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Claims-based studies of oral glucose-lowering medications can achieve balance in critical clinical variables only observed in electronic health records.
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- Author(s): Patorno E;Patorno E; Gopalakrishnan C; Gopalakrishnan C; Franklin JM; Franklin JM; Brodovicz KG; Brodovicz KG; Masso-Gonzalez E; Masso-Gonzalez E; Bartels DB; Bartels DB; Bartels DB; Liu J; Liu J; Schneeweiss S; Schneeweiss S
- Source:
Diabetes, obesity & metabolism [Diabetes Obes Metab] 2018 Apr; Vol. 20 (4), pp. 974-984. Date of Electronic Publication: 2018 Jan 12.- Publication Type:
Journal Article; Observational Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't- Language:
English - Source:
- Additional Information
- Source: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 100883645 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1463-1326 (Electronic) Linking ISSN: 14628902 NLM ISO Abbreviation: Diabetes Obes Metab Subsets: MEDLINE
- Publication Information: Original Publication: Oxford : Wiley-Blackwell, c1999-
- Subject Terms: Blood Glucose/*drug effects ; Diabetes Mellitus, Type 2/*drug therapy ; Diabetes Mellitus, Type 2/*epidemiology ; Electronic Health Records/*statistics & numerical data ; Hypoglycemic Agents/*administration & dosage ; Linagliptin/*administration & dosage; Administration, Oral ; Administrative Claims, Healthcare/statistics & numerical data ; Adult ; Aged ; Blood Glucose/metabolism ; Clinical Trials as Topic/statistics & numerical data ; Cohort Studies ; Databases, Factual ; Diabetes Mellitus, Type 2/blood ; Female ; Humans ; Male ; Middle Aged ; United States/epidemiology
- Abstract: Aim: To evaluate the extent to which balance in unmeasured characteristics of patients with type 2 diabetes (T2DM) was achieved in claims data, by comparing against more detailed information from linked electronic health records (EHR) data.
Methods: Within a large US commercial insurance database and using a cohort design, we identified patients with T2DM initiating linagliptin or a comparator agent within class (ie, another dipeptidyl peptidase-4 inhibitor) or outside class (ie, pioglitazone or a sulphonylurea) between May 2011 and December 2012. We focused on comparators used at a similar stage of diabetes to linagliptin. For each comparison, 1:1 propensity score (PS) matching was used to balance >100 baseline claims-based characteristics, including proxies of diabetes severity and duration. Additional clinical data from EHR were available for a subset of patients. We assessed representativeness of the claims-EHR-linked subset, evaluated the balance of claims- and EHR-based covariates before and after PS-matching via standardized differences (SDs), and quantified the potential bias associated with observed imbalances.
Results: From a claims-based study population of 166 613 patients with T2DM, 7219 (4.3%) patients were linked to their EHR data. Claims-based characteristics in the EHR-linked and EHR-unlinked patients were similar (SD < 0.1), confirming the representativeness of the EHR-linked subset. The balance of claims-based and EHR-based patient characteristics appeared to be reasonable before PS-matching and generally improved in the PS-matched population, to be SD < 0.1 for most patient characteristics and SD < 0.2 for select laboratory results and body mass index categories, which was not large enough to cause meaningful confounding.
Conclusion: In the context of pharmacoepidemiological research on diabetes therapy, choosing appropriate comparison groups paired with a new-user design and 1:1 PS matching on many proxies of diabetes severity and duration improves balance in covariates typically unmeasured in administrative claims datasets, to the extent that residual confounding is unlikely.
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J Clin Epidemiol. 2005 Apr;58(4):323-37. (PMID: 15862718) - Grant Information: K08 AG055670 United States AG NIA NIH HHS
- Contributed Indexing: Keywords: administrative data; electronic medical records; glucose-lowering medications; linkage; type 2 diabetes
- Accession Number: 0 (Blood Glucose)
0 (Hypoglycemic Agents)
3X29ZEJ4R2 (Linagliptin) - Publication Date: Date Created: 20171206 Date Completed: 20190111 Latest Revision: 20220318
- Publication Date: 20240628
- Accession Number: PMC6207375
- Accession Number: 10.1111/dom.13184
- Accession Number: 29206336
- Source:
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