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Randomized Controlled Trials$

Phyllis Solomon, Mary M. Cavanaugh, and Jeffrey Draine

Print publication date: 2009

Print ISBN-13: 9780195333190

Published to Oxford Scholarship Online: May 2009

DOI: 10.1093/acprof:oso/9780195333190.001.0001

(p.209) Index

Source:
Randomized Controlled Trials
Publisher:
Oxford University Press
ADAPT-ITT, 65–66
Advertising of RCTs, 148
Age factors, 125
Annie E. Casey Foundation, 183
Approvals, 34–35, 40, 50
Assertive Community Treatment (ACT)
contamination, 106
control condition, 89
design, 69, 83, 97–98
fidelity assessment, 106, 165
flow chart, 182 f
outcomes, generalizability of, 179
randomization procedure, 97–98, 101
Assignment of study participants. See Randomization
Attrition, 111–14
Autonomy, 22
Belmont Report, 21–23
Beneficence, 21–23
Blinding, 10, 11, 119–20
Blocked randomization, 118–19
Bond, G., 61, 73–74
Boruch, R.E., 54
Brief Problem-Solving Therapy in Home Care, 120
Bruns, E., 70, 73
Calibration, 104
Care standards, 62
Carroll, K., 61
Case managers as RCT participants, 32–33
Case study method, 173
Cavanaugh, M.M., 66, 184
Checklists, 77–78
Child abuse, 162
Children in RCTs, 31–32
Client–provider relationship, 62
Cluster randomization, 118
Coercion, 37–38
Communication skills, improvement of, 68
(p.210) Community-Based Outreach Model (CBOM), 66
Community-based psychosocial interventions, 6–7, 16–17
context, 90–91
culturally responsive strategies, 53, 55–56
EBP in, 14
ethics in, 22–23
fidelity assessment, 73, 167 (See also Fidelity assessment)
generalizability of, 171
practice guidelines, 67
provider participation, consent, 32–34
sample selection diversity, 38–39, 126
setting (See Settings)
treatment manuals (See Treatment manuals)
Concept mapping, 68–69, 166
Conceptualization development, 80–81, 83, 94–95
hypothesis formulation, 90–94
mediators/moderators, 83–87, 85 f, 86 f, 92–93, 93 f, 130–31
outcome measurement, 130–33
research question/control condition, 87–90
theory in, 80–82
Condom use, 68
Confidentiality, 35–37, 43
Connections, importance of, 49–50
Consolidated Standards of Reporting Trials (CONSORT), 178–81, 180 f, 181 f
Consumer case management study, 88–89
Consumer-run drop-in centers (CRDIs), 74–77, 165
Contamination, 105–7, 109–11
Control conditions, 20, 25–27
attrition and, 112
contamination in, 105–7
design components, 98–100
ethics of, 20, 25–30
informed consent, 27–30
preparation, 140, 141
randomization, 118–19
research question and, 87–90
staff training, 161
Cook, T., 138
Corcoran, J., 14
Cosden, M., 101, 103
Cost effectiveness of RCTs, 184–85
Critical Time Intervention (CTI) trial
design of, 105–6, 113–14
mediators, 85–87, 86 f
moderators, 92–93, 93 f
outcome measurement, 130–32
poverty as moderating factor, 86–87, 86 f, 93, 93 f
preparation, 144–45
randomization in, 117
sampling criteria, 127 f
Culturally responsive strategies, 53, 55–59
Data analysis, 133–34
Databases, 150–51
Data collection
design, 104–5
fidelity assessments, 163–66
participant tracking, 148–51, 150 t–151t
provider characteristics, 168
retention monitoring, 153–57
Data points, 130–33
Data safety, 39–40
Delphi method, 68, 75, 166
(p.211) Dennis, M.L., 110
Design of RCTs, 18, 96, 136–37
adaptive, 136
components, 98–100
confounds, 102–14
attrition, 111–14
contamination control, 105–7
intervention drift, 107–9
intervention environmental change, 109–11
data analysis, 133–34
data collection, 104–5
efficacy vs. effectiveness studies, 9–12
encouragement/randomized consent, 27, 29, 30, 136
ethical issues in, 15 (See also Ethics)
evidence hierarchy, 13 t
interventions, complex, 100–102
multifactorial, 101–2
operationalization, 129–30
outcome measurement, 130–33
quasi vs. pre-experimental, 8–9
randomization (See Randomization)
randomized preference, 136
reliability, 131–32
sampling, 122–29
service context and, 97–98
Solomon four-group, 103–4
Desmond, D., 154
