A prospective picture collection study for a grading atlas of radiation dermatitis for clinical trials in head-and-neck cancer patients
A prospective picture collection study for a grading atlas of radiation dermatitis for clinical trials in head-and-neck cancer patients
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头颈癌患者放射性皮炎分级图谱的前瞻性图片采集研究
DOI：
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发表时间：
2016
影响因子：
2
通讯作者：
Y. Uchitomi
中科院分区：
文献类型：
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作者：
S. Zenda;Y. Ota;H. Tachibana;H. Ogawa;S. Ishii;C. Hashiguchi;T. Akimoto;Y. Ohe;Y. Uchitomi
放射性皮炎是放疗和放化疗最常见的急性毒性之一。许多临床试验已使用不良事件通用术语标准版本评估了毒性水平。 4.03。该标准仅在单个句子中说明严重性，并且没有可用的视觉分类指南。因此，存在研究者个人主观解释的风险。这与血液学毒性的情况形成鲜明对比，可以客观地解释。这项前瞻性图片收集研究的目的是开发一种分级工具，用于确定临床试验中放射性皮炎的严重程度。四个参与癌症中心总共招募了 118 名计划接受确定性或术后放疗或放化疗的患者。我们组所有研究人员在相同的拍摄条件下使用相同型号的相机，以保持一致的摄影质量。总共收集了 1600 张照片。其中100幅作品进入第一轮评选，由六位专家进行评分，基本按照CTCAE ver.1进行评分。 4.03（JCOG 日语版本）。经过进一步研究，选取38张照片作为1-4级放射性皮炎的典型模型；根据这些照片制作了放射性皮炎分级图谱。该图集将在确保参与试验的机构之间的皮炎评级系统保持一致方面发挥重要作用。我们希望这有助于提高临床试验的质量，也有助于提高常规临床实践水平。
Radiation dermatitis is one of the most common acute toxicities of both radiotherapy and chemoradiotherapy. Many clinical trials have evaluated the level of toxicity using the Common Terminology Criteria for Adverse Events ver. 4.03. This criterion accounts for severity in a single sentence only, and no visual classification guide has been available. Thus, there is a risk of subjective interpretation by the individual investigator. This contrasts with the situation with hematologic toxicities, which can be interpreted objectively. The aim of this prospective picture collection study was to develop a grading tool for use in establishing the severity of radiation dermatitis in clinical trials. A total of 118 patients who were scheduled to receive definitive or postoperative radiotherapy or chemoradiotherapy were enrolled from the four participating cancer centers. All researchers in our group used the same model of camera under the same shooting conditions to maintain consistent photographic quality. In all, 1600 photographs were collected. Of these, 100 photographs qualified for the first round of selection and were then graded by six experts, basically in accordance with the CTCAE ver. 4.03 (JCOG ver. in Japanese). After further study, 38 photographs were selected as representing typical models for Grade 1–4 radiation dermatitis; the radiation dermatitis grading atlas was produced from these photographs. The atlas will play a major role in ensuring that the dermatitis rating system is consistent between the institutions participating in trials. We hope that this will contribute to improving the quality of clinical trials, and also to improving the level of routine clinical practice.
影响因子：
158.5
作者：
Bernier, J;Domenge, C;van Glabbeke, M
通讯作者：
van Glabbeke, M
影响因子：
158.5
作者：
Forastiere, AA;Goepfert, H;Cooper, J
通讯作者：
Cooper, J
影响因子：
45.3
作者：
Adelstein, DJ;Li, Y;Forastiere, AA
通讯作者：
Forastiere, AA