clinical evaluation

临床评价
  • 文章类型: Journal Article
    背景:日常生活活动(ADL)对于独立和个人福祉至关重要,反映个人的功能状态。执行这些任务的障碍会限制自主性并对生活质量产生负面影响。ADL期间的身体功能评估对于运动限制的预防和康复至关重要。尽管如此,其传统的基于主观观察的评价在精确性和客观性方面存在局限性。
    目的:本研究的主要目的是使用创新技术,特别是可穿戴惯性传感器结合人工智能技术,客观准确地评估人类在ADL中的表现。提出了通过实现允许在日常活动期间对运动进行动态和非侵入性监测的系统来克服传统方法的局限性。该方法旨在为早期发现功能障碍和个性化治疗和康复计划提供有效的工具,从而促进个人生活质量的提高。
    方法:要监视运动,开发了可穿戴惯性传感器,其中包括加速度计和三轴陀螺仪。开发的传感器用于创建专有数据库,其中6个动作与肩膀有关,3个动作与背部有关。我们在数据库中注册了53,165个活动记录(包括加速度计和陀螺仪测量),在处理以删除null或异常值后,将其减少到52,600。最后,通过组合各种处理层创建了4个深度学习(DL)模型,以探索ADL识别中的不同方法。
    结果:结果显示了4种提出的模型的高性能,有了准确的水平,精度,召回,所有类别的F1得分在95%至97%之间,平均损失0.10。这些结果表明,模型能够准确识别各种活动,在准确率和召回率之间取得了很好的平衡。卷积和双向方法都取得了稍微优越的结果,尽管双向模型在较少的时间内达到了收敛。
    结论:实现的DL模型表现出了良好的性能,表明识别和分类与肩部和腰部区域相关的各种日常活动的有效能力。这些结果是通过最小的传感器实现的-是非侵入性的,并且实际上对用户来说是不可察觉的-这不会影响他们的日常工作,并促进对连续监测的接受和坚持。从而提高了收集数据的可靠性。这项研究可能对运动受限患者的临床评估和康复产生重大影响,通过提供客观和先进的工具来检测关键的运动模式和关节功能障碍。
    BACKGROUND: Activities of daily living (ADL) are essential for independence and personal well-being, reflecting an individual\'s functional status. Impairment in executing these tasks can limit autonomy and negatively affect quality of life. The assessment of physical function during ADL is crucial for the prevention and rehabilitation of movement limitations. Still, its traditional evaluation based on subjective observation has limitations in precision and objectivity.
    OBJECTIVE: The primary objective of this study is to use innovative technology, specifically wearable inertial sensors combined with artificial intelligence techniques, to objectively and accurately evaluate human performance in ADL. It is proposed to overcome the limitations of traditional methods by implementing systems that allow dynamic and noninvasive monitoring of movements during daily activities. The approach seeks to provide an effective tool for the early detection of dysfunctions and the personalization of treatment and rehabilitation plans, thus promoting an improvement in the quality of life of individuals.
    METHODS: To monitor movements, wearable inertial sensors were developed, which include accelerometers and triaxial gyroscopes. The developed sensors were used to create a proprietary database with 6 movements related to the shoulder and 3 related to the back. We registered 53,165 activity records in the database (consisting of accelerometer and gyroscope measurements), which were reduced to 52,600 after processing to remove null or abnormal values. Finally, 4 deep learning (DL) models were created by combining various processing layers to explore different approaches in ADL recognition.
    RESULTS: The results revealed high performance of the 4 proposed models, with levels of accuracy, precision, recall, and F1-score ranging between 95% and 97% for all classes and an average loss of 0.10. These results indicate the great capacity of the models to accurately identify a variety of activities, with a good balance between precision and recall. Both the convolutional and bidirectional approaches achieved slightly superior results, although the bidirectional model reached convergence in a smaller number of epochs.
