Electronic health records to facilitate clinical research

Clinical Research in Cardiology

Volumn 106, Issue 1, 2017, Pages

  Cowie, Martin R ^a   Blomster, Juuso I ^b,c   Curtis, Lesley H ^d   Duclaux, Sylvie ^e   Ford, Ian ^f   Fritz, Fleur ^g   Goldman, Samantha ^h   Janmohamed, Salim ⁱ   Kreuzer, Jörg ^j   Leenay, Mark ^k   Michel, Alexander ^l   Ong, Seleen ^m   Pell, Jill P ^f   Southworth, Mary Ross ⁿ   Stough, Wendy Gattis ^o   Thoenes, Martin ^p   Zannad, Faiez ^q,r   Zalewski, Andrew ^s  

^a ROYAL BROMPTON HOSPITAL   (United Kingdom)

^b ASTRAZENECA R AND D   (Sweden)

^c UNIVERSITY OF TURKU   (Finland)

^d DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^e INSTITUT DE RECHERCHES INTERNATIONALES SERVIER   (France)

^f UNIVERSITY OF GLASGOW   (United Kingdom)

^g UNIVERSITY OF MÜNSTER   (Germany)

^h DAIICHI SANKYO CO   (Japan)

ⁱ GLAXOSMITHKLINE   (United Kingdom)

^j BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^k OPTUM   (United States)

^l BAYER PHARMA AG   (Germany)

^m PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

ⁿ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^o CAMPBELL UNIVERSITY   (United States)

^p EDWARDS LIFESCIENCES   (United States)

^q UNIVERSITY HOSPITAL OF NANCY   (France)

^r UNIVERSITÉ DE LORRAINE   (France)

^s GLAXOSMITHKLINE   (United States)

more..

Author keywords

Cardiovascular diseases; Clinical trials as topic; Electronic health records; Pragmatic clinical trials as topic

Indexed keywords

ACCESS TO INFORMATION; CARDIOVASCULAR DISEASE; CLINICAL PRACTICE; CLINICAL RESEARCH; COMPARATIVE EFFECTIVENESS; COMPUTER SECURITY; DATA ANALYSIS; DATA BASE; DISEASE SURVEILLANCE; ELECTRONIC HEALTH RECORD; FEASIBILITY STUDY; FOOD AND DRUG ADMINISTRATION; HUMAN; MARKETING; MEDICAL CARE; OBSERVATIONAL STUDY; PATIENT CARE; POSTMARKETING SURVEILLANCE; PRIVACY; PROSPECTIVE STUDY; PUBLICATION; REVIEW; RISK ASSESSMENT; RISK FACTOR; CARDIOVASCULAR DISEASES; CLINICAL TRIAL (TOPIC); CONFIDENTIALITY; DATA MINING; ETHICS; MEASUREMENT ACCURACY; MEDICAL RECORD; METHODOLOGY; PROCEDURES; SYSTEM ANALYSIS;

ACCESS TO INFORMATION; CARDIOVASCULAR DISEASES; CLINICAL TRIALS AS TOPIC; COMPARATIVE EFFECTIVENESS RESEARCH; CONFIDENTIALITY; DATA ACCURACY; DATA MINING; ELECTRONIC HEALTH RECORDS; HUMANS; MEDICAL RECORD LINKAGE; RESEARCH DESIGN; SYSTEMS INTEGRATION;

EID: 85013759867     PISSN: 18610684     EISSN: 18610692     Source Type: Journal    
DOI: 10.1007/s00392-016-1025-6     Document Type: Review

References (53)

