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Result reporting and early discontinuation of sepsis trials registered on ClinicalTrials.gov 在ClinicalTrials.gov上注册的败血症试验的结果报告和早期终止
IF 7.3 2区 医学 Q1 Medicine Pub Date : 2023-07-02 DOI: 10.1111/jebm.12543
Handan Hu, Xinyi Wang, Peng Huang

Objective

Sepsis is a leading cause of death from infectious disease or traumatic injury. The prevalence and predictor of results underreporting and early stop of sepsis clinical trials remain poorly studied. To fill the gap, we designed this study to characterize sepsis clinical trials registered on ClinicalTrials.gov, particularly to recognize features related to premature discontinuation and lack of results reporting.

Methods

We searched ClinicalTrials.gov to include interventional sepsis trials up to July 8, 2022. All structured data of the identified trials were extracted and reviewed. A descriptive analysis was conducted. Cox and logistic regression analyses were conducted to determine the significance of the association of trial characteristics with early termination and lack of results reporting.

Results

A total of 1654 records were identified, among which 1061 eligible trials were reserved. Results underreporting happened in 91.6% of these sepsis interventional trials. 12.0% were discontinued. Moreover, factors that led to the higher risk of discontinuation were the US-registered clinical research and the small sample size. The factor that contributed to results underreporting was non-US-registered clinical trials.

Conclusion

The frequent discontinuation and underreporting of sepsis trials have highly impaired the progress of sepsis management and studies. Therefore, solutions to early discontinuation and improving the quality of results dissemination remain an urgent problem.

目的败血症是感染性疾病或创伤性损伤导致死亡的主要原因。脓毒症临床试验结果漏报和早期停止的患病率和预测因素研究仍然很少。为了填补这一空白,我们设计了这项研究来描述在ClinicalTrials.gov上注册的败血症临床试验,特别是识别与过早终止和缺乏结果报告相关的特征。方法:检索ClinicalTrials.gov网站,纳入截至2022年7月8日的介入性败血症试验。提取并回顾所有已确定试验的结构化数据。进行描述性分析。进行Cox和logistic回归分析,以确定试验特征与早期终止和缺乏结果报告的相关性。结果共筛选到1654份文献,保留1061份符合条件的文献。91.6%的脓毒症介入试验存在漏报。12.0%停产。此外,导致停药风险较高的因素是在美国注册的临床研究和小样本量。导致结果少报的因素是未在美国注册的临床试验。结论脓毒症临床试验的频繁中断和少报严重影响了脓毒症治疗和研究的进展。因此,解决早期停药和提高结果传播质量仍然是一个紧迫的问题。
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引用次数: 0
Pericardial fat and cardiovascular diseases: A systematic review and meta-analysis 心包脂肪与心血管疾病:一项系统综述和荟萃分析
IF 7.3 2区 医学 Q1 Medicine Pub Date : 2023-06-18 DOI: 10.1111/jebm.12542
Hanna K. Al-Makhamreh, Ahmad A. Toubasi, Layla M. Al-Harasis, Farah H. Albustanji, Thuraya N. Al-Sayegh, Sarah M. Al-Harasis

Objective

Previous studies investigated the effect of pericardial fat on cardiovascular diseases. However, until now there was no systematic review and meta-analysis investigated this association, thus we conducted this article to assess the relationship between pericardial fat and cardiovascular diseases.

Methods

We searched PubMed, The Cochrane Library, Scopus, Google Scholar and Clinicaltrials.gov to select observational studies reported the relationship between pericardial fat and cardiovascular diseases including coronary artery disease (CAD), ventricular dysfunction, heart failure (HF), atrial fibrillation (AF), major adverse cardiac events (MACE), coronary artery calcifications (CAC), arrhythmias other than atrial fibrillation, and cardiovascular events prediction scores. Meta XL 5.3 was used for data analysis.

Results

A total of 83 articles that included 73,934 patients were included in our analysis. The results showed that pericardial fat was significantly associated with CAD (OR = 1.38; 95% CI: 1.28–1.50), ventricular dysfunction (OR = 1.53 per 1 mm3; 95% CI: 1.17–2.01), HF (OR = 1.32 per 1 mm3; 95% CI: 1.23–1.41), AF (OR = 1.16 per 1 mm3; 95% CI: 1.09–1.24), MACE (OR = 1.39 per 1 mm3; 95% CI: 1.22–1.57), and CAC (OR = 1.15 per 1 mm3; 95% CI: 1.05–1.27). On the other hand, there was no enough data about the relationship between pericardial fat with arrhythmias other than atrial fibrillation or cardiovascular risk scores.

Conclusion

The analysis demonstrated that the relationship between pericardial fat volume and cardiovascular diseases was significant. Since pericardial fat is a good predictor of obesity, it suggests investigating its relationship and adds on effect to previously established risk factor to evaluate the possibility of incorporating it with cardiovascular risk scores.

目的探讨心包脂肪对心血管疾病的影响。然而,到目前为止,还没有系统的综述和荟萃分析来研究这种关联,因此我们进行了这篇文章来评估心包脂肪与心血管疾病之间的关系。方法:检索PubMed、Cochrane图书馆、Scopus、谷歌Scholar和Clinicaltrials.gov,选择有关心包膜脂肪与心血管疾病(包括冠心病、心功能不全、心力衰竭、心房颤动、主要心脏不良事件、冠状动脉钙化、心房颤动以外的心律失常、心肌病、心肌病和心肌病)之间关系的观察性研究。以及心血管事件预测评分。数据分析采用Meta XL 5.3。结果共纳入83篇文献,73934例患者。结果显示,心包脂肪与冠心病有显著相关性(OR = 1.38;95% CI: 1.28-1.50),心室功能障碍(OR = 1.53 / 1 mm3;95% CI: 1.17-2.01), HF (OR = 1.32 / 1 mm3;95% CI: 1.23-1.41), AF (OR = 1.16 / 1 mm3;95% CI: 1.09-1.24), MACE (OR = 1.39 / 1 mm3;95% CI: 1.22-1.57)和CAC (OR = 1.15 / 1 mm3;95% ci: 1.05-1.27)。另一方面,除了心房颤动或心血管风险评分外,没有足够的数据表明心包脂肪与心律失常之间的关系。结论心包脂肪量与心血管疾病的关系显著。由于心包脂肪是肥胖的一个很好的预测指标,因此建议调查其关系,并在先前确定的风险因素的基础上增加影响,以评估将其纳入心血管风险评分的可能性。
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引用次数: 0
Estimation of death risk factors associated with the coronavirus pandemic in the Middle East and North Africa 中东和北非与冠状病毒大流行相关的死亡风险因素的估计
IF 7.3 2区 医学 Q1 Medicine Pub Date : 2023-06-15 DOI: 10.1111/jebm.12538
Sami Khedhiri

