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The characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria in China between 1965 and 2023: A cross-sectional study 1965-2023年间中国诊断标准的特点、制定方法、报告质量和证据基础:一项横断面研究。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-21 DOI: 10.1111/jebm.12624
Qi Zhou, Hongfeng He, Qinyuan Li, Janne Estill, Zhengxiu Luo, Kehu Yang, Jinling Tang, Yaolong Chen

Objective

As a large and populous country, China releases a high number of diagnostic criteria. However, the published diagnostic criteria have not yet been systematically analyzed. Therefore, the aim of this study is to investigate the characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria published in China.

Methods

We searched five databases for diagnostic criteria from their inception until July 31, 2023. All diagnostic criteria were screened through abstract and full-text reading, and included if satisfying the prespecified criteria. Two researchers independently extracted data on the characteristics, development methods, reporting quality, and evidence basis of diagnostic criteria.

Results

A total of 143 diagnostic criteria were included. In terms of development methods, the proportions of diagnostic criteria that involved a systematic literature search (n = 2; 1.4%; 95% confidence interval (CI), 0.4% to 5.0%), adoption of formal consensus methods (n = 4; 2.8%; 95% CI, 1.1% to 7.0%), and criteria validation (n = 9; 6.3%; 95% CI, 3.3% to 11.5%) were relatively low. Regarding reporting quality, the average compliance with the ACCORD checklist was 5.1%; none of the diagnostic criteria reported on registration, expert inclusion criteria, expert recruitment process, or consensus results. A majority (58.7%; 95% CI, 50.6% to 66.5%) of criteria did not cite any research, and only one (0.7%; 95% CI, 0.1% to 3.9%) criterion was derived from a systematic review. Moreover, only 16.1% (95% CI, 11.0% to 23.0%) of diagnostic criteria used evidence from the Chinese population.

Conclusion

The diagnostic criteria developed in China exhibit serious flaws, particularly in evidence retrieval, formation of expert panels, consensus methods, and validation. Additionally, only few diagnostic criteria used a systematic synthesis of the evidence or evidence from the China. There is an urgent need to enhance the methodology for developing diagnostic criteria.

目的:作为一个人口众多的大国,中国发布了大量的诊断标准。然而,目前尚未对已发布的诊断标准进行系统分析。因此,本研究旨在调查中国发布的诊断标准的特点、制定方法、报告质量和证据基础:方法:我们检索了五个数据库中自始至 2023 年 7 月 31 日的诊断标准。通过摘要和全文阅读对所有诊断标准进行筛选,如果符合预设标准则纳入。两名研究人员独立提取了诊断标准的特征、制定方法、报告质量和证据基础等方面的数据:结果:共纳入了 143 项诊断标准。在制定方法方面,涉及系统文献检索(n = 2;1.4%;95% 置信区间 (CI),0.4% 至 5.0%)、采用正式共识方法(n = 4;2.8%;95% CI,1.1% 至 7.0%)和标准验证(n = 9;6.3%;95% CI,3.3% 至 11.5%)的诊断标准比例相对较低。在报告质量方面,ACCORD 检查表的平均符合率为 5.1%;没有一项诊断标准报告了注册、专家纳入标准、专家招募过程或共识结果。大多数标准(58.7%;95% CI,50.6% 至 66.5%)没有引用任何研究,只有一项标准(0.7%;95% CI,0.1% 至 3.9%)来自系统综述。此外,只有 16.1%(95% CI,11.0% 至 23.0%)的诊断标准使用了来自中国人群的证据:结论:中国制定的诊断标准存在严重缺陷,尤其是在证据检索、专家小组的组建、共识方法和验证方面。此外,只有少数诊断标准使用了系统的证据综合或来自中国的证据。制定诊断标准的方法亟待改进。
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引用次数: 0
Impact of hormone replacement therapy on all-cause and cancer-specific mortality in colorectal cancer: A systematic review and dose‒response meta-analysis of observational studies 激素替代疗法对结直肠癌全因死亡率和癌症特异性死亡率的影响:观察性研究的系统回顾和剂量反应荟萃分析。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-20 DOI: 10.1111/jebm.12622
Kefeng Liu, Yazhou He, Qiong Li, Shusen Sun, Zubing Mei, Jie Zhao

Objective

The effect of hormone replacement therapy (HRT) on colorectal cancer (CRC) mortality and all-cause mortality remains unclear. We conducted a systematic review and dose–response meta-analysis to determine the effects of HRT on CRC mortality and all-cause mortality.

Methods

We searched the electronic databases of PubMed, Embase, and The Cochrane Library for all relevant studies published until January 2024 to investigate the effects of HRT exposure on survival rates for patients with CRC. Two reviewers independently extracted individual study data and evaluated the risk of bias between the studies using the Newcastle‒Ottawa Scale. We performed a two-stage random-effects dose–response meta-analysis to examine a possible nonlinear relationship between the year of HRT use and CRC mortality.

