Scott R Evans, Gene Pennello, Shanshan Zhang, Yixuan Li, Yike Wang, Qian Cao, Lauren Komarow, Toshimitsu Hamasaki, Victoria Petrides, Kristen Meier, Norberto Pantoja Galicia, Vance G Fowler, Helen W Boucher, Sarah B Doernberg, Ritu Banerjee, Maria Helena Rigatto, Barry N Kreiswirth, Robert A Bonomo, Henry F Chambers, Robin Patel
{"title":"Intention-to-diagnose and distinct research foci in diagnostic accuracy studies","authors":"Scott R Evans, Gene Pennello, Shanshan Zhang, Yixuan Li, Yike Wang, Qian Cao, Lauren Komarow, Toshimitsu Hamasaki, Victoria Petrides, Kristen Meier, Norberto Pantoja Galicia, Vance G Fowler, Helen W Boucher, Sarah B Doernberg, Ritu Banerjee, Maria Helena Rigatto, Barry N Kreiswirth, Robert A Bonomo, Henry F Chambers, Robin Patel","doi":"10.1016/s1473-3099(25)00070-2","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00070-2","url":null,"abstract":"The intention-to-diagnose principle, an analogue to the intention-to-treat principle in clinical trials, protects the foundation for inference in diagnostic test accuracy studies. This foundation provides for robust control of error rates during hypothesis testing and correct coverage probability during confidence interval estimation of accuracy parameters, in well defined populations for transparent generalisability. The intention-to-diagnose principle requires distinguishing between various non-positive non-negative (NPNN) test results, such as equivocal and invalid results, and appropriate handling of these distinct results during statistical analyses. Pragmatic application accuracy, pragmatic scientific accuracy, and explanatory scientific accuracy are three major research foci in studies of diagnostic test accuracy. Selection of appropriate analysis sets and appropriate handling of NPNN results depend on the specific focus. Selection has important implications regarding preservation of the foundation for statistical inference, generalisability, and comparability with results from other studies. We recommended analyses for diagnostic accuracy studies that include the estimation of accuracy parameters associated with each research foci. A free online tool is available to estimate these accuracy parameters. As with dedicated commitment to the intention-to-treat principle in clinical trials, commitment to application of the intention-to-diagnose principle will lead to studies with high integrity, a comprehensive understanding of the scientific and administration characteristics of the diagnostic test, clarity of interpretation and generalisability, and better clinical decision making.","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"23 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143723710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Deaths of unknown cause in DR Congo","authors":"Talha Burki","doi":"10.1016/s1473-3099(25)00172-0","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00172-0","url":null,"abstract":"No Abstract","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"35 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143713481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Research in brief","authors":"Priya Venkatesan","doi":"10.1016/s1473-3099(25)00170-7","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00170-7","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Neutralising antibodies for hepatitis E infection</h2>No specific antiviral therapies currently exist for hepatitis E virus (HEV) infection. Using flow cytometry and X-ray crystallography, <span><span>researchers</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> isolated and characterised the antibodies produced in convalescent patients 1 year after clearing acute HEV infection. They noted glycan-sensitive broadly neutralising antibodies that interacted with the non-glycosylated form of the viral capsid protein pORF2. The antibodies neutralised primary isolates derived from 14 patients and were</section></section><section><section><h2>Zika virus vertical transmission</h2>The mechanisms underlying Zika virus’ propensity for vertical transmission are incompletely understood. A <span><span>study</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> using cultured human trophoblast cell lines and mass spectrometry suggested that one mechanism might be through the formation of tunnelling nanotubes in placental trophoblasts in response to Zika virus infection, driven by the N-terminal 1-50 amino acids of Zika virus non-structural protein 1 (NS1). The tunnelling nanotubes served as conduits for transmitting the virus between</section></section><section><section><h2>Male partner treatment for bacterial vaginosis</h2>An open-label randomised <span><span>trial</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> in Australia enrolled 164 adult male–female monogamous couples in which the woman had diagnosed symptomatic bacterial vaginosis. In 81 couples, both partners received treatment (the woman given first-line antimicrobial agents, and the man given oral metronidazole 400 mg tablets and 2% topical clindamycin cream applied to penile skin, both twice daily for 7 days). In 83 couples, only the woman received antimicrobial treatment (standard care). During the 12-week</section></section><section><section><h2>Invasive fungal infection in preterm neonates</h2>A randomised <span><span>trial</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> in Egypt assessed the efficacy of micafungin versus amphotericin B deoxycholate for treating invasive fungal infections in neonates aged less than 36 weeks’ gestation in a newborn intensive care unit. 56 neonates with signs of invasive fungal infect","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"26 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143713484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Infectious disease surveillance update","authors":"Cahal McQuillan","doi":"10.1016/s1473-3099(25)00175-6","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00175-6","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Legionnaires’ disease in Austria</h2>On Feb 12, 2025, public health authorities reported an <span><span>outbreak</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> of Legionnaires’ disease in the state of Vorarlberg in western Austria. As of March 7, a total of 47 cases have been identified. District authorities suspect that a cooling tower in the Lower Rhine Valley may be the source of the infections and have shut it down for renovations; however, district officials have not ruled out other sources of infection and are continuing to investigate. There have been no new cases since March 4.</section></section><section><section><h2><em>Listeria</em> in the USA</h2>As of Feb 21, 2025, 38 people have been infected with a <span><span>specific outbreak strain</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> of <em>Listeria monocytogenes</em> in 21 states in the USA. The first and most recent cases were identified on Aug 17, 2018, and Jan 23, 2025, respectively. Of the 38 individuals with data available, 37 were hospitalised and 12 died. All infections occurred in residents of long-term care facilities and nursing homes. After investigations into the outbreak in 2018, 2021, and 2023 by the US Centers for Disease Control and</section></section><section><section><h2>Pertussis in Colombia</h2>In a recent statement, the Colombian Ministry of Health announced that on Feb 27, 2025, a 1-month-old infant died from <span><span>pertussis</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> in Bogotà. This news comes as cases of the illness are on the rise across the country. According to officials, 22 probable cases and three confirmed cases of pertussis were reported in children younger than 5 years between Jan 1 and Feb 21, 2025, in Bogotà alone. In response, public health officials are making urgent calls to promote vaccine uptake, particularly in</section></section><section><section><h2>HIV in India</h2>In February 2025, newly published <span><span>data</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> revealed that Mizoram, a state in the north-east of India, has the highest prevalence of HIV in the country. Figures show that Mizoram has an HIV prevalence of 2·73%, compared with a national average of 0·2%. According to a public health official, between April 1, 2024, and Jan 31, ","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"48 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143713483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Georgia R Layton, James B Veater, Rebecca Thombre, Baharak Afshar, Michael L Beeton, Sapna Ladani, Zein El-Dean, Iain Stephenson, Mustafa Zakkar
{"title":"Disseminated Mycoplasma pneumoniae infection presenting with polyarthritis and endocarditis","authors":"Georgia R Layton, James B Veater, Rebecca Thombre, Baharak Afshar, Michael L Beeton, Sapna Ladani, Zein El-Dean, Iain Stephenson, Mustafa Zakkar","doi":"10.1016/s1473-3099(25)00059-3","DOIUrl":"https://doi.org/10.1016/s1473-3099(25)00059-3","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Contributors</h2>GRL: conceptualisation, data curation, project administration, validation, and writing (original draft, review, and editing). JBV: conceptualisation, data curation, validation, and writing (original draft, review, and editing). RT: data curation and writing (review and editing). MLB: data curation and writing (review and editing). BA: data curation and writing (review and editing). SL: data curation and writing (review and editing). ZE-D: data curation and writing (review and editing). IS:</section></section><section><section><h2>Declaration of interests</h2>We declare no competing interests.</section></section>","PeriodicalId":49923,"journal":{"name":"Lancet Infectious Diseases","volume":"10 1","pages":""},"PeriodicalIF":56.3,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143713536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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