Journal of Clinical Epidemiology最新文献

{"title":"Research culture influences in health and biomedical research: rapid scoping review and content analysis","authors":"Lesley Uttley ,&nbsp;Louise Falzon ,&nbsp;Jennifer A. Byrne ,&nbsp;Andrea C. Tricco ,&nbsp;Marcus R. Munafò ,&nbsp;David Moher ,&nbsp;Thomas Stoeger ,&nbsp;Limbanazo Matandika ,&nbsp;Cyril Labbé ,&nbsp;Florian Naudet","doi":"10.1016/j.jclinepi.2024.111616","DOIUrl":"10.1016/j.jclinepi.2024.111616","url":null,"abstract":"<div><h3>Background</h3><div>Research culture is strongly influenced by academic incentives and pressures such as the imperative to publish in academic journals, and can influence the nature and quality of the evidence we produce.</div></div><div><h3>Objective</h3><div>The purpose of this rapid scoping review is to capture the breadth of differential pressures and contributors to current research culture, drawing together content from empirical research specific to the health and biomedical sciences.</div></div><div><h3>Study Design and Setting</h3><div>PubMed and Web of Science were searched for empirical studies of influences and impacts on health and biomedical research culture, published between January 2012 and April 2024. Data charting extracted the key findings and relationships in research culture from included papers such as workforce composition; equitable access to research; academic journal trends, incentives, and reproducibility; erroneous research; questionable research practices; biases vested interests; and misconduct. A diverse author network was consulted to ensure content validity of the proposed framework of i) inclusivity, ii) transparency, iii) rigor, and iv) objectivity.</div></div><div><h3>Results</h3><div>A growing field of studies examining research culture exists ranging from the inclusivity of the scientific workforce, the transparency of the data generated, the rigor of the methods used and the objectivity of the researchers involved. Figurative diagrams are presented to storyboard the links between research culture content and findings.</div></div><div><h3>Conclusion</h3><div>The wide range of research culture influences in the recent literature indicates the need for coordinated and sustained research culture conversations. Core principles in effective research environments should include inclusive collaboration and diverse research workforces, rigorous methodological approaches, transparency, data sharing, and reflection on scientific objectivity.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"178 ","pages":"Article 111616"},"PeriodicalIF":7.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142711243","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}

{"title":"A systematic review of stepped wedge cluster randomized trials in high impact journals: assessing the design, rationale, and analysis","authors":"Elizabeth Varghese ,&nbsp;Anny Briola ,&nbsp;Titouan Kennel ,&nbsp;Abby Pooley ,&nbsp;Richard A. Parker","doi":"10.1016/j.jclinepi.2024.111622","DOIUrl":"10.1016/j.jclinepi.2024.111622","url":null,"abstract":"<div><h3>Objectives</h3><div>Stepped wedge cluster randomized trials (SW-CRTs) are an appealing study design because they enable sequential roll out of an intervention across clusters, bringing logistical advantages. This review aimed to evaluate the design rationale, design features, stepped wedge diagram, and analytical approaches of SW-CRTs published in high-impact medical journals from 2020 to 2023, focusing particularly on adherence to key guidelines from the Consolidated Standards of Reporting Trials extension to SW-CRTs.</div></div><div><h3>Study Design and Setting</h3><div>We conducted searches across PubMed and Cochrane Central Registry of Controlled Trials databases for SW-CRTs published between January 2020 and December 2023 in eight high-impact journals. Eligibility criteria included peer-reviewed publications of randomized SW-CRTs involving human participants, published in English.</div></div><div><h3>Results</h3><div>Of the 23 SW-CRTs included in the review, 70% had \"stepped wedge\" explicitly mentioned in their titles. Most studies (96%) included a stepped wedge diagram, but only 65% of these diagrams clearly communicated the duration of each time period. There was considerable variability in design features, including number of sequences (median of 7, range 3–20) and clusters (median of 15, range 9–19). The majority of trials (78%) provided robust justifications for selecting a SW-CRT design, for example, citing practical or logistical constraints. However, 22% of the studies offered less convincing rationales. Generalized linear mixed models were the most frequent analysis method employed.</div></div><div><h3>Conclusion</h3><div>Our review has highlighted areas for improvement in the presentation of SW-CRTs, particularly in clearly indicating the duration of time periods within diagrams and providing robust justifications for selecting a SW-CRT design.</div></div><div><h3>Plain Language Summary</h3><div>The stepped wedge cluster randomized trial (SW-CRT) is a type of study design that introduces interventions to different groups at different times. This review examined reports of SW-CRTs published in top medical journals from 2020 to 2023 to see if they followed certain guidelines such as including the word “stepped wedge” in their title. A total of 23 SW-CRTs were included in the review, with 70% mentioning \"stepped wedge\" in the title. Most (96%) included diagrams, but only 65% showed the duration of each time period clearly. There was variability in design, such as variations in the number of sequences and groups. 78% gave valid reasons for using SW-CRTs, citing practical benefits, whereas 22% did not give convincing reasons. This review suggests that improvements can be made in the presentation of stepped wedge diagrams and in the reporting of SW-CRTs. Researchers should clearly report the length of time periods and provide strong justifications for their design choice.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"178 ","pages":"Article 111622"},"PeriodicalIF":7.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142781874","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}

