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Index

ability to work 396

Activities of Daily Living (ADL), survivorship studies 249

Acute Radiation Morbidity Scoring Criteria 206

adjuvant therapy, breast cancer 93, 95

cost-effectiveness study 507–8

HRQOL studies 106–7, 109

long-term late effects 115

administrative data 526–8

enhancements to support outcomes research 529

strengths and limitations 528–9

Affect Balance Scale (ABS) 249

Agency for Healthcare Research and Quality (AHRQ)

Healthcare Cost and Utilization Project (HCUP) 534, 537

Integrated Delivery System Research Network (IDSRN) 543

Medical Expenditure Panel Survey (MEPS) 534, 537

Primary Care Practice-Based Research Networks (PBRNs) 543

aggregated scores 392, 465

derivation for multidimensional instruments 476–7, 577

item aggregation 476

subscale aggregation 476–7

see also summary scales and scores

allowed amounts 488–9

ambulatory care costing algorithms 490

American Cancer Society, Study of Cancer Survivors-II

(SDS-II) 532, 536

American Society of Clinical Oncology (ASCO), National

Initiative on Cancer Care Quality (NICCQ) 540–1

analytical techniques 10

see also statistical analyses in outcomes research

androgen deprivation 127–8, 203

see also hormonal therapy

anemia 625–30

Appraisal of Caregiving Scale (ACS) 338, 339

Area Resource File (ARF) 537

area under curve (AUC) statistic 374

639

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640 Index

Assessment of Patients’ Experience of Cancer Care (APECC)

Study 533, 536

Asset and Health Dynamics (AHEAD) Study 493, 535,

538

audio-CASI (computer-assisted self-interview) 352

balance billing 489

balance of error 474

Bayesian methodology 379–80, 515, 561, 577–8,

632–3

in cost-effectiveness analysis 515–16

in patient-reported outcome analysis 632–3

Behavioral Risk Factor Surveillance System 530, 531

billed charges 488

bisphosphonates, symptom control in breast

cancer 110

blood pressure measurement 2

bowel symptoms

with prostate cancer treatment 131, 150

survivorship studies 245

see also colorectal cancer

BRCA1/BRCA2 genes 222–4

breast cancer 5

chemoprevention 220–1

short-term outcome measurement 219

economic burden 485

epidemiology 93

genetic testing 222–4


HRQOL studies 9, 94, 107–8, 570

added benefits of 111–13

adjuvant drug therapy 106–7, 109, 115

advanced disease treatment 107–8, 109–10

follow-up studies 108, 110

future research needs 113–16

history of 94–5

in clinical trials 95, 105–11, 114–15, 116

instrument selection 104–5

instruments used 96–7, 101, 105–6

literature review 96

primary breast tumor treatment 106, 107

psychosocial interventions 108, 110–11, 115

recommendations 113–16

studies using more than one instrument

101–5

symptom control 108, 110

prognosis 93–4

outcome prediction 112

psychological impacts 94–5, 115

screening 228–9

false positive screening results 228–9

negative screening results 228

short-term outcomes measurement 225–7

survivorship studies 243–4

instruments used 245–53

treatments 93, 202–3

adjuvant drug therapy 93, 95, 106–9, 115

advanced disease 109–10

cost-effectiveness analysis 507–8

cost-utility analysis 505

impact on patients 204–5, 210

primary breast tumor 106

treatment decisions 93, 106–10, 112, 115–16

see also cancer treatments

Breast Cancer Chemotherapy Questionnaire (BCQ) 95, 101, 105

Breast Cancer Prevention Trial (BCPT) 219, 220

Breast Cancer Surveillance Consortium 541

Brief Hospice Inventory (BHI) 267–9, 274, 277

Brief Male Sexual Function Inventory (BSFI) 126, 146–7

Brief Symptom Inventory-53 (BSI-53) 247, 252

burden, concept of 480

see also economic burden of cancer

Burden Scale 339

California Health Interview Survey (CHIS) 530, 531

cancer

disease focus 5

epidemiology 1

impact on individual 1, 24

outcomes see outcomes research

see also breast cancer; colorectal cancer; economic burden

of cancer; lung cancer; prostate cancer

cancer care

continuum of care 5

HRQOL assessment across 9–10

patient perspective across 297

prostate cancer 346

defining cancer care episodes 486–8

concurrent episode coding 486–7

retrospective computerized episode algorithms 488

retrospective episode coding 487–8

long-term care costs 491–2

medical care costs 1, 482–91

quality of care 3

categories of 291

patient perspectives 290–2






Index 641

see also cancer treatments; caregivers; patient perspectives on

cancer care

Cancer Inventory of Problem Situations (CIPS)

96–8

see also Cancer Rehabilitation Evaluation System

(CARES)

Cancer Outcomes Measurement Working Group

(COMWG) 3–4, 568–9

common approach establishment 7–8

approach to tables 8

categorization of HRQOL measures 7–8

defining HRQOL 7

evaluation of outcome measurement instruments

7

data sources 6–7

development of 4

focus groups 6–7

future directions 580–2

sustaining scientific advancement 580–1

membership 4

operations of 6

outcomes assessment framework 4–6

arenas of application 5

continuum of care 5

disease focus 5

outcome measures of prime interest 4–5

Cancer Outcomes Research and Surveillance Consortium

(CanCORS) 538, 540

Cancer Outcomes Research Teams (CORTs) 581

Cancer Patient Need Questionnaire (CPNQ) 310

Cancer Patient Need Survey (CPNS) 309, 310

cancer patients 10

needs of 310, 320–2

see also needs; needs assessment

terminally ill patients see end-of-life (EOL) care

treatment impact on 201–2, 210–13, 550

domains of HRQOL affected 204–5

late effects 115, 244

patient-reported instruments 207

treatment preferences 115–16, 288

direct studies 77–8

proxy assessment of patient preferences 349

see also patient perspectives on cancer care; patient-reported

Outcomes (PROs)

cancer prevention 216, 217

decision making 217

HRQOL studies 9

prophylactic surgery 224

short-term outcomes 217, 231–2


measurement of 229–31

measures 218

see also chemoprevention

cancer registries 523–6

enhancements to support outcomes research 525–6

strengths and limitations 525

Cancer Rehabilitation Evaluation System (CARES) 15, 45–54,

95

breast cancer studies 97, 98, 105

features 45–54

needs assessment 310, 316

performance across the cancer continuum 54

prostate cancer studies 126

psychometric data and validation 46–53

quality-of-life dimensions 16

Short Form (CARES-SF) 54, 95, 310, 316, 320–2

measuring importance of needs 322

translation and cultural adaptation 408–9

survivorship studies 246, 251

translation and cultural adaptation 408–9, 419,

420

psychometric performance 409

usage 54

Cancer Research Network (CRN) 541

cancer treatments 1

economic cost of 1

goal of 623

impact on cancer patients 201–2, 210–13, 550


late effects 115, 244

measurement 206–13


outcomes see outcomes research

survivor’s perspective 287

treatment decisions 201, 389–90

breast cancer 93, 106–10, 112, 115–16

colorectal cancer 193, 194–5

lung cancer 160

prostate cancer 147, 148–50, 558

see also clinical decision making

treatment preferences 115–16, 288

direct studies 77–8

proxy assessment of patient preferences 349

see also cancer care; chemotherapy; drug development;

