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Evaluation of the use of Swedish integrated electronic health records and register health care data as support clinical trials in severe asthma: the PACEHR study
Register Centrum, Gothenburg, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Respiratory Medicine and Allergology.
Karolinska Inst, Dept Environm Med, Solna, Sweden..
Univ Gothenburg, Ctr Appl Biostat, Gothenburg, Sweden..
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2016 (English)In: Respiratory Research, ISSN 1465-9921, E-ISSN 1465-993X, Vol. 17, article id 152Article in journal (Refereed) Published
Abstract [en]

Background: In the development of new drugs for severe asthma, it is a challenge from an ethical point of view to randomize severe asthma patients to placebo, and to obtain long-term safety data due to discontinuations. The aim of this study was to evaluate the feasibility of using electronic health record (EHR) data to create a real-world reference population of uncontrolled asthmatic patients to supplement the concurrent control/placebo group in long-term studies of asthma.

Methods: EHR data from 36 primary care centres and a University hospital in Sweden were linked to Swedish mandatory health registers (2005-2013), creating a population covering 33 890 asthma patients, including data on co-morbidities, risk factors and laboratory/respiratory measurements. A severe asthma EHR reference cohort was established. We used logistic regression to estimate the propensity score (probability) of each RCT or EHR patient existing in the EHR cohort given their covariates.

Results: We created an EHR-derived reference cohort of 240 patients, matching the placebo group (N = 151) in an RCT of severe asthma. The exacerbation rate during follow-up in the EHR study population was 1.24 (weighted) compared to 0.9 in the RCT placebo group. Patients in the EHR cohort were of similar age as in the RCT placebo group, 50.6 years versus 50.1 years; had slightly higher body mass index 27.0 kg/m(2) versus 27.3 kg/m(2); and consisted of 40% versus 34% males.

Conclusions: The results indicate that EHRs provide an opportunity to supplement the control group in RCTs of severe diseases.

Place, publisher, year, edition, pages
2016. Vol. 17, article id 152
Keywords [en]
Electronic health records, Registries, Asthma, Exacerbation, Placebo studies
National Category
Respiratory Medicine and Allergy
Identifiers
URN: urn:nbn:se:uu:diva-309798DOI: 10.1186/s12931-016-0461-1ISI: 000387607200001PubMedID: 27842551OAI: oai:DiVA.org:uu-309798DiVA, id: diva2:1056581
Funder
AstraZenecaAvailable from: 2016-12-15 Created: 2016-12-07 Last updated: 2017-11-29Bibliographically approved

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