Skip to main content

Basics of Clinical Investigation

  • Reference work entry
  • First Online:
Pediatric Nephrology

Abstract

How can we best evaluate, treat, and assess long-term risks for children with kidney disease? Who is at risk of developing end-stage renal disease (ESRD) in childhood or young adulthood? Clinicians are often faced with questions such as these with uncertain answers in the practice of pediatric nephrology. Parents ask, “Why did my child get this disease?” “What is the most effective method to treat this condition?” “What’s the prognosis of this condition in my child?” Frequently, these answers are not known, and these questions are the inspiration for high-quality clinical research. The first step in developing a valuable clinical study is determining whether the initial query can be translated into a good research question.

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

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 949.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 1,299.99
Price excludes VAT (USA)
  • Durable hardcover 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

References

  1. Cook TD, Campbell DT. Quasi’-experimentation: design and analysis issues for field settings. Boston: Houghton Mifflin; 1979.

    Google Scholar 

  2. Porras D, Stein DR, et al. Midaortic syndrome: 30 years of experience with medical, endovascular and surgical management. Pediatr Nephrol. 2013;28:2023–33.

    Article  PubMed  Google Scholar 

  3. Fadrowski JJ, Navas-Acien A, et al. Blood lead level and kidney function in US adolescents. Arch Intern Med. 2010;170:75–82.

    Article  CAS  PubMed  Google Scholar 

  4. Bettinelli A, Vigano C, et al. Phosphate homeostasis in Bartter syndrome: a case-control study. Pediatr Nephrol. 2014. doi:10.1007/s00467-014-2846-z (published online).

    PubMed Central  Google Scholar 

  5. Kupferman JC, Friedman LA, et al. BP control and left ventricular hypertrophy regression in children with CKD. J Am Soc Nephrol. 2014;25:167–74.

    Article  PubMed Central  PubMed  Google Scholar 

  6. ESCAPE Trial Group, Wuhl E, et al. Strict blood-pressure control and progression of renal failure in children. N Engl J Med. 2009;361:1639–50.

    Article  Google Scholar 

  7. Wang R, Lagakos SW, Ware JH, et al. Statistics in medicine – reporting of subgroup analyses in clinical trials. N Engl J Med. 2007;357:2189–94.

    Article  CAS  PubMed  Google Scholar 

  8. Furth SL, Hwang W, et al. Relation between pediatric experience and treatment recommendations for children and adolescents with kidney failure. JAMA. 2001;258:1027–33.

    Article  Google Scholar 

  9. U.S. Renal Data System. USRDS 2013 annual data report: atlas of chronic kidney disease and end-stage renal disease in the United States. Bethesda: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2013.

    Google Scholar 

  10. American Academy of Pediatrics. Subcommittee on Urinary Tract Infection and Steering Committee on Quality Improvement and Management. Urinary tract infection: clinical practice guidelines for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011;128:595–610.

    Article  Google Scholar 

  11. Filler G, Young E, et al. Is there really an increase in non-minimal change nephrotic syndrome in children? Am J Kidney Dis. 2003;42:1107–13.

    Article  PubMed  Google Scholar 

  12. International Study of Kidney Disease in Children. The primary nephrotic syndrome in children Identification of patients with minimal change nephrotic syndrome from initial response to prednisone. A report of the International Study of Kidney Disease in Children. J Pediatr. 1981;98:561–4.

    Article  Google Scholar 

  13. Department of Clinical Epidemiology and Biostatistics, McMaster University. How to read clinical journals. I. Why to read them and how to start reading them critically. Can Med Assoc J. 1981;124:555–8.

    Google Scholar 

  14. Sackett DL, Haynes RB, et al. Clinical epidemiology: a basic science for clinical medicine. 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 1991.

    Google Scholar 

  15. Guyatt GH, Fvennie D. Users’ guides to the medical literature (editorial). JAMA. 1993;270:2096–7.

    Article  CAS  PubMed  Google Scholar 

  16. Oxman AD, Sackett DL, Guyatt GH. Users’ guide to the medical literature: I. How to get started. JAMA. 1993;270:2093–5.

    Article  CAS  PubMed  Google Scholar 

  17. Guyatt GH, Sackett DL, Cook DJ. Users’ guides to the medical literature: II. How to use an article about therapy or prevention A. Are the results of the study valid? JAMA. 1993;270:2598–601.