radiation therapy; specific types of cancer; surgical

treatment






642 Index

Cancer Worry Scale 249

Caregiver Appraisal Scale 339

Caregiver Quality of Life Index (CQLI) 339–40

Caregiver Quality of Life Index-Cancer (CQOLC) 334, 335–6,

338, 340–1, 342–3

comparison with Caregiver Reaction Assessment

(CRA) 340–1

construct validity 338, 341

reliability 338, 341

responsiveness 338, 339, 341

Caregiver Reaction Assessment (CRA) 334–6, 338, 340–1,

342–3

comparison with Caregiver Quality of Life Index-Cancer

(CQOLC) 340–1

construct validity 337, 341

reliability 337, 341

responsiveness 337, 341

subscales 337

caregivers 10, 331

at-risk caregivers 342

impacts on 10, 329–30, 331, 332, 340

analysis 330–1

conceptual model 331–4

data abstraction 330

economic burden 493–4

emotional domain 331–3

end-of-life care 264–5

future research 341–2

literature search 330

objective impacts 329

physical domain 333

positive impacts 333, 341

social/role domain 333

spiritual domain 333–4, 341–2

subjective impacts 329–30, 331, 332

uses of caregiver impact information 342

measures of caregiver impact 334–6, 340, 342–3

overall description 334

needs of 310, 320–2

proxy measures of patient-oriented outcomes

348–9

see also family members and friends

CARES see Cancer Rehabilitation Evaluation System

(CARES)

cascading 231

category response curves (CRCs) 431, 448–51

ceiling effects 597

Center for Epidemiologic Studies-Depression (CES-D)


cervical cancer

chemoprevention 221–2


screening 228–9




chaining 231

Charlson Index 151

chemoprevention 217, 218–22

breast cancer 219, 220–1

cervical cancer 219, 221–2

colorectal cancer 219, 221

impact on HRQOL 219–22, 230

prostate cancer 126, 219, 221

short-term outcomes 217, 231–2


measurement of 219, 229–31

measures 218

see also cancer prevention

chemotherapy

breast cancer 202–3

cost-effectiveness analysis 507–8

HRQOL studies 95, 109

symptom control 110


HRQOL studies 185, 193, 194–5

impact on cancer patients 201–2, 550, 625–30

cognitive impact 630

domains of HRQOL affected 205

HRQOL endpoint data 559

measurement 208–10


toxicity criteria 206–7

see also specific types of cancer

lung cancer 203

cost-effectiveness analysis 504

HRQOL studies 166

prostate cancer 128, 203

see also adjuvant therapy; cancer treatments; drug

development; hormonal therapy

Chemotherapy Symptom Assessment Scale (C-SAS) 208–9

childhood cancers 346–7

City of Hope (COH)

model 17

Quality of Life Scale (QOLS) 271–3, 275, 277

Clarke and Talcott prostate cancer specific questionnaire 126,

135, 136

psychometric properties 135






Index 643

classical test theory (CTT) 425, 590–1

comparison to item response theory (IRT) modeling 433–8,

575–8, 591

computerized adaptive testing 439

differential item functioning 439–40, 576

information 436–8

invariance 435–6

optimal scaling/scale score interpretation 440–1

scale development and analysis 438–9

limitations 445, 469, 590

clinical decision making 389–90

cost-effectiveness plane 506–7

in cancer prevention 217

in screening 217

levels of 391

macro level 391

meso level 391

micro level 391

use of HRQOL information 10, 389–90, 554, 558–9,

581

from observational studies and clinical trials 588


interpretation of HRQOL data 397


clinical response benefit 368, 379

clinical significance 370, 631–2

assessment 379, 560–1

clinical trials 11

breast cancer 95, 105–11, 114–15, 116

design of 587

economic analyses 347

see also cost-effectiveness analysis (CEA)

economic studies for new products 633–6

challenges and timing 634–5

modeling in economic evaluations 635–6

HRQOL instrument selection 578

incorporation of patient-reported outcomes 346–7, 552–3,

624

data collection modes 348–53

decision modeling 633

measurement across phases of drug development 348

measurement across stages of disease 346–8

missing data 353–5, 631

multiple testing 631


regulatory perspective 552–3

timing and administration 355–6

lung cancer 169

prostate cancer 148–50

cognitive aspects of survey methodology (CASM) 610

cognitive interviewing technique 610, 611, 621

detecting and fixing problems with questions 611–12

general versus specific application 612

investigating frame-of-reference effects 618–19

item selection related to respondent interpretation 613–16

how respondents conceive of health 614–15

investigator and respondent characterization of

concepts 613–14

selection of response category 615–16

reference periods 616–17

probing the past 617

probing the present 616

responses to sensitive topics 617–18

responses to socially desirable behaviors 617–18

strengths and weaknesses 619–21

logistics 619

potential for bias 619–20

replacement of other evaluation methods 620

use in cross-cultural assessment 621

use in self-administered instruments 620–1

verbal probing versus think-aloud 611

cognitive testing 301

colon cancer 178

treatment 178


colonoscopy 224


colorectal cancer (CRC) 5

chemoprevention 221


economic burden of 485

epidemiology 178

HRQOL studies 9, 571

clinical implications 193–5

future research needs 195



measurement issues 184–5

performance of HRQOL measures 192–3

qualitative findings 190–1

recommendations 195

treatment impact 185–90

value added 191–2

screening 178, 224–8, 536










644 Index

colorectal cancer (CRC) (cont.)

treatments 9, 178, 187, 203

impact on patients 185–90, 205

metastatic disease 186–7, 188–90

mixed treatments 185–8



Common Toxicity Criteria 206

communication issues

facilitation of communication 390–1

in end-of-life care 280

interaction analysis 291–2

survivor’s perspective 287–8

see also interpersonal care

comparator therapy 511–12

Comprehensive Assessment of Satisfaction with Care

Questionnaire (CASC) 293–4

computer use for patient-reported data collection 351–2

digital divide significance 596

hand-held computers 352

computer-assisted preference elicitation 86–7

computer-assisted self-interview (CASI) 352

computerized adaptive testing (CAT) 439, 445–6, 459–61, 576,

592

health status assessment 598

model selection 600

conceptual equivalence 595

concurrent episode coding 486–7

conjoint analysis 322–4

hybrid conjoint model 324, 325

ConQuest program 477

construct map 466–8

Consumer Assessment of Health Plans (CAHPS) survey 292,

295, 299, 300, 530, 532

response options 296

continuum of care 5

HRQOL assessment across 9–10, 570

patient perspective across 297


see also cancer prevention; end-of-life (EOL) care; screening

core constructs 579–80

cost management information systems (CMISs) 489

Cost of Cancer Treatment Study 495

cost-benefit analysis (CBA) 505–6

cost-effectiveness analysis (CEA) 70–1, 347–8, 398, 494, 503, 504

Bayesian methods 515–16

decision analytic models 507–11

data incorporation 508

data modeling 508–10

model structure 507–8

model validation 510–11

expected value of information 516

integration of trials and models 516–18

net benefit analysis 514–15

randomized cost-effectiveness trials 511–13

efficacy versus effectiveness endpoints 512

integration of evidence 513

protocol effects 512

truncated follow-up time 512–13

wrong comparator therapy 511–12

sensitivity analysis 513–14

summary score 577

see also economic evaluation


cost-minimization analysis (CMA) 504

cost-utility analysis (CUA) 70, 504–5

costing algorithms 490

costs

assigning costs to specific procedures and services

488–90

allowed amounts 488–9

balance billing 489

costing algorithms 490

list prices/billed charges 488

paid amounts 489

production costs 489–90

revenues 489

drug costs 490

versus prices 588–9

hospitalization costs 485

household costs induced 492–4

long-term care costs induced 491–2

lost productivity costs induced 492–4

measurement of attributable costs 485–8

comparison sample strategy 486

defining cancer care episodes 486–8

microcosting strategy 486

top-down strategy 485–6

medical care costs induced 1, 482–91

societal costs 495–6

counseling see genetic counseling; psychosocial interventions

Cronbach’s alpha 316–17

cross-cultural use of HRQOL assessments 406–7

Cancer Rehabilitation Evaluation System (CARES) 408–9, 420


Short Form (CARES-SF) 408–9

EORTC QLQ-C30 411–12, 419, 420–1

psychometric performance 412–13, 416






Index 645

Functional Assessment of Cancer Therapy-General

(FACT-G) 416, 419, 420–1

psychometric performance 416–18

Functional Living Index Cancer (FLIC) 407–8



Rotterdam Symptom Checklist (RSCL) 409–10


cultural issues 296, 596

cognitive interviewing 621

disenfranchisement 595–6

see also cross-cultural use of HRQOL assessments

Dale et al. prostate cancer specific questionnaire 126, 135,

136

psychometric properties 135, 136

data collection from patients see patient-reported outcomes

(PROs)

