-175, 177, 179, 180-181,
185-186, 192, 193, 196-197,
198-199, 214, 216, 244, 254,
262-264
CONSORT guidelines
Blinding, 256, 296
eHealth interventions, 273
Feasibility and pilot studies, 147, 148-149,
164
Parallel group randomized trials, 15
Random assignment, 176-177
Trials of social and psychologic
interventions, 15, 296
Control group (see : Comparator)
Coronary Drug Project, 185-186
Costs, 3, 19, 274
Covariate adjustment, 177-178
Covey S, 44
Creativity, 39-40
Credibility of a treatment, 157-158
Index
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307
Cross-disciplinary science (includes:
Multidisciplinary; Interdisciplinary)
Examples, 36, 44-45, 55, 106-108, 113-115
Methods, 8, 27, 34, 36, 40-42, 42-43, 79,
83-87, 94, 270-272, 283
Culture, 8, 33, 241, 246, 265, 281-283
Czajkowski SM, 31, 33, 35-36, 39, 53, 57, 58,
60, 105, 134, 144, 155, 158, 188,
265, 299
D
Data and Safety Monitoring Board, 137,
250-251, 252, 286
Deductive reasoning, 70-74, 99
Denitive clinical trials (see : Conrmatory
clinical trials)
Diabetes Prevention Program
Effectiveness studies, 138, 194-195
Eligibility, 194
Evidence, 5
Hypothesized pathway, 88-89
Placebo control, 88
Recruitment, 194
Replications, 75, 121, 229
Scientic progression, 44-45, 55-56, 88,
229-230
Treatment development, 55-56, 88
DIETFITS Trial, 267
Differential ascertainment, 85, 243-244
Differential dropout, 184, 244
Discipline, investigator, 246, 254-255
Discovery (see : Behavioral treatment
development; ORBIT model)
Dissemination and implementation, 7, 57, 261,
274-275, 297
Dodo bird conjecture, 131-132, 143-144
Don Quixote, 238
Double-blind clinical trials (see : Randomized
controlled trials)
Dropouts (see : Retention)
Drug Abuse Resistance Education Program
(DARE), 43
Drug development
Consumer protection, 28-29
Cost, 19, 31
High failure rates, 31
International Conference of
Harmonisation, 28, 31
Multidisciplinary collaboration, 31
Progressive, 19, 29-30, 31, 74
Signal vs. noise, 32
Tufts Center for the Study of Drug
Development Research, 31
Drug trials (see : Randomized controlled trials)
Duchamp M, 76
Dylan B, 264, 281
E
Ecologic model, 269-270
Ecologic validity, 181-182, 261, 263
Effect size, 110-111, 115-116, 155-156, 163
Effectiveness trials (see : Phase IV behavioral
effectiveness trials; Randomized
controlled trials)
Efcacy trials (see : Phase II behavioral
efcacy trials; Phase III behavioral
efcacy trials; Randomized
controlled trials)
Efron B, 105, 299
eHealth, 273
Einstein A, 1, 72, 237
Electronic medical records, 160, 272
Eligibility, 186-188, 194-195, 229-230,
267-268
ENGAGE study, 269
Enhancing Recovery in Coronary Heart
Disease (ENRICHD) Trial
Clinical vs. statistical signicance,
116-118
Consensus method for clinical
signicance, 222
Equipoise, 251-252
Multiplicity of outcomes, 224
Null trial, 116-118, 251-252
Epidemiologic methods
Behavioral trials, 8, 44-45, 69-70, 104,
175, 290
Bias, 69-70, 79, 83-87
Causality, 172, 175
Clinical research, 244, 290
Clinical trial “rules”, 14, 31, 104
Clinically signicant treatment target,
106-108, 113-115
Confounding, 175, 180-181
Continuous vs. categorical outcomes, 78,
104, 107
Non-adherence, 183-184, 185
Per-protocol analyses, 184-186
Psychosocial epidemiology, 113-115
Web of causation, 77, 93, 175, 262-263, 270
Epidemiologic studies, 3-4, 94, 106-108,
136, 172
Equipoise (see also : Preferences)
Bias, 23, 237-259
Clinical, Community, 73, 244-245, 254
Ethics, 245-246, 250
Investigator, 244-246, 251-252
Trial leadership, 246
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Equipoise (cont.)