1. Jackson N, Atar D, Borentain M, Breithardt G, van Eickels M, Endres M, Fraass U, Friede T, Hannachi H, Janmohamed S, Kreuzer J, Landray M, Lautsch D, Le Floch C, Mol P, Naci H, Samani N, Svensson A, Thorstensen C, Tijssen J, Vandzhura V, Zalewski A, Kirchhof P (2016) Improving clinical trials for cardiovascular diseases: a position paper from the Cardiovascular Roundtable of the European Society of Cardiology. Eur Heart J 37:747–754
2. Eisenstein EL, Collins R, Cracknell BS, Podesta O, Reid ED, Sandercock P, Shakhov Y, Terrin ML, Sellers MA, Califf RM, Granger CB, Diaz R (2008) Sensible approaches for reducing clinical trial costs. Clin Trials 5:75–84
3. Denaxas SC, Morley KI (2015) Big biomedical data and cardiovascular disease research: opportunities and challenges. European Heart Journal - Quality of Care and Clinical Outcomes 1:9–16
4. Hayrinen K, Saranto K, Nykanen P (2008) Definition, structure, content, use and impacts of electronic health records: a review of the research literature. Int J Med Inform 77:291–304
5. Appari A, Eric JM, Anthony DL (2013) Meaningful use of electronic health record systems and process quality of care: evidence from a panel data analysis of U.S. acute-care hospitals. Health Serv Res 48:354–375
6. Blumenthal D, Tavenner M (2010) The “meaningful use” regulation for electronic health records. N Engl J Med 363:501–504
7. Roumia M, Steinhubl S (2014) Improving cardiovascular outcomes using electronic health records. Curr Cardiol Rep 16:451
8. Doods J, Botteri F, Dugas M, Fritz F (2014) A European inventory of common electronic health record data elements for clinical trial feasibility. Trials 15:18
9. Collins FS, Hudson KL, Briggs JP, Lauer MS (2014) PCORnet: turning a dream into reality. J Am Med Inform Assoc 21:576–577
10. James S, Rao SV, Granger CB (2015) Registry-based randomized clinical trials–a new clinical trial paradigm. Nat Rev Cardiol 12:312–316
11. Krumholz HM, Normand SL, Wang Y (2014) Trends in hospitalizations and outcomes for acute cardiovascular disease and stroke, 1999-2011. Circulation 130:966–975
12. Hlatky MA, Ray RM, Burwen DR, Margolis KL, Johnson KC, Kucharska-Newton A, Manson JE, Robinson JG, Safford MM, Allison M, Assimes TL, Bavry AA, Berger J, Cooper-DeHoff RM, Heckbert SR, Li W, Liu S, Martin LW, Perez MV, Tindle HA, Winkelmayer WC, Stefanick ML (2014) Use of Medicare data to identify coronary heart disease outcomes in the Women’s Health Initiative. Circ Cardiovasc Qual Outcomes 7:157–162
13. Chung SC, Gedeborg R, Nicholas O, James S, Jeppsson A, Wolfe C, Heuschmann P, Wallentin L, Deanfield J, Timmis A, Jernberg T, Hemingway H (2014) Acute myocardial infarction: a comparison of short-term survival in national outcome registries in Sweden and the UK. Lancet 383:1305–1312
14. Brindis RG, Fitzgerald S, Anderson HV, Shaw RE, Weintraub WS, Williams JF (2001) The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR): building a national clinical data repository. J Am Coll Cardiol 37:2240–2245
15. Scholte op Reimer W, Gitt A, Boersma E, Simoons Me (2006) Cardiovascular diseases in Europe. Euro Heart Survey−2006. European Society of Cardiology,. Sophia Antipolis
16. Ferrari R (2010) EURObservational research programme. Eur Heart J 31:1023–1031
17. Smaha LA (2004) The American Heart Association Get With The Guidelines program. Am Heart J 148:S46–S48
18. Krumholz HM (2014) Big data and new knowledge in medicine: the thinking, training, and tools needed for a learning health system. Health Aff (Millwood) 33:1163–1170
19. Wood R, Clark D, King A, Mackay D, Pell J (2013) Novel cross-sectoral linkage of routine health and education data at an all-Scotland level: a feasibility study. Lancet 382(Supplement 3):S10