{"title":"Development of a refined harmonization approach for longitudinal cognitive data in people with HIV","authors":"Lang Lang ,&nbsp;Leah H. Rubin ,&nbsp;Raha M. Dastgheyb ,&nbsp;David E. Vance ,&nbsp;Scott L. Letendre ,&nbsp;Donald R. Franklin Jr. ,&nbsp;Yanxun Xu","doi":"10.1016/j.jclinepi.2024.111620","DOIUrl":"10.1016/j.jclinepi.2024.111620","url":null,"abstract":"<div><h3>Objectives</h3><div>The aim of this study was to develop a refined method for harmonizing longitudinal cognitive data across several large-scale studies in people with HIV (PWH), in whom cognitive complications are common and heterogeneous in presentation.</div></div><div><h3>Study Design and Setting</h3><div>We developed a refined method for harmonizing longitudinal cognitive data across five large-scale studies in PWH that used different cognitive batteries with only some overlapping tests—Women's Interagency HIV Study (WIHS), Multicenter AIDS Cohort Study, CNS HIV Antiretroviral Therapy Effects Research (CHARTER), National NeuroAIDS Tissue Consortium, and the HIV Neurobehavioral Research Program. Traditional data harmonization methods using latent variable models focus on cross-sectional data and require the presence of common cognitive tests to serve as “linking” assessments. However, the absence of such common tests for certain cognitive domains can preclude the direct application of these traditional techniques. To address these challenges, we developed a harmonization method that leveraged a second-order factor model, which capitalized on the structural relationships among cognitive domains.</div></div><div><h3>Results</h3><div>Our approach yielded harmonized cognitive domain scores that are demographically consistent across different cohorts and exhibit strong correlations with the raw or log transformed (eg, timed outcomes) cognitive test scores. These harmonized scores accurately reflected variations according to age, educational status, and other demographic factors, while preserving participants’ longitudinal cognitive trajectories.</div></div><div><h3>Conclusion</h3><div>Our harmonization methods are essential for future analyses of large-scale, retrospective data to understand the heterogeneity in cognitive complications in PWH. These methods can be applied to harmonize new datasets with similar measures.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"178 ","pages":"Article 111620"},"PeriodicalIF":7.3,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142774385","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}

