Workflow in clinical trial sites & its association with near miss events for data quality: Ethnographic, workflow & systems simulation

PLoS ONE

Volumn 7, Issue 6, 2012, Pages

  Araujo de Carvalho, Elias Cesar ^a,b,c   Batilana, Adelia Portero ^a   Claudino, Wederson ^d   Reis, Luiz Fernando ^e   Schmerling, Rafael A ^e   Shah, Jatin ^f,h   Pietrobon, Ricardo ^f,g,h  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Aperfeiçoamento em Osteopatia em andamento na Escuela de Osteopatia de Madrid   (Brazil)

^c STATE UNIVERSITY OF MARINGÁ   (Brazil)

^d Oncologistas Associados Cancer Institute   (Brazil)

^e HOSPITAL SÍRIO LIBANÊS   (Brazil)

^f DUKE NUS MEDICAL SCHOOL   (Singapore)

^g DUKE UNIVERSITY HEALTH SYSTEM   (United States)

^h DUKE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL DATA REPOSITORY; CLINICAL RESEARCH; CLINICAL TRIAL SITE; COMPUTER SIMULATION; DATA EXTRACTION; DATA PROCESSING; DATA SYNTHESIS; DECISION SUPPORT SYSTEM; ETHNOGRAPHIC RESEARCH; FIELD STUDY; INFORMATION RETRIEVAL; INFORMED CONSENT; QUALITY CONTROL; RESEARCH SUBJECT; STANDARDIZATION; WORKFLOW;

ANTHROPOLOGY, CULTURAL; BIOMEDICAL RESEARCH; BRAZIL; CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; HEALTH POLICY; HUMANS; MODELS, THEORETICAL; RESEARCH DESIGN; TERMINOLOGY AS TOPIC; WORKFLOW;

EID: 84863112458     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0039671     Document Type: Article

References (56)

