To Örebro University

oru.seÖrebro University Publications
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Health care registers can be instrumental for endpoint capture in clinical diabetes trials: example of microvascular complications in Swedish patients with type 2 diabetes
Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Örebro University, School of Medical Sciences. Örebro University Hospital. Faculty of Medicine and Health, University Health Care Research Center, Örebro University, Örebro, Sweden; Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.ORCID iD: 0000-0001-6864-4679
Center for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden.
Show others and affiliations
2023 (English)In: Diabetes & Vascular Disease Research, ISSN 1479-1641, E-ISSN 1752-8984, Vol. 20, no 3, article id 14791641231179878Article in journal (Refereed) Published
Abstract [en]

AIMS: SMARTEST is a register-based randomized clinical trial (RRCT) that compares dapagliflozin to metformin in early-stage type 2 diabetes. The primary outcome includes progression of microvascular complications based on data from the Swedish National Diabetes Register (NDR). In this sub-study, the aim was to validate microvascular complication variables in the NDR against electronic health records (EHRs).

METHODS: Data were extracted from EHRs of 276 SMARTEST participants with a median observation period of 3 years in the Uppsala, Örebro and Sörmland counties and compared with NDR data. Agreement was determined for all corresponding data entries as well as for progression of microvascular complications after randomization.

RESULTS: The agreement for all corresponding data entries was 98.9% (Intraclass Correlation Coefficient 0.999) for creatinine and eGFR, 95.1% for albuminuria, 91.6% for foot-at-risk and 98.2% for retinopathy status (Kappa 0.67-0.91). The agreement for progression of microvascular complications was 98.0% for CKD stage, 98.9% for albuminuria grade, 96.3% for foot-at-risk grade and 99.6% for retinopathy grade progression (Gwet's AC1 0.96-1.00). CONCLUSION: Microvascular complication variables in the NDR show good agreement with EHR data. The use of a well-established national health care registry, exemplified by the NDR, for endpoint collection in RRCTs such as SMARTEST is supported by this study.

Place, publisher, year, edition, pages
Sage Publications, 2023. Vol. 20, no 3, article id 14791641231179878
Keywords [en]
Type 2 diabetes, diabetes register, endpoint, microvascular complications, register-based randomized clinical trial, validation
National Category
Endocrinology and Diabetes
Identifiers
URN: urn:nbn:se:oru:diva-106404DOI: 10.1177/14791641231179878ISI: 001019606800001PubMedID: 37318227Scopus ID: 2-s2.0-85163904302OAI: oai:DiVA.org:oru-106404DiVA, id: diva2:1775013
Funder
Swedish Research Council, 2018-00904 2019-00978VinnovaSwedish Heart Lung Foundation, 20190403Eye FoundationDiabetesfonden
Note

Funding agencies:

Uppsala-Orebro Regional Research Council RFR-930976

ALF grant

Available from: 2023-06-26 Created: 2023-06-26 Last updated: 2023-08-03Bibliographically approved

Open Access in DiVA

No full text in DiVA

Other links

Publisher's full textPubMedScopus

Authority records

Jansson, Stefan P. O.

Search in DiVA

By author/editor
Jansson, Stefan P. O.
By organisation
School of Medical SciencesÖrebro University Hospital
In the same journal
Diabetes & Vascular Disease Research
Endocrinology and Diabetes

Search outside of DiVA

GoogleGoogle Scholar

doi
pubmed
urn-nbn

Altmetric score

doi
pubmed
urn-nbn
Total: 33 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf