Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
BMC Medical Informatics and Decision Making
Published in: BMC Medical Informatics and Decision Making 1/2015

Open Access 01-12-2015 | Research article

Using an electronic medical record (EMR) to conduct clinical trials: Salford Lung Study feasibility

Authors: Hanaa F Elkhenini, Kourtney J Davis, Norman D Stein, John P New, Mark R Delderfield, Martin Gibson, Jorgen Vestbo, Ashley Woodcock, Nawar Diar Bakerly

Published in: BMC Medical Informatics and Decision Making | Issue 1/2015

Login to get access

Abstract

Background

Real-world data on the benefit/risk profile of medicines is needed, particularly in patients who are ineligible for randomised controlled trials conducted for registration purposes. This paper describes the methodology and source data verification which enables the conduct of pre-licensing clinical trials of COPD and asthma in the community using the electronic medical record (EMR), NorthWest EHealth linked database (NWEH-LDB) and alert systems.

Methods

Dual verification of extracts into NWEH-LDB was performed using two independent data sources (Salford Integrated Record [SIR] and Apollo database) from one primary care practice in Salford (N = 3504). A feasibility study was conducted to test the reliability of the NWEH-LDB to support longitudinal data analysis and pragmatic clinical trials in asthma and COPD. This involved a retrospective extraction of data from all registered practices in Salford to identify a cohort of patients with a diagnosis of asthma (aged ≥18) and/or COPD (aged ≥40) and ≥2 prescriptions for inhaled bronchodilators during 2008. Health care resource utilisation (HRU) outcomes during 2009 were assessed. Exacerbations were defined as: prescription for oral corticosteroids (OCS) in asthma and prescription of OCS or antibiotics in COPD; and/or hospitalisation for a respiratory cause.

Results

Dual verification demonstrated consistency between SIR and Apollo data sources: 3453 (98.6%) patients were common to both systems; 99.9% of prescription records were matched and of 29,830 diagnosis records, one record was missing from Apollo and 272 (0.9%) from SIR. Identified COPD patients were also highly concordant (Kappa coefficient = 0.98).
A total of 7981 asthma patients and 4478 COPD patients were identified within the NWEH-LDB. Cohort analyses enumerated the most commonly prescribed respiratory medication classes to be: inhaled corticosteroids (ICS) (42%) and ICS plus long-acting β2-agonist (LABA) (40%) in asthma; ICS plus LABA (55%) and long-acting muscarinic antagonists (36%) in COPD. During 2009 HRU was greater in the COPD versus asthma cohorts, and exacerbation rates in 2009 were higher in patients who had ≥2 exacerbations versus ≤1 exacerbation in 2008 for both asthma (137.5 vs. 20.3 per 100 person-years, respectively) and COPD (144.6 vs. 41.0, respectively).