Results

Ten cohort studies with 480,628 individuals were included. HRT was inversely associated with the risk of CRC mortality (hazard ratios (HR) = 0.77, 95% CI (0.68, 0.87), I2 = 69.5%, p < 0.05). The pooled results of seven cohort studies revealed a significant association between HRT and the risk of all-cause mortality (HR = 0.71, 95% CI (0.54, 0.92), I2 = 89.6%, p < 0.05). A linear dose–response analysis (p for nonlinearity = 0.34) showed a 3% decrease in the risk of CRC for each additional year of HRT use; this decrease was significant (HR = 0.97, 95% CI (0.94, 0.99), p < 0.05). An additional linear (p for nonlinearity = 0.88) dose–response analysis showed a nonsignificant decrease in the risk of all-cause mortality for each additional year of HRT use.

Conclusions

This study suggests that the use of HRT is inversely associated with all-cause and colorectal cancer mortality, thus causing a significant decrease in mortality rates over time. More studies are warranted to confirm this association.

目的:激素替代疗法(HRT)对结直肠癌(CRC)死亡率和全因死亡率的影响仍不清楚。我们进行了一项系统综述和剂量反应荟萃分析,以确定激素替代疗法对 CRC 死亡率和全因死亡率的影响:我们在 PubMed、Embase 和 Cochrane 图书馆的电子数据库中检索了 2024 年 1 月之前发表的所有相关研究,研究内容是探讨接触 HRT 对 CRC 患者生存率的影响。两名审稿人独立提取了单个研究数据,并使用纽卡斯尔-渥太华量表评估了研究之间的偏倚风险。我们进行了两阶段随机效应剂量反应荟萃分析,以研究使用 HRT 的年份与 CRC 死亡率之间可能存在的非线性关系:结果:共纳入了 10 项队列研究,涉及 480628 人。HRT与CRC死亡风险成反比(危险比(HR)=0.77,95% CI(0.68,0.87),I2=69.5%,P 2=89.6%,P 结论:HRT与CRC死亡风险成反比:本研究表明,使用 HRT 与全因死亡率和结直肠癌死亡率成反比,从而使死亡率随着时间的推移显著下降。需要进行更多的研究来证实这种关联。
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引用次数: 0
Effectiveness of narrowband ultraviolet B monotherapy versus combination therapy with systemic agents in patients with early-stage mycosis fungoides and the association with plaque lesions 窄带紫外线 B 单药治疗与全身用药联合治疗对早期真菌病患者的疗效以及与斑块病变的关系。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-19 DOI: 10.1111/jebm.12623
Yao Qin, Yuwei Lin, Zhuojing Chen, Qiuli Zhang, Yingyi Li, Yujie Wen, Ping Tu, Pei Gao, Yang Wang

Objective

Narrowband ultraviolet B (NB-UVB) has been recommended as first-line therapy for early-stage mycosis fungoides (MF) in international guidelines. NB-UVB can be used as monotherapy or part of a multimodality treatment regimen. There is limited evidence on the effectiveness and optimal patients of NB-UVB in combination with systemic therapies in MF. We aimed to assess the effectiveness of the combination versus NB-UVB monotherapy in early-stage MF and if plaque lesion status was related to these effects.

Methods

This observational cohort study included 247 early-stage MF patients who had received NB-UVB combined with systemic therapies vs. NB-UVB monotherapy from 2009 to 2021. The primary outcome was partial or complete response. Overall response rate and median time to response were calculated. Hazard ratios (HRs) were estimated using the Cox model.

Results

In 139 plaque-stage patients, the response rate for combination therapy group was higher than that of monotherapy group (79.0% vs. 54.3%, = 0.006). The adjusted HR for combination therapy compared with NB-UVB monotherapy was 3.11 (95% CI 1.72–5.63). The combination therapy group also showed shorter time to response (4 vs. 6 months, = 0.002). In 108 patch-stage patients, the response rate and time to response in two treatment groups showed no significant difference. There was therefore an observed interaction with patients’ plaque lesion status for the effect size of NB-UVB combination therapy. No serious adverse events were observed.

Conclusions

Adding systemic treatments to NB-UVB did not improve the treatment outcome of patch-stage patients, but it surpassed NB-UVB monotherapy for early-stage patients with plaques.

