NFDI4Health Metadata Schema

false

"nonInterventional" (2.16.840.1.113883.3.1937.777.64.2.2.75) from dataset Module Design (V3.3) (nfdhtfcov19-dataset-2)

Version

2023-12-04

Status

Final

Version Label

v3.3

Description

Non-interventional [RESOURCE] type

Relations

Specialization

nonInterventional - 2.16.840.1.113883.3.1937.777.64.2.2.75 as of 2022-11-28 (repository: nfdhtfcov19-)

Source

CT.gov [https://prsinfo.clinicaltrials.gov/definitions.html], [https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

DDI [https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html]

MIABIS [https://github.com/BBMRI-ERIC/miabis]

Rationale

Description: The primary strategy for participant identification and follow-up.

Comment

Cardinality: 1..*, if Design.primaryDesign == 'Non-interventional'; otherwise 0..0

Cardinality: 1..*, if Design.primaryDesign == 'C142615'; otherwise 0..0

Properties

false

Properties

Design.studyType.nonInterventional

Operationalization

Short input help: Select all that apply.
If 'Other' is selected, please specify the type of the [RESOURCE] in the field 'Additional information about the [RESOURCE]'.

false

Value

Type

Code

Concepts

Level/Type	Concept	Synonyms	Ordinal	Exception	Description	Code	Ordinal	Display Name	Codesystem	Equivalence
-	Case-control				Group of individuals with specific characteristics (for example, conditions or exposures) compared to group(s) with different characteristics, but otherwise similar. A case-control study design compares two groups of subjects: those with the disease or condition under study (cases) and a very similar group of subjects who do not have the disease or condition (controls) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), MIABIS (https://github.com/BBMRI-ERIC/miabis)].
-	Nested case-control				(1) A study in which a group or cohort of individuals is followed for a certain length of time or until a specific outcome is reached. Studies of this type incorporate the strengths of both cohort and case-control studies but eliminates a portion of the methodologic challenges inherent in both types of studies; (2) For each identified case one or more controls are selected, which are still under observation in a cohort study at the time when the case developed the disease of interest [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)].
-	Case-only				Single group of individuals with specific characteristics [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)].
-	Case-crossover				Characteristics of case immediately prior to disease onset (sometimes called the hazard period) compared to characteristics of same case at a prior time (that is, control period) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)].
-	Ecologic or community studies				Geographically defined populations, such as countries or regions within a country, compared on a variety of environmental (for example, air pollution intensity, hours of sunlight) and/or global measures not reducible to individual level characteristics (for example, healthcare system, laws or policies median income, average fat intake, disease rate) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)].
-	Family-based				Studies conducted among family members, such as genetic studies within families or twin studies and studies of family environment [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)].
-	Twin study				Twin studies measure the contribution of genetics (as opposed to environment) to a given trait or condition of interest [MIABIS (https://github.com/BBMRI-ERIC/miabis)].
-	Cohort				(1) Group of individuals, initially defined and composed, with common characteristics (for example, condition, birth year), who are examined or traced over a given time period; (2) Data collected over time from the same cohort of respondents. The individuals in the cohort are connected in some way or have shared some significant experience within a given period. In some cases, the samples may differ between waves but are drawn from the same cohort. Examples: birth year, disease (clinical trials), common problem (intervention studies), education, employment, family formation, participation in an event; (3) A form of longitudinal study for the analysis of risk factors following a group of people who do not have a disease, and uses correlations to determine the absolute risk of subject contraction [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), MIABIS (https://github.com/BBMRI-ERIC/miabis), DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)].
-	Case-cohort				A random subcohort from the overall cohort is picked and all cases (either within this random subcohort or outside) will be selected as well. Also a suitable design for the investigation of several diseases in parallel.
-	Birth cohort				A cohort study for which the subjects are followed from the time of birth usually including information about gestation and follow up [MIABIS (https://github.com/BBMRI-ERIC/miabis)].
-	Trend				Data are collected from different samples or different groups of people from the same population at several points in time, using at least partly the same set of questions/variables. Conclusions are drawn for the population. Examples: European Social Survey (ESS), national longitudinal crime surveys [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)].
-	Panel				Data are collected over time from, or about, the same sample of respondents. Differs from cohort data in that the selection of respondents is not based on their being connected in some way or having shared some significant experience [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)].
-	Longitudinal				(1) Data collected repeatedly over time to allow studying change in a population. At least some of the questions or modules are repeated over waves. Use the broad term when none of the subterms is suitable; (2) Research studies involving repeated observations of the same entity over time. In the biobank context, longitudinal studies sample a group of people in a given time period, and study them at intervals by the acquisition and analyses of data and/or samples over time [MIABIS (https://github.com/BBMRI-ERIC/miabis), DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)].
-	Cross-section				(1) Data collected by observing subjects within the study period, without regard to changes over time. May include more than one collection event. Analysis of cross-sectional data often consists in comparing the differences and similarities among subjects; (2) A type of observational study that involves data collection from a population, or a representative subset, at one specific point in time [MIABIS (https://github.com/BBMRI-ERIC/miabis), DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)].
-	Cross-section ad-hoc follow-up				Data are collected at one point in time to complete information collected in a previous cross-sectional study; the decision to collect follow-up data was not included in the original study design [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)].
-	Time series				Data are collected repeatedly over time to study change in observations. These are typically "objective" measurements of phenomena that can be observed externally, as opposed to attitudes/opinions or feelings. Examples may include economic/financial indicators, natural/meteorological phenomena, vital statistics, etc. [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)].
-	Quality control				A quality control testing study design type is where some aspect of the experiment is quality controlled for the purposes of quality assurance [MIABIS (https://github.com/BBMRI-ERIC/miabis)].
-	Registry				An observational study which includes an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]
-	Other				A study type that is not covered by any of the other values in this list [NFDI4Health].
-	Unknown				The study type is unknown [NFDI4Health].