Quality management

质量管理
  • 文章类型: Journal Article
    背景和研究目的低质量结肠镜检查增加癌症风险,但测量质量仍然具有挑战性。我们开发了一个自动化的,使用机器学习(ML)的结肠镜检查质量(AI-CQ)的交互式评估。方法根据质量方针,为AI开发选择的指标包括插入时间(IT)、退出时间(WT),息肉检出率(PDR),每次结肠镜检查(PPC)和息肉。还开发了两个新的度量:HQ-WT(具有清晰图像的戒断期间的时间)和WT-PT(戒断时间减去息肉切除时间)。使用自监督视觉转换器对未标记的结肠镜检查图像进行预训练,然后在另一个互斥的结肠镜检查图像数据集上进行多标签分类。除了使用基于Web的应用程序的原始视频之外,还向临床医生提供了视频预测和度量计算的时间表。该模型在第二医院使用50个结肠镜检查进行了外部验证。结果AI-CQ识别盲肠插管的准确率为88%。IT(P=0.99)和WT(P=0.99)在手动和AI-CQ测量之间高度相关,中位数差异为1.5秒和4.5秒,分别。AI-CQPDR与手动PDR没有显着差异(47.6%对45.5%,P=0.66)。在95.2%的结肠镜检查中正确识别了后屈体,在100%的结肠镜检查中正确识别了右结肠评估的数量。总部-WT占45.9%,与WT时间显著相关(P=0.85)。结论结肠镜检查技能的交互式AI评估可以自动评估质量。我们建议可以利用此工具来快速识别和培训需要补救的提供商。
    Background and study aims Low-quality colonoscopy increases cancer risk but measuring quality remains challenging. We developed an automated, interactive assessment of colonoscopy quality (AI-CQ) using machine learning (ML). Methods Based on quality guidelines, metrics selected for AI development included insertion time (IT), withdrawal time (WT), polyp detection rate (PDR), and polyps per colonoscopy (PPC). Two novel metrics were also developed: HQ-WT (time during withdrawal with clear image) and WT-PT (withdrawal time subtracting polypectomy time). The model was pre-trained using a self-supervised vision transformer on unlabeled colonoscopy images and then finetuned for multi-label classification on another mutually exclusive colonoscopy image dataset. A timeline of video predictions and metric calculations were presented to clinicians in addition to the raw video using a web-based application. The model was externally validated using 50 colonoscopies at a second hospital. Results The AI-CQ accuracy to identify cecal intubation was 88%. IT ( P = 0.99) and WT ( P = 0.99) were highly correlated between manual and AI-CQ measurements with a median difference of 1.5 seconds and 4.5 seconds, respectively. AI-CQ PDR did not significantly differ from manual PDR (47.6% versus 45.5%, P = 0.66). Retroflexion was correctly identified in 95.2% and number of right colon evaluations in 100% of colonoscopies. HQ-WT was 45.9% of, and significantly correlated with ( P = 0.85) WT time. Conclusions An interactive AI assessment of colonoscopy skill can automatically assess quality. We propose that this tool can be utilized to rapidly identify and train providers in need of remediation.
