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2026-06-05T20:07:03Z
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https://www.bioontology.org//mediawiki/index.php?title=High-level_Concepts_v0.2&diff=5599
High-level Concepts v0.2
2007-05-10T15:37:46Z
<p>Wjzheng: /* High-Level Concepts version 0.2 */</p>
<hr />
<div>Go back to [[CTO:Main Page]]<br />
<br />
==High-Level Concepts version 0.2==<br />
Initial High-level Concepts in black font<br />
<br />
Additions from Simona in <font style=color:blue>blue</font> font<br />
<br />
Additions from Richard in <font style=color:green>green</font> font<br />
<br />
Additions from Wenle and Jim in <font style=color:orange>orange</font> font<br />
*Events<br />
*Periods<br />
**Study phases<br />
***<font style="color:orange">patient screening phase - reach out patients for potential study subjects<br />
***subject enrollment phase - obtain informed consent for eligible subejcts<br />
***baseline phase - perform assessment before study treatment<br />
***treatment phase - treat study subjects<br />
***follow-up phase - obtain assessments after study treatment</font><br />
**Protocol phases <br />
*Sequence of events<br />
*Study designs<br />
**<font style="color:green">Descriptive research – research in which the investigator attempts to describe a group of individuals based on a set of variable in order to document their characteristics<br />
***Case study – description of one or more patients<br />
***Developmental research – description of pattern of change over time<br />
***Normative research – establishing normal values<br />
***Qualitative research – gathering data through interview or observation<br />
***Evaluation research – objectively assess a program or policy by describing the needs for the services or policy, often using surveys or questionaires<br />
**Exploratory research<br />
***Cohort or case-control studies – establish associations through epidemiological studies<br />
***Methodological studies – establish reliability and validity of a new method<br />
***Secondary analysis – exploring new relationships in old data<br />
***Historical research – reconstructing the past through an assessment of archives or other records<br />
**Experimental research<br />
***Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br />
****Single-subject design<br />
****Sequential clinical trial<br />
****Evaluation research – assessment of the success of a program or policy<br />
***Quasi-experimental research<br />
***Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br />
</font><br />
*Research types<br />
**<font style="color:blue">Randomized Clinical Trial</font><font style="color:orange"> - can we change this term to "Clinical Trial"?<br />
***phase I - dose finding, safety<br />
***phase II - dose finding - efficacy<br />
****phase II a - small scale feasibility<br />
****phase II b - randomized comparative using intermediate endpoints<br />
***phase III trial - Randomized comparative with definitive clinical endpoints<br />
***phase IV trial - post marketing safety and efficacy<br />
</font><br />
*Methods<br />
*Stakeholders<br />
**Participants<br />
**Investigators<br />
**Monitors<br />
***<font style="color:blue">Study committee</font><br />
**Sponsors<br />
*Populations<br />
**<font style="color:blue">Recruited population<br />
***Randomized population<br />
***Enrolled population<br />
***Eligible population<br />
***Screened population</font><br />
***<font style="color:orange">Completer population<br />
***Premature termination population</font><br />
**<font style="color:blue">Excluded population<br />
***Excluded postrandomization population<br />
***Not-randomized-population<br />
***Not-enrolled-population<br />
***Not-eligible-population</font><br />
**<font style="color:blue">Analyzed-population<br />
***All subjects<br />
***Study arm population<br />
***Crossover population<br />
***Subgroup population</font><br />
***<font style="color:orange">Intent-to-treat population - based on randomization<br />
***per-protocol population - exclude those with servious protocol violations</font><br />
*Variables<br />
**Independent variable<br />
***<font style="color:blue">Intervention<br />
****Procedure<br />
****Device implantation<br />
****Drug treatment<br />
****Placebo treatment<br />
****Sham procedure<br />
****Usual care<br />
****Counseling<br />
***Cointervention</font><br />
**Dependent variable (responding variable)<br />
***Outcome<br />
****<font style="color:blue">Primary outcome<br />
****Secondary outcome<br />
****Adverse event/Side effect<br />
****Ancillary outcome</font><br />
****<font style="color:orange">efficacy assessment<br />
****safety assessment<br />
*****adverse events<br />
******severity<br />
******relationship to study treatment<br />
******serious</font><br />
*Digital and paper artifacts<br />
*Protocol<br />
**<font style="color:blue">Intended protocol<br />
**Executed protocol<br />
**Protocol change</font><br />
*Protocol application<br />
