Abstract：
OBJECTIVE: To compare patient discomfort and immobilisation performance of open-face and closed immobilization masks in cranial radiotherapy.
METHODS: This was a single-center randomized self-controlled clinical trial. At CT simulation, an open-face and closed mask was made for each patient and treatment plans with identical dose prescription were generated for each mask. Patients were randomised to start treatment with an open-face or closed mask. Masks were switched halfway through the treatment course; every patient was their own control. Patients self-reported discomfort, anxiety and pain using the visual analogue scale (VAS). Inter- and intrafraction set-up variability was measured with planar kV imaging and a surface guided radiotherapy (SGRT) system for the open-face masks.
RESULTS: 30 patients with primary or metastatic brain tumors were randomized - 29 completed radiotherapy to a median total dose of 54 Gy (range 30-60 Gy). Mean discomfort VAS score was significantly lower with open-face masks (0.5, standard deviation 1.0) vs. closed masks (3.3, standard deviation 2.9), P < 0.0001. Anxiety and pain VAS scores were significantly lower with open-face masks (P < 0.0001). Closed masks caused more discomfort in infraorbital (P < 0.001) and maxillary (P = 0.02) areas. Two patients and 27 patients preferred closed or open-face masks, respectively. Interfraction longitudinal shifts and roll and yaw rotations were significantly smaller and lateral shifts were significantly larger with closed masks in combination with the laser system (P < 0.05) compared to open masks in combination with a SGRT system. Intrafraction variability did not differ between the masks.
CONCLUSIONS: Open-face masks are associated with decreased patient discomfort without compromising patient positioning and immobilisation accuracy.
METHODS: This was a single-center randomized self-controlled clinical trial. At CT simulation, an open-face and closed mask was made for each patient and treatment plans with identical dose prescription were generated for each mask. Patients were randomised to start treatment with an open-face or closed mask. Masks were switched halfway through the treatment course; every patient was their own control. Patients self-reported discomfort, anxiety and pain using the visual analogue scale (VAS). Inter- and intrafraction set-up variability was measured with planar kV imaging and a surface guided radiotherapy (SGRT) system for the open-face masks.
RESULTS: 30 patients with primary or metastatic brain tumors were randomized - 29 completed radiotherapy to a median total dose of 54 Gy (range 30-60 Gy). Mean discomfort VAS score was significantly lower with open-face masks (0.5, standard deviation 1.0) vs. closed masks (3.3, standard deviation 2.9), P < 0.0001. Anxiety and pain VAS scores were significantly lower with open-face masks (P < 0.0001). Closed masks caused more discomfort in infraorbital (P < 0.001) and maxillary (P = 0.02) areas. Two patients and 27 patients preferred closed or open-face masks, respectively. Interfraction longitudinal shifts and roll and yaw rotations were significantly smaller and lateral shifts were significantly larger with closed masks in combination with the laser system (P < 0.05) compared to open masks in combination with a SGRT system. Intrafraction variability did not differ between the masks.
CONCLUSIONS: Open-face masks are associated with decreased patient discomfort without compromising patient positioning and immobilisation accuracy.
摘要：
目的：比较头颅放疗中患者的不适感和开放性和封闭式固定面罩的固定表现。
方法：这是一项单中心随机自我对照临床试验。在CT模拟中,为每位患者制作了开放式和封闭式面罩,并为每个面罩制定了相同剂量处方的治疗计划.患者被随机分配开始使用开放式或封闭式口罩进行治疗。在治疗过程的中途更换了口罩；每个患者都是自己的对照组。患者自我报告不适，使用视觉模拟量表（VAS）进行焦虑和疼痛。使用平面kV成像和表面引导放射治疗（SGRT）系统测量了帧间和帧内设置的变异性。
结果：30例原发性或转移性脑肿瘤患者被随机分配-29例完成放疗，中位总剂量为54Gy（范围30-60Gy）。使用开放式口罩的平均不适感VAS评分显着降低（0.5，标准偏差1.0）与封闭面罩(3.3，标准偏差2.9)，P<0.0001。使用开放式面罩的焦虑和疼痛VAS评分显著降低(P<0.0001)。闭合面罩在眶下（P<0.001）和上颌（P=0.02）区域引起更多不适。两名患者和27名患者更喜欢闭式或开放式口罩，分别。与与SGRT系统组合的开放式面罩相比,在与激光系统组合的封闭式面罩的情况下(P<0.05),分数间纵向移动以及滚动和偏航旋转显著更小,并且横向移动显著更大。掩模之间的内交变异性没有差异。
结论：在不影响患者定位和固定准确性的情况下，开放式面罩可降低患者的不适感。
方法：这是一项单中心随机自我对照临床试验。在CT模拟中,为每位患者制作了开放式和封闭式面罩,并为每个面罩制定了相同剂量处方的治疗计划.患者被随机分配开始使用开放式或封闭式口罩进行治疗。在治疗过程的中途更换了口罩；每个患者都是自己的对照组。患者自我报告不适，使用视觉模拟量表（VAS）进行焦虑和疼痛。使用平面kV成像和表面引导放射治疗（SGRT）系统测量了帧间和帧内设置的变异性。
结果：30例原发性或转移性脑肿瘤患者被随机分配-29例完成放疗，中位总剂量为54Gy（范围30-60Gy）。使用开放式口罩的平均不适感VAS评分显着降低（0.5，标准偏差1.0）与封闭面罩(3.3，标准偏差2.9)，P<0.0001。使用开放式面罩的焦虑和疼痛VAS评分显著降低(P<0.0001)。闭合面罩在眶下（P<0.001）和上颌（P=0.02）区域引起更多不适。两名患者和27名患者更喜欢闭式或开放式口罩，分别。与与SGRT系统组合的开放式面罩相比,在与激光系统组合的封闭式面罩的情况下(P<0.05),分数间纵向移动以及滚动和偏航旋转显著更小,并且横向移动显著更大。掩模之间的内交变异性没有差异。
结论：在不影响患者定位和固定准确性的情况下，开放式面罩可降低患者的不适感。
