Evidence map›Paper›PMID 27842551›Full record

Observational studyRespiratory research2016

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.

Stefan Franzén, Christer Janson, Kjell Larsson, Max Petzold, Urban Olsson, Gunnar Magnusson, Gunilla Telg, Gene Colice, Gunnar Johansson, Mats Sundgren

Open access · goldAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Respiratory research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
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  6. Observational
  7. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 5 countries.

Stefan FranzénRegister Centrum, Gothenburg, Sweden.
Christer JansonDepartment of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden.
Kjell LarssonDepartment of Environmental Medicine, Karolinska Institute, Solna, Sweden.
Max PetzoldCentre for Applied Biostatistics, University Gothenburg, Gothenburg, Sweden.
Urban OlssonStatisticon AB, Uppsala, Sweden.
Gunnar MagnussonAstraZeneca, Gothenburg, Sweden.
Gunilla TelgAstraZeneca Nordic-Baltic, Södertälje, Sweden.
Gene ColiceAstraZeneca, Gaithersburg, USA.
Gunnar JohanssonPublic Health and Caring Science, Family Medicine and Preventive Medicine, Uppsala University, Uppsala, Sweden.
Mats SundgrenAstraZeneca, Gothenburg, Sweden. mats.sundgren@astrazeneca.com.ORCID 0000-0001-5300-5217
AstraZeneca (Sweden) · SEUppsala University · SEAstraZeneca (Netherlands) · NLAstraZeneca (United States) · USCentre of Registers Vastra Gotaland · SEKarolinska Institutet · SEStatisticon (Sweden) · SEUniversity of Gothenburg · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 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.

methodsEHR 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.

resultsWe 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

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

Indexed as

Electronic Health RecordsRandomized Controlled Trials as TopicRegistriesAdultAgedAnti-Asthmatic AgentsAsthmaData MiningFeasibility StudiesFemaleHealth Services ResearchHospitals, UniversityHumansLogistic ModelsMaleMiddle AgedAnti-Asthmatic AgentsAsthmaElectronic health recordsExacerbationPlacebo studiesRegistries

Identifiers

PMID27842551
PMCPMC5109788
OpenAlexW2556007083

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.