Profile of ArtifactAssessment for Evidence Based Medicine IG. The Adaptation Profile is used for assessments of a knowledge artifact that are used to create a new knowledge artifact through acceptance, rejection or modification of the assessed artifact.

Profile of Evidence for Evidence Based Medicine IG. The BaselineMeasureEvidence Profile is used for evidence with a measured variable (with the role of outcome for this Evidence) that is considered an independent variable with respect to the outcome of an exposure or intervention in a study.

Profile of Composition for Evidence Based Medicine IG. The BaselineMeasureReport Profile is used for an evidence report including the findings for any number of baseline measures in a research study.

Profile of Citation for Evidence Based Medicine IG. The BookCitation Profile is used for citations of a book.

Profile of Citation for Evidence Based Medicine IG. The BookPartCitation Profile is used for citations of a part of a book.

Profile of ArtifactAssessment for Evidence Based Medicine IG. The CertaintyOfEvidence Profile is used for expression of the certainty (also called quality or confidence in the estimates) of an Evidence artifact.

Profile of ArtifactAssessment for Evidence Based Medicine IG. The Classification Profile is used for classifier tags that may be created independently from Resource creators and may be used for search indexes.

Profile of Group for Evidence Based Medicine IG. The CohortDefinition Profile is used to provide a conceptual or definitional representation of a Group. In R6, membership = conceptual allows avoiding the required use of type. In R5, membership will be definitional and type value can be ignored for resource content processing.

Profile of ArtifactAssessment for Evidence Based Medicine IG. The Comment Profile is used for comments about a Resource that may be created independently from Resource creators.

Profile of Evidence for Evidence Based Medicine IG. The ComparativeBaselineMeasureEvidence Profile is used for comparative evidence with a measured variable (with the role of outcome for this Evidence) that is considered an independent variable with respect to the outcome of an exposure or intervention in a study.

Profile of Evidence for Evidence Based Medicine IG. The ComparativeEvidence Profile is used for evidence with a measured variable that is considered the outcome of an exposure or intervention, and an exposure variable with two or more categories that are being compared.

Profile of Composition for Evidence Based Medicine IG. The ComparativeEvidenceReport Profile is used for an evidence report including the study group, exposure, comparator, and findings for any number of outcomes comparing the exposure to the comparator in the study group.

Profile of Group for Evidence Based Medicine IG. The EvidenceReportSubject Profile is used to define the subject of an EvidenceReport.

Profile of Composition for Evidence Based Medicine IG. The ComparativeEvidenceSynthesisReport Profile is used for an evidence report including the intended population, intended exposure, intended comparator, and findings for any number of outcomes comparing the exposure to the comparator with observed study group, observed exposure group, and observed comparator group unique for each outcome.

Profile of Evidence for Evidence Based Medicine IG. The ComparativeParticipantFlowEvidence Profile is used for comparisons of counts of completion and reasons for non-completion of participation in a research study.

Profile of Group for Evidence Based Medicine IG. The ComparatorDefinition Profile is used to express the criteria defining a reference group for comparison.

Profile of Group for Evidence Based Medicine IG. The ComparatorGroup Profile is used to represent a group (definitional or enumerated) used as a comparator in a ComparativeEvidence.

Profile of Evidence for Evidence Based Medicine IG. The ComparatorOnlyEvidence Profile is used for evidence with a measured variable that is considered the outcome of an exposure or intervention, and a population that has an exposure with a categorical value that is the reference category for the exposure in a ComparativeEvidence Profile. The ComparatorOnlyEvidence describes the evidence for the comparator group.

Profile of ArtifactAssessment for Evidence Based Medicine IG. The Comparison Profile is used for assessments of similarities and differences between knowledge artifacts.

Profile of ArtifactAssessment for Evidence Based Medicine IG. The CompositeRating Profile is used for a composite rating or classification of a Resource that may be created following ratings or classifications by two or more parties.

Profile of CodeSystem for Evidence Based Medicine IG. The DataDictionaryCodeSystem Profile is used for a code key for variable names in a dataset.

Profile of Citation for Evidence Based Medicine IG. The DatabaseCitation Profile is used for citations of a database.

Profile of Citation for Evidence Based Medicine IG. The DatabaseEntryCitation Profile is used for citations of a record within a database.

Profile of Citation for Evidence Based Medicine IG. The DatasetCitation Profile is used for citations of a dataset.

Profile of ArtifactAssessment for Evidence Based Medicine IG. The DateAsRating Profile is used for representing a date or dateTime as a classifier value.

Profile of EvidenceVariable for Evidence Based Medicine IG. The DichotomousPatientImportantOutcome Profile is used to provide a common variable definition for the 'intended' variable in the role of 'outcome' in Evidence Resources, to allow mapping evidence with different observaed variables that relate to the same intended outcome.

Profile of Evidence for Evidence Based Medicine IG. The EndpointAnalysisPlan Profile is used for specification of the statistical model for analysis of a single endpoint.

Profile of List for Evidence Based Medicine IG. The EvidenceList Profile is used to provide a list of Evidence Resources. The EvidenceList Profile is used to represent a Group of Evidence for the population for an EvidenceSynthesisEvidence using a summary data meta-analysis approach and is referenced from a MetaanalysisStudyGroup.

Profile of Composition for Evidence Based Medicine IG. The EvidenceMap Profile is used for an organized listing of Resources used to generate EvidenceReport instances.

Profile of Composition for Evidence Based Medicine IG. THIS PROFILE WILL BE REPLACED WITH EvidenceTableReportPackage. The EvidenceMeasureReportPackage Profile is used for a base structure to extend the EvidenceReport Profile with optional relatesTo slices for Total Group, Intervention Group, Comparator Group, and Group Assignment.

Profile of Composition for Evidence Based Medicine IG. The EvidenceReport Profile is used for a base structure (canonical resource management) for a report combining any number of Citation, Evidence, EvidenceVariable, EvidenceReport, and related Resources.

Profile of Composition for Evidence Based Medicine IG. The EvidenceReportPackage Profile is used for a base structure to extend the EvidenceReport Profile with optional sections for Introduction, Discussion, Methods, References, Competing Interests, Acknowledgements, and Appendices.

Profile of Group for Evidence Based Medicine IG. The EvidenceReportSubject Profile is used to define the subject of an EvidenceReport.

Profile of Evidence for Evidence Based Medicine IG. The EvidenceSynthesisEvidence Profile is used for evidence that is combined from two or more studies, explicitly expressing the method by which evidence was synthesized.

Profile of Composition for Evidence Based Medicine IG. The EvidenceTableReportPackage Profile is used for a base structure to extend the EvidenceReport Profile with sections for Groups (Total Group, Intervention Group, Comparator Group, and Group Assignment), Evidence Variables, and Results.

Profile of Group for Evidence Based Medicine IG. The ExposureDefinition Profile is used to express the criteria defining an evidence variable (or categorical value for a variable) in the role of exposure.

Profile of Group for Evidence Based Medicine IG. The ExposureGroup Profile is used to represent a group (definitional or enumerated) used in a ComparativeEvidence.

Profile of EvidenceVariable for Evidence Based Medicine IG. The GroupAssignment Profile is used to classify an EvidenceVariable as an exposure managed as a categorical variable. The variable definitions are found in the category element instead of the definition element.

Profile of Group for Evidence Based Medicine IG. The GroupR6 Profile is used to add extensions to Group.

Profile of Composition for Evidence Based Medicine IG. The Guideline Profile is used for the composition of a clinical practice guideline and may be tightly related to use of Recommendation Profile of Composition for related content.

Profile of Evidence for Evidence Based Medicine IG. The InterventionOnlyEvidence Profile is used for evidence with a measured variable that is considered the outcome of an exposure or intervention. The InterventionOnlyEvidence describes the evidence for the intervention group.