**Assessments<br />
***Experimental assays<br />
***Observations<br />
****Physical exam<br />
***Interview<br />
***Self-assessments<br />
**Data analysis<br />
***Data partitioning<br />
***Data transformation<br />
***Data pooling<br />
***Data summarization<br />
***Reliability<br />
***Correlation<br />
**Specimen processing<br />
***Procurement<br />
***Specimen partitioning/purification<br />
***Specimen storage<br />
**<font style="color:blue">Treatment assignment<br />
**Blinding <br />
**Follow-up</font><br />
*Measurement scale<br />
**Nominal<br />
**Ordinal<br />
**Interval<br />
**Ratio<br />
*Participant characteristic (phenotype)<br />
**<font style="color:blue">Baseline characteristic</font></div>
Wjzheng
https://www.bioontology.org//mediawiki/index.php?title=Term_Lists&diff=5344
Term Lists
2007-04-19T13:33:27Z
<p>Wjzheng: </p>
<hr />
<div>'''RCT Schema Terms'''<br />
<br />
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]]<br />
<br />
We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document:<br />
[[Media:ForCTO_041807.doc|ForCTO_041807.doc]]<br />
<br />
*Secondary-study<br />
*Trial<br />
*Anchored-time<br />
*Interval<br />
*Double-anchored-interval<br />
*Single-anchored-interval<br />
*Timepoint<br />
*Time-range<br />
*Duration<br />
*Date<br />
*Exclusion-rule<br />
*Inclusion-rule<br />
*Recruitment-flowchart<br />
*Primary-recruitment-flowchart<br />
*Recruited-population<br />
*Randomized-population<br />
*Enrolled-population<br />
*Eligible-population<br />
*Screened-population<br />
*Excluded population<br />
*Analyzed population<br />
*Crossover population<br />
*Study-arm population<br />
*Site-enrollment<br />
*Protocol-concept<br />
*Follow-up activity<br />
*Protocol-change<br />
*Treatment-assignment<br />
*Protocol<br />
*Executed-protocol<br />
*Intended-protocol<br />
*Reason<br />
*Withdrawal-reason<br />
*Outcomes-followup<br />
*Secondary-study-protocol<br />
*Intended-secondary-study-protocol<br />
*Executed-secondary-study-protocol<br />
*Stopping-rule<br />
*Cost<br />
*Outcome<br />
*Baseline<br />
*Study-outcome<br />
*Primary-outcome<br />
*Secondary-outcome<br />
*Ancillary-outcome<br />
*Side-effect<br />
*Study-site<br />
*Trial-participant<br />
*Investigator<br />
*Study-committee<br />
*Funder<br />
*Institution<br />
*Blinding<br />
*Blinding-method<br />
*Intervention-step<br />
*Drug-step<br />
*Non-drug-intervention-step<br />
*Intervention-arm<br />
*Comparison-arm<br />
*Experimental-arm<br />
*Cointervention*<br />
*Intervention*<br />
*Procedure<br />
*Device<br />
*Drug<br />
*No-treatment<br />
*Placebo<br />
<br />
'''Foundations of Clinical Research (Scheuermann list)'''<br />
<br />
#Outcome assessment<br />
##Morbidity<br />
##mortality<br />
##length of stay<br />
##readmission<br />
##Physical<br />
##social<br />
##psychological well-being<br />
##Patient satisfaction<br />
##patient preference<br />
##self-assessment of functional capacity<br />
##quality of life<br />
#Acute conditions and chronic conditions<br />
#Sources of knowledge<br />
##Tradition (precedent)<br />
##Authority (trusted expert)<br />
##Trial and error<br />
##Logical reasoning - Deductive reasoning, Inductive reasoning<br />
##Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.<br />
#Types of research<br />
##Basic vs applied<br />
##Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)<br />
##Case study – description of one or more patients<br />
##Developmental research – description of pattern of change over time<br />
##Normative research – establishing normal values<br />
##Qualitative research – gathering data through interview or observation<br />
##Cohort or case-control studies – establish associations<br />
##Methodological studies – establish reliability and validity of a new method<br />
##Secondary analysis – exploring new relationships in old data<br />
##Historical research<br />
##Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes<br />
##Single-subject design<br />
##Sequential clinical trial<br />
##Evaluation research – assessment of the success of a program or policy<br />
##Quasi-experimental research<br />
##Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis<br />
##Qualitative vs quantitative research<br />
#Research process<br />
##Phase I: Identify the research question<br />
###Identify the research problem<br />
###Review of literature to provide a theoretical framework<br />
###Identify variables<br />
###State hypothesis<br />
##Phase II: Design the study<br />
###Design the protocol<br />
###Choose a sample<br />
##Phase III: Methods<br />
###Collect data<br />
###Reduce data<br />
##Phase IV: Data analysis<br />
###Analyze data<br />
###Interpret findings<br />
##Phase V: Communication<br />
###Report findings<br />
###Suggest future studies<br />
#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.<br />
#Hypothesis - specific predictions based on a theory.<br />
#Concepts – abstraction that allow us to classify natural phenomena and empirical observations<br />
#Constructs – concepts that represent non-observable behaviors or events<br />
#Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them<br />
#Propositions – state the relationships between variables<br />
##Hierarchical – show vertical relationships<br />
##Temporal – order concepts in time and states a sequence of events<br />
##Quantitative – frequency or duration of a specific behavior<br />
#Model – symbolic representation of the elements of a system<br />
##Physical<br />
##Schematic<br />
##Process<br />