data sources 6–7, 11, 522

administrative data 526–8


strengths and limitations 528–9

cancer registries 523–6

enhancements to support outcomes research 525–6


enhancement 581

focus group 523

literature search 522–3

mechanisms 523–6, 539–44

consortia and networks 540–4

industry-supported mechanisms 544

single organizations 539–40

medical records 526, 528



surveys 530–3, 539


health knowledge, practices, and outcomes 530–6

resource use and cost 534–5, 536–8


towards a national cancer data system 544–6

decision analytic models 507–11

data incorporation 508

data modeling 508–10

model structure 507–8

model validation 510–11

decision making see clinical decision making

decision modeling 633

decision significance 573

decision trees 507, 508, 509

Department of Defense (DoD), Military Cancer Institute 539

Department of Veterans Affairs (VA) 539

Colorectal Cancer Quality Enhancement Research Initiative

(CRC QUERI) project 539–40

depression

genetic counseling and 222

Hospital Anxiety and Depression Scale (HAD) 32–3

Derdiarian Informational Needs Assessment (DINA) 312

diagnosis, survivor’s perspective 286–7

Diagnosis Related Groups (DRGs) 490

differential item functioning (DIF) 439–40, 576, 592, 596,

620

alternative language instrument evaluation 412, 419

digital divide 596

dimensionality 592–3

multidimensional approach 11, 456, 465, 576–7

unidimensionality 432–3, 446–8, 465, 592, 593

disability measurement 590

disability-adjusted life years (DALYs) 485, 496–7

disadvantaged populations 595


disaggregated scores 392

discomfort measurement 590

discovery methods 591–2


digital divide 596

distance 469–70

drug costs 490

versus drug prices 588–9

drug development 624, 636

development phases 551

phase I studies 551

phase II studies 551

phase III studies 551

phase IV studies 551

economic studies for new products 633–6



promotional claims 553–4, 555, 556–7, 559–60

patient-reported outcomes and 630–1

regulatory issues 552–4

drug evaluation 588

use of HRQOL data 11–12, 550, 551–4, 555

industry perspective 554–5, 624

patient-reported outcome measures 348

see also clinical trials

drug labeling 552, 553–4, 555, 559–60

patient-reported outcomes and 625–9, 630






646 Index

drug therapy see chemotherapy

Dyadic Adjustment Scale (DAS) 249

Eastern Cooperative Oncology Group (ECOG) measure 369–70,

386

economic analysis see economic evaluation

economic burden of cancer 1, 11, 480–1, 572

applications 482

challenges 496–9

equity issues 496, 498–9

total societal value-loss 496–8

economic evaluations 482, 490–1, 494

formal long-term care costs induced 491–2

formal medical care costs induced 1, 482–91

household costs induced 492–4

lost productivity costs induced 492–4

methodological approaches 481–2

macrocosting 481, 485–90, 492

microcosting 481, 485, 486, 487, 492

modeling 481–2

patient-level burden 482, 485–90, 493–4

assigning costs to procedures and services

488–90

measuring attributable costs 485–8

population-level burden 482, 492–3

prostate cancer 485

see also cost-effectiveness analysis; costs

economic evaluation 480, 482, 503–7

clinical trials 347

cost-benefit analysis (CBA) 505–6


see also cost-effectiveness analysis

cost-minimization analysis (CMA) 504

cost-utility analysis (CUA) 70, 504–5

household costs 494

lost productivity costs 494

medical care costs 490–1

new oncology products 633–6



rationale 503–4

Edmonton Symptom Assessment System (ESAS) 269–71, 275,

277

Educational Testing Service (ETS) 601

effectiveness studies 398, 512

efficacy studies 398, 512

emotional impacts see psychological impacts

end results 1–2

see also endpoints

end-of-life (EOL) care 23, 264


physical well-being 266

psychological well-being 266

social well-being 266

spiritual well-being 266

HRQOL studies 10, 264, 276

barriers to EOL research 279

in health services research 279

instruments used 17, 266–73, 276

longitudinal designs 278–9

moving away from narrow symptom focus 276–7

posthumous approach 278

qualitative versus quantitative methods 279

role in palliative care research 279–80

subject burden 277–8

impact on caregivers 265

importance of HRQOL 264–5

prostate cancer 128

see also palliative care

end-of-scale aversion 72

endpoints 1–2, 386


construction and validation of 379

efficacy versus effectiveness endpoints 512


identification and measurement of 367–8

multiple endpoints 356–7, 370–1

see also health-related quality of life (HRQOL)

EORTC QLQ-C30 15, 54–5, 95

breast cancer module (BR-23) 97, 98, 99–100


representative scores 102

changes in scores 394–5

colorectal cancer module (CR-38) 179–80, 182,

194

colorectal cancer studies 179, 180, 188–9

performance of instrument 192

treatment impact 185

end-of-life studies 275–6, 277

features 54

lung cancer module (LC-13) 161, 162–4, 171

construct validity 164

content validity 162–4

lung cancer studies 161–2

performance across the cancer continuum 54–5

profiles 31

prostate cancer module 135, 136–45







Index 647

prostate cancer studies 126, 145, 148, 151


psychometric data and validation 46–53, 99–100, 412–13,

414, 415, 416


Subjective Significance Questionnaire (SSQ) 394–5

survivorship studies 246, 251, 255

translation and cultural adaptation 411–12, 419, 420–1


type of information elicited 21

usage 54–5

epoetin alfa 625–30

equity issues

conceptual equivalence 595

digital divide 596

disadvantaged populations 595

in economic burden measurement 496, 498–9

psychometric equivalence 595

European Organization for Research and Treatment of Cancer

(EORTC)

Core Quality of Life Questionnaire see EORTC QLQ-C30

toxicity criteria 206

European Randomized Study of Screening for Prostate

Cancer 127

EuroQol EQ-5D 78–80, 179

colorectal cancer studies 190

components 78–9

measurement properties 79–80


content validity 79

practical aspects 80

reliability 79–80

responsiveness 80


evaluations, in subjective assessment 19–23, 27

changes over time 23

in definitions of quality of life 20–2

influencing factors 22–3

measurement of 22

Expanded Prostate Cancer Index Composite (EPIC) 126, 135–7,

146, 152

psychometric properties 135–7


expectations 297–8

influence on patient evaluations 297–8, 299

expected utility theory 73

expected value of perfect information (EVPI) 516,

517

expected value of sample information (EVSI) 516

face-to-face interviews 350

FACT see Function Assessment of Cancer Therapy (FACT)

FAMCARE Scale 293, 314

Family Inventory of Needs (FIN) 314

Husbands (FIN-H) 314

family members and friends

HRQOL assessment 288

needs assessment 306

proxy measures of patient-oriented outcomes 348–9

see also caregivers

fatigue 625–30

Feeling Thermometer (FT) 71–3

Ferrans and Powers Quality of Life Index (QLI) 16–17, 21,

23





see also Quality of Life Index (QLI)

