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Cardiovascular risk and mortality in men receiving testosterone replacement therapy for Klinefelter syndrome in Denmark: a retrospective cohort study
IF 13.6
Lancet Regional Health-Europe Pub Date : 2025-02-01 DOI: 10.1016/j.lanepe.2025.101230
Simon Chang , Lars Pedersen , Anne Skakkebæk , Agnethe Berglund , Claus H. Gravholt
{"title":"Cardiovascular risk and mortality in men receiving testosterone replacement therapy for Klinefelter syndrome in Denmark: a retrospective cohort study","authors":"Simon Chang ,&nbsp;Lars Pedersen ,&nbsp;Anne Skakkebæk ,&nbsp;Agnethe Berglund ,&nbsp;Claus H. Gravholt","doi":"10.1016/j.lanepe.2025.101230","DOIUrl":"10.1016/j.lanepe.2025.101230","url":null,"abstract":"<div><h3>Background</h3><div>Men with Klinefelter syndrome (KS) have hypogonadism, increased morbidity, and excess mortality. Testosterone replacement therapy (TRT) has the potential to alleviate this burden. We assessed the risk of major cardiovascular events (MACE) and mortality in KS according to TRT exposure.</div></div><div><h3>Methods</h3><div>We performed a nationwide registry based matched cohort study. We compared incidences of MACE and mortality between TRT exposed (KS-TRT) or unexposed KS (KS-non-TRT), and a male background population comparison cohort. The study period was from 1 January 1994 to 31 December 2022.</div></div><div><h3>Findings</h3><div>We identified 557 KS-TRT, and matched these with unexposed men with KS born the same year (total KS n = 950). We similarly identified a comparison cohort of 50,150 men from the background population matched on month and year of birth. Median age at entry for KS-TRT was 31.1 years (interquartile range; 19.9–40.0) and median follow-up time was 12.9 years (interquartile range; 7.5–20.7). KS-TRT was associated with lower all-cause mortality (adjusted hazard ratio (95% CI); 0.56 (0.37–0.85)), with mortality in KS-TRT comparable to the comparison cohort (hazard ratio (95% CI); 1.27 (0.91–1.79)). Incidence of MACE was comparable between KS-TRT and KS-non-TRT.</div></div><div><h3>Interpretation</h3><div>TRT could alleviate excess mortality in KS and appears safe regarding cardiovascular risk. Today, most men with KS go undiagnosed, missing proper medical attention. There is a dire need for a policy change to ensure timely diagnosis and treatment in all men with KS.</div></div><div><h3>Funding</h3><div>The <span>A.P. Moller Foundation</span>, Fonden af 17-12-1981, <span>Danish Diabetes and Endocrine Academy</span>, <span>Novo Nordisk Foundation</span>, the <span>Independent Research Fund Denmark</span>, <span>Sygesikringen danmark</span>.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"51 ","pages":"Article 101230"},"PeriodicalIF":13.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143181516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Eligibility criteria for lung cancer screening in France: a modelling study
IF 13.6
Lancet Regional Health-Europe Pub Date : 2025-01-31 DOI: 10.1016/j.lanepe.2025.101221
Xiaoshuang Feng , Karine Alcala , Florence Guida , Marcel Goldberg , Marie Zins , Olivier Leleu , Pianpian Cao , Jihyoun Jeon , Sébastien Couraud , Mattias Johansson , Hilary A. Robbins
{"title":"Eligibility criteria for lung cancer screening in France: a modelling study","authors":"Xiaoshuang Feng ,&nbsp;Karine Alcala ,&nbsp;Florence Guida ,&nbsp;Marcel Goldberg ,&nbsp;Marie Zins ,&nbsp;Olivier Leleu ,&nbsp;Pianpian Cao ,&nbsp;Jihyoun Jeon ,&nbsp;Sébastien Couraud ,&nbsp;Mattias Johansson ,&nbsp;Hilary A. Robbins","doi":"10.1016/j.lanepe.2025.101221","DOIUrl":"10.1016/j.lanepe.2025.101221","url":null,"abstract":"<div><h3>Background</h3><div>We estimated the potential impact of different eligibility criteria for lung cancer screening in France, to inform a planned national pilot program.