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Clinical Investigation

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Pediatric Nephrology

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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.

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Suggested Reading

  • DeAngelis C. Introduction to Clinical Research. New York, Oxford University Press, 1990.

    Google Scholar 

  • Hulley SB, Cummings SR. Designing Clinical Research, 2nd edn. Philadelphia, Lippincott Williams & Wilkins, 2001.

    Google Scholar 

Clinical Epidemiology

  • Gordis L. Epidemiology, 2nd edn. Philadelphia, Saunders, 2000.

    Google Scholar 

  • Fletcher RH, Fletcher SW, Wagner EH. Clinical Epidemiology: The Essentials, 3rd edn. Baltimore, Williams & Wilkins, 1996.

    Google Scholar 

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

    Google Scholar 

Study Design

  • Cook TD, Campbell DT. Quad-Experimentation: Design and Analysis Issues for Field Settings. Boston, Houghton-Mifflin, 1979.

    Google Scholar 

  • Meinert CL. Clinical Trials: Design, Conduct and Analysis. New York, Oxford University Press, 1986.

    Google Scholar 

  • Schiesselman JJ. Case-Control Studies: Design, Conduct, Analysis. New York, Oxford University Press, 1982.

    Google Scholar 

General Statistic References

  • Dawson-Saunders B, Trapp RG. Basic and Clinical Biostatistics, 3rd edn. New York, Lange Medical Books-McGraw-Hill, 2001.

    Google Scholar 

  • Fleiss JL. Statistical Methods for Rates and Proportions. New York, John Wiley & Sons, 1981.

    Google Scholar 

  • Glaser AN. High Yield Biostatistics. Pennsylvania, Williams & Wilkins, 2001.

    Google Scholar 

  • Hollander M, Wolfe DA. Nonparametric Statistical Methods, 2nd edn. New York, Wiley, 1999.

    Google Scholar 

  • Kleinbaum DG, Kupper LL. Applied Regression Analysis and Other Multivariate Methods, 3rd edn. Pacific Grove, Duxbury Press, 1998.

    Google Scholar 

  • Tabachnick BG, Fidel LS. Using Multivariate Statistics, 4th edn. Boston, Allyn and Bacon, 2001.

    Google Scholar 

  • Zar JH. Biostatistical Analysis, 4th edn. Upper Saddle River, NJ, Prentice-Hall, 1999.

    Google Scholar 

References

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

    Google Scholar 

  2. Furth SL, Neu AM, Colombani P et al. Diabetes as a complication of FK506 in pediatric renal transplant patients. Pediatr Nephrol 1990;10:64–6.

    Article  Google Scholar 

  3. Fadrowski JJ, Pierce CB, Cole SR et al. Hemoglobin decline in children with chronic kidney disease: Baseline results from the chronic kidney disease in children prospective cohort study. Clin J Am Soc Nephrol 2008;3:457–62.

    Article  PubMed  CAS  Google Scholar 

  4. Fored CM, Ejerblad E, Lindblad P et al. Acetaminophen, aspirin, and chronic renal failure. N Engl J Med 2001;345:l80l–8.

    Article  Google Scholar 

  5. Furth SL, Cole SR, Moxey-Mims M et al. Design and methods of the chronic kidney disease in children (CKiD) prospective cohort study. Clin J Am Soc Nephrol 2006;1(5):1006–15.

    Article  PubMed  Google Scholar 

  6. Wong CS, Jelacic S, Habeeb RL et al. The risk of the hemolytic-uremic syndrome after antibiotic treatment of Escherichia coli 0157:H7 infections. N Engl J Med 2000;342:1930–6.

    Article  PubMed  CAS  Google Scholar 

  7. Hogg RJ, Lee J, Nardelli N, Julian BA et al. Clinical trial to evaluate omega-3 fatty acids and alternate day prednisone in patients with IgA nephropathy: Report from the Southwest pediatric nephrology group. Clin J Am Soc Nephrol 2006;1:467–74.

    Article  PubMed  CAS  Google Scholar 

  8. Wang R, Lagakos SW, Ware JH et al. Statistics in medicine-reporting of subgroup analyses in clinical trials. N Engl J Med 2007;357(21):2189–94.

    Article  PubMed  CAS  Google Scholar 

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

    Article  Google Scholar 

  10. What is Epi info? Accessed 16 May 2008. Available: htrp://www.cdc.gov/epiinfo/.

  11. U.S. Renal Data System. USRDS 2007 annual data report: Atlas of chronic kidney disease and end-stage renal disease in the United States. Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2007.