Ferrans model 17

field testing 301

Fieller’s Theorem 514

final endpoints see endpoints

finasteride 221

FLIC see Functional Living Index – Cancer (FLIC)

focus groups 6–7

Food and Drug Administration (FDA) 550, 552–4

regulatory perspective on HRQOL endpoints 552–4

guidance and standards 555, 556–7, 581

foreign language questionnaires see translation

forms, design of 354

Forrest plot 375, 377

Fowler Prostate Cancer Outcomes Assessment 250

frame-of-reference effects 618–19

friends see family members and friends

Function Assessment of Cancer Therapy (FACT) 21, 23,

95

breast cancer module (FACT-B) 97, 98, 99–100, 105


colorectal cancer module (FACT-C) 179–84, 194


end-of-life studies 276, 277

endocrine subscale 210

FACIT 251, 276

General (FACT-G) 55, 98

breast cancer studies 97, 98, 99–100

changes in scores 395

colorectal cancer studies 180–4

features 55






648 Index

Function Assessment of Cancer Therapy (FACT) (cont.)


prostate cancer studies 126, 135, 145, 148, 151

psychometric data and validation 46–53, 99–100, 135,

418

translation and cultural adaptation 416, 417, 419, 420–1

usage 55

lung cancer module (FACT-L) 162, 163–5, 171


content validity 165

criterion-related validity 165

Trial Outcome Index 164–5

profiles 31

prostate cancer module (FACT-P) 126, 135, 146, 148




survivorship studies 246, 251, 255


functional assessment 386, 597–8

Functional Living Index – Cancer (FLIC) 55–6, 95



colorectal cancer studies 179, 189

features 55–6


prostate cancer studies 126, 150–1




translation and cultural adaptation 407–8, 419


usage 56

functional status 26

assessment 386, 597–8

measures 7

see also health status

GBU (Good-Bad-Uncertain) Index 369–70

gemcitabine 630

genetic counseling 222–4


genetic testing 217, 222–4

breast cancer 222–3, 224

negative test result 222

ovarian cancer susceptibility 223

positive test result 222–4

prophylactic surgery and 224

subsequent surveillance and 222–4

short-term outcomes 217


measurement of 223, 229–31

see also screening

Gibbs Sampling 515

Giesler et al. prostate cancer specific questionnaire 126, 135,

136


global rating measures 7, 394–6

relationship to magnitude of HRQOL change

394–6

goserelin see hormonal therapy

graded response model (GRM) 430–2, 448–51

graphical presentation of data 375, 376, 377

grief 280

Group Health Cooperative of Puget Sound 539

health

conception of 614–15

determinants of 593–5

physical versus mental health 614

see also health status

health care policy, influence of patient-reported

outcomes 587–8

health care utilization 396

Health, Eating, Activity, and Lifestyle (HEAL) Study 532,

536

Health Insurance Portability and Accountability Act

(HIPAA) 545

health state preference measurement 8–9, 496–7

hypothetical health states 77

see also disability-adjusted life years (DALYs);

preference-based outcome measures; quality-adjusted

life years (QALYs)

health status 593–5

marker states 72

model 24

quality of life relationship 25, 26, 558


see also functional status; health state preference

measurement

Health Utilities Index (HUI) 80–3

Mark 1 (HUI1) 80

Mark 2 (HUI2) 79, 80

Mark 3 (HUI3) 79, 80–1, 82



content validity 81







Index 649

reliability 82

responsiveness 82–3


health-related quality of life (HRQOL) 14–15, 27, 584,

625

added value of HRQOL data 555–9, 574–5

prognostic value 559

relationship with clinical status 558

treatment differences 558–9

breast cancer studies 105–6, 107–8, 570

added benefits of HRQOL measurement 111–13

adjuvant drug therapy 106–7, 109, 115

advanced disease treatment 107–8, 109–10

follow-up studies 108, 110

primary breast tumor treatment 106, 107

psychosocial interventions 108, 110–11, 115

survivorship studies 243–4

symptom control 108, 110


assessment

causal models 23–7

Patrick and Chiang model 25–6

Ware health status model 24

Wilson and Cleary model 24–5, 26

chemoprevention impact 219–22


qualitative findings 190–1

treatment impact 185–90

value added 191–2


assessment

cultural variation 421

definitions 7, 8, 18–19, 568, 571

as attitudinal versus objective variable 613

categories of 18–19

diversity of 613

issues 591

selection of 19

domains of 15–18, 571–2

impact of cancer therapy 204–5

in instruments for cancer care 16

end-of-life studies 264


importance of HRQOL at end of life 264–5


HRQOL outcomes 389–90

classification based on level of decision making 391

health determinants and 595

primary outcomes 389

relationship among different outcomes 573–5

role in palliative care 279–80

secondary outcomes 389–90

see also patient-reported outcomes (PROs)

HRQOL profile 388–9

impact of cancer therapy 204–5, 210–13, 550

chemotherapy 208–10

radiation therapy 207–8

surgery 207

see also patient perspectives on cancer care

interpretation of HRQOL data 391–8, 399–400, 573

aggregated versus disaggregated scores 392

anchor-based interpretations 393–6

by clinicians 397

by regulatory agencies 397–8

decision significance 573

distribution-based interpretations 392–3

in efficacy, effectiveness or cost-effectiveness studies

398


lung cancer studies 166, 571


value added 166–9

measurement of see health-related quality of life (HRQOL)

assessment

mortality relationship 396

needs relationships 308

prostate cancer studies 128–9, 571


see also health-related quality of life (HRQOL) assessment


survivors see survivorship studies

use of HRQOL information

by patients and caregivers 10, 554

by regulatory agencies 11–12, 397–8, 550, 552–4

current situation 586

future directions 559–61

guidance and standards 555, 556–7, 559–60, 581

in clinical decision making 10, 389–90, 554, 581, 588

in drug development 11–12, 550, 551–5, 624

in drug labeling 552, 553–4, 555, 559–60

patient monitoring 390

versus quality of life 14–15

see also quality of life

health-related quality of life (HRQOL) assessment 2–3, 306–8,

387, 399–400

across the cancer continuum 9–10, 570

see also cancer prevention; cancer treatment; end-of-life

(EOL) care; screening; survivorship studies






650 Index

health-related quality of life (HRQOL) assessment (cont.)

breast cancer 9, 94

added benefits of HRQOL measurement 111–13


history of 94–5

in randomized clinical trials 95, 105–11, 114–15, 116





studies using more than one instrument 101–5


classification according to purpose of assessment

387–91

clinical decision making 389–90

communication facilitation 390–1

preference (utility) assessment 390

profile description 388–9

screening 388

cognitive interviewing application 612–19

colorectal cancer 9

clinical implications 193–5

future research needs 195

instruments 179–84

measurement issues 184–5


recommendations 195

targeted assessments 195


distinction from symptom assessment 387, 552

during treatment 9

colorectal cancer 9

domains of HRQOL affected by cancer therapy 204–5

lung cancer 9

prostate cancer 9

end-of-life studies 10, 264, 276

instruments used 17, 266–73, 276

methodological considerations 277–9

moving away from narrow symptom focus 276–7


families and friends of patients 288

feasibility 569

frame-of-reference effects 618–19

funding issues 113–14

future needs 399

in clinical trials 346, 551–3

assessment after discontinuation of therapy 355–6


duration of HRQOL assessment 355

frequency of evaluations 355

instrument selection 578

measurement across phases of drug development

348



timing of follow-up assessments 356

timing of initial assessment 356

timing when therapy is cyclic 356

instruments 15–16, 17, 27, 31, 32, 406, 570

adaptation of 10–11

balance of error 474

challenges 571–3, 587, 591–2



core set of measures 579

crosswalking scores between instruments 458–9, 576

evaluation of 453–5, 560–1

future research issues 57–8, 114, 580

general cancer instruments 45–53, 57

generic instruments 32–42, 45

in survivorship studies 245–53

incorporation of patients’ concerns 16–17

item bias 461–2, 463

nonstandard use of 379

positive accomplishments of 367–8

profiles 31

psychometric data and validation 34–42, 46–53, 99–100,

587

quality of 569

redesign of 453–5, 572–3

reliability 573

responsiveness 560–1

selection of 17, 578–9

types of information elicited 21

validity assessment 595

see also instrument construction; item banks;

patient-reported outcomes (PROs); specific instruments

lung cancer 9, 170–2

analytic concerns 169–70

curative treatment 166–9

instruments 161–4, 166, 167–8

non-randomized studies 169

randomized studies 169


measurement approaches 11

item response theory modeling 11


see also item response theory (IRT)






