Advertisement

How to Write a Study Protocol

  • Lukas B. Moser
  • Michael T. HirschmannEmail author
Chapter

Abstract

This chapter aims to provide a guide for young trainees writing their first study protocol. It includes important aspects junior researchers should consider before getting started and preparing their first study protocol. After having read the chapter, the reader should have a good idea about what a study protocol is about and be able to answer the question why, when, and how a study protocol should be written. Finally, the reader will be prepared to master the very first step of conducting a successful study—writing a brief, concise, but comprehensive study protocol.

Study protocol examples of typical clinical scenarios further illustrate the approach to this mandatory and important part of a research project.

Keywords

Scientific writing Instruction Study protocol Research Paper 

References

  1. 1.
    Al-Jundi A, Sakka S. Protocol writing in clinical research. J Clin Diagn Res. 2016;10:ZE10–3.PubMedPubMedCentralGoogle Scholar
  2. 2.
    Babyak MA. What you see may not be what you get: a brief, nontechnical introduction to overfitting in regression-type models. Psychosom Med. 2004;66:411–21.PubMedGoogle Scholar
  3. 3.
    Bando K, Sato T. Did you write a protocol before starting your project? Gen Thorac Cardiovasc Surg. 2015;63:71–7.CrossRefGoogle Scholar
  4. 4.
    Barletta JF. Conducting a successful residency research project. Am J Pharm Educ. 2008;72:92.CrossRefGoogle Scholar
  5. 5.
    Brody BA, McCullough LB, Sharp RR. Consensus and controversy in clinical research ethics. JAMA. 2005;294:1411–4.CrossRefGoogle Scholar
  6. 6.
    Doran G. There’s a S.M.A.R.T. way to write management’s goals and objectives. Manag Rev. 1981;70:35–6.Google Scholar
  7. 7.
    Doran PC. Understanding dentures: instructions to patients. J Colo Dent Assoc. 1981;59:4–8.PubMedGoogle Scholar
  8. 8.
    Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med. 1996;125:605–13.CrossRefGoogle Scholar
  9. 9.
    Fronteira I. How to design a (good) epidemiological observational study: epidemiological research protocol at a glance. Acta Medica Port. 2013;26:731–6.Google Scholar
  10. 10.
    Ghooi RB, Divekar D. Insurance in clinical research. Perspect Clin Res. 2014;5:145–50.CrossRefGoogle Scholar
  11. 11.
    Gilmore SJ. Evaluating statistics in clinical trials: making the unintelligible intelligible. Australas J Dermatol. 2008;49:177–84; quiz 185–176.CrossRefGoogle Scholar
  12. 12.
    Huang Y, Gilbert PB. Comparing biomarkers as principal surrogate endpoints. Biometrics. 2011;67:1442–51.CrossRefGoogle Scholar
  13. 13.
    Kanji S. Turning your research idea into a proposal worth funding. Can J Hosp Pharm. 2015;68:458–64.PubMedPubMedCentralGoogle Scholar
  14. 14.
    O’Brien K, Wright J. How to write a protocol. J Orthod. 2002;29:58–61.CrossRefGoogle Scholar
  15. 15.
    Richardson WS, Wilson MC, Nishikawa J, Hayward RS. The well-built clinical question: a key to evidence-based decisions. ACP J Club. 1995;123:A12–3.PubMedGoogle Scholar
  16. 16.
    Rosenthal R, Schafer J, Briel M, Bucher HC, Oertli D, Dell-Kuster S. How to write a surgical clinical research protocol: literature review and practical guide. Am J Surg. 2014;207:299–312.CrossRefGoogle Scholar
  17. 17.
    Sade RM, Akins CW, Weisel RD. Managing conflicts of interest. J Thorac Cardiovasc Surg. 2015;149:971–2.CrossRefGoogle Scholar
  18. 18.
    Skelly AC, Dettori JR, Brodt ED. Assessing bias: the importance of considering confounding. Evid Based Spine Care J. 2012;3:9–12.PubMedPubMedCentralGoogle Scholar
  19. 19.
    Van Spall HG, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007;297:1233–40.CrossRefGoogle Scholar
  20. 20.
    Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. PLoS Med. 2007;4:e297.CrossRefGoogle Scholar
  21. 21.
    Vavken P, Culen G, Dorotka R. Management of confounding in controlled orthopaedic trials: a cross-sectional study. Clin Orthop Relat Res. 2008;466:985–9.CrossRefGoogle Scholar
  22. 22.
    Warren MD. Aide-memoire for preparing a protocol. Br Med J. 1978;1:1195–6.CrossRefGoogle Scholar

Copyright information

© ISAKOS 2019

Authors and Affiliations

  1. 1.Department of Orthopaedic Surgery and TraumatologyKantonsspital Baselland (Bruderholz, Liestal, Laufen)BruderholzSwitzerland
  2. 2.University of BaselBaselSwitzerland

Personalised recommendations