</div></div><div><h3>Methods</h3><div>We simulated the French population by integrating national population estimates and smoking prevalence with lung cancer risk factors from the CONSTANCES cohort. We predicted lung cancer cases and deaths using the Lung Cancer [Death] Risk Assessment Tool for individuals with a smoking history. We evaluated four screening eligibility strategies: the US Preventive Services Task Force criteria (USPSTF) 2013, USPSTF-2021, NELSON, and a risk-based strategy (PLCOm2012 model).</div></div><div><h3>Findings</h3><div>We simulated 14,860,000 individuals with a smoking history aged 50–80 years in France. We estimated 11,000–14,000 preventable lung cancer deaths over 5 years by screening 2.4–4.0 million individuals, depending on eligibility criteria. When screening the same number of individuals, we estimated the risk-based strategy would identify an additional 12–22% preventable lung cancer deaths compared with categorical criteria. Individuals selected by risk-based criteria were typically 5–7 years older, with 4–6 years shorter life expectancy, but categorical criteria selected many individuals with low anticipated screening benefit (33% among USPSTF-2021-eligible). Restricting to individuals aged 50–74, 55–80, and 55–74 years gave smaller differences between categorical and risk-based criteria in age (2–6 years difference), life expectancy (2–5 years difference), and preventable lung cancer deaths (6–17% difference).</div></div><div><h3>Interpretation</h3><div>Screening high-risk individuals for lung cancer might prevent over 10,000 lung cancer deaths in France over 5 years, with potentially higher efficiency for risk-based eligibility compared with categorical criteria.</div></div><div><h3>Funding</h3><div><span>l’Institut National du Cancer</span>.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"51 ","pages":"Article 101221"},"PeriodicalIF":13.6,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143181517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
One brain, one mind, one health, one planet—a call from Switzerland for a systemic approach in brain health research, policy and practice
IF 13.6
Lancet Regional Health-Europe Pub Date : 2025-01-31 DOI: 10.1016/j.lanepe.2025.101229
Indrit Bègue , Antoine Flahault , Isabelle Bolon , Rafael Ruiz de Castañeda , Ana Maria Vicedo-Cabrera , Claudio L.A. Bassetti
{"title":"One brain, one mind, one health, one planet—a call from Switzerland for a systemic approach in brain health research, policy and practice","authors":"Indrit Bègue ,&nbsp;Antoine Flahault ,&nbsp;Isabelle Bolon ,&nbsp;Rafael Ruiz de Castañeda ,&nbsp;Ana Maria Vicedo-Cabrera ,&nbsp;Claudio L.A. Bassetti","doi":"10.1016/j.lanepe.2025.101229","DOIUrl":"10.1016/j.lanepe.2025.101229","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"50 ","pages":"Article 101229"},"PeriodicalIF":13.6,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143143869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
2024 update of the AGIHO guideline on diagnosis and empirical treatment of fever of unknown origin (FUO) in adult neutropenic patients with solid tumours and hematological malignancies
IF 13.6
Lancet Regional Health-Europe Pub Date : 2025-01-31 DOI: 10.1016/j.lanepe.2025.101214
Michael Sandherr , Jannik Stemler , Enrico Schalk , Tessa Hattenhauer , Marcus Hentrich , Bernd Hertenstein , Christian Hohmann , Sibylle C. Mellinghoff , Rebekka Mispelbaum , Christina Rieger , Martin Schmidt-Hieber , Rosanne Sprute , Guenter Weiss , Oliver A. Cornely , Larissa Henze , Cornelia Lass-Floerl , Gernot Beutel , Annika Y. Classen , Noemi F. Freise , Meinolf Karthaus , Elena Busch
