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"We used standard Cochrane methods" - observational study on reporting according to PRISMA-A in Cochrane review abstracts between 2016 and 2023.
IF 7.3 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-07 DOI: 10.1016/j.jclinepi.2025.111713
Kathrin Wandscher, Jasmin Helbach, Dawid Pieper, Falk Hoffmann

Objectives: To evaluate reporting of abstracts of Cochrane reviews (CRs) according to PRISMA-A over the last years and trends in reporting the use of standard Cochrane methods and GRADE.

Study design and setting: This was a retrospective, observational study based on eligible CRs indexed in MEDLINE (via PubMed) from 2016 to 2023. Stratified random sample with a total of 520 abstracts was drawn and 489 CRs on effectiveness were included. PRISMA-A adherence, reporting use of standard methods and GRADE were extracted by two reviewers independently. Data were analyzed descriptively and stratified by publication year and reporting of standard methods.

Results: Mean score of fully reported PRISMA-A items ranged from 6.9 to 7.2 out of 12 between 2016 and 2023, while abstract length increased from a median of 686 to 866 words, particularly in the results section. Over the years, reporting that standard methods were used increased from 27.4% to 53.2% and for GRADE from 30.7% to 74.2%. Abstracts reporting the use of standard methods more often adhere to individual PRISMA-A items on results and less often on methods with no differences in overall PRISMA-A adherence.

Conclusion: PRISMA-A adherence in CR abstracts has remained unchanged over the years, with reporting more information on results than methods. This conflicts with PRISMA-A, which recommends specifying the methods used, and forms the basis for reporting abstracts in the Cochrane Handbook since August 2023. Therefore, Cochrane authors and editors should closely monitor the reporting whether standard methods were used.

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引用次数: 0
Potential interactions between digoxin and direct oral anticoagulants: application of cohort & novel case-crossover designs
IF 7.3 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-05 DOI: 10.1016/j.jclinepi.2025.111709
Angel Y.S. Wong , Charlotte Warren-Gash , Krishnan Bhaskaran , Clémence Leyrat , Amitava Banerjee , Liam Smeeth , Ian J. Douglas

Objectives

Direct oral anticoagulants (DOACs) are commonly co-prescribed with digoxin, but whether there is a drug interaction between them is unclear. We aimed to investigate potential drug interactions between DOACs and digoxin.

Study Design and Setting

We identified DOAC users during January 1, 2011–December 31, 2019 using data from Clinical Practice Research Datalink Aurum in cohort design with propensity score to compare the hazards of effectiveness cardiovascular and mortality outcomes and safety bleeding outcomes, respectively, in DOAC + digoxin users versus DOAC + beta-blocker users. A case-crossover design was conducted to compare odds of exposure to different drug initiation patterns in hazard period versus referent period.

Results

Of 397,459 DOAC users, we identified 25,251 co-prescribed digoxin and 109,779 co-prescribed beta-blockers in cohort study. A lower proportion of DOAC + digoxin users were men (46%) in contrast with that of DOAC + beta-blocker users (53%). Mean age of DOAC + digoxin users (77.1 years) were higher than DOAC + beta-blocker users (74.5 years). No increased risk of pharmacologically predictable DOAC safety outcomes or specific effectiveness outcomes was seen with DOAC + digoxin. A higher risk of all-cause mortality (hazard ratio: 1.35; 99% confidence interval [CI]: 1.14–1.61) was observed with DOAC + digoxin versus DOAC + beta-blockers. In the case-crossover study, a 24% higher odds of all-cause mortality was seen with initiating digoxin while taking DOAC (odds ratio: 1.24; 99% CI: 1.06–1.45); and a 63% higher odds was also seen with initiating DOAC while taking digoxin (odds ratio: 1.63; 99% CI: 1.41–1.88).

Conclusion

We found no increased risk of bleeding when DOACs are used with digoxin, suggesting combined use does not lead to drug-drug interaction. Future work is recommended to investigate the underlying mechanism of association with all-cause mortality.