Several issues related to the coronavirus pandemic have not yet been fully and unequivocally identified despite the attempts made in the literature to explain why COVID-19 case-fatality rates vary among countries and why in some developed countries, fatality rates were high. For instance, a study1 investigated the clinical risk factors of COVID-19 fatality, which might include obesity and diabetes.2 Other researchers studied the impact of demographic factors such as age, socioeconomic factors, environmental factors, and all these indicators combined.3 Countries worldwide reported different case-fatality rates (CFR), a measure defined as the proportion of cases of COVID-19 that were fatal within a specified time. However, these differences in mortality rates might not be attributed to just the above-mentioned factors. There were other explanations, including the difference in the number of people tested and the characteristics of the healthcare system. Countries with fewer resources might have a higher mortality risk because their hospitals became overwhelmed with the increased number of infections.

The current study applied statistical methods to investigate the association between COVID-19 deaths and potential clinical, demographic, and socioeconomic risk factors. In addition, the variation of case-fatality rates across the countries and over time was also studied. There was ample research published in the literature about this issue,4 with evidence from different countries and regions. Our contribution was to examine how the results for the MENA (Middle East and North Africa) region compared with results from other populations and whether the association of pandemic mortality and risk factors was confounded with population genotypes and racial differences, as these factors had not been sufficiently emphasized in the literature.

The MENA region includes 22 countries and makes up 6% of the world's population and more than 50% of the world's total oil reserves. Like most countries, the Middle East and North Africa have had their share of human and economic losses because of the COVID-19 outbreak, and as of April 2022, it was estimated that nearly 20 million people had been infected and 300 thousand had died from the coronavirus in the region.5 Although governments in the MENA countries at first reacted swiftly to contain the coronavirus by implementing strict health protocols and developing policy and institutional plans to support households and firms, which helped to limit the first wave of the pandemic, however, after relaxing health restrictions in summer 2020, the situation quickly diverged and cases and death tolls rapidly increased. To compare this situation with the European management of the pandemic, a study6 found that in the first phase of the pandemic, the inefficiency of the he

尽管文献中试图解释为什么新冠肺炎病死率因国家而异,以及为什么在一些发达国家,病死率很高,但与冠状病毒大流行有关的几个问题尚未得到充分明确的确定。例如,一项研究1调查了新冠肺炎死亡的临床风险因素,其中可能包括肥胖和糖尿病。2其他研究人员研究了人口统计学因素的影响,如年龄、社会经济因素、环境因素和所有这些指标的总和。3世界各国报告了不同的病死率(CFR),一种定义为在特定时间内致命的新冠肺炎病例比例的指标。然而,这些死亡率差异可能不仅仅归因于上述因素。还有其他解释,包括检测人数的差异和医疗系统的特点。资源较少的国家可能会有更高的死亡率,因为它们的医院因感染人数的增加而不堪重负。目前的研究应用统计学方法调查新冠肺炎死亡与潜在的临床、人口统计学和社会经济风险因素之间的关联。此外,还研究了各国病死率随时间的变化。文献中发表了大量关于这个问题的研究,4有来自不同国家和地区的证据。我们的贡献是研究中东和北非地区的结果与其他人群的结果相比如何,以及大流行死亡率和风险因素的关联是否与人群基因型和种族差异混淆,因为这些因素在文献中没有得到充分强调。中东和北非地区包括22个国家,占世界人口的6%,石油储量占世界总储量的50%以上。与大多数国家一样,中东和北非也因新冠肺炎疫情而承担了各自的人力和经济损失,截至2022年4月,据估计,该地区已有近2000万人感染新冠病毒,30万人死于新冠病毒。5尽管中东和北非地区国家政府最初迅速采取行动,通过实施严格的卫生协议和制定政策和机构计划来遏制新冠病毒的传播,以支持家庭和企业,这有助于限制第一波疫情,然而,在2020年夏天放松健康限制后,情况迅速出现分歧,病例和死亡人数迅速增加。为了将这种情况与欧洲对疫情的管理进行比较,一项研究6发现,在疫情的第一阶段,西欧的卫生系统效率相对较高,无论是在放松阶段还是在第二波疫情中。研究发现,欧洲国家在疫情初期受到了严重影响。然而,与中东和北非地区国家不同,欧洲人能够采取足够的措施,并成功地提高了医疗系统的效率。中东和北非地区国家在人均国内生产总值、人均卫生支出和卫生系统特征方面差异很大。例如,在富裕的海湾国家,卡塔尔的人均GDP是埃及或突尼斯的近14倍,是叙利亚的37倍多。然而,与以色列相比,卡塔尔每1000人中的医生人数还不到一半。此外,根据世界银行最近的数据,阿联酋老年人(65岁或以上)的比例仅为邻国沙特阿拉伯或科威特老年人比例的三分之一。当我们观察临床因素时,世界银行的数据显示,沙特阿拉伯的糖尿病患病率是伊朗的两倍多。这些说明清楚地说明了地理位置相同的国家之间的显著差异,本文的目的是调查这是否可以解释为什么各国的病死率差异很大。最近发表了几篇论文,分析新冠疫情的影响,对感染和死亡进行建模和预测,并研究新冠疫情在中东和北非地区的影响。7此外,还提出了新的病死率变化动态指标8。然而,只有有限的研究来调查该地区风险因素与大流行死亡人数之间的关系。例如,研究发现,科威特患有高血压和心血管疾病等合并症的老年患者的死亡率更高,9一项与土耳其新冠肺炎患者相关的研究表明,年龄、慢性阻塞性肺病和吸烟是死亡的危险因素。 表1左中面板中显示的结果显示了中东和北非地区国家疫情致死率国家间差异的统计证据,并证明CFR指标随时间和国家间存在显著差异。随机效应参数由(αO t${alpha_{Ot}}$)和s$beta^{prime}s$表示模型方程(1)中解释的固定效应。统计结果证明,最受数据支持的模型应该包括老年人的百分比和糖尿病患病率或它们的相互作用,加上人均GDP或人均医疗支出,但不能同时包括这两个变量,因为这两个因素之间存在高度共线性。表1的上部面板列出了两个回归模型的结果。然而,应该注意的是,当我们将老年人、糖尿病及其相互作用包括在内时,结果并不显著。研究结果可以通过注意到模型2的结果来解释,该结果发现了强有力的证据,表明人均卫生支出较高的国家平均因新冠肺炎而死亡率较低。此外,有强有力的统计证据表明,在中东和北非地区,老年人糖尿病患病率较高的国家,新冠疫情更致命。模型3的结果还表明,有证据表明,人均卫生支出较高的国家平均因新冠肺炎而死亡率较低。此外,较高的老年人比例与疫情的致命性密切相关,但糖尿病患病率,如果不与老年人混淆,也不是死亡率的有力预测因素。此外,如表1左中面板所示,它发现了新冠肺炎病死率在各国之间存在显著差异的证据,因此建议可以使用基于功能主成分(FPC)的数据分析技术来识别这些变化的类型。该分析是使用fdpace软件包的FPCA功能用R编码进行的。基于B样条曲线的平滑器用于将面板CFR轨迹转换为具有通过广义交叉验证技术选择的平滑参数的函数,并且可以估计和表示新冠肺炎病死率测量的潜在函数。表1的下表显示,前3个组成部分占解释的死亡率变化的大部分。事实上,解释的变异分数达到了90%,只需要3个本征分量和6个分量就可以达到99%的样本方差水平。该研究强调,糖尿病本身并不是新冠肺炎死亡率上升的主要危险因素;然而,研究表明,人口统计学特征(年龄)和糖尿病的混杂是主要的风险因素。这证明,在中东地区,患有糖尿病的老年患者死于该疾病的风险更高。这一混杂效应的结果也与一项与美国哮喘患者相关的研究中的类似发现一致,10该研究表明,单独的哮喘不是一个重要的临床因素。然而,他们警告说,患有哮喘的老年冠状病毒患者因新冠肺炎住院的风险增加。我们的一些发现与之前关于人口统计变量的研究结果一致。例如,统计分析显示,吸烟对冠状病毒死亡率增加没有影响;一项研究得出了类似的结果,11该研究表明,吸烟增加了住院新冠肺炎患者患严重疾病的风险,但尽管中国和美国的研究结果存在一些差异,但吸烟与死亡率增加之间没有显着关联。然而,关于吸烟对新冠肺炎严重程度和最终死亡风险的影响,研究结果与其他研究结果不同。事实上,最近一项基于欧洲血统参与者的研究12表明,吸烟增加了对败血症和严重新冠肺炎的易感性,并使用英国生物银行队列进行了13项研究,得出的结论是,两种分析方法的结果支持吸烟对严重冠状病毒风险的因果影响,这可能导致死亡。这些结果具有区域特异性,与欧洲新冠肺炎患者有关。目前的研究针对中东和北非地区国家,没有发现吸烟与新冠肺炎潜在死亡之间存在显著关联。
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引用次数: 0
Systematic reviews were the perceived most important source of information for updating a potentially inappropriate medication list for the elderly: An online survey 系统评价被认为是最重要的信息来源,用于更新可能不合适的老年人药物清单:一项在线调查
IF 7.3 2区 医学 Q1 Medicine Pub Date : 2023-06-14 DOI: 10.1111/jebm.12540
Dawid Pieper, Nina-Kristin Mann, Mahmoud Moussa, Tim Mathes, Andreas Sönnichsen, Petra Thürmann