Diagnoses specificity, 125
Dialectical Behavior Therapy (DBT), 66
Dixon, L., 177
Dobson, D., 138
Dosage effects, 134
Draft implementation resource kits, 64–65
Draine, J., 24, 88–89, 152
Effectiveness studies, 10–12
ethics, 19–20
generalizability of, 171
payment, 37
recruitment strategies, 53
treatment manuals in, 60
Efficacy studies, 9–10, 22–23, 60, 64
Eligibility
determination of, 54, 55, 153
factors affecting, 177
informed consent, 31–32, 153 (See also Informed consent)
sampling criteria, 124–26, 127 f, 135
staff training, 161
Environmental context assessment, 166–68
Equipoise, 21, 47, 148
Error measurement, 138, 163
Ethics, 17, 19, 44
approvals, 34–35, 40, 50
coercion, 37–38
confidentiality, 35–37
control conditions, 20, 25–30
data safety, 39–40
effectiveness studies, 19–20
efficacy studies, 22–23
informed consent (See Informed consent)
Internet RCTs, 40–43
interventions, untested, 24–25
monitoring, 39–40, 43
payment, 37–38, 53
practice/research integration, 23–24
randomization, 19–21, 158
research personnel, 34–35
(p.212)
respect/beneficence/justice, 21–23
sampling, 38–39, 126
social worker evaluation, 15
termination responsibilities, 38, 63
waiting list controls, 25–26, 28
Evidence-based practice (EBP), 12–14
draft implementation resource kits, 64–65
generalizability of, 171
hierarchy, 13 t
RCT contribution to, 97, 184
training, 159
treatment manuals, 69–71
validity, external, 176
Experimental study, 7–8
Family education RCTs, 24, 26
Family-to-Family, 177
Federal-wide Assurance (FWA), 34–35
Festinger, D., 37, 114
Fidelity assessments, 71–78, 74 t, 108, 134, 163–66, 173. See also Validity
Fidelity criteria, 73
Fidelity forms, 160, 161
Fidelity measures, 72–74, 74 t, 134
Fidelity Rating Instrument for Consumer-Run Drop-In Centers (FRI-CRDI), 74–77
Focus groups, 67–68, 166
Follow-up procedures, 154–56
Funding
cost effectiveness, 184–85
as design confound, 109
ethics of payment, 37–38, 53
factors affecting, 123, 177
planning, 48–49
preparation, 141
Gellis, Z., 89–90, 120
Generalizability of outcomes, 116, 170–71, 185–86. See also Outcomes; Validity
Generalized estimating equations (GEE) models, 134
Geographic considerations, 126
Glisson, C., 166
Health Insurance Portability and Accountability Act (HIPAA), 35–36
Helper therapy principle, 83
Herbst, J.H., 84–85, 85 f
HIPAA, 35–36
History, 109
HIV/AIDS risk reduction trial, 84–85, 85 f, 118, 147, 167, 168
HIV/STI prevention RCT, 24, 55, 57–59, 68
Housing/employment RCTs, 46–47, 69, 113. See also Critical Time Intervention (CTI) trial
Human subject protection training, 34, 157
Hypothesis formulation, 90–94
Ideal circumstances, 9–10
Implementation, 5, 18, 138–39, 169
changes, 146
computer technology in, 147–57
recruitment, 147–48
recruitment monitoring, 151–53
retention monitoring, 153–57
tracking, 148–51, 150 t–151t, 155, 156
cooperation in, 145–47
efficacy studies, 10
environmental context assessment, 166–68
(p.213)
evidence-based practice, 159
factors affecting, 122–23
fidelity assessments, 71–78, 74 t, 108, 134, 163–66, 173
fidelity forms, 160, 161
follow-up procedures, 154–56
integrity, maintaining, 159–60, 163–66
setting preparation, 139–45
standardized, 10
training (See Training)
treatment manuals, 62 (See also Treatment manuals)
In-depth interviews, 67–68
Index cards, 149
Informed consent, 22, 27–34, 44
attrition and, 111–12
blinding and, 120
eligibility, 31–32, 153
forms, 27–32, 41
HIPAA, 35–36
as inclusion criterion, 127 f
Internet RCTs, 40–43
from providers, 32–34
randomization, 27, 29, 30, 136
timing, 31
Institutional Review Board (IRB) authorization, 34–35, 40, 50
Instrumentation, 104
Integrity, maintaining, 159–60, 163–66
Intent-to-treat, 133–34
Internet RCTs, 40–43
Interpretation of data, 5
Intervention drift, 107–9
Interventions
complex, 100–102
environmental change, 109–11
implementation (See Implementation)
specifications, 62
untested, ethics of, 24–25
Justice, 21–23
Kaufman, C., 16