Plain Language Summary

This study aimed to examine potential drug interactions between direct oral anticoagulants (DOACs) (a drug class to prevent blood clots) and digoxin (treatment of abnormal heart rhythms). We compared a range of clinical outcomes in people prescribed DOAC and digoxin with people prescribed DOAC and beta-blockers (a treatment alternative to digoxin). We also used a new study design (case-crossover design) to compare the risk of clinical outcomes between different periods within a person as a validation. In both study designs, we found no increased risk of bleeding when DOACs are used with digoxin, suggesting combined use does not lead to drug-drug interaction. However, we found an increased risk of all-cause death associated with digoxin in DOAC users which requires further investigation.
{"title":"Potential interactions between digoxin and direct oral anticoagulants: application of cohort & novel case-crossover designs","authors":"Angel Y.S. Wong ,&nbsp;Charlotte Warren-Gash ,&nbsp;Krishnan Bhaskaran ,&nbsp;Clémence Leyrat ,&nbsp;Amitava Banerjee ,&nbsp;Liam Smeeth ,&nbsp;Ian J. Douglas","doi":"10.1016/j.jclinepi.2025.111709","DOIUrl":"10.1016/j.jclinepi.2025.111709","url":null,"abstract":"<div><h3>Objectives</h3><div>Direct oral anticoagulants (DOACs) are commonly co-prescribed with digoxin, but whether there is a drug interaction between them is unclear. We aimed to investigate potential drug interactions between DOACs and digoxin.</div></div><div><h3>Study Design and Setting</h3><div>We identified DOAC users during January 1, 2011–December 31, 2019 using data from Clinical Practice Research Datalink Aurum in cohort design with propensity score to compare the hazards of effectiveness cardiovascular and mortality outcomes and safety bleeding outcomes, respectively, in DOAC + digoxin users versus DOAC + beta-blocker users. A case-crossover design was conducted to compare odds of exposure to different drug initiation patterns in hazard period versus referent period.</div></div><div><h3>Results</h3><div>Of 397,459 DOAC users, we identified 25,251 co-prescribed digoxin and 109,779 co-prescribed beta-blockers in cohort study. A lower proportion of DOAC + digoxin users were men (46%) in contrast with that of DOAC + beta-blocker users (53%). Mean age of DOAC + digoxin users (77.1 years) were higher than DOAC + beta-blocker users (74.5 years). No increased risk of pharmacologically predictable DOAC safety outcomes or specific effectiveness outcomes was seen with DOAC + digoxin. A higher risk of all-cause mortality (hazard ratio: 1.35; 99% confidence interval [CI]: 1.14–1.61) was observed with DOAC + digoxin versus DOAC + beta-blockers. In the case-crossover study, a 24% higher odds of all-cause mortality was seen with initiating digoxin while taking DOAC (odds ratio: 1.24; 99% CI: 1.06–1.45); and a 63% higher odds was also seen with initiating DOAC while taking digoxin (odds ratio: 1.63; 99% CI: 1.41–1.88).</div></div><div><h3>Conclusion</h3><div>We found no increased risk of bleeding when DOACs are used with digoxin, suggesting combined use does not lead to drug-drug interaction. Future work is recommended to investigate the underlying mechanism of association with all-cause mortality.</div></div><div><h3>Plain Language Summary</h3><div>This study aimed to examine potential drug interactions between direct oral anticoagulants (DOACs) (a drug class to prevent blood clots) and digoxin (treatment of abnormal heart rhythms). We compared a range of clinical outcomes in people prescribed DOAC and digoxin with people prescribed DOAC and beta-blockers (a treatment alternative to digoxin). We also used a new study design (case-crossover design) to compare the risk of clinical outcomes between different periods within a person as a validation. In both study designs, we found no increased risk of bleeding when DOACs are used with digoxin, suggesting combined use does not lead to drug-drug interaction. However, we found an increased risk of all-cause death associated with digoxin in DOAC users which requires further investigation.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"181 ","pages":"Article 111709"},"PeriodicalIF":7.3,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374911","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
Income inequality and access to advanced immunotherapy for lung cancer: the case of Durvalumab in the Netherlands
IF 7.3 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-04 DOI: 10.1016/j.jclinepi.2025.111711
Dimitris Katsimpokis , Mieke J. Aarts , Gijs Geleijnse , Peter Kunst , Maarten J. Bijlsma

Background and Objectives

With the introduction of immunotherapy with nonsmall cell lung cancer, prognosis of these patients has improved. However, socioeconomic differences in access to various immunotherapy treatments have been reported. In the Netherlands, such differences are not expected due to universal insurance coverage.

