Abstract
Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, to ensure adequate samples, to measure input and output variables appropriately, to consider external and internal validities, to limit bias, and to address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision-making places randomized controlled trials (RCT) or systematic review of good quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.
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
Chertow GM, Moe SM (2005) Calcification or classification? J Am Soc Nephrol 16:293–295
Daugirdas JT, Depner TA, Gotch FA et al (1997) Comparison of methods to predict equilibrated Kt/V in the HEMO Pilot Study. Kidney Int 52:1395–1405
Wright JT Jr, Kusek JW, Toto RD et al (1996) Design and baseline characteristics of participants in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study. Control Clin Trials 17:3S–16S
Thorpe LE, Gwynn RC, Mandel-Ricci J et al (2006) Study design and participation rates of the New York City Health and Nutrition Examination Survey. Prev Chronic Dis 3:A94
Robbins JM, Vaccarino V, Zhang H, Kasl SV (2000) Excess type 2 diabetes in African-American women and men aged 40-74 and socioeconomic status: evidence from the Third National Health and Nutrition Examination Survey. J Epidemiol Community Health 54:839–845
Julious SA (2004) Sample sizes for clinical trials with normal data. Stat Med 23:1921–1986
Eknoyan G, Hostetter T, Bakris GL et al (2003) Proteinuria and other markers of chronic kidney disease: a position statement of the national kidney foundation (NKF) and the national institute of diabetes and digestive and kidney diseases (NIDDK). Am J Kidney Dis 42:617–622
Manns B, Owen WF Jr, Winkelmayer WC, Devereaux PJ, Tonelli M (2006) Surrogate markers in clinical studies: problems solved or created? Am J Kidney Dis 48:159–166
Viera AJ, Bangdiwala SI (2007) Eliminating bias in randomized controlled trials: importance of allocation concealment and masking. Fam Med 39:132–137
http://www.cebm.net/levels_of_evidence.asp. Accessed 23 Mar 2007
Sibbald B, Roberts C (1998) Understanding controlled trials: crossover trials. BMJ 316:1719
Antman EM, Grudzien C, Sacks DB (1995) Evaluation of a rapid bedside assay for detection of serum cardiac troponin T. JAMA 273:1279–1282
Sackett DL, Haynes RB, Guyatt GH, Tugwell P (1991) The interpretation of diagnostic data. In: Sackett DL, Haynes RB, Guyatt GH, Tugwell P (eds) Clinical Epidemiology: a basic science for clinical medicine. Little, Brown and Company, Toronto, CA, pp 117–119
Alp NJ, Bell JA, Shahi M (2001) A rapid troponin-I-based protocol for assessing acute chest pain. QJM 94:687–694
www.equator-network.org. Accessed 4 Apr 2014
http://www.consort-statement.org. Accessed 4 Apr 2014
http://www.strobe-statement.org. Accessed 4 Apr 2014
http://prisma-statement.org. Accessed 4 Apr 2014
Ravani P, Parfrey PS, Curtis B, Barrett BJ (2007) Clinical research of kidney diseases I: researchable questions and valid answers. Nephrol Dial Transplant 22:3681–3690
Ravani P, Parfrey PS, Dicks E, Barrett BJ (2007) Clinical research of kidney diseases II: problems of research design. Nephrol Dial Transplant 22:2785–2794
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2015 Springer Science+Business Media New York
About this protocol
Cite this protocol
Parfrey, P.S., Ravani, P. (2015). On Framing the Research Question and Choosing the Appropriate Research Design. In: Parfrey, P., Barrett, B. (eds) Clinical Epidemiology. Methods in Molecular Biology, vol 1281. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-2428-8_1
Download citation
DOI: https://doi.org/10.1007/978-1-4939-2428-8_1
Published:
Publisher Name: Humana Press, New York, NY
Print ISBN: 978-1-4939-2427-1
Online ISBN: 978-1-4939-2428-8
eBook Packages: Springer Protocols