Polypharmacy in the elderly is a recognized public health problem. For many diseases several drugs are available. Thus, it is important to rule out drugs with an unfavorable risk-benefit profile in older patients, and to suggest safer alternatives. This is often done by developing and publishing lists of potentially inappropriate medications (PIM).

Making evidence-based decisions for the elderly is often challenging as randomized controlled trials frequently do not include older adults with multimorbidity and are not sufficiently powered for analyzing harms. Despite many PIM lists having been published, there is no methodological guidance on how they should be developed, what we recognized while preparing our update of the German PRISCUS list.1 Most PIM lists use the Delphi method to find consensus.2, 3

When using a Delphi study to develop a PIM list it is crucial to consider what information will be provided to the participants of the Delphi study to formulate recommendations. There is no research on what type of information experts need or prefer to support rating of PIM criteria or derive recommendations for PIMs. Our aim was to investigate the process of providing information and the importance of different sources of information in the context of developing a PIM list.

Our study was carried out as part of updating the Potentially inappropriate medications list in the elderly in Germany (henceforth termed “the PRISCUS list”).1 This included a three-round Delphi process to derive the list of PIMs. In total, 95 experts from clinical practice and research from general medicine, geriatrics, clinical pharmacy, pharmacology, psychiatry, palliative medicine, and internal medicine evaluated whether selected substances are PIM for the elderly. Due to limited resources, we were only able to conduct 13 de novo SRs. Altogether, 187 substances were classed as PIM.4

We conducted a closed follow-up survey of all experts who took part in the assessment of PIM for the update of the PRISCUS list. The survey was administered in German via SurveyMonkey (https://de.surveymonkey.com/). We sent out an invitation email including a hyperlink to all experts who took part in the assessment for the update of the PRISUCS list. The follow-up survey took place between May and June 2021. One reminder was sent via email to all experts.

Participants were told that taking the survey would not take longer than 5 min. There was no incentive for participating in the survey. Collected data was imported into an Excel spreadsheet where all analyses were conducted. The number of participants taking part in at least one Delphi round was 59. These participants were invited to take part in our follow-up study. Of the 59 invitees, 40 (68%) responded, that is, accessed the survey. Of those (n = 40), 36 (90%) completed the entire survey.

