基于患者出射EPID剂量验证的在体调强放疗质控技术研究

背景与目的：调强放疗（intensity-modulated radiation therapy，IMRT）中剂量投照失误可导致严重后果，而目前常用的治疗前计划验证方法并不能反映患者真实投照剂量。实现一种评估患者在体剂量执行准确度的方法，能够在分次治疗中及时发现较大剂量错误，避免发生患者投照剂量过高或不足。方法：复旦大学附属肿瘤医院收治的患者首次实施治疗前行锥形束计算机断层成像（cone beam computed tomography，CBCT）扫描，与定位CT图像进行配准保证治疗体位与模拟定位时一致，实时治疗中使用电子射野影像装置（electronic portal imaging device，EPID）获取患者出射剂量影像，并把首次出射EPID影像作为剩余分次治疗的基准值，后续分次实时治疗野结束后快速将其出射EPID影像与对应基准影像进行γ分析比较，以验证治疗计划是否准确执行于患者身上。设计模体实验对治疗部位错误和摆位误差情况进行分析，来评估本方法识别放疗差错的准确性。结果：本方法可有效地识别出IMRT放疗中患者治疗部位错误和非平行于射野角度方向的摆位误差，但对平行于射野角度方向的摆位误差并不敏感，30例鼻咽癌患者临床应用结果中能够直观显示分次治疗间摆位重复性情况。结论：基于EPID实现的一种在体剂量验证方法能够对调强放疗中患者实时剂量的准确性进行评估，在单个治疗野结束后可快速检测出较大治疗错误。     

药品审评检查机构质量管理体系建设实践探索

目的:贯彻国务院强化质量管理、落实全国药监部门完善自身质量管理体系工作部署,梳理山东省药品审评检查机构质量管理体系建设情况,总结经验、查找不足,加强审评检查质量管理。方法:调研药品审评检查机构导入质量管理体系的现实意义,剖析山东省药品审评检查机构质量管理体系建设的实践经验,思考存在的问题。结果:行之有效的质量管理体系对药品审评检查机构规范化建设和药品审评检查发展起到了积极的推动作用。结论:药品审评检查机构推进质量管理体系建设,对规范自身建设、提高工作质量、降低业务风险、服务医药产业发展具有重要作用,也是必然要求,药品审评检查机构质量管理体系需要持续改进,逐渐与国际接轨。     

Re-engineering the interpretation of electronic fetal monitoring to identify reversible risk for cerebral palsy: a case control series

Background: Even key opinion leaders now concede that electronic fetal monitoring (EFM) cannot reliably identify fetal acidemia which many vouch as the only labor mediated pathophysiologic precursor for cerebral palsy (CP). We have developed the “Fetal Reserve Index” – an algorithm combining five dynamic components of EFM (1. Rate, 2. Variability, 3. Accelerations, 4. Decelerations, and 5. Excessive uterine activity) considered individually that are combined with the presence of: 6. maternal, 7. obstetrical, and 8. fetal risk factors.

Objective: Here, we compare this 8-point fetal reserve index (FRI) against the performance of ACOG monograph criteria and ACOG Category systems for predicting risk for both CP and the need for emergency operative delivery (EOD). We then studied how varied management for screen positives (Red zone-defined below) impacts the outcome of such cases.

Study design: Four hundred twenty term patients were studied: all entered labor with normal EFMs and no apparent cause of harm except events of labor and delivery. Sixty subsequently developed CP, and 360 were apparently normal controls. An FRI, normal on all eight parameters scored 100%, 4 of the 8 was 50%, etc. We divided cases into Green zone >50%, Yellow 50–26%, and Red ≤25%. An FRI in the Red zone was considered a positive screen. We then compared performance metrics for the three evaluation schemes and differences between controls that reached Red against those controls whose worst scores were Green/Yellow.

Results: For detection of injury during labor, the FRI performed much better than the ACOG Category criteria (sensitivity 28%), and Category III (45%) (p?Conclusions: FRI shows better discrimination for adverse fetal outcome and EOD than traditional EFM interpretation. The Category system is a very poor, subjective screening method as the vast majority of CP babies never reach the “action point” result of Category III. While reaching the Red zone does not ordain a bad outcome, how it is managed, does. Compared to CP cases, Red controls were delivered faster, had higher FRIs, and often had prompt management including IR maneuvers, which improved the FRI and lowered the risk of EODs even for cases with normal outcomes. With further study and validation, the quantitative FRI approach may replace the current, very subjective interpretation with a quantitative “lab test” approach.     