##Statistical<br />
#Inductive theory – theory based on empirically verifiable observations<br />
#Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations<br />
#Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.<br />
#Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts<br />
#Deduction – theory testing<br />
#Induction – theory development<br />
<br />
<br />
Terms collected by Wenle Zhao from MUSC<br />
* adherence<br />
* accrual rate<br />
* active control<br />
* adjustment<br />
* type I error<br />
* type II error<br />
* balanced design<br />
* baseline<br />
* bias<br />
* prognostic factor<br />
* confounding factor<br />
* block<br />
* permuted block randomization<br />
* minimization randomization<br />
* biased coin randomizaiton<br />
* urn randomization<br />
* response adaptive randomization<br />
* play the winner <br />
* random play the winner<br />
* case report<br />
* case report form<br />
* data clarification request<br />
* data clarification query<br />
* censoring<br />
* efficacy<br />
* safety<br />
* treatment<br />
* intervention<br />
* crossover<br />
* comparative treatment efficacy<br />
* interim analysis<br />
* deterministic<br />
* stop rule<br />
* phase I trial<br />
* phase II trial<br />
* phase III trial<br />
* phase IV trial<br />
* dichotomous<br />
* dose finding<br />
* dropouts<br />
* eligibility<br />
* experiment<br />
* estimate<br />
* follow-up<br />
* sequential design<br />
* group sequential<br />
* endpoint<br />
* intention to treat<br />
* data-dependent stopping<br />
* lost to follow-up<br />
* meta-analysis<br />
* monitoring<br />
* data and safety monitoring board<br />
* institutional review board<br />
* null hypothesis<br />
* alternative hypothesis<br />
* nesting design<br />
* observation<br />
* odds<br />
* odds ratio<br />
* parallel design<br />
* plecabo<br />
* power<br />
* sample size<br />
* primary outcome<br />
* surrogate outcome<br />
* protocol<br />
* per-protocol population<br />
* intention to treat population<br />
* pseudorandom<br />
* p-value<br />
* treatment allocation<br />
* imbalance<br />
* selection bias<br />
* expectation bias<br />
* statistical significant<br />
* stratification<br />
* univariable<br />
* multivariable<br />
* adverse event<br />
* serious adverse event<br />
* cluster randomization<br />
* community intervention trial<br />
* coding<br />
* complaince<br />
* protocal complaince<br />
* protocol violation<br />
* protocol exception<br />
* auditing<br />
* allocation ratio<br />
* assessment<br />
* assessment bias<br />
* early termination<br />
* informed consent<br />
* withdrawal consent<br />
* source document<br />
* principal investigator<br />
* study coordinator<br />
* data management<br />
* project management<br />
* regulatory management<br />
* case-control design<br />
* blinding<br />
* double blinding <br />
* tocxicity<br />
* cohort<br />
* evaluation<br />
* confidence interval<br />
* confirmatory trial<br />
* confounder<br />
* CONSORT statement<br />
* constrain<br />
* context<br />
* diagnostic trial<br />
* controls<br />
* concurrent controls<br />
* historic controls<br />
* crossover trial<br />
* carryover effect<br />
* recruitment<br />
* washout period<br />
* equivalence trials<br />
* statistical analysis plan<br />
* data management plan<br />
* project management plan<br />
* sponsor<br />
* inclusion criteria<br />
* equipoise<br />
* exclusion criteria<br />
* factorial design<br />
* interaction<br />
* main effect<br />
* one-sided test<br />
* two-sided test<br />
* missing data<br />
* imputation of missing data<br />
* investigator competence<br />
* local control<br />
* masking<br />
* double masking<br />
* triple masking<br />
* trilple blinding<br />
* data safety monitoring committee<br />
* minority representation<br />
* negative findings<br />
* positive findings<br />
* noninferiority<br />
* nonadherence<br />
* sample size inflation<br />
* noncomplaince<br />
* repeat measurement<br />
* time to event<br />
* medical safety monitor<br />
* pivotal trials<br />
* prevention trials<br />
* assessment schedule<br />
* data collection schedule<br />
* quality assurance<br />
* electronic data capture<br />
* clinical trial management system<br />
* database<br />
* analysis datasets<br />
* retrospective design<br />
* screening<br />
* sham treatment<br />
* steering committee<br />
* excecutive committee<br />
* baseline comparability<br />
* optimal allocation<br />
* Neyman allocation<br />
* response<br />
* intersubject<br />
* subject<br />
* intrasubject<br />
* population<br />
* varibility<br />
* binormial<br />
* continous<br />
* derived data<br />
* discret<br />
* primary efficacy<br />
* primary response<br />
* placebo controlled<br />
* single-site<br />
* single-center<br />
* multi-site<br />
* multi-center<br />
* superiority<br />
* bioequivalence<br />
* treatment group<br />
* titration<br />
* tolerability<br />
* phase IIA<br />
* phase IIB<br />
* phase IIB<br />
* investigational new drug (IND) application<br />
* new drug application (NDA)<br />
* over-the -count (OTC)<br />
* drug lot<br />
* treatment-emergenet adverse event (TEAE)<br />
* as-treated<br />
* cross-sectional analysis</div>
Wjzheng