Kraemer, H., 52–53, 174
Language considerations, 126
Leakage forms, 160, 161
Leakage scale, 72
Liability, 51
Linehan, M.M., 66
Littell, J., 14, 183, 186
Locator forms, 151, 155
Locator information, 113
McDonald, A., 53
McKay, M., 12, 32, 73
McNeece, C., 17
Mediators/moderators, 83–87, 85 f, 86 f, 92–93, 93 f, 130–31
Medicaid, 67
Mental illness
consumer case management study (Solomon/Draine), 88–89
Critical Time Intervention (CTI) trial (See Critical Time Intervention (CTI) trial)
draft implementation resource kits, 64–65
housing/employment RCTs, 46–47, 69, 113 (See also Critical Time Intervention (CTI) trial)
hypotheses in RCTs, 91
research questions, 89
Meta-analyses, 14, 183
Minors in RCTs, 31–32
Moderators, 83–87, 85 f, 86 f, 92–93, 93 f, 130–31
Monitoring ethics, 39–40, 43
Mowbray, C., 73–77, 165
Mueser, K.T., 113
Multilevel modeling, 134
Multi-site RCT, 123, 174–75
Multisystemic therapy (MST) RCTs, 183–84
Narrative summaries, 182
National Association of Social Work (NASW) Code of Ethics, 15, 20, 23
National Institute of Mental Health (NIMH), 183
Nazi concentration camp experiments, 22
No-service controls, ethics, 25
Operationalization of, 129–30
Orwin, R., 72, 164
Outcomes, 90, 93
administrative data set measurement, 100
critique of, 178
factors affecting, 167–68
generalizability, 116, 170–71, 185–86
interventions, complex, 101
measurement, design, 130–33
reporting criteria, 154, 178–81, 180 f, 181 f
Participant diaries, 165
Participant retention, pilot studies, 56–59
Participant tracking, 148–51, 150 t–151t, 155, 156
Patient selection, 3–4
diversity, 38–39
factors affecting, 177–78
pilot studies, 53–55
quasi vs. pre-experimental designs, 8–9
Paulson, R., 165
Payment
attrition and, 113–14
ethics, 37–38, 53
Pillai, V., 14
Pilot studies, 52–53
benefits of, 108
culturally responsive strategies, 53, 55–59
participant retention, 56–59
payment, 53
recruitment assessment, 53–55
Pipeline study, 53–55
Placebo effects, 88
Planning, 17–18, 45–46, 78–79
agency demands, 50–51
authority issues, 49–50
checklists, 77–78
expectations, establishment of, 51–52
funding, 48–49
negotiation, 49–52, 52 t
pilot studies (See Pilot studies)
plausibility, 46–52
site selection, 47–49, 54
treatment manuals (See Treatment manuals)
Policy, research and, 46–47
Policy-level confounds, 109–10
Poverty as moderating factor, CTI trial, 86–87, 86 f, 93, 93 f
Practice, 23
Practice-based evidence, building, 69–71
Practice guidelines, 67
Preventing AIDS Through Health (PATH), 66–67, 89, 91
(p.215) Prevention intervention RCTs, 26–27
Principle of equipoise, 21, 47, 148
Privacy, 35–37, 43
Problem-solving educational intervention study, 89–90
Proctor, E., 67
Program evaluation vs. research, 7–8
Program/practice manuals, 60, 61. See also Treatment manuals
Providers
client relationships with, 62
environmental context influence on, 166–68
informed consent from, 32–34
research personnel, 34–35, 161–63
selection/training/supervision, 63, 77, 158–60
Psychosocial intervention, 7. See also Community-based psychosocial interventions
Psychotherapy efficacy studies design, 10
Qualitative syntheses, 182–83
Quality of life (QOL) measurement, 132
Quality of Reporting of Meta-Analyses (QUOROM), 183
Quantitative reviews, 14, 183
Random generators, 115–16
Randomization, 5, 97–98
attrition and, 113
control conditions, 118–19
ethics of, 19–21, 158
informed consent, 27, 29, 30, 136
multifactorial designs, 102
as objection, 3, 4
procedures, 115–22
ACT trial, 97–98, 101
application, 120–22
blinding, 10, 11, 119–20
blocked, 118–19
cluster, 118
CTI trial, 117
stratification, 117–18
training in, 158
Randomized controlled trial (RCT), 5–6, 11, 16–17
advertising of, 148
benefits of, 45–46
cost effectiveness, 184–85
criticisms of, 135
design (See Design of RCTs)
EBP and, 184
ethics (See Ethics)
failure/problem areas, 175–76
focus of, 6–7
as gold standard, 6, 15, 170
hypotheses in, 91
Internet RCTs, 40–43