{"title":"2024 update of the AGIHO guideline on diagnosis and empirical treatment of fever of unknown origin (FUO) in adult neutropenic patients with solid tumours and hematological malignancies","authors":"Michael Sandherr ,&nbsp;Jannik Stemler ,&nbsp;Enrico Schalk ,&nbsp;Tessa Hattenhauer ,&nbsp;Marcus Hentrich ,&nbsp;Bernd Hertenstein ,&nbsp;Christian Hohmann ,&nbsp;Sibylle C. Mellinghoff ,&nbsp;Rebekka Mispelbaum ,&nbsp;Christina Rieger ,&nbsp;Martin Schmidt-Hieber ,&nbsp;Rosanne Sprute ,&nbsp;Guenter Weiss ,&nbsp;Oliver A. Cornely ,&nbsp;Larissa Henze ,&nbsp;Cornelia Lass-Floerl ,&nbsp;Gernot Beutel ,&nbsp;Annika Y. Classen ,&nbsp;Noemi F. Freise ,&nbsp;Meinolf Karthaus ,&nbsp;Elena Busch","doi":"10.1016/j.lanepe.2025.101214","DOIUrl":"10.1016/j.lanepe.2025.101214","url":null,"abstract":"<div><div>Febrile Neutropenia is an emergency in the treatment of cancer patients. It requires prompt and evidence-based clinical and antimicrobial management. The implementation of standard operating procedures (SOP) across hospitals and outpatient cancer departments can improve the outcome of FN patients by reducing FN-related morbidity and mortality and by the continuation of cancer treatment. This guideline describes an evidence-based approach to risk stratification, epidemiology, diagnosis, and treatment. It is provided by the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO) and is an update of the 2017 version. Emerging aspects in epidemiology, diagnostic procedures, risk stratification, first-line antimicrobial treatment, empiric antifungal treatment and the duration of antimicrobial treatment are discussed and rated on evidence-based strength of recommendation and quality of evidence as described by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). By this, the aim of this guideline is to provide evidence-based recommendations on the management of febrile neutropenia in cancer patients for the practicing clinician.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"51 ","pages":"Article 101214"},"PeriodicalIF":13.6,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143181533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Neonatal professorships in Europe: insufficient to protect the tiniest and frailest
IF 13.6
Lancet Regional Health-Europe Pub Date : 2025-01-31 DOI: 10.1016/j.lanepe.2025.101224
Manuel Sanchez-Luna , Francesco Raimondi , Daniele De Luca
{"title":"Neonatal professorships in Europe: insufficient to protect the tiniest and frailest","authors":"Manuel Sanchez-Luna ,&nbsp;Francesco Raimondi ,&nbsp;Daniele De Luca","doi":"10.1016/j.lanepe.2025.101224","DOIUrl":"10.1016/j.lanepe.2025.101224","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"50 ","pages":"Article 101224"},"PeriodicalIF":13.6,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143139792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Burden of bacterial antimicrobial resistance among hospitalised patients in Spain: findings from three nationwide prospective studies 西班牙住院病人的细菌抗菌药耐药性负担:三项全国性前瞻性研究的结果
IF 13.6
Lancet Regional Health-Europe Pub Date : 2025-01-30 DOI: 10.1016/j.lanepe.2025.101220
Germán Peñalva , Rafael Cantón , María Teresa Pérez-Rodríguez , Juan José González-López , Jesús Rodríguez-Baño , Ester del Barrio-Tofiño , Cristina Kirkegaard-Biosca , Isabel Sánchez-Romero , Andrea Gutiérrez-Villanueva , Teresa Marrodán-Ciordia , José Manuel Guerra-Laso , Cristóbal del Rosario-Quintana , Laura Suárez-Hormiga , Jordi Cámara , Mireia Puig-Asensio , Eva Heredero , María Antonia Sepúlveda , Juan Carlos Rodríguez-Díaz , Esperanza Merino , Emilia Cercenado , José Ramón Paño-Pardo
{"title":"Burden of bacterial antimicrobial resistance among hospitalised patients in Spain: findings from three nationwide prospective studies","authors":"Germán Peñalva ,&nbsp;Rafael Cantón ,&nbsp;María Teresa Pérez-Rodríguez ,&nbsp;Juan José González-López ,&nbsp;Jesús Rodríguez-Baño ,&nbsp;Ester del Barrio-Tofiño ,&nbsp;Cristina Kirkegaard-Biosca ,&nbsp;Isabel Sánchez-Romero ,&nbsp;Andrea Gutiérrez-Villanueva ,&nbsp;Teresa Marrodán-Ciordia ,&nbsp;José Manuel Guerra-Laso ,&nbsp;Cristóbal del Rosario-Quintana ,&nbsp;Laura Suárez-Hormiga ,&nbsp;Jordi Cámara ,&nbsp;Mireia Puig-Asensio ,&nbsp;Eva Heredero ,&nbsp;María Antonia Sepúlveda ,&nbsp;Juan Carlos Rodríguez-Díaz ,&nbsp;Esperanza Merino ,&nbsp;Emilia Cercenado ,&nbsp;José Ramón Paño-Pardo","doi":"10.1016/j.lanepe.2025.101220","DOIUrl":"10.1016/j.lanepe.2025.101220","url":null,"abstract":"<div><h3>Background</h3><div>Assessing the burden of antimicrobial resistance is essential to determine the magnitude of this problem and to set its priority. We aimed to estimate the burden of disease caused by multidrug-resistant microorganisms (MDRO) in hospitalised patients in Spain.