Syste

老年人的综合用药是一个公认的公共卫生问题。对于许多疾病,有几种药物可用。因此,重要的是要排除对老年患者不利的风险-收益特征的药物,并建议更安全的替代方案。这通常是通过制定和公布潜在不适当药物清单(PIM)来完成的。为老年人做出基于证据的决定通常是具有挑战性的,因为随机对照试验通常不包括患有多种疾病的老年人,也没有足够的证据来分析危害。尽管已经发布了许多PIM清单,但没有关于如何开发它们的方法学指导,这是我们在准备更新德国PRISCUS清单时认识到的大多数PIM列表使用德尔菲法来寻找共识。2,3当使用德尔菲研究来制定PIM清单时,考虑将向德尔菲研究的参与者提供哪些信息以制定建议是至关重要的。目前还没有关于专家需要或喜欢哪种类型的信息来支持PIM标准的评级或得出PIM的建议的研究。我们的目的是调查提供信息的过程,以及在制定PIM清单的背景下不同信息来源的重要性。我们的研究是作为更新德国老年人潜在不适当药物清单(以下称为“PRISCUS清单”)的一部分进行的这包括一个三轮德尔菲过程,以派生出pim列表。共有来自普通医学、老年医学、临床药学、药理学、精神病学、姑息医学和内科的95名临床实践和研究专家对所选物质是否为老年人的PIM进行了评估。由于资源有限,我们只能进行13次从头开始的sr。共有187种物质被列为有害化学物质。4我们对所有参与有害化学物质评估的专家进行了封闭式跟进调查,以更新PRISCUS清单。该调查是通过SurveyMonkey (https://de.surveymonkey.com/)用德语进行的。我们向所有参与评估的专家发送了一封邀请电子邮件,其中包含一个超链接,以更新PRISUCS列表。后续调查于2021年5月至6月进行。一个提醒通过电子邮件发送给所有专家。参与者被告知,完成调查的时间不会超过5分钟。参与调查没有任何激励措施。收集的数据被导入到Excel电子表格中,所有的分析都在这里进行。参与至少一轮德尔菲的人数为59人。这些参与者被邀请参加我们的后续研究。在59位被邀请者中,有40位(68%)回应,即访问了调查。其中(n = 40), 36(90%)完成了整个调查。受访者最重视包括发现表摘要在内的系统评价(平均4.19)(表1)。绝大多数参与者(86%;30/36)同意或完全同意所提供的信息很容易理解的说法,而只有一个人不同意这一点。除了一名与会者以外,所有与会者都同意这样一种说法,即提供的信息有助于为与会者的决策提供信息。只有22%(8/36)的人同意,如果没有获得所提供的信息,他们也会给出同样的评级。大多数参与者(44%;16/36)部分同意这种说法(表S1)。我们的研究结果表明,大多数提供的信息被很好地感知,并对PIM评级有很高的影响。有趣的是,在六个不同的信息源中,包括结果摘要表在内的SRs被发现是最有价值的信息源,其次是抗胆碱能作用的信息。我们不知道有任何研究可以直接与我们的结果进行比较。我们的研究是第一个显示德尔菲参与者在制定PIM清单的后续调查结果。我们的研究中最引人注目的发现是,sr是最有价值的信息来源。与此相冲突的是,在开发PIM列表时通常不使用sr。存在一些PIM列表,声称进行了文献综述然而,由于没有提供任何细节,因此大多不清楚文献综述的内容。我们不能排除在某些情况下搜索了SRs,而重新执行SRs以通知PIM列表的开发似乎不太可能,因为这将被报告。从2019年开始,比尔斯名单的最新更新突出了制定PIM清单的方法方法的演变进行了一项更新的文献回顾,报告了更多的细节,但无法复制。此外,值得注意的是,在制定比尔斯清单时,第一次提到进行了GRADE评估。 据我们所知,没有其他PIM清单是使用GRADE标准制定的。然而,在公布的比尔斯名单中,没有提供进一步的细节或GRADE评估。这很遗憾,因为我们发现通常的GRADE标准需要修改,以满足制定PIM清单的目的。6第二个最有价值的信息是抗胆碱能作用,这是影响认知的潜在副作用的具体指标,并导致各种各样的症状,所有这些症状都与老年人特别相关。9,10因此,这方面的资料也受到高度赞赏,并被认为是特别有关的,这并不奇怪。PIM列表为实践提供了建议。从这个角度来看,它们与临床实践指南(cpg)非常相似。然而,CPGs往往是基于SRs,包括GRADE评估。在制定cpg时,需要透明度以确保可信度。与建议一起报告的还有所有细节,如文献综述和GRADE评估。对于未来的PIM列表,我们没有理由不这样做,因为它们的预期用途非常相似。这一点显得尤为重要,因为它们对实践和减少规定的pim数量的能力有很大的影响。11-13总体而言,受访者对向他们展示信息的方式非常积极。然而,似乎仍有改进的余地。我们不知道专家是如何根据提供给他们的信息做出决定的。专家的临床专业知识也很重要,发挥着重要作用。没有一个参与调查的人完全同意,如果没有提供的信息,他们会做出同样的决定。理解GRADE软桌对读者来说可能是一个挑战。因此,软体桌的呈现方式也是研究的主题。14,15我们的结果可能受到少数回答者的限制。然而,对PIM列表的比较发现,专家的数量从4到62不等,大约每两个PIM列表中就有一个只有20名专家因此,我们的结果需要谨慎对待,尽管与其他PIM列表相比,样本量仍然可以被认为是高的。调查人员应特别注意向专家提供了什么信息的问题。目前,PIM列表的开发遵循“一刀切的方法”。鉴于并非所有潜在药物都可以进行SRs,未来的研究需要关注哪些问题SRs是最重要的。我们的结论是,包含软件表的SRs很容易理解,并为PIM列表的开发提供了有价值的信息来源。PIM清单和可比较产出的制定者应以不良事件的特殊事件发生率为其建议的基础,但需要平衡资源、时间表和方法的严密性。这项研究没有从公共、商业或非营利部门的资助机构获得任何具体的资助。该研究被纳入德国教育和研究部(BMBF 01KX1812)资助的“老年人潜在不适当药物清单”的更新中。DP和TM是GRADE工作组的成员。
{"title":"Systematic reviews were the perceived most important source of information for updating a potentially inappropriate medication list for the elderly: An online survey","authors":"Dawid Pieper,&nbsp;Nina-Kristin Mann,&nbsp;Mahmoud Moussa,&nbsp;Tim Mathes,&nbsp;Andreas Sönnichsen,&nbsp;Petra Thürmann","doi":"10.1111/jebm.12540","DOIUrl":"10.1111/jebm.12540","url":null,"abstract":"<p>Polypharmacy in the elderly is a recognized public health problem. For many diseases several drugs are available. Thus, it is important to rule out drugs with an unfavorable risk-benefit profile in older patients, and to suggest safer alternatives. This is often done by developing and publishing lists of potentially inappropriate medications (PIM).</p><p>Making evidence-based decisions for the elderly is often challenging as randomized controlled trials frequently do not include older adults with multimorbidity and are not sufficiently powered for analyzing harms. Despite many PIM lists having been published, there is no methodological guidance on how they should be developed, what we recognized while preparing our update of the German PRISCUS list.<span><sup>1</sup></span> Most PIM lists use the Delphi method to find consensus.<span><sup>2, 3</sup></span></p><p>When using a Delphi study to develop a PIM list it is crucial to consider what information will be provided to the participants of the Delphi study to formulate recommendations. There is no research on what type of information experts need or prefer to support rating of PIM criteria or derive recommendations for PIMs. Our aim was to investigate the process of providing information and the importance of different sources of information in the context of developing a PIM list.</p><p>Our study was carried out as part of updating the <i>Potentially inappropriate medications list in the elderly</i> in Germany (henceforth termed “the PRISCUS list”).<span><sup>1</sup></span> This included a three-round Delphi process to derive the list of PIMs. In total, 95 experts from clinical practice and research from general medicine, geriatrics, clinical pharmacy, pharmacology, psychiatry, palliative medicine, and internal medicine evaluated whether selected substances are PIM for the elderly. Due to limited resources, we were only able to conduct 13 de novo SRs. Altogether, 187 substances were classed as PIM.<span><sup>4</sup></span></p><p>We conducted a closed follow-up survey of all experts who took part in the assessment of PIM for the update of the PRISCUS list. The survey was administered in German via SurveyMonkey (https://de.surveymonkey.com/). We sent out an invitation email including a hyperlink to all experts who took part in the assessment for the update of the PRISUCS list. The follow-up survey took place between May and June 2021. One reminder was sent via email to all experts.</p><p>Participants were told that taking the survey would not take longer than 5 min. There was no incentive for participating in the survey. Collected data was imported into an Excel spreadsheet where all analyses were conducted. The number of participants taking part in at least one Delphi round was 59. These participants were invited to take part in our follow-up study. Of the 59 invitees, 40 (68%) responded, that is, accessed the survey. Of those (<i>n</i> = 40), 36 (90%) completed the entire survey.</p><p>Syste","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":null,"pages":null},"PeriodicalIF":7.3,"publicationDate":"2023-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12540","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9794464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparative analysis of systemic oncological treatments and best supportive care for advanced gastresophageal cancer: A comprehensive scoping review and evidence map 晚期食管癌的系统肿瘤治疗和最佳支持治疗的比较分析:一项全面的范围审查和证据图
IF 7.3 2区 医学 Q1 Medicine Pub Date : 2023-06-12 DOI: 10.1111/jebm.12539
Santero Marilina, Meade Adriana, Selva Anna, Acosta-Dighero Roberto, Meza Nicolás, Quintana Maria Jesús, Bracchiglione Javier, Requeijo Carolina, Salazar Josefina, Rodríguez Grijalva Gerardo, Solà Ivan, Urrútia Gerard, Bonfill Cosp Xavier, Appropriateness of Systemic Oncological Treatments for Advanced Cancer (ASTAC) Research Group

