CLINICAL EPIDEMIOLOGICAL RESEARCH METHODS: THE BASICS AND POTENTIAL PITFALLS

Authors

  • Sileshi Lulseged

Abstract

Research is defined as a quest for knowledge through diligent investigation aimed at the discovery and interpretation of new knowledge using the scientific method. In the clinical setting, epidemiological methods are used to make a prediction about exposure to and/or health outcome for an individual based on scientific studies of groups of similar patients. Inadequacies in clinical epidemiological research methodologies constitute a challenge to generating and publishing sound, scientific clinical evidence. Flaws in methodology constitute the major reasons for this and indeed, for rejection of manuscripts submitted to health journals in general. Use of research methods not rigorous enough to answer a proposed research question and/or lack of adequate details on the research methods in the manuscripts submitted for publication are commonly observed features. These, not only compromise the quality of evidence generated and disseminated, but also contribute substantially to delays in the publication of manuscripts. This article describes the basic concepts of clinical epidemiological research and highlights common pitfalls and errors to be avoided.

 

References

Lulseged S. Editorial: Evidence to Inform Policy and Action: Going with the Flow. Ethiop Med J 2004;42(3).

Masic I, Miokovic M, and Muhamedagic . Evidence Based Medicine – New Approaches and Challenges. Acta Inform Med. 2008; 16(4): 219–225. Accessed on February 13 at doi: 10.5455/aim.2008.16.219-225 PMCID: PMC3789163

Godlee F. Milestones on the long road to knowledge. BMJ. 2007;334(Suppl 1):s2–3

Sackett DL, Rosenberg WM, Gray JA. Evidence based medicine: What it is and what it isn't. BMJ. 1996;312:71–2.

Fletcher R, Fletcher S. The Scientific Basis Clinical Medicine. In Fletcher R, Fletcher S (eds). Clinical Epidemiology: The Essentials, 4th ed. Lippincott: Williams and Wilkins: Philadelphia, PA 2005, pp2-3.

World Health Organization. Health Research Methodology: A Guide for Training in Health Research, 2nd ed. WHO Regional Office for the Western Pacific, 2001, pp9-10.

World Health Organization. The WHO Strategy on Research for Health. WHO, 2012, pp17-8.

Rothman J. Causal Inference in Epidemiology. Modern Epidemiology. Little, Brown and Company: Boston, MA 1986. pp7-21

Gabriel D. Inductive and deductive approaches to research. Accessed on February 13 at http://deborahgabriel.com/2013/03/17/

World Health Organization. Health Research Methodology: A Guide for Training in Health Research, 2nd ed. WHO Regional Office for the Western Pacific, 2001, pp9-10.

Suresh K, Thomas S, Suresh G. Design, data analysis and sampling techniques for clinical research. Ann Indian Acad Neurol. 2011 Oct-Dec; 14(4): 287–90).

World Health Organization. The WHO Strategy on Research for Health. WHO, 2012, pp17-8.

Write Content Solutions. Data Triangulation: How the Triangulation of Data Strengthens Your Research. Accessed on February 13 athttp://www.write.com/writing-guides/research-writing/research-process/data-triangulation-how-the-triangulation-of-data-strengthens-your-research.

Ellis P. 2010. The Essential Guide to Effect Sizes: Statistical Power, Meta-Analysis, and the Interpretation of Research Results. Cambridge University Press. p. 52

Smith, GD; Ebrahim, S (2002) Data dredging, bias, or confounding. BMJ 325;7378:437-8. 5833

Hennekens CH, Buring JE. Epidemiology in Medicine. Little, Brown, and Company; Boston: 1987.

Sacket D. Bias in analytical research. J Chron Dis 1979;32:51-63

Althubaiti A. Information bias in health research: definition, pitfalls, and adjustment methods. J Multidiscip Health C. 2016; 9: 211–7.

Greenland S, Morgenstern H. Confounding in health research. Annu Rev Public Health. 2001;22:189-212.