Study Design and Setting

We investigated the existence of differential susceptibility by socioeconomic status (SES) of the effect of distance to treatment hospital on access to Durvalumab in patients with stage III nonsmall cell lung cancer who received chemoradiation, and the influence of differential mortality. We used data from the Netherlands Cancer Registry (n = 3774) from the period 2017–2021. First, we fitted Bayesian discrete failure time models and compared SES-by-distance-to-hospital interaction to a baseline model including age, distance, SES, and performance score. We then fitted a time to mortality model and used both models in a g-formula to simulate a scenario where mortality levels were equalized.

Results

Our results showed that the high SES group received Durvalumab more often than the low SES group (hazard ratio = 1.26; 95% credible interval = [1.06, 1.53]), and even 4 km distance increase leads to less Durvalumab (hazard ratio = 0.93; 95% credible interval = [0.86, 0.99]). Bayes factor < 3 indicated inconclusive evidence for a SES by distance interaction effect, while g-formula results showed that differential mortality does not affect SES differences. Secondary analyses showed strong evidence that SES differences in using Durvalumab were constant over the years (Bayes factor > 17).

Conclusion

Overall, these results are significant for understanding how socioeconomic inequality affects proper care and can be vital for public policy.
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引用次数: 0
Updating methods for artificial intelligence–based clinical prediction models: a scoping review 基于人工智能的临床预测模型的更新方法:范围综述。
IF 7.3 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-01 DOI: 10.1016/j.jclinepi.2024.111636
Lotta M. Meijerink , Zoë S. Dunias , Artuur M. Leeuwenberg , Anne A.H. de Hond , David A. Jenkins , Glen P. Martin , Matthew Sperrin , Niels Peek , René Spijker , Lotty Hooft , Karel G.M. Moons , Maarten van Smeden , Ewoud Schuit
<div><h3>Objectives</h3><div>To give an overview of methods for updating artificial intelligence (AI)-based clinical prediction models based on new data.</div></div><div><h3>Study Design and Setting</h3><div>We comprehensively searched Scopus and Embase up to August 2022 for articles that addressed developments, descriptions, or evaluations of prediction model updating methods. We specifically focused on articles in the medical domain involving AI-based prediction models that were updated based on new data, excluding regression-based updating methods as these have been extensively discussed elsewhere. We categorized and described the identified methods used to update the AI-based prediction model as well as the use cases in which they were used.</div></div><div><h3>Results</h3><div>We included 78 articles. The majority of the included articles discussed updating for neural network methods (93.6%) with medical images as input data (65.4%). In many articles (51.3%) existing, pretrained models for broad tasks were updated to perform specialized clinical tasks. Other common reasons for model updating were to address changes in the data over time and cross-center differences; however, more unique use cases were also identified, such as updating a model from a broad population to a specific individual. We categorized the identified model updating methods into four categories: neural network-specific methods (described in 92.3% of the articles), ensemble-specific methods (2.5%), model-agnostic methods (9.0%), and other (1.3%). Variations of neural network-specific methods are further categorized based on the following: (1) the part of the original neural network that is kept, (2) whether and how the original neural network is extended with new parameters, and (3) to what extent the original neural network parameters are adjusted to the new data. The most frequently occurring method (<em>n</em> = 30) involved selecting the first layer(s) of an existing neural network, appending new, randomly initialized layers, and then optimizing the entire neural network.</div></div><div><h3>Conclusion</h3><div>We identified many ways to adjust or update AI-based prediction models based on new data, within a large variety of use cases. Updating methods for AI-based prediction models other than neural networks (eg, random forest) appear to be underexplored in clinical prediction research.</div></div><div><h3>Plain Language Summary</h3><div>AI-based prediction models are increasingly used in health care, helping clinicians with diagnosing diseases, guiding treatment decisions, and informing patients. However, these prediction models do not always work well when applied to hospitals, patient populations, or times different from those used to develop the models. Developing new models for every situation is neither practical nor desired, as it wastes resources, time, and existing knowledge. A more efficient approach is to adjust existing models to new contexts (‘updating’),
目的:综述基于新数据更新人工智能临床预测模型的方法。研究设计和设置:我们全面检索了截至2022年8月的Scopus和EMBASE,以获取有关预测模型更新方法的发展、描述或评估的文章。我们特别关注了医学领域中涉及基于人工智能的预测模型的文章,这些模型是根据新数据更新的,不包括基于回归的更新方法,因为这些方法在其他地方已经被广泛讨论过。我们分类并描述了用于更新基于人工智能的预测模型的识别方法,以及使用它们的用例。结果:我们纳入了78篇文章。大多数纳入的文章讨论了以医学图像作为输入数据(65.4%)的神经网络方法的更新(93.6%)。在现有的许多文章(51.3%)中,针对广泛任务的预训练模型被更新为执行专门的临床任务。更新模型的其他常见原因是为了解决数据随时间的变化和跨中心差异;但是,还确定了更多独特的用例,例如将模型从广泛的人群更新为特定的个体。我们将确定的模型更新方法分为四类:神经网络特定方法(92.3%的文章中有描述),集成特定方法(2.5%),模型不可知方法(9.0%)和其他(1.3%)。神经网络专用方法的变化进一步分类基于:(1)原始神经网络的保留部分,(2)原始神经网络是否以及如何使用新参数进行扩展,(3)原始神经网络参数对新数据的调整程度。最常见的方法(n=30)涉及选择现有神经网络的第一层,附加新的,随机初始化的层,然后优化整个神经网络。结论:我们确定了许多方法来调整或更新基于人工智能的预测模型,这些模型基于各种各样的用例。在临床预测研究中,除了神经网络(如随机森林)之外,基于人工智能的预测模型的更新方法似乎还没有得到充分的探索。
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引用次数: 0
Cross-national statistical harmonization of the Center for Epidemiologic Studies Depression (CES-D) scale among older adults in China, England, India, Mexico, South Africa, and the United States 流行病学研究中心抑郁症(CES-D)量表在中国、英国、印度、墨西哥、南非和美国老年人中的跨国统计协调。
IF 7.3 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-01 DOI: 10.1016/j.jclinepi.2024.111623
Xuexin Yu , Richard N. Jones , Lindsay C. Kobayashi , Alden L. Gross