Index 651

measures 8–9, 25

cancer-specific measures 8

functional status measures 7

general cancer measures 7–8, 45–53, 57

generic measures 7, 32–42, 45

global rating measures 7

symptom measures 7


methodological issues 114

new directions 575–8

objective assessment 19

prostate cancer 9, 130–1

added value of HRQOL assessments 147–8, 288


instruments used 126, 131–47, 148, 150–2, 288

ongoing assessment 288



proxy measures of patient-oriented outcomes 349

qualitative approaches 254–5


statistical issues 368–9

subjective assessment 19–23

evaluations 19–22, 23, 27

perceived status 19–21, 22, 27

unanticipated findings 17–18

see also cognitive interviewing technique; health-related

quality of life (HRQOL); patient-reported outcomes

(PROs); quality of life

Healthcare Cost and Utilization Project (HCUP) 534,

537

HMO Cancer Research Network (CRN) 541

Hodgkin’s disease 17–18

Home Care Study

Caretaker Form (HCS-CF) 315

Patient Form (HCS-PF) 311

Home Caregiver Need Survey (HCNS) 314

hormonal therapy

breast cancer 202–3, 210

HRQOL studies 109

impact on patients 205

measurement 210

prostate cancer 127–8, 203


Hospital Anxiety and Depression Scale (HADS) 32–3



features 32–3

lung cancer studies 161


prostate cancer studies 126, 134–45



usage 33, 45

hospitalization costs 485

household costs induced by cancer 492–4

economic evaluations 494

patient-level burden 493–4

population-level burden 492–3

human papilloma virus (HPV) 221–2


Impact of Event Scale (IES) 248, 252

Index of Coexistent Disease (ICED) 151

Indian Health Service, Resource and Patient Management

System 539

informal caregivers see caregivers

information 598

Information and Support Needs Questionnaire (ISNQ) 315

instrument construction 453–5, 477, 575–6

discovery methods 591–2

Four Building Blocks 466–72, 477


items design 468

measurement model 469–72

outcome space 468–9

see also specific instruments

Instrumental Activities of Daily Living (IADL)


insurance claims data 526–8

see also administrative data

Integrated Delivery System Research Network (IDSRN) 543

intent-to-treat (ITT) analysis 372–4

interaction analysis 291–2

International Breast Cancer Study Group (IBCSG) 101

International Index of Erectile Function (IIEF) 126, 146–7

International Prostate Symptom Score (IPSS) 126, 147


international studies 406


interpersonal care 291


evaluations 291–2

reports 291–2

see also communication issues

interviews

face-to-face 350

telephone 350






652 Index

Inventory of Complicated Grief (ICG) 315


item banks 439, 445, 455, 592

adding items 456–8

debate 601

development of 455–6, 576, 580, 601

item bias 461–2, 463, 596

item difficulty 596–8

item discrimination 598–9

item information function (IIF) 436–7, 453

item response theory (IRT) modeling 11, 425–7, 445, 561, 575,

591

applicability 379

applications 425, 445, 446, 462–3, 561

computerized adaptive testing (CAT) 439, 459–61, 576,

579–80

crosswalking scores between instruments 458–9, 576

detecting potentially biased test items 461–2, 463

instrument construction and evaluation 453–5, 572–3,

575–6

item bank development 455–8, 576

model selection and 600

optimal scaling/scale score interpretation 440–1

reducing patient burden 369

scale development and analysis 438–9

summary scores 577

see also differential item functioning (DIF)

assumptions 432–3, 446–53

assessment of 446–53

local independence 433

model fit 448–53

monotonicity 432

unidimensionality 432–3, 446–8, 465

basics 427–32

dichotomous response data 428–30

polytomous response data 430–2

category response curves (CRCs) 431, 448–51

comparison with classic test theory (CTT) approach 434–8,

575–8, 591

estimation of item and person parameters 433–4

item-fit 434

person-fit 434

evaluation of fit 434

extensions to 620

future role in outcomes assessment 441–2

information concept 436–8

applications 438–41

item information function (IIF) 436–7, 453

scale information function (SIF) 437–8, 453–5

target information function 453

trait score estimation 454–5

invariance property 435–6

applications 438–41

item characteristic curve (ICC) 598

item response curve (IRC) 427–8, 434

model selection 599–600


see also multidimensional item response modeling

(MIRM)

obstacles to greater use 426

standardized residuals (SRs) 451–3

terminology 427

items design 468

Japanese Quality of Life Research Group 209

Kaiser Permanente 539

Karnofsky Performance Status Scale (KPS) 386

labeling see drug labeling

Late Effects of Normal Tissues/Subjective-Objective

Management Analytic (LENT/SOMA) scales

206

Late Morbidity Scoring Criteria 206

levels of evidence 386

linear analogue self-assessment (LASA) scales

breast cancer 101

Lipscomb, Joseph 4

list prices 488

local independence 433

long-term care costs 491–2

Long-Term Quality of Life (LTQL) 254

survivorship studies 247, 251–2

longitudinal analysis 301, 374–5

lost productivity costs 492–4

economic evaluations 494

patient-level burden of cancer 493–4

population-level burden of cancer 492–3

lung cancer 5


analytic concerns 169–70


findings 166



non-randomized studies 169

randomized studies 169

value added 166–9






Index 653

mortality 160

non-small-cell (NSCLC) 160, 203

small-cell (SCLC) 160, 203



treatments 160, 203



decision-making 160

HRQOL studies 9, 166–9

impact on patients 205


Lung Cancer Symptom Scale (LCSS) 162, 163–4, 165–6,

171



criterion-related validity 165–6

reliability 165

M-Plus program 477

McGill Quality of Life Questionnaire (MQOL) 15–16, 274–5

end-of-life studies 269–71, 274–5, 277

quality of life dimensions 16

macrocosting 481, 485–90

long-term care costs 492

mammography see breast cancer

Mammography Questionnaire 294

marker states 72

Markov State-Transition models 507–8, 510

Massachusetts Male Aging Study 146–7

mastectomy 202–3

HRQOL studies 106

impact on patients 204, 205

treatment decisions 93

Medicaid 588

claims files 527


Medical Care Attitude Scale (MCAS) 294

medical care costs 482–91

economic evaluations 490–1

patient-level burden of cancer 485–90

population-level burden of cancer 483–5

Medical Expenditure Panel Survey (MEPS) 534, 537, 539

Medical Outcomes Studies Short Form Health Survey see Short

Form 36 (SF-36)