目的:窄带紫外线 B(NB-UVB)已被国际指南推荐为早期真菌病(MF)的一线疗法。窄带紫外线 B 可作为单一疗法使用,也可作为多模式治疗方案的一部分。关于 NB-UVB 与系统疗法联合治疗霉菌性真菌病的有效性和最佳患者的证据有限。我们旨在评估联合治疗与 NB-UVB 单药治疗对早期 MF 的疗效,以及斑块病变状态是否与这些疗效相关:这项观察性队列研究纳入了2009年至2021年期间接受NB-UVB联合系统疗法与NB-UVB单药治疗的247名早期MF患者。主要结果为部分或完全应答。计算总反应率和中位反应时间。使用 Cox 模型估算了危险比(HRs):在139例斑块期患者中,联合疗法组的应答率高于单一疗法组(79.0% vs. 54.3%,P = 0.006)。与 NB-UVB 单一疗法相比,联合疗法的调整 HR 为 3.11(95% CI 1.72-5.63)。联合疗法组的反应时间也更短(4 个月对 6 个月,P = 0.002)。在 108 例斑贴期患者中,两个治疗组的反应率和反应时间没有明显差异。因此,NB-UVB联合疗法的效果大小与患者的斑块病变状态存在相互作用。未观察到严重不良事件:结论:在NB-UVB基础上增加全身治疗并不能改善斑块期患者的治疗效果,但对于早期斑块期患者来说,其效果优于NB-UVB单药治疗。
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引用次数: 0
MASTER scale for methodological quality assessment: Reliability assessment and update 方法学质量评估 MASTER 量表:可靠性评估与更新。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-12 DOI: 10.1111/jebm.12618
Ashraf I. Ahmed, Muhammad Zain Kaleem, Amgad Mohamed Elshoeibi, Abdalla Moustafa Elsayed, Elhassan Mahmoud, Yaman A. Khamis, Luis Furuya-Kanamori, Jennifer C. Stone, Suhail A. Doi
<p>In evidence synthesis of analytical studies, methodological quality (mQ) assessment is necessary to determine the extent to which internal validity safeguards are implemented in the included studies against a list of selected safeguards in an assessment tool. Such mQ tools consist of internal validity safeguards that are checked against those put in place by researchers when they undertake research to guard against systematic error in the design, conduct, and analysis of a study.<span><sup>1</sup></span> However, consistency or agreement among the individuals undertaking an assessment of implemented safeguards in published research against those listed in a mQ tool needs to be documented to ensure that the tool is reliable. Therefore mQ tools need to have their interrater reliability tested in order to ensure the consistency of their use in research.<span><sup>2</sup></span></p><p>Many existing tools are available to assess mQ or risk of bias (RoB) specific to a study design, which leads to a lack of comparability across studies of different designs when using different tools and assessment results which, as a whole, may lack meaning. For example, Cochrane's Risk of Bias (RoB2) tool is used to assess the RoB in RCTs while nonrandomized trials are assessed using the ROBINS-I tool. It is difficult to compare these scales to one another, and hence, there is a need for a unified scale that is not confined to one study design. The MASTER scale was developed to overcome some of these issues by providing a comprehensive list of methodological safeguards across analytic study designs that allow for comparative assessment between these studies. It uses an assessment approach that takes the reviewer all the way from mQ assessment through to an ability to make use of this for bias adjustment.<span><sup>3, 4</sup></span> A drawback for reviewers using the MASTER scale is that there is a lack of information regarding its reliability, with no studies conducted to assess this metric.</p><p>The degree to which studies maintain their relative position in a list over repeated measurements is referred to as reliability.<span><sup>5</sup></span> For example, when assessing the reliability of a tool such as the MASTER scale, it would be considered reliable if you see that studies which scored well on the tool by the first rater also scored well on subsequent assessments by different raters.<span><sup>5, 6</sup></span> The scoring system for this scale has been discussed previously.<span><sup>7</sup></span> Such consistency across the individuals undertaking mQ assessment needs to be established to ensure that the tool is reliable across different raters. Researchers trained in clinical epidemiology were chosen for this study so that they could also examine the scale item wordings to remove ambiguity and improve the readability and applicability of the wording. This study therefore serves the dual purpose of evaluating the reliability of the MASTER scale across rat
在对分析研究进行证据综述时,有必要进行方法学质量(mQ)评估,以便对照评估工具中的选定保障措施清单,确定所纳入研究在多大程度上实施了内部有效性保障措施。此类 mQ 工具由内部有效性保障措施组成,研究人员在开展研究时要对照这些保障措施进行检查,以防止在研究的设计、实施和分析过程中出现系统性错误。1 但是,对已发表研究中已实施的保障措施与 mQ 工具中列出的保障措施进行评估的人员之间是否保持一致或达成一致,需要记录在案,以确保工具的可靠性。2 现有的许多工具可用于评估特定研究设计的 mQ 或偏倚风险 (RoB),这导致不同设计的研究在使用不同工具时缺乏可比性,评估结果整体上可能缺乏意义。例如,Cochrane 的偏倚风险(RoB2)工具用于评估 RCT 的 RoB,而非随机试验则使用 ROBINS-I 工具进行评估。这些量表很难相互比较,因此需要一个不局限于一种研究设计的统一量表。开发 MASTER 量表的目的就是为了克服其中的一些问题,它提供了一份跨分析研究设计的方法学保障措施综合清单,以便在这些研究之间进行比较评估。该量表采用一种评估方法,让评审者从 mQ 评估一直到能够利用该量表进行偏倚调整。3, 4 评审者使用 MASTER 量表的一个缺点是缺乏有关其可靠性的信息,没有研究对这一指标进行评估。例如,在评估 MASTER 量表等工具的可靠性时,如果发现第一位评分者在该工具上得分较高的研究在不同评分者的后续评估中也得分较高,则可认为该工具是可靠的。本研究选择了受过临床流行病学培训的研究人员,这样他们也可以检查量表项目的措辞,以消除歧义,提高措辞的可读性和适用性。如表 S1 所示,共有 11 项研究8-18 被选中进行评估,这些研究共涉及 1344 名患者,采用不同的研究设计,比较了用生理盐水和环状乳酸盐治疗急性胰腺炎的效果。这 11 项研究中,5 项9-11、13、18 为随机对照试验,包括 299 名患者;3 项8、12、14 为队列研究,包括 433 名患者;3 项15-17 为摘要,包括 612 名患者。在 De-Madaria10 的研究中,所有评分者的平均质量保障计数(Qi)最高,为 33.17(标清 1.33)。相反,Vasu De Van 17 的研究报告中的平均质量保障指数最低,该研究摘要基于一项 50 名患者的 RCT,平均质量保障指数为 8.83(标准差为 4.45)。德-马达利亚(De-Madaria)10 的研究中也发现了最高的相对等级平均值,为 0.99(标度 0.01),而瓦苏-德-范(Vasu De Van)17 的研究中则发现了最低的相对等级平均值,为 0.27(标度 0.12)。同样,在绝对等级方面,De-Madaria10 的研究中平均等级最高,为 1.17(标准差 0.41),而 Vasu De Van17 的研究中平均等级最低,为 10.67(标准差 0.52)。值得注意的是,计数最高的研究的相对排名总是 1,随着研究排名的降低,相对排名也会降低7。图 S1 展示了六位评定者如何对 11 项研究中的一项进行评定。图中显示了每位评分者分配的总体保障措施计数,以及对总体计数的细分分析,显示了每项标准在总计数中所占的比例。如表 S2 所示,结果表明所有三项测量的内部一致性和可靠性都很高。保障措施总计数(Qi)和相对等级的 ICC 分别为 0.90(95% CI:0.79-0.97)和 0.90(95% CI:0.80-0.97),表明评分者之间的一致性极佳。
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引用次数: 0
Comparation of fixed-ratio (IDegLira and iGlarLixi) versus free combination of basal insulin and glucagon-like peptide-1 receptor agonist for uncontrolled type 2 diabetes: A systematic review and network meta-analysis 固定比例(IDegLira 和 iGlarLixi)与基础胰岛素和胰高血糖素样肽-1 受体激动剂自由组合治疗不受控制的 2 型糖尿病的比较:系统综述和网络荟萃分析。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-10 DOI: 10.1111/jebm.12620
Junling Weng, Ying Tao, Zian Xu, Shanyan Zhou, Dunming Xiao, Zhixu Zhu, Ruizhi Zheng, Yi Yang, Yingyao Chen

