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

BMC Medical Informatics and Decision Making

Volumn 15, Issue 1, 2015, Pages

  Elkhenini, Hanaa F ^a,b   Davis, Kourtney J ^c,d   Stein, Norman D ^a,b   New, John P ^a,b   Delderfield, Mark R ^a,b   Gibson, Martin ^a,b   Vestbo, Jorgen ^a,e   Woodcock, Ashley ^a,e   Bakerly, Nawar Diar ^a,b  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b SALFORD ROYAL NHS FOUNDATION TRUST   (United Kingdom)

^c GSK   (Belgium)

^d GLAXOSMITHKLINE   (United Kingdom)

^e MANCHESTER UNIVERSITY NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

Asthma; COPD; Dua verification; Electronic medical record; EMR; Primary and secondary healthcare; Real world data

Indexed keywords

ADULT; AGED; ASTHMA; CLINICAL TRIAL (TOPIC); ELECTRONIC HEALTH RECORD; FACTUAL DATABASE; FEASIBILITY STUDY; FEMALE; HEALTH SERVICE; HUMAN; MALE; MIDDLE AGED; PROCEDURES; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; STATISTICS AND NUMERICAL DATA;

ADULT; AGED; ASTHMA; CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; ELECTRONIC HEALTH RECORDS; FEASIBILITY STUDIES; FEMALE; HEALTH SERVICES; HUMANS; MALE; MIDDLE AGED; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE;

EID: 84924147809     PISSN: None     EISSN: 14726947     Source Type: Journal    
DOI: 10.1186/s12911-015-0132-z     Document Type: Article

References (41)

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.
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.
3. Hansell AL, Lam KA, Richardson S, Visick G, Soriano JB. Medical event profiling of COPD patients. Pharmacoepidemiol Drug Saf. 2004;13:547-55.
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.
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.
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.
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.
8. Department of Health (Research and Development Directorate) policy paper. Best research for best health: a new national health research strategy. 25 January 2006. Last accessed 06 June 2013 www.dh.gov. uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH-4127127.
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.
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.
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.
12. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention (updated 2014). http://www.ginasthma.com/GOLD.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
23. Corrado A, Rossi A. How far is real life from COPD therapy guidelines? An Italian observational study. Respir Med. 2012;106:989-97.
24. General Introduction to Secondary Uses Service. http://www.hscic.gov. uk/susguidance. Last accessed 28 August 2013.
25. Hospital Episode Statistics. http://www.hscic.gov. uk/hes. Last accessed 15 July 2013.
26. NHS Salford, Salford Integrated Record. Sharing patient information locally. http://www.salfordccg.nhs.uk/documents/Publications/SIRA5Booklet.pdf. Last accessed 14 February 2015.
27. Quality and Outcomes Framework: Online GP practice results database. Last accessed July 2011. http://www.qof.ic.nhs.uk/.
28. NHS document: The Clinical Terms Version 3 (The Read Codes). Last accessed July 2011. http://www.connectingforhealth.nhs.uk/systemsandservices/data/uktc/readcodes.
29. Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37-46.
30. StataCorp. Stata Statistical Software: Release 11. College Station, TX: StataCorp LP; 2009.
31. Open Exeter Database. http://systems.hscic.gov. uk/ssd/prodserv/vaprodopenexe/. Last accessed 15 February 2015.
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.
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.
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.
35. New JP, Bakerly ND, Leather D, Woodcock A. Obtaining real-world evidence: the Salford lung study. Thorax. 2014;69(12):1152-4.
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.
37. Dougherty RH, Fahy JV. Acute exacerbations of asthma: epidemiology, biology and the exacerbation-prone phenotype. Clin Exp Allergy. 2009;39:193-202.
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.
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.
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.
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.