Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3091_Библиотеки_им_академика_М_И_Перельмана
.pdf
311
ORBIT model for developing behavioral
treatments for chronic disease (cont.)
Proof of concept (also called: Phase IIa),
37-38, 50-53, 56, 58
Rene phase (also called: Phase Ib),
36-38, 47-50, 53-54, 56
Revised ORBIT model, 37-39, 53-54, 161
Signicant clinical question, 36-37, 40-42
Tinkering, 36, 43, 44
Treatment target, 44-46
Outcome-oriented trials, 137
Outcomes
Adjudication, 217-218
Assessment reactivity, 215-216, 228, 232
Ceiling effects, 215, 229-230
“Cherry picking”, 213, 217, 228
Clinical signicance (see : Clinical
signicance)
Composite, 219, 292
Exploratory, 78, 211
Intermediate, 210-211
Mechanisms (see : Mechanisms)
Mediators (see : Mediators)
Minimal Clinically Important Difference
(MCID), 220-223
M&M’s (see : Multiple)
Moderators (see : Moderators)
Multiple (also called: Multiplicity of
measures; M&M’s), 209, 213,
223-224, 226-229, 231-232, 264
Objective, 72, 74, 217-218
Patient-reported (also: Self-reported),
213-214, 218-219
Phase II vs. Phase III, 16, 210-211, 219
Pre-specication, 178, 212-213, 217
Primary, 193, 209, 210-211, 214, 216-218,
228-229
PROMIS, 219
Secondary, 210-211, 223-226, 232
Simplicity, 209, 216-217, 231
Subjective, 213-214, 241, 242
Surrogate, 16, 18, 38, 53, 161, 165,
210-212, 217
Timing, 48-49
Types, 210-211
Outcome-oriented trial, 17-18, 137
P
Paper reviewers (see : Reviewers)
Passenger variables (also called: “silent
riders”) (see also : Confounding),
173, 175
Patient-centered target population (see : Target
population)
Patient preference designs, 268, 296
Patient-reported outcomes (PRO’s), 216,
218-219
Patient-Reported Outcomes Measurement
Information System (PROMIS), 219
Per-protocol analyses (also called: Responder-
only; On-treatment), 89, 178-179,
184-186, 193, 197-199, 201
Phase I behavioral studies, 43-50, 53, 54, 56,
79, 108, 129
Phase II behavioral efcacy trials, 4, 28, 34,
37-39, 53-54, 74, 79, 111-113,
115-116, 161, 212, 216, 219, 222,
224, 229, 231
Phase III behavioral efcacy trials, 5, 7, 19,
20-21, 22, 23, 27, 34, 36, 41, 42,
44, 50, 53-54, 55, 56, 57, 59, 74,
79, 105, 113, 116-118, 138, 200,
212, 214, 217, 221, 248, 250, 261,
271, 273, 274, 281
Phase II or Phase III behavioral efcacy
trials, 8, 11, 15, 16, 17-18, 37-39,
79-81, 103, 106-108, 129, 130, 138,
155, 157, 159, 161, 165, 183, 188,
199, 209, 211-212, 216, 219, 222,
223, 229, 231
Phase IV behavioral effectiveness trials, 7,
17-18, 19-20, 21, 33, 37-38, 74,
165, 181-182, 200, 210, 211-212,
281, 297
Philosophy of science, 6-7, 19, 69, 70-73, 75,
98-99, 238, 265
Physicians’ Health Study, 183-184
Pilot studies
Comparator, 159
CONSORT guidelines, 147, 148-149
Contemporary trends, 163
Denition, 53, 148-149
Design, 153-154
Estimates of effect sizes, 155-156
Grant proposals, 164
Link to future trial, 148-149, 163
Miniature efcacy trials (see : Miniature
efcacy trials)
Plausibility, 159
Preliminary Efcacy Trials (PETS)
(see : Miniature efcacy trials)
Publication, 163, 164
Purpose, 153-154
Randomized design, 148, 153-154
Typical questions, 154
Index
https://t.me/medicina_free
312
Placebo (see also : Non-specic attention)
Control, 88, 127, 132, 134, 137, 180,
183-184, 239, 250
Response, 86, 158, 190-191, 242-243,
256-257
Plausibility of benet (see also: Proof of
concept), 38, 50-52, 115,
158-159
Pocock SJ, 177-178, 249, 285
Popper K, 34, 70-73, 93, 98, 224, 274
Population, Intervention, Comparator,
Outcome, and Timing (PICOT),
134
Post-randomization exclusions, 178-179,
195-197
Powell LH, 33, 35, 39, 51, 52, 53, 58, 61, 105,
115-116, 134, 144, 158, 188, 196,
221, 253, 265, 270, 283
POWeR+ trial, 252-253
Practice guidelines (see : Clinical practice
guidelines)
Pragmatic Model for Comparator Selection in
Health-Related Behavioral Trials,
133-135, 142-143
Precision lifestyle medicine, 200, 261,
266-269
Precision medicine, 266-267
Pre-contemplators, 182-183
Preferences (see also : Equipoise), 23, 83,
85-86, 237, 238-239, 240-241,