    Google Scholar 

  12. North American Pediatric Renal Trials and Collaborative Studies. NAPRTCS 2007 annual report. Accessed 16 May 2008. Available at: https://web.emmes.com/study/ped/annlrept/annlrept.html.

  13. Committee on Quality Improvement, Subcommittee on Urinary Tract Infection. Practice parameter: The diagnosis, treatment, and evaluation of the initial urinary tract infection in febrile infants and young children. Pediatrics 1999;103:843–52.

    Google Scholar 

  14. Filler G, Young E, Geier P et al. Is there really an increase in non-minimal change nephrotic syndrome in children? Am J Kidney Dis 2003;42(6):1107–13.

    Article  PubMed  Google Scholar 

  15. International Sudy 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.

    Google Scholar 

  16. 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 

  17. Sackett DL, Haynes RB, Guyatt GH et al. Clinical Epidemiology: A Basic Science for Clinical Medicine, 2nd edn. Boston, Little, Brown, 1991.

    Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  20. 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  PubMed  CAS  Google Scholar 

  21. 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  PubMed  CAS  Google Scholar 

  22. 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  PubMed  CAS  Google Scholar 

  23. 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  PubMed  CAS  Google Scholar 

  24. 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  PubMed  CAS  Google Scholar 

  25. 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  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  27. 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  PubMed  CAS  Google Scholar 

  28. 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  PubMed  CAS  Google Scholar 

  29. 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  PubMed  CAS  Google Scholar 

  30. 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 

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

    Article  PubMed  CAS  Google Scholar 

  32. 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  PubMed  CAS  Google Scholar 

  33. 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  PubMed  CAS  Google Scholar 

  34. Richardson WS, Wilson 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  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  36. McGinn TG, Guyatt GH, Wyer PC et al. Users’ guides to the medical literature: XXII: how to use articles about clinical decision rules. Evidence-based medicine working group. JAMA 2000;284(1):79–84.

    Article  PubMed  CAS  Google Scholar 

  37. 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  PubMed  CAS  Google Scholar 

  38. Richardson WS, Wilson MC, Williams JW Jr 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  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  Google Scholar 

  41. Guyatt.Users’ guides to the medical literature: essentials of evidence-based clinical practice. Chicago, AMA Press, 2002.

    Google Scholar 

  42. West S, King V, Carey TS et al. Systems to rate the strength of scientific evidence. Evidence report/technology assessment No. 47 (Prepared by the Research Triangle Institute-University of North Carolina Evidence-based Practice Center under Contract No. 290-97-0011). AHRQ publication No. 02-E016. Rockville, MD, Agency for Healthcare Research and Quality. April 2002. Accessed May 2008. Available at: http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1.chapter.70996.

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Authors
  1. Susan L. Furth
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  2. Jeffrey J. Fadrowski
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Editor information

Editors and Affiliations

  1. Medical College of Wisconsin, Wisconsin, USA

    Ellis Avner (Director, Children's Research Institute, CHHS, Associate Dean for Research, Professor of Pediatrics and Physiology) (Director, Children's Research Institute, CHHS, Associate Dean for Research, Professor of Pediatrics and Physiology)

  2. Harvard Medical School, Children's Hospital Boston, 300 Longwood Avenue, Boston, Massachusetts, 02115, USA

    William Harmon (Professor of Pediatrics, Director, Pediatric Nephrology) (Professor of Pediatrics, Director, Pediatric Nephrology)

  3. Service de Néphrologie Pédiatrique Centre de référence des Maladies Rénales Héréditaires de l'Enfant et de l'Adulte (MARHEA), Hôpital Necker‐Enfants Malades, 149, rue de Sèvres, 75743, Paris Cedex 15, France

    Patrick Niaudet

  4. Department of Pediatrics Wakayama Medical University, Wakayama Medical University Hospital, 641–8510811–1, Kimiidera, Wakayama City, Japan

    Norishige Yoshikawa (Professor and Chair Pediatrician‐in‐Chief) (Professor and Chair Pediatrician‐in‐Chief)

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© 2009 Springer-Verlag Berlin Heidelberg

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Furth, S.L., Fadrowski, J.J. (2009). Clinical Investigation. In: Avner, E., Harmon, W., Niaudet, P., Yoshikawa, N. (eds) Pediatric Nephrology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-76341-3_17

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  • DOI: https://doi.org/10.1007/978-3-540-76341-3_17

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-540-76327-7

  • Online ISBN: 978-3-540-76341-3

  • eBook Packages: MedicineReference Module Medicine

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