Vanderweele T. On the distinction between interaction and effect modification. Epidemiology 2009; 20:863-71

Heffner CL. Chapter 7.3 Test Validity and Reliability. August 21, 2014-11-22T02:53:24+00:00

Suresh K, Thomas SV, Suresh G. Design, data analysis and sampling techniques for clinical research. Ann Indian Acad Neurol. 2011 Oct-Dec; 14(4): 287–90

Kimberlin CL,Winterstein AG. Validity and reliability of measurement instruments used in research. Am J Health Syst Pharm. 2008 Dec 1;65(23):2276-84.

Pagano M. Gauvraeau. Data Presentation (Chapter 2). Principles of Biostatistics. Wadsworh Publishing Company; Belmont, CA: 1993. Pp7-30

Creative Research Systems. Significance in Statistics & Surveys. Accessed on February 13 athttp://www.surveysystem.com/signif.htm

Institute of Work and Health. What researchers mean by statistical significance. Accessed on February 12, 2017 at https://www.iwh.on.ca/wrmb/statistical-significance

World Medical Association (WMA) Declaration of Helsinki – Ethical Principles of for Medical Research Involving Human Subjects. Adopted by the 18th General Assembly, Helsinki, Finland, June 1964 and Amended by WMA Assembly, Fortaleza, Brazil, October 2013

National Research Ethics Review Guideline. FDRE Federal Ministry of Science and Technology 5th Ed. 2014

Council for International Organizations of Medical Sciences (CIOMS) 2002. International Ethical Guidelines for Biomedical Research Involving Human Subject. Accessed on December 28 at http://www.cioms.ch/frame_guidelines_nov_2002.htm (1 de 64)08/03/2007 9:10:05

World Health Organization 2011, Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Accessed on December 28 at http://apps.who.int/iris/bitstream/10665/44783/1/9789241502948_eng.pdf?ua=1&ua=1

Crimes D, Schultz, K. (2002) "Descriptive Studies: what they can and cannot do". The Lancet, 359,145-9.

Health Knowledge: Education, CPD and Revalidation from PHAST. Accessd on February 123, 2017 at https://www.healthknowledge.org.uk/public-health-textbook/research-methods/1a-epidemiology/cs-as-is/cross-sectional-studies

Whitaker H. Case series studies: rationale, design and analysis. Open University, UK. h.j.whitaker@open.ac.uk. Access on February 13, 2017 at https://www.ucl.ac.uk/pcph/research-groups-themes/thin-pub/research_ presentations/ Whitaker_case_seri.

Schulz K, Grimes D. Case-control studies: research in reverse. The Lancet 2002;359(9304): 431–4

Pearce N. Analysis of matched case-control studies. BMJ 2016;352:i969 doi: https://doi.org/10.1136/bmj.i969 (Published 25 February 2016) Cite this as:

Grimes Ds, Schulz K. Cohort studies: marching towards outcomes. The Lancet 2002;359(9303):341–5.

Ernster VL. Nested case-control studies. Prev Med. 1994 Sep;23(5):587-90

MacGil M. What is a randomized controlled trial in medical research? Updated on January 19, 2016. Accessed on February 13, 2017 at http://www.medicalnewstoday.com/articles/280574.php

Johnson D Crossover experiments. WIREs Comp Stat 2010;2: 620-5.

Kunz R, Vist G, Oxman AD. Randomization to protect against selection bias in healthcare trials. Cochrane Database Syst Rev. 2007 Apr 18;(2):MR000012.

Hollis S, Campbell F.What is meant by intention to treat analysis? Survey of published randomized controlled trials. BMJ. 1999 319(7211): 670–4.

Montedori M, Bonacini M, Casazza G, et al. Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study. Trials 2011;12:58. doi: 10.1186/1745-6215-12-58

Shah PB. Intention-to-treat and per-protocol analysis. CMAJ. 2011 183(6): 696. doi: 10.1503/cmaj.111-2033

Khan K, Kunz R, Kleijnen J, Antes G. Five steps to conducting a systematic review . R Soc Med. 2003 Mar; 96(3):118–121.PMCID: PMC539417.

Haidich AB. Meta-analysis in medical research. Hippokratia. 2010 Dec; 14(Suppl 1): 29–37

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2017-03-14

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