Subject Index. Berkson bias 72
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1 Subject Index AAAT study 62 Absolute risk reduction (ARR) 40 ACCORD study 62 AD, see Alzheimer s disease ADVANCE study 62 ALLHAT study 62 ALS, see Amyotrophic lateral sclerosis Alzheimer s disease (AD) cerebrospinal fluid biomarkers , 156 clinical significance assessment in trials 45 magnetic resonance imaging biomarkers patient selection for trials trials , 157 biomarkers 112, 113 randomized clinical trial design 9, 10 Amyloid-β, cerebrospinal fluid biomarker in Alzheimer s disease Amyotrophic lateral sclerosis (ALS) ALS Functional Rating Scale 152 ALS untangled 151 Centre for the Advancement of Sustainable Medical Innovation 151, 152 Clinical Research Learning Institute 151 clinical significance assessment in trials 44, 45 clinical versus statistical significance in randomized clinical trial 5 GM6 trials 147, 148 patient perspective clinical trial limitations impact on clinical trials 150, 151 trial community assistance 152, 153 Patient-Centered Outcomes Research Institute 151 patient selection for trials 27 29, 31 trials 129, 157, 158 randomized clinical trial design 19, 20 study population for randomized clinical trial 2 Antiepileptic drugs, see Epilepsy APOE, pharmacogenetic considerations in Alzheimer s disease clinical trials 126, 128, 157 ARR, see Absolute risk reduction ASCOT-LLA study 62 Berkson bias 72 CASMI, see Centre for the Advancement of Sustainable Medical Innovation CDR, see Clinical Dementia Rating Centre for the Advancement of Sustainable Medical Innovation (CASMI) 151, 152 Cerebrospinal fluid (CSF), biomarkers Alzheimer s disease , 156 Parkinson s disease 118, 119, 121, 122 CHANCE study 62 CHARISMA study 62 Clinical Dementia Rating (CDR) 10 Clinical Research Learning Institute (CRLI) 151 Clinical trial, see Randomized clinical trial design Comorbidity bias 72 classification 75 depression comorbidity with neurological disorders 73, 74, 77 epilepsy 76 migraine 74 multiple sclerosis 74 Parkinson s disease
2 randomized clinical trial design considerations 77, 78, 158 treatment outcome effects on neurological disorders 76, 77 CONSORT guidelines 32, 33 CRLI, see Clinical Research Learning Institute CSF, see Cerebrospinal fluid CYP, see Cytochrome P450 Cytochrome P450 (CYP), pharmacogenetic considerations in clinical trials , 158 Dementia with Lewy bodies (DLB), magnetic resonance imaging biomarkers 105 Depression, comorbidity with neurological disorders 73, 74, 77 Developing countries, see Randomized clinical trial design DIGAMI study 62 DLB, see Dementia with Lewy bodies Donepezil, randomized clinical trial design 9 L-DOPA, randomized clinical trial design 11, 12 EDSS, see Expanded Disability Status Scale Epilepsy antiepileptic drug effects added clinical benefits 86, 87 long-term epilepsy patterns 83, 84 outcome patterns 82, 83 patient-related outcome measures 85, 86 prospects for study 91 comorbidities 76 cure definition 85 predictors 89 placebo response 89, 90 prognostic features randomized clinical trial design seizure clusters seizure recurrence patterns 82, 83 ESPRIT study 62 Expanded Disability Status Scale (EDSS) 57, 58, 94, FASTER study 62 FI, see Fragility index Fingolomod, randomized clinical trial design 17 Fragility index (FI) 46 Frontotemporal dementia (FTD) magnetic resonance imaging biomarkers 105, 106 trials 129 FTD, see Frontotemporal dementia Galantamine, randomized clinical trial design 9 Generalizability, see Validity Generalized Unbiased Interaction Detection and Estimation (GUIDE) 52, 54 Ginkgo biloba, randomized clinical trial design 9 Glatiramer acetate, randomized clinical trial design 17 GM6, amyotrophic lateral sclerosis trials 147, 148 GUIDE, see Generalized Unbiased Interaction Detection and Estimation HAEST study 62 HD, see Huntington s disease Headache disorders migraine comorbidities 74 randomized clinical trial design HOPE study 61 Huntington s disease (HD) trials 130 study population for randomized clinical trial 2 IDI, see Integrated Discrimination Improvement Integrated Discrimination Improvement (IDI) 55 IRIS study 62 JPAD study 62 JUPITER study 62 LIPID study 62 Magnetic resonance imaging (MRI) biomarkers for clinical trials Alzheimer s disease dementia with Lewy bodies 105 frontotemporal dementia 105, 106 overview 101, 102, 156 Parkinson s disease 106, 107 progressive supranuclear palsy syndrome 106 prospects for study 107 multiple sclerosis studies 18, 93 MATCH study 62 MCI, see Mild cognitive impairment MCID, see Minimal clinically important difference MEGA study 62 Subject Index 165
