Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05)

Roos, D. E., Davis, S. R., Turner, S. L., OBrien, P. C., Spry, N. A., Burmeister, B. H., Hoskin, P. J. and Ball, D. L. (2003) Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05). Radiotherapy And Oncology, 67 2: 207-212. doi:10.1016/S0167-8140(03)00026-4


Author Roos, D. E.
Davis, S. R.
Turner, S. L.
OBrien, P. C.
Spry, N. A.
Burmeister, B. H.
Hoskin, P. J.
Ball, D. L.
Title Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05)
Journal name Radiotherapy And Oncology   Check publisher's open access policy
ISSN 0167-8140
Publication date 2003-05
Sub-type Article (original research)
DOI 10.1016/S0167-8140(03)00026-4
Volume 67
Issue 2
Start page 207
End page 212
Total pages 6
Editor Dr J Overgaard
Place of publication Ireland
Publisher Elsevier Ireland Ltd
Collection year 2003
Language eng
Subject C1
321023 Radiotherapy and Nuclear Medicine
730108 Cancer and related disorders
Abstract Background and purpose: Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270). Materials and methods: Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol. Results: Only one patient was found conclusively not to have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than +/- 10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P = 0.44). Conclusions: QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation. Crown Copyright (C) 2003 Published by Elsevier Science Ltd. All rights reserved.
Keyword Oncology
Radiology, Nuclear Medicine & Medical Imaging
Quality Assurance
Randomized
Radiotherapy
Neuropathic Pain
Clinical-trials
Single
Q-Index Code C1

Document type: Journal Article
Sub-type: Article (original research)
Collections: 2004 Higher Education Research Data Collection
School of Medicine Publications
 
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Created: Wed, 15 Aug 2007, 02:38:32 EST