Objective

This study aimed to evaluate the safety and efficacy of the fixed-ratio combination (FRC) and free combination of basal insulin and glucagon-like peptide-1 receptor agonist (GLP-1RA) in patients with type 2 diabetes mellitus (T2DM).

Methods

PubMed, Web of Science, Embase, The Cochrane Library, and four Chinese databases were searched for relevant studies from inception to April 13, 2023. Phase III clinical trials involving FRC or free combination in patients with uncontrolled T2DM were included. A network meta-analysis (NMA) was used to evaluate the effects of FRC and free combination. The Cochrane Collaboration's tool was used to evaluate the risk-of-bias. The primary outcomes were changes in hemoglobin A1c (HbA1c), body weight, and incident hypoglycemia. Secondary outcomes included changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP). This study was registered with PROSPERO (CRD42023409585).

Results

Forty-two trials with 23,619 patients were included in the NMA, and treatments were categorized as FRC, free combination and NOINSGLP (neither FRC nor free combination). The forest plots revealed comparable HbA1c control (mean difference (MD) = 0.07%, 95% confidence interval (CI): –0.17 to –0.30) between free combination and FRC. However, there were significant differences in the body weight (MD = –2.06 kg; 95% CI: –3.34 to –0.77), SBP (MD = –1.22 mmHg; 95% CI: –2.41 to –0.04), and DBP (MD = –1.09 mmHg; 95% CI: –1.94 to –0.24) between the two groups.

Conclusions

In patients with uncontrolled T2DM, the safety and efficacy of FRC and free combination therapy were comparable. The use of FRC is justifiable in patients requiring free combination.