{"title":"Guideline developers in low- and middle-income countries want to develop and use living guidelines, but are currently limited by important barriers: findings from a qualitative study","authors":"Bekele Tesfaye Meteku ,&nbsp;Kevindu De Silva ,&nbsp;Sally E. Green ,&nbsp;Tari Turner","doi":"10.1016/j.jclinepi.2025.111707","DOIUrl":"10.1016/j.jclinepi.2025.111707","url":null,"abstract":"<div><h3>Objectives</h3><div>Evidence-based clinical guidelines have the potential to improve health care and health outcomes. Living guidelines methods provide an approach to ensuring guidelines are always up-to-date, maximizing this potential. However, to date, most work on living guidelines has been conducted in high income countries. The objective of this study is to explore the barriers and facilitators to the development, adaptation, and use of living guidelines among evidence-based guideline developers in low- and middle-income countries (LMICs).</div></div><div><h3>Study Design and Setting</h3><div>We used a descriptive qualitative study design. We employed purposive and snowball sampling techniques to recruit guideline developers from LMICs and World Health Organization offices to participate in online, semistructured interviews. Data were analysed using a thematic approach with NVivo 20 software. Ethics approval was granted by Monash University.</div></div><div><h3>Results</h3><div>We interviewed 18 participants from LMICs (Colombia, India, Iran, Indonesia, Argentina, and Malaysia) and WHO offices (including headquarters, regional offices, and country offices). Two main themes emerged, along with six associated subthemes. The main themes were as follows: (1) People in LMICs want living guidelines and (2) Resource limitations and their implications for living guidelines in LMICs.</div></div><div><h3>Conclusion</h3><div>Our research identified that guideline developers in LMICs have a strong desire to both develop and use living guidelines, but are currently limited by important barriers. Initiatives to support development, adaptation, and use of living guidelines in LMICs may help overcome barriers and meet the need for living guidelines in LMICs. It is also essential to design strategies that overcome identified barriers to developing, adapting, and implementing living guidelines, such as a lack of resources, delays in updates, and limited accessibility.</div></div><div><h3>Plain Language Summary</h3><div>This study looked at how living (continuously updated) approaches can be used to develop, adapt, and use clinical guidelines in settings with limited resources, and explored the pros and cons of each. The findings revealed a strong need to develop and use living guidelines in low-resource settings despite challenges, such as resource scarcity, delays in updating, and limited access to these guidelines. Overall, the findings revealed that living guidelines were worthwhile in LMICs despite all of the related challenges.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"180 ","pages":"Article 111707"},"PeriodicalIF":7.3,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076368","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}

{"title":"Massive covidization and subsequent decovidization of the scientific literature involved 2 million authors","authors":"John P.A. Ioannidis ,&nbsp;Thomas A. Collins ,&nbsp;Eran Bendavid ,&nbsp;Jeroen Baas","doi":"10.1016/j.jclinepi.2025.111705","DOIUrl":"10.1016/j.jclinepi.2025.111705","url":null,"abstract":"<div><h3>Objectives</h3><div>We aimed to examine the growth trajectory and impact of COVID-19-related papers in the scientific literature and how the scientific workforce engaged in this work.</div></div><div><h3>Study Design and Setting</h3><div>We used Scopus data to August 1, 2024, and a search string for COVID-19-related publications. Authors of COVID-19 work were mapped against databases of top-cited authors.</div></div><div><h3>Results</h3><div>Scopus indexed 718,660 COVID-19-related publications. As the proportion of all indexed scientific publications, COVID-19-related publications peaked in September 2021 (4.7%) remained at 4.3%–4.6% for another year and then gradually declined but was still 1.9% in July 2024. COVID-19-related publications included 1,978,612 unique authors: 1,127,215 authors had ≥5 full papers in their career and 53,418 authors were in the top 2% of their scientific subfield. Authors with &gt;10%, &gt;30%, and &gt;50% of their total career citations attributed to COVID-19-related publications were 376,942, 201,702, and 125,523, respectively. As of August 1, 2024, 65 of the top 100 most cited papers published in 2020 were COVID-19-related, declining to 24/100, 19/100, 7/100, and 5/100 for the most cited papers published in 2021, 2022, 2023, and 2024, respectively. Across 174 scientific subfields, 132 had ≥10% of their active influential (top 2% by composite citation indicator) authors publish something on COVID-19 during 2020–2024. Among the 300 authors with highest composite citation indicator specifically for their COVID-19-related publications, 41 were editors or journalists or columnists.</div></div><div><h3>Conclusion</h3><div>COVID-19 massively engaged the scientific workforce in unprecedented ways. As the pandemic ended, there has been a sharp decline in the overall volume and high impact of newly published COVID-19-related publications.</div></div><div><h3>Plain Language Summary</h3><div>We evaluated Scopus, a bibliometric database, for the increase and waning of the COVID-19 scientific literature. Until August 1, 2024, we identified 718,660 COVID-19-related publications indexed in Scopus that had involved 1,978,612 unique authors. The rise and subsequent decline pattern of COVID-19 publications was similar to other previous epidemics like Zika, Ebola, and H1N1, but at a far larger, unprecedented scale. 125,523 authors had &gt;50% of their total career citations attributed to COVID-19 papers. 132/174 scientific subfields had at least one of every 10 of their top-cited authors publish something on COVID-19 during 2020–2024. Many influential authors were editors or journalists or columnists. Overall, COVID-19 massively engaged a huge number of authors and created a vast literature. As the interest has now sharply declined, one needs to examine what this immense COVID-19 scientific workforce will do in the future.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"180 ","pages":"Article 111705"},"PeriodicalIF":7.3,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076370","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}

