Placebo-controlled trials in pediatric urology: A cautionary view from an ethical perspective

Journal of Pediatric Urology

Volumn 6, Issue 5, 2010, Pages 435-442

  Braga, Luis H P ^a   Bagli, Darius J ^b   Lorenzo, Armando J ^b  

^a MCMASTER UNIVERSITY   (Canada)

^b HOSPITAL FOR SICK CHILDREN   (Canada)

Author keywords

Children; Consent form; Ethics; Narrative review; Placebo; Randomized clinical trials

Indexed keywords

ERYTHROPOIETIN; ONDANSETRON; PLACEBO; SODIUM AUROTHIOSULFATE;

ANEMIA; CHEMOTHERAPY INDUCED EMESIS; CHILD ADVOCACY; CHILD UROLOGY; CHRONIC KIDNEY FAILURE; CLINICAL PRACTICE; CLINICAL RESEARCH; DISEASE ASSOCIATION; DRUG APPROVAL; HUMAN; INTERVENTION STUDY; MEDICAL ETHICS; MORALITY; PHYSICIAN; PLACEBO EFFECT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SCIENTIFIC LITERATURE; TREATMENT FAILURE; TUBERCULOSIS;

ETHICS, RESEARCH; HELSINKI DECLARATION; HUMANS; PEDIATRICS; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; UROLOGY;

EID: 77956620315     PISSN: 14775131     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpurol.2010.02.208     Document Type: Review

References (36)