Pilot studies, 157
Reality, 245
Ethics, 180, 245-246, 250, 288
Evidence for behavioral risk factors
Observational studies, 3-4
Intervention studies, 4-5
Evidence-based
Behavioral treatments, 17-18, 32,
34, 262
Comparators, 130
National Registry of Evidence-Based
Programs and Practices, 34
Treatments, 12-15, 262
Expectancy bias
Denition, 23, 237, 239
Implications of, 241-244
Independent monitoring, 250-251
POWeR+ Trial, 252-253
Recurrent Coronary Prevention Project,
253-254
Single-blind designs, 240-241
Types, 85-86
Experiments, 17-18, 79, 104, 136
Expert, denition of, 5
Explicit rules for comparator selection, 125,
127-128
Exploratory outcomes, 78, 211, 224
Exploratory studies, 74, 76-79, 225, 226-229,
231-232, 264
External validity (also: Generalizability),
19-20, 181-182, 183, 200, 262,
263-264
F
Failure
Behavioral treatment development, 8, 22,
33, 34, 39, 43, 58, 59, 81-83, 93, 94,
165, 225, 246, 253, 264, 274-275
Drug development, 29, 31
Mediators, 225-226
Moderators, 224-225
ORBIT model, 39, 43
Planning for, 274-275
Publishing, 58
Random assignment, 195-197
Recruitment, 159
Reverse translation, 274-275
Scientic progression, 8, 29, 31, 39, 43,
58, 59, 69, 71-72, 93, 165, 246,
274-275
Subgroup hypotheses, 225
Treatment vs. hypothesis, 33, 81-83, 90-92,
94, 118
False security
Effect sizes from pilot studies, 157
Feasibility studies, 152-153, 165
Statistical signicance, 102
Falsication, 72-73
Feasibility studies
Comparator, 151
CONSORT guidelines, 147, 148-149
Contemporary trends, 163
Denition, 53, 147, 148-151
Evaluation, 152
False security, 152-153, 165
Funding for, 93
Grant proposals, 164-165
Inferences from, 151-152
Link to future trial, 148-149, 151-152, 165
Miniature efcacy trials (also called:
Preliminary efcacy trials (PETS))
(see : Miniature efcacy trials)
Pilot studies (see : Pilot studies)
Plausibility of benet (see also : Proof of
concept), 158-159
Publication, 151-152, 163, 164
Recruitment, 149-150, 159-160
Treatment (also called: Implementation;
Enactment) (see : Implementation
of treatment)
Trial operations, 149-151, 159-160
Typical questions, 154
Feyerabend PK, 19, 73
Feynman R, 125
Fidelity to treatment, 295, 296
Fisher RA, 73-74, 99, 101, 104-105,
172, 175
Food and Drug Administration (FDA), 27,
28-30, 127-128, 213, 218, 221
Frasure-Smith N, 117, 195-197, 246
Freedland KE, 17, 54, 58, 125-146, 147-167,
265, 271, 283
Friedman LM, 14, 175, 216, 283, 291
Friedman M, 39, 253-254
Frost R, 92
Future of behavioral randomized clinical trials,
261-279
G
Generalizability (see : External validity)
Genetics, 4, 264, 266-267
Glasgow RE, 181, 195
Goethe JW, 11
Index
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309
Good science, 6-7, 21, 93, 163
Grading of Recommendations Assessment,
Development, and Evaluation
(GRADE), 128
Grant reviews (see : Reviewers)
H
Hawthorne effect, 86, 215, 228
Health-care crisis, 1-3, 55
Heisenberg W, 215
HF-ACTION trial, 197-199
Hill’s criteria for causality, 172
HOMBRE Trial, 268
Hulley SB, 244, 290
Hume D, 70, 74, 75, 76, 98
Hypothesis
Deductive reasoning, 70-74
Falsication and renement, 69, 71-72
Hume’s challenge, 70, 74, 75, 76, 98
Inductive reasoning, 70-74, 98
Logic, 70-73, 73-76
Quantication, 69, 72, 74
Hypothesized pathway
Behavioral treatment development, 22-23,
36, 44, 47, 69, 92-93
vs. Conceptual model, 76-79
Diabetes Prevention Program, 88-89
Interpretation of trial results, 81-83, 89-90,
90-92, 94
Mechanisms, 80
Mediators, 80-81
Phase II trial template, 81
Phase III trial template, 81, 88-89
Progression toward simplicity, 69, 92-93
Quantication, 74, 78, 80-81
“Stick your neck out” (see : “Stick your
neck out”)
Structure, 79-81
Utility, 81-83, 89-90, 90-92, 94
Hypothesis test (see : Statistical hypothesis
testing)
I
Implementation studies (see : Dissemination
and implementation)
Implementation of treatment (also called:
Enactment), 20-21, 38, 45, 46, 151
Implicit rules for comparator selection,
126-127, 139-140
Inconclusive trial, 74-75, 118, 184, 196-197, 199
Independent trial monitoring (see : Data and
Safety Monitoring Board)
Inductive reasoning, 70-74, 98
Inferential statistics (see : Statistical
