Development of a core outcome set for venous leg ulceration (CoreVen) research evaluations (protocol)

BackgroundA venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines.AimThe aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration.MethodsThrough a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.     

Developmental validation of the ANDE™ rapid DNA system with FlexPlex™ assay for arrestee and reference buccal swab processing and database searching

A developmental validation was performed to demonstrate reliability, reproducibility and robustness of the ANDE System with the FlexPlex assay, including an integrated Expert System, across a number of laboratories and buccal sample variations. Previously, the related DNAscan™/ANDE 4C Rapid DNA System using the PowerPlex^®16 assay and integrated Expert System Software received NDIS approval in March 2016. The enhanced ANDE instrument, referred to as ANDE 6C, and the accompanying 6-dye, 27-locus STR assay, referred to as FlexPlex, have been developed to be compatible with all widely used global loci, including the expanded set of the CODIS core 20 loci.Six forensic and research laboratories participated in the FlexPlex Rapid DNA developmental validation experiments, testing a total of 2045 swabs, including those obtained from 1387 unique individuals. The goal of this extensive and comprehensive validation was to thoroughly evaluate and document the ANDE System and its internal Expert System to reliably genotype reference buccal swab samples in a manner compliant with the FBI’s Quality Assurance Standards and the NDIS Operational Procedures.The ANDE System, including automated Expert System analysis, generated reproducible and concordant results for buccal swabs when testing various instruments at different laboratories by a number of different operators. When testing a number of non-human DNAs, including oral bacteria, the ANDE System and FlexPlex assay demonstrated limited cross-reactivity. Potential PCR inhibitors were evaluated as part of the validation and no inhibition was detected. Reproducible and concordant profiles were generated from buccal swab samples collected with a limit of detection appropriate for buccal swab collections from arrestees. The precision and resolution of the System met industry standards for detection of microvariants and single base resolution.The integrated Expert System appropriately demonstrated the ability to correctly pass or fail profiles for CODIS upload without human review. During this comprehensive developmental validation, the ANDE System successfully interpreted over 2000 samples tested with over 99.99% concordant alleles. The data package described herein led to the ANDE System with the FlexPlex assay receiving NDIS approval in June 2018.     

慢性心力衰竭护理结局分类评价表的构建研究

目的本研究以护理结局分类(NOC)为基础,筛选符合慢性心力衰竭患者的相关护理结局,由此构建具有专科专病特点的慢性心力衰竭患者护理结局评价表。方法成立研究核心小组,应用文献回顾法、专家函询法确定护理结局分类指标,并进行统计学分析,最终建立慢性心力衰竭护理结局分类评价表。结果通过研究,确定慢性心力衰竭护理结局中包含4个领域、8个一级指标、68个二级指标。4个领域分别是生理健康、功能健康、健康知识和行为、心理社会健康。一级指标中包含心脏泵血功能、活动耐力、社会支持、抑郁水平等。二级指标中包含心脏指数、血压、呼吸困难、情绪波动大、步行距离、步行速度等68个指标。统计学分析中:第一、二轮函询专家的积极系数分别为90%、100%,专家权威系数为0.895,专家意见协调程度(P<0.05)。结论本研究成功建立慢性心力衰竭护理结局分类评价表,有助于临床护士用于评价护理措施的有效性,也使其成为一种标准化语言,便于应用到护理电子信息系统中进行绩效测算等。但是本研究不足之处是未能将该研究进行临床实证,未能进一步确认其有效性。     

Intelligent dialogue based on statistical models of clinical decision-making

The independence Bayesian model has been used widely in computer programs designed to support clinical decision-making. A reasoning strategy has been developed to enable these programs to conduct clinically pertinent dialogue and explain their reasoning. It has been implemented in a program for the diagnosis of acute abdominal pain based on the Bayesian model of de Dombal et al. Several features of the dialogue design have been adopted from artificial intelligence research, including shared initiative and critiquing. The program adopts a flexible goal-driven strategy, attempting to confirm the clinician's diagnosis or rule out the likeliest alternative. Symptoms and signs are selected in order of their expected weights of evidence in favour of the hypothesized disease.     

“Cervia II Working Group Report 2006”: Guidelines on diagnosis and treatment of Helicobacter pylori infection in Italy

Proper management of Helicobacter pylori infection in clinical practice--when supported by evidence-based data--is expected to produce substantial cost-efficacy advantages. This consideration has prompted the Cervia Working Group to organise a meeting of experts to update the National Guidelines on the diagnosis and treatment of H. pylori infection in Italy. Recommendations in the new European Guidelines were considered in the National setting, here in the light of factors such as the incidence of gastric cancer and gastric lymphoma, the accessibility to different diagnostic tools, the prevalence of bacterial resistance against antibiotics, and the availability of different drugs. The main revisions in respect to the previous guidelines include H. pylori eradication in non-ulcer dyspepsia patients and in non-steroidal, anti-inflammatory drug users, as well as in patients with idiopathic thrombocytopenic purpura and iron deficiency anaemia. The stool antigen test is now accepted as a valid test for confirmation of H. pylori eradication following therapy. New therapeutic approaches have been recommended for both first- (sequential therapy) and second-line (levofloxacin-based) treatment in our country.     