20. Cederholm S, Hill G, Asiimwe A, Bate A, Bhayat F, Persson BG, Bergvall T, Ansell D, Star K, Noren GN (2015) Structured assessment for prospective identification of safety signals in electronic medical records: evaluation in the health improvement network. Drug Saf 38:87–100
21. Trifiro G, Fourrier-Reglat A, Sturkenboom MC, Diaz AC, Van Der Lei J (2009) The EU-ADR project: preliminary results and perspective. Stud Health Technol Inform 148:43–49
22. Eichler HG, Pignatti F, Flamion B, Leufkens H, Breckenridge A (2008) Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat Rev Drug Discov 7:818–826
23. Goedecke T, Arlett P (2014) A Description of the European Network of Centres for pharmacoepidemiology and pharmacovigilance as a global resource for pharmacovigilance and pharmacoepidemiology. Mann’s pharmacovigilance. Wiley, New York, pp 403–408
24. Ball R, Robb M, Anderson SA, Dal Pan G (2016) The FDA’s sentinel initiative-A comprehensive approach to medical product surveillance. Clin Pharmacol Ther 99:265–268
25. Staffa JA, Dal Pan GJ (2012) Regulatory innovation in postmarketing risk assessment and management. Clin Pharmacol Ther 91:555–557
26. Peterson ED, Shah BR, Parsons L, Pollack CV Jr, French WJ, Canto JG, Gibson CM, Rogers WJ (2008) Trends in quality of care for patients with acute myocardial infarction in the National Registry of Myocardial Infarction from 1990 to 2006. Am Heart J 156:1045–1055
27. Chan PS, Maddox TM, Tang F, Spinler S, Spertus JA (2011) Practice-level variation in warfarin use among outpatients with atrial fibrillation (from the NCDR PINNACLE program). Am J Cardiol 108:1136–1140
28. Maddox TM, Chan PS, Spertus JA, Tang F, Jones P, Ho PM, Bradley SM, Tsai TT, Bhatt DL, Peterson PN (2014) Variations in coronary artery disease secondary prevention prescriptions among outpatient cardiology practices: insights from the NCDR (National Cardiovascular Data Registry). J Am Coll Cardiol 63:539–546
29. Jernberg T, Attebring MF, Hambraeus K, Ivert T, James S, Jeppsson A, Lagerqvist B, Lindahl B, Stenestrand U, Wallentin L (2010) The Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART). Heart 96:1617–1621
30. Cleland JG, Swedberg K, Follath F, Komajda M, Cohen-Solal A, Aguilar JC, Dietz R, Gavazzi A, Hobbs R, Korewicki J, Madeira HC, Moiseyev VS, Preda I, van Gilst WH, Widimsky J, Freemantle N, Eastaugh J, Mason J (2003) The EuroHeart Failure survey programme: a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. Eur Heart J 24:442–463
31. Nieminen MS, Brutsaert D, Dickstein K, Drexler H, Follath F, Harjola VP, Hochadel M, Komajda M, Lassus J, Lopez-Sendon JL, Ponikowski P, Tavazzi L (2006) EuroHeart Failure Survey II (EHFS II): a survey on hospitalized acute heart failure patients: description of population. Eur Heart J 27:2725–2736
32. Tofield A (2010) EURObservational research programme. Eur Heart J 31:1023–1031
33. McNamara RL, Herrin J, Bradley EH, Portnay EL, Curtis JP, Wang Y, Magid DJ, Blaney M, Krumholz HM (2006) Hospital improvement in time to reperfusion in patients with acute myocardial infarction, 1999 to 2002. J Am Coll Cardiol 47:45–51
34. Kopcke F, Trinczek B, Majeed RW, Schreiweis B, Wenk J, Leusch T, Ganslandt T, Ohmann C, Bergh B, Rohrig R, Dugas M, Prokosch HU (2013) Evaluation of data completeness in the electronic health record for the purpose of patient recruitment into clinical trials: a retrospective analysis of element presence. BMC Med Inform Decis Mak 13:37
35. Thadani SR, Weng C, Bigger JT, Ennever JF, Wajngurt D (2009) Electronic screening improves efficiency in clinical trial recruitment. J Am Med Inform Assoc 16:869–873