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  • 文章类型: Journal Article
    背景和研究目的国际指南推荐实时观看(RTV)在胶囊内镜胃排空监测,然而,它在临床实践中经常被忽视。我们旨在评估不完全小肠胶囊内镜(SBCE)的危险因素,并评估RTV实施的临床相关性和成本效益。方法我们纳入了2013年至2020年的连续SBCE。未按本地协议应用RTV。我们使用多变量逻辑回归来识别不完全SBCE的危险因素,包括延长的胃通过时间(GTT)和延长的小肠通过时间(SBTT)。结果分析858个SBCE,我们观察到完成率为94.6%。长期GTT和SBTT分别占完整SBCE的4.9%和18.2%,在13%(P=0.03)和10.8%(P=0.24)的不完全SBCE中,分别。只有0.7%(858个中的6个)的SBCE不完全,GTT延长。在单变量和多变量分析中,可改变的(延长GTT比值比[OR]2.9;95%置信区间[CI]1.1~7.5)和两个不可改变的危险因素(住院状态OR2.3;95%CI1.1~4.5)和不完全SBCE病史(OR4.2;95%CI1.3~13.7)与较高的不完全SBCE率独立相关.在有和没有不可改变的危险因素的患者中,预测试完成概率分别为90.5%和95.8%。分别为(P<0.01)。系统的RTV采用和前动力学管理的直接成本为5059欧元,旨在识别和治疗与不完全SBCE相关的延长GTT的每一例。结论现代设备使不完整的SBCE变得罕见,通常与延长的GTT无关。在低发病率的情况下,RTV的广泛使用带来了高成本和不确定的效果。
    Background and study aims International guidelines recommend real-time viewing (RTV) in capsule endoscopy for gastric emptying monitoring, yet it is often overlooked in clinical practice. We aimed to assess risk factors for incomplete small bowel capsule endoscopy (SBCE) and evaluate the clinical relevance and cost-effectiveness of RTV implementation. Methods We included consecutive SBCEs from 2013 to 2020. RTV was not applied per local protocol. We used multivariate logistic regression to identify risk factors for incomplete SBCE, including prolonged gastric transit time (GTT) and prolonged small bowel transit time (SBTT). Results Analyzing 858 SBCEs, we observed a completion rate of 94.6%. Prolonged GTT and SBTT were present in 4.9% and 18.2% of complete SBCEs, and in 13% ( P =0.03) and 10.8% ( P =0.24) of incomplete SBCEs, respectively. Only 0.7% (6 of 858) had incomplete SBCE with prolonged GTT. In both univariate and multivariate analysis, a modifiable (prolonged GTT odds ratio [OR] 2.9; 95% confidence interval [CI] 1.1-7.5) and two unmodifiable risk factors (inpatient status OR 2.3; 95% CI 1.1-4.5) and history of incomplete SBCE (OR 4.2; 95% CI 1.3-13.7) were independently linked to higher incomplete SBCE rates. The pretest completion probability was 90.5% and 95.8% in patients with and without unmodifiable risk factors, respectively ( P <0.01). The direct cost of systematic RTV adoption and prokinetics administration would be €5059, aiming to identify and treat each case of prolonged GTT associated with incomplete SBCE. Conclusions Modern devices make incomplete SBCE rare, usually not tied to prolonged GTT. In a low-incidence scenario, widespread RTV use brings high costs and uncertain effectiveness.
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  • 文章类型: Journal Article
    这项研究的主要目的是通过指导清单(HOKLAS016-02和HOKLAS021)定量确定香港实验室认可计划(HOKLAS015)要求的覆盖范围。
    HOKLAS016-02和HOKLAS021对HOKLAS015的符合性要求覆盖水平是根据HOKLAS015中的符合性要求通过评估清单计算得出的。还进行了与国际标准ISO15189:2012基于过程的质量管理体系模型相关的一致性要求的分布分析,以获取进一步的覆盖信息。
    发现HOKLAS016-02覆盖率为76%,而发现HOKLAS021覆盖率为11%。还发现HOKLAS015与国际标准ISO15189:2012基于过程的质量管理体系模型相关的分销覆盖率为78%。
    本分析结果对希望通过了解HOKLAS016-02和HOKLAS021提供的承保范围而保持HOKLAS015所要求的内部可审计性的医学实验室具有价值。
    UNASSIGNED: The primary aim of this study was to determine quantitatively the extent of coverage of the Hong Kong Laboratory Accreditation Scheme (HOKLAS 015) requirements by guidance checklists (HOKLAS 016-02 and HOKLAS 021).
    UNASSIGNED: The level of conformance requirement coverage of HOKLAS 015 by HOKLAS 016-02 and HOKLAS 021 was calculated by an evaluation checklist based on conformance requirements in HOKLAS 015. A distribution analysis of conformance requirements relating to the International Standard ISO 15189:2012 process-based quality management system model was also performed to elicit further coverage information.
    UNASSIGNED: HOKLAS 016-02 was found to provide coverage of 76% while HOKLAS 021 was found to provide coverage of 11%. HOKLAS 015 was also found to have a distribution coverage of 78% relating to the International Standard ISO 15189:2012 process-based quality management system model.
    UNASSIGNED: The results of this analysis should be of value to medical laboratories wishing to maintain the internal auditability required by HOKLAS 015 by gaining an awareness of the extent of coverage provided by HOKLAS 016-02 and HOKLAS 021.