    CONCLUSIONS: The DL models implemented have demonstrated solid performance, indicating an effective ability to identify and classify various daily activities related to the shoulder and lumbar region. These results were achieved with minimal sensorization-being noninvasive and practically imperceptible to the user-which does not affect their daily routine and promotes acceptance and adherence to continuous monitoring, thus improving the reliability of the data collected. This research has the potential to have a significant impact on the clinical evaluation and rehabilitation of patients with movement limitations, by providing an objective and advanced tool to detect key movement patterns and joint dysfunctions.
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  • 文章类型: Journal Article
    精确的放射治疗计划对于确保用于放射治疗的成胶质细胞瘤(GBM)的准确分割至关重要。然而,传统的人工分割过程是劳动密集型的,严重依赖放射肿瘤学家的经验。在这项回顾性研究中,提出了一种新的自动分割方法来解决这些问题。为了评估该方法在不同场景中的适用性,我们使用从四个多中心数据集和包括非对比CT在内的回顾性数据收集中抽取的148名合格患者进行了其开发和评估。多序列MRI扫描,和相应的医疗记录.所有患者均经组织学证实为高级别胶质瘤(HGG)。通过利用多模态成像的先验知识,提出了一种基于深度学习的方法(PKMI-Net),用于自动分割GBM的大体肿瘤体积(GTV)和临床目标体积(CTV1和CTV2)。所提出的PKMI-Net在分段方面表现出很高的准确性,分别,GTV,CTV1和CTV2在11名患者的测试集中,Dice相似系数(DSC)为0.94、0.95和0.92;95%Hausdorff距离(HD95)为2.07、1.18和3.95mm;平均表面距离(ASD)为0.69、0.39和1.17mm;相对体积差异(RVD)为5.50%,9.68%,3.97%。此外,绝大多数的GTV,PKMI-Net产生的CTV1和CTV2是临床上可接受的,并且不需要对临床实践进行修订。在我们的多中心评估中,PKMI-Net在各种数据集中表现出一致和强大的泛化能力,证明其在自动分割GBM中的有效性。所提出的多模态成像中使用先验知识的方法可以提高GBM的轮廓精度,这具有提高GBM放射治疗质量和效率的潜力。
    A precise radiotherapy plan is crucial to ensure accurate segmentation of glioblastomas (GBMs) for radiation therapy. However, the traditional manual segmentation process is labor-intensive and heavily reliant on the experience of radiation oncologists. In this retrospective study, a novel auto-segmentation method is proposed to address these problems. To assess the method\'s applicability across diverse scenarios, we conducted its development and evaluation using a cohort of 148 eligible patients drawn from four multicenter datasets and retrospective data collection including noncontrast CT, multisequence MRI scans, and corresponding medical records. All patients were diagnosed with histologically confirmed high-grade glioma (HGG). A deep learning-based method (PKMI-Net) for automatically segmenting gross tumor volume (GTV) and clinical target volumes (CTV1 and CTV2) of GBMs was proposed by leveraging prior knowledge from multimodal imaging. The proposed PKMI-Net demonstrated high accuracy in segmenting, respectively, GTV, CTV1, and CTV2 in an 11-patient test set, achieving Dice similarity coefficients (DSC) of 0.94, 0.95, and 0.92; 95% Hausdorff distances (HD95) of 2.07, 1.18, and 3.95 mm; average surface distances (ASD) of 0.69, 0.39, and 1.17 mm; and relative volume differences (RVD) of 5.50%, 9.68%, and 3.97%. Moreover, the vast majority of GTV, CTV1, and CTV2 produced by PKMI-Net are clinically acceptable and require no revision for clinical practice. In our multicenter evaluation, the PKMI-Net exhibited consistent and robust generalizability across the various datasets, demonstrating its effectiveness in automatically segmenting GBMs. The proposed method using prior knowledge in multimodal imaging can improve the contouring accuracy of GBMs, which holds the potential to improve the quality and efficiency of GBMs\' radiotherapy.
