Study designs in medical research and their key characteristics

Authors

DOI:

https://doi.org/10.20883/medical.e928

Keywords:

research methodology, study design, randomized controlled trial, cohort, case-control, review, cross-section

Abstract

Medical research study designs are many and varied. At first glance, they may be difficult to distinguish. Knowledge of their specific strengths and limitations is helpful for investigators planning new projects and for readers of the medical literature. The aims of the review are threefold: (i) to present an overview of medical research types, (ii) to attract attention to multiple characteristics of medical study designs, and (iii) to provide a concise educational resource for young researchers in the health sciences. Analysing the characteristics of medical study designs leads to achieving the goals.

Downloads

Download data is not yet available.

References

Song JW, Chung KC. Observational Studies: Cohort and Case-Control Studies. Plast Reconstr Surg, 2010;126:2234–42. doi: 10.1097/PRS.0b013e3181f44abc.

Subbiah V. The next generation of evidence-based medicine. Nat Med, 2023;29:49–58. doi: 10.1038/s41591-022-02160-z.

Superchi C, Brion Bouvier F, Gerardi C, Carmona M, San Miguel L, Sánchez-Gómez LM, et al. Study designs for clinical trials applied to personalised medicine: a scoping review. BMJ Open, 2022;12:e052926. doi: 10.1136/bmjopen-2021-052926.

Gamble J-M. An Introduction to the Fundamentals of Cohort and Case–Control Studies. Can J Hosp Pharm, 2014;67:366–72.

Mann CJ. Observational research methods. Research design II: cohort, cross sectional, and case-control studies. Emerg Med J, 2003;20:54–60. doi: 10.1136/emj.20.1.54.

Pearce N. Analysis of matched case-control studies. BMJ, 2016;352:i969. doi: 10.1136/bmj.i969.

Vandenbroucke JP, Pearce N. Case–control studies: basic concepts. Int J Epidemiol, 2012;41:1480–9. doi: 10.1093/ije/dys147.

Cohen JF, Korevaar DA, Altman DG, Bruns DE, Gatsonis CA, Hooft L, et al. STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration. BMJ Open, 2016;6:e012799. doi: 10.1136/bmjopen-2016-012799.

Piantadosi S. Clinical trials: a methodologic perspective. Third edition. Hoboken, NJ: Wiley; 2017.

Friedman LM, editor. Fundamentals of clinical trials. 5. ed. Cham Heidelberg: Springer; 2015.

Kang M, Ragan BG, Park J-H. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train, 2008;43:215–21. doi: 10.4085/1062-6050-43.2.215.

Cook JA, Julious SA, Sones W, Hampson LV, Hewitt C, Berlin JA, et al. DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. BMJ, 2018:k3750. doi: 10.1136/bmj.k3750.

Heneghan C, Goldacre B, Mahtani KR. Why clinical trial outcomes fail to translate into benefits for patients. Trials, 2017;18:122. doi: 10.1186/s13063-017-1870-2.

Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials, 2012;13:132. doi: 10.1186/1745-6215-13-132.

Hakoum MB, Noureldine H, Habib JR, Abou-Jaoude EA, Raslan R, Jouni N, et al. Authors of clinical trials seldom reported details when declaring their individual and institutional financial conflicts of interest: a cross-sectional survey. J Clin Epidemiol, 2020;127:49–58. doi: 10.1016/j.jclinepi.2020.05.026.

Baraldi JH, Picozzo SA, Arnold JC, Volarich K, Gionfriddo MR, Piper BJ. A cross-sectional examination of conflict-of-interest disclosures of physician-authors publishing in high-impact US medical journals. BMJ Open, 2022;12:e057598. doi: 10.1136/bmjopen-2021-057598.

Østengaard L, Lundh A, Tjørnhøj-Thomsen T, Abdi S, Gelle MHA, Stewart LA, et al. Influence and management of conflicts of interest in randomised clinical trials: qualitative interview study. BMJ, 2020;371:m3764. doi: 10.1136/bmj.m3764.

Grüning T, Gilmore AB, McKee M. Tobacco industry influence on science and scientists in Germany. Am J Public Health, 2006;96:20–32. doi: 10.2105/AJPH.2004.061507.

Ito C, Hashimoto A, Uemura K, Oba K. Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results: A Systematic Review. JAMA Netw Open, 2021;4:e2135765. doi: 10.1001/jamanetworkopen.2021.35765.

Yuan Z, Yao M. Is academic writing becoming more positive? A large-scale diachronic case study of Science research articles across 25 years. Scientometrics, 2022;127:6191–207. doi: 10.1007/s11192-022-04515-2.

Wedlund L, Kvedar J. Simulated trials: in silico approach adds depth and nuance to the RCT gold-standard. NPJ Digit Med, 2021;4:121. doi: 10.1038/s41746-021-00492-7.

Wang SV, Schneeweiss S, RCT-DUPLICATE Initiative, Franklin JM, Desai RJ, Feldman W, et al. Emulation of Randomized Clinical Trials With Nonrandomized Database Analyses: Results of 32 Clinical Trials. JAMA, 2023;329:1376–85. doi: 10.1001/jama.2023.4221.

Cuello-Garcia CA, Santesso N, Morgan RL, Verbeek J, Thayer K, Ansari MT, et al. GRADE guidance 24 optimizing the integration of randomized and non-randomized studies of interventions in evidence syntheses and health guidelines. J Clin Epidemiol, 2022;142:200–8. doi: 10.1016/j.jclinepi.2021.11.026.

Ahn E, Kang H. Introduction to systematic review and meta-analysis. Korean J Anesthesiol, 2018;71:103–12. doi: 10.4097/kjae.2018.71.2.103.

Pigott TD, Polanin JR. Methodological Guidance Paper: High-Quality Meta-Analysis in a Systematic Review. Rev Educ Res, 2020;90:24–46. doi: 10.3102/0034654319877153.

Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ, 2019:l4898. doi: 10.1136/bmj.l4898.

Whiting PF, Rutjes AWS, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med, 2011;155:529–36. doi: 10.7326/0003-4819-155-8-201110180-00009.

Östlund U, Kidd L, Wengström Y, Rowa-Dewar N. Combining qualitative and quantitative research within mixed method research designs: A methodological review. Int J Nurs Stud, 2011;48:369–83. doi: 10.1016/j.ijnurstu.2010.10.005.

Bespalov A, Michel MC, Steckler T, editors. Good research practice in non-clinical pharmacology and biomedicine. Cham, Switzerland: Springer; 2020.

Downloads

Published

2023-12-28

How to Cite

1.
Nowak JK, Walkowiak J. Study designs in medical research and their key characteristics. JMS [Internet]. 2023 Dec. 28 [cited 2024 Jun. 16];92(4):e928. Available from: https://jms.ump.edu.pl/index.php/JMS/article/view/928

Issue

Section

Review Papers
Received 2023-09-11
Accepted 2023-12-22
Published 2023-12-28