Objectives

We examined differential item functioning (DIF) of the Center for Epidemiologic Studies Depression Scale (CES-D) items by country and statistically harmonized common cross-national factor scores for the CES-D to aid further cross-national research.

Study Design and Setting

Data were from Harmonized Cognitive Assessment Protocol (HCAP) studies in China (N = 9639), England (N = 1262), India (N = 4048), Mexico (N = 1918), South Africa (N = 631), and the United States (N = 3321). Multiple indicators, multiple causes models were estimated to test DIF in the CES-D items by country. DIF items were defined as having an odds ratio (OR) outside the range of 0.75–1.25 in multiple indicators, multiple causes models. We evaluated DIF impact and identified salient DIF by examining whether the difference between DIF-adjusted factor scores and non-DIF–adjusted factor scores exceeded a threshold of 0.30 standard deviation (SD) units. Confirmatory factor analysis was used to create DIF-adjusted, cross-nationally harmonized CES-D factor scores.

Results

Controlling for underlying depressive symptoms, HCAP participants in India had higher odds of reporting being not hopeful about future (OR = 1.38, 95% confidence interval [CI]: 1.34–1.42), not enjoying life (OR = 1.43, 95% CI: 1.38–1.48), and being unhappy (OR = 1.29, 95% CI: 1.25–1.34), compared to HCAP participants in the United States. These identified DIF items artificially increased mean harmonized CES-D factor scores by 0.48 SD units in the India HCAP, with over 50% of the factor scores increased by over 0.30 SD units, indicating salient DIF in the India HCAP.

