Structures' validation profiles in Transmission of Imaging and Data (TRIAD) for automated National Clinical Trials Network (NCTN) clinical trial digital data quality assurance.

Transmission of Imaging and Data (TRIAD) is a standard-based system built by the American College of Radiology to provide the seamless exchange of images and data for accreditation of clinical trials and registries. Scripts of structures' names validation profiles created in TRIAD are used in the automated submission process. It is essential for users to understand the logistics of these scripts for successful submission of radiation therapy cases with less iteration.

Real-time pretreatment review limits unacceptable deviations on a cooperative group radiation therapy technique trial: quality assurance results of RTOG 0933.

PURPOSE: RTOG 0933 was a phase II trial of hippocampal avoidance during whole brain radiation therapy for patients with brain metastases. The results demonstrated improvement in short-term memory decline, as compared with historical control individuals, and preservation of quality of life. Integral to the conduct of this trial were quality assurance processes inclusive of pre-enrollment credentialing and pretreatment centralized review of enrolled patients. METHODS AND MATERIALS: Before enrolling patients, all treating physicians and sites were required to successfully complete a "dry-run" credentialing test. The treating physicians were credentialed based on accuracy of magnetic resonance imaging-computed tomography image fusion and hippocampal and normal tissue contouring, and the sites were credentialed based on protocol-specified dosimetric criteria. Using the same criteria, pretreatment centralized review of enrolled patients was conducted. Physicians enrolling 3 consecutive patients without unacceptable deviations were permitted to enroll further patients without pretreatment review, although their cases were reviewed after treatment. RESULTS: In all, 113 physicians and 84 sites were credentialed. Eight physicians (6.8%) failed hippocampal contouring on the first attempt; 3 were approved on the second attempt. Eight sites (9.5%) failed intensity modulated radiation therapy planning on the first attempt; all were approved on the second attempt. One hundred thirteen patients were enrolled in RTOG 0933; 100 were analyzable. Eighty-seven cases were reviewed before treatment; 5 (5.7%) violated the eligibility criteria, and 21 (24%) had unacceptable deviations. With feedback, 18 cases were approved on the second attempt and 2 cases on the third attempt. One patient was treated off protocol. Twenty-two cases were reviewed after treatment; 1 (4.5%) violated the eligibility criteria, and 5 (23%) had unacceptable deviations. CONCLUSIONS: Although >95% of the cases passed the pre-enrollment credentialing, the pretreatment centralized review disqualified 5.7% of reviewed cases, prevented unacceptable deviations in 24% of reviewed cases, and limited the final unacceptable deviation rate to 5%. Thus, pretreatment review is deemed necessary in future hippocampal avoidance trials and is potentially useful in other similarly challenging radiation therapy technique trials.

Compliance with therapeutic guidelines in Radiation Therapy Oncology Group prospective gastrointestinal clinical trials.

BACKGROUND: This report analyzes the adherence to radiation therapy protocol guidelines in contemporary Radiation Therapy Oncology Group (RTOG) gastrointestinal trials. We aim to provide insight into current standards and compliance of radiation therapy field design and administration. METHODS: From 1994 to 2006, the Gastrointestinal Cancer Committee of the RTOG initiated and completed 15 phase I-III clinical trials utilizing radiation therapy in the multimodality treatment of gastrointestinal cancers. In each protocol, details for planning and executing radiation therapy were outlined and each protocol contained scoring criteria for these components of radiation therapy, characterized according to per-protocol, variation acceptable and deviation unacceptable. Review of treatment planning and implementation was performed in all studies following therapy completion. RESULTS: Radiation therapy planning and implementation was reviewed in 2309 of 2312 (99.9%) patients. The mean rate of compliance over all for the 15 protocols was 65% (total of the 2309 analyzed patients). The mean variation acceptable rate was 21% whereas the mean deviation unacceptable rate was 5%. The mean "other" rate (no RT given or incomplete RT due to death, progression or refusal) was 8%. Two of the 15 trials (13%) had deviation unacceptable rates >10%. In four studies incorporating pre-treatment review of radiation therapy planning and treatment, compliance with protocol therapy was enhanced. CONCLUSIONS: The fidelity of radiation planning and execution detailed in protocol to actual therapy is heterogeneous, with a mean per-protocol rate of 65%. As clinical trials evolve, available technology should permit efficient pre-treatment review processes, thus facilitating compliance to protocol therapy. These analyses should also permit prospective analysis of outcome measures by compliance to therapy.

Afetividade e fluência na interação empresarial: um estudo sobre mediação

A partir de conflito interpessoal entre gestores de empresa de médio porte, esta pesquisa realiza estudo de caso com objetividade de investigar os reflexos da meditação na influência de interação e na afetividade dentro da empresa, enfocando 19 participantes, em três níveis: diretoria, equipe da diretoria e coordenadores. Tem como sustentação teórica às abordagens de mediação: Tradicional de Harvard; Transformativa; Narrativo-Circular e Facilitação, delineadas a partir do modelo dos sistemas dinâmicos da Teoria da complexidade. Após caracterização inicial da empresa, utiliza-se de técnicas de pre-mediação, mediação e facilitação em grupo, analisando-as qualitativamente. Com preocupação sobre racionalidade dos resultados sobre os reflexos do trabalho de mediação, compõe questionário sobre influencia de interação e afetividade na empresa, QFI. Os resultados do questionário comprovam os da analise da mediação, sendo que 51 por cento dos funcionários assinalam alterações positivas na interação e na afetividade na empresa como um todo. Os pontos nevrálgicos, apontados pelos participantes como reformulados na mediação referem-se a: Autoritarismo; Muita Pressão; Falta Transparência; Co-responsável; Cisão entre as áreas Administrativas e técnicas (Cisão AA-AT); Centralizada e Escuta Insuficiente. Os dados indicam uma abertura sistêmica na tomada de consciência dos conflitos, associada a uma maior responsabilidade conjunta em tentar resolvê-los, através do gerenciamento integrado e dinâmico de competências individuais, intra e inter-grupais na empresa. O estudo considera, portanto, que a mediação pode ser vista como uma abordagem alternativa de resolução de conflitos, com resultados positivos ao meio organizacional. Devido ao fato de as técnicas de mediação não estarem ainda muito difundidas em nossa realidade, recomenda a necessidade de novas pesquisas, diversificando seu foco em empresas de vários tamanhos e segmentos (AU)