minors in, 31–32
multi-site, 123, 174–75
multisystemic therapy, 183–84
prevention intervention, 26–27
purpose/utility, 15, 186
systematic reviews and, 181–84, 186
theory as foundation for, 80–82
Randomized field trial, 7–8
REAL SCORE, 52, 52 t
Recruitment
assessment, 53–55
computer technology in, 147–48
culturally responsive strategies, 53, 55–56
factors affecting, 124, 135, 177–78
integrity and, 163
methods, 58–59, 152
(p.216)
monitoring, 151–53
referrals, 98, 127–28, 152–54
sampling methods, 127–28
staff training, 161
strategies, 57–58
Referrals, 98, 127–28, 152–54. See also Recruitment
Regression models, 133
Reimbursement issues, 67. See also Payment
Release-of-information forms, 140, 149, 153
Reliability, 131–32
Repeatability. See Validity
Replicability. See Validity
Reporting criteria, validity, 178–81, 180 f, 181 f
Research, 23
Research personnel, 34–35, 161–63. See also Providers
Research question/control condition, 87–90
Research vs. program evaluation, 7–8
RESPECT, 66
Respect, 21–23
Retention monitoring, 153–57
Ribisl, K.M., 114, 148, 149
Rosen, A., 67
Rothbard, A., 185
Sampling, 122–23
capacity/fully-powered RCT, 123–24
challenges in, 135
ethics, 38–39, 126
inclusion/exclusion criteria, 124–26, 127 f, 135
method/recuritment, 127–28
quota, 128
size/power, 128–29
snowball, 128
Scared Straight intervention, 22
Scope, 4–5
Scouting research, 53–55
Service system, 110–11, 123
Settings, 46
cooperation in, 145–47
negotiations, 49–52, 52 t, 97
preparation, 139–45
in retention, 157
selection, 47–49, 54
validity measures, 177
Shadowing, 165
Site selection, 47–49, 54. See also Settings
Site visits, 165
Snijders, T.A.B., 85–87, 86 f
Social capital formulation, 86–87, 86 f
Social Enhancement Workbooks, 67–68
Solomon, P., 24, 88–89, 152
Solomon four-group design, 103–4
Speaker-Listener Technique, 68
Statistical analysis, 134
Stratification randomization, 117–18
Substance abuse, 37, 125, 167
Substance Abuse and Mental Health Services Administration (SAMHSA), 64, 183
Suicidal ideation, 41–43, 185
Systematic reviews, 13–14, 181–84, 186
TAU (treatment-as-usual), 25, 47, 87, 108, 130, 185
Termination responsibilities, 38, 63
Testing, 103
Theory as foundation for RCTs, 80–82
Thyer, B., 17
(p.217) Time-limited/control conditions in, 88
Tracking of participants, 148–51, 150 t151 t, 155, 156
Training, 157–63
control-condition staff, 161
evidence-based practice, 159
human subject protection, 34, 157
manuals, 158
of providers, 63, 77, 158–60
in randomization, 158
research staff, 161–63
Treatment access, factors affecting, 3–4
Treatment-as-usual (TAU), 25, 47, 87, 108, 130, 185
Treatment manuals
applications of, 61–63
care standards, 62
client–provider relationship, 62
criticisms of, 63–64
definitions, 60–61
development of, 65–71, 79
evidence-based practice, 69–71
fidelity assessment, 71–78
focus groups/in-depth interviews, 67–68
identification of, 64–65
intervention specifications, 62
practice guidelines, 67
provider selection/training/supervision, 63, 77, 158–60
special issue protocols, 62
support/resource relationships, 63
transitions/terminations, 63
Tuskegee Syphilis Study, 22, 39
Untested interventions, ethics of, 24–25
Validity
attrition and, 112, 113
construct, 172
contamination control, 105–7
ecological, 172
efficacy vs. effectiveness studies, 9, 11
external, 170–71
defined, 171–72
factors affecting, 152, 176–78
neglect of, 176
procedures, 172–76
reporting criteria, 178–81, 180 f, 181 f
fidelity assessment, 71–78, 108, 134, 163–66, 173
gold standards for, 122
inclusion/exclusion criteria in, 124–26, 127 f
internal, 109–11, 135, 173, 178–81
measures, 177, 178
multi-site RCTs, 174–75
outcome measurement, 133
restrictions in, 10
Van Der Gaag, M., 85–87, 86 f
Variables, 90–91
contamination of, 109–11
operationalization of, 129–30
Waiting list controls, 25–26, 28
Walker, J., 70
Wilber, C., 160
Witte, G., 24, 160
Working Alliance Inventory, 168 (p.218)