Skip to main content

Special Considerations

  • Chapter
  • First Online:
Writing Case Reports

Abstract

This chapter examines several variations on the traditional case report. The adverse drug reaction (ADR) case report has a vital role in pharmacovigilance. Since ADR case reports rely largely on temporal connections to support causality, a timeline is essential, and a validated causality scale, such as the Naranjo ADR Probability Scale or the Horn Drug Interaction Probability Scale, must be included. N-of-1 trials study individual patients in order to find the best treatment, using the subject’s own data. “Exceptional Responder” trials in oncology and studies using remote “phenotypic” monitoring devices demonstrate the important roles that n-of-1 trials can play in personalized medicine. Case series are similar in aim and focus to single case reports, but can offer more compelling evidence with “clusters” of new or unusual cases. Case series can be cross-sectional or longitudinal, and have applications in case definition, clues about cause, benchmarking studies, and case registries. Clinical images and clinical quiz articles have high educational value and can make powerful teaching points. Specific requirements and recommendations for these articles are reviewed.

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

Access this chapter

eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 16.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Similar content being viewed by others

References

  1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279:1200–5.

    Article  CAS  PubMed  Google Scholar 

  2. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255–9.

    Article  CAS  PubMed  Google Scholar 

  3. Choe M, Packer CD. Severe romiplostim-induced rebound thrombocytopenia after splenectomy for refractory ITP. Ann Pharmacother. 2015;49(1):140–4.

    Article  PubMed  Google Scholar 

  4. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239–45.

    Article  CAS  PubMed  Google Scholar 

  5. The use of the WHO-UMC system for standardized case causality assessment. http://who-umc.org/Graphics/24734.pdf. Accessed 7 Feb 2016.

  6. Gallagher RM, Kirkham JJ, Mason JR, et al. Development and inter-rater reliability of the Liverpool adverse drug reaction causality assessment tool. PLoS One. 2011;6:e28096.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Horn JR, Hansten PD, Chan LN. Proposal for a new tool to evaluate drug interaction cases. Ann Pharmacother. 2007;41(4):674–80.

    Article  PubMed  Google Scholar 

  8. Mookherjee S, Narayanan M, Uchiyama T, Wentworth KL. Three hospital admissions in 9 days to diagnose azathioprine hypersensitivity in a patient with Crohn's disease. Am J Ther. 2015;22(2):e28–32.

    Article  PubMed  Google Scholar 

  9. Frankel JK, Packer CD. Cushing’s Syndrome due to antiretroviral-budesonide interaction. Ann Pharmacother. 2011;45(6):823–4.

    Article  PubMed  Google Scholar 

  10. Kelly WN, Arellano FM, Barnes J, et al. Guidelines for submitting adverse event reports for publication. Drug Saf. 2007;30(5):367–73.

    Article  PubMed  Google Scholar 

  11. Kelly WN. The quality of published adverse drug event reports. Ann Pharmacother. 2003;37(12):1774–8.

    Article  PubMed  Google Scholar 

  12. Impicciatore P, Mucci M. Completeness of published case reports on suspected adverse drug reactions. Drug Saf. 2010;33(9):765–73.

    Article  PubMed  Google Scholar 

  13. Kane-Gill SL, Smithburger PL, Williams EA, Felton MA, Wang N, Seybert AL. Published cases of adverse drug reactions: has the quality of reporting improved over time? Ther Adv Drug Saf. 2015;6(2):38–44.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Lillie EO, Patay B, Diamant J, Issell B, Topol EJ, Schork NJ. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Per Med. 2011;8(2):161–73.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Schork NJ. Personalized medicine: Time for one-person trials. Nature. 2015;520(7549):609–11.

    Article  CAS  PubMed  Google Scholar 

  16. Exceptional responders initiative: questions and answers. http://www.cancer.gov/news-events/press-releases/2014/ExceptionalRespondersQandA. Accessed 7 Feb 2016.

  17. Brannon AR, Sawyers CL. “N of 1” case reports in the era of whole genome sequencing. J Clin Invest. 2013;123(11):4568–70.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  18. Topol EJ. Pharmacy benefit managers, pharmacies, and pharmacogenomics testing: prescription for progress? Sci Transl Med. 2010;2(44):44cm22.

