AN OVERVIEW OF RESEARCH STUDY DESIGNS

Authors

  • Ramalingam Sitharthan Principal & Professor, Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kottayam. Kerala.
  • Deepthi Gilla Assistant Professor, Department of Psychiatry, National Homoeopathy Research Institute in Mental Health (NHRIMH), Kottayam.

Abstract

The choice of the study design is a major determinant of scientific quality and clinical value of a research study. To select an appropriate study design is a perplex task for novice as well as veterans in research. AYUSH systems of medicines have evidence database showing the effectiveness in a wide range of clinical conditions, yet improving the quality of trials by well- designed studies is indispensable to demonstrate widespread utility on more scientific grounds. This article describes the structured classification of research designs done on the basis of a selective literature search concerning medical research. The study design and type that can best answer the particular research question at hand must be determined not only on a scientific basis, but also in view of the available resources, ethical issues and practical feasibility of study.

Keywords: Study design, Clinical trial phases, Observational studies, Experimental studies. Randomized Controlled Trial (RCT).

Author Biographies

  • Ramalingam Sitharthan, Principal & Professor, Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, Kottayam. Kerala.
    Principal & Professor, Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health (NHRIMH), Kottayam. PG Guide, MD(Hom) Practice of Medicine, Kerala University of Health Sciences, Thrissur. Member, Board of Studies- Homoeopathy (PG), Kerala University of Health Sciences, Thrissur. PG Coordinator, National Homoeopathy Research Institute in Mental Health (NHRIMH), Kottayam. Former Professor & HOD in Practice of Medicine & Research Guide, Vinayaka Missions Homoeopathic Medical College, Salem. Tamilnadu. External Examiner, for MD(Hom) Students - Practice of Medicine- Rajiv Gandhi University of Health Sciences, Karnataka. External Examiner, for MD(Hom) Students - Practice of Medicine- NTR University, Andra pradesh. Former, Member Secretary, Institutional Ethical Committee, Vinayaka Missions Homoeopathic Medical College, Salem. Tamilnadu. Former Research Coordinator, Vinayaka Missions Homoeopathic Medical College, Salem. Tamilnadu. Published article in various journals and presented papers in 3 international conferences
  • Deepthi Gilla, Assistant Professor, Department of Psychiatry, National Homoeopathy Research Institute in Mental Health (NHRIMH), Kottayam.
    Assistant Professor, Department of Psychiatry, National Homoeopathy Research Institute in Mental Health (NHRIMH), Kottayam.

References

Ranganathan P, Aggarwal R. Study designs: Part 1 - An overview and classification. Perspect Clin Res. 2018;9(4):184-186. doi: 10.4103/picr.PICR_124_18

Nair B. Clinical Trial Designs. Indian Dermatol Online J. 2019;10(2):193-201. doi:10.4103/idoj.IDOJ_475_18

Mathie RT. Controlled clinical studies of homeopathy. Homeopathy. 2015;104(4):328-332. doi:10.1016/j.homp.2015.05.003

Khurana A. Research design in Homoeopathy: A perspective. Indian J Res Homoeopathy [serial online] 2019 [cited 2020 Aug 7];13:207-8. Available from: http://www.ijrh.org/text.asp?2019/13/4/207/274026

Lim HJ, Hoffmann RG. Study design: The basics. Methods Mol Biol. 2007; 404:1‐17.

Umscheid CA, Margolis DJ, Grossman CE. Key concepts of clinical trials: A narrative review. Postgrad Med. 2011;123:194‐204.

Kapoor MC. Types of studies and research design. Indian J Anaesth. 2016;60(9):626-630. doi:10.4103/0019-5049.190616

Omair A. Selecting the appropriate study design for your research: Descriptive study designs. J Health Spec [serial online] 2015 [cited 2020 Oct 22];3:153-6. Available from: https://www.thejhs.org/text.asp?2015/3/3/153/159892

Grimes DA, Schulz KF. Descriptive studies: What they can and cannot do. Lancet 2002;359:145-9.

Ranganathan P, Aggarwal R. Study designs: Part 3 - Analytical observational studies. Perspect Clin Res. 2019;10(2):91-94. doi:10.4103/picr.PICR_35_19

Evans SR. Fundamentals of clinical trial design. J Exp Stroke Transl Med. 2010;3(1):19-27. doi:10.6030/1939-067x-3.1.19

Ryan EG, Stallard N, Lall R, Ji C, Perkins GD, Gates S. Bayesian group sequential designs for phase III emergency medicine trials: a case study using the PARAMEDIC2 trial. Trials. 2020;21(1):84. Published 2020 Jan 14. doi:10.1186/s13063-019-4024-x

Ryan EG, Bruce J, Metcalfe AJ, et al. Using Bayesian adaptive designs to improve phase III trials: a respiratory care example. BMC Med Res Methodol. 2019;19(1):99. Published 2019 May 14. doi:10.1186/s12874-019-0739-3

Thiese MS. Observational and interventional study design types; an overview. Biochem Med (Zagreb). 2014;24(2):199-210. doi:10.11613/BM.2014.022

Schweizer ML, Braun BI, Milstone AM. Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship-Quasi-Experimental Designs. Infect Control Hosp Epidemiol. 2016;37(10):1135-1140. doi:10.1017/ice.2016.117

Christensen E. Methodology of superiority vs. equivalence trials and non-inferiority trials. Journal of Hepatology. 2007 May;46(5):947-954. DOI: 10.1016/j.jhep

Nolan SJ, Hambleton I, Dwan K. The Use and Reporting of the Cross-Over Study Design in Clinical Trials and Systematic Reviews: A Systematic Assessment. PLoS One. 2016;11(7):e0159014. Published 2016 Jul 13. doi:10.1371/journal.pone.0159014

Baker TB, Smith SS, Bolt DM, et al. Implementing Clinical Research Using Factorial Designs: A Primer. Behav Ther. 2017;48(4):567-580. doi:10.1016/j.beth.2016.12.005

Pennell ML, Hade EM, Murray DM, Rhoda DA. Cutoff designs for community-based intervention studies [published correction appears in Stat Med. 2011 Sep 20;30(21):2669]. Stat Med. 2011;30(15):1865-1882. doi:10.1002/sim.4237

Pennell ML, Hade EM, Murray DM, Rhoda DA. Cutoff designs for community-based intervention studies [published correction appears in Stat Med. 2011 Sep 20;30(21):2669]. Stat Med. 2011;30(15):1865-1882. doi:10.1002/sim.4237

Downloads

Published

2020-11-04