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  • 文章类型: Journal Article
    Dega截骨术越来越广泛地用于治疗发育性髋关节发育不良(DDH)。
    由于许多技术方面尚未完全定义,因此需要对此程序进行全面描述。此外,还需要更多的后续系列来评估其结果。
    在这项研究中,我们对该手术进行了详细的解剖学描述,并介绍了我们作为回顾性影像学和病例记录研究的经验.我们检查了44例(48髋)不同程度的DDH患者的临床和影像学记录。
    患者平均年龄为2个月和7个月,平均随访时间为41个月。进行了临床和影像学评估,包括CT和3D重建以检查截骨术的解剖特征。我们发现同心减少了93.7%,具有出色的临床和影像学结果。只有3例需要修正Dega截骨术。再次手术率为12.5%。CT扫描显示,在大多数情况下,截骨穿过弓形线。在20.7%的病例中,我们发现,原本打算做Dega截骨术的骨切口,在不经意间被实施为另一种截骨术变体.然而,这对结果没有显著影响。
    我们发现,实施良好的Dega截骨术是应对DDH髋臼变化的可靠工具。
    UNASSIGNED: Dega osteotomy is becoming more widely used for the treatment of developmental dysplasia of the hip (DDH).
    UNASSIGNED: A thorough description of this procedure is needed as many of the technical aspects are not fully defined. Moreover, more follow-up series are also needed to evaluate its outcomes.
    UNASSIGNED: In this study, we gave a detailed anatomic description for this procedure and also presented our experience as a retrospective radiographic and case-note study. We examined the clinical and radiographic records of 44 patients (48 hips) with varying degrees of DDH.
    UNASSIGNED: The average age of the patients was 2 months and 7 months while the average follow up period was 41 months. Clinical and radiographic assessment including CT with 3D reconstruction to examine the anatomic characteristics of the osteotomy were undertaken. We found that concentric reduction was achieved in 93.7% with excellent clinical and radiographic outcomes. Only 3 cases needed revision of the Dega osteotomy. The re-operation rate was 12.5%. CT scan revealed that the arcuate line was crossed by the osteotomy in the majority of cases. In 20.7% of cases, a bone cut that was intended to be a Dega osteotomy was found to have been inadvertently implemented as another osteotomy variant. However, this bore no significant effect on the outcome.
    UNASSIGNED: We found that a well-implemented Dega osteotomy is a reliable tool to cope with the acetabular changes in DDH.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Editorial
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  • 文章类型: English Abstract
    从技术评价的角度来看,本研究综述了近年来市场上液相色谱-串联质谱检测医疗器械产品的应用现状和临床应用情况。这些产品在中国的监管要求,美国,欧盟和日本进行了对比分析,以及上市后不良事件的监测情况,参考标准和国内外规范性文件相结合,对该产品的临床应用和监管风险进行分析。预处理等问题,系统匹配,性能指标要求的充分性,房间间的一致性,讨论了参考间隔和注册单位,并提出了监督建议,着眼于产品研发和生产领域,为监理审批提供技术参考。
    From the perspective of technical evaluation, this study reviewed the current situation of application and clinical application of medical device products were detected by liquid chromatography-tandem mass spectrometry in the market in recent years. The regulatory requirements of these products in China, USA, EU and Japan were compared and analyzed, and the monitoring situation of adverse events after listing, the standards for reference and the domestic and foreign regulatory documents were combined, the clinical application and regulatory risks of the product were analyzed. The problems such as pre-treatment, system matching, adequacy of performance index requirements, inter-room consistency, reference interval and registration unit were discussed and suggestions for supervision were given, with a view to the field of product R&D and production, review and approval of supervision to provide technical reference.