Life-threatening cardiac arrhythmia and sudden death during electronic gaming: An international case series and systematic review

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Mixed-mode versus paper surveys for patient-reported outcomes after critical illness: A randomised controlled trial

ObjectiveThe aim of the study was to determine the response rate to a mixed-mode survey using email compared with that to a paper survey in survivors of critical illness.DesignThis is a prospective randomised controlled trial.SettingThe study was conducted at a single-centre quaternary intensive care unit (ICU) in Adelaide, Australia.ParticipantsStudy participants were patients admitted to the ICU for ≥48 h and discharged from the hospital.InterventionsThe participants were randomised to receive a survey by paper (via mail) or via online (via email, or if a non-email user, via a letter with a website address). Patients who did not respond to the initial survey received a reminder paper survey after 14 days. The survey included quality of life (EuroQol-5D-5L), anxiety and depression (Hospital Anxiety and Depression Scale), and post-traumatic symptom (Impact of Event Scale-Revised) assessment.Main outcome measuresSurvey response rate, extent of survey completion, clinical outcomes at different time points after discharge, and survey cost analysis were the main outcome measures. Outcomes were stratified based on follow-up time after ICU discharge (3, 6, and 12 months).ResultsA total of 239 patients were randomised. The response rate was similar between the groups (mixed-mode: 78% [92/118 patients] vs. paper: 80% [97/121 patients], p = 0.751) and did not differ between time points of follow-up. Incomplete surveys were more prevalent in the paper group (10% vs 18%). The median EuroQol-5D-5L index value was 0.83 [0.71–0.92]. Depressive symptoms were reported by 25% of patients (46/187), anxiety symptoms were reported by 27% (50/187), and probable post-traumatic stress disorder was reported by 14% (25/184). Patient outcomes did not differ between the groups or time points of follow-up. The cost per reply was AU$ 16.60 (mixed-mode) vs AU$ 19.78 (paper).ConclusionThe response rate of a mixed-mode survey is similar to that of a paper survey and may provide modest cost savings.     

Distribution and Surgical Management of Visceral Ewing Sarcoma Among Children and Adolescents

IntroductionEwing sarcoma (EWS) is a highly malignant tumor of bone and soft tissue that occasionally arises from viscera. Visceral EWS (V-EWS) is challenging to manage given its varied organ distribution and often late-stage presentation. We aimed to characterize our institutional experience with V-EWS, focusing on its surgical management, and to compare V-EWS outcomes against those with osseous (O-EWS) and soft tissue EWS (ST-EWS).MethodsRetrospective review of all EWS patients ≤21 years presenting to a single institution between 2000 and 2022. Patient- and disease-specific characteristics were compared. Overall and relapse-free survival were estimated using Kaplan Meier methods and log-rank test.Results156 EWS patients were identified: 117 O-EWS, 20 ST-EWS, and 19 V-EWS. V-EWS arose in the kidney (n = 5), lung (n = 5), intestine (n = 2), esophagus (n = 1), liver (n = 1), pancreas (n = 1), adrenal gland (n = 1), vagina (n = 1), brain (n = 1), and spinal cord (n = 1). No significant demographic differences were detected between EWS groups. V-EWS was more frequently metastatic at presentation (63.2%; p = 0.005), yet no significant overall or relapse-free survival differences emerged between EWS groups, with similar follow-up intervals. While V-EWS required multiple unique operative strategies to gain primary control, no significant difference in treatment strategies appeared between groups. Surgery-only primary control was associated with improved overall and relapse-free survival in all groups.ConclusionsV-EWS presents unique management challenges in children and adolescents given its variable sites of origin. This large cohort is the first to describe the surgical management and outcomes of V-EWS, demonstrating more frequent metastatic presentation, while achieving similar survival across groups.Level of evidenceLevel 2 – Cohort Study.