Optimizing Radiation Therapy Quality Assurance in Clinical Trials: A TROG 08.03 RAVES Substudy
| Autor: | Colin Tang, A. Paneghel, K. Wiltshire, Yuvnik Trada, Andrew Kneebone, Jarad Martin, Carol Fraser-Browne, Maria Pearse, Annette Haworth, Mark Sidhom |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Quality Assurance Health Care medicine.medical_treatment Salvage therapy Radiotherapy Setup Errors Credentialing law.invention Clinical Protocols Randomized controlled trial law medicine Humans Radiology Nuclear Medicine and imaging Medical physics Prostatectomy Salvage Therapy Radiation business.industry Patient Selection Prostatic Neoplasms Radiotherapy Dosage Odds ratio Resubmission Radiography Clinical trial Radiation therapy Benchmarking Oncology Feasibility Studies Radiotherapy Adjuvant Radiotherapy Intensity-Modulated Radiotherapy Conformal business |
| Zdroj: | International Journal of Radiation Oncology*Biology*Physics. 93:1045-1051 |
| ISSN: | 0360-3016 |
| DOI: | 10.1016/j.ijrobp.2015.08.029 |
| Popis: | Purpose To explore site- and clinician-level factors associated with protocol violations requiring real-time-review (RTR) resubmission in a multicenter clinical trial to help tailor future quality assurance (QA) protocols. Methods and Materials RAVES (Radiation Therapy–Adjuvant vs Early Salvage) (Trans-Tasman Radiation Oncology Group 08.03) is a randomized trial comparing adjuvant with early salvage radiation therapy in men with positive surgical margins or pT3 disease after prostatectomy. Quality assurance in RAVES required each clinician and site to submit a credentialing dummy run (DR) and for each patient's radiation therapy plan to undergo external RTR before treatment. Prospectively defined major violations from trial protocol required remedy and resubmission. Site and clinician factors associated with RTR resubmission were examined using hierarchical modeling. Results Data were collected from 171 consecutive patients, treated by 46 clinicians at 32 hospitals. There were 47 RTR resubmissions (27%) due to 65 major violations. The relative rate of resubmission decreased by 29% per year as the study progressed (odds ratio OR. 0.71, P =.02). The majority of resubmissions were due to contouring violations (39 of 65) and dosimetric violations (22 of 65). For each additional patient accrued, significant decreases in RTR resubmission were seen at both clinician level (OR 0.75, P =.02) and site level (OR 0.72, P =.01). The rate of resubmission due to dosimetric violations was only 1.6% after the first 5 patients. Use of IMRT was associated with lower rates of resubmission compared with 3-dimensional conformal radiation therapy (OR 0.38, P =.05). Conclusion Several low- and high-risk factors that may assist with tailoring future clinical trial QA were identified. Because the real-time resubmission rate was largely independent of the credentialing exercise, some form of RTR QA is recommended. The greatest benefit from QA was derived early in trial activation and clinician experience. |
| Databáze: | OpenAIRE |
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