1. Normile D, (2008) The promise and pitfalls of clinical trials overseas. Science 322: 214-216. doi:10.1126/science.322.5899.214.
2. Thiers FA, Sinskey AJ, Berndt ER, (2008) Trends in the globalization of clinical trials. Nature Reviews Drug Discovery 7: 13-14. doi:10.1038/nrd2441.
3. Ali M, Park J-K, von Seidlein L, Acosta CJ, Deen JL, et al. (2006) Organizational aspects and implementation of data systems in large-scale epidemiological studies in less developed countries. BMC Public Health 6: 86. doi pp. 10.1186/1471-2458-6-86.
4. Borycki EM, Kushniruk AW, Kuwata S, Kannry J, (2006) Use of Simulation Approaches in the Study of Clinician Workflow. AMIA Annu Symp Proc 2006: 61-65.
5. Dwivedi A, Bali RK, Wickramasinghe N, Naguib RNG, (2007) How workflow management systems enable the achievement of value driven healthcare delivery. Int J Electron Healthc 3: 382-393.
6. Lang M, Kirpekar N, Bürkle T, Laumann S, Prokosch H-U, (2007) Results from data mining in a radiology department: the relevance of data quality. Stud Health Technol Inform 129: 576-580.
7. Noumeir R, (2006) Radiology interpretation process modeling. J Biomed Inform 39: 103-114. doi:10.1016/j.jbi.2005.07.001.
8. Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, et al. (2007) Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health Technol Assess 11: iii, ix-105.
9. Fuhrer MJ, (2005) Conducting multiple-site clinical trials in medical rehabilitation research. Am J Phys Med Rehabil 84: 823-831.
10. Heller B, Herre H, Lippoldt K, Loeffler M, (2004) Standardized terminology for clinical trial protocols based on top-level ontological categories. Stud Health Technol Inform 101: 46-60.
11. Merzweiler A, Weber R, Garde S, Haux R, Knaup-Gregori P, (2005) TERMTrial-terminology-based documentation systems for cooperative clinical trials. Comput Methods Programs Biomed 78: 11-24. doi:10.1016/j.cmpb.2004.11.001.
12. Willenberg KM, (2004) Managing clinical trials-frustration or bliss? J Oncol Manag 13: 24-26.
13. Khan SA, Kukafka R, Payne PRO, Bigger JT, Johnson SB, (2007) A day in the life of a clinical research coordinator: observations from community practice settings. Stud Health Technol Inform 129: 247-251.
14. Fowler M, Scott K, (1999) UML Distilled: A Brief Guide to the Standard Object Modeling Language. 2nd ed. Addison-Wesley Pub (Sd). 224 p.
15. de Carvalho ECA, Batilana AP, Simkins J, Martins H, Shah J, et al. (2010) Application description and policy model in collaborative environment for sharing of information on epidemiological and clinical research data sets. PLoS ONE 5: e9314. doi:10.1371/journal.pone.0009314.
16. Kumarapeli P, De Lusignan S, Ellis T, Jones B, (2007) Using Unified Modelling Language (UML) as a process-modelling technique for clinical-research process improvement. Med Inform Internet Med 32: 51-64. doi:10.1080/14639230601097705.
17. Borlawsky T, LaFountain J, Petty L, Saltz JH, Payne PRO, (2008) Leveraging an existing data warehouse to annotate workflow models for operations research and optimization. AMIA Annu Symp Proc:885.
18. Anderson JG, (2002) Evaluation in health informatics: computer simulation. Comput Biol Med 32: 151-164.
19. Despont-Gros C, Mueller H, Lovis C, (2005) Evaluating user interactions with clinical information systems: a model based on human-computer interaction models. J Biomed Inform 38: 244-255. doi:10.1016/j.jbi.2004.12.004.
20. Borycki EM, Kushniruk AW, Kuwata S, Kannry J, (2006) Use of simulation in the study of clinician workflow. AMIA Annu Symp Proc pp. 61-65.
21. Bossel H, (2004) Systeme, Dynamik, Simulation: Modellbildung, Analyse und Simulation komplexer Systeme. 1st ed. Books on Demand Gmbh. 400 p.
22. Sterman J, Sterman JD, (2000) Business Dynamics: Systems Thinking and Modeling for a Complex World with CD-ROM. McGraw-Hill/Irwin. 1008 p.
23. Lyneis JM, Ford DN, (2007) System dynamics applied to project management: a survey, assessment, and directions for future research. System Dynamics Review 23: 157-189. doi:10.1002/sdr.377.
24. van Ackere A, Smith PC, (1999) AID-SDR171&3.0.CO;2-P.
25. Homer J, Ritchie-Dunham J, Rabbino H, Puente LM, Jorgensen J, et al. (2000) Toward a dynamic theory of antibiotic resistance. System Dynamics Review 16: 287-319. doi:10.1002/sdr.200.
26. McDaniel RR, Driebe DJ, (2001) Complexity science and health care management. Advances in Health Care Management: 11-36. doi pp. 10.1016/S1474-8231(01)02021-3.
27. Cloutier LM, Boehlje M, Université du Québec à Montréal. Centre de recherche en gestion (2001) Innovation management under uncertainty: a system dynamics model of R&D investments in biotechnology. Montréal: Université du Québec à Montréal, Centre de recherche en gestion]. p.