Objective

To identify, describe, and organize the available evidence regarding systemic oncological treatments compared to best supportive care (BSC) for advanced gastresophageal cancer.

Methods

We conducted a thorough search across MEDLINE (PubMed), EMbase (Ovid), The Cochrane Library, Epistemonikos, PROSPERO, and Clinicaltrials.gov. Our inclusion criteria encompassed systematic reviews, randomized controlled trials, quasi-experimental and observational studies involving patients with advanced esophageal or gastric cancer receiving chemotherapy, immunotherapy or biological/targeted therapy compared to BSC. The outcomes included survival, quality of life, functional status, toxicity, and quality of end-of-life care.

Results

We included and mapped 72 studies, comprising SRs, experimental and observational designs, 12 on esophageal cancer, 51 on gastric cancer, and 10 both locations. Most compared schemes including chemotherapy (47 studies), but did not report therapeutic lines. Moreover, BSC as a control arm was poorly defined, including integral support and placebo. Data favor the use of systemic oncological treatments in survival outcomes and BSC in toxicity. Data for outcomes including quality of life, functional status, and quality of end-of-life care were limited. We found sundry evidence gaps specifically in assessing new treatments such as immunotherapy and important outcomes such as functional status, symptoms control, hospital admissions, and the quality of end-life care for all the treatments.

Conclusions

There are important evidence gaps regarding new for patients with advanced gastresophageal cancer and the effect of systemic oncological treatments on important patient-centered outcomes beyond survival. Future research should clearly describe the population included, specifying previous treatments and considering therapeutic, and consider all patient-centered outcomes. Otherwise, it will be complex to apply research results into practice.

