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Outcomes Assessment in Cancer
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  • Page extent: 676 pages
  • Size: 247 x 174 mm
  • Weight: 1.663 kg

Hardback

 (ISBN-13: 9780521838900 | ISBN-10: 0521838908)




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

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

     short-term outcome measurement 223

   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

   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

     literature review 218

     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

     domains of HRQOL affected 204–5

     late effects 115, 244

     measurement 206–13

     patient-reported instruments 207

   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

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)

   survivorship studies 247, 252

cervical cancer

   chemoprevention 221–2

     short-term outcome measurement 219

   screening 228–9

     false positive screening results 228–9

     negative screening results 228

     short-term outcomes measurement 225–7

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

     literature review 218

     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

   colorectal cancer 178, 203

     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

     patient-reported instruments 207

     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

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

     instrument selection 578–9

     interpretation of HRQOL data 397

   see also cancer treatments

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

     recommendations 358–9

     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

   see also colorectal cancer

colonoscopy 224

   cost-effectiveness analysis 512

colorectal cancer (CRC) 5

   chemoprevention 221

     short-term outcome measurement 219

   economic burden of 485

   epidemiology 178

   HRQOL studies 9, 571

     clinical implications 193–5

     future research needs 195

     instruments used 179–84

     literature search 179

     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

     cost-effectiveness analysis 512

     short-term outcomes measurement 225–7

   survivorship studies 245

     instruments used 245–53

   treatments 9, 178, 187, 203

     impact on patients 185–90, 205

     metastatic disease 186–7, 188–90

     mixed treatments 185–8

     treatment decisions 193, 194–5

     see also cancer treatments

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

   prostate cancer 126–8

   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-effectiveness plane 506–7

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

     psychometric performance 409

     Short Form (CARES-SF) 408–9

   EORTC QLQ-C30 411–12, 419, 420–1

     psychometric performance 412–13, 416

   Functional Assessment of Cancer Therapy-General (FACT-G) 416, 419, 420–1

     psychometric performance 416–18

   Functional Living Index Cancer (FLIC) 407–8

     psychometric performance 407–8

   recommendations 418–21

   Rotterdam Symptom Checklist (RSCL) 409–10

     psychometric performance 410–11

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

     enhancements to support outcomes research 529

     strengths and limitations 528–9

   cancer registries 523–6

     enhancements to support outcomes research 525–6

     strengths and limitations 525

   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

     enhancements to support outcomes research 529

     strengths and limitations 529

   surveys 530–3, 539

     enhancements to support outcomes research 539

     health knowledge, practices, and outcomes 530–6

     resource use and cost 534–5, 536–8

     strengths and limitations 538

     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

   disenfranchisement 595–6

disaggregated scores 392

discomfort measurement 590

discovery methods 591–2

disenfranchisement 595–6

   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

     challenges and timing 634–5

     modeling in economic evaluations 635–6

   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

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

   cost-effectiveness plane 506–7

     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

     challenges and timing 634–5

     modeling in economic evaluations 635–6

   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

   domains of HRQOL affected 265–6

     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

   clinical response benefit 368, 379

   construction and validation of 379

   efficacy versus effectiveness endpoints 512

   end-of-life care 276–7

   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

   breast cancer studies 97, 98, 105

     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

     psychometric properties 135

   prostate cancer studies 126, 145, 148, 151

     representative scores 141

   psychometric data and validation 46–53, 99–100, 412–13, 414, 415, 416

   quality-of-life dimensions 16

   Subjective Significance Questionnaire (SSQ) 394–5

   survivorship studies 246, 251, 255

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

     psychometric performance 412–13, 416

   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

     construct validity 79

     content validity 79

     practical aspects 80

     reliability 79–80

     responsiveness 80

   strengths and limitations 85

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

   representative scores 144

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

   psychometric data and validation 34–42

   quality-of-life dimensions 16

   survivorship studies 246, 251

   type of information elicited 21

   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

     representative scores 102

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

     construct validity 81

   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

     performance across the cancer continuum 55

     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

     construct validity 165

     content validity 165

     criterion-related validity 165

     Trial Outcome Index 164–5

   profiles 31

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

     psychometric properties 135

     representative scores 142

   quality-of-life dimensions 16

   survivorship studies 246, 251, 255

   type of information elicited 21

functional assessment 386, 597–8

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

   breast cancer studies 96, 97, 105