Medical Outcomes Trust (MOT) 7, 569

medical records 526, 528

computer-based systems 529


incorporation of patient-reported outcomes 529


Medicare 588

claims data 526–7


Cost Reports (MCRs) 489

Current Beneficiary Survey (MCBS) 535, 537–8, 539

Health Outcomes Survey (HOS) 530, 532

Memorial Symptom Assessment Scale (MSAS) 271–3, 275,

277

Global Distress Index (GDI) 275

Mental Adjustment to Cancer (MAC) Scale 248, 252

microcosting 481, 485

assigning costs to specific procedures and services 488

attributable cost measurement 486, 487

long-term care costs 492

minimum important difference (MID) 394

mirror image stream plot 375, 376

missing data 353–5, 372, 373, 561, 631

analysis approaches 356–8, 371–2, 561, 631

avoidance of 353–4, 569

education and training 354

form design 354

primary prevention 353–4

secondary prevention 354


data collection and management 353

follow-up procedures 354–5

lung cancer studies 169–70, 171

Missoula-VITAS Quality of Life Index (MVQOLI) 268–9, 274,

277

mitoxantrone 630

Montreal Prostate Cancer Model 511

multi-attribute preference-based measures see

preference-based outcome measures

Multiattribute Health Status (MAHS) 190


multidimensional item response modeling (MIRM) 465, 474–6,

477

aggregate score derivation 476–7, 577


subscale aggregation 476–7

comparison with unidimensional approaches 466

future research and applications 477–8

software options 477

multidimensional random coefficients multinomial logit

(MRCML) model 475

multinational studies 406







654 Index


Multiple Outcomes of Raloxifene Evaluation (MORE) Trial

220

National Cancer Data Base (NCDB) 524, 525


national cancer data system 544–6

National Cancer Institute (NCI) 3

Assessment of Patients’ Experience of Cancer Care (APECC)

Study 533, 536

Breast Cancer Surveillance Consortium 536

Clinical Trials Cooperative Group 541–2

Community Clinical Oncology Programs (CCOPs) 541–2

Comprehensive Cancer Centers (CCC) 543

Health, Eating, Activity, and Lifestyle (HEAL) Study 532, 536

Physician Survey of Cancer Susceptibility Testing 533, 536

Survey of Colorectal Cancer Screening Practices 533, 536

toxicity criteria 206

see also Cancer Outcomes Measurement Working Group

(COMWG)

National Cancer Institute of Canada Clinical Trials Group

(NCIC-CTG) 206

National Center for Health Statistics (NCHS)

National Ambulatory Medical Care Survey (NAMCS) 534,

537

National Hospital Discharge Survey (NHDS) 534, 537

National Comprehensive Cancer Network (NCCN) 541

National Health and Nutrition Examination Survey 530,

531

national health care policy see health care policy

National Health Interview Survey (NHIS) 530, 531, 590

National Hospital Discharge Survey (NHDS) 534, 537

National Initiative on Cancer Care Quality (NICCQ) 540–1

National Institute for Clinical Excellence (NICE), UK 588

National Long-Term Care Survey 536

National Program of Cancer Registries (NPCR) 524


National Survey of Colorectal Cancer Screening Practices 533,

536

National Survey of Mammography Facilities 536

nausea assessment 19

Need Evaluation Questionnaire (NEQ) 311

needs 305, 310, 320–2

hierarchy of 305

identification of 318–19, 324–5

critical incident technique 318

person-focused techniques 318–19

importance of


measurement 322–4

trade-offs 322

of caregivers 310, 320–2

relationships among needs 308, 325

relationships with satisfaction and HRQOL 308, 325

needs assessment 10, 306–8, 573–4

developing and conducting a needs assessment 317–24

factors influencing the importance of needs 319–22

measuring importance of needs 322–4

needs identification 318–19, 324–5

distinction from satisfaction and HRQOL assessment 306–8

family members 306

importance of 305–6

instruments review 308–15, 317

domains 309–17

instrument characteristics 309



Needs Near the End-of-Life Care Screening Tool (NEST) 313

net benefit analysis 514–15

net monetary benefit (NMB) 514–15

Bayesian methods 515–16

non-steroidal anti-inflammatory agents (NSAIDs) 221

Nottingham Health Profile (NHP) 34–42



nursing home care costs 490

objective assessment 19

On-Line Guide to Quality-of-Life Assessment (OLGA) 32

Oncology Treatment Toxicity Assessment Tool (OTTAT) 207

1-parameter logistic model (1PLM) 429–30

optical scanning 351


outcomes measurement 2–4, 590–1

desirable characteristics of outcome measures 3

identification of 7

Five D’s 590

new directions 575–8, 580–2


outcomes assessment framework 4–6

arenas of application 5

continuum of care 5, 570

disease focus 5

outcome measures of prime interest 4–5

proxy measures of patient-oriented outcomes 348–9

see also health-related quality of life (HRQOL) assessment;

patient-reported outcomes (PROs); preference-based

outcome measures






Index 655

outcomes research 1–2, 522

common clinical outcomes 386

current situation 586

endpoints 1–2, 386

construction and validation of 379


identification and measurement of 367–8


future research needs 445, 580–2, 586–9

data source enhancement 581

role of outcome measures in decision making 581


HRQOL outcomes 389–90

primary outcomes 389

secondary outcomes 389–90

see also health-related quality of life (HRQOL) assessment

influence on health care policy 587–8

literature review 3, 6–7, 364

methodological challenges 10–11, 587

analytical techniques 10

study guidelines 587

psychometric theory in 11

statistical issues see statistical analyses in outcomes

research

see also data sources; outcomes measurement

ovarian cancer susceptibility testing 223

paid amounts 489

pain

assessment in prostate cancer palliative treatments 147

management of 265

quality-of-life relationship 585

palliative care 264

lung cancer 170–1

prostate cancer 147

role for HRQOL outcomes 279–80

see also end-of-life (EOL) care

Palliative Care Assessment (PACA) 313

pancreatic cancer economic burden 485

Pap smear test see cervical cancer

Paradox of Cancer Survivorship 255

patient education 288–9

patient expectations 297–8

influence on patient evaluations 297–8, 299

Patient Information Need Questionnaire (PINQ) 312

Patient Needs Assessment Tool (PNAT) 312, 316

patient perspectives on cancer care 10, 290–1, 623–4

challenges with patient evaluation measures 297–9

influence of expectations 297–8, 299

influence of patient characteristics 298–9

predispositions 298

evaluations versus reports 291–2, 299

instrument review 292–5, 297

cancer specific versus general measures 296–7

continuum of care and cancer site 297

cultural and language differences 296

domains 295

reference period 296

reliability and validity 296

respondents 296

response options 296

sensitivity of measures 296

weighting the importance of domains 295–6

interpersonal care 291–2


measurement of 292

questionnaire development 300–1

cognitive testing 301

domain development and refinement 300–1

field testing 301

longitudinal research 301

new item construction 301

ratings 291

recommended strategy 300–1

questionnaire content 300

reports 291–2

potential usefulness of 299–300

satisfaction 291

needs relationships 308

technical care 291

value of 623–4


patient satisfaction see patient perspectives on cancer care;

satisfaction surveys

patient satisfaction with medical care (PSMC) item bank 456

development of 456–8

Patient Satisfaction with Medical Care Questionnaire

(PSQ-III) 446, 447, 449, 456–7, 460

principal components analysis 448

scale information function 453–5

patient well-being see well-being

patient-oriented prostate utility scale (PORPUS) 84–5

patient-reported outcomes (PROs) 530–6, 584, 623, 624–31

clinically important effects 631–2

current usage of 586


cost considerations 351

face-to-face interview 350






656 Index

patient-reported outcomes (PROs) (cont.)

