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Evaluation of the u...
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
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- Franzen, S. (författare)
- Register Centrum, Gothenburg, Sweden.
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- Janson, Christer (författare)
- Uppsala universitet,Lungmedicin och allergologi
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- Larsson, K. (författare)
- Karolinska Institutet,Karolinska Inst, Dept Environm Med, Solna, Sweden.
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- Petzold, Max, 1973 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för samhällsmedicin och folkhälsa, enheten för hälsometri,Institute of Medicine, Department of Public Health and Community Medicine, Health Metrics,Univ Gothenburg, Ctr Appl Biostat, Gothenburg, Sweden.
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- Olsson, U. (författare)
- Statisticon AB, Uppsala, Sweden.
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- Magnusson, G. (författare)
- AstraZeneca, Gothenburg, Sweden.
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- Telg, G. (författare)
- AstraZeneca Nord Balt, Sodertalje, Sweden.
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- Colice, G. (författare)
- AstraZeneca, Gaithersburg, MD USA.
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- Johansson, Gunnar (författare)
- Uppsala universitet,Allmänmedicin och preventivmedicin
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- Sundgren, M. (författare)
- AstraZeneca, Gothenburg, Sweden.;AstraZeneca, Biometr & Informat Sci, SE-43183 Molndal, Sweden.
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Register Centrum, Gothenburg, Sweden Lungmedicin och allergologi (creator_code:org_t)
- 2016-11-15
- 2016
- Engelska.
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Ingår i: Respiratory Research. - : Springer Science and Business Media LLC. - 1465-993X .- 1465-9921. ; 17
- Relaterad länk:
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https://doi.org/10.1...
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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http://kipublication...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Annan medicin och hälsovetenskap (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Other Medical and Health Sciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)
Nyckelord
- Electronic health records
- Registries
- Asthma
- Exacerbation
- Placebo studies
- arthritis
- project
- placebo
- Respiratory System
- Electronic health records
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Franzen, S.
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Janson, Christer
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Larsson, K.
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Petzold, Max, 19 ...
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Olsson, U.
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Magnusson, G.
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Telg, G.
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Colice, G.
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Johansson, Gunna ...
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Sundgren, M.
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- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Annan medicin oc ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Lungmedicin och ...
- Artiklar i publikationen
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Respiratory Rese ...
- Av lärosätet
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Göteborgs universitet
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Karolinska Institutet
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Uppsala universitet