目的鉴别、描述和整理晚期食管癌的系统性肿瘤治疗与最佳支持治疗(BSC)比较的现有证据。方法我们在MEDLINE (PubMed)、EMbase (Ovid)、Cochrane图书馆、Epistemonikos、PROSPERO和Clinicaltrials.gov上进行了彻底的检索。我们的纳入标准包括系统评价、随机对照试验、准实验和观察性研究,涉及晚期食管癌或胃癌患者接受化疗、免疫治疗或生物/靶向治疗,与BSC相比。结果包括生存、生活质量、功能状态、毒性和临终关怀质量。结果:我们纳入并绘制了72项研究,包括SRs、实验和观察设计,其中12项研究涉及食管癌,51项涉及胃癌,10项涉及两个部位。大多数比较方案包括化疗(47项研究),但没有报道治疗线。此外,平衡记分卡作为对照组的定义不明确,包括整体支持和安慰剂。数据支持在生存结果方面使用全身肿瘤治疗,在毒性方面使用BSC。包括生活质量、功能状态和临终关怀质量在内的结果数据有限。我们发现了各种各样的证据差距,特别是在评估新疗法(如免疫疗法)和重要结果(如功能状态、症状控制、住院率和所有治疗的临终关怀质量)方面。结论关于晚期食管癌患者的新发病情况以及系统性肿瘤治疗对生存期以外以患者为中心的重要预后的影响存在重要的证据缺口。未来的研究应清楚地描述纳入的人群,说明既往治疗并考虑治疗性,并考虑所有以患者为中心的结果。否则,将研究成果应用于实践将是复杂的。
{"title":"Comparative analysis of systemic oncological treatments and best supportive care for advanced gastresophageal cancer: A comprehensive scoping review and evidence map","authors":"Santero Marilina,&nbsp;Meade Adriana,&nbsp;Selva Anna,&nbsp;Acosta-Dighero Roberto,&nbsp;Meza Nicolás,&nbsp;Quintana Maria Jesús,&nbsp;Bracchiglione Javier,&nbsp;Requeijo Carolina,&nbsp;Salazar Josefina,&nbsp;Rodríguez Grijalva Gerardo,&nbsp;Solà Ivan,&nbsp;Urrútia Gerard,&nbsp;Bonfill Cosp Xavier,&nbsp;Appropriateness of Systemic Oncological Treatments for Advanced Cancer (ASTAC) Research Group","doi":"10.1111/jebm.12539","DOIUrl":"10.1111/jebm.12539","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To identify, describe, and organize the available evidence regarding systemic oncological treatments compared to best supportive care (BSC) for advanced gastresophageal cancer.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We conducted a thorough search across MEDLINE (PubMed), EMbase (Ovid), The Cochrane Library, Epistemonikos, PROSPERO, and Clinicaltrials.gov. Our inclusion criteria encompassed systematic reviews, randomized controlled trials, quasi-experimental and observational studies involving patients with advanced esophageal or gastric cancer receiving chemotherapy, immunotherapy or biological/targeted therapy compared to BSC. The outcomes included survival, quality of life, functional status, toxicity, and quality of end-of-life care.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>We included and mapped 72 studies, comprising SRs, experimental and observational designs, 12 on esophageal cancer, 51 on gastric cancer, and 10 both locations. Most compared schemes including chemotherapy (47 studies), but did not report therapeutic lines. Moreover, BSC as a control arm was poorly defined, including integral support and placebo. Data favor the use of systemic oncological treatments in survival outcomes and BSC in toxicity. Data for outcomes including quality of life, functional status, and quality of end-of-life care were limited. We found sundry evidence gaps specifically in assessing new treatments such as immunotherapy and important outcomes such as functional status, symptoms control, hospital admissions, and the quality of end-life care for all the treatments.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>There are important evidence gaps regarding new for patients with advanced gastresophageal cancer and the effect of systemic oncological treatments on important patient-centered outcomes beyond survival. Future research should clearly describe the population included, specifying previous treatments and considering therapeutic, and consider all patient-centered outcomes. Otherwise, it will be complex to apply research results into practice.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":null,"pages":null},"PeriodicalIF":7.3,"publicationDate":"2023-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jebm.12539","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9794421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Necessitating evidence-based practice in COVID-19 intramuscular vaccination techniques (to aspirate or not) in the context of scientific/evidence uncertainty amidst the pandemic 在大流行期间,在科学/证据不确定的背景下,需要以证据为基础的COVID-19肌肉注射疫苗技术(是否抽吸)实践
IF 7.3 2区 医学 Q1 Medicine Pub Date : 2023-06-06 DOI: 10.1111/jebm.12537
Asokan G. Vaithinathan, Leena Khonji, Gayathripriya Narayanan
Globally, on average, 16 billion injections are administered every year; of these, vaccination accounts for 5%.1 The World Health Organization’s (WHO) toolkit on best practices classifies injections based on target tissue of delivery as intradermal (ID), subcutaneous (SC), intramuscular (IM), intravenous (IV), intraosseous, intraarterial, and peritoneal. Adhering to the safety standards, the choice of the IM sites (deltoid, dorsogluteal, rectus femoris, vastus lateralis, and ventrogluteal muscles) depends on the volume to be administered2; a “safe injection” does not harm the recipient, provider, or health of the community.1 The Centers for Disease Control and Prevention (CDC) says: aspiration before injection of vaccines or toxoids (i.e., pulling back on the syringe plunger after needle insertion before injection) is not necessary because no large blood vessels are present at the recommended injection sites.3 Most vaccines are given via the IM route to optimize immunogenicity, whereas inadvertent administration may lead toadverseevents, vaccine failure, or poor seroconversion. The status of the coronavirus (COVID-19) vaccinations as of May 23, 2023, indicates that 70% of the world’s population had received at least one dose of a COVID-19 vaccine, 13.38 billion doses have been administered globally, and 3.09million doses each day. Only 29.9% of people in low-income countries have received at least one dose.4 The purpose of this perspective is to appraise the prevailing IM injection techniques while administering the authorized COVID-19 vaccines in the context of adverse events reported; identify the evidence and knowledge gaps chiefly on aspiration technique before administering the COVID-19 vaccine; and address the best evidencebased practice to adopt. An EUA is a mechanism to facilitate the use of therapeutics and vaccines during public health emergencies. The US Food and Drug Administration (FDA) approved five vaccines under EUA; the European Medicines Agency (EMA) approved eight vaccines for marketing or conditional marketing (Table 1). Almost 50 COVID-19 vaccines that have been approved by various agencies around the world, but the WHO has granted emergency use status for the 11 vaccines. Currently, there are 242 vaccine candidates and 821 vaccine trials in 80 countries.5 The COVID-19 vaccines are considered safe and effective. Like any other vaccine, vaccinees have reported mild to moderate side
{"title":"Necessitating evidence-based practice in COVID-19 intramuscular vaccination techniques (to aspirate or not) in the context of scientific/evidence uncertainty amidst the pandemic","authors":"Asokan G. Vaithinathan,&nbsp;Leena Khonji,&nbsp;Gayathripriya Narayanan","doi":"10.1111/jebm.12537","DOIUrl":"10.1111/jebm.12537","url":null,"abstract":"Globally, on average, 16 billion injections are administered every year; of these, vaccination accounts for 5%.1 The World Health Organization’s (WHO) toolkit on best practices classifies injections based on target tissue of delivery as intradermal (ID), subcutaneous (SC), intramuscular (IM), intravenous (IV), intraosseous, intraarterial, and peritoneal. Adhering to the safety standards, the choice of the IM sites (deltoid, dorsogluteal, rectus femoris, vastus lateralis, and ventrogluteal muscles) depends on the volume to be administered2; a “safe injection” does not harm the recipient, provider, or health of the community.1 The Centers for Disease Control and Prevention (CDC) says: aspiration before injection of vaccines or toxoids (i.e., pulling back on the syringe plunger after needle insertion before injection) is not necessary because no large blood vessels are present at the recommended injection sites.3 Most vaccines are given via the IM route to optimize immunogenicity, whereas inadvertent administration may lead toadverseevents, vaccine failure, or poor seroconversion. The status of the coronavirus (COVID-19) vaccinations as of May 23, 2023, indicates that 70% of the world’s population had received at least one dose of a COVID-19 vaccine, 13.38 billion doses have been administered globally, and 3.09million doses each day. Only 29.9% of people in low-income countries have received at least one dose.4 The purpose of this perspective is to appraise the prevailing IM injection techniques while administering the authorized COVID-19 vaccines in the context of adverse events reported; identify the evidence and knowledge gaps chiefly on aspiration technique before administering the COVID-19 vaccine; and address the best evidencebased practice to adopt. An EUA is a mechanism to facilitate the use of therapeutics and vaccines during public health emergencies. The US Food and Drug Administration (FDA) approved five vaccines under EUA; the European Medicines Agency (EMA) approved eight vaccines for marketing or conditional marketing (Table 1). Almost 50 COVID-19 vaccines that have been approved by various agencies around the world, but the WHO has granted emergency use status for the 11 vaccines. Currently, there are 242 vaccine candidates and 821 vaccine trials in 80 countries.5 The COVID-19 vaccines are considered safe and effective. Like any other vaccine, vaccinees have reported mild to moderate side","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":null,"pages":null},"PeriodicalIF":7.3,"publicationDate":"2023-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10154403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The potential benefits of the TIP framework to characterize health services interventions for network meta-analysis TIP框架为网络荟萃分析表征卫生服务干预的潜在益处
IF 7.3 2区 医学 Q1 Medicine Pub Date : 2023-06-05 DOI: 10.1111/jebm.12536
Kenton Cooksey, Sajesh K. Veettil, Nathorn Chaiyakunapruk, Teerapon Dhippayom
The recent growth of networkmeta-analysis (NMA) has revolutionized outcomes research and our abilities to compare treatments to improve patient outcomes.1 Despite this innovation, most evidence synthesis of health service interventions (HSI) have focused on exploring the effect of interventions rather than how to deliver such interventions.2 To fill this gap, a framework classifying delivery by Theme (T), Intensity (I), and Provider/Platform (P) (TIP framework) was developed.3 In brief, the TIP framework was designed to be analogous to three elements of a medication intervention that contribute to its pharmaceutical effects: (1) active ingredient, (2) dose, and (3) dosage form or route of administration.3 These elements also the constitute of HSI. The theme corresponds to the active ingredient and specifies the main element of the intervention. Intensity corresponds to the dose regimen, while the provider or platform corresponds to the dosage form or route of administration and indicates how the main element is delivered. Three NMAs have been published utilizing this framework to provide granular data on effective delivery techniques. Compared to T-only NMA, which only reports data on type of intervention, this new framework provides further practical data on real-world clinical delivery. In this paper, we compared the findings of three NMAs of HSI with and without the use of the TIP framework. The first NMA to incorporate TIP evaluated patient selfmanagement of asthma, where “T” was the strategy to support asthma self-management (i.e., behavior, educational and psychosocial interventions), “I” was frequency of providing these interventions, and “P” was the provider/platform (i.e., health care personal and e-Health) that delivered information to the patient.4 The secondNMAwith a TIP framework evaluated warfarin self-care strategies (T = Patient selftesting, patient self-management; I = frequency which is more (high) or less (low) often or flexible; and P =Healthcare practitioner, patient, and e-Health) and the third one evaluated music interventions to reduce depression in older adults (T = Active music therapy, receptive music therapy, music medicine; I = >60 min per week (high), ≤60 min per week (low); and P=with or without music therapist). As the use of the framework grows, a gap remains in if the knowledge presented by TIP NMA is pertinent to clinical practice compared to T-only NMA. To investigate the potential benefits of the TIP framework, T-only NMAs were performed using the same data as previously published TIP NMAs and the surface under the cumulative ranking curve
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引用次数: 0
Contrast-enhanced ultrasound studies registered on ClinicalTrials.gov: A cross-sectional analysis of characteristics, early discontinuation, and reporting results 注册在ClinicalTrials.gov上的对比增强超声研究:特征、早期终止和报告结果的横断面分析
IF 7.3 2区 医学 Q1 Medicine Pub Date : 2023-06-01 DOI: 10.1111/jebm.12531
Wuyongga Bao, Youlin Long, Jiayan Huang, Min Liao, Jie Yang, Liang Du, Qiang Lu

