Adequacy

充分性
  • 文章类型: Journal Article
    目的:评估用于规范儿科研究的国际伦理原则和实践的可比性,作为确定相互尊重国际伦理审查是否可行的第一步。作者先前的研究集中在国际卫生研究的其他方面,例如生物库和直接面向参与者的基因组研究。儿科研究的独特性质及其许多国家的独特法规值得单独研究。
    方法:选择了21个国家的代表性样本,地理上,民族,文化,政治,经济多样性。选择了儿科研究伦理和法律方面的领先专家,以总结每个国家儿科研究的伦理审查。为了确保答复的可比性,研究者编写了一份由5部分组成的美国儿科研究伦理原则摘要,并分发给所有国家代表.国际专家被要求评估和描述他们国家和美国的原则是否一致。结果在2022年春季和夏季获得并汇编。
    结果:一些国家对儿科研究的一个或多个伦理原则的概念化或描述各不相同,但总的来说,研究中的国家表现出基本的一致性。
    结论:21个国家对儿科研究的类似规定表明,国际互惠是一种可行的策略。
    To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study.
    A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022.
    Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance.
    Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.
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  • 文章类型: Journal Article
    背景:目前,在中国,16G和18G针均用于经皮肾活检。本研究旨在比较18G针与18G针进行活检的疗效和安全性。16G针。
    方法:对2015年1月至2019年12月在我院接受经皮肾穿刺活检的患者资料进行回顾性分析。比较了使用16G和18G针进行活检的患者通过穿刺获得的肾小球数量和术后并发症。连续变量通过t检验或Mann-WhitneyU检验进行比较,和分类变量的卡方检验。采用相关性分析探讨不同变量与血肿大小的关系。
    结果:在总共3138例肾脏活检中,2526用18G针进行,612用16G针进行。两组之间获得的肾小球数量没有显着差异(P=0.078)。16G组的大血肿明显多于18G组(9.31%vs.5.98%,P=0.003)。动静脉瘘在16G组中也更常见(1.14%vs.0.23%,P=0.005)。其他并发症很少见,两组发病率相似。
    结论:对于经皮肾活检,18G针与16G针一样有效。使用18G针时,大血肿和动静脉瘘的风险似乎较低。
    BACKGROUND: At present, both 16G and 18G needles are used for percutaneous renal biopsy in China. This study aimed to compare the efficacy and safety of biopsy performed with the 18G needle vs. the 16G needle.
    METHODS: The data of patients who underwent percutaneous renal biopsy at our hospital between January 2015 and December 2019 were retrospectively analyzed. The number of glomeruli obtained by puncture and postoperative complications were compared between patients undergoing biopsy with the 16G and 18G needles. Continuous variables were compared by the t test or the Mann-Whitney U test, and categorical variables by the chi-square test. Correlation analysis was used to examine the relationship of different variables with hematoma size.
    RESULTS: Of the total 3138 kidney biopsies, 2526 were performed with the18G needle and 612 with the 16G needle. The number of glomeruli obtained was not significantly different between the two groups (P = 0.078). Large hematomas were significantly more common the 16G group than in the 18G group (9.31% vs. 5.98%, P = 0.003). Arteriovenous fistula was also more common in the 16G group (1.14% vs. 0.23%, P = 0.005). Other complications were rare, with similar incidence in the two groups.
    CONCLUSIONS: The 18G needle is as effective as the 16G needle for percutaneous renal biopsy. The risk of large hematoma and arteriovenous fistula appear to be lower with the 18G needle.
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  • 文章类型: Journal Article
    本研究旨在确定超声造影(CEUS)对高风险甲状腺结节的细针穿刺(FNA)的临床价值。
    回顾性分析2018年4月至2021年4月期间连续3748个甲状腺结节行FNA。CEUS引导下的FNA(CEUS-FNA)应用于岭南校区115个高风险结节。接受CEUS-FNA检查的10个结节未增强,并将进一步独立分析。其他105个部分或全部增强结节作为CEUS-FNA组,天河校区210个风险较高的结节与US-FNA对照组相匹配。收集FNA样本用于基于液体的制备。根据Bethesda甲状腺细胞病理学报告系统对细胞学结果进行分类。
    我们中心的总体FNA标本不合格率为6.6%。在CEUS下的所有十个非增强结节在细胞病理学分析中的结果都不充分。随后的术后病理和随访超声检查显示,非增强结节是良性或稳定的,没有进一步的恶性特征。CEUS-FNA组高不充分风险甲状腺结节总标本不充分率显著低于US-FNA组(6.7%vs.16.7%,P=0.014)。进一步的分层分析表明,在美国指导下的FNA,囊性疾病的比率不足,主要是囊性的,以固体为主和固体亚组为28.1%,17.1%,10.0%和9.2%(P=0.019)。相比之下,囊性疾病的比率不足,主要是囊性的,以固体为主和固体亚组为7.4%,6.7%,CEUS-FNA组分别为5.6%和6.7%(P=0.996)。
    CEUS可以通过避免非增强结节的不必要的FNA来改善高风险甲状腺结节中FNA的标本充分性。准确定位活组织和实时精确引导。CEUS是FNA指导高风险甲状腺结节的推荐方式。
    This study aims to determine the clinical value of contrast enhanced ultrasound (CEUS) for fine-needle aspiration (FNA) of high inadequate risky thyroid nodules.