Conclusion

Apollo and SIR data extracts into NWEH-LDB showed a high level of concordance for asthma and COPD patients. Longitudinal data analysis characterized the COPD and asthma populations in Salford including medications prescribed and health care utilisation outcomes suitable for clinical trial planning.
Literature
1.
Hansell A, Hollowell J, Nichols T, McNiece R, Strachan D. Use of the General Practice Research Database (GPRD) for respiratory epidemiology: a comparison with the 4th Morbidity Survey in General Practice (MSGP4). Thorax. 1999;54:413–9.CrossRefPubMedPubMedCentral
2.
Soriano JB, Maier WC, Egger P, Visick G, Thakrar B, Sykes J, et al. Recent trends of physician-diagnosed COPD in women and men in the UK. Thorax. 2000;55:789–94.CrossRefPubMedPubMedCentral
3.
Hansell AL, Lam KA, Richardson S, Visick G, Soriano JB. Medical event profiling of COPD patients. Pharmacoepidemiol Drug Saf. 2004;13:547–55.CrossRefPubMed
4.
Soriano JB, Kiri VA, Maier WC, Strachan D. Increasing prevalence of asthma in UK primary care during the 1990s. Int J Tuberc Lung Dis. 2003;7:415–21.PubMed
5.
Kemp L, Haughney J, Barnes N, Sims E, von Ziegenweidt J, Hillyer EV, et al. Cost-effectiveness analysis of corticosteroid inhaler devices in primary care asthma management: a real world observational study. Clinicoecon Outcomes Res. 2010;2:75–85.PubMedPubMedCentral
6.
Gulliford MC, van Staa T, McDermott L, Dregan A, McCann G, Ashworth M, et al. Cluster randomised trial in the General Practice Research Database: 1. Electronic decision support to reduce antibiotic prescribing in primary care (eCRT study). Trials. 2011;12:115.CrossRefPubMedPubMedCentral
7.
van Staa T-P, Goldacre B, Gulliford M, Cassell J, Pirmohamed M, Taweel A, et al. Pragmatic randomised trials using routine electronic health records: putting them to the test. BMJ. 2012;344:e55.CrossRefPubMedPubMedCentral
8.
9.
Goodman K, Krueger J, Crowley J. The automatic clinical trial: Leveraging the electronic record in multi-site cancer clinical trials. Curr Oncol Rep. 2012;14(6):502–8.CrossRefPubMedPubMedCentral
10.
Yamamoto K, Sumi E, Yamazaki T, Asai K, Yamori M, Teramukai S, et al. A pragmatic method for electronic medical record-based observational studies: developing an electronic medical records retrieval system for clinical research. BMJ. 2012;2:e001622.CrossRef
11.
Murphy EC, Ferris FL, O’Donnell WR. An electronic Medical Records System for clinical research and EMR-EDC interface. Invest Ophthalmol Vis Sci. 2007;48:4383–9.CrossRefPubMedPubMedCentral
12.
13.
Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, et al. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease, GOLD Executive Summary. Am J Respir Crit Care Med. 2013;187:347–65.CrossRefPubMed
14.
Rabe KF, Adachi M, Lai C, Soriano JB, Vermeire PA, Weiss KB, et al. Worldwide severity and control of asthma in children and adults. The global Asthma and Insights and Reality surveys. J Allergy Clin Immunol. 2004;114:40–7.CrossRefPubMed
15.
Demoly P, Gueron B, Annunziata K, Adamek L, Walters RD. Update on asthma control in five European countries: results of a 2008 survey. Eur Respir Rev. 2010;19(116):150–7.CrossRefPubMed
16.
Bellamy D, Bouchard J, Henrichsen S, Johansson G, Langhammer A, Reid J, et al. International Primary Care Respiratory Group (IPCRG) Guidelines: Management of Chronic Obstructive Pulmonary Disease (COPD). Prim Care Respir. 2006;15:48–57.CrossRef
17.
Bellamy D, Harris T. Poor perceptions and expectations of asthma control: Results of the International Control of Asthma Symptoms (ICAS) survey of patients and general practitioners. Prim Care Respir J. 2005;14:252–8.CrossRefPubMed
18.
Van Ganse E, Antonicelli L, Zhang Q, Laforest L, Yin DD, Nocea G, et al. Asthma-related resource use and cost by GINA classification of severity in three European countries. Respir Med. 2006;100:140–7.CrossRefPubMed
19.
Juniper EF, Chauhan A, Neville E, Chatterjee A, Svensson K, Mork A-C, et al. Clinicians tend to overestimate improvements in asthma control: an unexpected observation. Prim Care Respir J. 2004;13:181–4.CrossRefPubMed