Objective

Contrast-enhanced ultrasound offers numerous potential applications in diagnostic and interventional radiology. However, systematic studies on the status of clinical studies are limited. Hence, the aim of this study was to analyze the characteristics of registered contrast-enhanced ultrasound studies on ClinicalTrials.gov and identify features associated with early discontinuation and results reporting.

Methods

A data set containing all contrast-enhanced ultrasound clinical studies from ClinicalTrials.gov registered was downloaded. Then, a cross-sectional descriptive study of clinical contrast-enhanced ultrasound studies was conducted. Cox and logistic regression of early discontinuation and reported results, respectively, were also performed.

Results

A total of 225 studies were identified; 174 were interventional and 51 were observational. Regarding the outcomes measure, 175 (77.78%) were diagnosis-oriented, and the remaining 50 (22.22%) were interventional radiology studies. The most common regions of interest were abdominal (56%), superficial (14.22%), or vascular (7.11%) organs. As of the contrast agents, SonoVue/Lumason (39.11%) was most frequently used, followed by Definity (20.89%) and Sonazoid (8.89%). Of all contrast-enhanced ultrasound studies, 32 (14.22%) were discontinued early, and 29 (12.89%) completed studies reported their results. Cox regression analysis revealed that a large sample size and US registration were factors reducing early discontinuation risk. Among completed studies, factors associated with reported results were industry funding and US registration.

Conclusion

The findings suggest that the number of contrast-enhanced ultrasound studies has grown over time, but is still small. Developing new advancements in contrast-enhanced ultrasound will require a concerted effort to increase the quality and quantity of clinical studies in this field.