246-247, 253-255
Pre-specication, 178, 212-213, 217
Primary outcome (see : Outcomes)
Prochaska JJ, 183
Prochaska JO, 182
Progressive translational science
Cross-disciplinary teams, 31, 36, 40-43,
79, 83, 104, 270-272, 282, 291
Cultural movement, 7-8, 281-283
Methods linked to questions
(also: “One size ts all”), 104,
265-266, 282
Progressive studies (also: “One fell
swoop”; Signal vs. noise; Internal
precedes external validity; Efcacy
precedes effectiveness), 11, 19-20,
21, 22, 27-28, 32, 33, 34, 36-38, 54,
55, 69, 121, 142-143, 181-182, 195,
224, 226, 263-264
Quantied hypotheses (also: Milestones;
“Stick your neck out”), 72, 74, 78,
93, 102, 120, 231
Strong treatments (also: Progressive
treatment development; Clinically
signicant milestones; Failure), 34,
39, 55, 59, 93, 119
Targeted populations (also: Representative;
Patient-centered), 182-184;
186-188; 200
PROMIS, 219
Proof of concept, 37-38, 50-53, 56, 58, 90,
115, 158-159
Psychological Rehabilitation After Myocardial
Infarction Trial, 215
Psychosocial epidemiology, 113-115
Purposes of behavioral clinical trials
Conduct experiment, 17-18, 136
Investigate intervention, 17-18, 137
Improve outcomes, 17-18, 137, 212
Increase utility, 17-18, 137-138, 212
Purpose-Guided Trial Design Framework,
135-138, 141-142
Q
“Quacks”, 27, 35
Qualitative studies, 45, 48, 81, 151
Quality
Behavioral clinical trial, 16-18
Clinical trial, 11-25
Scientic evidence, 5, 11, 12-15, 34,
118-121, 128
R
Random assignment
Basic elements, 175-177, 291
Benets, 23, 175, 176
Causal inferences, 17, 172, 262
Confounding, 169-170, 173-175, 176,
180-181, 195-197, 199
CONSORT guidelines, 176-177
Ethics, 180, 245-246, 288
History, 170-172, 298
Intent-to-treat analyses, 179-180
Limitations, 177-178
“Luck of the draw”, 177-178
Per-Protocol Analyses, 184-186
Post-randomization dropouts, 184, 195-197
Post-randomization exclusions, 178-179
Post-randomization imbalance, 177-178
Process, 176-177, 291
Protection of, 23, 179, 193, 195-197
Rationale, 17, 172-175, 262-264
Index
https://t.me/medicina_free
313
Randomized controlled trials (RCT) (also
called: Drug trials; Medical trials;
Double-blind trials)
Adaptive designs, 292
Bias (see also : Bias), 75, 173
Books, 285-293
Causal inferences, 181, 262-263, 273
Conclusive result (see : Conclusive trial
result)
Conict of interest, 250, 298
Confounding, 14, 173, 185-186
Covariate adjustment, 177-178
Cross-Disciplinary science, 31, 104
Data Safety and Monitoring Board, 137,
250-251, 286
Denition, 148
Double-blind design, 8, 14, 16, 23, 214,
239-240, 250, 290
Ethics, 180, 245-246, 288
Evidence-based, 12-15
Food and Drug Administration, 28-30,
127-128, 288
Hybrid trials, 272
Interim reports, 248
International trials, 288
Investigator-initiated trials, 291
Mendelian randomization, 264
Non-adherence, 14, 183-184, 288
Null trial, 185-186, 224-225, 242, 245
Operations, 291, 292
Phase I, 14, 29-31, 74
Phase II, 14, 29-31, 74, 161
Phase III, 14-15, 29-31, 74, 161, 250
Phase IV, 14, 29-30
Per-Protocol analyses (see : Per-protocol
analyses)
Publishing, 289
Quality, 12-16
Rationale, 262-264
Regulations, 28-29
Replication, 12, 75, 102, 121, 197
“Rules”, 14-15, 291
Sample size, 287
Terminology, 289
Types, 212
Virtual, 272-273, 293
Rating of Included Trials on the Efcacy-
Effectiveness Spectrum (RITES), 20
RCT (see : Randomized controlled trials)
Recruitment
Challenges, 188-189
Feasibility studies, 149-150, 159-160
“Hard sell”, 188, 189-190
Patient-centered, 169-170, 188-190
Run-in periods, 187, 194
Web-based, 272-273
Recurrent Coronary Prevention Project
(RCPP), 253-254
Renement studies (also: Optimization)
(see also : ORBIT model), 17, 34, 72, 82,
90, 104, 193, 225, 226, 230, 264
Regulatory approval, 28-31, 32, 35
Remote clinical trials (also called: Virtual
clinical trials), 272-273, 293
Replication, 7, 12, 75, 82, 90, 98, 99, 100, 102,
118, 119, 121, 178, 197, 225, 264
Representative participants (see : Target
population)
Responder-only analyses (see : Per-protocol
analyses)
