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

Roos, DE; Davis, SR; Turner, SL; O'Brien, PC; Spry, NA; Burmeister, BH; Hoskin, PJ; (2003) Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05). Radiotherapy And Oncology , 67 (2) pp. 207-212.

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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

Type: Article
Title: Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05)
Additional information: Journal English Article ELSEVIER SCI IRELAND LTD 0 MAY 694WP CLARE Roos DE Royal Adelaide Hosp, Adelaide, SA 5000, Australia RADIOTHER ONCOL CUSTOMER RELATIONS MANAGER, BAY 15, SHANNON INDUSTRIAL ESTATE CO, CLARE, IRELAND
Keywords: ACTIVATION, activity, ADVERSE, ARM, audit, Australia, bone, bone metastases, bone pain, CLINICAL-TRIALS, CO, COHORT, COMMITTEE, Compliance, COMPONENT, CONTROLLED TRIAL, CRITERIA, developing, difference, English, EXPERIENCE, FIELD, fields, Form, fracture, IMPROVEMENT, INDEX, industrial, Ireland, Materials, May, METASTASES, Methods, monitoring, neuropathic, neuropathic pain, ONCOLOGY, ONCOLOGY GROUP, Other, pain, palliative, PAPER, Patient, patients, Protocol, PUBLISHED, QUALITY, Quality assurance, radiation, Radiotherapy, randomized, RANDOMIZED CONTROLLED TRIAL, Result, Science, SINGLE, SITE, target, treatment, TRIAL, TRIALS, verification
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Oncology
URI: http://discovery.ucl.ac.uk/id/eprint/31111
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