Difference between revisions of "Term Lists"

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Go back to [[OCI:Main Page]]
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'''RCT Schema Terms'''
 
'''RCT Schema Terms'''
 +
 +
The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: [[Media:ForCTO_031207.doc|ForCTO_031207.doc]]
 +
 +
We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:
 +
[[Media:ForCTO_041807.doc|ForCTO_041807.doc]]
 +
 +
[[High-level_Concepts_v0.2|On this page]] there is a draft positioning of some of our terms into the high level concept list drafted by Richard.
  
 
*Secondary-study
 
*Secondary-study
Line 71: Line 81:
 
'''Foundations of Clinical Research (Scheuermann list)'''
 
'''Foundations of Clinical Research (Scheuermann list)'''
  
−
*Outcome assessment
+
#Outcome assessment
−
Morbidity, mortality, length of stay, readmission
+
##Morbidity
−
Physical, social and psychological well-being
+
##mortality
−
Patient satisfaction, patient preference, self-assessment of functional capacity, quality of life
+
##length of stay
−
 
+
##readmission
−
*Disablement Model
+
##Physical
−
Pathology=>impairment (organ system dysfunction)=>functional limitation (restrictions in ADL)=>disability (limitations in role performance as a member of society)
+
##social
−
 
+
##psychological well-being
−
*Acute conditions and chronic conditions
+
##Patient satisfaction
−
 
+
##patient preference
−
*Sources of knowledge
+
##self-assessment of functional capacity
−
Tradition (precedent)
+
##quality of life
−
Authority (trusted expert)
+
#Acute conditions and chronic conditions
−
Trial and error
+
#Sources of knowledge
−
Logical reasoning - Deductive reasoning, Inductive reasoning
+
##Tradition (precedent)
−
Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.
+
##Authority (trusted expert)
−
 
+
##Trial and error
−
Types of research
+
##Logical reasoning - Deductive reasoning, Inductive reasoning
−
Basic vs applied
+
##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.
−
Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
+
#Types of research
−
Case study – description of one or more patients
+
##Basic vs applied
−
Developmental research – description of pattern of change over time
+
##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
−
Normative research – establishing normal values
+
##Case study – description of one or more patients
−
Qualitative research – gathering data through interview or observation
+
##Developmental research – description of pattern of change over time
−
+
##Normative research – establishing normal values
−
Cohort or case-control studies – establish associations
+
##Qualitative research – gathering data through interview or observation
−
Methodological studies – establish reliability and validity of a new method
+
##Cohort or case-control studies – establish associations
−
Secondary analysis – exploring new relationships in old data
+
##Methodological studies – establish reliability and validity of a new method
−
Historical research
+
##Secondary analysis – exploring new relationships in old data
−
 
+
##Historical research
−
Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
+
##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
−
Single-subject design
+
##Single-subject design
−
Sequential clinical trial
+
##Sequential clinical trial
−
Evaluation research – assessment of the success of a program or policy
+
##Evaluation research – assessment of the success of a program or policy
−
Quasi-experimental research
+
##Quasi-experimental research
−
Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
+
##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
−
 
+
##Qualitative vs quantitative research
−
Qualitative vs quantitative research
+
#Research process
−
 
+
##Phase I: Identify the research question
−
Research process
+
###Identify the research problem
−
Phase I: Identify the research question
+
###Review of literature to provide a theoretical framework
−
Identify the research problem
+
###Identify variables
−
Review of literature to provide a theoretical framework
+
###State hypothesis
−
Identify variables
+
##Phase II: Design the study
−
State hypothesis
+
###Design the protocol
−
Phase II: Design the study
+
###Choose a sample
−
Design the protocol
+
##Phase III: Methods
−
Choose a sample
+
###Collect data
−
Phase III: Methods
+
###Reduce data
−
Collect data
+
##Phase IV: Data analysis
−
Reduce data
+
###Analyze data
−
Phase IV: Data analysis
+
###Interpret findings
−
Analyze data
+
##Phase V: Communication
−
Interpret findings
+
###Report findings
−
Phase V: Communication
+
###Suggest future studies
−
Report findings
+
#Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena.  A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.
−
Suggest future studies
+
#Hypothesis - specific predictions based on a theory.
−
 
+
#Concepts – abstraction that allow us to classify natural phenomena and empirical observations
−
Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena.  A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.
+
#Constructs – concepts that represent non-observable behaviors or events
−
 
+
#Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them
−
Hypothesis - specific predictions based on a theory.
+
#Propositions – state the relationships between variables
−
 
+
##Hierarchical – show vertical relationships
−
Concepts – abstraction that allow us to classify natural phenomena and empirical observations
+
##Temporal – order concepts in time and states a sequence of events
−
 