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  • 文章类型: Observational Study
    背景:评估运动质量和功能测试的临床方法对临床医生很重要。在正向降压测试(FSDT)的临床试验中,与正常运动学的典型偏差是骨盆倾斜和髋关节内收,这与膝盖疼痛的风险有关。
    目的:(1)检查FSDT的临床评估与骨盆关节角度测量之间的相关性,臀部,男性和女性的膝关节和踝关节;(2)检查被评为良好的个体之间的关节角度差异,在FSDT性能测试中公平或较差。
    方法:使用二维数码摄像机对92名进行FSDT的健康个体进行视频录制。两名经验丰富的物理治疗师将FSDT的临床评估评为良好,公平,或基于Crossley等人的穷人。(2011)验证量表。骨盆滴的测量,使用ImageJ软件采集髋关节内收和膝关节外翻。
    结果:在177个下肢中,74(每条肢体37条)在临床上被评为“良好/一般”(41.80%),而103(优势腿52条,非优势腿51条)被评为“差”(58.19%)。在FSDT的临床评级中,优势腿和非优势腿之间或男性和女性之间没有观察到显着差异。在男性和女性中,与优势腿和非优势腿的“良好/正常”相比,“差”的临床评分明显较高,髋关节内收角度明显较低(p<0.001)。女性表现出更高的骨盆下降,与男性相比,髋关节内收较低,膝关节外翻角度较高(p<0.05)。
    结论:这项研究表明,FSDT的临床评分与关节角度测量值相关,表明该评估可用于临床实践。FSDT质量表现较差的个体表现出更高的骨盆下垂和髋关节内收运动。进一步的研究检查具有不同疾病或病理的不同人群是必不可少的。
    BACKGROUND: Clinical methods for assessing quality of movement and functional tests are important to clinicians. Typical deviations from normal kinematics during the clinical test of Forward Step Down Test (FSDT) are pelvic tilt and hip adduction which are associated with the risk of knee pain.
    OBJECTIVE: (1) to examine the correlation between clinical assessment of the FSDT and joint angle measurements of pelvis, hip, knee and ankle joints in males and females; (2) to examine the differences in joint angles between individuals rated as good, fair or poor in a FSDT performance test.
    METHODS: Ninety-two healthy individuals performing FSDT were video-taped with two-dimensional digital video cameras. The clinical assessment of the FSDT was rated by two experienced physical therapists as good, fair, or poor based on a Crossley et al. (2011) validated scale. Measurements of pelvic drop, hip adduction and knee valgus were taken using Image J software.
    RESULTS: Out of 177 lower limbs, 74 (37 in each limb) were clinically rated as \"good/fair\" (41.80%) while 103 (52 in the dominant leg and 51 in the non-dominant leg) were rated as \"poor\" (58.19%). No significant differences were observed between dominant and non-dominant legs or between males and females in clinical rating of the FSDT. Pelvic drop angle was significantly higher and hip adduction angle was significantly lower for \"poor\" clinical rating compared to \"good/fair\" in both dominant and non-dominant legs (p < 0.001) in males and females. Females demonstrated higher pelvic drop, lower hip adduction and higher knee valgus angles compared with males (p < 0.05).
    CONCLUSIONS: This study showed that the clinical rating of FSDT is correlated with joint angle measurements suggesting that this assessment can be utilized in clinical practice. Individuals with poor quality performance of FSDT showed higher pelvic drop and hip adduction movement. Further studies examining different populations with diverse disorders or pathologies are essential.
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  • 文章类型: Journal Article
    背景:经皮椎体后凸成形术(PKP)或经皮短节段固定术(PSSF)通常用于治疗Kummell病。然而,尚不清楚哪种治疗对患者更好。
    目的:回顾性比较PVP和PSSF治疗Kummell病的临床疗效。
    方法:60例患者参与了这项研究,随访时间至少为2年。其中27人用PVP治疗(I组),其余人接受PSSF治疗(II组)。术前和1周测量了每个参与者的视觉模拟量表(VAS)和影像学指标,3个月,术后2年。此外,在最后一个时间点评估Oswestry残疾指数(ODI)评分.