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  • 文章类型: Journal Article
    必须记录医学实验室活动的许多方面,以促进维持持续的服务质量。因此,许多文件,生成表单和报告。必须指定这些中的每一个的保留时间。除了医学实验室报告作为患者病历的一部分,医学实验室必须根据国家立法或专业组织的指导保留许多文件和标本,如果这些存在。如果不是,实验室管理层需要定义一个保留时间表,其中应定义储存条件和储存期限,根据ISO15189:2022要求保留一般质量管理文件和记录。EFLM认证和ISO/CEN标准工作组在此提供了基于故障模式-效应分析(FMEA)基于风险的方法的文档和样本保留期的建议。降低风险的概念已成为现代标准的组成部分。
    Many aspects of the activity of a medical laboratory have to be documented so as to facilitate the maintenance of the ongoing quality of service. As a consequence, many documents, forms and reports are generated. The retention time for each of these has to be specified. In addition to medical laboratory reports as part of the patient\'s medical record, the medical laboratory has to retain many documents and specimens according to national legislation or guidance from professional organizations, if these exist. If not, the laboratory management needs to define a retention schedule, which shall define the storage conditions and period of storage, according to ISO 15189:2022 requirements for retention of general quality management documents and records. The EFLM Working Group on Accreditation and ISO/CEN standards provides here a proposal on retention periods of documentation and specimens based on a failure-mode-effects-analysis (FMEA) risk-based approach, a concept of risk reduction that has become an integral part of modern standards.
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  • 文章类型: Journal Article
    本研究通过对患者对牙科护理的满意度进行全面分析,解决了文献中的差距。
    方法:通过将定量和定性调查方法与PSQ相结合,这项研究旨在通过更全面地描述患者的满意度来增强正在进行的活动,以增强牙科患者的体验。
    结果:当被问及他们的总体满意度时,77.1%的患者表示他们从办公室人员那里得到了出色的服务,72.2%的患者表示他们信任他们的医生。
    结论:在牙科服务质量领域评估患者满意度对于提高服务质量和准确性至关重要。这对病人和牙医都有好处,最终,改善公众健康。
    This research addresses a gap in the literature by conducting a comprehensive analysis of patients\' level of satisfaction with dental care.
    METHODS: By combining quantitative and qualitative survey methods with a PSQ, this study aims to augment ongoing initiatives to enhance dental patients\' experiences by painting a more comprehensive depiction of patients\' level of satisfaction.
    RESULTS: When asked about their overall level of satisfaction 77.1% of the patients said that they received excellent services from office personnel and 72.2% said they trust their doctors.
    CONCLUSIONS: Assessing patient satisfaction in the realm of dental service quality is crucial for enhancing service quality and accuracy, which would benefit both patients and dentists and, ultimately, improve public health.
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  • 文章类型: Journal Article
    免疫细胞化学(ICC)是诊断性细胞病理学中广泛可用且广泛使用的辅助方法,在所有测试阶段都具有很大的变异性,并且适当的质量管理水平较低。现在,随着新的欧洲(EU)体外诊断医疗器械法规(IVDR)的引入,非标准化的ICC格局受到了挑战。根据这个条例,细胞切片上的ICC属于实验室开发测试(LDT)类别,这需要严格的标准化,验证,全面的质量管理。由于方法的复杂性和不断发展的抗体,不可能完全标准化ICC中的分析前和分析步骤。检测系统,和平台。然而,类似于免疫组织化学(IHC)的方法,改进和规范质量管理中的“最佳实践”将导致高质量,正确,准确,和可靠的ICC结果。以与患者样品相同的方式制备的对照载玻片,优化的ICC协议和参与ICC的外部质量控制是良好质量管理的支柱,对于确保安全可靠的患者诊断至关重要。在这次审查中,将讨论当前免疫细胞化学(ICC)在诊断细胞病理学中的挑战,以及对ICC标准化和验证的实际见解。
    BACKGROUND: Immunocytochemistry (ICC) is a widely available and extensively used ancillary method in diagnostic cytopathology with great variability in all test phases and a low level of adequate quality management. The non-standardized ICC landscape is now challenged with the introduction of the new European (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR). According to this regulation, ICC on cytological slides falls under the category of Laboratory-Developed Tests (LDT), which requires rigorous standardization, validation, and thorough quality management.
    CONCLUSIONS: Complete standardization of pre-analytical and analytical steps in ICC is impossible due to the complexity of the method and the constantly evolving antibodies, detection systems, and platforms. However, similar to the approach in immunohistochemistry, improving and standardizing \"best practices\" in quality management will result in high-quality, correct, accurate, and reliable ICC results. In this review, the current challenges of ICC in diagnostic cytopathology will be discussed, along with practical insights into ICC standardization and validation.
