Abstract
Every scientist knows that research results are only as good as the data upon which the conclusions were formed. However, most scientists receive no training in methods for achieving, assessing, or controlling the quality of research data—topics central to clinical research informatics. This chapter covers the basics of collect and process research data given the available data sources, systems, and people. Data quality dimensions specific to the clinical research context are used, and a framework for data quality practice and planning is developed. Available research is summarized, providing estimates of data quality capability for common clinical research data collection and processing methods. This chapter provides researchers, informaticists, and clinical research data managers basic tools to plan, achieve, and control the quality of research data.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Davis JR, Nolan VP, Woodcock J, Estabrook EW, editors. Assuring data quality and validity in clinical trials for regulatory decision making. Institute of Medicine Workshop report. Roundtable on research and development of drugs, biologics, and medical devices. Washington, DC: National Academy Press; 1999. http://books.nap.edu/openbook.php?record_id=9623&page=R1. Accessed 6 July 2009.
Deming WE, Geoffrey L. On sample inspection in the processing of census returns. J Am Stat Assoc. 1941;36:351–60.
Deming WE, Tepping BJ, Geoffrey L. Errors in card punching. J Am Stat Assoc. 1942;37:525–36.
Donabedian A. A guide to medical care administration, vol. II: medical care appraisal – quality and utilization. New York: American Public Health Association; 1969. 176.
Arndt S, Tyrell G, Woolson RF, Flaum M, Andreasen NC. Effects of errors in a multicenter medical study: preventing misinterpreted data. J Psychiatr Res. 1994;28:447–59.
Juran JM, Gryna FM. Juran’s quality control handbook. 4th ed. New York: McGraw-Hill; 1988.
Guidance for industry E6 good clinical practice: consolidated guidance, ICH E6. April 1996. Available from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf. Accessed Aug 2011.
Reprinted with permission from Data Gone Awry, DataBasics, vol 13, no 3, Fall. 2007. Society for Clinical Data Management. Available from http://www.scdm.org
Nagurney JT, Brown DF, Sane S, Weiner JB, Wang AC, Chang Y. The accuracy and completeness of data collected by prospective and retrospective methods. Acad Emerg Med. 2005;12:884–95.
Feinstein AR, Pritchett JA, Schimpff CR. The epidemiology of cancer therapy. 3. The management of imperfect data. Arch Intern Med. 1969;123:448–61.
Reason J. Human error. Cambridge: Cambridge University Press; 1990.
Nahm M, Dziem G, Fendt K, Freeman L, Masi J, Ponce Z. Data quality survey results. Data Basics. 2004;10:7.
Schuyl ML, Engel T. A review of the source document verification process in clinical trials. Drug Info J. 1999;33:789–97.
Batini C, Catarci T, Scannapieco M. A survey of data quality issues in cooperative information systems. In: 23rd international conference on conceptual modeling (ER 2004), Shanghai; 2004.
Pipino L, Lee Y, Wang R. Data quality assessment. Commun ACM. 2002;45:8.
Tayi GK, Ballou DP. Examining data quality. Commun ACM. 1998;41:4.
Redman TC. Data quality for the information age. Boston: Artech House; 1996.
Wand Y, Wang R. Anchoring data quality dimensions in ontological foundations. Commun ACM. 1996;39:10.
Wang R, Strong D. Beyond accuracy: what data quality means to data consumers. J Manage Inform Syst. 1996;12:30.
Batini C, Scannapieco M. Data quality concepts, methodologies and techniques. Berlin: Springer; 2006.
Wyatt J. Acquisition and use of clinical data for audit and research. J Eval Clin Pract. 1995;1:15–27.
U.S. Food and Drug Administration. Guidance for industry. Computerized systems used in clinical trials. In: Services DoHaH, editor. Rockville: U.S. Food and Drug Administration; 2007.
Arts DG, De Keizer NF, Scheffer GJ. Defining and improving data quality in medical registries: a literature review, case study, and generic framework. J Am Med Inform Assoc. 2002;9:600–11.
(CDISC) CDISC. The Protocol Representation Model version 1.0 draft for public comment: CDISC; 2009. p. 96. Available from http://www.cdisc.org
Jacobs M, Studer L. Forms design II: the course for paper and electronic forms. Cleveland: Ameritype & Art Inc.; 1991.
Eisenstein EL, Lemons PW, Tardiff BE, Schulman KA, Jolly MK, Califf RM. Reducing the costs of phase III cardiovascular clinical trials. Am Heart J. 2005;9:482–8.