Profile of Citation for Evidence Based Medicine IG. The JournalArticleCitation Profile is used for citations of an article published in a periodical venue classified as a journal.

Profile of Composition for Evidence Based Medicine IG. The M11Report Profile is used for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification.

Profile of ResearchStudy for Evidence Based Medicine IG. The M11ResearchStudy Profile is used to add extensions for use with an M11 Report.

Profile of Group for Evidence Based Medicine IG. The MetaanalysisEligibilityCriteria Profile is used to describe inclusion and exclusion criteria for a meta-analysis.

Profile of Group for Evidence Based Medicine IG. The MetaanalysisOutcomeDefinition Profile is used to express the criteria defining an evidence variable in the role of outcome where the population (dataset) is a set of Evidence Resources. Characteristics define the characteristics of the Evidence Resource to be eligible to be used for this outcome.

Profile of Group for Evidence Based Medicine IG. The MetaanalysisStudyGroup Profile is used to represent an enumerated group of participants in a meta-analysis where the participants are Evidence Resources.

Profile of Evidence for Evidence Based Medicine IG. The NetEffectContribution Profile is used for evidence in which the effect estimates, expressed as risk differences, is multiplied by a relative importance rating of the outcomes.

Profile of List for Evidence Based Medicine IG. The NetEffectContributionList Profile is used to provide a list of Evidence Resources (NetEffectContribution Profile). The NetEffectContributionList Profile is used to represent a Group of Evidence for the population for a NetEffectEstimate (Profile of Evidence) using a net effect analysis approach and is referenced from a NetEffectContributions (Profile of Group).

Profile of Group for Evidence Based Medicine IG. The NetEffectContributions Profile is used to represent an enumerated group of participants in a net effect analysis where the participants are Evidence Resources (NetEffectContribution Profile).

Profile of Evidence for Evidence Based Medicine IG. The NetEffectEstimate Profile is used for evidence in which the observed data is net effect contributions (effect estimates expressed as risk differences, multiplied by relative importance ratings of outcomes).

Profile of Evidence for Evidence Based Medicine IG. The NonComparativeEvidence Profile is used for evidence about a single group with no comparisons between groups.

Profile of Group for Evidence Based Medicine IG. The OutcomeDefinition Profile is used to express the criteria defining an evidence variable (or categorical value for a variable) in the role of outcome.

Profile of ArtifactAssessment for Evidence Based Medicine IG. The OutcomeImportance Profile is used for expression of the relative importance of an outcome. The outcome is typically expressed with an EvidenceVariable Resource and may use the VariableDefinition Profile of EvidenceVariable (or OutcomeDefinition Profile of Group).

Profile of List for Evidence Based Medicine IG. The OutcomeList Profile is used to provide a list of outcomes. The OutcomeList Profile is referenced in the EvidenceReportSubject Profile as a way to define the set of outcomes that an EvidenceReport is about.

Profile of Composition for Evidence Based Medicine IG. The OutcomeMeasureReport Profile is used for an evidence report including the findings for any number of outcome measures in a research study.

Profile of Evidence for Evidence Based Medicine IG. The ParticipantFlowEvidence Profile is used for counts of completion and reasons for non-completion of participation in a research study.

Profile of EvidenceVariable for Evidence Based Medicine IG. The ParticipantFlowEvidenceVariable Profile is used to describe outcome measures for completion and reasons for non-completion of participation in a research study.

Profile of Composition for Evidence Based Medicine IG. The ParticipantFlowReport Profile is used for an evidence report including the counts (and proportions) for any number of participant flow measures in a research study. For example, the ParticipantFlowReport may include the data for a CONSORT Participant Flow Diagram reported with a randomized controlled trial.

Profile of Citation for Evidence Based Medicine IG. The PreprintCitation Profile is used for citations of an article published in a form prior to peer-reviewed publication in a journal, book, or other permanent record.

Profile of ArtifactAssessment for Evidence Based Medicine IG. The Rating Profile is used for classifier tags that may include quantitative ratings and may be created independently from Resource creators.

Profile of Composition for Evidence Based Medicine IG. The Recommendation Profile is used for the composition of a recommendation (such as that from a clinical practice guideline) and may be tightly related to a RecommendationPlan Profile of PlanDefinition and a RecommendationJustification Profile of ArtifactAssessment.

Profile of ActivityDefinition for Evidence Based Medicine IG. The RecommendationAction Profile is used for a recommendation from a clinical practice guideline.

Profile of Group for Evidence Based Medicine IG. The RecommendationEligibilityCriteria Profile is used to express the criteria defining a group for whom a recommendation applies.

Profile of ArtifactAssessment for Evidence Based Medicine IG. The RecommendationJustification Profile is used for expressing the rationale, evidence, and judgments supporting a recommendation, such as from a clinical practice guideline.

Profile of PlanDefinition for Evidence Based Medicine IG. The RecommendationPlan Profile is used for the implementable representation of a recommendation (such as that from a clinical practice guideline).

Profile of Composition for Evidence Based Medicine IG. The ResearchStudyDataDictionary Profile is used for a code key for variable names in a dataset containing the observations collected in a research study. Each variable is included in a section.entry instance which references a VariableDefinition Profile of EvidenceVariable.

Profile of ArtifactAssessment for Evidence Based Medicine IG. The RiskOfBias Profile is used for expression of the assessment of the threats to validity (or risk of bias) of an Evidence artifact or an artifact consisting of Evidence or the plan to create Evidence.

Profile of Library for Evidence Based Medicine IG. The SearchResults Profile is used to represent search results, such as for a systematic review.

Profile of Group for Evidence Based Medicine IG. The SearchStrategy Profile is used to express the criteria defining a search strategy, such as for a systematic review.

Profile of Evidence for Evidence Based Medicine IG. The SingleStudyEvidence Profile is used for evidence from single studies, explicitly expressing that no studies were synthesized.

Profile of PlanDefinition for temporary testing to coordination with M11 use.

Profile of Citation for Evidence Based Medicine IG. The SoftwareCitation Profile is used for citations of executable code.

Profile of Evidence for Evidence Based Medicine IG. The StatisticModel Profile is used to add extensions to Evidence for complex expressions for the statistical model or endpoint analysis plan.

Profile of Group for Evidence Based Medicine IG. The StudyEligibilityCriteria Profile is used to describe inclusion and exclusion criteria for a clinical trial or other research study.

Profile of Group for Evidence Based Medicine IG. The StudyGroup Profile is used to represent an enumerated group of participants in a research study.

Profile of Composition for Evidence Based Medicine IG. The SummaryOfFindings Profile is used for an evidence report combining Evidence and EvidenceVariable Resources, organized around VariableDefinition (Profile of EvidenceVariable), to represent the summary of findings of comparative evidence.

Profile of Composition for Evidence Based Medicine IG. The SummaryOfNetEffect Profile is used for an evidence report combining ArtifactAssessment and Evidence and EvidenceVariable Resources, organized around VariableDefinition (Profile of EvidenceVariable), to represent the summary of net effect contributions of comparative evidence, adjusted for the relative importance of outcomes.

Profile of ResearchStudy for Evidence Based Medicine IG. The SystematicReview Profile is used for a scientific study based on a protocol that includes search and selection of eligible studies, study quality assessment, data extraction, and synthesis.

Profile of Group for Evidence Based Medicine IG. The SystematicReviewEligibilityCriteria Profile is used to describe inclusion and exclusion criteria for a systematic review.

Profile of Library for Evidence Based Medicine IG. The SystematicReviewExcludedStudies Profile is used to represent the subset of search results of a systematic review which did not meet the inclusion criteria.

Profile of Library for Evidence Based Medicine IG. The SystematicReviewIncludedStudies Profile is used to represent the subset of search results of a systematic review which meet the inclusion criteria.