28. Marjamaa RA, Torkki PM, Hirvensalo EJ, Kirvelä OA, (2009) What is the best workflow for an operating room? A simulation study of five scenarios. Health Care Manag Sci 12: 142-146.
29. Dumas M, Hofstede AHM ter, (2001) UML Activity Diagrams as a Workflow Specification Language Springer Verlag. pp. 76-90.
30. Payne PRO, Mendonca EA, Starren JB, (2007) Modeling Participant-Related Clinical Research Events Using Conceptual Knowledge Acquisition Techniques. AMIA Annu Symp Proc 2007: 593-597.
31. Fishman GS, (1978) Principles of Discrete Event Simulation. New York, NY, USA: John Wiley & Sons, Inc. p.
32. Landsberger HA, (1958) Hawthorne Revisited: Management and the Worker, Its Critics, and Developments in Human Relations in Industry. Available:http://www.eric.ed.gov/ERICWebPortal/detail?accno=ED024106. Accessed: 15 April 2011.
33. Barach P, Small SD, (2000) Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. BMJ 320: 759-763.
34. Silverman D, (2004) Qualitative Research: Theory, Method and Practice. Second ed. Sage Publications Ltd. 390 p.
35. ATLAS.ti website (2011) Available www.atlas.ti.com.
36. Strauss AC, Corbin JM, (1997) Grounded Theory in Practice. 1st ed. Sage Publications, Inc. 288 p.
37. de Carvalho ECA, Jayanti MK, Batilana AP, Kozan AMO, Rodrigues MJ, et al. (2010) Standardizing clinical trials workflow representation in UML for international site comparison. PLoS ONE 5: e13893. doi:10.1371/journal.pone.0013893.
38. Astah Community website (2011) Available http://astah.change-vision.com/.
39. White S, (2004) Process Modeling Notations and Workflow Patterns. In L. Fischer, editor, Workflow Handbook 2004, pages 265-294. Future Strategies Inc. Lighthouse Point, FL, USA.
40. SD modeling software. Available from http://www.vensim.com/.
41. Grossman M, Bates S, (2008) Knowledge capture within the biopharmaceutical clinical trials environment. VINE 38: 118-132. doi:10.1108/03055720810870932.
42. Brixey JJ, Robinson DJ, Johnson CW, Johnson TR, Turley JP, et al. (2007) A concept analysis of the phenomenon interruption. ANS Adv Nurs Sci 30: E26-42.
43. Bennett JW, Glasziou PP, (2003) Computerised reminders and feedback in medication management: a systematic review of randomised controlled trials. Med J Aust 178: 217-222.
44. Walton R, Dovey S, Harvey E, Freemantle N, (1999) Computer support for determining drug dose: systematic review and meta-analysis. BMJ 318: 984-990. doi:10.1136/bmj.318.7189.984.
45. Walton RT, Harvey E, Dovey S, Freemantle N, (2001) Computerised advice on drug dosage to improve prescribing practice. Cochrane Database Syst Rev: CD002894. doi:10.1002/14651858.CD002894.
46. Kaushal R, Shojania KG, Bates DW, (2003) Effects of computerized physician order entry and clinical decision support systems on medication safety: a systematic review. Arch Intern Med 163: 1409-1416. doi:10.1001/archinte.163.12.1409.
47. Bates DW, Teich JM, Lee J, Seger D, Kuperman GJ, et al. (1999) The Impact of Computerized Physician Order Entry on Medication Error Prevention. J Am Med Inform Assoc 6: 313-321.
48. Hunt DL, Haynes RB, Hanna SE, Smith K, (1998) Effects of computer-based clinical decision support systems on physician performance and patient outcomes: a systematic review. JAMA 280: 1339-1346.
49. Shiffman RN, Liaw Y, Brandt CA, Corb GJ, (1999) Computer-based guideline implementation systems: a systematic review of functionality and effectiveness. J Am Med Inform Assoc 6: 104-114.
50. Breitfeld PP, Weisburd M, Overhage JM, Sledge G Jr, Tierney WM, (1999) Pilot study of a point-of-use decision support tool for cancer clinical trials eligibility. J Am Med Inform Assoc 6: 466-477.
51. Ohno-Machado L, Wang SJ, Mar P, Boxwala AA, (1999) Decision support for clinical trial eligibility determination in breast cancer. Proc AMIA Symp pp. 340-344.
52. McCarney R, Warner J, Iliffe S, van Haselen R, Griffin M, et al. (2007) The Hawthorne Effect: a randomised, controlled trial. BMC Medical Research Methodology 7: 30. doi pp. 10.1186/1471-2288-7-30.
53. Holden JD, (2008) Hawthorne effects and research into professional practice. Journal of Evaluation in Clinical Practice 7: 65-70. doi 10 (1046/j.1365-2753.2001.00280): x.
54. Institute of Medicine (IOM) (2000) To Err Is Human: Building a Safer Health System (n.d.). Available: http://www.nap.edu/openbook.php?isbn=0309068371. Accessed: 1 June 2011.
55. Shah J, Shah A, Pietrobon R, (2009) Scientific writing of novice researchers: what difficulties and encouragements do they encounter? Acad Med 84: 511-516. doi:10.1097/ACM.0b013e31819a8c3c.
56. Pietrobon R, Guller U, Martins H, Menezes AP, Higgins LD, et al. (2004) A suite of web applications to streamline the interdisciplinary collaboration in secondary data analyses. BMC Med Res Methodol 4: 29. doi pp. 10.1186/1471-2288-4-29.