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''' | ||
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+ | 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 | ||
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#Deduction – theory testing | #Deduction – theory testing | ||
#Induction – theory development | #Induction – theory development | ||
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+ | 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)
- Outcome assessment
- Morbidity
- mortality
- length of stay
- readmission
- Physical
- social
- psychological well-being
- Patient satisfaction
- patient preference
- self-assessment of functional capacity
- quality of life
- Acute conditions and chronic conditions
- Sources of knowledge
- Tradition (precedent)
- Authority (trusted expert)
- Trial and error
- Logical reasoning - Deductive reasoning, Inductive reasoning
- Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.
- Types of research
- Basic vs applied
- Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
- Case study – description of one or more patients
- Developmental research – description of pattern of change over time
- Normative research – establishing normal values
- Qualitative research – gathering data through interview or observation
- Cohort or case-control studies – establish associations
- Methodological studies – establish reliability and validity of a new method
- 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
- Single-subject design
- Sequential clinical trial
- Evaluation research – assessment of the success of a program or policy
- Quasi-experimental research
- Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
- Qualitative vs quantitative research
- Research process
- Phase I: Identify the research question
- Identify the research problem
- Review of literature to provide a theoretical framework
- Identify variables
- State hypothesis
- Phase II: Design the study
- Design the protocol
- Choose a sample
- Phase III: Methods
- Collect data
- Reduce data
- Phase IV: Data analysis
- Analyze data
- Interpret findings
- Phase V: Communication
- Report findings
- Suggest future studies
- Phase I: Identify the research question
- 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.
- Hypothesis - specific predictions based on a theory.
- Concepts – abstraction that allow us to classify natural phenomena and empirical observations
- 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
- Propositions – state the relationships between variables
- Hierarchical – show vertical relationships
- Temporal – order concepts in time and states a sequence of events
- Quantitative – frequency or duration of a specific behavior
- Model – symbolic representation of the elements of a system
- Physical
- 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