Retention, 169-170, 192-193, 200-201
Reverse translation, 274-275
Reviewers, 9, 57, 59, 121, 135, 140, 144, 157,
164-165, 253, 265, 283
Revised ORBIT model, 37-38, 53-54, 161
Risk of bias, 128, 249, 251
Rosenzweig S, 131
Run-in period, 52, 187, 189, 192, 194
Rural Behavioral Health Trial, 139-143
S
Sackett DL, 83, 239
Sample Size
Clinical signicance, 110-113
Effect size, 110-111, 115-116
Estimates from pilot data, 111, 155-157
Phase II efcacy trial, 111-113, 115-116
Phase III efcacy trial, 113, 116-118
Scalable Collaborative Infrastructure for a
Learning Healthcare System
(SCILHS), 272
Science of Behavior Change, 42, 158, 269
“Science of science”, 274-275
Scientic
Conclusion, 75, 98, 102, 103, 105, 119-121
Hypothesis (see : Hypothesis)
Mindset, 5, 93, 237, 238, 246, 254-255
Progression (see : Progressive translational
science)
Screening, Motivational Assessment, Referral,
and Treatment in Emergency
Departments (SMART-ED) trial, 216
Signal vs. noise, 19-20, 32, 34
Secondary outcomes (see : Outcomes)
Signicance testing (see : Statistical
hypothesis testing)
Simplicity, 92-93, 209, 216-217, 231-232
Index
https://t.me/medicina_free
314
Sloan RP, 136
Small N studies, 48-50, 51-52
Social desirability, 87, 228
Social interventions (see : Behavioral
treatments: Denition)
Social program evaluation, 33
SPIRIT 2013 Statement: Dening Standard
Protocol Items for Clinical Trials, 218
Stages of change, 182-183
Statistical hypothesis testing
Condence interval, 100, 102, 120,
152-153
Errors: Type I and Type II, 100
False security, 102
Hybrid p-value, 101
Hypothesis test, 73, 99-100, 105
Inferential statistics, 98-100
Limitations of, 100-103, 220
P-value, 99, 101-103, 105
Statistical signicance, 98, 100-103,
104-105, 119-120
Statistical vs. clinical signicance, 103,
108-110, 116-118
Statistics (see : Statistical hypothesis testing)
Status quo, 7-8, 73, 104-105, 125, 126, 132,
137, 161, 163, 164, 200, 265, 266,
282-283
Stevens J, 33, 47
“Stick your neck out”, 69, 72, 74, 78, 93,
231, 236
Strategic planning, 274-275
Subjective outcomes (see : Outcomes)
Summer Institute for Randomized Behavioral
Trials, vii, 6
Surrogate outcome (see : Outcomes)
T
Tailored behavioral treatments, 268-269
Target population
Non-adherence (see : Non-adherence)
Patient-centered, 23, 170, 186-191, 200,
267-268
Patient-centered consent, 190-191
Patient-centered eligibility, 186-188,
194-195, 267-268
Patient-centered recruitment, 188-190
Patient-centered retention, 192-193,
200-201
Pre-contemplators, 182-183
Representative, 7, 43, 52, 158, 182-184,
186-187, 200, 271
Targeted behavioral treatments, 266-268
Team science, 270-272, 297
Tinkering, 27, 36, 43-44
Third-party reimbursement, 5, 9, 195, 199,
214, 262, 274, 281
Thrombolysis in Myocardial Infarction Trial
(TIMI) Study Group, 271
Training opportunities, 5, 9, 31, 57-58, 93-94,
104, 164, 265-266, 272, 283
Translational science (see : Progressive
translational science)
Treatment as usual (TAU) (see : Usual care)
Treatment crossover/contamination
(see : Bias)
Treatment delity (see also : Implementation
of treatment), 295, 296
Treatment target, 44-45, 106-108, 113-115
Trial purposes
Conduct experiment, 17-18, 136
Study intervention, 17-18, 137
Improve outcomes, 17-18, 137
Increase utility, 17-18, 137-138
Primary purpose, 17-18, 135
Trials of Hypertension Prevention (TOHP),
90-92
“True believer” (see : Preferences)
Turner JR, 29-30
Twain M, 147
U
Unintended treatments (see : Bias)
United States health-care system, 1-3
Usual care (UC) (see : Comparator)
US Preventive Services Task Force, 34
Utility-oriented trial, 17-18, 137
V
Virtual clinical trials (see : Remote clinical
trials)
Voils C, 47
W
Wasserstein RL, 100-102, 103, 119, 121
Watts DJ, 265, 283
Web of causation, 77, 93, 175, 262-263, 270
“Why should you?” vs. “How to”, 6-7, 21
Window of opportunity, 1-3
Wing R, 44-45, 55
Women’s Health Initiative, 89-90, 118, 137, 246
Index
https://t.me/medicina_free
Соседние файлы в папке Библиотека им академика М.И. Перельмана