    Article  CAS  PubMed  Google Scholar 

  18. Guyatt GH, Sackett DL, Cook DJ. Users’ guides to the medical literature: II. How to use an article about therapy or prevention B. What were the results and will they help me in caring for my patients? JAMA. 1994;271:59–63.

    Article  CAS  PubMed  Google Scholar 

  19. Jaeschke R, Guyatt G, Sackett DL. Users’ guide to the medical literature: III. How to use an article about a diagnostic test A. Are the results of the study valid? JAMA. 1994;271:389–91.

    Article  CAS  PubMed  Google Scholar 

  20. Jaeschke R, Guyatt G, Sackett DL. Users’ guide to the medical literature: III. How to use an article about a diagnostic test B. What are the results and will they help me in caring for my patients? JAMA. 1994;271:703–7.

    Article  CAS  PubMed  Google Scholar 

  21. Levine M, Walter S, Lee H, et al. Users’ guide to the medical literature: IV. How to use an article about harm. JAMA. 1994;271:1615–9.

    Article  CAS  PubMed  Google Scholar 

  22. Laupacis A, Wells G, Richardson WS, et al. Users’ guide to the medical literature: V. How to use an article about prognosis. JAMA. 1994;272:234–7.

    Article  CAS  PubMed  Google Scholar 

  23. Oxman AD, Cook DJ, Guyatt GH. Users’ guide to the medical literature: VI. How to use an overview. JAMA. 1994;272:1367–71.

    Article  CAS  PubMed  Google Scholar 

  24. Richardson WS, Detsky AS. Users’ guide to the medical literature: VII. How to use a clinical decision analysis. A. Are the results valid? JAMA. 1995;273:1292–5.

    Article  CAS  PubMed  Google Scholar 

  25. Richardson WS, Detsky AS. Users’ guide to the medical literature: VII. How to use a clinical decision analysis. B. What are the results and how will they help me in caring for my patients? JAMA. 1995;273:1610–3.

    Article  CAS  PubMed  Google Scholar 

  26. Hayward RSA, Wilson MC, Tunis SR, et al. Users’ guide to the medical literature: VIII. How to use clinical practice guidelines. B. What are the recommendations and how will they help you in caring for your patients? JAMA. 1995;274:1630–2.

    Article  PubMed  Google Scholar 

  27. Hayward RSA, Wilson MC, Tunis SR, et al. Users’ guide to the medical literature: VIII. How to use clinical practice guidelines. A. Are the guidelines valid? JAMA. 1995;274:570–4.

    Article  CAS  PubMed  Google Scholar 

  28. Guyatt GH, Sackett DL, Sinclair JC, et al. Users’ guide to the medical literature: IX. A method for grading health care recommendations. JAMA. 1995;274:1800–4.

    Article  CAS  PubMed  Google Scholar 

  29. Naylor CD, Guyatt GH. Users’ guide to the medical literature: X. How to use an article reporting variations in the outcomes of health services. JAMA. 1996;275:554–8.

    Article  CAS  PubMed  Google Scholar 

  30. Dans AL, Dans LF, Guyatt GH, et al. Users’ guides to the medical literature: XIV. How to decide on the applicability of clinical trial results to your patient. Evidence-Based Medicine Working Group. JAMA. 1998;279(7):545–9.

    Article  CAS  PubMed  Google Scholar 

  31. Richardson WS, WiJson MC, Guyatt GH, et al. Users’ guides to the medical literature: XV. How to use an article about disease probability for differential diagnosis. Evidence-Based Medicine Working Group. JAMA. 1999;281(13):1214–9.

    Article  CAS  PubMed  Google Scholar 

  32. Berlin JA, Rennie D. Measuring the quality of trials: the quality of quality scales. JAMA. 1999;282(11):1083–5.

    Article  CAS  PubMed  Google Scholar 

  33. McGinn TG, Guyatt GH, Wyer PC, et al. Users’ guides to die medical literature: XXII. How to use articles about clinical decision rides. Evidence-Based Medicine Working Group. JAMA. 2000;284(1):79–84.

    Article  CAS  PubMed  Google Scholar 

  34. Giacomini MK, Cook DJ. Users’ guides to the medical literature: XXIII. Qualitative research in health care B. What are the results and how do they help me care for my patients? Evidence-Based Medicine Working Group. JAMA. 2000;284(4):478–82.