Profile of EvidenceVariable for Evidence Based Medicine IG. The VariableDefinition Profile uses a CodeableReference Datatype to provide a concept (e.g. coding in a code system) and/or a reference to a Group Resource for structured data to define the variable.

Profile of Citation for Evidence Based Medicine IG. The WebPageCitation Profile is used for citations of a web page or website, typically when there is not another type being used to classify the cited artifact.

When the resource was approved by publisher.

The artifact being compared to the referenced artifact.

A date or dateTime value as the classifier or rating value.

The period during which the resource content was or is planned to be in active use.

When the resource was approved by publisher.

Timing in which the characteristic is determined or action is taken.

Classification of the EvidenceVariable.

The context in which the EvidenceVariable is assessed.

Limit on acceptability of data used to express values of the variable.

A method or transformation applied for data that does not match required patterns.

How the data element is organized and where the data element (expressing the value of the variable) is found in the dataset.

A method or transformation applied for missing data.

Date(s) and time(s) when the variable is observed.

An outcome measure described with the estimand framework.

Link to a research study excluded from the systematic review.

Link to a research study included in the systematic review.

Number of studies found on search to be evaluated for inclusion.

Number of studies selected for inclusion.

Link to results generated by the study, using a Composition Resource.

Method for reporting Serious Adverse Events.

Link to search terms and sources for finding studies for inclusion.

Sponsor Confidentiality Statement.

An amendment to a study protocol.

Link to criteria for inclusion of studies in the systematic review.

An expression that defines the statistical analysis.

The condition under which the variable (or modelCharacteristic) will be included.

The role in influencing the content of the Resource.

The sub-role that the variable plays.

Codes for use with the Classifier drop-down menu for FEvIR(R): Recommendation Justification Builder.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

COVID-19 pneumonia remdesivir vs. placebo 14-day mortality (779 events among 6,744 participants, 3 randomized trials) Risk ratio 0.85 (95% CI 0.74 to 0.96) in fixed-effect analysis Risk ratio 0.81 (95% CI 0.60 to 1.08) in random-effects analysis

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This is an example describing the Boots Finger Pulse Oximeter for use in an example of Group.characteristic.determinedByReference and does not contain substantial detail as the focus is not the expression of device definition details.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

Glucagon-Like Peptide-1 (GLP-1) receptor agonists

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

Eligible randomised controlled trials compared drugs used to treat adults with type 2 diabetes. We considered the following drug classes: SGLT-2 inhibitors, GLP-1 receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, thiazolidinediones, sulfonylureas, metformin, α-glucosidase inhibitors, meglitinides, insulins, dual GIP/GLP-1 receptor agonists, and non-steroidal mineralocorticoid receptor antagonists. Appendix 1.3 describes the detailed drug names and definitions of control arms (typically standard treatment at the time the trials were conducted, representing the treatment regimens the patient received before the clinician considered adding a new drug). Eligible trials had a follow-up of 24 weeks or longer. Trials systematically comparing combinations of more than one drug treatment class with no drug treatment, subgroup analyses of randomised controlled trials, and non-English language studies were deemed ineligible.

An example of a search strategy for a systematic review.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

SGLT-2 inhibitors, GLP-1 receptr agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, thiazolidinediones, sulfonylureas, metformin, α-glucosidase inhibitors, meglitinides, insulins, dual GIP/GLP-1 receptor agonists, or non-steroidal mineralocorticoid receptor antagonists

An example of CohortDefinition used to support a SystematicReviewEligibilityCriteria example.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

Inclusion Criteria Patients are eligible for inclusion in the study only if they meet all of the following criteria at screening and/or enrollment:

1. Meet either T1DM-specific eligibility criteria or T2DM-specific eligibility criteria .a. T1DM-specific criteria ..i. Diagnosis of T1DM based on the World Health Organization (WHO) diagnostic criteria ..ii. have been on the following daily insulin therapy for at least 1 year …1) multiple daily injection of long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) and rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine), or …2) continuous subcutaneous insulin infusion (CSII) ..iii. are between 18 and 64 years old at the time of informed consent ..iv. have a body mass index of 18.5 to 30.0 kg/m2 at the time of screening .b. T2DM-specific criteria ..i. Diagnosis of T2DM based on the World Health Organization (WHO) diagnostic criteria ..ii. have received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year …1) insulin: long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) alone, or in combination with rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine) or CSII …2) OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine ..iii. are between 20 and 70 years old at the time of informed consent ..iv. have a body mass index of 18.5 to 35.0 kg/m2 at the time of screening
2. have a hemoglobin A1c value ≤10% at the time of screening
3. agree to use an effective method of contraception, defined by study protocol
4. have clinical laboratory test results within normal reference range (except for glycemic parameters) for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
5. have venous access sufficient to allow for blood sampling and administration of insulin for IV administration as per the protocol
6. are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
7. are able and willing to give signed informed consent.

Exclusion Criteria Patients will be excluded from study enrollment if they meet any of the following criteria at screening and/or enrollment:

1. are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, biological or legal guardian, child, or sibling
2. are Lilly employees
3. are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
4. have participated, within the last 4 months, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 4 months or 5 half-lives (whichever is longer) should have passed from the last dose of investigational product
5. have previously completed or withdrawn from this study or any other study investigating LY900018, and have previously received LY900018
6. have known allergies or sensitivity to LY900018, glucagon, related compounds, or any components of the formulation, or history of significant atopy
7. have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study
8. any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator
9. have received a total daily dose of insulin >1.2 U/kg at the time of screening
10. have poorly controlled hypertension (ie, supine systolic BP >165 mm Hg or supine diastolic BP >95 mm Hg) at screening, or a change in antihypertensive medications within 30 days prior to screening
11. have a history of pheochromocytoma (ie, adrenal gland tumor) or insulinoma
12. have a history of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the 1 month prior to screening or have a history of loss of consciousness within the last 2 years induced other than by hypoglycemia
13. have a history of epilepsy or seizure disorder
14. have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM or T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
15. have known or ongoing psychiatric disorders that, in the opinion of the investigator, may preclude the patient from following and completing the protocol
16. regularly use known drugs of abuse and/or show positive findings on urinary drug screening
17. show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies and/or antigen
18. show evidence of hepatitis C and/or positive hepatitis C antibody
19. show evidence of hepatitis B and/or positive hepatitis B surface antigen
20. show evidence of syphilis and/or are positive for syphilis test
21. are women who are lactating
22. use of daily systemic beta-blocker, indomethacin, warfarin, anticholinergic drugs
23. have donated 400 mL or more blood in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks, or total volume of blood donation within 12 months is 1200 mL (males)/800 mL (females) or more at screening
24. have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption from Day -2 to discharge from CRU in each period (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
25. in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
26. have pre-proliferative and proliferative retinopathy or maculopathy requiring treatment or not clinically stable in the last 6 months, or patients with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months. Note: If an eye examination has been performed no more than 6 months before screening, it will not have to be repeated; however, the investigator will need to confirm via interview that there is no change in subjective symptoms.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

diagnosis of either: . a. T1DM based on the World Health Organization (WHO) diagnostic criteria, and have been on the following daily insulin therapy for at least 1 year .. i. multiple daily injection of long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) and rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine), or .. ii. continuous subcutaneous insulin infusion (CSII) Or . b. T2DM based on the WHO diagnostic criteria, and have received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year .. i. insulin: long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) alone, or in combination with rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine) or CSII .. ii. OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