+
##Quantitative – frequency or duration of a specific behavior
−
Constructs – concepts that represent non-observable behaviors or events
+
#Model – symbolic representation of the elements of a system
−
 
+
##Physical
−
Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them
+
##Schematic
−
 
+
##Process
−
Propositions – state the relationships between variables
+
##Statistical
−
Hierarchical – show vertical relationships
+
#Inductive theory – theory based on empirically verifiable observations
−
Temporal – order concepts in time and states a sequence of events
+
#Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations
−
Quantitative – frequency or duration of a specific behavior
+
#Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.
−
 
+
#Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts
−
Model – symbolic representation of the elements of a system
+
#Deduction – theory testing
−
Physical
+
#Induction – theory development
−
Schematic
 
−
Process
 
−
Statistical
 
−
 
 
−
Inductive theory – theory based on empirically verifiable observations
 
−
 
 
−
Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations
 
−
 
 
−
Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.
 
−
 
 
−
Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts
 
  
−
Deduction – theory testing
 
  
−
Induction – theory development
+
Terms collected by Wenle Zhao from MUSC
 +
* adherence
 +
* accrual rate
 +
* active control
 +
* adjustment
 +
* type I error
 +
* type II error
 +
* balanced design
 +
* baseline
 +
* bias
 +
* prognostic factor
 +
* confounding factor
 +
* block
 +
* permuted block randomization
 +
* minimization randomization
 +
* biased coin randomizaiton
 +
* urn randomization
 +
* response adaptive randomization
 +
* play the winner
 +
* random play the winner
 +
* case report
 +
* case report form
 +
* data clarification request
 +
* data clarification query
 +
* censoring
 +
* efficacy
 +
* safety
 +
* treatment
 +
* intervention
 +
* crossover
 +
* comparative treatment efficacy
 +
* interim analysis
 +
* deterministic
 +
* stop rule
 +
* phase I trial
 +
* phase II trial
 +
* phase III trial
 +
* phase IV trial
 +
* dichotomous
 +
* dose finding
 +
* dropouts
 +
* eligibility
 +
* experiment
 +
* estimate
 +
* follow-up
 +
* sequential design
 +
* group sequential
 +
* endpoint
 +
* intention to treat
 +
* data-dependent stopping
 +
* lost to follow-up
 +
* meta-analysis
 +
* monitoring
 +
* data and safety monitoring board
 +
* institutional review board
 +
* null hypothesis
 +
* alternative hypothesis
 +
* nesting design
 +
* observation
 +
* odds
 +
* odds ratio
 +
* parallel design
 +
* plecabo
 +
* power
 +
* sample size
 +
* primary outcome
 +
* surrogate outcome
 +
* protocol
 +
* per-protocol population
 +
* intention to treat population
 +
* pseudorandom
 +
* p-value
 +
* treatment allocation
 +
* imbalance
 +
* selection bias
 +
* expectation bias
 +
* statistical significant
 +
* stratification
 +
* univariable
 +
* multivariable
 +
* adverse event
 +
* serious adverse event
 +
* cluster randomization
 +
* community intervention trial
 +
* coding
 +
* complaince
 +
* protocal complaince
 +
* protocol violation
 +
* protocol exception
 +
* auditing
 +
* allocation ratio
 +
* assessment
 +
* assessment bias
 +
* early termination
 +
* informed consent
 +
* withdrawal consent
 +
* source document
 +
* principal investigator
 +
* study coordinator
 +
* data management
 +
* project management
 +
* regulatory management
 +
* case-control design
 +
* blinding
 +
* double blinding
 +
* tocxicity
 +
* cohort
 +
* evaluation
 +
* confidence interval
 +
* confirmatory trial
 +
* confounder
 +
* CONSORT statement
 +
* constrain
 +
* context
 +
* diagnostic trial
 +
* controls
 +
* concurrent controls
 +
* historic controls
 +
* crossover trial
 +
* carryover effect
 +
* recruitment
 +
* washout period
 +
* equivalence trials
 +
* statistical analysis plan
 +
* data management plan
 +
* project management plan
 +
* sponsor
 +
* inclusion criteria
 +
* equipoise
 +
* exclusion criteria
 +
* factorial design
 +
* interaction
 +
* main effect
 +
* one-sided test
 +
* two-sided test
 +
* missing data
 +
* imputation of missing data
 +
* investigator competence
 +
* local control
 +
* masking
 +
* double masking
 +
* triple masking
 +
* trilple blinding
 +
* data safety monitoring committee
 +
* minority representation
 +
* negative findings
 +
* positive findings
 +
* noninferiority
 +
* nonadherence
 +
* sample size inflation
 +
* noncomplaince
 +
* repeat measurement
 +
* time to event
 +
* medical safety monitor
 +
* pivotal trials
 +
* prevention trials
 +
* assessment schedule
 +
* data collection schedule
 +
* quality assurance
 +
* electronic data capture
 +
* clinical trial management system
 +
* database
 +
* analysis datasets
 +
* retrospective design
 +
* screening
 +
* sham treatment
 +
* steering committee
 +
* excecutive committee
 +
* baseline comparability
 +
* optimal allocation
 +
* Neyman allocation
 +
* response
 +
* intersubject
 +
* subject
 +
* intrasubject
 +
* population
 +
* varibility
 +
* binormial
 +
* continous
 +
* derived data
 +
* discret
 +
* primary efficacy
 +
* primary response
 +
* placebo controlled
 +
* single-site
 +
* single-center
 +
* multi-site
 +
* multi-center
 +
* superiority
 +
* bioequivalence
 +
* treatment group
 +
* titration
 +
* tolerability
 +
* phase IIA
 +
* phase IIB
 +
* phase IIB
 +
* investigational new drug (IND) application
 +
* new drug application (NDA)
 +
* over-the -count (OTC)
 +
* drug lot
 +
* treatment-emergenet adverse event (TEAE)
 +
* as-treated
 +
* cross-sectional analysis