36. De Moor G, Sundgren M, Kalra D, Schmidt A, Dugas M, Claerhout B, Karakoyun T, Ohmann C, Lastic PY, Ammour N, Kush R, Dupont D, Cuggia M, Daniel C, Thienpont G, Coorevits P (2015) Using electronic health records for clinical research: the case of the EHR4CR project. J Biomed Inform 53:162–173
37. Fordyce CB, Roe MT, Ahmad T, Libby P, Borer JS, Hiatt WR, Bristow MR, Packer M, Wasserman SM, Braunstein N, Pitt B, DeMets DL, Cooper-Arnold K, Armstrong PW, Berkowitz SD, Scott R, Prats J, Galis ZS, Stockbridge N, Peterson ED, Califf RM (2015) Cardiovascular drug development: is it dead or just hibernating? J Am Coll Cardiol 65:1567–1582
38. New JP, Bakerly ND, Leather D, Woodcock A (2014) Obtaining real-world evidence: the Salford Lung Study. Thorax 69:1152–1154
39. Fleurence RL, Curtis LH, Califf RM, Platt R, Selby JV, Brown JS (2014) Launching PCORnet, a national patient-centered clinical research network. J Am Med Inform Assoc 21:578–582
40. Hernandez AF, Fleurence RL, Rothman RL (2015) The ADAPTABLE Trial and PCORnet: shining light on a new research paradigm. Ann Intern Med 163:635–636
41. Curtis LH, Brown J, Platt R (2014) Four health data networks illustrate the potential for a shared national multipurpose big-data network. Health Aff (Millwood) 33:1178–1186
42. Jha AK, DesRoches CM, Campbell EG, Donelan K, Rao SR, Ferris TG, Shields A, Rosenbaum S, Blumenthal D (2009) Use of electronic health records in U.S. hospitals. N Engl J Med 360:1628–1638
43. Hersh WR, Weiner MG, Embi PJ, Logan JR, Payne PR, Bernstam EV, Lehmann HP, Hripcsak G, Hartzog TH, Cimino JJ, Saltz JH (2013) Caveats for the use of operational electronic health record data in comparative effectiveness research. Med Care 51:S30–S37
44. Brennan L, Watson M, Klaber R, Charles T (2012) The importance of knowing context of hospital episode statistics when reconfiguring the NHS. BMJ 344:e2432
45. Green SM (2013) Congruence of disposition after emergency department intubation in the National Hospital Ambulatory Medical Care Survey. Ann Emerg Med 61:423–426
46. Weiskopf NG, Weng C (2013) Methods and dimensions of electronic health record data quality assessment: enabling reuse for clinical research. J Am Med Inform Assoc 20:144–151
47. Elnahal SM, Joynt KE, Bristol SJ, Jha AK (2011) Electronic health record functions differ between best and worst hospitals. Am J Manag Care 17:e121–e147
48. Flynn MR, Barrett C, Cosio FG, Gitt AK, Wallentin L, Kearney P, Lonergan M, Shelley E, Simoons ML (2005) The Cardiology Audit and Registration Data Standards (CARDS), European data standards for clinical cardiology practice. Eur Heart J 26:308–313
49. Simoons ML, van der Putten N, Wood D, Boersma E, Bassand JP (2002) The Cardiology Information System: the need for data standards for integration of systems for patient care, registries and guidelines for clinical practice. Eur Heart J 23:1148–1152
50. Sugarman J, Califf RM (2014) Ethics and regulatory complexities for pragmatic clinical trials. JAMA 311:2381–2382
51. Frobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angeras O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Karegren A, Nilsson J, Robertson L, Sandhall L, Sjogren I, Ostlund O, Harnek J, James SK (2013) Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 369:1587–1597
52. Hess CN, Rao SV, Kong DF, Aberle LH, Anstrom KJ, Gibson CM, Gilchrist IC, Jacobs AK, Jolly SS, Mehran R, Messenger JC, Newby LK, Waksman R, Krucoff MW (2013) Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women). Am Heart J 166:421–428
53. Barry SJ, Dinnett E, Kean S, Gaw A, Ford I (2013) Are routinely collected NHS administrative records suitable for endpoint identification in clinical trials? Evidence from the West of Scotland Coronary Prevention Study. PLoS One 8:e75379