研究目的本研究旨在评估基础胰岛素和胰高血糖素样肽-1 受体激动剂(GLP-1RA)固定比例组合(FRC)和自由组合在 2 型糖尿病(T2DM)患者中的安全性和有效性:检索了 PubMed、Web of Science、Embase、The Cochrane Library 和四个中文数据库中从开始到 2023 年 4 月 13 日的相关研究。研究纳入了针对未受控制的 T2DM 患者的 FRC 或自由组合的 III 期临床试验。采用网络荟萃分析(NMA)评估 FRC 和自由联合用药的效果。Cochrane 协作组织的工具用于评估偏倚风险。主要结果是血红蛋白 A1c (HbA1c)、体重和低血糖事件的变化。次要结果包括收缩压(SBP)和舒张压(DBP)的变化。本研究已在 PROSPERO(CRD42023409585)注册:42项试验共23619名患者被纳入NMA,治疗方法分为FRC、自由组合和NOINSGLP(既非FRC也非自由组合)。森林图显示,自由联合疗法与自由联合疗法的 HbA1c 控制率相当(平均差 (MD) = 0.07%,95% 置信区间 (CI):-0.17 至 -0.30)。然而,两组患者的体重(MD = -2.06 kg;95% CI:-3.34 至 -0.77)、SBP(MD = -1.22 mmHg;95% CI:-2.41 至 -0.04)和 DBP(MD = -1.09 mmHg;95% CI:-1.94 至 -0.24)存在显著差异:结论:在未得到控制的 T2DM 患者中,FRC 和自由联合疗法的安全性和有效性相当。对于需要自由联合疗法的患者,使用 FRC 是合理的。
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引用次数: 0
Induced abortion and ectopic pregnancy: A systematic review and meta-analysis 人工流产与宫外孕:系统回顾和荟萃分析。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-10 DOI: 10.1111/jebm.12619
Xin Wang, Mengcong Deng, Shangchun Wu, Qunxia Mao

Objective

Existing evidence of the relationship between induced abortion and ectopic pregnancy has not been assessed rigorously. This systematic review provides a comprehensive evaluation to examine whether induced abortion (IA) can increase the rate of ectopic pregnancy (EP).

Methods

We searched PubMed, EMBASE, Web of Science, Cochrane, CNKI, WanFang, and Sinomed databases since their inception until February 2023. Eligibility criteria included case-control studies and cohort studies that analyzed induced abortion associated with ectopic pregnancy. Data analyses were conducted by using R-studio Version 1.1.383 software.

Results

A total of 33 case-control studies and 7 cohort studies involving 132,926 participants were included. In case-control studies, there was a significant association between induced abortion and ectopic pregnancy by using single-factor analysis data (OR = 2.32, 95% CI = 1.81–2.98). Subgroup analysis by region suggested no statistical significance in the Americas (OR = 1.15, 95% CI = 0.92–1.43) and Eastern Mediterranean (OR = 3.64, 95% CI = 0.88–15.18). The relationship was significant by using multiple regression analysis data (OR = 1.97, 95% CI = 1.38–2.80). In cohort studies, statistical significance was found (OR = 1.42, 95% CI = 1.001–2.018) after omitting one study in sensitivity analysis. The combined results of the two types of studies suggested that induced abortion would increase the risk of ectopic pregnancy to some degree, but the conclusion needs to be considered with caution.

Conclusion

This study indicated that IA could increase the risk of EP to some degree and the times of IA had a negative impact on the risk. Safe abortion and avoiding repeat abortion due to unintended pregnancy could protect women's fertility.