Meet either T1DM-specific eligibility criteria or T2DM-specific eligibility criteria a. T1DM-specific criteria ..i. Diagnosis of T1DM based on the World Health Organization (WHO) diagnostic criteria ..ii. have been on the following daily insulin therapy for at least 1 year …1) multiple daily injection of long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) and rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine), or …2) continuous subcutaneous insulin infusion (CSII) ..iii. are between 18 and 64 years old at the time of informed consent ..iv. have a body mass index of 18.5 to 30.0 kg/m2 at the time of screening b. T2DM-specific criteria ..i. Diagnosis of T2DM based on the World Health Organization (WHO) diagnostic criteria ..ii. have received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year …1) insulin: long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) alone, or in combination with rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine) or CSII …2) OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine ..iii. are between 20 and 70 years old at the time of informed consent ..iv. have a body mass index of 18.5 to 35.0 kg/m2 at the time of screening

i. Diagnosis of T2DM based on the World Health Organization (WHO) diagnostic criteria ii. have received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year ..1) insulin: long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) alone, or in combination with rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine) or CSII ..2) OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine iii. are between 20 and 70 years old at the time of informed consent iv. have a body mass index of 18.5 to 35.0 kg/m2 at the time of screening

i. Diagnosis of T1DM based on the World Health Organization (WHO) diagnostic criteria ii. have been on the following daily insulin therapy for at least 1 year ..1) multiple daily injection of long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) and rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine), or…2) continuous subcutaneous insulin infusion (CSII) iii. are between 18 and 64 years old at the time of informed consent iv. have a body mass index of 18.5 to 30.0 kg/m2 at the time of screening

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

Study results (Evidence Resources) included in Mean difference in HbA1c effect of bariatric surgery in 2016 meta-analysis

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This ResearchStudy Resource was derived from data in the ClinicalTrials.gov record then modified for use to support an M11 Report.

An example of an EndpointAnalysisPlan Profile which uses intended='true' and include-if extensions within Evidence.statistic.modelCharacteristic elements.

This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.

The peer-reviewed report for combination of 3 adaptive RCTs

Inclusion Criteria: [[1]] Adults. [[2]] Diagnosed with type 2 diabetes. [[3]] Body Mass Index (BMI) ≥ 40.0 kg/m2 (BMI ≥ 37.5 kg/m2 in Asian Americans), or BMI ≥ 35.0 kg/m2 and ≤ 39.9 kg/m2 (BMI 32.5-37.4 kg/m2 in Asian Americans) who do not achieve durable weight loss and improvement in comorbidities (including hyperglycemia) with nonsurgical methods. [[4]] Screened surgical candidates.

Inclusion Criteria: [[1]] Adults. [[2]] Diagnosed with type 2 diabetes. [[3]] Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 34.9 kg/m2 (BMI 27.5-32.4 kg/m2 in Asian Americans) who do not achieve durable weight loss and improvement in comorbidities (including hyperglycemia) with nonsurgical methods. [[4]] Screened surgical candidates.

Any of 4 bariatric surgery procedures (Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy, Laparoscopic Adjustable Gastric banding, Biliopancreatic Diversion)

This example of a BaselineMeasureReport Profile shows a report from a single observational study with 2 baseline measures.

Age in Medical Group (n = 956) mean 45.7 years, SD 13.5 years

Age in Surgical Group (n = 932) mean 41.2 years, SD 10.5 years

BMI in Medical Group (n = 956) mean 42.9 kg/m2, SD 5.7 kg/m2

BMI in Surgical Group (n = 932) mean 45.4 kg/m2, SD 6.2 kg/m2

Objective To compare the benefits and harms of drug treatments for adults with type 2 diabetes, adding non-steroidal mineralocorticoid receptor antagonists (including finerenone) and tirzepatide (a dual glucose dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist) to previously existing treatment options. Design Systematic review and network meta-analysis. Data sources Ovid Medline, Embase, and Cochrane Central up to 14 October 2022. Eligibility criteria for selecting studies Eligible randomised controlled trials compared drugs of interest in adults with type 2 diabetes. Eligible trials had a follow-up of 24 weeks or longer. Trials systematically comparing combinations of more than one drug treatment class with no drug, subgroup analyses of randomised controlled trials, and non-English language studies were deemed ineligible. Certainty of evidence was assessed following the GRADE (grading of recommendations, assessment, development and evaluation) approach. Results The analysis identified 816 trials with 471 038 patients, together evaluating 13 different drug classes; all subsequent estimates refer to the comparison with standard treatments. Sodium glucose cotransporter-2 (SGLT-2) inhibitors (odds ratio 0.88, 95% confidence interval 0.83 to 0.94; high certainty) and GLP-1 receptor agonists (0.88, 0.82 to 0.93; high certainty) reduce all cause death; non-steroidal mineralocorticoid receptor antagonists, so far tested only with finerenone in patients with chronic kidney disease, probably reduce mortality (0.89, 0.79 to 1.00; moderate certainty); other drugs may not. The study confirmed the benefits of SGLT-2 inhibitors and GLP-1 receptor agonists in reducing cardiovascular death, non-fatal myocardial infarction, admission to hospital for heart failure, and end stage kidney disease. Finerenone probably reduces admissions to hospital for heart failure and end stage kidney disease, and possibly cardiovascular death. Only GLP-1 receptor agonists reduce non-fatal stroke; SGLT-2 inhibitors are superior to other drugs in reducing end stage kidney disease. GLP-1 receptor agonists and probably SGLT-2 inhibitors and tirzepatide improve quality of life. Reported harms were largely specific to drug class (eg, genital infections with SGLT-2 inhibitors, severe gastrointestinal adverse events with tirzepatide and GLP-1 receptor agonists, hyperkalaemia leading to admission to hospital with finerenone). Tirzepatide probably results in the largest reduction in body weight (mean difference −8.57 kg; moderate certainty). Basal insulin (mean difference 2.15 kg; moderate certainty) and thiazolidinediones (mean difference 2.81 kg; moderate certainty) probably result in the largest increases in body weight. Absolute benefits of SGLT-2 inhibitors, GLP-1 receptor agonists, and finerenone vary in people with type 2 diabetes, depending on baseline risks for cardiovascular and kidney outcomes (https://matchit.magicevidence.org/230125dist-diabetes). Conclusions This network meta-analysis extends knowledge beyond confirming the substantial benefits with the use of SGLT-2 inhibitors and GLP-1 receptor agonists in reducing adverse cardiovascular and kidney outcomes and death by adding information on finerenone and tirzepatide. These findings highlight the need for continuous assessment of scientific progress to introduce cutting edge updates in clinical practice guidelines for people with type 2 diabetes.

An example to map the BookCitation Profile

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

An example to map the BookCitation Profile

An example of an EndpointAnalysisPlan Profile which uses intended='true' and include-if extensions within Evidence.statistic.modelCharacteristic elements.

This example of a Group Resource is referenced from an example in the EBMonFHIR Implementation Guide. This example shows a definitional value for the membership element and a person value for the type element.

This example of a CertaintyOfEvidence Profile shows a recursive pattern of component elements with type/classifier paired values for different aspects of rating the certainty of evidence.

A citation of a Resource on the FEvIR Platform

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

A Evidence Resource to demonstrate complex evidence reporting

This Classification Profile example is used to represent the study design classifiers (as CodeableConcept datatype values) in support of a ComparativeEvidenceReport Profile.

This example shows used of combinationMethod (at-least) and combinationThreshold (2) to express at least 2 of a set of characteristics.

BMI 27.5-32.4 in Asian Americans who do not achieve durable weight loss and improvement in comorbidities without surgery

BMI 30-34.9 in persons who do not achieve durable weight loss and improvement in comorbidities without surgery

BMI 32.5-37.4 in Asian Americans who do not achieve durable weight loss and improvement in comorbidities without surgery

BMI 35-39.9 in persons who do not achieve durable weight loss and improvement in comorbidities without surgery

BMI ≥ 35 and at least 1 obesity-related comorbidity

BMI ≥ 37.5 kg/m2 in Asian Americans

Body Mass Index (BMI) ≥ 40.0 kg/m2 (BMI ≥ 37.5 kg/m2 in Asian Americans), or BMI ≥ 35.0 kg/m2 and ≤ 39.9 kg/m2 (BMI 32.5-37.4 kg/m2 in Asian Americans) who do not achieve durable weight loss and improvement in comorbidities (including hyperglycemia) with nonsurgical methods.

Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years

Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke)

This example shows how to express a Group defined by meeting either of two phenotype definitions for 'heart failure' where the phenotype definitions are found by URL in a system not using FHIR for phenotype expression. This demonstrates the Group.characteristic.valueUri element.

Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 34.9 kg/m2 (BMI 27.5-32.4 kg/m2 in Asian Americans) who do not achieve durable weight loss and improvement in comorbidities (including hyperglycemia) with nonsurgical methods.

Nonfatal myocardial infarction

Nonfatal myocardial infarction

A characteristic of oxygen saturation < 96% on Boots Finger Pulse Oximeter is shown here, specifically at least 3 episodes lasting at least 5 minutes. LOINC Code for oxygen saturation does not specify the device used. If defining a Group characteristic by the device used, for example, in research comparing devices, one needs to reference the DeviceDefinition, Device, or DeviceMetric Resources. This example uses Group.characteristic.determinedByReference to show where the device may be reported, Group.characteristic.instancesQuantity to express at least 3 episodes, and Group.characteristic.durationDuration to express at least 5 minutes.

A characteristic of oxygen saturation < 96% on Boots Finger Pulse Oximeter is shown here, specifically 2-4 episodes lasting 10-15 minutes. LOINC Code for oxygen saturation does not specify the device used. If defining a Group characteristic by the device used, for example, in research comparing devices, one needs to reference the DeviceDefinition, Device, or DeviceMetric Resources. This example uses Group.characteristic.determinedByReference to show where the device may be reported, Group.characteristic.instancesRange to express 2-4 episodes, and Group.characteristic.durationRange to express 10-15 minutes.

Exclusion Criteria: Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months. Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. Cardiac stress test indicating that surgery or IMM would not be safe. Pulmonary embolus or thrombophlebitis in the past six months. Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years. Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy. Serum creatinine ≥ 1.5 mg/dl. HbA1c > 14.0%.

BMI at least 40 or at least 35 with at least 1 obesity-related comorbidity

This example of a Comment Profile shows a comment about another Resource (Guideline Profile) in which the commenter is not the author of the Resource commented upon.

Mean age 41.2 in Surgical Group vs. 45.7 in Medical Group (p < 0.001)

Mean BMI 45.4 in Surgical Group vs. 42.9 in Medical Group (p < 0.001)

effect estimate for bariatric surgery on all-cause mortality pooled hazard ratio (HR) 0.55 (95% confidence interval 0.49 to 0.62; P < 0.001 vs. controls) in meta-analysis of 21 cohort studies with 133,524 patients after bariatric surgery and 263,478 obese controls

Of 120 participants who were initially randomized, 98 (82%) completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01).

Surgical patients had a greater risk for undergoing at least 1 additional gastrointestinal surgical procedure (AR, 31.3% vs 15.5%; RD, 15.8% [95% CI, 13.1%-18.5%]; RR, 2.0 [95% CI, 1.7-2.4]).

Bariatric surgery was associated with a reduced number of cardiovascular deaths (28 events among 2010 patients in the surgery group vs 49 events among 2037 patients in the control group; adjusted hazard ratio [HR], 0.47; 95% CI, 0.29-0.76; P = .002). The number of total first time (fatal or nonfatal) cardiovascular events (myocardial infarction or stroke, whichever came first) was lower in the surgery group (199 events among 2010 patients) than in the control group (234 events among 2037 patients; adjusted HR, 0.67; 95% CI, 0.54-0.83; P < .001). – Extrapolated from this data the outcome of Nonfatal myocardial infarction or stroke occurred in 188 out of 2037 patients in the control group and 171 out of 2010 patients in the surgery group, and the adjusted HR for total events is assumed to apply (adjusted HR 0.67, 95% CI 0.54 to 0.83)

greater risk of new-onset depression: AR, 8.9% vs 6.5%; RD, 2.4% [95% CI, 1.3%-3.5%], RR, 1.5 [95% CI, 1.4-1.7]

greater likelihood of diabetes remission: AR, 57.5% vs 14.8%; RD, 42.7% [95% CI, 35.8%-49.7%], RR, 3.9 [95% CI, 2.8-5.4]

greater risk of treatment with opioids: AR, 19.4% vs 15.8%, RD, 3.6% [95% CI, 2.3%-4.9%], RR, 1.3 [95% CI, 1.2-1.4]

Mean HbA1c at 12 months in Courcoulas 2014 was 6.6 % in Surgery group (n = 41) and 7.0% in Medical/Lifestyle group (n = 17), mean difference -0.40% (95% CI -0.89% to 0.09%)

Mean HbA1c at 36 months in Courcoulas 2015 was 7.1% in Surgery group (n = 38) and 7.2% in Medical/Lifestyle group (n = 14), mean difference -0.10% (95% CI -0.35% to 0.15%)

Mean HbA1c at 12 months in Cummings 2016 was 6.4% in Surgery group (n = 15) and 6.9% in Medical/Lifestyle group (n = 17), mean difference -0.50% (95% CI -1.52% to 0.52%)

Mean HbA1c at 12 months in Ding 2015 was 7.17 % in Surgery group (n = 18) and 7.15% in Medical/Lifestyle group (n = 22), mean difference 0.02% (95% CI -0.16% to 0.20%)

Mean HbA1c at 24 months in Dixon 2008 was 6% in Surgery group (n = 30) and 7.2% in Medical/Lifestyle group (n = 30), mean difference -1.20% (95% CI -1.78% to -0.62%)

Mean HbA1c at 12 months in Halperin 2014 was 6.2 % in Surgery group (n = 19) and 8.8% in Medical/Lifestyle group (n = 19), mean difference -2.60% (95% CI -3.37% to -1.83%)

Mean HbA1c at 12 months in Ikramuddin 2013 was 6.3 % in Surgery group (n = 57) and 7.8% in Medical/Lifestyle group (n = 19), mean difference -1.50% (95% CI -1.95% to -1.05%)

Mean HbA1c at 24 months in Ikramuddin 2015 was 6.5% in Surgery group (n = 56) and 8.4% in Medical/Lifestyle group (n = 54), mean difference -1.90% (95% CI -2.78% to -1.02%)

Mean HbA1c at 12 months in Liang 2013 was 6 % in Surgery group (n = 31) and 7.6% in Medical/Lifestyle group (n = 70), mean difference -1.60% (95% CI -1.94% to -1.26%)

Mean HbA1c at 24 months in Mingrone 2012 was 5.65% in Surgery group (n = 20) and 7.69% in Medical/Lifestyle group (n = 20), mean difference -2.04% (95% CI -2.53% to -1.55%)

Mean HbA1c at 60 months in Mingrone 2015 was 6.55% in Surgery group (n = 38) and 6.9% in Medical/Lifestyle group (n = 15), mean difference -0.35% (95% CI -0.69% to -0.01%)

Mean HbA1c at 6 months in Parikh 2014 was 6.2 % in Surgery group (n = 20) and 7.8% in Medical/Lifestyle group (n = 24), mean difference -1.60% (95% CI -2.39% to -0.81%)

Mean HbA1c at 12 months in Schauer 2012 was 6.5% in Surgery group (n = 99) and 7.5% in Medical/Lifestyle group (n = 41), mean difference -1.00% (95% CI -1.58% to -0.42%)

Mean HbA1c at 36 months in Schauer 2014 was 6.85% in Surgery group (n = 97) and 8.4% in Medical/Lifestyle group (n = 40), mean difference -1.55% (95% CI -2.28% to -0.82%)

Mean HbA1c at 24 months in Wentworth 2014 was 6.1% in Surgery group (n = 23) and 7.3% in Medical/Lifestyle group (n = 25), mean difference -1.20% (95% CI -1.84% to -0.56%)

effect estimate for differences in mean HbA1c at study end point between Surgery and Medical/Lifestyle groups -1.14% (95% CI -1.57% to -0.71%) in meta-analysis of 15 trials with 1,067 participants

This example of a ComparativeEvidenceReport Profile shows a report from a single observational study with 2 baseline measures, 2 participant flow measures, and 4 outcome measures.