Conclusion

Our findings demonstrate cross-national heterogeneity in the expression of depressive symptoms. We provide DIF-adjusted CES-D factor scores to improve the quality of cross-national comparisons in aging research.
目的:我们按国家检查流行病学研究中心抑郁量表(CES-D)项目的差异项目功能(DIF),并统计协调CES-D的常见跨国因素得分,以帮助进一步的跨国研究。研究设计和设置:数据来自中国(N=9,639)、英国(N=1,262)、印度(N=4,048)、墨西哥(N=1,918)、南非(N=631)和美国(N=3,321)的统一认知评估方案(HCAP)研究。估计采用多指标、多原因模型(MIMIC)按国家检验CES-D项目中的DIF。DIF项目被定义为在MIMIC中具有0.75-1.25范围外的优势比(OR)。我们评估了DIF的影响,并通过检查DIF调整因子评分与非DIF调整因子评分之间的差异是否超过0.30 SD单位的阈值来确定显著的DIF。验证性因子分析用于创建经dif调整的、跨国家统一的CES-D因子评分。结果:控制潜在的抑郁症状,与美国的HCAP参与者相比,印度的HCAP参与者报告对未来不希望(OR=1.38, 95% CI: 1.34-1.42)、不享受生活(OR=1.43, 95% CI: 1.38-1.48)和不快乐(OR=1.29, 95% CI: 1.25-1.34)的几率更高。这些确定的DIF项目人为地将印度HCAP的平均协调CES-D因子得分提高了0.48个标准差(SD)单位,其中超过50%的因子得分提高了0.30个标准差以上,表明印度HCAP的DIF显著。结论:我们的研究结果显示了抑郁症状表达的跨国异质性。我们提供了dif调整的CES-D因子评分,以提高老龄化研究中跨国比较的质量。
{"title":"Cross-national statistical harmonization of the Center for Epidemiologic Studies Depression (CES-D) scale among older adults in China, England, India, Mexico, South Africa, and the United States","authors":"Xuexin Yu ,&nbsp;Richard N. Jones ,&nbsp;Lindsay C. Kobayashi ,&nbsp;Alden L. Gross","doi":"10.1016/j.jclinepi.2024.111623","DOIUrl":"10.1016/j.jclinepi.2024.111623","url":null,"abstract":"<div><h3>Objectives</h3><div>We examined differential item functioning (DIF) of the Center for Epidemiologic Studies Depression Scale (CES-D) items by country and statistically harmonized common cross-national factor scores for the CES-D to aid further cross-national research.</div></div><div><h3>Study Design and Setting</h3><div>Data were from Harmonized Cognitive Assessment Protocol (HCAP) studies in China (<em>N</em> = 9639), England (<em>N</em> = 1262), India (<em>N</em> = 4048), Mexico (<em>N</em> = 1918), South Africa (<em>N</em> = 631), and the United States (<em>N</em> = 3321). Multiple indicators, multiple causes models were estimated to test DIF in the CES-D items by country. DIF items were defined as having an odds ratio (OR) outside the range of 0.75–1.25 in multiple indicators, multiple causes models. We evaluated DIF impact and identified salient DIF by examining whether the difference between DIF-adjusted factor scores and non-DIF–adjusted factor scores exceeded a threshold of 0.30 standard deviation (SD) units. Confirmatory factor analysis was used to create DIF-adjusted, cross-nationally harmonized CES-D factor scores.</div></div><div><h3>Results</h3><div>Controlling for underlying depressive symptoms, HCAP participants in India had higher odds of reporting being not hopeful about future (OR = 1.38, 95% confidence interval [CI]: 1.34–1.42), not enjoying life (OR = 1.43, 95% CI: 1.38–1.48), and being unhappy (OR = 1.29, 95% CI: 1.25–1.34), compared to HCAP participants in the United States. These identified DIF items artificially increased mean harmonized CES-D factor scores by 0.48 SD units in the India HCAP, with over 50% of the factor scores increased by over 0.30 SD units, indicating salient DIF in the India HCAP.</div></div><div><h3>Conclusion</h3><div>Our findings demonstrate cross-national heterogeneity in the expression of depressive symptoms. We provide DIF-adjusted CES-D factor scores to improve the quality of cross-national comparisons in aging research.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"178 ","pages":"Article 111623"},"PeriodicalIF":7.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142792547","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
Determinants of cost-effectiveness results of biological therapies for severe asthma: a systematic methodological assessment 严重哮喘生物治疗成本-效果结果的决定因素:系统的方法学评估。
IF 7.3 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-01 DOI: 10.1016/j.jclinepi.2024.111621
Laura de la Torre-Pérez , Marilina Santero , Wendy Nieto-Gutierrez , Christine Giesen , Angela Nardin , Claudia Cosma , Pedro Silva Pires , Andrea Guida , Marcello Simonini , Camila Quirland Lazo , Feng Xie , Pablo Alonso-Coello

Objectives

To assess the associations between cost-effectiveness analysis’ (CEA) methodological characteristics and incremental cost-effectiveness ratio outcomes and conclusions, in biological treatments for asthma.

