Journal of Clinical Epidemiology最新文献

{"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}

{"title":"To adjust, or not to adjust, for multiple comparisons","authors":"Richard Hooper","doi":"10.1016/j.jclinepi.2025.111688","DOIUrl":"10.1016/j.jclinepi.2025.111688","url":null,"abstract":"<div><div>Questions often arise concerning when, whether, and how we should adjust our interpretation of the results from multiple hypothesis tests. Strong arguments have been put forward in the epidemiological literature against any correction or adjustment for multiplicity, but regulatory requirements (particularly for pharmaceutical trials) can sometimes trump other concerns. The formal basis for adjustment is often the control of error rates, and hence the problems of multiplicity may seem rooted in a purely frequentist paradigm, though this can be a restrictive viewpoint. Commentators may never wholly agree on any of these things. This article draws some of the key threads from the discussion and suggests further reading.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"180 ","pages":"Article 111688"},"PeriodicalIF":7.3,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048492","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":"Pain and physical function are common core domains across 40 core outcome sets of musculoskeletal conditions: a systematic review","authors":"Tamer S. Sabet ,&nbsp;David B. Anderson ,&nbsp;Peter W. Stubbs ,&nbsp;Rachelle Buchbinder ,&nbsp;Caroline B. Terwee ,&nbsp;Alessandro Chiarotto ,&nbsp;Joel Gagnier ,&nbsp;Arianne P. Verhagen","doi":"10.1016/j.jclinepi.2025.111687","DOIUrl":"10.1016/j.jclinepi.2025.111687","url":null,"abstract":"<div><h3>Objectives</h3><div>To determine common domains across existing musculoskeletal core outcome sets (COSs). Secondary aims were to assess the development quality of existing musculoskeletal COSs and whether development quality and patient participation was associated with domain selection.</div></div><div><h3>Study Design and Setting</h3><div>A systematic review of musculoskeletal COSs. We searched six databases from inception until December 2023. Studies were included if they reported on the development of a COS in adults with musculoskeletal conditions for any type of intervention. Quality was assessed using the Core Outcome Set-Standards for Development recommendations (COS-STAD). Data extracted included scope of the COS, health condition, interventions, and outcome domains. We defined a common core domain when present in &gt;66% of all COSs. Analyses were performed using descriptive statistics.</div></div><div><h3>Results</h3><div>We included 51 studies reporting on 40 COSs, 25 were developed for research settings only, five for clinical settings only, and 10 for both. We identified 310 domains consisting of 255 mandatory or compulsory or not specified, 45 important, and 10 for further research. Pain (90%) and physical function (88%) were common core domains. COS development quality varied (range: 4–11 recommendations met); six COS met all standards. Domain definitions were provided in 13 COSs, 27 included patients or representatives in their development process, while nine met all recommendations for the consensus process. COSs involving patients were of higher quality (median: nine vs five for those not involving patients).</div></div><div><h3>Conclusion</h3><div>Pain and physical function core domains should be considered for inclusion in all new musculoskeletal COSs. Developers should follow COS development recommendations and include patients or their representatives.</div></div>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":"180 ","pages":"Article 111687"},"PeriodicalIF":7.3,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048460","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":"Visualizing the value of diagnostic tests and prediction models, part I: introduction and expected gain in utility as a function of pretest probability.","authors":"Michael A Kohn, Thomas B Newman","doi":"10.1016/j.jclinepi.2025.111689","DOIUrl":"10.1016/j.jclinepi.2025.111689","url":null,"abstract":"<p><strong>Background: </strong>In this first of a 3-part series, we review expected gain in utility (EGU) calculations and graphs; in later parts, we contrast them with net benefit calculations and graphs. Our example is plasma D-dimer as a test for pulmonary embolism.</p><p><strong>Methods: </strong>We approach EGU calculations from the perspective of a clinician evaluating a patient. The clinician is considering 1) not testing and not treating, 2) testing and treating according to the test result; or 3) treating without testing. We use simple algebra and graphs to show how EGU depends on pretest probability and the benefit of treating someone with disease (B) relative to the harms of treating someone without the disease (C) and the harm of the testing the procedure itself (T).</p><p><strong>Results: </strong>The treatment threshold probability, i.e., the probability of disease at which the expected benefit of treating those with disease is balanced by the harm of treating those without disease (EGU = 0) is C/(C + B). When a diagnostic test is available, the course of action with the highest EGU depends on C, B, T, the pretest probability of disease, and the test result. For a given C, B, and T, the lower the pretest probability, the more abnormal the test result must be to justify treatment.</p><p><strong>Conclusion: </strong>EGU calculations and graphs allow visualization of how the value of testing can be calculated from the prior probability of the disease, the benefit of treating those with disease, the harm of treating those without disease, and the harm of testing itself.</p>","PeriodicalId":51079,"journal":{"name":"Journal of Clinical Epidemiology","volume":" ","pages":"111689"},"PeriodicalIF":7.3,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048556","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}