目的:关于人工流产与异位妊娠之间关系的现有证据尚未得到严格评估。本系统综述对人工流产(IA)是否会增加异位妊娠(EP)的发生率进行了全面评估:方法:我们检索了 PubMed、EMBASE、Web of Science、Cochrane、CNKI、万方和 Sinomed 数据库自建立以来至 2023 年 2 月的所有文献。资格标准包括分析与异位妊娠相关的人工流产的病例对照研究和队列研究。数据分析采用 R-studio 1.1.383 版软件:结果:共纳入 33 项病例对照研究和 7 项队列研究,涉及 132926 名参与者。在病例对照研究中,通过使用单因素分析数据,人工流产与宫外孕之间存在显著关联(OR = 2.32,95% CI = 1.81-2.98)。按地区进行的分组分析表明,美洲(OR = 1.15,95% CI = 0.92-1.43)和地中海东部(OR = 3.64,95% CI = 0.88-15.18)没有统计学意义。通过使用多元回归分析数据(OR = 1.97,95% CI = 1.38-2.80),这种关系非常明显。在队列研究中,在敏感性分析中省略一项研究后,发现统计学意义(OR = 1.42,95% CI = 1.001-2.018)。两类研究的综合结果表明,人工流产会在一定程度上增加宫外孕的风险,但这一结论需要慎重考虑:本研究表明,人工流产会在一定程度上增加宫外孕的风险,而人工流产的时间对宫外孕的风险有负面影响。安全人工流产和避免因意外怀孕而再次人工流产可保护妇女的生育能力。
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引用次数: 0
The fate of rejected manuscripts in different biomedical disciplines 不同生物医学学科的退稿命运。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-06-06 DOI: 10.1111/jebm.12617
Clovis M. Faggion Jr, Max C. Menne
<p>A scientific journal may reject a submitted manuscript for several reasons. For example, desk rejection occurs when a topic is addressed that does not fit a journal's aims. Or the submitted manuscript has insufficient methodological quality. Therefore, authors need to manage manuscript rejection as a normal part of the publication process. Because methodological quality is not the only reason for rejection, authors will typically submit a rejected manuscript to another journal. This allows research authors to maintain efficiency and avoid wasted effort.<span><sup>1</sup></span> Actually, not attempting to publish research material due to one journal's rejection can be considered a form of publication bias.<span><sup>2</sup></span></p><p>The fate of rejected manuscripts has already been researched in different biomedical disciplines. However, the quality and characteristics of the studies assessing rejected manuscripts have not been performed. The aim of the present survey was to examine the characteristics of studies assessing the fate of rejected manuscript submissions in various biomedical disciplines and to provide manuscript rejection rates.</p><p>Studies assessing the fate of rejected manuscripts in different biomedical disciplines were included. Similar studies focused on other scientific disciplines were excluded. Only articles written in English were included. The PubMed, Scopus, and Web of Science Core Collection databases were searched on 12 May 2024, and articles published from the database's inception to the date of search were considered for inclusion. The following keywords and Boolean operators were applied in a search of the database: “rejected manuscript” OR “rejected manuscripts” OR “rejected articles” OR “rejected papers.” Additionally, the reference lists of the articles included were scrutinized for further potential studies to include (Section S1). We selected articles based on the eligibility criteria. Those not meeting these criteria were excluded, first in a title/abstract assessment and then in a full-text assessment (Sections S2–S4, Figure S1).</p><p>The reasons for exclusion were individually determined. When data on rejection rates were not reported, we calculated them by dividing the number of manuscripts submitted by the number of manuscripts rejected. The data were extracted into an Excel datasheet, and the included information is reported in Table 1. Study selection and data extraction were performed in duplicate for 10 studies. After good agreement (more than 80%), the remaining process was performed by one author (M.C.M.).<span><sup>3</sup></span> Data were presented as frequencies and percentages and, when applicable, as means and medians.</p><p>A total of 36 studies meeting the eligibility criteria were found (Section S5). The most prevalent affiliation of the first author of the studies was the USA (<i>n</i> = 17, 47%), followed by Italy and Switzerland (each <i>n</i> = 3, 9%). The discipline of radiology
我们的调查发现了有关退稿命运的研究特点以及这些研究在方法上的一些局限性。我们还发现,在我们的样本中,普通医学和内科学领域的退稿率最高(被评估期刊包括:《柳叶刀》、《英国医学杂志》和《美国医学杂志》):柳叶刀》、《英国医学杂志》、《内科学年鉴》),而临床神经学领域的退稿率最低。需要强调的是,我们使用专业期刊作为医学学科的代表。在麻醉学领域(我们数据集中退稿率第二高的领域),我们只从一项评估投稿给单一期刊的退稿率的研究中检索到数据。该期刊(《麻醉学》)的IF为10.7(JCR 2022),是同类期刊中IF最高的。我们可以假设,由于该期刊的IF相对较高,它可能会收到很多投稿,因此,该期刊在发表稿件时会非常挑剔。有证据表明,IF 以及期刊是否被索引和同行评议是医学领域作者选择投稿期刊的最重要标准。从方法论质量的角度来看,评估退稿的研究可以遵循 AMSTAR-2(多系统综述评估)3 等工具中报告的项目指导。事实上,对退稿研究进行评估的研究也应该像任何系统综述一样,采用系统的方法来识别、选择和提取信息。这种方法可以让读者相信,所有可能的研究都被纳入其中,从而减少潜在的出版偏差,并确保研究的方法质量尽可能高。这些研究还可以遵守关于其设计的更加统一的定义,使其标准化。这种标准化将有助于在系统综述框架内对这些研究进行评估,也有助于读者正确识别研究类型。另一项可以改善这些研究方法特点的措施是在研究项目的不同阶段实施试点战略。例如,在数据选择和提取方面,这种策略有可能最大限度地降低项目开发过程中出现错误的风险。例如,通过明确说明潜在的财务和非财务CoI11, 12 以及研究是否获得经济支持的详细情况,未来有关该主题的研究中可以改进的另一个领域是研究是否获得任何伦理委员会的批准。本样本中有三分之二的研究没有提供任何有关伦理审批的信息。事实上,当有接受治疗的病人参与时,这种批准可能更为重要。然而,有趣的是,样本中的少数研究报告了某种审批,科学界应进一步讨论开展此类研究是否需要此类审批。13 简而言之,本研究报告指出,一些生物医学学科有不同的退稿率,被退稿的稿件再次投稿时,发表在IF 低于首次投稿退稿的期刊上。此外,评估生物医学学科退稿命运的研究方法报告还有改进的余地。
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引用次数: 0
Five aspects of research waste in biomedicine: A scoping review 生物医学研究浪费的五个方面:范围审查。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-05-26 DOI: 10.1111/jebm.12616
Louise Olsbro Rosengaard, Mikkel Zola Andersen, Jacob Rosenberg, Siv Fonnes

Background

The number of published journal articles has grown exponentially during the last 30 years, which may have led to some wasteful research. However, the terminology associated with research waste remains unclear. To address this, we aimed to identify, define, and categorize the aspects of research waste in published biomedical reports.