    结果:比较两组,术前所有参数均无统计学意义.I组手术时间和失血量较少,术后各时间点,Ⅱ组影像学指标较低(P<0.05)。治疗后一周,第一组的VAS得分较低,同样,3个月相同(P<0.05),而VAS在最后一个时间点是相似的。在ODI评分方面,在长期随访期间,第二组的水平较低。
    结论:对于Kummell病的治疗,已经发现PVP和PSSF都是有效的。PVP可以以更短的手术时间提供快速的疼痛缓解。然而,在严重后凸畸形的病例中,应优先考虑PSSF。
    BACKGROUND: Percutaneous kyphoplasty (PKP) or percutaneous short-segment fixation (PSSF) is often used to treat Kummell\'s disease. However, it is not clear which treatment is better for patients.
    OBJECTIVE: To retrospectively compare the clinical efficacy of PVP and PSSF for the treatment of Kummell\'s disease.
    METHODS: 60 patients were involved in this research and the period of follow-up was at least 2 years. 27 of them were treated with PVP (Group I) and the rest who received PSSF (Group II). The visual analog scale (VAS) and radiographic indexes of each participant had been measured preoperatively as well as 1 week, 3 months, and 2 years postoperatively. Additionally, the Oswestry Disability Index (ODI) scores were assessed at the last time point.
    RESULTS: Comparing the two groups, no statistical significance was found among all parameters preoperatively. The time of operations and blood loss is less in Group I. At each time point after operation, the imaging indices in Group II are lower (P< 0.05). One week after treatments, the VAS scores are lower in Group I, and similarly, 3 months are the same (P< 0.05), while VAS are similar at the last time point. In the aspect of ODI scores, they are lower in Group II during long-term follow-up.
    CONCLUSIONS: For the treatment of Kummell\'s disease, both PVP and PSSF have been found to be effective. PVP can provide rapid pain relief with a shorter operation time. However, in cases with severe kyphosis deformity, PSSF should be given priority.
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  • 文章类型: Journal Article
    目的:我们的前瞻性研究的目的是评估18F-FDGPET/CT治疗肛管肿瘤2个月后的预后价值。
    方法:连续的经组织学证实的肛门癌患者,包括治疗前和治疗后两个月的18F-FDGPET/CT。患者以前没有接受过这种肿瘤的治疗,然后接受了放疗±化疗。收集临床和病理数据,并进行18F-FDGPET/CT视觉和定量分析(标准化摄取值,代谢体积);根据EORTC和PERCIST标准对反应进行分类。使用log-Rank检验结果评估无病生存率和无局部复发生存率:2014年12月至2019年9月,筛选了94例连续患者,其中78例纳入本研究。中位随访时间为51个月。治疗后两个月,根据EORTC和PERCIST标准,37例患者(47.4%)有完全的放射学反应,66例(84.6%)患者临床完全缓解。为了无疾病生存,在18F-FDGPET/CT和临床检查中,完全缓解的预后价值具有统计学意义(p=0.02)(p<0.001).对于局部无复发生存,18F-FDGPET/CT的预后价值(p=0.04)低于临床检查(p<0.007).
    结论:虽然临床检查仍然是肛门癌治疗后评估的金标准,18F-FDGPET/CT具有统计学意义的预后价值。这两项评估可以结合起来,以改善早期评估。
    OBJECTIVE: The aim of our prospective study was to assess the prognostic value of 18F-FDG PET/CT performed two months post treatment for anal canal neoplasm.