Study Design and Setting

We included CEAs comparing biological treatments to standard care, in adults with severe asthma. We performed a search in MEDLINE, EMBASE, and Web of Science (September 2022). We extracted and summarized CEA’s characteristics and critically appraised the studies using the extended Consensus Health Economic Criteria. In those reporting benefits as quality-adjusted life years, we conducted bivariate and regression analyses.

Results

We identified 33 CEAs that showed overall good quality (above 66.6% of compliance) with variable results across extended Consensus Health Economic Criteria sections. We included 28 cost-utility analyses on biological treatments in asthma in our analysis. Only industry sponsorship showed significant differences in the bivariate analysis (P = .021 for the difference in incremental cost-effectiveness ratio medians, and P = .027 for the different percentage in reported cost-effectiveness). In the regression adopting a nonlifetime horizon and nonuse of a model (β = 4.25 and β = 0.16, P < .05), significantly associated in the multivariate analysis. Only nonindustry sponsorship showed a significant association with the drug being reported as not cost-effective, both in the bivariate and multivariate analysis (odds ratio = 13.2 and odds ratio = 20.15 P < .05).

Conclusion

Our study identified significant limitations, including poor reporting practices and the impact of industry sponsorship on outcomes, with notable effects on cost-effectiveness conclusions. These findings highlight the need for policymakers and health-care decision-makers to meticulously consider methodological rigor and potential biases in economic evaluations.
目的:评估哮喘生物治疗中成本-效果分析(CEA)方法学特征与增量成本-效果比(ICER)结果和结论之间的关系。研究设计和背景:我们纳入了比较生物治疗和标准治疗的cea,研究对象为患有严重哮喘的成人。我们在MEDLINE、EMBASE和Web of Science(2022年9月)中进行了检索。我们提取并总结了CEA的特征,并使用扩展的共识健康经济标准(e-CHEC)对研究进行了批判性评价。在那些以质量调整生命年(QALY)报告的获益中,我们进行了双变量和回归分析。结果:我们确定了33个cea,总体质量良好(66.6%以上的依从性),在e-CHEC切片中结果不同。我们在分析中纳入了28项关于哮喘生物治疗的成本效用分析(CUA)。只有行业赞助在双变量分析中显示显著差异(ICER中位数差异p=0.021,报告成本-效果百分比差异p=0.027)。在采用非生命周期范围和不使用模型的回归中(β = 4.25和β = 0.16),结论:我们的研究发现了显著的局限性,包括不良的报告实践和行业赞助对结果的影响,对成本效益结论有显著影响。这些发现突出了决策者和医疗保健决策者在经济评估中仔细考虑方法严谨性和潜在偏见的必要性。
{"title":"Determinants of cost-effectiveness results of biological therapies for severe asthma: a systematic methodological assessment","authors":"Laura de la Torre-Pérez ,&nbsp;Marilina Santero ,&nbsp;Wendy Nieto-Gutierrez ,&nbsp;Christine Giesen ,&nbsp;Angela Nardin ,&nbsp;Claudia Cosma ,&nbsp;Pedro Silva Pires ,&nbsp;Andrea Guida ,&nbsp;Marcello Simonini ,&nbsp;Camila Quirland Lazo ,&nbsp;Feng Xie ,&nbsp;Pablo Alonso-Coello","doi":"10.1016/j.jclinepi.2024.111621","DOIUrl":"10.1016/j.jclinepi.2024.111621","url":null,"abstract":"<div><h3>Objectives</h3><div>To assess the associations between cost-effectiveness analysis’ (CEA) methodological characteristics and incremental cost-effectiveness ratio outcomes and conclusions, in biological treatments for asthma.</div></div><div><h3>Study Design and Setting</h3><div>We included CEAs comparing biological treatments to standard care, in adults with severe asthma. We performed a search in MEDLINE, EMBASE, and Web of Science (September 2022). We extracted and summarized CEA’s characteristics and critically appraised the studies using the extended Consensus Health Economic Criteria. In those reporting benefits as quality-adjusted life years, we conducted bivariate and regression analyses.</div></div><div><h3>Results</h3><div>We identified 33 CEAs that showed overall good quality (above 66.6% of compliance) with variable results across extended Consensus Health Economic Criteria sections. We included 28 cost-utility analyses on biological treatments in asthma in our analysis. Only industry sponsorship showed significant differences in the bivariate analysis (<em>P</em> = .021 for the difference in incremental cost-effectiveness ratio medians, and <em>P</em> = .027 for the different percentage in reported cost-effectiveness). In the regression adopting a nonlifetime horizon and nonuse of a model (β = 4.25 and β = 0.16, <em>P</em> &lt; .05), significantly associated in the multivariate analysis. Only nonindustry sponsorship showed a significant association with the drug being reported as not cost-effective, both in the bivariate and multivariate analysis (odds ratio = 13.2 and odds ratio = 20.15 <em>P</em> &lt; .05).</div></div><div><h3>Conclusion</h3><div>Our study identified significant limitations, including poor reporting practices and the impact of industry sponsorship on outcomes, with notable effects on cost-effectiveness conclusions. These findings highlight the need for policymakers and health-care decision-makers to meticulously consider methodological rigor and potential biases in economic evaluations.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"178 ","pages":"Article 111621"},"PeriodicalIF":7.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787750","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
Editors’ Choice: February 2025
IF 7.3 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-01 DOI: 10.1016/j.jclinepi.2025.111681
David Tovey, Andrea C. Tricco
{"title":"Editors’ Choice: February 2025","authors":"David Tovey,&nbsp;Andrea C. Tricco","doi":"10.1016/j.jclinepi.2025.111681","DOIUrl":"10.1016/j.jclinepi.2025.111681","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"178 ","pages":"Article 111681"},"PeriodicalIF":7.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143030333","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 definition of predictor and outcome variables in mortality prediction models: a scoping review and quality of reporting study "死亡率预测模型中预测变量和结果变量的定义:范围审查和报告质量研究"。
IF 7.3 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-01 DOI: 10.1016/j.jclinepi.2024.111605
Eline G.M. Cox , Daniek A.M. Meijs , Laure Wynants , Jan-Willem E.M. Sels , Jacqueline Koeze , Frederik Keus , Bianca Bos - van Dongen , Iwan C.C. van der Horst , Bas C.T. van Bussel