    CONCLUSIONS: Control slides prepared in the same manner as the patient samples, optimized ICC protocols, and participation in external quality control for ICC are the pillars of good quality management and essential to ensure safe and reliable patient diagnostics.
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    求助全文

  • 文章类型: Journal Article
    尽管有各种术前干预措施,但肠道准备不足仍然很常见。需要在结肠镜检查时进行干预以对抗不良的准备。在这次回顾中,46例患者的观察性研究,我们评估了实施第三代Pure-VuEVS系统的临床疗效和可行性,美国食品和药物管理局批准的基于超范围的程序内清洁装置,在明尼阿波利斯VA医学中心(明尼阿波利斯,明尼苏达,美国)。为了研究临床疗效,我们在使用该设备之前和之后测量了肠道准备的充分性,根据波士顿肠道准备评分,并回顾了结肠镜检查监测间隔建议。通过手术成功率和持续时间来衡量使用该设备的技术成功和可行性。我们发现使用该设备时,BBPS得分从4.4增加到7.9。技术成功率为78.3%(36/46例)。结肠镜检查的中位持续时间为46分钟,尽管随着时间的推移,程序有缩短的趋势。这是第三代术中清洁装置的首次临床评估。我们发现该设备有效且易于使用,程序故障率低,但它确实有一个学习曲线。我们怀疑采用该设备将使患者和卫生系统相互受益,并有可能提高资源利用率。
    Inadequate bowel preparation is common despite various preprocedure interventions. There is a need for an intervention at the time of colonoscopy to combat poor preparation. In this retrospective, observational study of 46 patients, we evaluated the clinical efficacy and feasibility of implementing the third generation of the Pure-Vu EVS System, a US Food and Drug Administration-cleared over-the-scope-based intraprocedural cleansing device, into our practice at the Minneapolis VA Medical Center (Minneapolis, Minnesota, United States). To study clinical efficacy, we measured bowel preparation adequacy before and after using the device, as measured by the Boston Bowel Preparation Score, and reviewed colonoscopy surveillance interval recommendations. Technical success and feasibility of using the device were measured by procedure success rates and duration. We found that BBPS scores increased from 4.4 to 7.9 when using the device. Technical success was achieved 78.3% of the time (36/46 cases). Median colonoscopy duration was 46 minutes, although there was a trend toward shorter procedures over time. This is the first clinical evaluation of the third generation of an intraprocedural cleansing device. We found the device efficacious and easy to use with low procedure failure rates, but it does come with a learning curve. We suspect that adoption of this device mutually will benefit patients and health systems with the potential to improve resource utilization.
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  • 文章类型: Journal Article
    开展遗传咨询质量管理,重要的是要知道遗传咨询的确切含义以及参与者是谁。“遗传咨询”一词最早由里德在1947年定义。它描述了一个处理遗传事实和社会心理方面的交流过程,是一个教育过程,也是。它总是在个人和家庭问题的背景下被理解,与优生学无关。1975年,美国人类遗传学会特设委员会发表了更详细的描述。随着人类遗传学新诊断技术和方法的发展,遗传咨询的要求及其内容发生了变化。今天,遗传咨询师必须应用诊断,预测性,易感性,药物遗传学,承运人,产前,和植入前测试,以及基因筛查。德国人类基因检查法(基因诊断法)和国家和国际协会建议将基因检测嵌入到遗传咨询。根据作者的经验,举例说明了遗传咨询中的一些陷阱,因为有如此多的个人情况和要求,似乎不可能进行质量管理。然而,德国人类遗传学家专业协会的遗传咨询和临床遗传学质量委员会于2018年开始了一项试点环试验,在给定的咨询情况下.任务是在包含所有必要问题的清单的帮助下撰写人类遗传学评论。评估是在事先建立的标准目录和根据个人情况调整的分数的帮助下进行的。第一个真正的试点试验于2020年启动。它代表了遗传咨询质量管理的可能性。
    To carry out quality management of genetic counseling, it is important to know what genetic counseling exactly means and who the players are. The term \"genetic counseling\" was first defined by Reed in 1947. It describes a communication process dealing with genetic facts and psychosocial aspects and is an education process, too. It has always been understood in the context of individual and family problems, and is unrelated to eugenics. In 1975 the Ad Hoc Committee of the American Society of Human Genetics published a more detailed description. With the development of new diagnostic techniques and methods in human genetics, the requirements of genetic counseling and its contents changed. Today a genetic counselor has to apply diagnostic, predictive, susceptibility, pharmacogenetic, carrier, prenatal, and preimplantation testing, as well as genetic screening. The German Human Genetic Examination Act (Genetic Diagnosis Act - GenDG) and national and international associations recommend to embed genetic testing into genetic counseling. Based on experiences of the author, some examples of pitfalls in genetic counseling are illustrated, as there are so many individual situations and requests that it seems impossible to carry out quality management. Nevertheless, the Commission for Quality in Genetic Counseling and Clinical Genetics of the Professional Association of German Human Geneticists started a pilot ring trial in 2018 with a given counseling situation. The task was to write the human genetics comment with the help of a checklist containing all issues necessary. The evaluation was conducted with the help of a catalogue of criteria which had been established beforehand and a score adjusted to the individual situation. The first genuine pilot trial was launched in 2020. It represents a possibility for quality management in genetic counseling.
