Skip to main content
SpringerLink
Log in

Statistics: Setting the Stage

  • Chapter
  • First Online:
Success in Academic Surgery: Clinical Trials

Part of the book series: Success in Academic Surgery ((SIAS))

  • 1541 Accesses

Abstract

Results from clinical trials are often cited as the highest-quality evidence available to guide clinical practice. While many reported clinical trials are of high quality, many have significant deficiencies in study design, data analysis, and interpretation of results. Up-front attention to the fundamentals of statistics is paramount to the design and conduct of a high-quality clinical trial. This chapter will address the fundamentals of study design, focusing on statistical topics including randomization, treatment allocation, cohort stratification, sample size, power, and type II errors.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 59.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637–9.

    Article  PubMed  CAS  Google Scholar 

  2. Tiruvoipati R, Balasubramanian SP, Atturu G, Peek GJ, Elbourne D. Improving the quality of reporting randomized controlled trials in cardiothoracic surgery. The way forward. J Thorac Cardiovasc Surg. 2006;132:233–40.

    Article  PubMed  Google Scholar 

  3. Dimick JB, Diener-West M, Lipsett PA. Negative results of randomized clinical trials published in the surgical literature. Equivalency or error? Arch Surg. 2001;136:796–800.

    Article  PubMed  CAS  Google Scholar 

  4. Designing research. In: Altman DG, editor. Practical statistics for medical research. London: Chapman & Hall/CRC; 1999.

    Google Scholar 

  5. Sacks MH. The interaction between clinical research and treatment. Hillside J Clin Psychiatry. 1983;5:169–76.

    PubMed  CAS  Google Scholar 

  6. The Canadian Cooperative Study Group. A randomized trial of aspirin and sulfinpyrazone in threatened stroke. N Engl J Med. 1978;229:53–9.

    Article  Google Scholar 

  7. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. New York: Springer; 1998.

    Book  Google Scholar 

  8. The GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993;329:673–82.

    Article  Google Scholar 

  9. Randomized clinical trials. In: Levine RJ, editor. Ethics and regulations of clinical research. 2nd ed. New Haven: Yale University Press; 1988.

    Google Scholar 

  10. Blazeby JM, Donovan J, Sharples L, Morton D. Recruiting patients into randomized clinical trials in surgery. Br J Surg. 2012;99:307–8.

    Article  PubMed  CAS  Google Scholar 

  11. Bonenkamp JJ, Hermans J, Sasako M, et al. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999;340:908–14.

    Article  PubMed  CAS  Google Scholar 

  12. Brennan MF. Lymph-node dissection for gastric cancer. N Engl J Med. 1999;340:956–8.

    Article  PubMed  CAS  Google Scholar 

  13. Fleshman J, Sargent DJ, Green E, et al. Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group trial. Ann Surg. 2007;246:655–62.

    Article  PubMed  Google Scholar 

  14. Serruys PW, Morice MC, Kappetein AP, SYNTAX Investigators, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009;360:961–72.

    Article  PubMed  CAS  Google Scholar 

  15. Rose PG, Nerenstone S, Brady MF, et al. Secondary surgical cytoreduction for advanced ovarian carcinoma. N Engl J Med. 2004;351:2489–97.

    Article  PubMed  CAS  Google Scholar 

  16. Grant AM, Wileman SM, Ramsay CR, et al. Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomized trial. BMJ. 2008;337:a2664.

    Article  PubMed  Google Scholar 

  17. Jarvik JG, Comstock BA, Kliot M, et al. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomized parallel-group trial. Lancet. 2009;374:1074–81.

    Article  PubMed  Google Scholar 

  18. Birkmeyer NJO, Weinstein JN, Tosteson ANA, et al. Design of the spine patient outcomes research trial (SPORT). Spine. 2002;27:1361–472.

    Article  PubMed  Google Scholar 

  19. Reynolds T. Why randomized surgical oncology trials are so scarce. J Natl Cancer Inst. 1999;91:1182–3.

    Article  PubMed  CAS  Google Scholar 

  20. DeMatteo RP, Ballman KV, Antonescu CR, et al. Adjuvant imatinib mesylate after resection of localized, primary gastrointestinal stromal tumour: a randomized, double-blind, placebo-controlled trial. Lancet. 2009;373:1097–104.

    Article  PubMed  CAS  Google Scholar 

  21. Ong EGP, Eaton S, Wade AM, et al. Randomized clinical trial of glutamine-supplemented versus standard parenteral nutrition in infants with surgical gastrointestinal disease. Br J Surg. 2012;99:929–38.

    Article  PubMed  CAS  Google Scholar 

  22. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624–32.

    Article  PubMed  CAS  Google Scholar 

  23. Evidence-based practice center systematic review protocol. Comparative Effectiveness of Surgical Options for Inguinal Hernia. Accessed at: www.effectivehealthcare.ahrq.govpublished. 15 Aug 2011.

  24. Clinical trials. In: Altman DG, editor. Practical statistics for medical research. London: Chapman & Hall/CRC; 1999.

    Google Scholar 

  25. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med. 1989;8:431–40.

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Surgery, University of Michigan, Ann Arbor, MI, USA

    Sandra L. Wong MD, MS

Authors
  1. Sandra L. Wong MD, MS
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Sandra L. Wong MD, MS .

Editor information

Editors and Affiliations

  1. Department of Surgery, Johns Hopkins, Baltimore, USA

    Timothy M. Pawlik

  2. Department of Surgery,, Duke University School of Medicine,, Durham, North Carolina, USA

    Julie A. Sosa

Rights and permissions

Reprints and permissions

Copyright information

© 2014 Springer-Verlag London

About this chapter

Cite this chapter

Wong, S.L. (2014). Statistics: Setting the Stage. In: Pawlik, T., Sosa, J. (eds) Success in Academic Surgery: Clinical Trials. Success in Academic Surgery. Springer, London. https://doi.org/10.1007/978-1-4471-4679-7_3

Download citation

  • DOI: https://doi.org/10.1007/978-1-4471-4679-7_3

  • Published:

  • Publisher Name: Springer, London

  • Print ISBN: 978-1-4471-4678-0

  • Online ISBN: 978-1-4471-4679-7

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation