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

被引：10

作者：

Braga, Luis H. P. ^{[1
]}

Bagli, Darius J. ^{[2
]}

Lorenzo, Armando J. ^{[2
]}

机构：

[1] McMaster Univ, Div Pediat Urol, McMasters Children Hosp, Hamilton, ON L8N 3Z5, Canada

[2] Univ Toronto, Hosp Sick Children, Toronto, ON M5S 1A1, Canada

来源：

JOURNAL OF PEDIATRIC UROLOGY | 2010年 / 6卷 / 05期

关键词：

Ethics; Children; Consent form; Placebo; Randomized clinical trials; Narrative review; URINARY-TRACT-INFECTION; ANTIBIOTIC-PROPHYLAXIS; VESICOURETERAL REFLUX; POSTNATAL MANAGEMENT; DOUBLE-BLIND; CHILDREN; INFANTS; HYDRONEPHROSIS; PREVENTION; ENURESIS;

D O I：

10.1016/j.jpurol.2010.02.208

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

The ethical dispute regarding placebo-controlled trials is discussed in this review. Important issues, such as clinical equipoise, fiduciary obligation and middle ground theory, are examined in the context of pediatric urology clinical research. After reviewing the literature, the authors summarize specific indications for placebo-controlled trials in pediatric urology, and emphasize that physicians have ethical and moral obligations to patients, in the sense that one should carefully plan and conduct such trials in order to gain clinically important information without exposing children to undue risks. (C) 2010 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

引用

页码：435 / 442

页数：8

共 36 条

[1] Postnatal management of infants with antenatally detected hydronephrosis [J].

Aksu, N ;

Yavascan, O ;

Kangin, M ;

Kara, OD ;

Aydin, Y ;

Erdogan, H ;

Tuncel, TÇ ;

Çetinkaya, E ;

Özbay, E ;

Sandikçioglu, TG .

PEDIATRIC NEPHROLOGY, 2005, 20 (09) :1253-1259

[2] Mild antenatal hydronephrosis: management controversies [J].

Alconcher, L ;

Tombesi, M .

PEDIATRIC NEPHROLOGY, 2004, 19 (07) :819-820

[3]

Appelbaum PS, 2008, HASTINGS CENT REP, V38, P5

[4] Assessment of patients' competence to consent to treatment [J].

Appelbaum, Paul S. .

NEW ENGLAND JOURNAL OF MEDICINE, 2007, 357 (18) :1834-1840

[5] Combination Therapy With Desmopressin and an Anticholinergic Medication for Nonresponders to Desmopressin for Monosymptomatic Nocturnal Enuresis: A Randomized, Double-Blind, Placebo-Controlled Trial [J].

Austin, Paul F. ;

Ferguson, Genoa ;

Yan, Yan ;

Campigotto, Mary J. ;

Royer, Michele E. ;

Coplen, Douglas E. .

PEDIATRICS, 2008, 122 (05) :1027-1032

[6]

Cohen Peter J., 2002, American Journal of Bioethics, V2, P24, DOI 10.1162/152651602317533604

[7] Antibiotic Prophylaxis and Recurrent Urinary Tract Infection in Children [J].

Craig, Jonathan C. ;

Simpson, Judy M. ;

Williams, Gabrielle J. ;

Lowe, Alison ;

Reynolds, Graham J. ;

McTaggart, Steven J. ;

Hodson, Elisabeth M. ;

Carapetis, Jonathan R. ;

Cranswick, Noel E. ;

Smith, Grahame ;

Irwig, Les M. ;

Caldwell, Patrina H. Y. ;

Hamilton, Sana ;

Roy, Leslie P. .

NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (18) :1748-1759

[8] The ethics of placebo-controlled trials - A middle ground. [J].

Emanuel, EJ ;

Miller, FG .

NEW ENGLAND JOURNAL OF MEDICINE, 2001, 345 (12) :915-919

[9]

Emanuel EzekielJ., 2004, Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary

[10] Placebo orthodoxy in clinical research .1. Empirical and methodological myths [J].

Freedman, B ;

Weijer, C ;

Glass, KC .

JOURNAL OF LAW MEDICINE & ETHICS, 1996, 24 (03) :243-251

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