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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.

https://arctichealth.org/en/permalink/ahliterature287527
Source
Respir Res. 2016 Nov 15;17(1):152
Publication Type
Article
Date
Nov-15-2016
Author
Stefan Franzén
Christer Janson
Kjell Larsson
Max Petzold
Urban Olsson
Gunnar Magnusson
Gunilla Telg
Gene Colice
Gunnar Johansson
Mats Sundgren
Source
Respir Res. 2016 Nov 15;17(1):152
Date
Nov-15-2016
Language
English
Publication Type
Article
Keywords
Adult
Aged
Anti-Asthmatic Agents - therapeutic use
Asthma - diagnosis - drug therapy - physiopathology
Data Mining
Electronic Health Records
Feasibility Studies
Female
Health Services Research
Hospitals, University
Humans
Logistic Models
Male
Middle Aged
Primary Health Care
Propensity Score
Randomized Controlled Trials as Topic
Registries
Retrospective Studies
Severity of Illness Index
Sweden
Time Factors
Treatment Outcome
Abstract
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.
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.
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/m2 versus 27.3 kg/m2; and consisted of 40% versus 34% males.
The results indicate that EHRs provide an opportunity to supplement the control group in RCTs of severe diseases.
Notes
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PubMed ID
27842551 View in PubMed
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Prevalence and management of severe asthma in primary care: an observational cohort study in Sweden (PACEHR).

https://arctichealth.org/en/permalink/ahliterature295883
Source
Respir Res. 2018 01 18; 19(1):12
Publication Type
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Date
01-18-2018
Author
Kjell Larsson
Björn Ställberg
Karin Lisspers
Gunilla Telg
Gunnar Johansson
Marcus Thuresson
Christer Janson
Author Affiliation
Work Environment Toxicology, The National Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden. kjell.larsson@ki.se.
Source
Respir Res. 2018 01 18; 19(1):12
Date
01-18-2018
Language
English
Publication Type
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Keywords
Adult
Aged
Aged, 80 and over
Anti-Asthmatic Agents - therapeutic use
Asthma - diagnosis - epidemiology - therapy
Cohort Studies
Disease Management
Female
Humans
Male
Middle Aged
Prevalence
Primary Health Care - methods
Registries
Severity of Illness Index
Sweden - epidemiology
Abstract
Severe and uncontrolled asthma is associated with increased risk of exacerbations and death. A substantial proportion of asthma patients have poor asthma control, and a concurrent COPD diagnosis often increases disease burden. The objective of the study was to describe the prevalence and managemant of severe asthma in a Swedish asthma popuöation.
In this observational cohort study, primary care medical records data (2006-2013) from 36 primary health care centers were linked to data from national mandatory Swedish health registries. The studied population (>18 years) had a record of drug collection for obstructive pulmonary disease (ATC code R03) during 2011-2012, and a physician diagnosed asthma (ICD-10 code J45-J46) prior to drug collection. Severe asthma was classified as collection of high dose inhaled steroid (> 800 budesonide or equivalent per day) and leukotriene receptor antagonist and/or long-acting beta-agonist. Poor asthma control was defined as either collection of =600 doses of short-acting beta-agonists, and/or =1 exacerbation(s) during the year post index date.
A total of 18,724 asthma patients (mean 49 years, 62.8% women) were included, of whom 17,934 (95.8%) had mild to moderate and 790 (4.2%) had severe asthma. Exacerbations were more prevalent in severe asthma (2.59 [2.41-2.79], Relative Risk [95% confidence interval]; p?
Notes
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PubMed ID
29347939 View in PubMed
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