{"title":"Characteristics of search methods in dental metaresearch studies: a methodological study","authors":"Leonie Weeber ,&nbsp;Naichuan Su ,&nbsp;Clovis Mariano Faggion Jr.","doi":"10.1016/j.jclinepi.2025.111693","DOIUrl":"10.1016/j.jclinepi.2025.111693","url":null,"abstract":"<div><h3>Background and Objective</h3><div>Metaresearch studies, defined as, “research on research,” should transparently report search methods used to identify the assessed research. Currently, there is no published evaluation of search methods reporting in metaresearch studies. The aim of this study was to assess the characteristics of search methods in dental meta-research studies and to identify factors associated with the completeness of the reported search strategies.</div></div><div><h3>Methods</h3><div>With a focus on the assessment of reporting quality and methodological quality, we searched in the Web of Science (WoS) Core Collection database for dental metaresearch studies published from the database's inception to February 13, 2024. The extracted data included the examined metaresearch studies, characteristics of their authors and journals, and search methods reporting of the examined studies. Logistic regression models were applied to examine the associations between relevant variables and search strategy reporting completeness.</div></div><div><h3>Results</h3><div>The search generated 3774 documents, and 224 meta-research studies were included in the final analysis. Nearly all studies (99.6%) disclosed their general search methods, but only 130 studies (58%) provided both keywords and Boolean operators. Regression analyses indicated that metaresearch studies published more recently, with prospective registration, with a shorter time between the searches and publication, a lack of language restrictions, and librarian involvement were more likely to report a more complete search strategy.</div></div><div><h3>Conclusion</h3><div>The results highlight the importance of unrestricted language searches, structured methodologies, and librarian support in improving the quality and transparency of reporting search strategies in dental metaresearch.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"181 ","pages":"Article 111693"},"PeriodicalIF":7.3,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076365","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}

{"title":"Supplementary databases increased literature search coverage beyond PubMed and Embase","authors":"Tove Faber Frandsen ,&nbsp;Caroline Moos ,&nbsp;Cecilia Isabella Linnemann Herrera Marino ,&nbsp;Mette Brandt Eriksen","doi":"10.1016/j.jclinepi.2025.111704","DOIUrl":"10.1016/j.jclinepi.2025.111704","url":null,"abstract":"<div><h3>Objectives</h3><div>In health sciences, comprehensive literature searches are crucial for ensuring the accuracy and completeness of systematic reviews. Relying on only a few databases can lead to the omission of relevant studies. The variability in database coverage for different specialties means that important literature might be missed if searches are not broadened. Supplementary databases can enhance the thoroughness of literature reviews, but the efficiency and necessity of these additional searches remain subject to debate. This study aims to explore methods for retrieving publications not indexed in PubMed and Embase, examining coverage of various specialties to determine the most effective search strategies for systematic reviews.</div></div><div><h3>Methods</h3><div>We selected reviews from the following Cochrane review groups: public health, incontinence, hepato-biliary, and stroke groups. All reviews published in these groups between 2017 and 2022 were analyzed. Publications included in these reviews were manually searched for in PubMed and Embase. If the publication was not found, additional databases such as Cochrane Library, PsycInfo, CINAHL, and ClinicalTrials.gov were searched. Descriptive statistics were used to analyze the data.</div></div><div><h3>Results</h3><div>The mean coverage of publications in PubMed and Embase across all four speciality groups was 71.5%, with individual group coverage ranging from 64.5% to 75.9%. An average of 5.8% of publications could not be retrieved in any of the databases studied. Additional databases varied in their coverage.</div></div><div><h3>Conclusion</h3><div>While PubMed and Embase provide substantial coverage, supplementary databases can increase retrieval of more relevant studies and are essential for a comprehensive literature search.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"181 ","pages":"Article 111704"},"PeriodicalIF":7.3,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076373","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}