Eisenstein EL, Collins R, Cracknell BS, et al. Sensible approaches for reducing clinical trial costs. Clin Trials. 2008;5:75–84.
Galešic M. Effects of questionnaire length on response rates: review of findings and guidelines for future research. 2002. http://mrav.ffzg.hr/mirta/Galesic_handout_GOR2002.pdf. Accessed 29 Dec 2009.
Roszkowski MJ, Bean AG. Believe it or not! Longer questionnaires have lower response rates. J Bus Psych. 1990;4:495–509.
Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I. Increasing response rates to postal questionnaires systematic review. Br Med J. 2002;324:1183.
Wickens CD, Hollands JG. Engineering psychology and human performance. 3rd ed. Upper Saddle River: Prentice Hall; 2000.
Stevens SS. On the theory of scales of measurement. Science. 1946;103:677–80.
Allison JJ, Wall TC, Spettell CM, et al. The art and science of chart review. Jt Comm J Qual Improv. 2000;26:115–36.
Banks NJ. Designing medical record abstraction forms. Int J Qual Health Care. 1998;10:163–7.
Engel L, Henderson C, Fergenbaum J, Interrater A. Reliability of abstracting medical-related information medical record review conduction model for improving. Eval Health Prof. 2009;32:281.
Cunningham R, Sarfati D, Hill S, Kenwright D. An audit of colon cancer data on the New Zealand Cancer Registry. N Z Med J. 2008;121(1279):46–56.
Fritz A. The SEER program’s commitment to data quality. J Registry Manag. 2001;28(1):35–40.
German RR, Wike JM, Wolf HJ, et al. Quality of cancer registry data: findings from CDC-NPCR’s breast, colon, and prostate cancer data quality and patterns of care study. J Registry Manag. 2008;35(2):67–74.
Herrmann N, Cayten CG, Senior J, Staroscik R, Walsh S, Woll M. Interobserver and intraobserver reliability in the collection of emergency medical services data. Health Serv Res. 1980;15(2):127–43.
Pan L, Fergusson D, Schweitzer I, Hebert PC. Ensuring high accuracy of data abstracted from patient charts: the use of a standardized medical record as a training tool. J Clin Epidemiol. 2005;58(9):918–23.
Reeves MJ, Mullard AJ, Wehner S. Inter-rater reliability of data elements from a prototype of the Paul Coverdell National Acute Stroke Registry. BMC Neurol. 2008;8:19.
Scherer R, Zhu Q, Langenberg P, Feldon S, Kelman S, Dickersin K. Comparison of information obtained by operative note abstraction with that recorded on a standardized data collection form. Surgery. 2003;133(3):324–30.
Stange KC, Zyzanski SJ, Smith TF, et al. How valid are medical records and patient questionnaires for physician profiling and health services research? A comparison with direct observation of patients visits. Med Care. 1998;36(6):851–67.
Thoburn KK, German RR, Lewis M, Nichols PJ, Ahmed F, Jackson-Thompson J. Case completeness and data accuracy in the Centers for Disease Control and Prevention’s National Program of Cancer Registries. Cancer. 2007;109(8):1607–16.
To T, Estrabillo E, Wang C, Cicutto L. Examining intra-rater and inter-rater response agreement: a medical chart abstraction study of a community-based asthma care program. BMC Med Res Methodol. 2008;8:29.
Yawn BP, Wollan P. Interrater reliability: completing the methods description in medical records review studies. Am J Epidemiol. 2005;161(10):974–7.
La France BH, Heisel AD, Beatty MJ. A test of the cognitive load hypothesis: investigating the impact of number of nonverbal cues coded and length of coding session on observer accuracy. Communication Reports. 1 Apr 2007.
Helms Ron. Redundancy: an important data forms/design data collection principle. In: Proceedings Stat computing section, Alexandria; 1981. p. 233–237.
Helms R. Data quality issues in electronic data capture. Drug Inf J. 2001;35:827–37.
U.S. Food and Drug Administration regulations Title 21 CFR Part 58. 2011. Available from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58. Accessed Aug 2011.
Nahm ML, Pieper CF, Cunningham MM. Quantifying data quality for clinical trials using electronic data capture. PLoS One. 2008;3(8):e3049.
Winchell T. The mystery of source documentation. SOCRA Source 62. 2009. Available from http://www.socra.org/.