mailed self-assessment 351

proxy measures from caregivers/family 348–9

self-administration versus interviewer

administration 349–50

telephone interview 350

definitional considerations 624–5

drug advertising and promotion and 630–1

history of research 584–6

in clinical trials 346–7, 551–3, 587, 624

assessment after discontinuation of therapy 355–6

duration of HRQOL assessment 355

frequency of evaluations 355

measurement across phases of drug development 348


multiple testing 631



timing of assessments when therapy is cyclic 356

timing of follow-up assessments 356

timing of initial assessment 356

in medical records 529

influences on 587

media for data collection 351–2

computer-assisted self-interview (CASI) 352

computers 351–2

cost considerations 352

hand-held computers (PDAs) 352

optical scanning 351

pencil and paper 351

missing data 353–5, 631

analysis approaches 356–8, 371–2, 631

avoidance of 353–4

data collection and management 353

follow-up procedures 354–5

of HRQOL 7, 16–17, 21, 69


of treatment-related toxicity 169, 207

product labeling and 625–9, 630

significance for health care policy 587–8

statistical considerations 631–3

Bayesian approaches 632–3

study quality 352–3

value added 107–8

see also health-related quality of life (HRQOL); patient

perspectives on cancer care; subjective

assessment

patients see cancer patients

PCOS Prostate Index 250

perceived status 19–21, 27


measurement of 22

Person Trade-Off (PTO) technique 498

personal data assistants (PDAs), for patient-reported data

collection 352

pharmaceutical industry see drug development

Physician Estimate of Survival 33

Physician Survey of Cancer Susceptibility Testing 533, 536

Picker Survey 295, 300

Policy Analysis Institute Questionnaire 249

policy issues see health care policy

POLYFIT program 451–2

Post-Traumatic Stress Disorder (PTSD) Checklist 249

preference-based outcome measures 69–71, 87

direct 69, 71–8, 86

hypothetical health states 77

standard gamble (SG) 73, 74, 75–7


surrogate informants 77

time trade-off (TTO) 74, 75–7

visual analogue scale (VAS) 71–3

employment of in cancer intervention studies 70–1

implications for research agenda 85–7

computer-assisted preference elicitation 86–7

direct versus multi-attribute measures 86

future directions 87

importance of choice-based preference elicitation 86

preference-based measures as complement to other

approaches 86

indirect (multi-attribute approach) 69–70, 78–85, 86

disease-specific multi-attribute systems 84–5

EuroQol EQ-5D 78–80

Health Utilities Index (HUI) 80–3

Quality of Well-Being Scale (QWB) 83–4

selection of multi-attribute system 84


see also outcomes measurement; patient-reported outcomes

(PROs)

prevention see cancer prevention

prices, versus costs 588–9

Primary Care Practice-Based Research Networks (PBRNs)

543

Princess Margaret Hospital Patients Satisfaction with Doctor

Questionnaire 293

principal components analysis (PCA) 446, 448

privacy regulations 545

probabilistic sensitivity analysis 513–14

probability (P) value 393






Index 657

problem-oriented medical record (POMR) 486–7

production costs 489–90

Profile of Mood States (POMS) 43

alternative language studies 417

breast cancer studies 97, 98–101, 105


features 43


prostate cancer studies 126, 134–45, 150–1



usage 43


prostate cancer 5

chemoprevention 126, 221


continuum of care 126–8

economic burden of 485

end-of-life care 128


added value of HRQOL assessments 147–8

during treatment 9


instruments used 126, 131–47, 148, 150–2, 288


measurement of HRQOL 130–1

multi-attribute preference systems 84–5

ongoing assessment 288


need for 287–8

screening 126–7, 228


support groups 289


diagnosis 286–7

long-term survivorship 287–8

potential contributions of HRQOL assessment 288


treatment 287



treatments 127–8, 203

HRQOL endpoints 147–8

impact on patients 9, 131, 150, 205

quality of life issues 129

treatment decisions 147, 148–50, 558

treatment preferences 288


Prostate Cancer Index 23

Prostate Cancer Intervention Versus Observation (PIVOT)

trial 148

Prostate Cancer Needs Assessment (PCNA) 312

Prostate Cancer Prevention Trial (PCPT) 126, 149, 219,

221

Prostate Cancer Specific Quality of Life Instrument

(PROSQOLI) 126, 135


Prostate Cancer Treatment Outcome Questionnaire 250

Prostate, Lung, Colon and Ovary Trial (PLCO) 127

prostate-specific antigen (PSA) screening 126

Psychological Adjustment to Illness Scale (PAIS)


psychological impacts



on caregivers 331–3




late effects of cancer treatment 244

see also Profile of Mood States (POMS)

psychometric equivalence 595

psychosocial interventions, breast cancer 108, 110–11,

115

qualitative approaches 254–5




quality of care 3

categories of 291


evaluations 291–2

instrument review 292–7

reports 291–2

quality of life 14, 15, 625

definitions 19–21, 22, 591

health status relationship 25, 26, 550


versus health-related quality of life 14–15

see also health-related quality of life (HRQOL); well-being

Quality of Life and Well-being Questionnaire 179

Quality of Life-Cancer Survivors (QOL-CS) 247, 252, 254

Quality of Life Index (QLI) 43–4

features 43–4









658 Index

Quality of Life Index (QLI) (cont.)


usage 44

see also Ferrans and Powers Quality of Life Index

Quality of Life Inventory 23

Quality of Life Questionnaire for Cancer Patients Treated with

Anticancer Drugs (QOL-ACD) 209–10

Quality of Life Questionnaire-C30 see EORTC

QLQ-C30

Quality of Life-Radiation Therapy Instrument

(QOL-RTI) 207–8, 209

Quality of Life Scale for Cancer (QOL-CA) 16–17



Quality of Well-Being Scale (QWB) 79, 83–4



content validity 83


reliability 83–4

responsiveness 81

quality-adjusted life years (QALYs) 70, 398, 504–5

cancer burden measurement 485, 496–7

equity issues 498

quality-adjusted time without symptoms or toxicity

(Q-TWIST) 78

radiation therapy



HRQOL studies 106

treatment decisions 93


impact on cancer patients 201–2


measurement 207–8



lung cancer 203

prostate cancer 203



Radiation Therapy Oncology Group (RTOG) toxicity criteria

206

raloxifene 220–1

RAND Mental Health Index 150–1

randomized clinical trials see clinical trials

randomized cost-effectiveness trials see cost-effectiveness

analysis (CEA)

Rasch model 17, 266–76, 430, 470, 598–9

model selection 599–600

recall bias 395

rectal cancer treatment 178


reference periods 296, 616–17

probing the past 617

probing the present 616

reframing 188

regulatory agencies

interpretation of HRQOL data 397–8

use of HRQOL data 11–12, 550

guidance and standards 555, 556–7, 559–60, 581

regulatory perspective on HRQOL endpoints 552–4

Research Association of Practicing Physicians (RAPP)

543

Resource-Based Relative Value Scale (RBRVS) 490

response shift 378–9, 395, 573, 618–19

retrospective computerized episode algorithms 488

retrospective episode coding 487–8

revenues 489

Revised Grief Experience Inventory (RGEI) 315

Rotterdam Symptom Checklist (RSCL) 56–7



features 56

lung cancer studies 161





translation and cultural adaptation 409–10, 419


usage 56–7

RSCL see Rotterdam Symptom Checklist (RSCL)

sample attrition 371–2

satisfaction surveys 291, 306–8, 590

use in needs assessment 322

see also patient perspectives on cancer care

scale information function (SIF) 437–8, 453–5

scales

development and analysis 438–9

optimal scaling/scale score interpretation

440–1

screening 216, 217, 224–9

breast cancer 225–7, 228–9








Index 659

cervical cancer 225–7, 228–9



colorectal cancer 178, 224–7, 228, 536


decision making 217

HRQOL status 388

HRQOL studies 9

negative test result 217–18, 228

false negative 217–18

positive test result 217, 218

false positive 217, 228–9

prostate cancer 126, 225–7, 228

short-term outcomes 217, 218, 231–2


measurement of 225–7, 229–31

measures 218

see also genetic testing

selection bias 375

selective estrogen receptor modulators (SERMs) 220

see also raloxifene; tamoxifen

Selenium and Vitamin E Cancer Prevention Trial (SELECT)