Background and Objectives

Mortality prediction models are promising tools for guiding clinical decision-making and resource allocation in intensive care units (ICUs). Clearly specified predictor and outcome variables are necessary to enable external validation and safe clinical application of prediction models. The objective of this study was to identify the predictor and outcome variables used in different mortality prediction models in the ICU and investigate their reporting.

Methods

For this scoping review, MEDLINE, EMBASE, Web of Science, and the Cochrane Central Register of Controlled Trials were searched. Studies developed within a general ICU population reporting on prediction models with mortality as a primary or secondary outcome were eligible. The selection criteria were adopted from a review by Keuning et al. Predictor and outcome variables, variable characteristics (defined as units, definitions, moments of measurement, and methods of measurement), and publication details (defined as first author, year of publication and title) were extracted from the included studies. Predictor and outcome variable categories were demographics, chronic disease, care logistics, acute diagnosis, clinical examination and physiological derangement, laboratory assessment, additional diagnostics, support and therapy, risk scores, and (mortality) outcomes.

Results

A total of 56 mortality prediction models, containing 204 unique predictor and outcome variables, were included. The predictor variables most frequently included in the models were age (40 times), admission type (27 times), and mechanical ventilation (21 times). We observed that single variables were measured with different units, according to different definitions, at a different moment, and with a different method of measurement in different studies. The reporting of the unit was mostly complete (98% overall, 95% in the laboratory assessment category), whereas the definition of the variable (74% overall, 63% in the chronic disease category) and method of measurement (70% overall, 34% in the demographics category) were most often lacking.