hypothesis testing)
Informed consent, 190-191
Innovation, 7, 22, 36, 39-40, 42-43, 98, 121,
189, 256, 265, 269
Institute of Medicine, 12-13, 264, 270
Intent-to-treat analyses, 13, 14, 18,
87, 179-180, 181, 193,
198-199, 201
Interdisciplinary methods (see : Cross-
disciplinary science)
Interim reports, 248
Internal validity, 14, 19-20, 21, 23, 181-182,
263-264
International Behavioral Trials Network
(IBTN), 265, 271-272
Intervention-oriented trial, 17-18, 137
Ioannidis JPA, 5, 8, 57, 102, 164, 213, 262,
264-265, 266
Ischemic Heart Disease Life Stress Monitoring
Program, 195-197
J
Jadad AR, Enkin MW, 5, 286
“Just-in-time” treatments, 46, 48
K
Kaplan RM, 245, 300
Kaufmann PG, 209-236, 245, 283
Kennedy JF, 271
Kiernan M, 189-190, 268, 300
Kraemer HC, 21, 33, 82, 103, 110-111,
155-156, 163, 177-178, 182,
223, 296
Kuopio Ischemic Heart Disease Risk Factor
Study, 113-115
Kurosawa A, 132
L
Lauer M, 264, 270, 273
Lavoie K, 265, 271-272, 283, 300
Learning healthcare system, 272-273
Lewens T, 69, 72
Look AHEAD trial, 219, 229-230
M
Ma J, 42, 48, 158, 200, 266, 300
Markowitz JC, 162-163
Masking (see : Blinding)
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Mechanisms
Behavior change, 42, 158, 269
Health benet, 38, 80, 209, 223, 226
Medawar P, 74
Mediators, 7, 76, 78, 80-81, 173-174, 209,
223, 225-226, 230, 232
Mendelian randomization, 264
Metascience, 8, 261, 265-266
M-HART trial, 196-197
Mill JS, 172
Miniature efcacy trial (also called:
Preliminary efcacy trials
(PETS)), 147, 155, 157, 159, 161,
162-163, 164
Minimal clinically important difference
(MCID), 220-223
Missing data, 15-16, 87, 179, 196, 231, 244
M&M’s (see : Outcomes)
Moderators, 49-50, 209, 223, 224-225,
230, 232
Mohr DC, 128-129, 130
Mosnaim G, 52, 115-116
Mosteller F, 176
Mother Teresa, 242
Motivation, 182, 183, 187, 194, 267-268
Multi-component treatment, 42, 45, 46-47, 137
Multidisciplinary science (see : Cross-
disciplinary science)
Multi-level interventions, 261, 269-270
Multimodal Treatment Study of Attention-
Decit Hyperactivity Disorder
(ADHD) Trial, 226-229
Multi-site trial (also called: Multi-center trial),
271-272
Munafò MR, 8, 164, 265-266
N
National Institutes of Health (NIH), 6, 36,
42, 45, 55, 57, 118, 133, 219, 245,
251
National Registry of Evidence-Based
Programs and Practices, 34
Neuroscience, 42-43, 269
Neyman J, Pearson E, 73, 99, 99-100
Newton I, 6, 209
Nirvana fallacy, 262
Nocebo response, 242-243
Non-adherence (also: Adherence), 14-15, 18,
23, 41, 52, 85, 87, 109, 115-116,
120, 140, 158-159, 179, 183-186,
187, 189, 192, 193, 198-199,
200-201, 213, 221, 231, 239, 243,
244, 248, 286, 291
Non-specic attention (also: Common
factors), 38, 52, 131-132,
143-144, 257
Null trials, examples (see also : Behavioral
randomized clinical trial (BRCT)
methods), 82, 89-90, 91, 116-118,
185-186, 197-199, 229-230, 245,
251-253
Number needed to treat (NNT), 221
O
Obesity-Related Behavioral Intervention Trials
(ORBIT) Consortium, 36, 60-61
Observational studies (see : Epidemiologic
studies)
Ofce of Behavioral and Social Sciences
Research, 6, 36, 57-58, 133, 144, 219
“One fell swoop” trials, 19, 34, 142-143, 224,
263-264
“One size ts all” methods, 50, 104, 182,
200, 266
On-treatment analyses (see : Per-protocol
analyses)
Optimization (see : Renement studies)
ORBIT model for developing behavioral
treatments for chronic disease
(see also : Behavioral treatment
development)
Background, 35-36, 44
Basic behavioral and social science, 36-37,
42-43
Comparator choices, 134, 144
Dene phase (also called: Phase Ia), 37,
44-47, 56
Design phase (also called: Phase I), 36-37,
43-50
Discovery phase, 36-37, 39-43, 56
Failure, 39, 43
Feasibility and pilot studies (also called:
Phase IIb), 37, 38, 53
Hypothesized pathway, 22, 36, 45
Investigators, 60-61
Milestones, 36, 45, 47, 48, 50, 51, 53, 54
Outcomes, 217
Overview, 27-28, 36-39
Phase II efcacy trial (also called: Phase
IIc), 37, 38, 39, 53-54
Phase III efcacy trial, 37, 38, 39, 41, 53,
54, 55
Phase-specic goals, 188
Preliminary testing phase (also called:
Phase II), 36-37, 50-54
Progression, 36-38, 47, 50, 53, 54
Index
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