221

self-explicated utility model 324


sensitivity analysis 513–14

sexual dysfunction

measurement 146–7

prostate cancer treatment and 131, 150


Short Form 6D (SF-6D) 87

Short Form 36 (SF-36) 21, 31, 33–43, 465–6, 472–6



features 33

item response theory (IRT) modeling 426–7, 430–2

Mental Health (MH) subscale 426–7, 428, 430–2

dimensionality 432–3

scale information function 437

standard error of measurement function 438

multidimensional item response modeling (MIRM)

approach 474–6, 477

Omnibus Summary Scale 476


Physical Functioning (PF-10) subscale


construct validity 470–2

items design 469

outcome space 469

prostate cancer studies 126, 134, 150–1



quality of life dimensions 16

reliability coefficients 473

subscales perspective 473–4, 477

summary scale perspective 473–4, 477

survivorship studies 245–50, 255


usage 33–43, 45

short-term outcomes 217

measurement of 219, 223, 225–7, 229–31

see also cancer prevention; genetic testing; screening

Sickness Impact Profile (SIP) 31, 44–5, 179


features 44



Short Form (SF-SIP) 44

usage 44–5

skilled nursing facilities (SNF) costs 490

slope parameter 470

Snyder, Claire 4

social impacts

end-of-life care 266

on caregivers 333

social well-being 266

societal costs 495–6

societal value 481

total societal value-loss 496–8

soft-tissue sarcoma 346–8

Southwest Oncology Group Quality of Life Questionnaire 190

Specific Disease and Continence-Related Symptoms

questionnaire 179

specific objectivity 430

spiritual domain 266, 587

caregivers 333–4

end-of-life care and 266

Spitzer Quality of Life (QL-Index)




standard deviation (SD) 393

standard error of measurement (SEM) 393, 436, 438

standard gamble (SG) 73, 74, 75–7


construct validity 72, 75–6

content validity 75

practical aspects 73, 77






660 Index

standard gamble (SG) (cont.)

reliability 76

responsiveness 76

standardized residuals (SRs) 451–3

statistical analyses in outcomes research 10, 362–4, 365, 380–1,

569–70

aggregated versus disaggregated scores 392

anchor-based interpretations 393–6

ability to work 396

global ratings 394–6

health care utilization 396

mortality 396

relationship to disease status and treatment 396

challenges 363–5, 366

distribution-based interpretations 392–3


Bayes methodology role 379–80, 561, 577–8

clinical significance assessment 379, 560–1

endpoint construction and validation 379

item response theory applicability 379

nonstandard use of instruments 379

response shift 378–9

training needs 379

gold standard 365–6, 367

issues 367–78


clinical significance 370, 631–2

graphical presentation of results 375, 376, 377

HRQOL assessment 368–9

identifying and measuring endpoints 367–8

intent-to-treat (ITT) analysis 372–4

longitudinal analysis 374–5

missing data and sample attrition 371–2, 373

multiple endpoints 370–1

role of complex statistical methods 375–8

selection bias 375

stratification 369–70

patient-reported outcomes 631–3

see also item response theory (IRT)

stratification 369–70

structural equation modeling (SEM) 572

Study of Cancer Survivors-II (SDS-II) 532, 536

subjective assessment 19–23

evaluations 19–23, 27

changes over time 23



measurement of 22

perceived status 19–21, 27


measurement of 22

subjective significance 394–5

Subjective Significance Questionnaire (SSQ) 394–5

subscales 465, 466

aggregation 476–7

Four Building Blocks 466–72, 477


items design 468

measurement model 469–72


multidimensional item response model approach 474–6

reliability 473, 475, 477

validity 466, 475

see also specific instruments

summary scales and scores 465, 466, 577, 592–3

see also aggregated scores

support groups, prostate cancer 289

need for 287–8

Support Team Assessment Schedule (STAS) 313

Supportive Care Needs Survey (SCNS) 311, 316

measuring importance of needs 322

surgical treatment


HRQOL studies 106



clinical implications of HRQOL studies 193, 194

impact on HRQOL 185–8, 192

impact on cancer patients 201–2


measurement 207


lung cancer 203


prostate cancer 150, 203



Surveillance, Epidemiology, and End Results (SEER)

program 485, 523–4

combined SEER/administrative data 526–8, 529


surveys 530–3, 539


health knowledge, practices, and outcomes 530–6

resource use and cost 534–5, 536–8







Index 661

survival curves 33

survivorship studies 241–2, 243


colorectal cancer 245

data abstraction techniques 242

HRQOL assessment 9–10, 241–2, 243–5

adding value 253


instruments used HRQOL 245–53

performance of instruments 253–5

positive outcomes 242

qualitative approaches 253, 254–5

late effects of cancer treatment 244


lung cancer 244

Paradox of Cancer Survivorship 255

prostate cancer 128, 244–5


SWOG Prostate Outcomes Questionnaire 250

Symptom Checklist 179

symptoms 264–5

control of 265

breast cancer 110


impact on HRQOL 265

measures of 7

distinction from HRQOL assessment 387, 552

T scores 101

tamoxifen

breast cancer chemoprevention 220

HRQOL impact 220–1

see also hormonal therapy

target information function 453

taxanes, cost-effectiveness 503

technical care 291

patient perspectives 291

telephone interviews 350

terminally ill patients see end-of-life (EOL) care

test characteristic function (TCF) 458, 459

Therapy-Related Symptom Checklist (TRSC) 207, 208

think-aloud responses 611

see also cognitive interviewing technique

TIME (Toolkit of Instruments to Measure End of life care)

266

time trade-off (TTO) 74, 75–7


construct validity 72, 75–6

content validity 75

practical aspects 73, 77

reliability 76

responsiveness 76

Tobacco Use Supplement, Current Population Survey, US

Census Bureau 530

Toronto Informational Needs Questionnaire-Breast Cancer

(TINQ-BC) 313

Total Mood Disturbance (TMD) score 98

toxicity data 386

patient-reported measures 169, 207

toxicity criteria 206–7, 212

training

missing data avoidance 354

statisticians 379

trait scores

computerized adaptive assessment 459–61

estimation of 454–5

statistically equating scores 458–9

translation

Cancer Rehabilitation Evaluation System (CARES) 408–9,

419, 420


Short Form (CARES-SF) 408–9

EORTC QLQ-C30 411–12, 419, 420–1


Functional Assessment of Cancer Therapy-General

(FACT-G) 416, 419, 420–1


Functional Living Index Cancer (FLIC) 407–8, 419



Rotterdam Symptom Checklist (RSCL) 409–10, 419


treatment decisions see cancer treatments; clinical decision

making

2-parameter logistic model (2PLM) 428–9

UCLA Prostate Cancer Index (UCLA PCI) 126, 135–7, 146, 151,

152




unidimensionality 432–3, 446–8, 465, 592, 593

urinary function

measurement 147

prostate cancer treatment and 131, 150







662 Index

utilities 231


expected utility theory 73

measurement of 231, 390

utility scores 71, 390

see also Health Utilities Index (HUI)

value scores 71

verbal probing 611

see also cognitive interviewing technique

Veterans Affairs Information Resource Center (VIReC) 539

video-CASI (computer-assisted self-interview) 352

visual analogue scale (VAS) 71–3



content validity 72


reliability 72–3

responsiveness 73

vomiting assessment 19

von Neumann–Morgenstern expected utility theory 73

well-being 585

physical 266

psychological 266

social 266

spiritual 266

see also quality of life

willingness-to-accept (WTA) approach 498

willingness-to-pay (WTP) approach 497–8,

505–6

equity issues 498–9

withholds 488

working group 4

see also Cancer Outcomes Measurement Working Group

(COMWG)

World Health Organization Quality of Life Questionnaire

(WHOQOL-BREF) 417

Worthington Chemotherapy Satisfaction Questionnaire

(WCSQ) 210, 293–4

Wright map 470–2, 477

Zarit Burden Interview/Inventory 340






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