     representative scores 103

   colorectal cancer studies 179, 189

   features 55–6

   performance across the cancer continuum 56

   prostate cancer studies 126, 150–1

   psychometric data and validation 46–53

   quality-of-life dimensions 16

   survivorship studies 247, 251

   translation and cultural adaptation 407–8, 419

     psychometric performance 407–8

   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

   short-term outcome measurement 223

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

     literature review 218

     measurement of 223, 229–31

   see also screening

Gibbs Sampling 515

Giesler et al. prostate cancer specific questionnaire 126, 135, 136

   psychometric properties 135–7

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

     functional status 26

   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

   measurement properties 81–3

     construct validity 81

     content validity 81

     practical aspects 83

     reliability 82

     responsiveness 82–3

   strengths and limitations 85

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

     see also health-related quality of life (HRQOL) 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

   colorectal cancer studies 571

     qualitative findings 190–1

     treatment impact 185–90

     value added 191–2

     see also health-related quality of life (HRQOL) 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

     domains of HRQOL affected 265–6

     importance of HRQOL at end of life 264–5

     role in palliative care research 279–80

   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

     recommendations 398–9

   lung cancer studies 166, 571

     survivorship studies 244

     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

     survivor’s perspective 286–9

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

   regulatory perspective 552–4

   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

   breast cancer 9, 94

     added benefits of HRQOL measurement 111–13

     future research needs 113–16

     history of 94–5

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

     instrument selection 104–5

     instruments used 96–7, 101, 105–6

     literature review 96

     recommendations 113–16

     studies using more than one instrument 101–5

     see also health-related quality of life (HRQOL)

   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

     performance of HRQOL measures 192–3

     recommendations 195

     targeted assessments 195

     see also health-related quality of life (HRQOL)

   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

     role in palliative care research 279–80

   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

     data collection modes 348–53

     duration of HRQOL assessment 355

     frequency of evaluations 355

     instrument selection 578

     measurement across phases of drug development 348

     measurement across stages of disease 346–8

     regulatory perspective 552–3

     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

     construct validity 573

     content validity 572

     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

     see also health-related quality of life (HRQOL)

   measurement approaches 11

     item response theory modeling 11

     multidimensional approach 11, 456, 465, 576–7

     see also item response theory (IRT)

   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

     see also patient-reported outcomes (PROs)

   methodological issues 114

   new directions 575–8

   objective assessment 19

   prostate cancer 9, 130–1

     added value of HRQOL assessments 147–8, 288

     future research needs 152–3

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

     ongoing assessment 288

     performance of HRQOL measures 148–52

     see also health-related quality of life (HRQOL)

   proxy measures of patient-oriented outcomes 349

   qualitative approaches 254–5

   recommendations 398–9

   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

     survivorship studies 245

Hospital Anxiety and Depression Scale (HADS) 32–3

   breast cancer studies 97, 98, 105

   colorectal cancer studies 179, 189

   features 32–3

   lung cancer studies 161

   performance across the cancer continuum 33

   prostate cancer studies 126, 134–45

   psychometric data and validation 34–42

   survivorship studies 249

   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

hybrid conjoint model 324, 325

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

     construct map 466–8

     items design 468

     measurement model 469–72

     outcome space 468–9

   see also specific instruments

Instrumental Activities of Daily Living (IADL)

   survivorship studies 249

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

   survivorship studies 250

international studies 406

   see also cross-cultural use of HRQOL assessments

interpersonal care 291

   patient perspectives 291–2

     evaluations 291–2

     reports 291–2

   see also communication issues

interviews

   face-to-face 350

   telephone 350

Inventory of Complicated Grief (ICG) 315

item aggregation 476

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

   multidimensional approach 11, 456, 465, 576–7

     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

   HRQOL studies 170–2, 571

     analytic concerns 169–70

     curative treatment 166–9

     findings 166

     instruments used 161–4, 166, 167–8

     literature search 160–1

     non-randomized studies 169

     randomized studies 169

     value added 166–9

   mortality 160

   non-small-cell (NSCLC) 160, 203

   small-cell (SCLC) 160, 203

   survivorship studies 244

     instruments used 245–53

   treatments 160, 203

     cost-effectiveness analysis 504

     curative treatment 166–9

     decision-making 160

     HRQOL studies 9, 166–9

     impact on patients 205

     see also cancer treatments

Lung Cancer Symptom Scale (LCSS) 162, 163–4, 165–6, 171

   construct validity 165

   content validity 165

   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

     see also administrative data

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

   enhancements to support outcomes research 529

   incorporation of patient-reported outcomes 529

   strengths and limitations 529

Medicare 588

   claims data 526–7

     see also administrative data

   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

   colorectal cancer studies 191–2

   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 approach 11, 456, 465, 576–7