</div></div><div><h3>Methods</h3><div>Three prospective nationwide studies were conducted in 2018, 2019 and 2023. All patients with a new diagnosis of infection with any of 10 selected MDROs plus <em>Clostridioides difficile</em> during the study period (one week in 2018 and 2019 and two weeks in 2023) were included. Patient demographic, and clinical outcomes were analysed, including incidence, crude all-cause 30-day mortality and years of life lost (YLL). These results were used to calculate weighted and seasonally adjusted annual estimates for the whole country.</div></div><div><h3>Findings</h3><div>In total, 82, 133 and 130 centres participated in the study in 2018, 2019 and 2023, respectively, recording a total of 907, 1392 and 2351 MDRO infections, representing a weighted incidence density of 3.54 (95% CI 2.92–4.17), 5.01 (3.95–6.07), and 4.41 (3.55–5.27) cases/1000 stays, respectively. A total of 161, 198 and 352 patients died with an MDRO infection, representing a weighted incidence density of 0.46 (0.16–0.76), 0.43 (0.17–0.69), and 0.62 (0.52–0.72) deaths/1000 stays, respectively. Based on these data, a nationwide occurrence of 155,294 MDRO infections (95% CI 127,928–182,569) with 20,065 deaths (6938–32,958) was estimated for 2018, 210,451 MDRO infections (165,963–254,975) with 17,982 deaths (7071–28,700) for 2019, and 173,653 MDRO infections (139,814–207258) with 24,582 deaths (20,461–28,796) for 2023.</div></div><div><h3>Interpretation</h3><div>The burden of disease caused by MDRO infections among hospitalised patients in Spain is very high and remains stable over the study period. National actions to combat bacterial resistance need to be intensified.</div></div><div><h3>Funding</h3><div>The management costs of this study were funded by the <span>Spanish Society of Infectious Diseases and Clinical Microbiology</span> (SEIMC). Researchers have participated voluntarily and none of the investigators received funding for conducting the study.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"51 ","pages":"Article 101220"},"PeriodicalIF":13.6,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143181518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Coeliac disease and chronic liver disease: a double-face issue
IF 13.6
Lancet Regional Health-Europe Pub Date : 2025-01-24 DOI: 10.1016/j.lanepe.2025.101216
Marco Vincenzo Lenti , Paola Ilaria Bianchi , Antonio Di Sabatino
{"title":"Coeliac disease and chronic liver disease: a double-face issue","authors":"Marco Vincenzo Lenti ,&nbsp;Paola Ilaria Bianchi ,&nbsp;Antonio Di Sabatino","doi":"10.1016/j.lanepe.2025.101216","DOIUrl":"10.1016/j.lanepe.2025.101216","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"50 ","pages":"Article 101216"},"PeriodicalIF":13.6,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143139743","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rapid diagnostics to improve antibiotic prescribing in children: one piece of a much larger jigsaw
IF 13.6
Lancet Regional Health-Europe Pub Date : 2025-01-21 DOI: 10.1016/j.lanepe.2025.101218
Ann Van den Bruel
{"title":"Rapid diagnostics to improve antibiotic prescribing in children: one piece of a much larger jigsaw","authors":"Ann Van den Bruel","doi":"10.1016/j.lanepe.2025.101218","DOIUrl":"10.1016/j.lanepe.2025.101218","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"51 ","pages":"Article 101218"},"PeriodicalIF":13.6,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143181513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Avoidable mortality does not allow valid conclusions on population health and health system quality in Western Europe
IF 13.6
Lancet Regional Health-Europe Pub Date : 2025-01-21 DOI: 10.1016/j.lanepe.2025.101210
Susanne Stolpe, Bernd Kowall