20.
Sobradillo-Peña V, Miravitlles M, Gabriel R, Jiménez-Ruiz CA, Villasante C, Masa JF, et al. Geographic variations in prevalence and underdiagnosis of COPD: results of the IBERPOC multicentre epidemiological study. Chest. 2000;118:981–9.CrossRef
21.
Soriano JB, Miravitlles M, Borderías L, Duran-Tauleria E, García Río F, Martínez J, et al. Geographical variations in the prevalence of COPD in Spain: relationship to smoking, death rates and other determining factors. Arch Bronconeumol. 2010;46:522–30.PubMed
22.
Aisanov Z, Bai C, Bauerle O, Colodenco FD, Feldman C, Hashimoto S, et al. Primary care physician perceptions on the diagnosis and management of chronic obstructive pulmonary disease in diverse regions of the world. Int J Chron Obstruct Pulmon Dis. 2012;7:271–82.PubMedPubMedCentral
23.
Corrado A, Rossi A. How far is real life from COPD therapy guidelines? An Italian observational study. Respir Med. 2012;106:989–97.CrossRefPubMed
24.
25.
26.
27.
28.
29.
Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37–46.CrossRef
30.
StataCorp. Stata Statistical Software: Release 11. College Station, TX: StataCorp LP; 2009.
31.
32.
Embi PJ, Jain A, Clark J, Bizjack S, Hornung R, Harris CM. Effect of a clinical trial alert system on physician participation in trial recruitment. Arch Intern Med. 2005;165:2272–7.CrossRefPubMedPubMedCentral
33.
Weiner DL, Butte AJ, Hibberd PL, Fleisher GR. Computerized recruiting for clinical trials in real time. Ann Emerg Med. 2003;41(2):242–6.CrossRefPubMed
34.
Dugas M, Lange M, Müller-Tidow C, Kirchhof P, Prokosch HU. Routine data from hospital information systems can support patient recruitment for clinical studies. Clin Trials. 2010;7(2):183–9.CrossRefPubMed
35.
36.
Jones PW, Brusselle G, Dal Negro RW, Ferrer M, Kardos P, Levy ML, et al. Health-related quality of life in patients by COPD severity within primary care in Europe. Respir Med. 2011;1:57–66.CrossRef
37.
38.
Han MK, Agusti A, Calverley PM, Celli BR, Criner G, Curtis JL, et al. Chronic Obstructive Pulmonary Disease Phenotypes. The Future of COPD. Am J Respir Crit Care Med. 2010;182:598–604.CrossRefPubMed
39.
Burgel P-R, Paillasseur J-L, Caillaud D, Tillie-Leblond I, Chanez P, Escamillae R, et al. Clinical COPD phenotypes: a novel approach using principal component and cluster analyses. Eur Respir J. 2010;36:531–9.CrossRefPubMed
40.
Hurst JR, Vestbo J, Anzuet A, Locantore N, Müllerova H, Tal-Singer R, et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010;363:1128–38.CrossRefPubMed
41.
Rennard SI, Calverley PMA, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD. Respir Res. 2011;12:18.CrossRefPubMedPubMedCentral
Metadata
Title
Using an electronic medical record (EMR) to conduct clinical trials: Salford Lung Study feasibility
Authors
Hanaa F Elkhenini
Kourtney J Davis
Norman D Stein
John P New
Mark R Delderfield
Martin Gibson
Jorgen Vestbo
Ashley Woodcock
Nawar Diar Bakerly
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Medical Informatics and Decision Making / Issue 1/2015
Electronic ISSN: 1472-6947
DOI
https://doi.org/10.1186/s12911-015-0132-z

Other articles of this Issue 1/2015

BMC Medical Informatics and Decision Making 1/2015 Go to the issue

Study protocol

The influence of a biopsychosocial educational internet-based intervention on pain, dysfunction, quality of life, and pain cognition in chronic low back pain patients in primary care: a mixed methods approach

Research article

Predicting asthma control deterioration in children

Research article

Justified granulation aided noninvasive liver fibrosis classification system

Research article

Multiple perspectives on clinical decision support: a qualitative study of fifteen clinical and vendor organizations

Research article

Framing optional genetic testing in the context of mandatory newborn screening tests

Erratum

Erratum to: Fine-grained information extraction from German transthoracic echocardiography reports