multidimensional item response modeling (MIRM) 465, 474–6, 477

   aggregate score derivation 476–7, 577

     item aggregation 476

     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

   see also cross-cultural use of HRQOL assessments

multiple endpoints 356–7, 370–1

Multiple Outcomes of Raloxifene Evaluation (MORE) Trial 220

National Cancer Data Base (NCDB) 524, 525

   strengths and limitations 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

   strengths and limitations 525

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

     influencing factors 319–22

     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

     literature search 308–9

   recommendations 324–5

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

   colorectal cancer studies 179, 185

   survivorship studies 248

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

outcome space 468–9

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

     sustaining scientific advancement 580–1

   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

outcomes research 1–2, 522

   common clinical outcomes 386

   current situation 586

   endpoints 1–2, 386

     construction and validation of 379

     end-of-life care 276–7

     identification and measurement of 367–8

     multiple endpoints 356–7, 370–1

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

     data source enhancement 581

     role of outcome measures in decision making 581

     sustaining scientific advancement 580–1

   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

   literature search 292

   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

   see also patient-reported outcomes (PROs)

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

   data collection modes 348–53

     cost considerations 351

     face-to-face interview 350

     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

     measurement across stages of disease 346–8

     multiple testing 631

     recommendations 358–9

     regulatory perspective 552–3

     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

     prostate cancer 149–50

   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

   in definitions of quality of life 20–2

   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

     strengths and limitations 85

     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

     strengths and limitations 85

   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

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

   colorectal cancer studies 179

   features 43

   performance across the cancer continuum 43

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

   psychometric data and validation 34–42

   survivorship studies 248, 252–3

   usage 43

prophylactic surgery 224

prostate cancer 5

   chemoprevention 126, 221

     short-term outcome measurement 219

   continuum of care 126–8

   economic burden of 485

   end-of-life care 128

   HRQOL studies 128–9, 571

     added value of HRQOL assessments 147–8

     during treatment 9

     future research needs 152–3

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

     literature search 129

     measurement of HRQOL 130–1

     multi-attribute preference systems 84–5

     ongoing assessment 288

     performance of HRQOL measures 148–52

   need for 287–8

   screening 126–7, 228

     short-term outcomes measurement 225–7

   support groups 289

   survivor’s perspective 286–8

     diagnosis 286–7

     long-term survivorship 287–8

     potential contributions of HRQOL assessment 288

     recommendations 288–9

     treatment 287

   survivorship studies 128, 244–5

     instruments used 245–53

   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

     see also cancer treatments

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

   psychometric properties 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)