1. B. Welk, K. Afshar, and A.E. MacNeily Randomized controlled trials in pediatric urology: room for improvement J Urol 176 2006 306 309
2. E.J. Emanuel, R.A. Crouch, J.D. Arras, J.D. Moreno, and C. Grady Ethical and regulatory aspects of clinical research 2004 The Johns Hopkins University Press Baltimore, Maryland
3. B. Freedman Placebo-controlled trials and the logic of clinical purpose IRB 12 1990 1 6
4. N. Aksu, O. Yavacan, M. Kangin, O.D. Kara, Y. Aydin, and H. Erdoan Postnatal management of infants with antenatally detected hydronephrosis Pediatr Nephrol 20 2005 1253 1259
5. K. Ismaili, F.E. Avni, A. Piepsz, K.M. Wissing, P. Cochat, and D. Aubert Current management of infants with fetal renal pelvis dilation: a survey by French-speaking pediatric nephrologists and urologists Pediatr Nephrol 19 2004 966 971
6. L. Alconcher, and M. Tombesi Mild antenatal hydronephrosis: management controversies Pediatr Nephrol 19 2004 819 820
7. M. Woodward, and D. Frank Postnatal management of antenatal hydronephrosis BJU Int 89 2002 149 156
8. D. Misra, S.T. Kempley, and M.F. Hird Are patients with antenatally diagnosed hydronephrosis being over-investigated and overtreated? Eur J Pediatr Surg 9 1999 303 306
9. G. Williams, and J. Craig Antibiotics for the prevention of urinary tract infection in children: a systemic review of randomized controlled trials J Pediatr 138 2001 868 874
10. M. Pennesi, L. Travan, L. Peratoner, A. Bordugo, A. Cattaneo, and L. Ronfani North East Italy prophylaxis in VUR study group. Is antibiotic prophylaxis in children with vesicoureteral reflux effective in preventing pyelonephritis and renal scars? A randomized, controlled trial Pediatrics 121 2008 1489 1494
11. G. Roussey-Kesler, V. Gadjos, N. Idres, B. Horen, L. Ichay, and M.D. Leclair Antibiotic prophylaxis for the prevention of recurrent urinary tract infection in children with low grade vesicoureteral reflux: results from a prospective randomized study J Urol 179 2008 674 679
12. E.H. Garin, F. Olavarria, V. Garcia Nieto, B. Valenciano, A. Campos, and L. Young Clinical significance of primary vesicoureteral reflux and urinary antibiotic prophylaxis after acute pyelonephritis: a multicenter, randomized, controlled study Pediatrics 117 2006 626 632
13. S.H. Song, S.B. Lee, Y.S. Park, and K.S. Kim Is antibiotic prophylaxis necessary in infants with obstructive hydronephrosis? J Urol 177 2007 1098 1101
14. T.J. Polascik, K.M. Chan-Tack, R.D. Jeffs, and J.P. Gearhart Reappraisal of the role of human chorionic gonadotropin in the diagnosis and treatment of the nonpalpable testis: a 10-year experience J Urol 156 1996 804 806
15. P.J. Cohen Failed to conduct a placebo-controlled trial may be unethical Am J Bioeth 2 2002 24
16. R. Keren RIVUR trial. Introduction Pediatrics 5 Suppl. 122 2008 S231 S232
17. R. Keren, M.A. Carpenter, A. Hoberman, N. Shaikh, T.K. Matoo, and R.W. Chesney Rationale and design issues of the randomized intervention for children with vesicoureteral reflux (RIVUR) study Pediatrics 5 Suppl. 122 2008 S240 S250
18. S.P. Greenfield, R.W. Chesney, M. Carpenter, M. Moxey-Mims, L. Nyberg, and A. Hoberman Vesicoureteral reflux: the RIVUR study and the way forward J Urol 179 2008 405 407
19. J.C. Craig, J.M. Simpson, G.J. Williams, A. Lowe, G.J. Reynolds, and S.J. McTaggart Prevention of recurrent urinary tract infection in children with vesicoureteric reflux and normal renal tracts (PRIVENT) investigators. Antibiotic prophylaxis and recurrent urinary tract infection in children N Engl J Med 361 2009 1748 1759
20. R. Temple, and S.S. Ellemberg Placebo-controlled trials and active-control trials in the evaluation of new treatments, part 1: ethical and scientific issues Ann Intern Med 133 2000 455 463
21. D.A. Husmann Use of sympathetic alpha antagonists in the management of pediatric urologic disorders Curr Opin Urol 4 2006 277 282
22. S.A. Kramer, S.R. Rathbun, D. Elkins, R.J. Karnes, and D.A. Husmann Double-blind placebo controlled study of alpha-adrenergic receptor antagonists (doxazosin) for treatment of voiding dysfunction in the pediatric population J Urol 173 2005 2121 2124
23. S. Yucel, E. Akkaya, E. Guntekin, E. Kukul, S. Akman, and M. Melikoglu Can alpha-blocker therapy be an alternative to biofeedback for dysfunctional voiding and urinary retention? A prospective study J Urol 174 2005 1612 1615
24. National placebo initiative. Final report of the national placebo working committee on the appropriate use of placebos in clinical trials in Canada 2004 Canadian Institutes of Health Research
25. C. Weijer, and P.B. Miller When are research risks reasonable in relation to anticipated benefits? Nat Med 10 2004 570 573
26. P.S. Appelbaum, and C.W. Lidz Twenty-five years of therapeutic misconception Hastings Cent Rep 38 2008 5 6
27. P.S. Appelbaum Clinical practice. Assessment of patients' competence to consent to treatment N Engl J Med 357 2007 1834 1840
28. R. Klitzman, I. Albala, J. Siragusa, J. Patel, and P.S. Appelbaum Disclosure of information to potential subjects on research recruitment web sites IRB 30 2008 15 20
29. B. Freedman, C. Weijer, and K.C. Glass Placebo orthodoxy in clinical research I: empirical and methodological myths J Law Med Ethics 24 1996 243 251 (Pubitemid 126434957)
30. P.F. Austin, G. Ferguson, Y. Yan, M.J. Campigotto, M.E. Royer, and D.E. Coplen Combination therapy with desmopressin and an anticholinergic medication for nonresponders to desmopressin for monosymptomatic nocturnal enuresis: a randomized, double-blind, placebo-controlled trial Pediatrics 122 2008 1027 1032
31. T. Nevéus, and K. Tullus Tolterodine and imipramine in refractory enuresis; a placebo-controlled crossover study Pediatr Nephrol 23 2008 263 267
32. C.R. Sumner, K.J. Schuh, V.K. Sutton, R. Lipetz, and D.K. Kelsey Placebo-controlled study of the effects of atomoxetine on bladder control in children with nocturnal enuresis J Child Adolesc Psychopharmacol 16 2006 699 711
33. C.J. Kowaiski Placebo controls: scientific and ethical issues Am J Bioeth 2 2002 33 34
34. K.J. Rothman, and K.B. Michels The continuing unethical use of placebo controls N Engl J Med 331 1994 394 398
35. E.J. Emanuel, and F.G. Miller The ethics of placebo-controlled trials: a middle ground N Engl J Med 345 2001 915 919
36. F.G. Miller, and H. Brody What makes placebo-controlled trials unethical? Am J Bioeth 2 2002 3 9