{"title":"Meta-analysis of individual participant data and informed consent: a small step, but important and neglected","authors":"Rafael Dal-Ré ,&nbsp;Lars G. Hemkens","doi":"10.1016/j.jclinepi.2025.111692","DOIUrl":"10.1016/j.jclinepi.2025.111692","url":null,"abstract":"","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"180 ","pages":"Article 111692"},"PeriodicalIF":7.3,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143068847","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}

{"title":"Visualizing the value of diagnostic tests and prediction models, part II. Net benefit graphs: net benefit as a function of the exchange rate.","authors":"Michael A Kohn, Thomas B Newman","doi":"10.1016/j.jclinepi.2025.111690","DOIUrl":"10.1016/j.jclinepi.2025.111690","url":null,"abstract":"<p><strong>Background and objective: </strong>In this second of a 3-part series, we move from expected gain in utility (EGU) graphs to net benefit (NB) graphs, which show how NB depends on w= C/B, the treatment threshold odds, equal to the harm of treating unnecessarily (C) divided by the benefit of treating appropriately (B).</p><p><strong>Method: </strong>For NB graphs, we shift from the perspective of testing individual patients with varying pretest probabilities of disease to the perspective of applying a test or risk model to an entire population with a given prevalence of disease, P₀. As with EGU graphs, we subtract the harm of testing and the expected harm of treating according to the results of a test or model when it is wrong from the expected benefit of treating when it is right. The difference is that for NB graphs, the prevalence is fixed at P₀ , and the x-axis is w. NB graphs show the NB of 3 strategies: 1) \"Treat None\"; 2) \"Test\" and treat those with predicted risk greater than the treatment threshold; and 3) \"Treat All\" in the population regardless of predicted risk.</p><p><strong>Results: </strong>The \"Treat All\" line intersects the y-axis at NB = P₀ and the x-axis at w = P₀/(1 - P₀). The \"Test\" line intersects the \"Treat All\" line at the Treat-Test threshold value of w; it intersects the x-axis at the Test-No Treat value of w.</p><p><strong>Conclusion: </strong>When NB is plotted as a function of w, NB graphs can be drawn as straight lines from easily calculated intercepts.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"111690"},"PeriodicalIF":7.3,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048559","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}

{"title":"Visualizing the value of diagnostic tests and prediction models, part III. Numerical example with discrete risk groups and miscalibration.","authors":"Michael A Kohn, Thomas B Newman","doi":"10.1016/j.jclinepi.2025.111691","DOIUrl":"10.1016/j.jclinepi.2025.111691","url":null,"abstract":"<p><strong>Background and objectives: </strong>In this third of a 3-part series, we use net benefit (NB) graphs to evaluate a risk model that divides D-dimer results into 8 intervals to estimate the probability of pulmonary embolism (PE). This demonstrates the effect of miscalibration on NB graphs.</p><p><strong>Method: </strong>We evaluate the risk model's performance using pooled data on 6013 participants from 5 PE diagnostic management studies. For a range of values of the \"exchange rate\" (w, the treatment threshold odds), we obtained NB of applying the risk model by subtracting the number of unnecessary treatments weighted by the exchange rate from the number of appropriate treatments and then dividing by the population size.</p><p><strong>Results: </strong>In NB graphs, in which the x-axis is scaled linearly with the exchange rate w, miscalibration causes vertical changes in NB. If the risk model overestimates risk, as in this example, the NB graph for the risk model has vertical jumps up. These are due to the sudden gain in NB resulting from less overtreatment when the treatment threshold first exceeds the overestimated predicted risks.</p><p><strong>Conclusion: </strong>Calculating NB is a logical approach to quantifying the value of a diagnostic test or risk prediction model. In the same dataset at the same treatment threshold probability, the risk model with the higher net benefit is the better model in that dataset. Most net benefit calculations omit the harm of doing the test or applying the risk model, but if it is nontrivial, this harm can be subtracted from the net benefit.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"111691"},"PeriodicalIF":7.3,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048563","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}