3 Memantine, randomized clinical trial design 9 Migraine, see Headache disorders Mild cognitive impairment (MCI), randomized clinical trial design 9, 10 Mini-Mental State Examination (MMSE) 10 Minimal clinically important difference (MCID) MMSE, see Mini-Mental State Examination MOSES study 61 MRI, see Magnetic resonance imaging MS, see Multiple sclerosis Multiple sclerosis (MS) comorbidities 74 functional decline assessment long-term extension randomized clinical trials long-term observational studies overview interferon-β trials 94, magnetic resonance imaging studies 18, 93 randomized clinical trial design tree-shaped algorithms for prognosis and treatment 56 58, 158, 159 NASCET study 62 Natalizumab, randomized clinical trial design 17, 99 National Institutes of Health Stroke Scale (NIHSS) 64, 65 NAVIGATOR study 62 Net Reclassification Improvement (NRI) 55, 56 Neurogranin, cerebrospinal fluid biomarker in NIHSS, see National Institutes of Health Stroke Scale NRI, see Net Reclassification Improvement NTT, see Number needed to treat Number needed to treat (NTT) 40, 48 ONTARGET study 61 ORIGIN study 62 Orphan Disease Act 149 Parkinson s disease (PD) cerebrospinal fluid biomarkers 118, 119, 121, 122 comorbidities magnetic resonance imaging biomarkers 106, 107 trials , 158 biomarkers randomized clinical trial design early diagnosis 25, 26 overview 9 12 patient selection 27, 28, 30 Patient-Centered Outcomes Research Institute (PCORI) 151 PatientsLikeMe 150, 151 PCORI, see Patient-Centered Outcomes Research Institute PD, see Parkinson s disease PET, see Positron emission tomography POPADAD study 62 Positron emission tomography (PET) biomarkers in clinical trials Alzheimer s disease 112, 113 Parkinson s disease prospects for study 114, 115, 156, 157 stroke 113, 114 overview 109, 110 Progressive supranuclear palsy syndrome (PSPS), magnetic resonance imaging biomarkers 106 PSPS, see Progressive supranuclear palsy syndrome Randomized clinical trial design adverse events 5, 6 alternative design models 6 blinding 4 comorbidity consideration 77, 78 CONSORT guidelines 32, 33 developing countries data extraction 138 growth in trials 143, 144 inclusion criteria 138 literature search strategy 137, 138 methodological considerations 140, 142, 143 methodological quality 141, 145 overview 136, 137, 159 pathological fields 139, 140, 144 phases of trials and needs 144, 145 study selection 138 temporal evolution and geographic distribution 138, 139, 141, 143 diagnosis 3, 25, 155 disease-specific design amyotrophic lateral sclerosis 19, 20 dementia 9, Subject Index
4 epilepsy headache multiple sclerosis overview 9 Parkinson s disease stroke 20, 21 duration 5 end point selection 4 overview 1, 2 patient selection age and sex 27 29, 155, 156 ethnicity 30, 31, 155, 156 overview 2, 3 recruitment site 26 sample representativeness 31, 32 personalized and precision medicine impact 161, 162 randomization of patients 3, 4 significance assessment clinical versus statistical significance 5 statistical analysis, see Statistics validity, internal versus external 6 RANTTAS study 65 RECPAM, see Recursive Partitioning and Amalgamation Recursive Partitioning and Amalgamation (RECPAM) 52, 53, 55 Relative risk (RR) 40, 41 Riluzole, amyotrophic lateral sclerosis trials 5, 19 Rivastigmine, randomized clinical trial design 9 RR, see Relative risk SAMMPRIS study 62 SAPPHIRE study 62 Seizure, see Epilepsy SIDES, see Subgroup Identification based on Differential Effect Search Single-photon (SPECT) biomarkers in clinical trials Alzheimer s disease 112, 113 Parkinson s disease prospects for study 114, 115, 156, 157 stroke 113, 114 overview 109, 110 SNAP-25, cerebrospinal fluid biomarker in Sniff nasal inspiratory pressure test (SNIP) 55, 56 SNIP, see Sniff nasal inspiratory pressure test SOD, see Superoxide dismutase SPARCL study 62 SPECT, see Single-photon emission computed tomography SPRINT study 61 Statistics Bayesian inference 39, 40, 47 classical inference confidence intervals 39 hypothesis testing 38 significance levels 38, 39 generalizability of randomized clinical trials outcome measures and follow-up 43 termination of trials 43 threats to generalizability 42, 43 metrics for randomized clinical trials 40, 41 significance assessment clinical versus statistical 5 size of randomized clinical trials 41, 42 stratified medicine 50, 51 tree-based methods applications and extensions performance benchmarking prognosis and treatment Stroke outcome measures in clinical trials acute stroke trials heterogeneity of outcomes 66, 67 prevention trials prospects 67 biomarkers 113, 114 randomized clinical trial design 20, 21 Subgroup Identification based on Differential Effect Search (SIDES) Superoxide dismutase (SOD), pharmacogenetic considerations in clinical trials 129 α-synuclein, cerebrospinal fluid biomarker Parkinson s disease 118, 121 Tau, cerebrospinal fluid biomarker in Alzheimer s disease 118, 120, 121 TRANSCEND study 61 Triptans, randomized clinical trial design 13 Subject Index 167
5 VADT, see Veterans Affairs Diabetes Trial Validity generalizability of randomized clinical trials outcome measures and follow-up 43 termination of trials 43 threats to generalizability 42, 43 internal versus external 6 Vascular dementia, randomized clinical trial design 9, 10 Veterans Affairs Diabetes Trial (VADT) 62 VISTA 65 WASID study Subject Index
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