This example of a ComparativeEvidenceReportSubject Profile expresses the conceptual group of PICO elements using the 'all of'' code in the combinationMethod element. Each of the characteristics described in this example are defined by reference to another Resource so the characteristic.code element has a value of text:'Defined by Reference' and uses a valueReference element. Three of the characteristics are defined by reference to a Group Resource and the last characteristic (Outcomes) is defined by reference to a List Resource. This example demonstrates the use of the 'conceptual' code for the membership element. In this case the Group Resource is being used for the conceptual grouping of characteristics and is not a group of people or physical objects.

Dropout due to stopping intervention 18/33 with Lofexidine vs. 12/35 with Placebo in opioid detoxification trial

Absence of any of 4 bariatric surgery procedures (Roux-en-Y Gastric Bypass, Vertical Sleeve Gastrectomy, Laparoscopic Adjustable Gastric banding, Biliopancreatic Diversion)

Description: usual-care pharmacologic thromboprophylaxis Note: Thromboprophylaxis was provided at a dose and duration determined by the treating clinician according to local practice. Note: Usual-care pharmacological thromboprophylaxis included both intermediate-intensity (in 27%) and prophylactic-intensity dosing (in 72%). Subgroup analyses may be informative to determine if there is a difference related to the intensity used in the control arm of the trial.

Example of an ComparatorGroup Profile with an enumerated group (quantity = 956) meeting 2 characteristics defined by Group Resources (Member of a StudyGroup Profile, excluding a Procedure defined by an ExposureDefinition Profile)

This example of a ComparatorGroup Profile expresses the definition of a group by the combination of meeting both (all of) two characteristics by using the 'all-of' code in the combinationMethod element. Each of the two characteristics in this example are defined by reference to another Group Resource, so the characteristic.code element has a value of text:'Defined by Reference' and uses a valueReference element.

Risk of additional GI surgical procedure in control group was 15.5%.

estimate for all-cause mortality without bariatric surgery 4.75% based on median control event rate in 26 cohort studies with post-bariatric surgery patients and obese controls

Bariatric surgery was associated with 49 cardiovascular deaths among 2037 patients in the control group. The number of total first time (fatal or nonfatal) cardiovascular events (myocardial infarction or stroke, whichever came first) in the control group was 234 events among 2037 patients. Extrapolated from this data the outcome of Nonfatal myocardial infarction or stroke occurred in 188 out of 2037 patients in the control group.

Risk of New onset depression in control group was 6.5%.

Risk of Remission of diabetes in control group was 14.8%.

Risk of Treatment with opioids in control group was 15.8%.

This Comparison Profile shows a comparison of top-level elements between two Resources and classifies each element pairing as Same or Different based on whether the content is a match.

This example of a CompositeRating Profile is a result from evaluating 2 or more Rating Profile instances about the same artifactReference and path, and reporting the agreed value in the summary element with a classifier value of SAME when all ratings were in agreement, and reporting MISMATCH in both elements when disagreements occurred.

Computable Publishing® augments digital publishing with machine-interpretable forms. Computable Publishing® offers publishers of any type (commercial, nonprofit, academic, government) the ability to extend their published works with computable (machine-interpretable) forms of expression, and users of any type support in using computable data to enhance, improve and achieve desired outcomes.

Patients who were hospitalized for COVID-19 and who were not critically ill were randomized in a response-adaptive manner to therapeutic-dose anticoagulation with heparin vs. usual-care pharmacologic thromboprophylaxis. The outcome reported here is the effect on organ support-free days (i.e. days without oxygen delivered by high-flow nasal cannula, noninvasive or invasive mechanical ventilation, or the use of vasopressors or inotropes). The statistical result was a median adjusted odds ratio 1.27 (95% credible interval 1.03 to 1.58), based on 1,740 events among 2,219 participants with known outcome out of 2,244 enrolled participants. The probability of superiority of therapeutic-dose anticoagulation with heparin was 98.6%. The risk of bias in this effect estimate is of extremely serious concern based on a serious concern for confounding covariate bias (confounding difference in calendar time), a very serious concern for performance bias (inadequate blinding of intervention deliverers who may determine the outcome based in part on exposure status), and very serious concern for analysis bias (bias related to selection of the analysis, and early trial termination).

A data dictionary (variable names) for research studies designed to measure the rate of scientific knowledge transfer.

This is an example of a DataDictionary Profile for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

A citation of a Resource on the FEvIR Platform

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This example shows classifications with classifier values including dates.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This value set is a temporary workspace while drafting the Evidence Based Medicine Implementation Guide. It may not be stable and may not be persistent.

A characteristic of estimated glomerular filtration rate (eGFR) of 45-59 mL/min/1.73m2 is shown here. LOINC Code guidance states 'If transitioning to the new 2021 calculations, note there are separate equations for male and female patients that need to be implemented. The same LOINC code is applied regardless of which sex-based equation is used to generate the result. Laboratories need to build each male and female equation within their LIS and validate per their accreditation requirements.' and 'While LOINC does not have a specific code for reporting the exact equation used to calculate eGFR, it may be appropriate for labs to transmit this information as part of the information contained in the result comment field. The individual laboratory should determine whether it is better to include the equation, or the author(s) of the equation, to identify the method used to perform the eGFR calculation.' This example uses Group.characteristic.determinedByExpression to show where the exact equation may be reported.

This code system is a temporary workspace while drafting the Evidence Based Medicine Implementation Guide. It may not be stable and may not be persistent.

A list of study results used to provide the group members for a MetaAnalysisStudyGroup Profile.

A list of Evidence Resources (ComparativeEvidence Profile) used to provide the group members for a MetaAnalysisStudyGroup Profile.

This example EvidenceMap has content that can be used for a SummaryOfFindings Profile of Composition.

This value set is a temporary workspace while drafting the Evidence Based Medicine Implementation Guide. It may not be stable and may not be persistent.

Population Patients eligible for bariatric surgery, Intervention Bariatric surgery, Comparator No bariatric surgery, selected Clinical Outcomes

This value set is a temporary workspace while drafting the Evidence Based Medicine Implementation Guide. It may not be stable and may not be persistent.

An example of an EndpointAnalysisPlan Profile which uses intended='true' and include-if extensions within Evidence.statistic.modelCharacteristic elements.

Description: therapeutic-dose anticoagulation with heparin Note: Therapeutic-dose anticoagulation with unfractionated or low-molecular-weight heparin was administered according to local protocols for the treatment of acute venous thromboembolism for up to 14 days or until recovery; the latter was defined as hospital discharge or a discontinuation of supplemental oxygen for at least 24 hours.

Example of an ExposureGroup Profile with an enumerated group (quantity = 932) meeting 2 characteristics defined by Group Resources (Member of a StudyGroup Profile, Procedure defined by an ExposureDefinition Profile)

This example expresses the variable 'Age' as a continuous variable with a simple definition using definition.concept.coding and is used with the BaselineMeasureEvidence Profile of Evidence in the Evidence.variableDefinition with variableRole='outcome'

This example expresses the variable 'Body Mass Index' as a continuous variable with a simple definition using definition.concept.coding and is used with the BaselineMeasureEvidence Profile of Evidence in the Evidence.variableDefinition with variableRole='outcome'

Subject age at diagnosis - datatype integer, encoded value

Self-reported race - datatype string

Self-reported sex - datatype CodeableConcept

Subject ID - datatype string

Analyte type of the sample - datatype string

Body site where sample was collected - datatype string

The tumor status of the sample - datatype CodeableConcept

Sample ID - datatype string

Technology employed on the sample - datatype string

Source of sample - datatype string

This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This example of a GroupAssignment Profile describes a 2-group study (so handling='dichotomous') and lists the 2 study arms in category.name elements. Because the definition of this EvidenceVariable Resource is fully expressed in the handling and category elements, the defintion.concept element uses a CodeableConcept for 'Defined in handling and category elements'.