    During April 2018 and April 2021, consecutive 3748 thyroid nodules underwent FNA were retrospectively analyzed. CEUS guided FNA (CEUS-FNA) was applied in 115 nodules with high inadequate risk in Lingnan Campus. Ten nodules underwent CEUS-FNA presented non-enhancing, and would be further analyzed independently. Other 105 partial or total enhancing nodules were included as CEUS-FNA group, and 210 nodules with high inadequate risk in Tianhe Campus were match as the US-FNA control group. FNA specimens were collected for liquid-based preparation. Cytological results were classified following the Bethesda System for Reporting Thyroid Cytopathology.
    The overall FNA specimen inadequate rate in our center was 6.6%. All of the ten non-enhancing nodules under CEUS have an inadequate result in cytopathological analyzes. The subsequent postoperative pathology and follow-up ultrasonography showed the non-enhancing nodules were benign or stable without further malignant features. Total specimen inadequate rate of high inadequate risk thyroid nodules in CEUS-FNA group was significantly lower than US-FNA group (6.7% vs. 16.7%, P = 0.014). Further stratified analyzed shown that FNA under US guidance, the inadequate rates in cystic, predominantly cystic, predominantly solid and solid sub-groups were 28.1%, 17.1%, 10.0% and 9.2% (P = 0.019). In contrast, the inadequate rates in cystic, predominantly cystic, predominantly solid and solid sub-groups were 7.4%, 6.7%, 5.6% and 6.7% (P = 0.996) in CEUS-FNA group.
    CEUS can improve the specimen adequacy of FNA in high inadequate risk thyroid nodules by avoiding unnecessary FNAs of the non-enhancing nodules, and accurately locating the viable tissue and precise guidance in real-time. CEUS is a recommend modality for FNA guidance of high inadequate risk thyroid nodules.
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  • 文章类型: Comparative Study
    经皮肾活检(PRB)是主要的活检技术,在中国被16G针或18G针使用,但两种不同直径的效果和安全性存在争议。这项研究旨在比较充分性,使用18G时的并发症发生率和病理分类16G针在中国人的本地肾脏上进行超声引导下进行肾活检。
    我们回顾性分析了肾小球的数量,足够的采样率,2011年1月至2017年5月使用18G或16G针头的270例患者的并发症发生率和病理分类,并验证针头规格是否影响疾病诊断。
    总共进行了270例肾脏活检。其中,72个是用18G针头进行的,和198用16G针头进行。在光学显微镜下使用18G相对于16G针的肾小球数量没有差异(24±11vs.25±11,p=0.265),而使用免疫荧光显微镜在16G组中发现的肾小球多于16G组(3±2vs.5±3,p<0.05)。18G组和16G组之间的适当采样率没有显着差异(90.28%vs.93.94%,p=0.298)。轻微的并发症,包括腰痛或腹痛的发生率(4.17%vs.7.07%,p=0.57),肉眼血尿(4.17%vs.3.54%,p=0.729),和无症状的肾周血肿(4.17%vs.1.52%,p=0.195),18G和16G组之间没有显着差异。在16G组中,2例发生严重并发症:严重肉眼血尿需要输血,腹膜后血肿需要手术治疗。18G组无严重并发症发生。尽管18G和16G组之间的严重并发症发生率没有显着差异(0%vs.1.02%,p=1)。
    肾小球数量无显著差异,足够的采样率,或使用18G或16G针头进行肾活检时的并发症发生率,使用直径较小的18G针不影响IgA肾病和狼疮性肾炎的病理诊断或分类。
    Percutaneous renal biopsy (PRB) is the primary biopsy technique and it was used by 16G needles or 18G needles in China, but there is controversy about the effect and safety of the two different diameters. The study aims to compare the adequacy, complication rate and pathological classification when using 18G vs. 16G needles to perform renal biopsy with ultrasound-guidedance on native kidneys in Chinese individuals.
    We retrospectively analyzed the number of glomeruli, adequate sample rates, complication rates and pathological classification in 270 patients with the use of 18G or 16G needles from January 2011 to May 2017 and verified whether the needle gauge affected the disease diagnosis.
    A total of 270 kidney biopsies were performed. Among them,72 were performed with 18G needles, and 198 were performed with 16G needles. There was no difference in the number of glomeruli under light microscope using 18G relative to 16G needles (24 ± 11 vs. 25 ± 11, p = 0.265), whereas more glomeruli were found in the 16G group than in the 16G group using immunofluorescence microscopy (3 ± 2 vs. 5 ± 3, p < 0.05). There was no significant difference in the adequate sample rates between the 18G group and the 16G group (90.28% vs. 93.94%, p = 0.298). Minor complications including the incidence of lumbar or abdominal pain (4.17% vs. 7.07%, p = 0.57), gross hematuria (4.17% vs. 3.54%, p = 0.729), and perinephric hematoma without symptoms (4.17% vs. 1.52%, p = 0.195), were not significantly different between the 18G and 16G groups. In the 16G group, 2 cases of serious complications occurred: severe gross hematuria requiring blood transfusion and retroperitoneal hematoma requiring surgery. No serious complications were observed in the 18G group, although there was no significant difference in serious complications rates between the 18G and 16G groups (0% vs. 1.02%, p = 1).