    METHODS: Consecutive patients with histologically proved anal cancer, with 18F-FDG PET/CT pre and two months post treatment were included. Patients were not previously treated for this neoplasm and then received radiotherapy ± chemotherapy. Clinical and pathologic data were collected and for 18F-FDG PET/CT visual and quantitative analysis (standardized uptake value, metabolic volume) were performed; response was classified according to EORTC and PERCIST criteria. The results were assessed for disease free survival and local recurrence free survival using the log-Rank test RESULTS: From December 2014 to September 2019, 94 consecutive patients were screened and 78 were included in this study. Median follow-up was 51 months. Two months post treatment, 37 patients (47.4%) had a complete radiological response according to both EORTC and PERCIST criteria, 66 patients (84.6%) had a clinical complete response. For disease free survival, the prognostic value of complete response was statistically significant (p=0.02) with 18F-FDG PET/CT and with clinical examination (p<0.001). For local recurrence free survival, the prognostic value with 18F-FDG PET/CT was lower (p=0.04) than clinical examination (p < 0.007).
    CONCLUSIONS: While clinical examination remains the gold standard for post treatment evaluation in anal cancer, 18F-FDG PET/CT has a statistically significant prognostic value. These two assessments could be combined to improve early evaluation.
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  • 文章类型: Journal Article
    目的:这项研究的目的是确定低狼疮疾病活动度(LLDAS)和临床缓解(CR)的belimumab联合标准治疗(SoC)治疗是否是儿童期发病的SLE(cSLE)可实现的目标。
    方法:这个多中心,一项干预前后研究在中国15个中心进行.主要终点是描述使用贝利木单抗加SoC治疗后3、6和12个月达到LLDAS和CR的患者比例。使用多元回归模型来估算缺失数据。使用泊松回归模型来计算贝利木单抗治疗对降低严重疾病风险和新损伤发生率的影响。
    结果:来自15个中心的193例(92.2%为女性)患有活动性cSLE。在3、6和12个月时,LLDAS(CR)的比例为12.4%(1.0%),25.6%(4.5%)和70.3%(29.7%),分别。平均SELENA-SLEDAI评分从基线时的11.0下降到第3、6和12个月时的3.7、2.9和1.7。在基线,所有患者均接受类固醇治疗,平均(SD)泼尼松等效剂量为31.0(18.2)mg/天,在第3个月降至19.4(10.8)mg/天,在第6个月降至12.6(7.2)mg/天,在第12个月降至6.7(5.3)mg/天。症状和免疫学指标也明显改善。
    结论:这是中国第一个也是最大样本量的对接受贝利木单抗治疗的cSLE患者的前瞻性临床干预研究。LLDAS和CR是cSLE中belimumab加SoC治疗的目标。
    OBJECTIVE: The aim of this study is to identify whether low lupus disease activity status (LLDAS) and clinical remission (CR) of belimumab plus standard of care (SoC) therapy are achievable goals in childhood-onset SLE (cSLE).
    METHODS: This multicentre, one arm pre-post intervention study was conducted at 15 centres in China. The primary end point was to describe the proportion of patients who achieved LLDAS and CR after 3, 6 and 12 months after treatment with belimumab plus SoC therapy. A multiple regression model was used to impute missing data. A Poisson regression model was used to calculate the effect of belimumab treatment on the reduced risk of serious diseases and the incidence of new damage.
    RESULTS: A total of 193 (92.2% female) with active cSLE from 15 centres were included. At 3, 6 and 12 months, the proportion of LLDAS (CR) was 12.4% (1.0%), 25.6% (4.5%) and 70.3% (29.7%), respectively. The mean SELENA-SLEDAI score decreased from 11.0 at baseline to 3.7, 2.9 and 1.7 at 3, 6 and 12 months. At baseline, all patients received steroids at a mean (s.d.) prednisone equivalent dose of 31.0 (18.2) mg/day, which decreased to 19.4 (10.8) mg/day at month 3, 12.6 (7.2) mg/day at month 6 and 6.7 (5.3) mg/day at month 12. The symptoms and immunological indicators were also significantly improved.
    CONCLUSIONS: This is the first and largest sample size prospective clinical intervention study of cSLE patients treated with belimumab in China. LLDAS and CR were attainable treat-to-target of belimumab plus SoC therapy in cSLE.
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