    Article  CAS  PubMed  Google Scholar 

  35. Richardson WS, Wilson MC, Williams Jr JW, et al. Users’ guides to the medical literature: XXIV. How to use an article on the clinical manifestations of disease. Evidence-Based Medicine Working Group. JAMA. 2000;284(7):869–75.

    Article  CAS  PubMed  Google Scholar 

  36. Shah NR. What is the best evidence for making clinical decisions? JAMA. 2000;284(24):3127–8.

    Article  CAS  PubMed  Google Scholar 

  37. Airman DG. Poor-quality medical research: what can journals do? JAMA. 2002;287(21):2765–7.

    Article  Google Scholar 

  38. Guyatt GH. Users’ guides to the medical literature: essentials of evidence-hosed clinical practice. Chicago: AMA Press; 2002.

    Google Scholar 

  39. Agency for Healthcare Research and Quality. Systems to rate the strength of scientific evidence. AHRQ Publication No. 02-E016. Rockville: Agency for Healthcare Research and Quality; 2002.

    Google Scholar 

Suggested Reading

  • Cook TD, Campbell DT. Quad-experimentation: design and analysis issues for field settings. Boston: Houghron-Mifflin; 1979.

    Google Scholar 

  • Dawson-Saunders B, Trapp RG. Basic and clinical biostatistics. 3rd ed. New York: Lange Medical Books-McGraw-Hill; 2001.

    Google Scholar 

  • DeAngelis C. Introduction to clinical research. New York: Oxford University Press; 1990.

    Google Scholar 

  • Fleiss JL. Statistical methods for rates and proportions. New York: Wiley; 1981.

    Google Scholar 

  • Fletcher RH, Fletcher SW, Wagner EH. Clinical epidemiology: the essentials. 3rd ed. Baltimore: Lippincott Williams & Wilkins; 1996.

    Google Scholar 

  • Glaser AN. High yield biostatistics. Pennsylvania: Lippincott Williams & Wilkins; 2001.

    Google Scholar 

  • Gordis L. Epidemiology. 2nd ed. Philadelphia: Saunders; 2000.

    Google Scholar 

  • Hollander M, Wolfe DA. Nonparametric statistical methods. 2nd ed. New York: Wiley; 1999.

    Google Scholar 

  • Hulley SB, Cummings SR. Designing clinical research. 2nd ed. Philadelphia: Lippincott Williams & Wilkins; 2001.

    Google Scholar 

  • Kleinbaum DG, Kupper LL. Applied regression analysis and other multivariate methods. 3rd ed. Pacific Grove: Duxbury Press; 1998.

    Google Scholar 

  • Lilienfeld AM, Lilienfeld DE. Foundations of epidemiology. 2nd ed. New York: Oxford University Press; 1980.

    Google Scholar 

  • Meinert CL. Clinical trials: design, conduct and analysis. New York: Oxford University Press; 1986.

    Book  Google Scholar 

  • Sacketr DL, Haynes RB, Guyatr GH, et al. Clinical epidemiology: a basic science for clinical medicine. 2nd ed. Boston: Little Brown; 1991.

    Google Scholar 

  • Schiesselman JJ. Case control studies: design, conduct, analysis. New York: Oxford University Press; 1982.

    Google Scholar 

  • Tabachnick BG, Fidel LS. Using multivariate statistics. 4th ed. Boston: Allyn and Bacon; 2001.

    Google Scholar 

  • Zar JH. Biostatistical analysis. 4th ed. Upper Saddle River: Prentice-Hall; 1999.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Susan L. Furth .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2016 Springer-Verlag Berlin Heidelberg

About this entry

Cite this entry

Furth, S.L., Fadrowski, J.J. (2016). Basics of Clinical Investigation. In: Avner, E., Harmon, W., Niaudet, P., Yoshikawa, N., Emma, F., Goldstein, S. (eds) Pediatric Nephrology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-43596-0_15

Download citation

  • DOI: https://doi.org/10.1007/978-3-662-43596-0_15

  • Published:

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-662-43595-3

  • Online ISBN: 978-3-662-43596-0

  • eBook Packages: MedicineReference Module Medicine

Publish with us

Policies and ethics