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  • 文章类型: Journal Article
    德国和奥地利新生儿筛查针对先天性原发性甲状腺功能减退症(CH)和先天性肾上腺增生(CAH)。对于这两种疾病,有质量改进的登记处,基于长期患者随访的标准化观察数据,在DGKED研究小组的主持下。到2021年9月,CH注册中心HypoDOK包括来自1,840名患者的23,348次访问的数据集。CAH注册表包含来自1,976名患者的36,237次访问的数据集。这里,我们报告招聘过程,患者特征,以及注册管理机构的研究贡献,并强调注册是改善患者护理和预后的重要工具。因此,应将罕见疾病的登记处视为一项重要的公共卫生措施,并应将其充分制度化和供资。
    Congenital primary hypothyroidism (CH) and congenital adrenal hyperplasia (CAH) are targeted by the German and Austrian newborn screening. For both diseases, there are registries for quality improvement, based on standardized observational data from long-term patient follow-up, under the auspices of the DGKED study group. By September 2021, the CH registry HypoDOK includes datasets from 23,348 visits of 1,840 patients, and the CAH registry contains datasets from 36,237 visits of 1,976 patients. Here, we report on the recruitment process, patient characteristics, and research contributions from the registries, and underline that the registries are an important tool to improve patient care and outcomes. Registries for rare conditions should thus be considered as an important public health measure and they should be adequately institutionalized and funded.
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  • 文章类型: Journal Article
    结肠镜检查通常用于诊断结直肠疾病,但可能与高度焦虑和不适有关。这可能导致镇静期间的并发症和降低患者的舒适度和合作。这项研究是在卡拉奇的三级护理医院进行的,目的是评估音乐疗法对手术前焦虑的有效性。镇静要求,疼痛,接受结肠镜检查的患者的手术时间。这项比较研究包括110名门诊患者。在结肠镜检查之前和期间,介入手臂通过耳机接收非抒情的轻柔音乐,而对照组没有收到任何音乐。在干预臂中,术前焦虑评分显著降低(p<0.001),生理指标(p<0.001),镇静剂量(p<0.001),和手术持续时间(p<0.05)。对照臂显示心率和收缩压增加(p<0.001)。两组的疼痛评分相似。音乐疗法是减少患者术前焦虑的有效工具。这是一个简单的,安全,和非侵入性放松干预,可在结肠镜检查之前和期间用作镇静药物的辅助手段。
    A colonoscopy is a procedure commonly used for the diagnosis of colorectal diseases but may be associated with high levels of anxiety and discomfort, which can lead to complications during sedation and decreased patient comfort and cooperation. This study was conducted at a tertiary care hospital in Karachi to assess the effectiveness of music therapy on pre-procedural anxiety, sedation requirements, pain, and procedure duration among patients undergoing colonoscopies. This comparative study included 110 outpatients. The intervention arm received non-lyrical soft music through earphones before and during the colonoscopy procedure, while the control group did not receive any music. In the intervention arm, significant reductions were seen in pre-procedural anxiety scores (p < 0.001), physiological measures (p < 0.001), sedation doses (p < 0.001), and procedure durations (p < 0.05). Control arm showed an increase in heart rate and systolic blood pressure (p < 0.001). Pain scores were similar for both groups. Music therapy is an effective tool to reduce patient anxiety pre- procedure. It is a simple, safe, and noninvasive relaxing intervention that could be used as an adjunct to sedative medications before and during the colonoscopy procedure.
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