Abstract
Data collection is fundamental to any clinical surgical research study. Without collecting reliable and accurate data, it is impossible to draw meaningful conclusions regarding the research question of interest. This chapter aims to provide an overview of how to plan generic data collection and data storage, protocols, training and analysis that promote accurate and reliable data collection. Additionally, the fundamentals of database models and storage are covered to aid the novice researcher. A wealth of more detailed database design information and administration is available elsewhere for those who wish to pursue more complex designs. Throughout this chapter, we illustrate principles explained using clinically relevant examples.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Altman DG, Schulz KF, Moher D et al (2001) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134:663–694
Holbrook JT, Shade DM, Wise RA (2005) Data collection and quality controltranslational and experimental clinical research: principles of translational and experimental medicine. Lippincott Williams & Wilkins, Philadelphia, pp. 136–151
Boissel JP (2004) Planning of clinical trials. J Intern Med 255:427–438
Cohen J (1989) Statistical power analysis for the behavioural sciences, 2nd edn. Lawrence Erlbaum Associates, Hillsdale
Hollis S, Campbell F (1999) What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 319:670–674
CONSORT (2008) CONSORT flow diagram. Available from http://www.consort-statement.org/index.aspx?o = 1077
Anonymous (1991) North American Symptomatic Carotid Endarterectomy Trial. Methods, patient characteristics, and progress. Stroke 22:711–720
Anonymous (1991) MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70–99%) or with mild (0–29%) carotid stenosis. European Carotid Surgery Trialists' Collaborative Group. Lancet 337:1235–1243
Altman DG, Dore CJ (1990) Randomisation and baseline comparisons in clinical trials. Lancet 335:149–153
Beller EM, Gebski V, Keech AC (2002) Randomisation in clinical trials. Med J Aust 177:565–567
Viera AJ, Bangdiwala SI (2007) Eliminating bias in randomized controlled trials: importance of allocation concealment and masking. Fam Med 39:132–137
Kunz R, Vist G, Oxman AD (2007) Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev MR000012
Department of Health (2005) Research governance framework for health and social care, 2nd edn. DoH, London. Available from http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4108962
Holzenbein J, Kretschmer G, Glanzl R et al (1997) Endovascular AAA treatment: expensive prestige or economic alternative? Eur J Vasc Endovasc Surg 14:265–272
Mulvhill DA, Gibson DW, Cole TG (2005) Translational and experimental clinical research: principles of transla-tional and experimental medicine. Lippincott Williams & Wilkins, Philadelphia
Bachman C (1973) The programmer as navigator (ACM Turing Award lecture). Commun ACM 16:653–658
Codd E (1982) Relational database: a practical foundation for productivity. Commun.ACM 25:109–117
United Kingdom Act_of Parliament (1998) Data Protection Act. Available from http://www.opsi.gov.uk/Acts/Acts1998/ukpga_19980029_en_1
O'Neill S, Ford R (2008) Thousands of criminal files lost in data fiasco In: The Times 22 August 2008. Available from http://www.timesonline.co.uk/tol/news/uk/crime/arti-cle4583747.ece
Further Reading
A wealth of information on database design and development is available both online and from good book retailers. Readers may wish to look at the following information on Microsoft Access, Microsoft SQL Server and MySQL databases.
Ben-Gan I (2006) Microsoft SQL Server 2005: applied techniques step by step. Microsoft Press
Ben-Gan I (2006) Microsoft SQL Server 2005: database essentials step by step. Microsoft Press
Ben-Gan I, Kollar L, Sarka D (2006) Inside Microsoft SQL Server 2005: T-SQL querying. Microsoft Press
Brust AJ, Forte S (2006). Programming Microsoft SQL Server 2005. Microsoft Press
DeBetta P (2004) Introducing Microsoft SQL Server 2005 for developers. Microsoft Press
Dow Lambert M, Lambert JPS (2007) Microsoft Office Access 2007 step by dtep. Microsoft Press
Microsoft TechNet From http://technet.microsoft.com/en-gb/sqlserver/default.aspx
MySQL AB (2006) MySQL administrator's guide and language reference, 2nd edn. MySQL Press
Online Documentation From http://dev.mysql.com/doc/
Schneider RD (2005) MySQL database design and tuning. MySQL Press
Ulrich Fuller L, Cook K, Kaufeld J (2006) Access 2007 for dummies. Wiley, New York
Viescas J, Conrad (2008) Microsoft Office Access 2007 inside out. Microsoft Press
Welling L, Thomson L (2003) MySQL tutorial. MySQL Press
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2010 Springer-Verlag Berlin Heidelberg
About this chapter
Cite this chapter
Leff, D.R., Lovegrove, R.E., Darzi, L.A., Athanasiou, T. (2010). Data Collection, Database Development and Quality Control: Guidance for Clinical Research Studies. In: Athanasiou, T., Debas, H., Darzi, A. (eds) Key Topics in Surgical Research and Methodology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-71915-1_25
Download citation
DOI: https://doi.org/10.1007/978-3-540-71915-1_25
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-540-71914-4
Online ISBN: 978-3-540-71915-1
eBook Packages: MedicineMedicine (R0)