    There was no significant difference in the number of glomeruli, adequate sample rates, or complication rates when using 18G or 16G needles to perform renal biopsy, and the use of an 18G needle with a smaller diameter did not affect the pathological diagnosis or classification of IgA nephropathy and lupus nephritis.
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  • 文章类型: Journal Article
    BACKGROUND: To describe the associated factors for non-medical reasons for dropout in peritoneal dialysis (PD) patients.
    METHODS: A retrospective cohort study was performed using registry data of adult patients commencing PD as their initial renal replacement therapy in one hospital-facilitated PD center in Taiwan between 2014 and 2018. The collected data included socio-demographics and relevant medical and PD-related parameters. Kaplan-Meier analysis was used to determine the impact of non-medical reasons and medical reasons on PD dropout.
    RESULTS: The analysis included 224 PD patients, of whom 37 dropped out for non-medical reasons and 187 for medical reasons during the study period. There was significant difference between the two cohorts in age (62.3 years vs. 56.1 years, P = 0.010) and PD vintage (median 3.4 years vs. 4.8 years, P = 0.001). Diabetes was more predominant in the cohort for non-medical reasons than in the one for medical reasons (54.1% vs. 27.3% respectively, P = 0.001). In non-medical reason cohort, two leading reasons given for dropping out were lacking of caregivers (n = 12) and losing confidence (n = 10), whereas PD-related peritonitis (n = 101) was the main medical reason for PD dropout. Using Kaplan-Meier curve analysis, patients in the non-medical reason cohort demonstrated higher cumulative dropout rate compared to patients in the medical reason cohort during a 10-year period (P < 0.001).
    CONCLUSIONS: The main characteristics of PD dropout patients for non-medical reasons are age, diabetes, patients\' perception and caregiver support.
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  • 文章类型: Journal Article
    In recent years, some large rigorous acupuncture randomized controlled trials (RCTs) frequently draw the conclusion that the therapeutic effects of acupuncture is equivalent to placebo effect, which has aroused wide attention and controversy. Thus, some studies attempted to assess the adequacy of acupuncture regimen in clinical trials. In this study, the concept of acupuncture regimen adequacy in clinical trials is clarified and the research status and limitations are summarized. Moreover, the suggestions in the future researches are proposed in association with clinical practice characteristics of acupuncture, i.e. classifying assessment according to different types of acupuncture; conducting the assessment according to the treatment characteristics of different types of acupuncture; assessing the maturity of acupuncture regimens; evaluating the rationality of the control group according to the purpose of the study; and focusing on domains evaluation.
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  • 文章类型: Comparative Study
    目的:比较23-,25-,在甲状腺结节细针穿刺活检中使用27号针,以制定收集更好的细胞学诊断标本的指南。
    方法:这项随机前瞻性研究包括156名连续入组的156个结节患者。用每种尺寸的针抽吸每个结节。获得的标本由2名细胞病理学家独立分析,并计算了充足率。
    结果:在我们的调查中,23-,25-,和27号针头(88.5%,90.4%,和89.7%,分别为;P>.05)。在高回声结节中使用所有3种大小的针头所达到的充足率均高于低回声样本(P<0.05)。最后,根据结节大小,观察到不同大小的针头是否足够(P>.05)。
    结论:我们得出的结论是,使用27号针细针穿刺活检可以抽吸足够的标本,用于甲状腺结节的细胞病理学诊断。从低回声结节获得的材料不足的可能性高于高回声结节。
    OBJECTIVE: To compare the adequacy of 23-, 25-, and 27-gauge needles in the fine-needle aspiration biopsy of thyroid nodules to develop guidelines for the collection of better specimens for cytologic diagnosis.
    METHODS: This randomized prospective study included 156 consecutively enrolled patients with 156 nodules. Each nodule was aspirated with a needle of each size. The obtained specimens were analyzed independently by 2 cytopathologists, and adequacy rates were calculated.
    RESULTS: In our investigation, there were no statistically significant differences among the adequacy rates achieved with 23-, 25-, and 27-gauge needles (88.5%, 90.4%, and 89.7%, respectively; P > .05). The adequacy rates achieved with all 3 needle sizes in hyperechoic nodules were higher than those in hypoechoic samples (P < .05). Finally, no differences in adequacy for the different needle sizes were observed according to nodule size (P > .05).
    CONCLUSIONS: We conclude that fine-needle aspiration biopsy with a 27-gauge needle can aspirate an adequate specimen for cytopathologic diagnosis of thyroid nodules. The likelihood that inadequate materials will be obtained from hypoechoic nodules is higher than that for hyperechoic nodules.
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