Nahm, M. Data Accuracy in Medical Record Abstraction. Doctoral Dissertation, University of Texas at Houston, School of Biomedical Informatics, Houston Texas, May 6, 2010.
SCDM. Good clinical data management practices. http://www.scdm.org. Society for Clinical Data Management; 2010. Available from http://www.scdm.org
Rostami R, Nahm M, Pieper CF. What can we learn from a decade of database audits? The Duke Clinical Research Institute experience, 1997–2006. Clin Trials. 2009;6(2):141–50.
Svolba G, Bauer P. Statistical quality control in clinical trials. Control Clin Trials. 1999;20(6):519–30.
Chilappagari S, Kulkarni A, Bolick-Aldrich S, Huang Y, Aldrich TE. A statistical process control method to monitor completeness of central cancer registry reporting data. J Registry Manag. 2002;29(4):121–7.
Chiu D, Guillaud M, Cox D, Follen M, MacAulay C. Quality assurance system using statistical process control: an implementation for image cytometry. Cell Oncol. 2004;26(3):101–17.
McNees P, Dow KH, Loerzel VW. Application of the CuSum technique to evaluate changes in recruitment strategies. Nurs Res. 2005;54(6):399–405.
Baigent C, Harrell FE, Buyse M, Emberson JR, Altman DG. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clin Trials. 2008;5(1):49–55.
Matheny ME, Morrow DA, Ohno-Machado L, Cannon CP, Sabatine MS, Resnic FS. Validation of an automated safety surveillance system with prospective, randomized trial data. Med Decis Making. 2009;29(2):247–56.
Freedman LS, Schatzkin A, Wax Y. The impact of dietary measurement error on planning sample size required in a cohort study. Am J Epidemiol. 1990;132:1185–95.
Perkins DO, Wyatt RJ, Bartko JJ. Penny-wise and pound-foolish: the impact of measurement error on sample size requirements in clinical trials. Biol Psychiatry. 2007;47:762–6.
Mullooly JP. The effects of data entry error: an analysis of partial verification. Comput Biomed Res. 1990;23:259–67.
Liu K. Measurement error and its impact on partial correlation and multiple linear regression analyses. Am J Epidemiol. 1988;127:864–74.
Stepnowsky Jr CJ, Berry C, Dimsdale JE. The effect of measurement unreliability on sleep and respiratory variables. Sleep. 2004;27:990–5.
Myer L, Morroni C, Link BG. Impact of measurement error in the study of sexually transmitted infections. Sex Transm Infect. 2004;80(318–323):328.
Williams SC, Watt A, Schmaltz SP, Koss RG, Loeb JM. Assessing the reliability of standardized performance indicators. Int J Qual Health Care. 2006;18:246–55.
Watt A, Williams S, Lee K, Robertson J, Koss RG, Loeb JM. Keen eye on core measures. Joint Commission data quality study offers insights into data collection, abstracting processes. J AHIMA. 2003;74:20–5; quiz 27–8.
US Government Accountability Office. Hospital quality data: CMS needs more rigorous methods to ensure reliability of publicly released data. In: Office UGA, editor. Washington, DC; 2006. www.gao.gov/new.items/d0654.pdf
Braun BI, Kritchevsky SB, Kusek L, et al. Comparing bloodstream infection rates: the effect of indicator specifications in the evaluation of processes and indicators in infection control (EPIC) study. Infect Control Hosp Epidemiol. 2006;27:14–22.
Jacobs R, Goddard M, Smith PC. How robust are hospital ranks based on composite performance measures? Med Care. 2005;43:1177–84.
Pagel C, Gallivan S. Exploring consequences on mortality estimates of errors in clinical databases. IMA J Manage Math. 2008;20(4):385–93. http://imaman.oxfordjournals.org/content/20/4/385.abstract
Goldhill DR, Sumner A. APACHE II, data accuracy and outcome prediction. Anaesthesia. 1998;53:937–43.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2012 Springer-Verlag London Limited
About this chapter
Cite this chapter
Nahm, M. (2012). Data Quality in Clinical Research. In: Richesson, R., Andrews, J. (eds) Clinical Research Informatics. Health Informatics. Springer, London. https://doi.org/10.1007/978-1-84882-448-5_10
Download citation
DOI: https://doi.org/10.1007/978-1-84882-448-5_10
Published:
Publisher Name: Springer, London
Print ISBN: 978-1-84882-447-8
Online ISBN: 978-1-84882-448-5
eBook Packages: MedicineMedicine (R0)