Methods

In this scoping review, we systematically searched for biomedical literature reports from 1993 to 2023 in two databases, focusing on those addressing and defining research waste. Through data charting, we analyzed and categorized the aspects of research waste.

Results

Based on 4285 initial records in the searches, a total of 832 reports were included in the analysis. The included reports were primarily narrative reviews (26%) and original reports (21%). We categorized research waste into five aspects: methodological, invisible, negligible, underreported, and structural (MINUS) research waste. More than half of the reports (56%) covered methodological research waste concerning flaws in study design, study conduct, or analysis. Invisible research waste covered nonpublication, discontinuation, and lack of data-sharing. Negligible research waste primarily concerned unnecessary repetition, for example, stemming from the absence of preceding a trial with a systematic review of the literature. Underreported research waste mainly included poor reporting, resulting in a lack of transparency. Structural research waste comprised inadequate management, collaboration, prioritization, implementation, and dissemination.

Conclusion

MINUS encapsulates the five main aspects of research waste. Recognizing these aspects of research waste is important for addressing and preventing further research waste and thereby ensuring efficient resource allocation and scientific integrity.

背景:在过去 30 年里,期刊论文的发表数量呈指数级增长,这可能导致了一些研究的浪费。然而,与研究浪费相关的术语仍不明确。为了解决这个问题,我们旨在对已发表的生物医学报告中研究浪费的各个方面进行识别、定义和分类:在此次范围界定综述中,我们在两个数据库中系统地搜索了 1993 年至 2023 年的生物医学文献报告,重点关注那些涉及和定义研究浪费的报告。通过数据图表,我们对研究浪费的各个方面进行了分析和分类:结果:根据搜索的 4285 条初始记录,共有 832 篇报告被纳入分析。纳入的报告主要是叙事性综述(26%)和原创性报告(21%)。我们将研究浪费分为五个方面:方法性研究浪费、隐形研究浪费、可忽略不计的研究浪费、报告不足的研究浪费和结构性研究浪费(MINUS)。一半以上的报告(56%)涉及方法论研究浪费,包括研究设计、研究实施或分析中的缺陷。隐形研究浪费包括未发表、中止和缺乏数据共享。可忽略不计的研究浪费主要涉及不必要的重复,例如,在试验之前没有对文献进行系统回顾。未充分报告的研究浪费主要包括报告不充分,导致缺乏透明度。结构性研究浪费包括管理不足、合作不足、优先次序安排不足、实施不足和传播不足:MINUS 囊括了研究浪费的五个主要方面。认识到研究浪费的这些方面对于解决和防止进一步的研究浪费,从而确保有效的资源分配和科学诚信非常重要。
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引用次数: 0
Reconciling conflicting evidence in the evaluation of the MitraClip system: Assessment of and response to the MITRA-FR and COAPT trials by key stakeholders 调和 MitraClip 系统评估中相互矛盾的证据:主要利益相关者对 MITRA-FR 和 COAPT 试验的评估和回应。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-05-24 DOI: 10.1111/jebm.12614
Manuela Montagnon, Yenfu Chen, Amy Grove, Jieun Park, Jean-François Obadia, Xavier Armoiry
<p>Two clinical trials (MITRA-FR and COAPT), which were set out to evaluate the effectiveness of adding percutaneous repair (PR) for patients with severe secondary mitral regurgitation (SMR), came to very different conclusions. The MITRA-FR showed no benefit of PR,<span><sup>1</sup></span> while the COAPT trial reported a dramatic improvement of clinical outcomes.<span><sup>2</sup></span> We reviewed the assessment of and response to the MITRA-FR and COAPT trials by key stakeholders, whether regulators and Health Technology Assessment (HTA) bodies, or authors of publications in medical journals.</p><p>Briefly, a systematic literature search was conducted to identify documents that met the following criteria: (1) licensing/reimbursement decisions, clinical guidelines, and academic papers from top medical journals; (2) published between September 2018 and December 2023; (3) dealing with the conflicting evidence from the two trials. A total of 53 studies meeting our inclusion criteria over the period among our selected sources (details methods and details could be accessed by contacting the authors), reflecting the major controversy resulting from the publication of the two trials. The majority were authored by clinicians (46 out of 53) while five (9%) were elaborated by health services managers/HTA bodies, and two (4%) by regulatory agencies.