目的对比增强超声在诊断和介入放射学中有许多潜在的应用。然而,对临床研究现状的系统研究却十分有限。因此,本研究的目的是分析ClinicalTrials.gov上注册的对比增强超声研究的特征,并确定与早期停药和结果报告相关的特征。方法下载ClinicalTrials.gov网站注册的所有超声造影临床研究数据集。然后,对临床超声造影研究进行了横断面描述性研究。对早期停药和报告结果分别进行Cox和logistic回归分析。结果共纳入225项研究;174例为干预性,51例为观察性。在结局指标方面,175例(77.78%)以诊断为导向,其余50例(22.22%)为介入放射学研究。最常见的病变区域是腹部(56%)、浅表(14.22%)或血管(7.11%)器官。对比剂中,使用频率最高的是SonoVue/Lumason(39.11%),其次是Definity(20.89%)和Sonazoid(8.89%)。在所有对比增强超声研究中,32例(14.22%)提前终止,29例(12.89%)完成研究报告其结果。Cox回归分析显示,大样本量和美国注册是降低早期停药风险的因素。在已完成的研究中,与报告结果相关的因素是行业资助和美国注册。结论对比增强超声研究的数量随着时间的推移而增加,但仍然很少。在对比增强超声方面取得新进展需要各方共同努力,以提高该领域临床研究的质量和数量。
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引用次数: 0
Positive relationships between masticatory function, blood lipids, and complement components in Chinese oldest-old and centenarian population 中国老年人和百岁老人咀嚼功能、血脂和补体成分之间的正相关关系
IF 7.3 2区 医学 Q1 Medicine Pub Date : 2023-05-30 DOI: 10.1111/jebm.12535
Lijun Zhou, Ping Ping, Ting Yang, Xiang Zhu, Lihua Bian, Yali Zhao, Qing Song, Shihui Fu
Nowadays, oral health has become a global academic consensus. A major threat to the oral health of the elderly population is the loss of teeth. In many countries, the rate of total teeth loss in people over 65 years old is between 7% and 45%.1 Recessionary masticatory ability in edentulous populations leads to lacked food diversity, changes the dietary structure and insufficient nutritional intake, whichmay further lead to decreased blood lipids and body resistance.2 Meanwhile, lipid metabolism also plays an important role in immune cell function.3 It is closely related to liver physiology and pathology and is also involved in regulating macrophage biology.4 Abnormal blood lipids may affect the basic life activities of cells and lead to an imbalance of immune function. A recent study has found that blood lipids were correlated with immune function.5 The change inmasticatory function could affect the metabolism of blood lipids and the risk of immune abnormality. The evaluation of immune function is of great significance in the elderly population. Complement components, produced partly in the liver and secreted partly by the macrophages, are essential to immune system.6 Complement components play an important role in body resistance through immunoconditioning and interfere with the release of cytokines involved in immune responses.7 Whether masticatory function affects the alteration in blood lipids and complement levels has not yet been determined, especially in Chinese elderly population. This study investigated the relationships between masticatory function, blood lipids, and complement components in Chinese oldest-old and centenarians (Figure S1A). Based on the China Hainan Centenarian Cohort Study (CHCCS), this survey was carried out in 18 cities and counties of Hainan, China. All 1712 oldest-old and centenarian participants with complete data and had no diagnosed rheumatoid arthritis and other autoimmune diseases. Home interviews and physical checkups were conducted following standard procedures by our strictly trained investigator.8 A portable ultrasound machine (Philips CX50, Philips Medical Systems, Andover, MA, USA) was used to measure the periumbilical fat thickness (PFT) by experienced radiologists. In the oral examination of each participant, professional dentists were arranged to record the number of remaining teeth, missing teeth, tooth position, and denture restoration using mouth mirror and probe. Edentulous participants without dentures were assigned to the group without masticatory function,
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引用次数: 0
Introducing value-based healthcare perspectives into hospital performance assessment: A scoping review 将基于价值的医疗保健观点引入医院绩效评估:范围审查
IF 7.3 2区 医学 Q1 Medicine Pub Date : 2023-05-25 DOI: 10.1111/jebm.12534
Wenbo He, Meixuan Li, Liujiao Cao, Rui Liu, Jiuhong You, Fangyuan Jing, Jiawen Zhang, Wei Zhang, Mengling Feng

Objective

Value-based healthcare (VBHC) puts patient outcomes at the center of the healthcare process while optimizing the use of hospital resources across multiple stakeholders. This scoping review was conducted to summarize how VBHC had been represented in theory and in practice, how it had been applied to assess hospital performance, and how well it had been ultimately implemented.

Methods

For this review, we followed the PRISMA-ScR protocol and searched five major online databases for articles published between January 2006 and July 2022. We included original articles that used the concept of VBHC to conduct performance assessments of healthcare organizations. We extracted and analyzed key concepts and information on the dimensions of VBHC, specific strategies and methods for using VBHC in performance assessment, and the effectiveness of the assessment.

Results

We identified 48 eligible studies from 7866 articles. Nineteen nonempirical studies focused on the development of a VBHC performance assessment indicator system, and 29 empirical studies reported on the ways and points of introducing VBHC into performance assessment and its effectiveness. Ultimately, we summarized the key dimensions, processes, and effects of performance assessment after introducing VBHC.

Conclusion

Current healthcare performance assessment has begun to focus on implementing VBHC as an integrated strategy, and future work should further clarify the reliability of metrics and their association with evaluation outcomes and consider the effective integration of clinical outcomes and patient-reported outcomes.

基于价值的医疗保健(VBHC)将患者的结果置于医疗保健流程的中心,同时在多个利益相关者之间优化医院资源的使用。进行这一范围审查是为了总结VBHC在理论和实践中的表现,如何应用于评估医院绩效,以及最终实施情况如何。方法在本综述中,我们按照PRISMA-ScR协议检索了2006年1月至2022年7月间发表的5个主要在线数据库的文章。我们收录了使用VBHC概念对医疗保健组织进行绩效评估的原创文章。我们提取和分析了VBHC维度的关键概念和信息、在绩效评估中使用VBHC的具体策略和方法以及评估的有效性。结果我们从7866篇文章中筛选出48篇符合条件的研究。有19项非实证研究关注VBHC绩效评估指标体系的构建,29项实证研究报道了将VBHC引入绩效评估的方式、要点及其有效性。最后,我们总结了引入VBHC后绩效评估的关键维度、流程和效果。结论目前的医疗保健绩效评估已经开始将VBHC作为一种综合策略来实施,未来的工作应进一步明确指标的可靠性及其与评估结果的关联,并考虑临床结果和患者报告结果的有效整合。
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引用次数: 1
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Journal of Evidence‐Based Medicine
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