This EvidenceVariable Resource (GroupAssignment Profile) describes a 2-group study (so handling='dichotomous') and lists the 2 study arms in category.name elements. Because the definition of this EvidenceVariable Resource is fully expressed in the handling and category elements, the defintion.concept element uses a CodeableConcept for 'Defined in handling and category elements'.

This EvidenceVariable Resource (GroupAssignment Profile) describes a 2-group study (so handling='dichotomous') and lists the 2 study arms in category.name elements. Because the definition of this EvidenceVariable Resource is fully expressed in the handling and category elements, the defintion.concept element uses a CodeableConcept for 'Defined in handling and category elements'.

This example of a GroupAssignment Profile describes a 2-group study (so handling='dichotomous') and lists the 2 study arms in category.name elements. Because the definition of this EvidenceVariable Resource is fully expressed in the handling and category elements, the defintion.concept element uses a CodeableConcept for 'Defined in handling and category elements'.

This example of a GroupAssignment Profile describes a 2-group study (so handling='dichotomous') and lists the 2 study arms in category.name elements. Because the definition of this EvidenceVariable Resource is fully expressed in the handling and category elements, the defintion.concept element uses a CodeableConcept for 'Defined in handling and category elements'.

This example of a GroupAssignment Profile describes a 2-group study (so handling='dichotomous') and lists the 2 study arms in category.name elements. Because the definition of this EvidenceVariable Resource is fully expressed in the handling and category elements, the defintion.concept element uses a CodeableConcept for 'Defined in handling and category elements'.

This EvidenceVariable Resource is referenced in an example for the EBMonFHIR Implementation Guide.

Therapeutic-dose anticoagulation with heparin vs. Usual-care pharmacologic thromboprophylaxis in multi-platform RCT of anticoagulation for non-critically ill patients with COVID-19

This example of a GroupAssignment Profile describes a 3-arm trial (so handling='polychotomous') and lists the 3 trial arms in category.name elements. Because the definition of this EvidenceVariable Resource is fully expressed in the handling and category elements, the defintion.concept element uses a CodeableConcept for 'Defined in handling and category elements'.

Example of Guideline Profile of Composition Resource

This example uses the Dosage datatype to represent dosing for IV remdesivir.

Risk of additional GI surgical procedure in intervention group was 31.3%. 292 out of 932 observed with percentage of: 31.3%

Risk of New onset depression in intervention group was 8.9%.

Risk of Remission of diabetes in intervention group was 57.5%.

Risk of Treatment with opioids in intervention group was 19.4%.

For all ANOVA and ANCOVA models, data collected from investigators who enrolled fewer than 3 patients in any one treatment group will be combined prior to analysis. If this combination still results in a treatment group having fewer than 3 patients in any one treatment group, then this group of patients will be combined with the next fewest enrolling investigator. In the event that there is a tie for fewest-enrolling investigator, one of these will be chosen at random by a random-number generator.

The Investigator-by-treatment interaction variable is polychotomous (a category for each investigator) but the investigator names are unknown at the time of trial planning so the category element is not used to define the categories.

This example of an Adaptation Profile shows the specific content that was changed when adapting one Recommendation Profile instance to create a new Recommendation Profile instance, serving a role of 'track changes' for structured data.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

An example using the ArtifactAssessment Resource for representation of the many judgments and concepts used to justify a recommendation.

An example using the ArtifactAssessment Resource for representation of the many judgments and concepts used to justify a recommendation.

This is an example of how an M11 Report can be supported in FHIR Profiles, and is actively revised in the Vulcan UDP meetings and Connectathons.

This M11Report Profile of Composition includes the instructions in each section.text.div element for creating an M11Report instance.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

Study population includes type 2 diabetes and BMI > 25 kg/m2; study design includes randomized assignment; exposure is bariatric surgery vs. no bariatric surgery; outcome measured is mean difference in HbA1c comparing bariatric surgery vs. no bariatric surgery

Mean difference in HbA1c between Surgery and Medical/Lifestyle groups at end of follow-up. As a MetaanalysisOutcomeDefinition, the type of object that has the characteristics in the definition is an Evidence Resource.

Effect Estimates for Mortality at 14 days from COVID19 Remdesivir vs. Placebo RCTs (Biegel 2020 data 35/541 vs. 61/521) (Wang 2020 data 15/153 vs. 7/78) (SOLIDARITY data 219/2743 vs. 219/2708)

mortality at 14 days

This variable definition is used for an NHANES data dictionary.

This variable definition is used for an NHANES data dictionary.

This Composition summarizes the code key for understanding a research study dataset, including references to EvidenceVariable Resources (VariableDefinition Profile) for each of the data elements (variables) in the dataset.

This variable definition for NHANES data dictionaries is for the research subject (respondent) identifier used to coordinate data across datasets.

This variable definition is used for an NHANES data dictionary.

-1.24 (-1.74 to -0.87)

2.14 (1.8 to 2.42)

-0.16 (-0.23 to -0.13)

0.91 (0.47 to 1.27)

2.15 (1.33 to 3.26) - example showing statistic.extension:modelExpression

-0.24 (-0.32 to -0.16)

A list of Evidence Resources (NetEffectContribution Profile) used to provide the group members for a NetEffectContributions Profile.

This is an example of a NetEffectContributions Profile of a Group Resource. This is a conceptual group (membership = 'conceptual') where the type of group member is an Evidence Resource (NetEffectContribution Profile) and this type is not supported in the type element so the type element is not used. The characteristic is defined by reference to a NetEffectContributionList Profile of List Resource where the 'group members' can be found.

Net Effect Estimate = 3.55 (2.38 to 4.73)

The main purpose of this study is, in combination with data from the Register and Biobank study and follow-up data from the Norwegian Prescription Database, to compare the long-term effects (4-10 years) of surgical and non-surgical treatment of morbid obesity on obesity related comorbidities by studying changes in medicine usage after treatment.

Hypotheses

1. Primary hypothesis: As compared to non-surgical treatment, bariatric surgery will be associated with higher rates of remission, and lower rates of new-onset drug treated hypertension during a follow-up period of ≤ 10 years.
2. Secondary hypotheses: Changes in the usage of other drugs, particularly drugs related to obesity related comorbidities, will differ significantly between patients undergoing bariatric surgery or non-surgical treatment during the follow-up period.

The primary outcome was organ support–free days, evaluated on an ordinal scale that combined in-hospital death and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. Patients who were discharged from the hospital before day 21 were assumed to be alive and free of organ support through day 21. Any death during the index hospitalization through 90 days was assigned the worst score on the outcome scale (–1). This end point reflects both the use of ICU-level interventions and survival, with higher values indicating better outcomes.

This example expresses the outcome desirability with a CodeableConcept datatype and the relative outcome importance (100%) with a Quantity datatype.

This example expresses the outcome desirability with a CodeableConcept datatype and the relative outcome importance (30%) with a Quantity datatype.

This example expresses the outcome desirability with a CodeableConcept datatype and the relative outcome importance (5%) with a Quantity datatype.

This example expresses the outcome desirability with a CodeableConcept datatype and the relative outcome importance (5%) with a Quantity datatype

This example expresses the outcome desirability with a CodeableConcept datatype and the relative outcome importance (5%) with a Quantity datatype.

This example expresses the outcome desirability with a CodeableConcept datatype and the relative outcome importance (8%) with a Quantity datatype.