Latest revision as of 11:52, 6 July 2007

Go back to OCI:Main Page


RCT Schema Terms

The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: ForCTO_031207.doc

We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document: ForCTO_041807.doc

On this page there is a draft positioning of some of our terms into the high level concept list drafted by Richard.

  • Secondary-study
  • Trial
  • Anchored-time
  • Interval
  • Double-anchored-interval
  • Single-anchored-interval
  • Timepoint
  • Time-range
  • Duration
  • Date
  • Exclusion-rule
  • Inclusion-rule
  • Recruitment-flowchart
  • Primary-recruitment-flowchart
  • Recruited-population
  • Randomized-population
  • Enrolled-population
  • Eligible-population
  • Screened-population
  • Excluded population
  • Analyzed population
  • Crossover population
  • Study-arm population
  • Site-enrollment
  • Protocol-concept
  • Follow-up activity
  • Protocol-change
  • Treatment-assignment
  • Protocol
  • Executed-protocol
  • Intended-protocol
  • Reason
  • Withdrawal-reason
  • Outcomes-followup
  • Secondary-study-protocol
  • Intended-secondary-study-protocol
  • Executed-secondary-study-protocol
  • Stopping-rule
  • Cost
  • Outcome
  • Baseline
  • Study-outcome
  • Primary-outcome
  • Secondary-outcome
  • Ancillary-outcome
  • Side-effect
  • Study-site
  • Trial-participant
  • Investigator
  • Study-committee
  • Funder
  • Institution
  • Blinding
  • Blinding-method
  • Intervention-step
  • Drug-step
  • Non-drug-intervention-step
  • Intervention-arm
  • Comparison-arm
  • Experimental-arm
  • Cointervention*
  • Intervention*
  • Procedure
  • Device
  • Drug
  • No-treatment
  • Placebo

Foundations of Clinical Research (Scheuermann list)

  1. Outcome assessment
    1. Morbidity
    2. mortality
    3. length of stay
    4. readmission
    5. Physical
    6. social
    7. psychological well-being
    8. Patient satisfaction
    9. patient preference
    10. self-assessment of functional capacity
    11. quality of life
  2. Acute conditions and chronic conditions
  3. Sources of knowledge
    1. Tradition (precedent)
    2. Authority (trusted expert)
    3. Trial and error
    4. Logical reasoning - Deductive reasoning, Inductive reasoning
    5. Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.
  4. Types of research
    1. Basic vs applied
    2. Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
    3. Case study – description of one or more patients
    4. Developmental research – description of pattern of change over time
    5. Normative research – establishing normal values
    6. Qualitative research – gathering data through interview or observation
    7. Cohort or case-control studies – establish associations
    8. Methodological studies – establish reliability and validity of a new method
    9. Secondary analysis – exploring new relationships in old data
    10. Historical research
    11. Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
    12. Single-subject design
    13. Sequential clinical trial
    14. Evaluation research – assessment of the success of a program or policy
    15. Quasi-experimental research
    16. Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
    17. Qualitative vs quantitative research
  5. Research process
    1. Phase I: Identify the research question
      1. Identify the research problem
      2. Review of literature to provide a theoretical framework
      3. Identify variables
      4. State hypothesis
    2. Phase II: Design the study
      1. Design the protocol
      2. Choose a sample
    3. Phase III: Methods
      1. Collect data
      2. Reduce data
    4. Phase IV: Data analysis
      1. Analyze data
      2. Interpret findings
    5. Phase V: Communication
      1. Report findings
      2. Suggest future studies
  6. Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.
  7. Hypothesis - specific predictions based on a theory.
  8. Concepts – abstraction that allow us to classify natural phenomena and empirical observations
  9. Constructs – concepts that represent non-observable behaviors or events
  10. Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them
  11. Propositions – state the relationships between variables
    1. Hierarchical – show vertical relationships
    2. Temporal – order concepts in time and states a sequence of events
    3. Quantitative – frequency or duration of a specific behavior
  12. Model – symbolic representation of the elements of a system
    1. Physical
    2. Schematic
    3. Process
    4. Statistical
  13. Inductive theory – theory based on empirically verifiable observations
  14. Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations
  15. Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.
  16. Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts
  17. Deduction – theory testing
  18. Induction – theory development


