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肾病患儿生长发育不良研究中的屏蔽程序、随机分组与分层以及依从性监测

Masking procedure, randomization and stratification, and compliance monitoring in the Growth Failure in Children with Renal Diseases Study.

作者信息

Shasky D A, Coppedge S H, Boyle R M, Chan J C

机构信息

Medical College of Virginia, Health Sciences Division of Virginia Commonwealth University, Richmond 23298.

出版信息

J Pediatr. 1990 Feb;116(2):S22-3. doi: 10.1016/s0022-3476(05)82919-1.

DOI:10.1016/s0022-3476(05)82919-1
PMID:2299482
Abstract

Ensuring the integrity of a study such as the GFRD Study requires close cooperation among all groups involved with the study and the patient. Many factors may influence the outcome and validity of a multicenter, double-masked, randomized trial. Any dosage modifications that may need to be made rely totally on established communication between the centers, the DCC, and the Core Pharmacy. When the procedures outlined above are followed, masking is ensured and patient compliance can be measured.

摘要

确保像全球疾病负担研究(GFRD Study)这样的研究的完整性,需要参与研究的所有团队与患者之间密切合作。许多因素可能会影响多中心、双盲、随机试验的结果和有效性。任何可能需要进行的剂量调整完全依赖于各中心、数据协调中心(DCC)和中心药房之间已建立的沟通。当遵循上述程序时,就能确保设盲,并且可以衡量患者的依从性。

相似文献

1
Masking procedure, randomization and stratification, and compliance monitoring in the Growth Failure in Children with Renal Diseases Study.肾病患儿生长发育不良研究中的屏蔽程序、随机分组与分层以及依从性监测
J Pediatr. 1990 Feb;116(2):S22-3. doi: 10.1016/s0022-3476(05)82919-1.
2
A prospective, double-blind study of growth failure in children with chronic renal insufficiency and the effectiveness of treatment with calcitriol versus dihydrotachysterol. The Growth Failure in Children with Renal Diseases Investigators.
J Pediatr. 1994 Apr;124(4):520-8. doi: 10.1016/s0022-3476(05)83128-2.
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Statistical methods and determination of sample size in the Growth Failure in Children with Renal Diseases Study.儿童肾病生长发育不良研究中的统计方法及样本量确定
J Pediatr. 1990 Feb;116(2):S32-6. doi: 10.1016/s0022-3476(05)82922-1.
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Protocol of the Growth Failure in Children with Renal Diseases Study.《儿童肾脏疾病生长发育迟缓研究方案》
J Pediatr. 1990 Feb;116(2):S17-21. doi: 10.1016/s0022-3476(05)82918-x.
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Growth Failure in Children with Renal Diseases Study: an overview from the National Institutes of Health and the Advisory Committee.
J Pediatr. 1990 Feb;116(2):S8-10. doi: 10.1016/s0022-3476(05)82916-6.
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Data coordination and management in the Growth Failure in Children with Renal Diseases Study.
J Pediatr. 1990 Feb;116(2):S28-31. doi: 10.1016/s0022-3476(05)82921-x.
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History and organization of the Growth Failure in Children with Renal Diseases Study.儿童肾病生长发育迟缓研究的历史与组织架构。
J Pediatr. 1990 Feb;116(2):S3-7. doi: 10.1016/s0022-3476(05)82915-4.
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Masking of physicians in the Growth Failure in Children with Renal Diseases Clinical Trial.在儿童肾病生长发育不良临床试验中对医生进行设盲。
Pediatr Nephrol. 1993 Apr;7(2):204-6. doi: 10.1007/BF00864403.
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Rationale of the Growth Failure in Children with Renal Diseases Study.儿童肾病生长发育迟缓研究的基本原理。
J Pediatr. 1990 Feb;116(2):S11-6. doi: 10.1016/s0022-3476(05)82917-8.
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Descriptions of the participating centers and patient population in the Growth Failure in Children with Renal Diseases Study.《儿童肾脏疾病生长发育障碍研究》中参与研究的中心及患者群体描述。
J Pediatr. 1990 Feb;116(2):S24-7. doi: 10.1016/s0022-3476(05)82920-8.

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