Conclusion

Accurate and transparent reporting of predictor and outcome variables is paramount to enhance reproducibility, model performance in different contexts, and validity. Since unclarity about the required input data may introduce bias and thereby affect model performance, this study advocates that prognostic ICU models can be improved by transparent and clear reporting of predictor and outcome variables and their characteristics.
背景:死亡率预测模型是指导重症监护病房(ICU)临床决策和资源分配的有效工具。明确规定预测变量和结果变量对于预测模型的外部验证和安全临床应用是必要的。本研究旨在确定重症监护室不同死亡率预测模型中使用的预测变量和结果变量,并调查其报告情况:方法:本范围综述检索了 MEDLINE、EMBASE、Web of Science 和 Cochrane 对照试验中央注册中心 (CENTRAL)。以死亡率为主要或次要结果的预测模型为研究对象的研究均为在普通重症监护病房人群中开展的研究。从纳入的研究中提取了预测变量和结果变量、变量特征(定义为单位、定义、测量时刻和测量方法)以及发表的详细信息(定义为第一作者、发表年份和标题)。预测因子和结果变量类别包括人口统计学、慢性疾病、护理后勤、急性诊断、临床检查和生理失调、实验室评估、额外诊断、支持和治疗、风险评分和(死亡率)结果:结果:共纳入了 56 个死亡率预测模型,其中包含 204 个独特的预测变量和结果变量。最常被纳入模型的预测变量是年龄(40 次)、入院类型(27 次)和机械通气(21 次)。我们注意到,在不同的研究中,单一变量的测量单位不同、定义不同、时间不同、测量方法也不同。单位的报告大多是完整的(总体为98%,实验室评估类别为95%),而变量的定义(总体为74%,慢性病类别为63%)和测量方法(总体为70%,人口统计学类别为34%)则往往缺乏:结论:准确、透明地报告预测变量和结果变量对于提高可重复性、模型在不同情况下的表现和有效性至关重要。由于所需输入数据的不明确性可能会带来偏差,从而影响模型的性能,因此本研究提倡通过透明、清晰地报告预测变量和结果变量及其特征来改进 ICU 预后模型。
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引用次数: 0
Key challenges in epidemiology: embracing open science 流行病学的主要挑战:拥抱开放科学。
IF 7.3 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-01 DOI: 10.1016/j.jclinepi.2024.111618
Edward Xu , Anna Catharina V. Armond , David Moher , Kelly Cobey
Open science is a movement that fosters research transparency, reproducibility, and equity. Open science has been put forward by numerous stakeholders in the research ecosystem as a key science policy goal, with the United Nations Educational, Scientific, and Cultural Organization creating recommendations on open science and aligning these with UN Sustainability Goals. Open science practices are not standard to epidemiology despite their potential value to the field and especially during disease outbreaks. This article highlights core open science practices, including study registration, open data, code, material, use of reporting guideline, open access publishing, and preprints. It aims to provide readers with the fundamentals about open science, relevant international policy for open science, and the value of implementing open science for epidemiology and society as a whole. It is a practical piece that will provide readers with a starting point to expand their understanding of open science and to identify tools to learn more. The article also highlights the challenges of open science in its implementation and the importance of monitoring open science practices.
开放科学是一项促进研究透明度、可重复性和公平性的运动。开放科学已被研究生态系统中的众多利益攸关方提出,作为一项关键的科学政策目标,联合国教育、科学及文化组织(UNESCO)制定了关于开放科学的建议,并将这些建议与联合国可持续发展目标保持一致。开放科学实践并非流行病学的标准,尽管它们对该领域具有潜在价值,特别是在疾病暴发期间。本文重点介绍了核心开放科学实践,包括研究注册、开放数据、代码和材料、报告指南的使用、开放获取出版和预印本。它旨在为读者提供有关开放科学的基础知识,开放科学的相关国际政策,以及实施开放科学对流行病学和整个社会的价值。这是一篇实用的文章,将为读者提供一个起点,以扩展他们对开放科学的理解,并确定学习更多知识的工具。这篇文章还强调了开放科学在实施过程中的挑战以及监测开放科学实践的重要性。
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引用次数: 0
Addressing feature importance biases in machine learning models for early diagnosis of type 1 Gaucher disease 解决1型戈谢病早期诊断机器学习模型中的特征重要性偏差。
IF 7.3 2区 医学 Q1 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-01 DOI: 10.1016/j.jclinepi.2024.111619
Yoshiyasu Takefuji
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引用次数: 0
期刊
Journal of Clinical Epidemiology
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