{"title":"Avoidable mortality does not allow valid conclusions on population health and health system quality in Western Europe","authors":"Susanne Stolpe,&nbsp;Bernd Kowall","doi":"10.1016/j.lanepe.2025.101210","DOIUrl":"10.1016/j.lanepe.2025.101210","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"50 ","pages":"Article 101210"},"PeriodicalIF":13.6,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trial
IF 13.6
Lancet Regional Health-Europe Pub Date : 2025-01-20 DOI: 10.1016/j.lanepe.2024.101205
Marietta Stadler , Natalie Zaremba , Amy Harrison , Jennie Brown , Divina Pillay , Jacqueline Allan , Rachael Tan , Salma Ayis , Emmanouela Konstantara , Janet Treasure , David Hopkins , Khalida Ismail
{"title":"Safety of a co-designed cognitive behavioural therapy intervention for people with type 1 diabetes and eating disorders (STEADY): a feasibility randomised controlled trial","authors":"Marietta Stadler ,&nbsp;Natalie Zaremba ,&nbsp;Amy Harrison ,&nbsp;Jennie Brown ,&nbsp;Divina Pillay ,&nbsp;Jacqueline Allan ,&nbsp;Rachael Tan ,&nbsp;Salma Ayis ,&nbsp;Emmanouela Konstantara ,&nbsp;Janet Treasure ,&nbsp;David Hopkins ,&nbsp;Khalida Ismail","doi":"10.1016/j.lanepe.2024.101205","DOIUrl":"10.1016/j.lanepe.2024.101205","url":null,"abstract":"<div><h3>Background</h3><div>Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY) is a complex intervention for people with type 1 diabetes and mild-to-moderate disordered eating (T1DE) integrating cognitive behavioural therapy (CBT) with diabetes education. Aim was to test feasibility of STEADY in a randomised controlled trial.</div></div><div><h3>Methods</h3><div>Feasibility parallel-group, randomised (blocks of four) controlled open-label trial (RCT) of STEADY against usual care (Control) at King's College London, UK. Participants were referred by clinicians or self-referred via social media advertisements. Forty adults with T1DE (Hba1c &lt; 15%, body mass index 15–35 kg/m<sup>2</sup>, age ≥ 18 years) were randomised. STEADY was delivered in 12 sessions by a CBT-trained Diabetes Specialist Nurse through video-conferencing and mobile app. Main outcome at 6 months post-randomisation was feasibility. Baseline mental health data (Structured Clinical Interview for DSM-5, SCID-5RV), and secondary biomedical outcomes (HbA1c; glucose time in range; TIR) and person-reported outcome measures (PROM: Diabetes Eating Problems Survey-Revised, DEPS-R; Eating Disorder Examination Questionnaire Short, EDE-QS; Type 1 Diabetes Distress Scale, T1DDS; Generalised Anxiety Disorder Assessment, GAD-7; Patient Health Questionnaire, PHQ-9; Impact of Diabetes Profile, DIDP) were collected. Analyses were conducted as intention-to-treat. <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT05140564</span><svg><path></path></svg></span>.</div></div><div><h3>Findings</h3><div>Of the 98 screened, 40 participants with T1DE were randomised (recruitment rate: 40.81%; 95% CI: 31.60%, 50.72%): 38 women, 1 man, 1 trans man (37 White, 1 White/Asian, 1 Black; 39 ± 11 years old, diabetes duration 22 ± 15 years, HbA1c 9.1 ± 2.6%). The drop-out rate was 3/20 = 15% (4.39%, 36.55%) in STEADY and 2/20 = 10% (1.57%, 31.32%) in Control. STEADY reported lower GAD-7 (5.75 ± 2.89 vs 10.18 ± 5.31, p = 0.0060) and higher DIDP (3.13 ± 0.63 vs 2.46 ± 0.87, p = 0.020) at follow-up compared with Control, indicating lower anxiety and higher diabetes-specific quality-of-life. Compared to baseline, STEADY improved in DEPS-R, EDE-QS, GAD-7, PHQ-9 and T1DDS.</div></div><div><h3>Interpretation</h3><div>The STEADY-feasibility RCT demonstrated proof-of-concept for feasibility and mental health improvements in T1DE without deteriorating glycaemic control. A full scale RCT of STEADY will test effectiveness and implementation.</div></div><div><h3>Funding</h3><div><span>National Institute for Health Research</span> (CS-2017-17-023).</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"50 ","pages":"Article 101205"},"PeriodicalIF":13.6,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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