小儿遗尿症指南和专家共识质量评价

背景 小儿遗尿症是儿科常见病之一,有效的小儿遗尿症诊疗指南有助于症状的规范化控制和缓解,而制定高质量的临床实践指南是提高小儿遗尿症诊疗水平的重要方式。目的 基于AGREEⅡ和RIGHT工具,评价2010年以来国内外发布的小儿遗尿症指南和专家共识的质量,以期为临床实践及后续指南的制订提供参考。方法 检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献数据库和PubMed(补充检索医脉通、世界卫生组织以及英国国家临床示范研究所等数据库)2010-01-01至2022-01-31公开发表的小儿遗尿症相关的诊疗指南和专家共识。采用AGREEⅡ和RIGHT工具评价纳入文献的方法学和报告质量。根据AGREE Ⅱ工具评价结果,将各指南/共识推荐等级评定为“推荐(A级)”“更新后推荐(B级)”和“不推荐(C级)”。使用组内相关系数(ICC)进行一致性评价。结果 纳入8部指南和5部专家共识。共形成推荐意见185条,其中44条为诊断评估方面的意见,140条为治疗方面的推荐意见,1条为随访推荐意见。AGREEⅡ工具评价结果显示,范围和目的、参与人员、严谨性、清晰性、应用性和独立性6个领域的总得分(报...     

An epidemiologic approach to computerized medical diagnosis—AEDMI program

A program called “An Epidemiological Approach to Computerized Medical Diagnosis” (AEDMI) is presented. Using an interactive questionnaire, physician-patient interviews are conducted and a summary of the relevant clinical data is provided. Standard items, obained on a multi-centre basis, form a large-scale data base. Simultaneously, the reasoning of clinical experts in each real case is analyzed to obtain a knowledge-rules data base. The methodology of the program combines Bayesian systems, expert systems, and other new lines of researcg such as neural networks or case-based reasoning. The general concepts of clinical decision making aid systems are reviewed. This publication is aimed at obtaining international cooperation.     

Some notes on uncertainty; Federal policy and innovation

The legislative background and current responsibilities of the new National Center for Health Care Technology (NCHCT) are discussed. The NCHCT's charge is to consider the stage of development, the actual or potential risks, costs and rate of use of health care technology. The role of Government in supporting new technologies, stimulating innovation and encouraging application of research products is considered. These issues are discussed in the context of the uncertainty inherent in planning and the formulation of public policy.     

Real-time identification and archiving of micro-embolic Doppler signals using a knowledge-based DSP system

Identification of micro-emboli in the cerebral circulation using transcranial Doppler ultrasound provides valuable clinical information, but, currently, embolic signal detection and analysis are significantly limited because they mainly rely on costly off-line analysis by human experts. In this study, a reliable, high-resolution, real-time automated system for the detection and archiving of embolic signals was designed and implemented using expert system theory and modern DSP technology. Preliminary tests were conducted to evaluate the functions and the performance of the system using data from ten carotid endarterectomy patients and two normal volunteers. Using the widely accepted 7 dB threshold for human reliability and a human expert, majority-decision gold standard, the real-time system reached sensitivity and specificity of 93.6% and 99.3%, respectively, which were close to the results obtained by three human experts under ideal laboratory conditions (90.1% and 99.8%, 98.4% and 99.9%, 98.9 and 99.9%). The new system has the potential to be used either as a bedside monitoring and signal acquisition device, or as a laboratory investigation tool.     

Discrepancies Between Australian Eating Disorder Clinicians and Consumers Regarding Essential Components of Dietetic Treatment

BackgroundA recent Delphi study indicated that, compared with eating disorder (ED) consumers and carers, ED specialists were less likely to endorse involvement of a dietitian as a standard component of treatment. In addition, there was disagreement between these groups regarding the inclusion of a number of components of dietetic treatment.ObjectiveThis study aimed to further investigate these data to identify areas of disagreement among ED specialist dietitians, ED specialist non–dietetic clinicians, consumers, and carers with regard to outpatient dietetic treatment.Design and participants/settingThe ED specialists panel from a previous Delphi study was recoded into 2 panels: ED specialist dietitians (n = 31) and ED specialist non–dietetic clinicians (n = 48) to compare responses of these panels with responses from consumers (n = 32) and carers (n = 23).Main outcome measuresStatements in 7 categories relating to referral to dietitian, essential components of outpatient dietetic treatment regarding 4 ED patient populations, strategies to promote multidisciplinary collaboration, and skills dietitians should possess if treating patients with an ED were rated on a 5-point Likert scale.Statistical analysis performedOne-way analysis of variance was conducted with post-hoc multiple comparisons to compare mean statement ratings.ResultsThirty-seven statements (30%) showed statistically significant differences (P < .05) in responses between panels. Discrepancies were primarily observed for statements regarding how and when dietetics is included in treatment and essential components of dietetic treatment, particularly the use of behavioral tasks, such meal plans and self-monitoring. Results also highlighted deficits in participants’ understanding of core responsibilities of dietitians in ED treatment and dietitians “drifting” from delivering evidence-based components of dietetic treatment.ConclusionsResults of this study show discrepancies among ED dietitians, clinicians, consumers, and carers regarding what dietetic treatment for people with EDs should encompass. It also indicates the need for further research into optimizing dietetic treatment for EDs that is conducted in collaboration with individuals with lived experience.