   survivorship studies 248, 253

psychological impacts

   breast cancer 94–5

   end-of-life studies 266

   on caregivers 331–3

   prostate cancer 134–45

     survivor’s perspective 287–8

   survivorship studies 243, 254

     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

   colorectal cancer studies 190–1

   end-of-life studies 279

   survivorship studies 253, 254–5

quality of care 3

   categories of 291

   patient perspectives 290–2

     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

     functional status 26

   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

   performance across the cancer continuum 44

   prostate cancer studies 126

   psychometric data and validation 34–42

   quality-of-life dimensions 16

   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-life dimensions 16

   type of information elicited 21

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

   measurement properties 83–4

     construct validity 83

     content validity 83

     practical aspects 84

     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

   breast cancer 93, 202–3

     cost-utility analysis 505

     HRQOL studies 106

     treatment decisions 93

   colorectal cancer 178, 203

   impact on cancer patients 201–2

     domains of HRQOL affected 204–5

     measurement 207–8

     patient-reported instruments 207

     toxicity criteria 206–7

   lung cancer 203

   prostate cancer 203

     survivorship studies 245

   see also cancer treatments

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

   see also colorectal cancer

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

   breast cancer studies 96, 97, 105

   colorectal cancer studies 179, 189

   features 56

   lung cancer studies 161

   performance across the cancer continuum 56–7

   prostate cancer studies 126

   psychometric data and validation 46–53

   survivorship studies 249

   translation and cultural adaptation 409–10, 419

     psychometric performance 410–11

   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

     false positive screening results 228–9

     negative screening results 228

   cervical cancer 225–7, 228–9

     false positive screening results 228–9

     negative screening results 228

   colorectal cancer 178, 224–7, 228, 536

     cost-effectiveness analysis 512

   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

     literature review 218

     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

   hybrid conjoint model 324, 325

sensitivity analysis 513–14

sexual dysfunction

   measurement 146–7

   prostate cancer treatment and 131, 150

     survivorship studies 245

Short Form 6D (SF-6D) 87

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

   breast cancer studies 97, 98, 105

     representative scores 103

   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

   performance across the cancer continuum 33–43

   Physical Functioning (PF-10) subscale

     construct map 467–8

     construct validity 470–2

     items design 469

     outcome space 469

   prostate cancer studies 126, 134, 150–1

     representative scores 143

   psychometric data and validation 34–42

   quality of life dimensions 16

   reliability coefficients 473

   subscales perspective 473–4, 477

   summary scale perspective 473–4, 477

   survivorship studies 245–50, 255

   type of information elicited 21

   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

   colorectal cancer studies 189–90

   features 44

   performance across the cancer continuum 44–5

   psychometric data and validation 34–42

   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)

   colorectal cancer studies 179, 189

   quality-of-life dimensions 16

   survivorship studies 249

standard deviation (SD) 393

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

standard gamble (SG) 73, 74, 75–7

   measurement properties 75–7

     construct validity 72, 75–6

     content validity 75

     practical aspects 73, 77

     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

   future research needs 378–80

     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 response benefit 368, 379

     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

     in definitions of quality of life 20–2

     influencing factors 22–3

   measurement of 22

   perceived status 19–21, 27

     in definitions of quality of life 20–2

     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

     construct map 466–8

     items design 468

     measurement model 469–72

     outcome space 468–9

   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

   breast cancer 93, 202–3

     HRQOL studies 106

     treatment decisions 93, 115–16

   colorectal cancer 178, 203

     clinical implications of HRQOL studies 193, 194

     impact on HRQOL 185–8, 192

   impact on cancer patients 201–2

     domains of HRQOL affected 204–5

     measurement 207

     toxicity criteria 206–7

   lung cancer 203

   prophylactic surgery 224

   prostate cancer 150, 203

     survivorship studies 245

   see also cancer treatments

Surveillance, Epidemiology, and End Results (SEER) program 485, 523–4

   combined SEER/administrative data 526–8, 529

   strengths and limitations 525

surveys 530–3, 539

   enhancements to support outcomes research 539

   health knowledge, practices, and outcomes 530–6

   resource use and cost 534–5, 536–8

   strengths and limitations 538

survival curves 33

survivorship studies 241–2, 243

   breast cancer 243–4

   colorectal cancer 245

   data abstraction techniques 242

   HRQOL assessment 9–10, 241–2, 243–5

     adding value 253

     future research needs 255–6

     instruments used HRQOL 245–53

     performance of instruments 253–5

     positive outcomes 242

     qualitative approaches 253, 254–5

   late effects of cancer treatment 244

   literature search 242

   lung cancer 244

   Paradox of Cancer Survivorship 255

   prostate cancer 128, 244–5

     survivor’s perspective 286–9

SWOG Prostate Outcomes Questionnaire 250

Symptom Checklist 179

symptoms 264–5

   control of 265

     breast cancer 110

     end-of-life care 279–80

   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

   measurement properties 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

     psychometric performance 409

     Short Form (CARES-SF) 408–9

   EORTC QLQ-C30 411–12, 419, 420–1

     psychometric performance 412–13, 416

   Functional Assessment of Cancer Therapy-General (FACT-G) 416, 419, 420–1

     psychometric performance 416–18

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

     psychometric performance 407–8

   recommendations 418–21

   Rotterdam Symptom Checklist (RSCL) 409–10, 419

     psychometric performance 410–11

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

   psychometric properties 135–7

   representative scores 144

   survivorship studies 250

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

urinary function

   measurement 147

   prostate cancer treatment and 131, 150

     survivorship studies 245

utilities 231

   cost-utility analysis 70

   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

   measurement properties 72–3

     construct validity 72

     content validity 72

     practical aspects 73

     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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