    Article  PubMed  Google Scholar 

  19. Hamburg MA, Collins FS. The path to personalized medicine. N Engl J Med. 2010;363(4):301–4.

    Article  CAS  PubMed  Google Scholar 

  20. Kung S, Espinel Z, Lapid MI. Treatment of nightmares with prazosin: a systemic review. Mayo Clin Proc. 2012;87(9):890–900.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  21. Dekkers OM, Egger M, Altman DG, Vandenbroucke JP. Distinguishing case series from cohort studies. Ann Intern Med. 2012;156:37–40.

    Article  PubMed  Google Scholar 

  22. Abu-Zidan FM, Abbas AK, Hefny AF. Clinical “case series”: a concept analysis. Afr Health Sci. 2012;12(4):557–62.

    CAS  PubMed  PubMed Central  Google Scholar 

  23. Vandenbroucke JP. In defense of case reports and case series. Ann Intern Med. 2001;134:330–4.

    Article  CAS  PubMed  Google Scholar 

  24. Johnson LL. Observational studies. In: Gallin JI, Ognibene FP, editors. Principles and practice of clinical research. 3rd ed. Amsterdam: Academic Press; 2012. p. 209–10.

    Google Scholar 

  25. Jenicek M. Clinical case reporting in evidence-based medicine. Oxford: Butterworth-Heinemann; 1999. p. 101.

    Google Scholar 

  26. Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo J, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008;358:2649–51.

    Article  CAS  PubMed  Google Scholar 

  27. Hess DR. Retrospective studies and chart reviews. Respir Care. 2004;49(10):1171–4.

    PubMed  Google Scholar 

  28. Martyn C. Case reports, case series, and systemic reviews. QJM. 2002;95(4):197–8.

    Article  CAS  PubMed  Google Scholar 

  29. Wakefield AJ, Murch SH, Anthony A, et al. RETRACTED: Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet. 1998;351(9103):637–41.

    Article  CAS  PubMed  Google Scholar 

  30. Carvalho SM, Dalben I, Corrente JE, Magalhaes CS. Rheumatic fever presentation and outcome: a case-series report. Rev Bras Reumatol. 2012;52(2):236–46.

    Article  Google Scholar 

  31. Hymes KB, Greene JB, Marcus A, William DC, Cheung T, Prose NS, et al. Kaposi’s sarcoma in homosexual men – a report of eight cases. Lancet. 1981;2(8247):598–600.

    Article  CAS  PubMed  Google Scholar 

  32. Sampathkumar K, Muralidharan U, Kannan A, Ramakrishnan M, Ajeshkumar R. Childhood Bartter’s syndrome: an Indian case series. Indian J Nephrol. 2010;20(4):207–10.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  33. NEJM Author Center: images in clinical medicine. http://www.nejm.org/page/author-center/images-in-clinical-medicine. Accessed 28 Feb 2016.

  34. BMJ Minerva Pictures. http://www.bmj.com/about-bmj/resources-authors/article-types. Accessed 28 Feb 2016.

  35. Clinical Pictures. Lancet. Information for authors. http://www.thelancet.com/pb/assets/raw/Lancet/authors/lancet-information-for-authors.pdf. Accessed 28 Feb 2016.

  36. CMAJ Submission guidelines: clinical images. http://www.cmaj.ca/site/authors/preparing.xhtml#practiceImages. Accessed 28 Feb 2016.

  37. Tung MKY, Healy S. Cannon A waves. N Engl J Med. 2016;374:e4.

    Article  PubMed  Google Scholar 

  38. Strohl M, Packer C. When asthma is not asthma. JGIM clinical images. 2015. http://www.sgim.org/web-only/clinical-images/when-asthma-is-not-asthma. Accessed 23 Feb 2016.

  39. Khatri A, Naeger Murphy N, Wiest P, Osborn M, Garber K, Hecker M, et al. Community-acquired pyelonephritis in pregnancy caused by KPC-producing Klebsiella pneumoniae. Antimicrob Agents Chemother. 2015;59:4375–8.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  40. Arias CA, Rice LB. A new AAC section: translating resistance to the bedside. Antimicrob Agents Chemother. 2015;59:4365.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Clifford D. Packer MD .

Rights and permissions

Reprints and permissions

Copyright information

© 2017 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Packer, C.D. (2017). Special Considerations. In: Writing Case Reports. Springer, Cham. https://doi.org/10.1007/978-3-319-41899-5_8

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-41899-5_8

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-41898-8

  • Online ISBN: 978-3-319-41899-5

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics