http://hl7.org/fhir/uv/ebm/ResearchStudy/208285
type: ResearchStudy
node role: treeRoot
id:
  v: 208285
meta:
  version id:
    v: 19
  last updated:
    v: 2025-05-13T04:03:52.308Z
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Title: Norwegian Cohort Study Comparing Bariatric Surgery vs Medical Obesity Treatment for Long-term Medical Complications and Obesity-Related Comorbidities Name: 2018 Norwegian Cohort Study Official title (coded as: official from http://hl7.org/fhir/title-type): The Long-Term Effect of Treatment of Morbid Obesity Acronym (coded as: acronym from http://hl7.org/fhir/title-type); LETMO: Short title (coded as: short-title from http://hl7.org/fhir/title-type): LETMO - a cohort study Identifier: FOI 208285 Identifier: REK project number identifier 2010/2329 Study start and end: July 2010 to 2015 Progress Status: Completed (coded as: completed from http://hl7.org/fhir/research-study-status)( ) Description: 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. Condition: morbid obesity Region: Norway (coded as: NO from urn:iso:std:iso:3166) Study Design: Observational research (coded as: SEVCO:01002 from http://hl7.org/fhir/study-design) Study Design: Parallel cohort design (coded as: SEVCO:01011 from http://hl7.org/fhir/study-design) Study Design: Longitudinal data collection (coded as: SEVCO:01028 from http://hl7.org/fhir/study-design) Related Item (specification-of): eAppendix 2. Research Protocol Relat…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/artifact-author
    l: artifact-author
  value: ContactDetail
    name:
      v: Brian S. Alper
extension:
  url:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
    l: artifact-publication-status
  value: CodeableConcept
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/cited-artifact-status-type
        l: cited-artifact-status-type
      code:
        v: active
      display:
        v: Active
url:
  v: https://fevir.net/resources/ResearchStudy/208285
  l: https://fevir.net/resources/ResearchStudy/208285
identifier:
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0203
        l: v2-0203
      code:
        v: ACSN
      display:
        v: Accession ID
    text:
      v: FEvIR Object Identifier
  system:
    v: https://fevir.net/FOI
    l: FOI
  value:
    v: 208285
  assigner:
    display:
      v: Computable Publishing LLC
identifier:
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0203
        l: v2-0203
      code:
        v: ACSN
      display:
        v: Accession ID
    text:
      v: REK project number
  value:
    v: 2010/2329
name:
  v: Year_2018_Norwegian_Cohort_Study
title:
  v: Norwegian Cohort Study Comparing Bariatric Surgery vs Medical Obesity Treatment for Long-term Medical Complications and Obesity-Related Comorbidities
label:
  type:
    coding:
      system:
        v: http://hl7.org/fhir/title-type
        l: title-type
      code:
        v: official
      display:
        v: Official title
  value:
    v: The Long-Term Effect of Treatment of Morbid Obesity
label:
  type:
    coding:
      system:
        v: http://hl7.org/fhir/title-type
        l: title-type
      code:
        v: acronym
      display:
        v: Acronym
    text:
      v: LETMO
label:
  type:
    coding:
      system:
        v: http://hl7.org/fhir/title-type
        l: title-type
      code:
        v: short-title
      display:
        v: Short title
  value:
    v: LETMO - a cohort study
cite as:
  v: Norwegian Cohort Study Comparing Bariatric Surgery vs Medical Obesity Treatment for Long-term Medical Complications and Obesity-Related Comorbidities [Database Entry: FHIR ResearchStudy Resource]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 208285. Revised 2025-05-13. Available at: https://fevir.net/resources/ResearchStudy/208285. Computable resource at: https://fevir.net/resources/ResearchStudy/208285#json.
relates to:
  type:
    v: specification-of
  target: Attachment
    content type:
      v: application/pdf
    title:
      v: jama-319-291-s001
relates to:
  type:
    v: derived-from
  target: Reference
    l: http://hl7.org/fhir/uv/ebm/Citation/104116
    reference:
      v: Citation/104116
    type:
      v: Citation
      l: Citation
    display:
      v: JournalArticleCitation: Association of Bariatric Surgery with Complications and Comorbidities JAMA 2018 Norwegian Cohort
status:
  v: active
study design:
  coding:
    system:
      v: http://hl7.org/fhir/study-design
      l: study-design
    code:
      v: SEVCO:01002
    display:
      v: Observational research
study design:
  coding:
    system:
      v: http://hl7.org/fhir/study-design
      l: study-design
    code:
      v: SEVCO:01011
    display:
      v: Parallel cohort design
study design:
  coding:
    system:
      v: http://hl7.org/fhir/study-design
      l: study-design
    code:
      v: SEVCO:01028
    display:
      v: Longitudinal data collection
condition:
  text:
    v: morbid obesity
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
      l: 3166
    code:
      v: NO
    display:
      v: Norway
description:
  v: 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.
period:
  start:
    v: 2010-07
  end:
    v: 2015
site:
  display:
    v: Vestfold Hospital Trust
associated party:
  name:
    v: Jøran Hjelmesæth, Leader of the Morbid Obesity Center, Vestfold Hospital Trust, and Professor at the Department for Endocrinology, Morbid Obesity and Preventitive Medicine, Medical Clinic, the Institute for Clinical Medicine, the University of Oslo.
  role:
    coding:
      system:
        v: http://hl7.org/fhir/research-study-party-role
        l: research-study-party-role
      code:
        v: primary-investigator
      display:
        v: Principal investigator
    text:
      v: Project Leader and Main Supervisor

name:
  v: Gunn Signe Jakobsen, cand. med. at the Morbid Obesity Center, South-Eastern Norway Regional Health Authority. Doctor with a specialisation at the department for Gastroenterological Surgery, Akershus University Hospital. Mobil: 916 25 647, email: gunn.signe.jakobsen@siv.no
role:
  coding:
    system:
      v: http://hl7.org/fhir/research-study-party-role
      l: research-study-party-role
    code:
      v: collaborator
    display:
      v: collaborator
  text:
    v: PhD Candidate

name:
  v: Jens Kristoffer Hertel, PhD, the Morbid Obesity Center, Vestfold Hospital Trust.
role:
  coding:
    system:
      v: http://hl7.org/fhir/research-study-party-role
      l: research-study-party-role
    code:
      v: collaborator
    display:
      v: collaborator
  text:
    v: Co-supervisor

name:
  v: Arild Nesbakken, Professor, the Surgical Clinic, Oslo University Hospital
role:
  coding:
    system:
      v: http://hl7.org/fhir/research-study-party-role
      l: research-study-party-role
    code:
      v: collaborator
    display:
      v: collaborator
  text:
    v: Co-supervisor

name:
  v: Rune Sandbu, dr.med, the Morbid Obesity Center and Department of Surgery, Vestfold Hospital Trust.
role:
  coding:
    system:
      v: http://hl7.org/fhir/research-study-party-role
      l: research-study-party-role
    code:
      v: collaborator
    display:
      v: collaborator
  text:
    v: Co-supervisor

name:
  v: Milada Cvancarova Småstuen, PhD, the Morbid Obesity Center, South-Eastern Norway Regional Health Authority, Vestfold Hospital Trust
role:
  coding:
    system:
      v: http://hl7.org/fhir/research-study-party-role
      l: research-study-party-role
    code:
      v: collaborator
    display:
      v: collaborator
  text:
    v: Biostatistician

state:
  coding:
    system:
      v: http://hl7.org/fhir/research-study-status
      l: research-study-status
    code:
      v: completed
    display:
      v: Completed

target number:
  v: 505
actual number:
  v: 1888
actual group:
  l: http://hl7.org/fhir/uv/ebm/Group/178427
  reference:
    v: Group/178427
  type:
    v: Group
    l: Group
  display:
    v: StudyGroup: Severely Obese Adults 2018 Norwegian Cohort

eligibility:
  display:
    v: Bariatric Surgery
observed group:
  l: http://hl7.org/fhir/uv/ebm/Group/172934
  reference:
    v: Group/172934
  type:
    v: Group
    l: Group
  display:
    v: ExposureGroup: JAMA 2018 Norwegian cohort study Surgery cohort

eligibility:
  display:
    v: Medical Obesity Treatment
observed group:
  l: http://hl7.org/fhir/uv/ebm/Group/172939
  reference:
    v: Group/172939
  type:
    v: Group
    l: Group
  display:
    v: ComparatorGroup: JAMA 2018 Norwegian cohort study Control cohort

outcome measure:
  name:
    v: Remission of diabetes
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/104117
    reference:
      v: EvidenceVariable/104117
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: OutcomeDefinition: Remission of diabetes
outcome measure:
  name:
    v: New onset depression
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/104118
    reference:
      v: EvidenceVariable/104118
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: OutcomeDefinition: New onset depression
outcome measure:
  name:
    v: Treatment with opioids
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/104119
    reference:
      v: EvidenceVariable/104119
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: OutcomeDefinition: Treatment with opioids
outcome measure:
  name:
    v: Additional GI surgical procedure
  endpoint:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/104120
    reference:
      v: EvidenceVariable/104120
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: OutcomeDefinition: Additional GI surgical procedure

l: http://hl7.org/fhir/uv/ebm/Citation/104116
reference:
  v: Citation/104116
type:
  v: Citation
  l: Citation
display:
  v: JournalArticleCitation: Association of Bariatric Surgery with Complications and Comorbidities JAMA 2018 Norwegian Cohort

l: http://hl7.org/fhir/uv/ebm/Citation/247416
reference:
  v: Citation/247416
type:
  v: Citation
  l: Citation
display:
  v: Citation for Composition: ComparativeEvidenceReport: Association of Bariatric Surgery vs Medical Obesity Treatment With Long-term Medical Complications and Obesity-Related Comorbidities (2018 Norwegian Cohort)