</p><p>The main factors highlighted as potential reasons for the conflicting results were differences in terms of patients’ echocardiographic characteristics (<i>n</i> = 52), the concurrent control therapy (64%), and the rate of interventional procedure success (43%). Less frequently, document authors explained the divergence in findings by focusing on the definition and measurement of outcomes (<i>n</i> = 9), or considering differences in the learning curve and/or the experience of operators (<i>n</i> = 8). Only one document (2%) mentioned the difference between industrial and academic support as a potential explanation for the discrepancy.</p><p>In 51% of cases (<i>n</i> = 27) (Table 1), authors were deemed to be in favor of the findings of COAPT when drawing conclusions while in 34% (<i>n</i> = 18) of the documents, conclusions were equivocal with authors accepting the unexplained heterogeneity in the findings. Less frequently, the conclusions were that effectiveness depended on contextual factors (<i>n</i> = 5), or were not clearly drawn (<i>n</i> = 3). None of the selected documents seemed to favor the findings of the MITRA-FR trial. All six official documents, either originating from policymakers, managers of health services, or regulators, supported the findings of COAPT.</p><p>Irrespective of their main conclusions, 26% (<i>n</i> = 14) of authors suggested further research to be conducted, either mentioning the ongoing RESHAPE-2 RCT as an additional source of evidence or advocating for an individual-patient data meta-analysis based on the two trials (<i>n</i> = 4). In 34 cases (64%), analyses were carri
两项临床试验(MITRA-FR 和 COAPT)旨在评估为严重继发性二尖瓣反流(SMR)患者增加经皮修复术(PR)的有效性,但得出的结论却大相径庭。2 我们回顾了主要利益相关者对 MITRA-FR 和 COAPT 试验的评估和反应,无论是监管机构和卫生技术评估 (HTA) 机构,还是在医学期刊上发表文章的作者:(1) 来自顶级医学期刊的许可/报销决定、临床指南和学术论文;(2) 发表于 2018 年 9 月至 2023 年 12 月之间;(3) 涉及两项试验中相互冲突的证据。在我们所选的资料来源中,共有 53 项研究在此期间符合我们的纳入标准(详细方法和细节可联系作者获取),反映了两项试验发表后引发的重大争议。大多数论文由临床医生撰写(53 篇中的 46 篇),5 篇(9%)由医疗服务管理者/HTA 机构撰写,2 篇(4%)由监管机构撰写。造成结果冲突的主要因素包括患者超声心动图特征(52 例)、同期对照疗法(64%)和介入手术成功率(43%)的差异。较少见的是,文献作者通过关注结果的定义和测量(9 篇)或考虑学习曲线和/或操作者经验的差异(8 篇)来解释研究结果的差异。在 51% 的案例中(n = 27)(表 1),作者在得出结论时被认为支持 COAPT 的研究结果,而在 34% 的文件中(n = 18),结论模棱两可,作者接受了研究结果中无法解释的异质性。较少出现的情况是,结论认为有效性取决于背景因素(5 份),或结论不明确(3 份)。所选文件似乎都不支持 MITRA-FR 试验的结论。无论其主要结论如何,26%(n = 14)的作者建议开展进一步研究,或提及正在进行的 RESHAPE-2 RCT 作为额外的证据来源,或主张在两项试验的基础上进行个体患者数据荟萃分析(n = 4)。在 34 个病例(64%)中,研究人员仅使用两项试验的数据进行了分析,以探讨出现差异的原因。其中大部分病例(20 例)的作者试图在简单比较基线特征和纳入标准的基础上进一步进行分析。2 在剩余的 14 例(41%)病例中,作者进行了或参考了额外的分析(事后分析或荟萃分析),探讨超声心动图因素对结果的影响。在 8 个病例(16%)中,作者根据其他来源的数据(包括检测 COAPT 类标准是否可预测成功结果的观察性研究)探讨了差异背后的原因。我们发现,COAPT 试验结果在医学界以及监管机构或 HTA 利益相关者中普遍得到了更多的认可和欢迎。我们的研究表明,大多数已发表的文件倾向于支持 COAPT 试验结果,并因此认为使用 MitraClip 系统进行 PR 能有效改善预后。不过,这些观点似乎并非毫无保留。我们查阅的文献强调了许多关于患者选择和试验入组前药物管理的反思,这可能是造成差异的原因。在超过三分之一的案例中,作者认为有必要开展进一步研究,以得出更明确的结论。在解释结果矛盾的原因中,不成比例-不成比例 MR 的概念被反复讨论。其原则3 是,根据左心室舒张末期容积(LVEDV)和有效反流孔面积(EROA)的平均测量值,MITRA-FR 中登记的 LV 扩张程度与严重 MR 成比例的患者不太可能对 PR 有反应。相反,与左心室扩张相比,MR 严重程度不成比例的患者,如参加 COAPT 的普通患者,则有可能在 PR 后获得良好的预后。这一新的概念框架试图调和两项试验中相互矛盾的结果。
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引用次数: 0
COVID-19 vaccine hesitancy and uptake among adults living with HIV in the eastern coast of Tanzania: A nested cross-sectional study 坦桑尼亚东部沿海地区感染艾滋病毒的成年人对 COVID-19 疫苗的犹豫不决和接受情况:嵌套横断面研究。
IF 3.6 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Pub Date : 2024-05-06 DOI: 10.1111/jebm.12609
Goodluck G. Nyondo, Fredrick K. Msalenge, Frank A. Majaliwa, Erca Deograthias, Erick Philipo, Belinda J. Njiro, Emmanuel Mang'ombe, David T. Myemba, George M. Bwire
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引用次数: 0
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Journal of Evidence‐Based Medicine
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