Clinics in Shoulder and Elbow

Korean Shoulder and Elbow Society (대한견·주관절의학회)
권호 표지
DOI QR코드

DOI QR Code

Calculation of Sample Size in Clinical Trials

임상 연구에서 연구 표본수의 산출

  • Lee, Hyo-Jin (Department of Orthopedic Surgery, Seoul St. Mary's Hospital Catholic University of Korea) ;
  • Kim, Yang-Soo (Department of Orthopedic Surgery, Seoul St. Mary's Hospital Catholic University of Korea) ;
  • Park, In (Department of Orthopedic Surgery, Seoul St. Mary's Hospital Catholic University of Korea)
  • 이효진 (가톨릭대학교 의과대학 서울성모병원 정형외과) ;
  • 김양수 (가톨릭대학교 의과대학 서울성모병원 정형외과) ;
  • 박인 (가톨릭대학교 의과대학 서울성모병원 정형외과)
  • Received : 2013.06.04
  • Accepted : 2013.06.20
  • Published : 2013.06.30
Download PDF
⟨ Previous Next ⟩

Abstract

Purpose: This review aims to explain the definition and basic principle of statistical analysis and to clarify statistical issues related to the sample size calculation. Materials and Methods: Many formulas are available that can be applied for different types of data and study design. Results: The sample size is the number of patients or other experimental units that need to be calculated prior to the study. Determining the appropriate sample size is required to answer the research question. Conclusion: Caution is needed when applying formula for the calculation of the sample size, as it is sensitive to error and even small differences in selected parameters can lead to large differences in the sample size.

목적: 임상 연구의 통계 분석에 있어서 표본수 산출의 의미와 기본 방식에 대해서 알고자 한다. 대상 및 방법: 자료의 분류, 연구 디자인 및 도출하고자 하는 결과의 성격에 따라 각기 다른 식을 적용시켜 표본수를 산출 한다. 결과: 표본수 산출은 임상 연구를 시작하기 전에 선행되어야 하며, 적절한 표본수 산출은 유의한 결론 도출에 필수 불가결하다. 결론: 표본수 산출은 에러나 작은 변수에 민감하기 때문에 특정 식에 적용시킬 때는 주의를 요한다.

Keywords

References

  1. Whitley E, Ball J. Statistics review 4: Sample size calculations. Crit Care. 2002;6:335-41. https://doi.org/10.1186/cc1521
  2. Kirby A, Gebski V, Keech AC. Determining the sample size in a clinical trial. Med J Aust. 2002;177: 256-7.
  3. Altman DG. Practical statistics for medical research. 1st ed. London: Chapman and Hall; 1991. 25-101.
  4. Bae JM. An illustrated guide to medical statistics using SPSS. 1st ed. Seoul: Hannarae; 2012. 20-1.
  5. Machin D, Campbell MJ, Fayers PM, Pinol APY. Sample size tables for clinical studies. 2nd ed. Oxford: Blackwell Science; 1997. 1-13.
  6. Pallant J. SPSS survival manual: A step by step guide to data analysis using SPSS. 4th ed. New York: McGraw-Hill; 2010. 121-202.
  7. Siegel S, Castellan NJ. Nonparametric statistics for the behavioral sciences. 2nd ed. New York: McGraw- Hill; 1988. 19-37.
  8. Hamilton LC. Data analysis for social scientists: A first course in applied statistics. 1st ed. London: Duxbury Press; 1996. 30-42.
  9. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale: L. Erlbaum Associates; 1988. 19-74.
  10. Bland M. An introduction to medical statistics. 3rd ed. Oxford: Oxford University Press; 2000. 14-32.
  11. Munro BH. Statistical methods for health care research. 5th ed. Philadelphia: Lippincott Williams & Wilkins; 2005. 73-106.
  12. Thorne BM. Statistics for the behavioral sciences. 1st ed. Houston: Mayfield; 1989. 16-44.
  13. Friedman LM, Furberg C, DeMets DL. Fundamentals of clinical trials. 4th ed. New York: Springer; 2010. 133-162.
  14. Kim YS, Chung SW, Kim JY, Ok JH, Park I, Oh JH. Is early passive motion exercise necessary after arthroscopic rotator cuff repair? Am J Sports Med. 2012;40:815-21. https://doi.org/10.1177/0363546511434287

Cited by

  1. Sample Size Estimation for Risk Assessment and Monitoring Based on Heavy Metal Monitoring Data from Food Items vol.30, pp.2, 2015, https://doi.org/10.13103/JFHS.2015.30.2.127