This example of an OutcomeMeasureReport Profile shows a report from a single observational study with 4 outcome measures.

All-cause mortality

Body weight

Cardiovascular mortality

Diabetic ketoacidosis

End-stage kidney disease

Genital infection

Health-related quality of life

Hospital admission for heart failure

Nonfatal myocardial infarction

Nonfatal stroke

Serious hyperglycaemia

Severe gastrointestinal events

The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years

Diabetes in remission

HbA1c at 12 months

HbA1c at 24 months

HbA1c at 36 months

HbA1c at 60 months

HbA1c at 6 months

New onset depression

Nonfatal myocardial infarction or stroke

A list of EvidenceVariable Resources (OutcomeVariable Profile) used to provide the value of a characteristic for a ComparativeEvidenceReportSubject Profile.

The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years

HbA1c at 12 months

HbA1c at 24 months

HbA1c at 36 months

HbA1c at 6 months

HbA1c at 60 months

Mean difference in HbA1c between Surgery and Medical/Lifestyle groups at end of follow-up for HbA1c end point

This example expresses the variable 'New onset depression' as a dichotomous variable with a definition using definition.reference which references an OutcomeDefinition Profile of Group Resource.

Nonfatal myocardial infarction or stroke

This example expresses the variable 'Remission of diabetes' as a dichotomous variable with a definition using both definition.concept (for a SNOMED CT term) and definition.reference which references an OutcomeDefinition Profile of Group Resource.

This example expresses the variable 'Additional GI surgical procedure' as a dichotomous variable with a simple definition using definition.concept.text

A dichotomous variable (outcome measure) defined by CodeableConcept.

This example expresses the variable 'Treatment with opioids' as a dichotomous variable with a simple definition using definition.concept.text

This example of a ParticipantFlowReport Profile shows a report from a single observational study with 2 participant flow measures.

1888 included in analysis

956 included in analysis

932 included in analysis

221 excluded from analysis

Dropout due to stopping intervention

This example expresses the variable 'Excluded from analysis' as a dichotomous variable with a simple definition using definition.concept.text and is used with the ParticipantFlow Profile of Evidence in the Evidence.variableDefinition with variableRole='outcome'

This example expresses the variable 'Inclusion in analysis' as a dichotomous variable with a simple definition using definition.concept.text and is used with the ParticipantFlow Profile of Evidence in the Evidence.variableDefinition with variableRole='outcome'

An enumerated group participating in a randomized trial.

An definitional group used to support the 'intended' element in Evidence.varaibleDefinition with variableRole = 'population'.

Placebo

8.16 Metabolic surgery should be a recommended option to treat type 2 diabetes in screened surgical candidates with BMI ≥40 kg/m2 (BMI ≥37.5 kg/m2 in Asian Americans) and in adults with BMI 35.0–39.9 kg/m2 (32.5–37.4 kg/m2 in Asian Americans) who do not achieve durable weight loss and improvement in comorbidities (including hyperglycemia) with nonsurgical methods. A

8.17 Metabolic surgery may be considered as an option to treat type 2 diabetes in adults with BMI 30.0–34.9 kg/m2 (27.5–32.4 kg/m2 in Asian Americans) who do not achieve durable weight loss and improvement in comorbidities (including hyperglycemia) with nonsurgical methods. A

A preprint that has only an abstract and data is different than CT.gov results

This resource (this entire set of content) is being used for active development of a code system to support a RecommendationJustification Profile of ArtifactAssessment Resource. This code system is not yet released for expected use and may not be stable. This resource may be used for the continuous development of the code system, and published versions of the code system (when ready) may be published as separate resources with stable identifiers.

Example of Recommendation Profile of Composition Resource.

This example of adapting a Recommendation (removing the A from the end of the Recommendation Statement) shows the use of an Adaptation Profile of ArtifactAssessment and the use of the extensions: artifact-approvalDate, arifact-lastReviewDate, and artifact-effectivePeriod.

Example of Recommendation Profile of Composition Resource.

Remdesivir

Remdesivir IV 200 mg once then 100 mg once daily for 9 days

Types of bias for use with risk of bias assessment. This is a snapshot version from a code system in development (original source at https://fevir.net/resources/CodeSystem/27270) and is provided for example support in the EBMonFHIR Implementation Guide.

The ArtifactAssessment Resource is used here to show a complex risk of bias assessment with multiple recursive components.

This code system was copied as a snapshot from the version being used for active development of the Scientific Evidence Code System (SEVCO). This code system is not yet released for expected use and may not be stable. This resource may be used for supporting the examples in the EBMonFHIR Implementation Guide, and published versions of the code system (when ready) will be published as separate resources with stable identifiers.

Example of searching for 'Wonder Woman' in titles and abstracts in PubMed

This value set is a temporary workspace while drafting the Evidence Based Medicine Implementation Guide. It may not be stable and may not be persistent.

We conducted a search in Pubmed and Embase databases from inception to 28 August 2021. The search strategy composed the PICO method: patients of interest were obese, adult (age ≥18 years old) patients, Intervention was bariatric surgery, Controls were obese patients who did not undergo bariatric surgery, and Outcomes were defined as all-cause mortality, CV mortality, and incidence of CV disease, i.e. incident AF, incident HF, incident myocardial infarction, incident stroke, and incident aortic stenosis. Further, for clarity reasons we investigated myocardial infarction, and not incident coronary artery disease, because it is very difficult if not impossible to define its onset, also this was not uniform across the studies. Somewhat similarly, we investigated stroke and not incident cerebrovascular disease. A few studies, however, further differentiated between ischaemic vs. haemorrhagic stroke, and thus we also separately investigated the effect on ischaemic stroke.

Example of searching for "Wonder Woman" in titles and abstracts in PubMed

Cohort study with baseline data of exposures from November 2005 through July 2010 and follow-up data from 2006 until death or through December 2015 at a tertiary care outpatient center, Vestfold Hospital Trust, Norway. Consecutive treatment-seeking adult patients (n = 2109) with severe obesity assessed (221 patients excluded and 1888 patients included).

Example of Schedule of Activities with follow-up assessment 3 months after study start

This Group Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

Inclusion Criteria: Age 30 to 67 years at eligibility visit. Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, and HbA1c ≥ 8.0%. Body Mass Index (BMI) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit. Willingness to accept random assignment to either treatment group. Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial. Willingness to comply with the follow-up protocol and successful completion of the run-in. Written informed consent. ///// Exclusion Criteria: Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months. Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. Cardiac stress test indicating that surgery or IMM would not be safe. Pulmonary embolus or thrombophlebitis in the past six months. Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years. Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy. Serum creatinine ≥ 1.5 mg/dl. HbA1c > 14.0%.

Patients aged 30-60 years with a body-mass index of 35 kg/m(2) or more and a history of type 2 diabetes lasting at least 5 years

obese, adult (age ≥18 years old) patients

An enumerated group with a single characteristic referencing the StudyEligibilityCriteria.

An enumerated group with a single characteristic referencing the StudyEligibilityCriteria.

Example of SummaryOfFindings Profile of Composition Resource.

Example of SummaryOfNetEffect Profile of Composition Resource.

Study selection criteria Types of Studies. Randomized controlled clinical trials (RCTs) with parallel design that compared the association of ADT and chemotherapy (docetaxel), versus ADT alone.

Types of participants. Patients aged ≥18 years with cytological or histological diagnosis of mHNPC.

11 excluded studies

3 included studies

Therapeutic-dose anticoagulation with unfractionated or low-molecular-weight heparin was administered according to local protocols for the treatment of acute venous thromboembolism for up to 14 days or until recovery; the latter was defined as hospital discharge or a discontinuation of supplemental oxygen for at least 24 hours.

A conceptual group with 2 characteristics for study participant eligibility criteria that were used for a meta-analysis.

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.