Terms collected by Wenle Zhao from MUSC

  • adherence
  • accrual rate
  • active control
  • adjustment
  • type I error
  • type II error
  • balanced design
  • baseline
  • bias
  • prognostic factor
  • confounding factor
  • block
  • permuted block randomization
  • minimization randomization
  • biased coin randomizaiton
  • urn randomization
  • response adaptive randomization
  • play the winner
  • random play the winner
  • case report
  • case report form
  • data clarification request
  • data clarification query
  • censoring
  • efficacy
  • safety
  • treatment
  • intervention
  • crossover
  • comparative treatment efficacy
  • interim analysis
  • deterministic
  • stop rule
  • phase I trial
  • phase II trial
  • phase III trial
  • phase IV trial
  • dichotomous
  • dose finding
  • dropouts
  • eligibility
  • experiment
  • estimate
  • follow-up
  • sequential design
  • group sequential
  • endpoint
  • intention to treat
  • data-dependent stopping
  • lost to follow-up
  • meta-analysis
  • monitoring
  • data and safety monitoring board
  • institutional review board
  • null hypothesis
  • alternative hypothesis
  • nesting design
  • observation
  • odds
  • odds ratio
  • parallel design
  • plecabo
  • power
  • sample size
  • primary outcome
  • surrogate outcome
  • protocol
  • per-protocol population
  • intention to treat population
  • pseudorandom
  • p-value
  • treatment allocation
  • imbalance
  • selection bias
  • expectation bias
  • statistical significant
  • stratification
  • univariable
  • multivariable
  • adverse event
  • serious adverse event
  • cluster randomization
  • community intervention trial
  • coding
  • complaince
  • protocal complaince
  • protocol violation
  • protocol exception
  • auditing
  • allocation ratio
  • assessment
  • assessment bias
  • early termination
  • informed consent
  • withdrawal consent
  • source document
  • principal investigator
  • study coordinator
  • data management
  • project management
  • regulatory management
  • case-control design
  • blinding
  • double blinding
  • tocxicity
  • cohort
  • evaluation
  • confidence interval
  • confirmatory trial
  • confounder
  • CONSORT statement
  • constrain
  • context
  • diagnostic trial
  • controls
  • concurrent controls
  • historic controls
  • crossover trial
  • carryover effect
  • recruitment
  • washout period
  • equivalence trials
  • statistical analysis plan
  • data management plan
  • project management plan
  • sponsor
  • inclusion criteria
  • equipoise
  • exclusion criteria
  • factorial design
  • interaction
  • main effect
  • one-sided test
  • two-sided test
  • missing data
  • imputation of missing data
  • investigator competence
  • local control
  • masking
  • double masking
  • triple masking
  • trilple blinding
  • data safety monitoring committee
  • minority representation
  • negative findings
  • positive findings
  • noninferiority
  • nonadherence
  • sample size inflation
  • noncomplaince
  • repeat measurement
  • time to event
  • medical safety monitor
  • pivotal trials
  • prevention trials
  • assessment schedule
  • data collection schedule
  • quality assurance
  • electronic data capture
  • clinical trial management system
  • database
  • analysis datasets
  • retrospective design
  • screening
  • sham treatment
  • steering committee
  • excecutive committee
  • baseline comparability
  • optimal allocation
  • Neyman allocation
  • response
  • intersubject
  • subject
  • intrasubject
  • population
  • varibility
  • binormial
  • continous
  • derived data
  • discret
  • primary efficacy
  • primary response
  • placebo controlled
  • single-site
  • single-center
  • multi-site
  • multi-center
  • superiority
  • bioequivalence
  • treatment group
  • titration
  • tolerability
  • phase IIA
  • phase IIB
  • phase IIB
  • investigational new drug (IND) application
  • new drug application (NDA)
  • over-the -count (OTC)
  • drug lot
  • treatment-emergenet adverse event (TEAE)
  • as-treated
  • cross-sectional analysis
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